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1.
ChiCTR; 2024-02-23; TrialID: ChiCTR2400081132
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400081132

ABSTRACT

Condition:

Long Covid

Intervention:

healthy group:Maintain daily habits;Rehabilitation group:Maintain daily habits;fatigue patients with Long Covid:Maintain daily habits;

Primary outcome:

Peak cardiorespiratory oxygen uptake;Proteomic features;Metabolomics profile;

Criteria:

Inclusion criteria: 1. Inclusion criteria for healthy populations
(1) No history of novel coronavirus infection and SARS infection or morbidity
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
2. Inclusion criteria for persons recovering from novel coronavirus infection
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses and no sequelae such as fatigue or malaise 12 weeks after the diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
3. Long Covid with Fatigue Patient Inclusion Criteria
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses with sequelae such as fatigue and malaise 12 weeks after diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time

Exclusion criteria: Subjects with the following conditions should be excluded:
(1) Pulmonary embolism;
(2) Absolute and relative contraindications to cardiopulmonary exercise testing or exercise training;
(3) Obvious arrhythmia or ischemia during low-intensity exercise and severe pulmonary hypertension;
(4) Severe pulmonary diseases (e.g., chronic obstructive pulmonary disease, severe COVID-19-related symptoms, severe asthma);
(5) Recent cardiovascular events (cardiac decompensation, angioplasty or cardiac surgery less than 4 weeks, valvular heart disease requiring surgical correction, pericarditis, fatigue caused by various arrhythmias);
(6) Renal failure requiring dialysis;
(7) Patients with New York Heart Association (NYHA) class ? or recurrent malignant arrhythmia;
(8) Drug-induced muscle atrophy, such as steroids or neuromuscular blocking drugs;
(9) Metabolic diseases ( such as hyperglycemia, malnutrition), and weakness caused by electrolyte disturbances;
(10) Myalgic encephalomyelitis/chronic fatigue syndrome;
(11) Allergic to known components of study drugs;
(12) Refusal to sign informed consent;
(13)Those who participated in other clinical trials or used Chinese medicine (proprietary Chinese medicine) in the last three months.

2.
ChiCTR; 2024-02-23; TrialID: ChiCTR2400081131
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400081131

ABSTRACT

Condition:

long-covid syndrome

Intervention:

treatment group:Chinese Herbal Medicine and Snap-Needle Therapy;control group:Western medicine for symptomatic treatment;

Primary outcome:

Chinese Medicine Score;

Criteria:

Inclusion criteria: ?Patients who meet the above diagnostic criteria of traditional Chinese medicine and western medicine;
? Age 18-65 years old, gender is not limited;
? Patients more than 1 week after negative nucleic acid or antigen test;
? Patients with symptoms of impaired cardiopulmonary function, such as cough, fatigue, palpitation, etc., which last for no more than half a year after turning negative from nucleic acid or antigen test;
? Patient's TCM evidence points, according to the symptoms in the recovery period, the primary symptoms are evaluated according to 0, 1, 2, 3 points, and the secondary symptoms are evaluated according to the presence or absence of the symptoms, using 1 or 0 points, and the sum of the scores is recorded as the TCM evidence points, and the higher the score, the more serious the condition is.
? Patients volunteered to be tested and signed an informed consent form.

Exclusion criteria: ?Patients with severe interstitial lung disease, bronchiectasis, and other underlying lung diseases;
? Patients with underlying diseases such as congenital respiratory malformations and congenital heart disease;
? Patients with severe cardiac, hepatic, renal dysfunction and abnormal coagulation function;
?Patients with diseases that affect cognitive function, such as alcoholism, drug addiction or psychotropic substance abuse;
? People with history of needle fainting and skin infection at the site of needling;
? Patients who are allergic to Chinese medicinal preparations;
? Pregnant or lactating women;
? Those who are participating in other clinical trials or those who have participated in other clinical trials for less than 3 months. Those who meet any of the above criteria should be excluded.

3.
ANZCTR; 23/02/2024; TrialID: ACTRN12624000172505
Clinical Trial Register | ICTRP | ID: ictrp-ACTRN12624000172505

ABSTRACT

Condition:

Recurrent urinary tract infections;Symptoms of recurrent urinary tract infections with negative urine culture (also referred to a irritative bladder symptoms).;
Recurrent urinary tract infections
Symptoms of recurrent urinary tract infections with negative urine culture (also referred to a irritative bladder symptoms).;Renal and Urogenital - Other renal and urogenital disorders

Intervention:

The intervention in our study involves the diathermy of the trigone procedure, administered by an experienced urologist, Dr. Dirk Drent. The procedure is a one-time intervention, initiated after an initial hour-long appointment with the urologist, encompassing a comprehensive assessment, including a medical history, clinical examination, bladder ultrasound, flow study, and post void residual volume measurement. During this appointment, details of the diathermy procedure are discussed thoroughly, allowing the patient to make an informed decision. If the patient opts for the intervention, they are scheduled for the procedure, which requires an approximately one-hour session and an overnight hospital stay for observation. A Coviden ValleyLab FT10 mono polar diathermy in used, initially on Cut (Pure, 20W, peak voltage 1287V) for removal of the lesions and followed by Coag (Fulgurate, 20W, peak voltage 3448V) for haemostasis. These two diathermy steps take a combined total of approximately 15minutes, Subsequently, an 8-week follow-up appointment lasting around 30 minutes involves additional assessments, including ultrasound, flow, residual volume measurement, and a urine dipstick test. One year post-procedure, patients complete a survey to evaluate the intervention's long-term outcomes. The intervention is provided individually, and informational materials are supplied to facilitate informed decision-making. During the process we will obtain consent to access the patient medical records and have contact with the patients GP to cross reference past medical history, positive urine tests and antibiotics courses/previous treatments.

Primary outcome:

The primary outcome to be assessed is the change in quantity and severity of irritative bladder symptoms experienced before and following the procedure.[A patient completed symptom questionnaire has been specifically designed for the study. Global Response Assessment (GRA) and Patient Satisfaction Questionnaire (PSQ) on a 7 point scale have been utilised to quantify the outcomes. Prior to surgery or the initial consultation and one year following the surgical intervention.]

