1.
ClinicalTrials.gov; 11/01/2024; TrialID: NCT06216600
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06216600
ABSTRACT
Condition:
HIV Infections;Substance Use;Trauma;Medication AdherenceIntervention:
Behavioral: Acceptance and Commitment Therapy (ACT);Behavioral: Body weight circuit training;Behavioral: Empathetic social support;Other: Control - list of resourcesPrimary outcome:
Antiretroviral therapy (ART) adherence by drug levelsCriteria:
Inclusion Criteria:
1. Is female sex at birth (cis-women)
2. Able to read and understand English
3. Able to participate in a low intensity exercise program
4. HIV-seropositive
5. At risk substance use (any illegal or unprescribed drug), tobacco, marijuana or
alcohol use (four or more drinks in one day or 8 or more in one week).
6. Reports missing more ART doses than previous months, or > 5 in a month, or has a
detectable HIV viral load
7. Experienced interpersonal violence
8. Able and willing to provide informed consent
9. Confirmed COVID-19 vaccinated x 2 or willingness to wear a mask during inperson
interactions.
Exclusion Criteria:
1. Unwilling to participate in video record sessions (used to evaluate the quality of the
intervention)
2. Enrolled in hospice
3. Not willing or not able to comply with study advisory board group participation
agreement.
2.
ClinicalTrials.gov; 28/03/2023; TrialID: NCT05841810
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05841810
ABSTRACT
Condition:
COVID-19Intervention:
Other: mHealth Outreach;Other: Care CoordinationPrimary outcome:
COVID-19 vaccination rate;COVID-19 vaccination rate;COVID-19 vaccination rate;COVID-19 vaccination rateCriteria:
Inclusion Criteria:
- Age 18 years or older.
- Speaks Spanish, Arabic and/or Vietnamese.
- Current San Ysidro Health patient and receives care at select clinics in study
locations (Escondido, El Cajon, Community Heights).
Exclusion Criteria:
- Not able to provide informed consent.
- < 18 years old
- Does not speak Spanish, Arabic or Vietnamese
- Is not a current San Ysidro Health patient or is a current San Ysidro Health patient
but does not receive care at select clinics in study locations (Escondido, El Cajon,
Community Heights).
3.
ClinicalTrials.gov; 02/03/2023; TrialID: NCT05894655
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05894655
ABSTRACT
Condition:
COVID-19;COVID-19 PandemicIntervention:
Behavioral: COVID-19 walk-up, on-site testing strategy;Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders;Behavioral: No-cost self-testing kit vending machinesPrimary outcome:
Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.Criteria:
Inclusion Criteria:
- Speak English and/or Spanish
- Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, Chula
Vista, Lincoln Park, and Logan Heights) OR
- A member of a community near a San Ysidro Health clinic (San Ysidro, Chula Vista,
Lincoln Park, and Logan Heights).
Exclusion Criteria:
- Institutionalization for psychiatric disorder, developmental delay, or criminal
activity.
- Unable to provide informed consent.
4.
ClinicalTrials.gov; 29/11/2022; TrialID: NCT05642000
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05642000
ABSTRACT
Condition:
COVID-19Intervention:
Behavioral: SASEA HUBPrimary outcome:
COVID-19 TestingCriteria:
Inclusion Criteria:
- Individuals ages 18 and above affiliated with students attending the 3 school
districts participating in the SASEA study
Exclusion Criteria:
- Children under the age of 18
5.
ClinicalTrials.gov; 19/09/2022; TrialID: NCT05553743
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05553743
ABSTRACT
Condition:
Breastfeeding;COVID-19 Infection;COVID-19 Vaccine;Remdesivir;AntibioticsIntervention:
Biological: COVID-19 Exposure;Drug: AntibioticPrimary outcome:
Human Milk Repository;Develop, maintain and manage the RepositoryCriteria:
Inclusion Criteria:
- Women who are 18 years old or older
- Breastfeeding
- Producing sufficient breast milk to donate an excess to the Biorepository
Exclusion Criteria:
- Women under 18 years old
6.
National Technical Information Service; 2020.
Non-conventional
in English
| National Technical Information Service | ID: grc-753635
ABSTRACT
The purpose of the study is to develop a blood-based TB test that meets or exceeds WHO Target Product Profiles for a rapid, biomarker-based, non-sputum triage test for detecting active TB disease. To accomplish this, activities in Year 1included improvements to the 3-gene mRNA signature and analysis of these improvements;development of a 9-genesignature;prototype cartridge development;recruitment and blood collection in Moldova;and development of a secure data transmission system. In Year 2, Aim 2 recruitment and blood collection/processing was completed in Moldova, Cepheid worked to develop two "open" prototype cartridges the Stanford 3-gene signature cartridge for non-stimulated blood, and a prototype antigen-stimulated cartridge -- and Stanford began discovery analysis toward a sub-9-gene signature using a machine learning framework. In Year 3, Cepheid will further develop the"open" prototype cartridges, complete biostatistics work necessary to lock the signatures, and assess and validate their performance;the result will be a final closed prototype cartridge which will be deployed in the field.
