1.
ClinicalTrials.gov; 16/11/2023; TrialID: NCT06137716
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06137716
ABSTRACT
Condition:
Robotic Exoskeleton;Post-acute Covid-19 Syndrome;Rehabilitation Outcome;Physical And Rehabilitation MedicineIntervention:
Device: Training with a Robotic Hand ExoskeletonPrimary outcome:
Barthel Index (BI);Functional Independence Measure (MIF);SF-36 Health Questionnaire;Range of motionCriteria:
Inclusion Criteria:
- Over 30 years old
- Patients infected with COVID-19 and has received care at the Centro Hospitalario
Benito Menni
- Patients with acute or limited functional or strength impairment in at least one of
the upper extremities
- Patients who would complete a rehabilitation program and a series of patient reported
outcome questionnaires and a follow up evaluation
- Patients who give inform written consent.
Exclusion Criteria:
- Presence of behavioral disorders
- Dementia (loss of memory of cognitive functions)
- Disorders of consciousness (confusional states and drowsiness)
- Uncontrolled or severely limiting delusions and hallucinations
- Infectious skin diseases
- Rrisk of epileptic seizures due to COVID itself or prior to it
- Severe visual impairments
- Severe spasticity with a Modified Ashworth Scale >2, joint stiffness in the wrist and
fingers
- Pain with a score >8 on the Visual Analog Scale (VAS) during mobilization of the
affected hand.
2.
ChiCTR; 2023-11-16; TrialID: ChiCTR2300077692
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077692
ABSTRACT
Condition:
Novel coronavirus infectionIntervention:
Step-up nutrition group:Step-up nutrition support;Hospital Dietary group:Hospital Dietary;Primary outcome:
Loss of 7-day skeletal muscle mass index;Criteria:
Inclusion criteria: ?Age = 70 years;?Edmonton debilitation scale score = 6;
?Medium and severe patients diagnosed with novel coronavirus infection;
?Patients who can eat autonomously by mouth.
Exclusion criteria: ? Metabolic disorders requiring a specific diet (e.g., phenylketonuria);
? History of gastrectomy or esophagectomy;
? Patients with end-stage tumors;
?Psychiatric disorders that may affect clinical study compliance, including dementia, active psychosis, anorexia nervosa, etc.
3.
ClinicalTrials.gov; 14/11/2023; TrialID: NCT06135610
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06135610
ABSTRACT
Condition:
Penetrating Injury;COVID-19;Social Determinants of HealthIntervention:
Diagnostic Test: Postive SAR-CoV-2 PCR nasopharyngeal swabPrimary outcome:
Penetrating injury rateCriteria:
Inclusion Criteria:
- emergency department presentation with a gunshot wound (GSW), stab wound, or assault
between March 2019 and February 2021.
Exclusion Criteria:
- All reported blunt injuries, motor vehicle incident-related injuries, suicide
attempts, or unintentional injuries were excluded.
4.
ClinicalTrials.gov; 14/11/2023; TrialID: NCT06136871
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06136871
ABSTRACT
Condition:
Post-COVID-19 SyndromeIntervention:
Behavioral: CO-OP Procedures;Behavioral: Inactive Control GroupPrimary outcome:
Feasibility measures;Telehealth Usability Questionnaire (TUQ);Acceptability of Intervention Measure (AIM);Intervention Appropriateness Measure (IAM);Feasibility of Intervention Measure (FIM);Canadian Occupational Performance Measure (COPM)Criteria:
Inclusion Criteria:
- self-reported cognitive symptoms persisting for at least 6 weeks following COVID-19
infection (Cognitive Failures Questionnaire (CFQ) score >43)
- self-identified activity performance goals per the Canadian Occupational Performance
Measure (COPM)
- documented prior diagnosis of COVID-19
- read, write, and speak English fluently
- ability to provide valid informed electronic consent
Exclusion Criteria:
- diagnosis of severe neurological or psychiatric condition(s)
- dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment
(MoCA)
- untreated sleep apnea (=5 on the STOPBANG)
- prior cancer treatment
- severe depressive symptoms (>21 on the Patient Health Questionnaire-9)
5.
ClinicalTrials.gov; 14/11/2023; TrialID: NCT06137651
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06137651
ABSTRACT
Condition:
Breast Carcinoma;Metastatic Malignant Neoplasm in the Brain;Metastatic Malignant Neoplasm in the LeptomeningesIntervention:
Procedure: Biospecimen Collection;Procedure: Computed Tomography;Procedure: Magnetic Resonance Imaging;Radiation: Radiation Therapy;Procedure: Resection;Drug: Trotabresib;Drug: VinorelbinePrimary outcome:
Dose limiting toxicities (Phase I);Incidence of adverse events (Phase Ib)Criteria:
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed diagnosis of HER2+ breast
cancer. Patients may be immunohistochemistry (IHC) 3+ and/or fluorescence in situ
hybridization (FISH) positive for HER2. IHC 2+ HER2 patients are eligible with reflex
FISH-positive testing with the ratio = 2.0. Alternatively, circulating tumor DNA
testing positive for HER2 mutation is accepted for eligibility
- Patients must have newly diagnosed or progressive brain and/or leptomeningeal
metastases, and a change in management and of treatment regimen is indicated. There is
no limit on the number and types of prior systemic or intrathecal therapies
- Subjects must have an estimated life expectancy = 3 months
- At registration, patients must have an interval of at least 2 weeks after the end of
prior cytotoxic chemotherapy or immunotherapy or previous RT, one week from prior
targeted small molecule drug treatment, interval of = 4 weeks from prior bevacizumab
or nitrosourea. At treatment start of trotabresib, there must be an interval of = 4
weeks since last cytotoxic chemotherapy (6 weeks for prior nitrosourea) or
immunotherapy
- Note: Anti-HER2 directed treatment is allowed to continue, however, should be
switched to trastuzumab before initiation of trotabresib. No washout period is
required
- Patients must be age = 18 years on the day of signing consent
- Patients must exhibit Cooperative Oncology Group (ECOG) performance status of = 2
- Leukocytes (WBC) = 3,000/mcL or absolute neutrophil count (ANC) = 1,500/mcL (within 14
days prior to registration)
- Hemoglobin (Hgb) = 10 g/dL (within 14 days prior to registration)
- Platelets (PLT) = 75,000/mcL (within 14 days prior to registration)
- Total bilirubin < 1.5 x upper limit of normal (ULN) (except patient with documented
Gilbert's syndrome, = 5 x ULN) (within 14 days prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 3 x institutional ULN (within 14 days prior to registration)
- Creatinine < 1.5x upper limit of normal (ULN) (within 14 days prior to registration)
- Patients must be able to swallow oral medication
- Patients must have recovered from the toxic effects of prior therapies (= Grade 1);
however, persistent alopecia, or other toxicities not constituting a safety risk or
being attributed to the tumor (e.g. neurological symptoms) based on investigator's
judgement are not an exclusion criterion)
- Patients who are currently participating in or have participated in a study of an
investigational agent or device must have discontinued the use of the investigational