Criteria:

Inclusion criteria: 1. Women with symptoms of recurrent UTIs (three or more times in the last year) or persistent symptoms of bladder irritation.
2. Women with confirmed Trigone pathology (Squamous metaplasia, Cystitis Cystica, Cystitis Glandularis, or Follicular Cystitis) on Cystoscopy.


Exclusion criteria: 1. Women with less than one year of follow-up.
2. Women found to have other potential causes for symptoms (e.g., kidney or bladder stones, bladder malignancy, vaginal infection, sexually transmitted infections, etc.).

4.
ClinicalTrials.gov; 19/02/2024; TrialID: NCT06267300
Clinical Trial Register | ICTRP | ID: ictrp-NCT06267300

ABSTRACT

Condition:

Post-COVID-19 Syndrome;Post-COVID Syndrome;Post COVID-19 Condition;Post-COVID Condition;Post COVID-19 Condition, Unspecified;Long COVID;Long Covid19

Intervention:

Drug: Hyperbaric oxygen

Primary outcome:

Physical and mental component scores of the 36-item Short Form Survey (SF-36)

Criteria:


Inclusion Criteria:

- Cognitive and/or physical symptoms = 12 months after acute COVID-19 infection

- Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by
questionnaires and/or NASA LEAN test

- Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical
functioning' score of = 50 at baseline).

- Current treatment regimen is stable for at least 1 months before inclusion

Exclusion Criteria:

- Unfit for hyperbaric treatment

- Previous diagnosis of ME/CFS

- Unable to provide informed consent


5.
ChiCTR; 2024-02-18; TrialID: ChiCTR2400080915
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400080915

ABSTRACT

Condition:

Long covid

Intervention:

Observation Group:None;

Primary outcome:

Incidence;Fatigue Severity Scale;

Criteria:

Inclusion criteria: This prospective cohort study encompasses a diverse patient population, ranging from neonates to individuals above 90, diagnosed with COVID-19. Patients admitted to the Gansu Provincial Hospital, Lanzhou, China, from December 2022 to May 2023, with RT-PCR confirmed SARS-CoV-2 infection, form the study cohort.

Exclusion criteria: Exclusions include patients with incomplete contact details, deceased during hospitalization or follow-up, those declining participation, or unreachable for follow-up.

6.
ClinicalTrials.gov; 12/02/2024; TrialID: NCT06268015
Clinical Trial Register | ICTRP | ID: ictrp-NCT06268015

ABSTRACT

Condition:

Colorectal Cancer

Intervention:

Drug: Botensilimab;Drug: Balstilimab;Drug: Oxaliplatin;Drug: Leucovorin;Drug: Fluorouracil;Drug: Bevacizumab;Drug: Panitumumab

Primary outcome:

Disease control rate based on iRECIST at second restaging scan;Proportion of subjects with a best overall response of complete response or partial response according to iRECIST

Criteria:


Inclusion Criteria:

1. Male or female participants who are at least 18 years of age on the day of signing
informed consent.

2. Histologically confirmed metastatic and/or unresectable colorectal cancer without
liver metastasis or known or suspected bone or brain metastases.

a. Up to 3 patients with peritoneal carcinomatosis will be included. Other than those
three, subjects must only have lung, lymph node, and locoregional sites of disease
(primary tumor or serosal implant without carcinomatosis).

3. Microsatellite stable disease.

4. Subject must be willing to provide fresh biopsy of tumor lesion. Those who do not have
a tumor lesion that is safe and amenable to biopsy may still be enrolled.

5. ECOG performance status of 0 or 1.

6. No prior systemic therapy for colon cancer.

a. Subjects who received systemic therapy in the neoadjuvant or adjuvant setting may
be eligible with approval from the principal investigator.

7. Measurable disease per RECIST v1.1.

8. Female participants must not be pregnant or breastfeeding and meet at least one of the
following conditions:

1. Not a woman of childbearing potential (WOCBP).

2. A WOCBP must agree to use a reliable method of contraception during the treatment
period and for at least 180 days after the last dose of study treatment.

9. Male participants must practice effective contraceptive methods during the treatment
period, unless documentation of infertility exists.

10. Expected to survive >3 months per investigator assessment.

11. The participant (or legally acceptable representative if applicable) provides written
informed consent for the trial.

12. Adequate organ function as defined below. Specimens must have been collected within 7
days prior to the start of study treatment:

- Absolute neutrophil count (ANC) =1500/µL

- Platelets =100,000/µL

- Hemoglobin =9.0 g/dL or =5.6 mmol/L (without packed red blood cell transfusion
within the last 2 weeks)

- Creatinine OR measured or calculated creatinine clearance (GFR can be used in
place of CrCl) =1.5 x ULN OR =45 mL/min for participant with creatinine levels
>1.5 x institutional ULN (Creatinine clearance should be calculated per
institutional standard.)

- Total bilirubin =1.5 x ULN OR direct bilirubin =ULN for participants with total
bilirubin levels > 1.5 x ULN

- AST (SGOT) and ALT (SGPT) =2.5 x ULN

- International normalized ratio (INR) OR prothrombin time (PT) =1.5 x ULN unless
participant is receiving anticoagulant therapy as long as PT or aPTT is within
therapeutic range of intended use of anticoagulants

- Activated partial thromboplastin time (aPTT) =1.5 x ULN unless participant is
receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range
of intended use of anticoagulants

Exclusion Criteria:

1. Prior therapy with an immune checkpoint inhibitor.

2. A WOCBP who is pregnant or breastfeeding or has a positive pregnancy test within 72
hours prior to receiving study treatment.

3. Not willing to use an effective method of birth control as defined in the protocol.

4. Known liver, bone, or CNS metastases and/or carcinomatous meningitis.

5. Diagnosis of other carcinomas within the last 2 years, except cured non-melanoma skin
cancer, treated thyroid cancer, curatively treated in-situ cervical cancer, or
localized prostate cancer treated curatively with no evidence of biochemical or
imaging recurrence.

6. Documented history of clinically significant autoimmune disease or syndrome that
requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, type 1
diabetes mellitus, psoriasis not requiring systemic treatment, well-controlled
hypothyroidism, or conditions not expected to recur in the absence of an external
trigger are permitted to enroll.

7. Any history of chronic or autoimmune pancreatitis.

8. Known history of or any evidence of active, non-infectious pneumonitis.

9. Current use of medications specified by the protocol as prohibited for administration
in combination with study drug.

1. Patients with a condition requiring systemic treatment with either
corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive
medications within 14 days prior to the start of study drug are not eligible.

2. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily
prednisone equivalents are permitted in the absence of active autoimmune disease.

3. Corticosteroids administered as pre-medication for IV contrast allergy are also
allowed.

10. Received a live vaccine within 30 days prior to the start of study drug.

1. Seasonal influenza vaccines for injection are generally killed virus vaccines and
are allowed. However, intranasal influenza vaccines (e.g. Flu-Mist) are
live-attenuated vaccines, and are not allowed within 28 days of study treatment.

2. COVID-19 vaccines will be allowed. However, COVID-19 vaccines are not allowed
within 7 days of starting study drug treatment.

11. Recent or current active infectious disease requiring systemic antivirals,
antibiotics, or antifungals, or treatment within 2 weeks prior to the start of study
drug.

12. Concurrent severe and/or uncontrolled medical conditions, which may compromise
participation in the study, including impaired heart function or clinically
significant heart disease.

13. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to the start of study drug (56 days for hepatectomy, open thoracotomy, major
neurosurgery) or anticipation of need for major surgical procedure during the course
of the study.

14. Serious, non-healing wound, ulcer, or bone fracture.

15. Patients with a history of organ or allogenic hematopoietic stem cell transplantation.

16. Partial or complete bowel obstruction within the last 3 months, signs/ symptoms of
bowel obstruction, or known radiologic evidence of impeding obstruction.

17. Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the
last 4 weeks or =4 times within the last 90 days or =1 time within the last 2 weeks
prior to study entry or requiring diuretics within 2 weeks of study entry.

18. Positive tuberculosis test at screening.

7.
ClinicalTrials.gov; 11/02/2024; TrialID: NCT06255600
Clinical Trial Register | ICTRP | ID: ictrp-NCT06255600

ABSTRACT

Condition:

Cardiovascular Diseases;Long Covid19

Intervention:

Other: High Definition-transcranial Direct Current Stimulation;Dietary Supplement: Chlorella Pyrenoidosa

Primary outcome:

Increasead B12 by blood analysis biochemical

Criteria:


Inclusion Criteria:

- Patients with cardiovascular diagnosis or risk;

- Adults and elderly people (18 to 80 years old);

- Able to respond to commands and grant consent to participate in the research through
the informed consent form;

- Who have post-COVID symptoms.

Exclusion Criteria:

- Patients with a clinical history of neuromuscular or cognitive instability, pregnancy
and contraindications for receiving neurostimulation (such as cardiac pacemakers and
metallic brain implants);

- Patients with contraindications to the use of Chlorella (gastritis, esophagitis,
peptic ulcers),

- Pregnant patients, patients with stroke and tumors


8.
ClinicalTrials.gov; 09/02/2024; TrialID: NCT06265012
Clinical Trial Register | ICTRP | ID: ictrp-NCT06265012

ABSTRACT

Condition:

Marburg Virus Disease

Intervention:

Biological: PHV01;Biological: Placebo

Primary outcome:

Solicited Adverse Events (AEs);Unsolicited AEs;Other AEs;Immunogenicity, Antibodies (Ab);Immunogenicity, Neutralizing antibodies (NEUT)

Criteria:


Inclusion Criteria:

- Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years

- Given written informed consent

- No clinically significant health problems

- Negative test for SARS-CoV-2

- Agree to avoid conception through Day 29

- Agree to minimize blood and body fluid exposures to others after vaccination through
Day 29

- Agree to avoid exposure to immunocompromised persons after vaccination through Day 29

Exclusion Criteria:

- Prior infection with Marburg virus, related filovirus, or Ebola virus

- Prior infection with vesicular stomatitis virus (VSV)

- Received any VSV-vectored vaccine

- BMI of = 35

- Household contact who is immunodeficient, or on immunosuppressive medication

- Hepatitis B, hepatitis C, HIV-1, HIV-2, history of long COVID, diabetes, atopic
dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory
disorder, malignancy, chronic or active neurologic disorder

- History of severe reactions to any vaccine or history of severe allergies

- Receipt of investigational product up to 30 days prior to randomization

- Receipt of licensed or authorized non-live vaccines within 14 days of planned study
immunization (30 days for live vaccines).

- Known allergy to components of PHV01

- Injection sites obscured by tattoos or physical condition

- Significant psychiatric or medical condition or laboratory abnormality on screening

- History of Guillain Barre Syndrome or any chronic or acute neurological disorder

- Alcohol or illicit drug abuse within past 5 years

- Pregnant or lactating female

- Administration of blood or IgG within 60 days preceding study

- Administration of systemic chronic immunosuppressants (defined as more than 14 days)
or other immune modifying drugs within 6 months of study entry

- History of blood donation within 60 days of study

- Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or
joint symptoms (arthrocentesis if indicated by joint effusion), in both cases if
acceptable to subject

- Elective surgery planned during the study period


9.
ClinicalTrials.gov; 08/02/2024; TrialID: NCT06255626
Clinical Trial Register | ICTRP | ID: ictrp-NCT06255626

ABSTRACT

Condition:

COVID-19

Intervention:

Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)

Primary outcome:

Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration;Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1

Criteria:


Inclusion Criteria:

- Healthy volunteers Age =18 and <85

- Able to understand and comply with planned study procedures and sign an informed
consent before performance of any study-related screening procedures