drug or device = 4 weeks from registration on this study
- Note: COVID-19 vaccination is allowed prior to and during study treatment
- Patients with a ventriculoperitoneal or ventriculoatrial shunt must have an on/off
device in their shunt systems to be eligible for the study. Patients must be able to
tolerate shunt closure for approximately 4 hours without development of clinical signs
of increased intracranial pressure
- Patients must be able and willing to undergo research blood draws
- Patients must consent to retrieval of archival tissue or pretreatment tumor biopsy for
research purposes if extra tissue is available
- The effects of trotabresib on the developing human fetus are unknown. Vinorelbineis
known to be teratogenic causing birth defects and fetal loss in animals at
concentrations which are below the human therapeutic dose range. For this reason,
patients of child-bearing potential, patients with sperm-producing reproductive
capacity and partners with child-bearing potential of patients with sperm-producing
reproductive capacity much use contraception as specified below. Additionally,
pregnant patients and patients that are nursing can not participate in this study
because vinorelbine has the potential for teratogenic or abortifacient effects as
described above. Because there is an unknown but potential risk for adverse events in
nursing infants secondary to treatment of the mother with vinorelbine, breastfeeding
should be discontinued if the mother is treated with vinorelbine
- A patient of childbearing potential (POCBP) is a person who: 1) has achieved
menarche at some point, 2) has not undergone a hysterectomy or bilateral
oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following
cancer therapy or other medical condition does not rule out childbearing
potential) for at least 12 consecutive months and verified by an FSH blood test
at screening. FSH test should be >30 mIU/mL but FSH will be low if the subject is
taking hormone replacement therapy or oral contraceptives. The requirement for
FSH testing may be waived for subjects greater than 62 years of age
- Patients of childbearing potential (POCBP) must:
- Either commit to true abstinence from heterosexual intercourse (which must be
reviewed monthly and source documented) or to use one highly effective
contraceptive method. True abstinence is acceptable when this is in line with the
preferred and usual lifestyle of the subject. (Periodic abstinence [e.g.,
calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are
not acceptable methods of contraception). Highly effective contraceptive methods
are combined (containing estrogen and progestogen) or progestogen-only hormonal
contraception associated with inhibition of ovulation (oral, injectable,
intravaginal, patch, or implantable); bilateral tubal ligation; intra-uterine
device; intrauterine hormone-releasing system; or vasectomized partner
sterilization (note that vasectomized partner is a highly effective birth control
method provided that partner is the sole sexual partner of the POCBP trial
participant and that the vasectomized partner has received medical assessment of
the surgical success). These measures should be used from 28 days before the
first dose of study medication, throughout the study, and for 7 months following
the last dose of trotabresib and 6 months after the last dose of vinorelbine,
whichever is longer
- Oocyte donations and nursing are prohibited during the same time period when
highly effective contraception is required. Should a patient of child bearing
6.
ClinicalTrials.gov; 14/11/2023; TrialID: NCT06137703
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06137703
ABSTRACT
Condition:
Biological AvailabilityIntervention:
Drug: Zavegepant 100mg non-enteric coated soft gel capsule;Drug: Zavegepant 100mg immediate release tablet;Drug: Zavegepant 2 x 100mg immediate release tablets;Drug: Zavegepant 4 x 25mg enteric coated soft gel capsulePrimary outcome:
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)];Maximum Observed Plasma Concentration (Cmax);Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)Criteria:
Inclusion Criteria:
- Participants must provide Informed Consent Form (ICF) obtained prior to the conduct of
any study activities.
- Healthy Male or female participants at least 18 and less than 56 years of age,
- Participants must be Non-smokers and not have used any nicotine-containing products
for 3 months prior to screening.
- Body Mass Index (BMI) >18.5 and <30.0kg/m2 and body weight = 50.0kg for males and =
45.0kg for females.
- All females participants must not be breastfeeding and have a negative urine pregnancy
test at Screening.
- Females of childbearing potential must be willing to use acceptable contraceptive
methods throughout the study and for 30 days after the last study drug administration.
- Male participants with a female partner of childbearing potential must be willing to
use acceptable contraceptive methods from the first study drug administration until at
least 90 days after the last study drug administration.
Exclusion Criteria:
- Current diagnosis of viral hepatitis or a history of liver disease.
- Any history of seizure disorder (e.g., epilepsy) other than a single childhood febrile
seizure.
- Current or recent (within 3 months of the first study drug administration)
gastrointestinal disease that may interfere with drug absorption.
- Prior gastrointestinal surgery that interferes with absorption and motility (e.g.,
gastric bypass, duodenectomy or gastric banding).
- History of drug or alcohol abuse.
- History of anaphylaxis, a documented hypersensitivity reaction, or a clinically
significant reaction to any drug or to any of the excipient supporting the zavegepant
formulations.
- Donation of plasma within 7 days prior to dosing, or donation or loss of blood
(excluding volume drawn at Screening) of 50 mL to 499 mL of blood within 30 days, or
more than 499 mL within 56 days prior to dosing.
- Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to the dosing,
extended to 90 days for biological products.
- Inability or difficulty to swallow tablets or capsules.
- Subjects with any clinically significant abnormality or significant abnormal
laboratory test results found during medical screening or Day-1. Positive test for
human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis
C virus (HCV) antibody during screening.
- Inadequate renal function - estimated glomerular filtration rate (eGFR) according to
the Modification of Diet in Renal Disease (MDRD) study equation = 60 mL/min/1.73 m2 at
Screening.
- Any of the following laboratory parameters greater than the upper limit of normal
(ULN) values at Screening or Baseline (Day -1): alkaline phosphatase (ALP) aspartate
aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct
bilirubin, and indirect bilirubin, and alkaline phosphatase.
- Any clinically significant abnormalities on 12-lead ECG or blood pressure (BP) at
Screening or Baseline (Day -1) visits.
- Any clinically significant abnormal haematological laboratory test values at Screening
or Baseline (Day -1) visits.