- Who has received a primary series of vaccination and = 1 booster(s) of COVID-19 mRNA
vaccination(s) with the last boost at least 6 months prior to the inclusion in the
study

- Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline
phosphatase

- Normal haematology lab values

- Negative virology assessment

- Normal Urine testing

- Volunteers must meet the eligibility criteria in the approved package labelling of the
active comparator

- For women of childbearing potential: use of an effective contraceptive method and
negative pregnancy test. For male participants, use of an effective method of
contraception with their partner

Exclusion Criteria:

- Acute febrile infection within the previous 72 hours and/or presenting symptoms
suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days

- Immunosuppressive medications received within last three months before first IMP
administration or within 6 months for chemotherapies

- Immunoglobulins within 90 days before first IMP administration

- Blood products within 120 days before first IMP administration

- Any medical condition, such as cancer, that might impair the immune response

- Use of any experimental therapy

- Intent to participate in another study of an investigational research agent within 4
weeks prior to the enrolment visit or until the end of the study

- Currently pregnant or breastfeeding

- History of severe adverse events following vaccine administration

- Any bleeding disorder considered as a contraindication to an intramuscular injection

- A condition that requires active medical intervention or monitoring to avert grave
danger to Asthma other than mild, well-controlled asthma.

- Hypertension

- BMI = 40 kg/m2; = 18 kg/m2; or BMI = 35 kg/m2 with 2 or more of the following: age >
45, current smoker, known hyperlipidemia, blood pressure is defined as consistently =
140 mm Hg systolic and = 90 mm Hg diastolic

- Malignancy

- Asplenia

- Seizure disorder

- History of hereditary angioedema acquired angioedema, or idiopathic angioedema

- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with
permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring
medication, treatment, or clinical follow-up

- History of autoimmune disease

- Any medical, occupational, or other condition that, in the judgment of the
investigator, would interfere with or serve as a contraindication to protocol
adherence

- Psychiatric condition that precludes compliance with the protocol.

- Live attenuated vaccines received within 30 days before first IMP administration or
scheduled within 28 days after one of the last injection according to the protocol

- Vaccines that are not live attenuated vaccines and were received within 21 days prior
to first IMP administration

- Allergy treatment with antigen injections within 30 days before first IMP
administration and until the end of the study


10.
ClinicalTrials.gov; 07/02/2024; TrialID: NCT06251011
Clinical Trial Register | ICTRP | ID: ictrp-NCT06251011

ABSTRACT

Condition:

COVID-19;Long COVID-19;Cardiopulmonary Function;Physical Function

Intervention:

Behavioral: Exercise training

Primary outcome:

Cardiopulmonary function;Patient's quality of life;Functional capacity;Anxiety and depression;Insomnia;Cognitive function;Muscle strength

Criteria:


Inclusion Criteria:

- Age between 20-60 years old

- Positive in COVID-19 testing

- Good communication and understanding

- Independent mobility

Exclusion Criteria:

- Cannot complete the study protocol


11.
ClinicalTrials.gov; 06/02/2024; TrialID: NCT06248151
Clinical Trial Register | ICTRP | ID: ictrp-NCT06248151

ABSTRACT

Condition:

Post-Acute COVID-19 Syndrome

Intervention:

Behavioral: Exercise session;Behavioral: Control session

Primary outcome:

Change in Blood pressure;Change in Heart rate variability;Change in flow mediated dilation;Change in peak exhalation flow;Change in oxygen saturation

Criteria:


Inclusion Criteria:

Post-Covid Syndrome group:

- have had a positive RT-PCR test for Covid-19;

- present persistent symptoms of Post Covid 19 syndrome, which have no other health
explanation according to the criteria of the World Health Organization (WHO);

- have the cognitive and physical capacity to perform the exercises; It is

- low cardiovascular risk classification according to the American College of Sports
Medicine criteria.

Healthy group:

- not present persistent symptoms of Post Covid 19 syndrome, which have no other health
explanation according to the criteria of the World Health Organization (WHO);

- have the cognitive and physical capacity to perform the exercises; It is

- low cardiovascular risk classification according to the American College of Sports
Medicine criteria.


12.
ClinicalTrials.gov; 06/02/2024; TrialID: NCT06258265
Clinical Trial Register | ICTRP | ID: ictrp-NCT06258265

ABSTRACT

Condition:

Healthy Volunteers

Intervention:

Drug: TAK-279;Drug: TAK-279 Placebo;Drug: Moxifloxacin;Drug: Moxifloxacin Placebo

Primary outcome:

Placebo-corrected Change From Baseline in QTc Interval (??QTc) for TAK-279

Criteria:


Inclusion Criteria:

1. Understand the study procedures in the informed consent form (ICF) and be willing and
able to comply with the protocol.

2. Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.

3. Female participants of childbearing potential must follow protocol specified
contraception guidance as described in protocol.

4. Continuous non-smoker who has not used nicotine- and tobacco-containing products for
at least 3 months prior to the first baseline cardiodynamic measurement (Day -1) based
on participant self-reporting.

5. BMI greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilograms
per meter square (kg/m^2) at the screening visit.

6. Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as
deemed by the Investigator or designee, including the following:

- Supine blood pressure is >=90/40 millimeter of mercury (mmHg) and <=140/90 mmHg
at the screening visit.

- Supine pulse rate is >=40 beats per minute (bpm) and <=99 bpm at the screening
visit.

- QTc using Fridericia's formula (QTcF) interval is <=450 milliseconds (msec)
(males) and <=460 msec (female) at the screening visit.

- QRS interval <=110 msec at the screening visit (if >110 msec, result will be
confirmed by a manual over read).

- PR interval <=220 msec at the screening visit.

- eGFR >=80 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) at the
screening visit.

- Liver function tests including alanine aminotransferase (ALT), aspartate
aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin <=upper
limit of normal (ULN) at the screening visit and at check-in.

- No clinically significant hypokalemia, hypomagnesemia, or other electrolyte
abnormalities at the screening visit.

Exclusion Criteria:

1. Is mentally or legally incapacitated or has significant emotional problems at the time
of the screening visit or expected during the conduct of the study.

2. History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the Investigator or designee.

3. History of any illness that, in the opinion of the Investigator or designee, might
confound the results of the study or poses an additional risk to the participant by
their participation in the study.

4. Has a history of any of the following:

- Active infection or febrile illness within 7 days prior to first baseline
cardiodynamic measurement (Day -1), as assessed by the Investigator or designee.

- Symptoms suggestive of systemic or invasive infection requiring hospitalization
or treatment within 8 weeks prior to first baseline cardiodynamic measurement
(Day -1).

- Chronic or recurrent bacterial disease, including but not limited to chronic
pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or
chronic skin ulcerations/infections or fungal infections (except superficial
nailbed mycosis).

- An infected joint prosthesis unless that prosthesis has been removed or replaced
greater than 60 days prior to first baseline cardiodynamic measurement (Day -1).

- Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis,
coccidiomycosis).

- Cancer or lymphoproliferative disease within 5 years prior to first baseline
cardiodynamic measurement (Day -1), with the exception of successfully treated
nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized
carcinoma in situ of the cervix is not exclusionary.

- Known or suspected condition/illness that is consistent with compromised
immunity, including but not limited to any identified congenital or acquired
immunodeficiency; splenectomy.

- Liver, kidney, heart, or other solid organ transplant.

- Myasthenia gravis.

- Peripheral neuropathy.

5. Has history or presence of alcoholism and/or drug abuse within the past 2 years prior
to first baseline cardiodynamic measurement (Day -1), as determined by the
Investigator or designee.

6. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.

7. Allergy to band aids, adhesive dressing, or medical tape.

8. History or presence of any of the following, deemed clinically relevant by the
Investigator or designee at the screening visit or at check-in:

- Cardiac disease; arrhythmias, presyncope, or syncopal episodes; heart failure,
heart disease or risk factors for torsades de pointes (including long QT syndrome
or family history of long QT syndrome).

- Sick sinus syndrome, second or third degree atrioventricular block, myocardial
infarction, pulmonary congestion, history of cardiac arrhythmia, prolonged QTcF
interval, or conduction abnormalities.

- Ischemic heart disease, poorly controlled hypertension, or other cardiovascular
disorder

- T wave flattening or other abnormalities which in the opinion of the Investigator
or designee may interfere with the analysis of QT intervals.

- A family history of sudden cardiac death.

9. Female participant with a positive pregnancy test at the screening visit or at
check-in or who is breastfeeding and/or lactating.

10. Positive urine drug or alcohol results at the screening visit or at check-in.

11. Positive Coronavirus disease 2019 (COVID-19) result at check-in.

12. Unable to refrain from or anticipates the use of:

- Any drugs, including prescription and non-prescription medications, herbal
remedies, or vitamin supplements, including any cytochrome P450 (CYP)3A4
inhibitors, beginning 14 days prior to the first baseline cardiodynamic
measurement (Day -1).

- Any drugs known to be inducers of CYP3A4 enzymes and/or P-glycoprotein (P-gp),
including St. John's Wort, for 28 days prior to the first baseline cardiodynamic
measurement (Day -1). Appropriate sources (eg, Flockhart Table™) including the
product label for moxifloxacin (Avelox [moxifloxacin hydrochloride] tablets and
intravenous injection 2020) will be consulted to confirm lack of pharmacokinetic


13.
ClinicalTrials.gov; 05/02/2024; TrialID: NCT06259578
Clinical Trial Register | ICTRP | ID: ictrp-NCT06259578

ABSTRACT

Condition:

COVID-19 Pandemic;COVID-19 Vaccines;COVID-19 Virus Disease

Intervention:

Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µg

Primary outcome:

Humoral Immune Reponse

Criteria:


Inclusion Criteria:

1. Healthy adults and elderly, males and females, 18 years of age and above. Healthy
status will be determined by the investigator based on medical history, clinical
laboratory results, vital sign measurements, and physical examination at screening.

2. Subjects already received 2 (two) doses of INAVAC vaccines (5 ug), mostly during the
phase I/II/III clinical trial of this vaccine. The interval between the second primary
injection and the booster is 12-18 months.

3. Subjects have been informed properly regarding the study and signed the informed
consent form

4. Subjects will commit to comply with the instructions of the investigator and the
schedule of the trial

5. Female subjects of childbearing potential must agree to postpone pregnancy from at
least 21 days before enrollment and through 6 months after the vaccination.

6. Participants agree not to donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the vaccine.

7. Participants must be willing to provide verifiable identification, have means to be
contacted and to contact the investigator during the study.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial

2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever
(axillary temperature 37.5oC or more) concurrently or within 7 days before study
vaccination. This includes respiratory or constitutional symptoms consistent with
SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)

3. Known history of allergy to any component of the vaccines

4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular
injection

5. Any autoimmune or immunodeficiency disease/condition

6. Subjects who have received in the previous 4 weeks a treatment likely to alter the
immune response (intravenous immunoglobulin, blood-derived products, long-term
corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for
immunosuppressive treatment within 6 months after last vaccination. The use of topical
or nasal steroids will be permitted. Inhaled glucocorticoids are prohibited.

7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart
failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, and
diabetes requiring the use of medicine. The final decision regarding this condition
will be made by the attending field clinicians or investigators.

8. Any abnormality or chronic disease which according to the investigator might interfere
with the assessment of the trial objectives

9. Individuals who previously received any vaccines against Covid-19, other than INAVAC.

10. Subjects already immunized with any other vaccines within 4 weeks prior and expect to
receive other vaccines within 60 days following the booster dose

11. Individuals who have a previously ascertained COVID-19 in 1 month (for mild, moderate,
or asymptomatic people) or 3 months (for severe COVID-19) before the first recruit of
this study, or in close contact in the last 14 days with a confirmed case of Covid-19.