- Positive test for COVID-19 performed on Day -1 of each period.
7.
ClinicalTrials.gov; 14/11/2023; TrialID: NCT06137755
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06137755
ABSTRACT
Condition:
Vaccine-Preventable Diseases;Herpes ZosterIntervention:
Biological: CVI-VZV-001;Biological: ShingrixPrimary outcome:
Immediate adverse events;Solicited local and systemic signs and symptoms;Unsolicited signs and symptoms;SAEs;MAAEs;AESIs;Safety as measured by clinical laboratory test, vial sign and physical examination parametersCriteria:
Inclusion Criteria:
1. Healthy adults over 50 years old and under 65 years old
2. Those who voluntarily decided to participate and gave written consent after hearing
and understanding the detailed explanation of this clinical trial
3. Women with childbearing potential and those who agree to use the contraceptive method*
permitted up to 3 months after the final vaccination for clinical trials (*
Combination use such as hormonal contraception, intrathyroidal device (IUD
(Intrauterine device) or IUS (Intrauterine system), vasectomy, tubal stomy, double
block method (cervical cap, use with contraceptive diaphragm)
4. Women of childbearing potential with negative result at pregnancy test before
vaccination for clinical trials.
Exclusion Criteria:
1. Those with a past history of shingles before screening
2. Persons with hypersensitivity to clinical investigational products or the ingredients
of clinical investigational products
3. Those with thrombocytopenia or other coagulation disorders who should not receive
intramuscular injections, or those receiving anticoagulant therapy*
*Anticoagulant therapy: Continuous use of anticoagulants such as coumarin/warfarin or
new oral anticoagulants/antiplatelet agents
4. Those with a history of immune dysfunction, including immunodeficiency disease
5. Those suffering from chronic underlying diseases that, in the opinion of the
investigator, may interfere with the progress and completion of this clinical trial
6. Those with a history of excessive alcohol consumption or drug addiction
7. Persons with a history of serious adverse events, allergies or hypersensitivity
reactions related to vaccination (e.g. anaphylaxis, Guillain-Barré Syndrome)
8. Those with a history of malignant tumor
9. Those who developed a fever (tympanic membrane temperature of 38.0°C or higher) within
3 days prior to the first vaccination of clinical investigational product, suffered
from a febrile illness on the day of vaccination, or suffered from a disease with
moderate or more acute symptoms (mild illness without fever) (e.g. If you have mild
diarrhoea, mild upper respiratory infection), you can participate in the clinical
trial at the discretion of the investigator.)
10. Those who have received chickenpox or shingles vaccine before screening
11. Those who have participated in past chickenpox or shingles vaccine clinical trials
12. Those who have been vaccinated with another vaccine within 4 weeks prior to the first
injection of the investigational product, or who plan to be vaccinated with another
vaccine by 48 weeks after the second injection of the investigational product
(however, seasonal or pandemic flu) (inactivated and subunit influenza vaccine and
COVID-19 vaccine for prevention of flu) are contraindicated only within 2 weeks before
and after vaccination of each clinical investigational product)
13. Those who have received blood products or immunoglobulin within 3 months prior to
receiving the first clinical investigational product, or those who plan to administer
it during the clinical trial period
14. Those who have received immunosuppressants, immunomodulating drugs, other cytotoxic
anticancer drugs that may affect immunity, or have experienced radiation therapy
within 6 months prior to receiving the first clinical investigational product.
15. Those who have experienced systemic steroid administration within 3 months prior to
receiving the first clinical investigation drug (those who are taking a dose of 20
mg/day or more based on prednisone continuously for more than 2 weeks) However,
topical, inhalation ( Inhaled, intranasal, intra-articular, and intra-bursal
administration is permitted regardless of dosage.
16. Organ transplant or hematopoietic stem cell transplant patients
17. Those with positive virus test results (HCV Ab, HBsAg, HIV Ab) performed at screening
18. Persons with clinically significant abnormalities in tests performed during screening
(clinical laboratory tests, electrocardiogram, vital signs, etc.)
19. Those taking antiviral drugs (Acyclovir, Valacyclovir, Famciclovir, Ganciclovir, etc.)
known to be effective against varicella-zoster virus at the time of screening (topical
use of antiviral drugs is permitted)
20. Those with a history of active tuberculosis
21. A person who has received another clinical investigational product or applied a
clinical trial medical device within 6 months before participating in a clinical trial
22. Pregnant or lactating women
23. If the investigator determines that the subject is unsuitable for this clinical trial
for other reasons
8.
A model for predicting the outcome and risk of sequelae of COVID-19 based on complex causal networks
ChiCTR; 2023-11-14; TrialID: ChiCTR2300077626
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077626
ABSTRACT
Condition:
COVID-19Intervention:
Case series:none;Primary outcome:
accuracy;F1 score;precision;recall;Criteria:
Inclusion criteria: (1) Age 18 or above, no restrictions on gender, ethnicity, occupation, etc.; (2) Have data on COVID-19 infection and recovery period; (3) Sign an informed consent form.Exclusion criteria: (1) In the acute phase of the disease, including acute heart failure, acute coronary syndrome, chronic obstructive pulmonary disease exacerbation, and acute pneumonia, etc.; (2) Have obvious data missing or errors, unable to perform effective causal network construction and prediction; (3) People who are unwilling to participate or cannot cooperate with the research data collection.
9.
ChiCTR; 2023-11-14; TrialID: ChiCTR2300077635
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077635
ABSTRACT
Condition:
COVID-19Intervention:
Leritvir tablets group:None;Conventional treatment group:None;Primary outcome:
Duration of recovery from clinical symptoms;Criteria:
Inclusion criteria: 1. Sign informed consent before the study, and fully understand the research content, process and possible adverse reactions;2. Age 18 (inclusive) or above, gender unlimited;
3. Confirmed mild and moderate COVID-19 patients;
Exclusion criteria: 1. During the course of the disease, she had received other small-molecule oral drugs for the treatment of COVID-19 infection before seeing a doctor;
2. Patients with severe kidney injury (Ccr<30 mL/min);
3. Patients suffering from mental disorders;
4. Coma, dysphagia patients;
5. Obvious abnormal liver function at screening (ALT or AST=10ULN);
6. Patients with uncontrolled HIV-1 infection;
7. Those who were vaccinated within 28 days before enrollment and planned to be vaccinated during the study period;
8. Pregnant or lactating women or pregnancy test positive;
9. Participants participating in and receiving other clinical trial drugs within 1 month before medication;
10. Other conditions deemed unsuitable for inclusion by the doctor.
10.