12. Positive test for SARS-CoV-2 (Antigen or PCR) at screening before the vaccination.
Testing may be repeated during the screening period if exposure to a positive
confirmed case of SARS-CoV-2 is suspected, at the discretion of the investigator.

13. History of alcohol or substance abuse

14. HIV patients.

15. Malignancy patients within 3 years before study vaccination.

16. Any neurological disease or history of significant neurological disorder such as
meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc

17. Vital sign abnormalities and clinical laboratory abnormalities as decided by the
investigators. Vital sign measurements and clinical laboratory testing may be repeated
before the final decision.

18. Women who are pregnant or who plan to become pregnant during the study.

19. Participant has a major psychiatric problem or illness

20. Participant cannot communicate reliably with the investigator

21. Participant has contraindications to intramuscular injection and blood draws, such as
bleeding disorders or phobia.

22. The participant had major surgery within 12 weeks before vaccination which will not be
fully recovered, or has major surgery planned during the time the participant is
expected to participate in the study or within 6 months after the last dose of study
vaccine administration.

23. Any condition that in the opinion of the investigators would pose a health risk to the
subject if enrolled or could interfere with the evaluation of the vaccine or
interpretation of the study results

24. Study team members.

25. Subject planning to move from the study area before the end of the study period.


14.
ClinicalTrials.gov; 04/02/2024; TrialID: NCT06256003
Clinical Trial Register | ICTRP | ID: ictrp-NCT06256003

ABSTRACT

Condition:

Attention Deficit Hyperactivity Disorder

Intervention:

Device: UC-A;Device: UC-N

Primary outcome:

Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)

Criteria:


Inclusion Criteria:

- The participant is aged 18-50 years at time of consent

- Fluent in English.

- Available for 2 contiguous months to participate in study, including 3 in-person
visits to the university.

- Able to sit in a regular chair for 30 minutes in a small room for testing.

- Able to use a keyboard with both hands.

- Normal or corrected to normal vision and hearing.

- Have a smart Phone.

- Estimated Intelligence Quotient (IQ) > 80 as assessed by the Wechsler Abbreviated
Scale Intelligence (WASI-II) Matrix Reasoning and Vocabulary subtests.

- Meet established Diagnostic and Statistical Manual of Mental Health-Fifth Edition
(DSM-5-TR) presentation for ADHD predominantly inattentive or combined subtype with
clinically significant levels of impairment, diagnosed by semi-structured clinical
interview and the Adult ADHD Clinical Diagnostic Scale (ACDS).

Exclusion Criteria:

- History of diagnosis of childhood neurodevelopmental disorder including autism
spectrum disorder and dyslexia, other than ADHD or those specifically allowed in the
Allowed Disorders section.

- Lifetime history of DSM5 bipolar disorder, psychotic disorder, panic disorder,
agoraphobia, obsessive compulsive disorder as assessed with the MINI International
Neuropsychiatric Interview (MINI).

- Current DSM5 diagnosis of posttraumatic stress disorder, or Major Depressive Disorder
or Major Depressive Episode via self-report or as assessed with the MINI.

- Current Persistent Depressive Disorder (Dysthymia) or Anxiety Disorder if not on
allowed medication that has been at a stable dose for at least 8 weeks (if on allowed
medication with stable dose for 8 weeks, then allow).

- Substance or Alcohol Use Disorder rated as moderate or severe, with symptoms = 4, as
assessed by the MINI, or self-report of a Substance/Alcohol Use Disorder (allow
endorsement of substance or alcohol use that does not meet moderate-severe use
disorder criterion, if clean at visit).

- History of severe sleep disorder, narcolepsy, epilepsy/seizure disorder, brain tumor,
stroke, TBI, severe concussion resulting in loss of consciousness and hospitalization,
serious oxygen deprivation (such as following heart attack, carbon monoxide poisoning,
near drowning or near suffocation), encephalitis, meningitis, or other major
neurological disorder.

- History of chronic fatigue syndrome, Long-COVID.

- Other medical or psychiatric conditions that are sufficient to likely compromise
current attentional function and assessment in the opinion of the investigator.

- Current ongoing treatment, deemed by the participant and their PCP as indicated for
continued use during the study, with psychotropics suspected to alter attentional
functioning such as antipsychotic medications, sedative hypnotics, mood stabilizers,
benzodiazepines, atypical antidepressants, or anticonvulsants (listed in the Excluded
Medications List, or in the opinion of the investigator are likely to interfere with
study cognitive assessments).

- Participant is currently considered a suicide risk in the opinion of the Investigator,
has previously made a suicide attempt, or has a prior history of, or is currently
demonstrating active suicidal ideation or self-injurious behavior as measured by
Columbia Suicide Severity Rating Scale at screening.

- Current treatment with guanfacine (due to the unacceptable risks of rapid withdrawal)
and other medications for focus and attention problems such as Strattera, Modafinil,
Armodafinil, and Clonidine that require long wash out periods (see Excluded ADHD
Medications List).

- Participant plans to initiate during the primary study new concomitant prescription
medications that are on the Excluded Medications List.

- Participant plans to initiate during the primary study behavioral therapy or training
to improve cognition by means of game or app-based cognitive trainings or
neurofeedback.


15.
ClinicalTrials.gov; 31/01/2024; TrialID: NCT06247332
Clinical Trial Register | ICTRP | ID: ictrp-NCT06247332

ABSTRACT

Condition:

Post-acute COVID-19 Syndrome

Intervention:

Other: Review of available clinical data sources related to use cases

Primary outcome:

Retrospective SENSING-AI cohort

Criteria:


Inclusion Criteria:

- Legal adult

- Diagnosed of long COVID-19 in the last year

- With the presence of any of these symptoms:

- Asthenia (Tiredness)

- Dyspnea

- Shortness of breath

- Anxiety

- Stress

- Depression

- Sleep disorder

Exclusion Criteria:

- Attended to specialized care consultation

- Was admitted in hospital in the last year due to a problem not related to the COVID
complications


16.
ClinicalTrials.gov; 31/01/2024; TrialID: NCT06262880
Clinical Trial Register | ICTRP | ID: ictrp-NCT06262880

ABSTRACT

Condition:

Intestinal Permeability

Intervention:

Dietary Supplement: plant derived phenolics;Other: Microcrystaline cellulose (MCC)

Primary outcome:

0-2 h urine 13C Mannitol excretion

Criteria:


Inclusion Criteria:

1. Male or female, 30-69 years of age, inclusive at Visit 1 (Day -7).

2. BMI of =29.0 to <40.0 kg/m2 at Visit 1 (Day -7).

3. Waist circumference >102 cm for men and >88 cm for women.

4. Non-user or former user (cessation =12 months) of tobacco or nicotine products (e.g.,
cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the
study period.

5. Non-user of marijuana or hemp products within 6 months of Visit 1, with no plans to
begin use during the study period. A washout of 7 days is required for topical
products (e.g., lotions) and willing to refrain from use during the study.

6. Willing to maintain physical activity and exercise patterns, body weight, and habitual
diet throughout the trial.

7. Willing to refrain from exclusionary medications, supplements, and products throughout
the study.

8. No health conditions that would prevent him/her from fulfilling the study requirements
as judged by the Clinical Investigator on the basis of medical history and routine
laboratory test results.

9. Understands the study procedures and signs forms providing informed consent to
participate in the study and authorizes the release of relevant protected health
information to the Clinical Investigator.

Exclusion Criteria:

1. Known sensitivity, intolerance, or allergy to any of the study products or their
excipients.

2. Abnormal chemistry or hematology laboratory test result(s) of clinical significance at
Visit 1 (Day -7), at the discretion of the Clinical Investigator. One re-test will be
allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal
laboratory test results.

3. Clinically important diagnosed GI condition that would potentially interfere with the
evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel
syndrome, gastroparesis / malabsorption conditions, eosinophilic disorders of the GI
tract, and clinically significant lactose or gluten intolerance or other food
allergies).

4. Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness
such as nausea/vomiting or diarrhea (defined as =3 loose or liquid stools/d).

5. Self-reported history (within 6 weeks of Visit 1; Day -7) of constipation (defined as
<3 bowel movements per week).

6. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma),
cardiac (including, but not limited to, atherosclerotic disease, history of myocardial
infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including
Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (e.g.,
Parkinson's disease, multiple sclerosis, etc.), psychiatric (including depression
and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled
or resolved will be assessed by the Clinical Investigator on a case-by-case basis.

7. Uncontrolled hypertension (systolic blood pressure =140 mm Hg or diastolic blood
pressure =90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7).
Stable use of hypertension medication is allowed [defined as no change in medication
regimen within the 3 months prior to Visit 1 (Day -7)].

8. Received a COVID-19 vaccine within 2 weeks of Visit 1 (Day -7) or expect to receive a
COVID-19 vaccine during the study period.

9. Received an influenza vaccine within 1 week of Visit 1 (Day -7). Influenza vaccine is
allowed during the study but must not be received within 7 days prior to a study
visit.

10. Had a positive SARS-CoV2 test and experienced symptoms for >2 months (i.e.,
"long-haulers").

11. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber,
vegan/vegetarian) at the discretion of the Clinical Investigator.

12. History or presence of cancer (including any malignant GI polyps) within 2 years of
Visit 1 (Day -7), except for non-melanoma skin cancer.

13. Major trauma or any other surgical event, including abdominal surgery which might
influence GI function, within 3 months of Visit 1 (Day -7).

14. Signs or symptoms of an active infection of clinical relevance* within 5 days of Visit
1 (Day -7). The visit may be rescheduled such that all signs and symptoms have
resolved (at the discretion of the Clinical Investigator) at least 5 days prior to
Visit 1 (Day -7).

15. Antibiotic use within 1 month of Visit 1 (Day -7) and throughout the study period.

16. Regular use (i.e., >3 days/week) of anti-inflammatory medications (e.g., NSAIDS)
within 1 month of Visit 1 (Day -7).

17. Use of medications (over-the-counter or prescription) and/or dietary supplements known
to influence GI function, including but not limited to, pre- and probiotic supplements
as well as foods or beverages containing live probiotics (e.g., yogurt, kombucha),
fiber supplements, laxatives, enemas, suppositories, histamine H2 receptor
antagonists, proton pump inhibitors, antacids, anti-diarrheal agents, and/or
anti-spasmodic within 2 weeks of Visit 1 (Day -7) and throughout the study period.
Standard multivitamin and mineral supplements are allowed.

18. Had a colonoscopy or endoscopy within 1 month prior to Visit 1 (Day -7).

19. Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7).

20. Female who is pregnant, planning to be pregnant during the study period, lactating, or
is of childbearing potential and is unwilling to commit to the use of a medically
approved form of contraception throughout the study period. Subjects who are pregnant
during the study will be discontinued.

21. Female subjects who is unwilling to wear a tampon during the collection of the 24-h
urine samples when these collections occur during the time of menstruation

22. Recent history (within 12 months of screening; Visit 1; Day -7) of alcohol or
substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz
beer, 5 oz wine, or 1½ oz distilled spirits).

23. Has a condition the Clinical Investigator believes would interfere with his ability to
provide informed consent, comply with the study protocol, which might confound the
interpretation of the study results, or put the subject at undue risk.

- If an infection occurs during the study period, test visits will be rescheduled
until signs and symptoms have resolved (at the discretion of the Clinical
Investigator) at least 5 days prior to the scheduled study visits.