ClinicalTrials.gov; 13/11/2023; TrialID: NCT06136455
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06136455
ABSTRACT
Condition:
HealthyIntervention:
Drug: Listerine Clinical Solutions Teeth Strength;Drug: Listerine Total Care Zero Alcohol Mouthwash;Other: Listerine Cool Mint Zero Alcohol Mouthwash;Drug: Colgate Cavity Protection ToothpastePrimary outcome:
Salivary Flow Rate;Saliva Potential of Hydrogen (pH)Criteria:
Inclusion Criteria:
- Able to comprehend and follow the requirements and restrictions of the clinical trial
(including willingness to use the assigned study products per instructions,
availability on scheduled visit dates and likeliness of completing the clinical trial)
based upon research site personnel's assessment
- Evidence of a personally signed and dated informed consent document indicating the
participant (or legally acceptable representative) has been informed of all pertinent
aspects of the trial
- Able to read and understand the local language (participant is capable of reading the
documents)
- Adequate oral hygiene [that is (i.e.), brush teeth daily and exhibit no signs of oral
neglect]
- Adults, 18 years of age and older, in good general and oral health without any known
allergy to commercial dental products or cosmetics
- Evidence of being fully vaccinated for COVID-19 (adults 60 years and older)
- Negative pregnancy urine tests (females of child-bearing potential only)
- Females of childbearing potential must be using a medically acceptable method of birth
control for at least one month prior to Visit 1 and agree to continue using this
method during their participation in the clinical trial
- Resting baseline unstimulated salivary sample must be equal to or greater than 0.3
mL/min to continue in the clinical trial
- A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that
are grossly carious, extensively restored, orthodontically banded, abutments,
exhibiting severe generalized cervical and/or enamel abrasion, or third molars will
not be included in the tooth count
- Absence of significant oral soft tissue pathology, excluding plaque-induced
gingivitis, based on a visual examination and at the discretion of the Investigator
- Absence of advanced periodontitis based on a clinical examination and discretion of
the dental examiner
- Absence of fixed or removable orthodontic appliance or removable partial dentures
Exclusion Criteria:
- History of significant adverse effects, including sensitivities or suspected
allergies, following use of oral hygiene products such as toothpastes, mouthwashes and
red food dye
- Dental prophylaxis within four weeks prior to Visit 1
- History of medical conditions requiring prophylactic antibiotic coverage prior to
invasive dental procedures
- Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or
diphenylhydantoin, cyclosporin A, immunostimulants/ immunomodulators during the
clinical trial or within the one month prior to the Baseline exam at Visit 1.
Intermittent use of certain antiinflammatory medication (ibuprofen, Aspirin); oral
steroids and calcium channel blockers are acceptable at the discretion of the
investigator
- Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan,
essential oils, cetylpyridinium chloride (CPC), sodium fluoride with CPC, stannous
fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes
within the four weeks prior to Visit 1
- Known allergy or sensitivity or history of significant adverse effects to any of the
investigational product and/or product ingredients (or other ingredients in the
products) specifically Cinnamyl Alcohol, Benzyl Alcohol, Citral, Citronellol, Linalool
and Limonene
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes
related to pregnancy and nursing which can affect interpretation of clinical trial
results)
- Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and
e-cigarette usage
- Males with a pregnant partner or a partner who is currently trying to become pregnant
- Suspected alcohol or substance abuse (for example, amphetamines, benzodiazepines,
cocaine, marijuana, opiates)
- Significant medical or oral condition which may interfere with a participant's
participation in the clinical trial, including cancer, chronic kidney disease, COPD
(chronic obstructive pulmonary disease), immunocompromised state (weakened immune
system) from solid organ transplant, serious heart conditions, (such as heart failure,
coronary artery disease, or cardiomyopathies) Sickle cell disease, Type 2 diabetes
mellitus at the discretion of the Investigator
- Participation in any clinical trial within 30 days of Visit 1
- Diagnosed Temporo-mandibular joint dysfunction/disorder
- Participants who wear bruxing devices, dental aligners, retainers
- Participants who were previously screened and ineligible or were randomized to receive
investigational product
- Participants who are related to those persons involved directly or indirectly with the
conduct of this clinical trial (i.e., principal investigator, sub-investigators, study
coordinators, other site personnel, employees of Johnson & Johnson subsidiaries,
contractors of Johnson & Johnson, and the families of each)
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the Investigator, would make the participant
inappropriate for entry into this clinical trial
11.
ClinicalTrials.gov; 13/11/2023; TrialID: NCT06136546
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06136546
ABSTRACT
Condition:
Depressive Disorder, Major;InflammationIntervention:
Drug: Infliximab;Other: PlaceboPrimary outcome:
Psychomotor Speed (TestMyBrain: Simple Reaction Time);Executive Function (TestMyBrain: Choice Reaction Time)Criteria:
Inclusion Criteria:
1. Aged 18-65 years
2. Able to read and understand English and willing to provide informed consent/comply
with the study protocol
3. Willingness to complete intravenous infusion and have blood drawn
4. Exhibit circulating blood level of C reactive protein = 3mg/L
5. Diagnosed with Major Depressive Disorder
6. Moderate depressive symptom severity, as indicated by score =15 on the Hamilton
Depression Rating Scale
7. Antidepressant treatment free for at least 4 weeks prior to study entry or be on a
fixed treatment regimen for at least 4 weeks; willingness to continue treatment status
(i.e., change/begin new treatment) until study termination
8. Willingness not to begin/change therapies until study termination (maximum of three
weeks following screening)
9. Be of non-childbearing potential per the following specific criteria:
a. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant,
i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or
is post-menopausal with her last menses at least one year prior to screening); or b.
Childbearing potential and meets the following criteria: i. A negative serum pregnancy
test within thirty days of infusion (may be repeated closer to infusion date at the
discretion of the PI or study staff) and abstinent after the negative serum pregnancy
test and prior to infusion; or ii. Using any form of hormonal birth control, on
hormone replacement therapy started prior to 12 months of amenorrhea, using an
intrauterine device (IUD), having a monogamous relationship with a partner who has had
a vasectomy, or is sexually abstinent; iii. Continuously use one of the following
methods of birth control over the last six months: implants, injectable or patch
hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual
abstinence.
Exclusion Criteria:
1. Medical conditions that could confound interpretation or increase participant risk, as
indicated via medical history or laboratory testing; exclusionary medical conditions
will include:
i. acute injury/infection within one week of study initiation or infection within one
month of study initiation that required antibiotic/antiviral treatment ii. chronic
infection (e.g., hepatitis B or C or HIV) or history of Covid 19 infection within the
past 6 months or with persisting symptoms.
iii. latent infection (e.g., tuberculosis, fungal infections), or history of recurrent
infections, iv. uncontrolled cardiovascular, endocrine, hematologic, hepatic, renal or
neurologic disease (as determined by medical history, physical exam and laboratory
testing) v. cancer history vi. autoimmune conditions; neurologic conditions
(controlled) that are known to substantially impact cognitive function (e.g., stroke).
Of note, stable medical conditions such as diabetes and cardiovascular disease, will
be allowed in the study as they can contribute to endogenous inflammation.
2. Active antipsychotic and anticonvulsant medication use (that interact with infliximab)
3. Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative
agents within one year of study entry
4. History of liver abnormalities
5. Major cognitive impairment as determined by study investigators
6. Active restrictive eating disorder or obsessive compulsive disorder deemed by study
investigators to be primary cause of depressive disorder
7. History of a psychotic disorder or Bipolar disorder type I/II
8. Current substance use disorder (i.e., present in last six months), of greater than
mild severity
9. Suicidal ideation based on a score =3 on the Columbia-Suicide Severity Rating Scale
10. Electroconvulsive therapy (ECT)/deep brain stimulation (DBS) within the last year, or
report of persistent negative cognitive effects of ECT/DBS
11. Presence of a transplanted solid organ
12. Medication use affecting immune or cognitive function:
i. Chronic use (>1 month) of a benzodiazepine more than the equivalent of 2 mg of
lorazepam ii. Use of anti-inflammatory agents during the study: non-steroidal
anti-inflammatory agents (NSAIDs) (excluding 81mg of aspirin), glucocorticoid
containing medicines or statins, or cyclooxygenase-2 (COX-2) inhibitors
13. Considered by the study investigators to be inappropriate for the study due to safety
concerns or to be unlikely to complete the protocol
14. History of allergic response to murine products
12.
ClinicalTrials.gov; 13/11/2023; TrialID: NCT06137001
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06137001
ABSTRACT
Condition:
SARS-CoV-2 Infection;COVID-19Intervention:
Biological: BNT162b2;Other: Placebo;Biological: Seasonal Inactivated Influenza VaccinePrimary outcome:
Local reactions (redness, swelling, and pain at the injection site) self-reported on e-diaries;Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) self-reported on e-diaries;Adverse Events;Serious Adverse Events;Full-length S-binding IgG levels;Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained)Criteria:
Inclusion Criteria:
1. Participants 18 through 64 years of age, inclusive, at the time of consent.
2. Are willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, lifestyle considerations, and other study procedures.
3. Adults determined by clinical assessment, including medical history and clinical
judgment, to be eligible for the study, including adults with preexisting stable
disease, defined as disease not requiring significant change in therapy in the
previous 6 weeks or hospitalization for worsening disease within 12 weeks before
receipt of study intervention.
4. Have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90
days before Visit 1 (Day 1). Documented confirmation of prior BNT162b2 receipt must be
obtained prior to randomization.
5. Capable of giving personal signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria:
1. Other medical or psychiatric condition, including recent (within the past year) or
active suicidal ideation/behavior, or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.
2. Allergy to egg proteins (egg or egg products) or chicken proteins.
3. History of Guillain-Barré syndrome.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. A positive SARS-CoV-2 test result (either by NAAT or rapid antigen test) within 28
days of Visit 1 (Day 1).
6. Immunocompromised individuals with known or suspected immunodeficiency, as determined
by history and/or laboratory/physical examination.
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
8. Women who are pregnant or breastfeeding.
9. Vaccination with any influenza vaccine <6 months before study intervention
administration, or planned receipt of any licensed or investigational nonstudy
influenza vaccine during study participation.
10. Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids
are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent),
eg, for COPD, or planned receipt throughout the study. Inhaled/nebulized,
intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study.
12. Receipt of any passive antibody therapy specific to COVID-19 from 90 days before study
intervention administration or planned receipt throughout the study.
13. Prior receipt of any COVID-19 vaccine other than BNT162b2 or receipt of more than 3
prior doses of BNT162b2.
14. Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation.
15. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
of the study, site staff otherwise supervised by the investigator, and their
respective family members.
13.
ChiCTR; 2023-11-13; TrialID: ChiCTR2300077554
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077554
ABSTRACT
Condition:
COVID-19Intervention:
Self control of volunteers before and after medication:Oral Daphne Capsules;Primary outcome:
ACE2;Criteria:
Inclusion criteria: On campus teachers and students of Wannan Medical College, aged between 30 and 40, 3 males and 3 females, healthy individuals, BMI index 18.5-24.99Exclusion criteria: Postoperative and bleeding prone; Liver and kidney dysfunction; Severe hypertension; Pregnant and lactating women; Individuals who are allergic to Daphne capsules.
14.
ClinicalTrials.gov; 12/11/2023; TrialID: NCT06135207
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06135207
ABSTRACT
Condition:
COVID-19;DysphagiaPrimary outcome:
Flexible Endoscopic Evaluation of Swallowing (FEES);The Penetration - Aspiration Scale;Oral Motor Dysfunction (OMD);Cranial Nerve Examination;Eating Assessment Tool-10 (EAT-10)Criteria:
Inclusion Criteria:
- Older than 18 years of age
- Suffering from dysphagia
- Not having mental retardation
Exclusion Criteria:
- Patients who did not have swallowing difficulties
- Refused to participate in the study
15.
ClinicalTrials.gov; 12/11/2023; TrialID: NCT06135597
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06135597
ABSTRACT
Condition:
AspergillosisIntervention:
Other: This is a blood test without regarding to intervention nor diagnostic testsPrimary outcome:
Overall survivalCriteria:
Inclusion Criteria:
- Confirmed cases include patients diagnosed with pulmonary aspergillosis, acute or
subacute Aspergillus infections, and aspergillosis in other anatomical sites (such as
sinuses, middle ear, liver). Additionally, this study will enroll patients with
chronic obstructive pulmonary disease (COPD), asthma, or those undergoing treatment
for pulmonary tuberculosis who continue to exhibit worsening pulmonary radiological
findings without a clear etiology, necessitating hospitalization or outpatient care
for unexplained community-acquired pneumonia. Patients with bronchiectasis, emphysema,
pulmonary fibrosis, or other chronic pulmonary conditions who are under continuous
follow-up and treatment at our institution will also be included if clinically
diagnosed with aspergillosis.