17.
ClinicalTrials.gov; 29/01/2024; TrialID: NCT06231238
Clinical Trial Register | ICTRP | ID: ictrp-NCT06231238

ABSTRACT

Condition:

Post-COVID-19 Syndrome;Long COVID

Intervention:

Behavioral: Balance Acceptance and Commitment Therapy

Primary outcome:

36-item Short Form Health Survey (SF-36)

Criteria:


Inclusion Criteria:

1. Age 18 or older

2. LC/PCS diagnosis as defined by National Health Service (NHS) / National Institute for
Health and Care Excellence (NICE) (i.e., symptoms that develop during or after an
infection consistent with COVID-19, continue for more than 12 weeks and are not
explained by an alternative diagnosis). A checklist will be used to ensure
participants fulfil the diagnostic criteria as per the NICE guidelines

3. Ability to travel to the research site for the study assessments

4. Consent to wear a smartwatch throughout the study

5. Having registered with a General Practitioner (GP) in the United Kingdom (UK) and
consent to provide their details for the study team to contact

6. Ability to provide informed consent

7. Ability to read and write English

Exclusion Criteria:

1. Current diagnosis of an active major mental health disorder likely to interfere with
participation

2. Unstable alcohol / drug dependency

3. Unstable complications associated with LC/PCS

4. Past hospitalisation for COVID-19

5. Current or recent participation in other treatment intervention studies (<4 weeks
after completion)

6. Currently receiving psychological support or psychotherapy

7. Implanted medical devices (ie., Pacemaker/defibrillator or implanted
neurostimulator/infusion device; implanted metal objects; artificial hip/knee
replacement, spinal surgery; cardiac surgery requiring the placement of metal clips,
valves or wires)

8. Pregnancy


18.
ClinicalTrials.gov; 28/01/2024; TrialID: NCT06245538
Clinical Trial Register | ICTRP | ID: ictrp-NCT06245538

ABSTRACT

Condition:

Healthy Adults;Adults With Stress-related Symptoms

Intervention:

Behavioral: Seated rest;Behavioral: Exercise at moderate intensity;Behavioral: Exercise at vigorous intensity

Primary outcome:

Changes in cerebral blood flow in prefrontal cortex

Criteria:


Inclusion Criteria:

For participants both with and without stress-related symptoms:

- Age: 20-40 years

- Absence of contraindications to physical exercise

- Do not participate in any other study

For participants with stress-related symptoms:

• Total score on the self-assessment scale 4-factor Shirom-Melamed Burnout Measure-19
greater than or equal to 2.95 but lower than 4.00

For healthy controls:

• Total score on the self-assessment scale 4-factor SMBM-19 lower than or equal to 2.21

Exclusion Criteria:

For participants both with and without stress-related symptoms:

- Medical contraindication to catheterization of the antecubital vein and blood sampling

- Dementia

- Alcohol abuse

- Smoking

- Chronic medication that is considered to affect study outcomes

- Chronic disease/syndrome such as migraine, fibromyalgia, chronic fatigue syndrome,
bipolar syndrome, high blood pressure, cardiovascular disease, chronic obstructive
pulmonary disease (COPD) or other lung disease

- Post-COVID

- Other somatic diseases, disorders, or injuries that may affect the physical ability
during physical exercise

Exclusively for healthy controls:

• Depression (HAD depression score < 8) and anxiety (HAD anxiety score < 8)


19.
ClinicalTrials.gov; 26/01/2024; TrialID: NCT06231225
Clinical Trial Register | ICTRP | ID: ictrp-NCT06231225

ABSTRACT

Condition:

COVID-19 Pandemic;Diabetes;Hypertension;Cardiac Disease;Long COVID

Intervention:

Behavioral: Incentive Spirometer respiratory training

Primary outcome:

Post-COVID-19 Functional Status scale

Criteria:


Inclusion Criteria:

1. Individuals who have contracted and recovered from COVID-19 within the past year must
present proof of diagnosis, such as medical certificates or screening results. The
ICD-10 diagnosis codes are: U07.1 for confirmed COVID-19 viral infection, and U09.0
for post-COVID-19 condition, unspecified. Recovery is defined as testing negative in a
COVID-19 rapid test.

2. Never diagnosed with hypertensive diseases (ICD-10 codes: I10.x or I11.x), diabetes
(ICD-10 codes: E10.x or E11.x), or heart diseases (ICD-10 codes: I25.x, I50.x, I65.x,
or I67.x and classified as Class I or II by the New York Heart Association functional
classification).

3. Exhibiting long-term respiratory symptoms related to COVID-19, such as post-exertional
breathlessness, chest discomfort, cough, difficulty breathing, rapid breathing, etc.,
and meeting at least one of these criteria for inclusion.

4. Aged between 20 - 90 years.

5. Able to communicate in and understand Mandarin or Taiwanese, either verbally or
non-verbally.

6. Willing to participate in the study and agree to be assigned.

Exclusion Criteria:

1. Patients with a functional status classified as level 5 or higher on the Modified
Rankin Scale (MRS), indicating severe disability and bedridden status.

2. Patients suffering from dementia, such as Alzheimer's, Parkinson's disease, etc.

3. Patients with acute psychiatric symptoms who are unable to communicate.

4. Individuals with a high risk of litigation.

5. Patients suffering from Chronic Obstructive Pulmonary Disease (COPD) or any other
respiratory system diseases.

6. Patients with moderate or severe heart disease, classified as Class III or IV by the
New York Heart Association functional classification.

-


20.
ClinicalTrials.gov; 25/01/2024; TrialID: NCT06234449
Clinical Trial Register | ICTRP | ID: ictrp-NCT06234449

ABSTRACT

Condition:

Pelvic Organ Prolapse;Vaginal Prolapse

Intervention:

Procedure: Vaginal pessary before surgery for pelvic organ prolapse

Primary outcome:

evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation.

Criteria:


Inclusion Criteria:

- Pelvic organ prolapse with POP-Q stage >/= 3 in anterior and/or central compartments

- Women between 45 and 80 years old

Exclusion Criteria:

- Women who refuse to participate in the study

- Patients without baseline POPQ examination documented or with a pessary previously
positioned

- Previous pelvic surgeries

- Women with any contraindication for surgery or preference for conservative treatment
only (pelvic muscle exercise, vaginal pessary)

- Women who are not successfully fitted with pessaries

- Current genital ulcers/infections

- Active or chronic pelvic infection

- Women who are mentally incapable of completing the questionnaires.


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