The control group will consist of patients who, based on clinical evidence, have no history
of prior exposure to Aspergillus or aspergillosis infection after contracting COVID-19.
Exclusion Criteria:
- Individuals aged below 20, pregnant women, patients with advanced-stage (stage II and
above) lung cancer, individuals diagnosed with malignancies, patients with mental
health disorders requiring consent from a legal guardian for participation, and those
in critical end-stage conditions.
16.
ClinicalTrials.gov; 12/11/2023; TrialID: NCT06135623
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06135623
ABSTRACT
Condition:
COVID-19;Social Interaction;Physical InactivityPrimary outcome:
Social Interaction Anxiety Scale (SIAS);Social Phobia Scale (SPS);International Physical Activity Questionnaire Short FormCriteria:
Inclusion Criteria:
- Young adults aged 18-25
- Agreeing to participate in the study
Exclusion Criteria:
- Having mental retardation
17.
ClinicalTrials.gov; 10/11/2023; TrialID: NCT06133517
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06133517
ABSTRACT
Condition:
Urothelial Bladder CarcinomaIntervention:
Drug: Sacituzumab govitecan;Drug: Zimberelimab;Drug: DomvanalimabPrimary outcome:
To evaluate the efficacy measured as pathologic complete response rates of the combo SG+ZIM+DOM in the perioperative setting in patients with MIBC who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy.Criteria:
Inclusion Criteria:
1. Willing and able to provide written informed consent.
2. Ability to comply with the study procedures and requirements and restrictions in this
protocol.
3. Age = 18 years.
4. Muscle invasive urothelial carcinoma stage cT2-T4cN0-1cM0. Patients with mixed
histologies are required to have a dominant (i.e. 50% at least) urothelial carcinoma
pattern.
5. Fit and planned for cystectomy (according to local guidelines).
6. Refusal of neoadjuvant cisplatin-based chemotherapy or patients in whom neoadjuvant
cisplatin-based therapy is not appropriate. (This will be determined by the
investigator and not solely based in Galsky Criteria).
7. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks
preferred) or at least 15 unstained slides, with an associated pathology report, for
testing at the study sponsor site. Patients with fewer than 15 unstained slides
available at baseline (but no fewer than 10) may be eligible following discussion with
the PI of the study.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
9. Adequate hematologic and end-organ function tests defined by the following:
1. White Blood Cell (WBC) = 2.0x109/L,
2. Neutrophils =1.5x109/L,
3. Platelets =100 x109/L,
4. Hemoglobin = 10 g/dL,
5. Creatinine clearance = 30 mL/min as assessed by the Cockcroft-Gault equation
6. Aspartate aminotransferase (AST) = 2.5 x upper limit of normal(ULN),
7. Alanine aminotransferase (ALT) =2.5 x ULN,
8. Bilirubin =1.5 X ULN.
10. Adequate coagulation (Prothrombin Time [PT]) or International Normalized Ratio [INR]
and Activated Partial Thromboplastin Time [aPTT]) = 1.5 x ULN unless subject is
receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of
intended use of anticoagulants.
11. Negative pregnancy test within 3 days of Day 1 Cycle 1 for female patients of
childbearing potential.
12. Male patients and female patients of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.
Exclusion Criteria:
1. Concurrent enrollment in another interventional clinical trial, unless in a follow-up
period or it is an observational study.
2. Having received previous anticancer therapy including:
1. Any investigational anticancer therapy received within 28 days or 5 half-lives
(whichever is longer) of first dose of study treatment.
2. Any previous intravenous chemotherapy specific for bladder cancer.
3. Previous systemic treatment with topoisomerase 1 inhibitors.
4. Prior Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) or Programmed death-1(PD-1)/
programmed death-ligand 1(PD-L)1-targeting immunotherapy.
5. Previous treatment with high dose chemotherapy and bone marrow transplant
6. Previous radiotherapy specific for bladder cancer
3. Underlying medical conditions that might make the administration of study drugs
hazardous or that might obscure the interpretation of adverse events including:
- 3.1 Known or suspected autoimmune disease. Patients with a history of
inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and
autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis
(scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g.,
Wegener's granulomatosis) are excluded from this study; Patients with other
autoimmune disorders such as a history of Hashimoto's thyroiditis [only requiring
hormone replacement], type I diabetes, psoriasis [not requiring systemic
treatment], or conditions not expected to recur in the absence of an external
trigger are allowed to participate.
- 3.2 History of primary immunodeficiency.
- 3.3 A positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic
acid (RNA), active tuberculosis, or other active infection requiring therapy at
the time of inclusion.
HIV positive patients are allowed as far as they have the disease controlled according
to their treating physicians based on lymphocyte counts and viral load.
- 3.4 Medical conditions requiring the use of immunosuppressive medications, with the
exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at
physiological doses not to exceed 10 mg/day of prednisone, or an equivalent
corticosteroid. Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication) will be allowed.
4. Patient receiving treatment with inhibitors or inducers of UGT1A1 at the time of
enrollment.
5. Patient receiving treatment with high dose systemic corticosteroids (>10 mg of
prednisone or its equivalent) within 2 weeks of C1D1.
6. Patients who have received a vaccination within 30 days prior to inclusion (examples
include, but are not limited to, intranasal influenza vaccines, typhoid [oral]
vaccines, and Bacillus Calmette-Guerin [BCG]). Patients are allowed to receive the
COVID-19 vaccine to reduce the risk and complications of COVID-19 infection. The study
visits should continue as planned if vaccination occurs while the patient is on the
study.
7. Malignancy, other than urothelial cancer, in the previous 2 years. Patients with
low-risk prostate cancer (defined as Stage T1/T2a, Gleason score = 6, and Prostatic
specific antigen (PSA) = 10 ng/mL) appropriately treated or that are treatment-naive
and undergoing active surveillance are eligible. Also, noninvasive malignancies such
as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal
carcinoma in situ of the breast, that have undergone potentially curative therapy are
not excluded.
8. Major surgical procedure within 4 weeks prior to enrollment or anticipation of need
for a major surgical procedure during the course of the study other than for diagnosis
or treatment of its urothelial cancer.
9. Severe infection within 4 weeks prior to enrollment in the study including but not
limited to hospitalization for complications of infection, bacteremia, or severe
pneumonia.
10. Met any of the following criteria for cardiac disease:
1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.
2. History of serious ventricular arrhythmia (ie, vent
18.
ClinicalTrials.gov; 10/11/2023; TrialID: NCT06133478
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06133478
ABSTRACT
Condition:
Healthy VolunteersIntervention:
Drug: NUV001 active cohort 1;Drug: NUV001 active cohort 2;Drug: NUV001 active cohort 3;Drug: NUV001 active cohort 4;Drug: NUV001 placebo cohort 1;Drug: NUV001 placebo cohort 2;Drug: NUV001 placebo cohort 3;Drug: NUV001 placebo cohort 4Primary outcome:
Safety as measured by subject incidence of treatment-emergent adverse events (SAD/MAD);Safety as measured by subject incidence of treatment-emergent clinically significant changes in vital signs (SAD/MAD);Safety as measured by subject incidence of treatment-emergent clinically significant changes in Electrocardiograms (SAD/MAD);Safety as measured by subject incidence of treatment-emergent clinically significant changes in Blood safety tests (SAD/MAD);Safety as measured by subject incidence of treatment-emergent clinically significant changes in Urinalysis safety tests (SAD/MAD);Safety as measured by subject incidence of treatment-emergent clinically significant changes in Weight (SAD/MAD)Criteria:
Inclusion Criteria:
Participants must satisfy all the following inclusion criteria before being allowed to
enter the study:
1. Male or female 18 to 55 years of age inclusive, at screening.
2. A body mass index (BMI) between 18.00 and 30.00 kg/m² inclusive and a body weight
between 60 kg and 100 kg for males (inclusive), and 50 kg and 100 kg for females
(inclusive).
3. Healthy as determined by the investigator based on medical history, physical
examination findings, clinical laboratory test results, and digital 12 lead ECG
readings (all results should be normal or, if out of range, non-clinically significant
as determined by the Investigator).
4. Vital signs at Screening and Admission are within the following ranges:
- Systolic blood pressure 90-140 mmHg (inclusive);
- Diastolic blood pressure 50-90 mmHg (inclusive);
- Heart rate 40-100 beats per minute (inclusive);
- Oral temperature 36.0-37.5°C (inclusive);
5. AST, ALT, and Total bilirubin are <1.5 x ULN Screening and Admission.
6. Serum creatinine is <1.5 mg/dL and estimated glomerular filtration rate is =60
mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration at Screening
and Admission.
7. QTcF is =450 ms for males and =470 ms for females at Screening and Admission.
8. Non-smoker and no use of tobacco or nicotine-containing products for 6 months prior to
screening.
9. Have a high probability for compliance with and completion of the study.
10. Female participants of childbearing potential [meaning who are not either surgically
sterile (bilateral tubal ligation/occlusion, bilateral salpingectomy, bilateral
oophorectomy or hysterectomy) or post-menopausal (no spontaneous menstrual periods for
at least two years), confirmed by serum follicle stimulating hormone [FSH] in
post-menopausal range based on laboratory reference range, must commit to using a
highly effective method of birth control and throughout the entire study and for 90
days after last dose of study drug:
1. Combined hormonal estrogen and progestogen-containing, or progestogen-only
hormonal contraception associated with inhibition of ovulation, started at least
4 weeks prior to the dosing and condom with spermicide for the male partner.
2. Intrauterine device or intrauterine hormone-releasing system placed at least 4
weeks prior to the dosing, and condom with spermicide for the male partner.
3. Simultaneous use of a diaphragm or cervical cap with intravaginally applied
spermicide and, for the male partner, a male condom with spermicide.
4. Sterile male partner, i.e., vasectomized since at least 3 months before dosing.
5. Female participants with same-sex or no partner (when in line with the preferred
and usual subject's lifestyle) must agree to use an acceptable form of birth
control for duration noted above if they were to become sexually active with a
male partner. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
post-ovulation methods) is not acceptable.
NB: Surgically sterile women, if the surgery (bilateral tubal ligation/occlusion,
bilateral salpingectomy, bilateral oophorectomy, or hysterectomy) was performed at
least 3 months prior to dosing, and female participants who have same-sex sexual
relations do not have to use contraception. If the surgery was performed less than 3
months before dosing, the female subject will be considered a woman of childbearing
potential (WOCBP).
11. Male participants with a female partner of childbearing potential will be required to
be vasectomized at least 3 months prior to screening or use a condom with spermicide
throughout the duration of the study and for 90 days after last dose of study drug.
12. Male participants with same-sex or no partner (when in line with the subject's
preferred and usual lifestyle) must agree to use an acceptable form of birth control
for duration noted above if they were to become sexually active with a female partner
of childbearing potential.
13. Agree to avoid sperm or egg donation during the study and for 90 days following last
dose of study drug.
14. Can provide a voluntary written informed consent to participate in the study prior to
any initiation of study-related procedures.
15. Participant is not subject to any of the following procedures: ward of court,
trusteeship, supervision order.
Exclusion Criteria:
If any of the following exclusion criteria apply, the participant must not enter in the
study:
Medical History
1. Any significant cardiovascular (e.g., heart failure), hepatic, renal, respiratory
(e.g., asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia),
immunologic, dermatological, hematological, neurologic, psychiatric disease or history
of any clinically important drug allergy.
2. Acute disease state (e.g., vomiting, fever, diarrhea) within 7 days before Day 1 of
Treatment Period 1 (SAD).
3. Pregnant or lactating female.
4. Inability to follow study procedures.
5. Use of recreational drugs within 1 year before Day 1 of Treatment Period 1 (SAD).
6. History of alcoholism within 1 year before Day 1 of Treatment Period 1 and/or Regular
alcohol consumption >14 units of alcohol per week (1 unit = ½ pint [approximately 240
mL] beer, 25 mL of 40% spirit or a 125 mL glass of wine) within 3 months prior to the
admission.
7. Donation of blood or blood loss (i.e., > 400 mL) within 90 days before Day 1 of
Treatment Period 1 (SAD).
8. Known allergy or intolerance to study drug, or excipients present in drug product.
Physical and Laboratory Findings
9. Positive serologic findings for human immunodeficiency virus (HIV) antibodies,
hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibody at
Screening.
10. Positive findings of urine drug screen [methadone, barbiturates, oxycodone,
amphetamines, methamphetamines, opiates, cannabinoids, cocaine, benzodiazepines,
tricyclic antidepressants (TCA), 3,4-methylenedioxy-methamphetamine (MDMA; ecstasy),
phencyclidine, cotinine] at screening or admission.
11. Positive Covid -19 by rapid antigen test at admission.
Prohibited Treatments and study restrictions:
12. Use of any investigational drug within 30 days before study drug administration on Day
1 of Treatment Period 1 (SAD) except for medications needed to treat Adverse Events
19.
ClinicalTrials.gov; 10/11/2023; TrialID: NCT06135337
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06135337
ABSTRACT
Condition:
Lip AbnormalityIntervention:
Device: Thioderm Elate;Device: Juvéderm Ultra 3Primary outcome:
Primary Safety EvaluationCriteria:
Inclusion Criteria:
1. Aged = 18 years at the time of screening (upper limit 75 years, inclusive).
2. Subjects with approximately symmetrical 'very thin' or 'thin' lips (scores of 1 or 2
on the 5-point Lip Fullness Scale) as assessed by the Blinded Evaluating Investigator
at Screening (Visit 0). The scores do not have to be the same on both (upper and
lower) lips, but must be 1 or 2.
3. Healthy skin in the perioral area and free of diseases that could interfere in
cutaneous aging evaluation.
4. Intact or permanently replaced central and lateral incisors, canine and first and
second premolars in the upper row of teeth and intact or replaced incisors, canines
and premolars in the lower row of teeth
5. Subject has a stable medical condition with no uncontrolled systemic disease.
6. Females of childbearing potential must have a negative urine pregnancy test and must
agree to use a highly effective method of birth control throughout the entire study.
7. Male subjects with female partners of child-bearing potential must agree to use
contraception throughout the entire study (surgical sterilization or a physical
barrier such as a condom).
8. Willingness to abstain from any aesthetic or surgical procedures in the treatment area
for the duration of study, including botulinum toxin injection (except glabella or
forehead botulinum toxin treatment).
9. Subjects who understand the purpose and conduct of the study and having given written
informed consent and are willing and able to attend the study visits as judged by the
Investigator.
Exclusion Criteria:
1. Females, who are pregnant and/or, lactating or planning to become pregnant during the
clinical investigation.
2. History of allergies or hypersensitivity to hyaluronic acid and/or to gram positive
bacterial proteins, lidocaine or any amide-based anaesthetic
3. History of severe allergies manifested by a history of anaphylaxis or history or
presence of multiple severe allergies
4. Tendency to keloid formation and/or hypertrophic scars.
5. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous
lesions in the area to be treated
6. Recurrent (three times a year over the last year) herpes simplex in the treatment
areas
7. Known human immune deficiency virus-positive individuals
8. History or presence of any autoimmune or connective tissue disease
9. Uncontrolled (or unstable) Diabetes mellitus or uncontrolled systemic diseases as per
Investigator discretion
10. Previous facial plastic surgery, tissue augmentation with silicone, fat or another
non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers
(e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of
device application and during the entire investigation
11. Implantation of dermal fillers in the treatment area within the preceding 24 months
prior to Visit 0 (Screening) and during the entire investigation
12. Subject has received any of the following aesthetic treatments in the perioral area
and or lower face third: e.g., laser therapy, absorbable and non-absorbable sutures
(threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including
treatment of crow´s feet in the outer eye region) as well as permanent make-up at the
lips within the last 12 months prior to Visit 0, chemical peeling within the last
three months prior to Visit 0 or is planning to undergo such procedures during entire
investigation
13. Facial lipolysis, including submental fat treatments, within the previous 12 months
prior to Visit 0 (Screening) and during the entire investigation
14. Bariatric surgery within 12 months prior to Visit 0 (Screening) and during the entire
investigation.
15. History of bleeding disorder and/or use of anticoagulant, antiplatelet or thrombolytic
medication from 10 days pre- to 3 days post-injection (initial treatment and touch-up
treatment).
16. Systemic glucocorticoids, including immunosuppressant or immunomodulators, within 8
weeks prior to undergoing investigational device injections.
17. Subjects suffering from untreated epilepsy.
18. Subjects with acute rheumatic fever with heart complications.
19. Subjects with symptoms of cardiac conduction disorders.
20. Planned dental/oral surgery or modification (bridgework, implants) within four weeks
prior to each injection and to a minimum of four weeks post injection (initial
treatment, touch-up treatment).
21. Beard longer than three-day beard, or excessive facial hair that could interfere in
evaluation of treatment as judged by the Investigator.
22. Subjects with active SARS-CoV-19 infection and Subjects with symptoms consistent with
COVID-19 infection including any other respiratory symptoms/illnesses within the past
14 days unless tested negative prior to Visit 0 (Screening).
23. Any medical condition prohibiting the inclusion in the clinical investigation
according to the judgment of the Investigator.
24. Previous enrolment in this clinical investigation.
25. Current participation in another clinical investigation, or treatment with any
investigational drug/medical device within 30 days prior to clinical investigation
enrolment, or 5 half-lives of the investigational drug, whichever is longer.
26. Subjects who experienced fat loss for a minimum of 10% of body weight over the last 12
months (e.g., post bariatric subjects), or Subjects who have the intention to change
eating habits that result in a weight gain or loss >10% during the entire
investigation.
27. Close affiliation with the Investigator (e.g., a close relative, financially dependent
on the study site) or Subject who is an employee of the Sponsor's company or group
companies of the Sponsor.
28. Any individual whose willingness to volunteer in this clinical investigation could be
unduly influenced by the expectation, whether justified or not, of benefits associated
with participation or of retaliatory response from senior members of a hierarchy in
case of refusal to participate (e.g., persons with a legal custodian appointed due to
mental disability, prisoners, soldiers and other members of the armed forces, civil
servants).
20.
ClinicalTrials.gov; 10/11/2023; TrialID: NCT06137534
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06137534
ABSTRACT
Condition:
Healthy IndividualsIntervention:
Other: Proprioceptive Neuromuscular Facilitation Upper Extremity PatternPrimary outcome:
Forced vital capacity (FVC);Forced expiratory volume in the first second (FEV1);Forced expiratory volume in the first second/Forced vital capacity (FEV1/FVC);Forced expiratory flow between 25% and 75% of vital capacity (FEF25-75);Body Image Perception ScaleCriteria:
Inclusion Criteria:
- Not diagnosed with any chronic disease
- No neurological problems
- Has not had COVID-19 for at least 6 months
Exclusion Criteria:
- Diagnosed with respiratory system diseases
- Regular medication use
- Suspected pregnancy
- Individuals with rheumatic or neurological diseases