7.
ClinicalTrials.gov; 04/01/2022; TrialID: NCT05181657
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05181657
ABSTRACT
Condition:
Motivational InterviewingIntervention:
Behavioral: COVID-19 educationPrimary outcome:
COVID-19 TestingCriteria:
Inclusion Criteria
1. Enrolled in La Frontera,
AND
2. Report NOT having been voluntarily tested for COVID-19 outside of La Frontera or
report having had a mandatory COVID-19 test more than 2 months ago
AND
3. a) Never vaccinated OR b) Received 1 shot of the Moderna vaccine (>=1 month ago) OR c)
received 1 shot of the Pfizer vaccine (>=3 weeks ago) OR d) received 1 shot of the
Jenssen vaccine (>=2 months ago) OR e) received 2 shots of the Moderna OR Pfizer
vaccine (last shot >=5 months ago) OR f) received 1 shot of another vaccine (>=1 month
ago) OR g) received 2 shots of another vaccine (last shot >=5 months ago). NOTE:
participants who indicate that they were vaccinated but don't remember what vaccine
they received would fall under the f category if they only received one shot and under
the g category if they received 2 shots.
OR
4. Enrolled in La Frontera AND report TWO or more of the following symptoms: a) new loss
of smell or taste, b) cough, c) sore throat/congestion/runny nose, d) skin rash within
the last week without having tested positive for COVID within the last month.
OR
5. Enrolled in La Frontera AND report having EITHER fever/chills OR shortness of breath
within the last week without having tested positive for COVID within the last month.
Exclusion Criteria
1. Not enrolled in La Frontera,
AND
2. Report having been voluntarily tested for COVID-19 outside of La Frontera or report
having had a mandatory COVID-19 test less than 2 months ago
AND
3. a) Be vaccinated OR b) Received 1 shot of the Moderna vaccine (<1 month ago) OR c)
received 1 shot of the Pfizer vaccine (<3 weeks ago) OR d) received 1 shot of the
Jenssen vaccine (<2 months ago) OR e) received 2 shots of the Moderna OR Pfizer
vaccine (last shot <5 months ago) OR f) received 1 shot of another vaccine (<1 month
ago) OR g) received 2 shots of another vaccine (last shot <5 months ago). NOTE:
participants who indicate that they were vaccinated but don't remember what vaccine
they received would fall under the f category if they only received one shot and under
the g category if they received 2 shots.
OR
4. Not enrolled in La Frontera AND do NOT report TWO or more of the following symptoms:
a) new loss of smell or taste, b) cough, c) sore throat/congestion/runny nose, d) skin
rash within the last week without having tested positive for COVID within the last
month.
OR
5. Not enrolled in La Frontera AND do NOT report having EITHER fever/chills OR shortness
of breath within the last week without having tested positive for COVID within the
last month.
8.
ClinicalTrials.gov; 30/06/2021; TrialID: NCT04951336
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04951336
ABSTRACT
Condition:
COVID-19 VaccinationIntervention:
Dietary Supplement: FoTvPrimary outcome:
Creatinine concentration;Aspartate transaminase concentration;Alanine transaminase concentration;Albumine concentration;Bilirubin concentration;Electrolyte balance;SARS-CoV-2 Antibody titer;Duration (number of days) of post-vaccination symptoms;Severity scores of post-vaccination symptomsCriteria:
Inclusion Criteria:
- Scheduled for or planning on scheduling COVID-19 vaccination
- Age 18 years and older
- Willing to avoid alcohol, cannabis, and dairy products during the study product
in-take period.
- Capable of documenting vitals, symptoms, and study product intake daily and
communicating this information to the study team
Exclusion Criteria:
- Known liver disease (or diagnosis of cirrhosis)
- Known renal disease or acute nephritis.
- Pregnant or breastfeeding women
9.
ClinicalTrials.gov; 21/06/2021; TrialID: NCT04939415
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04939415
ABSTRACT
Condition:
Covid19Intervention:
Drug: mQFPD;Drug: organic brown ricePrimary outcome:
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];Feasibility of the interventionCriteria:
Inclusion Criteria:
- Positive COVID-19 diagnosis within the prior 72 hours or within 9 days of symptom
onset
- Age 18 years and older
- Women of childbearing potential must have a negative urine or serum hCG.
- Women of childbearing potential must have a negative serum pregnancy test at screening
and agree to use contraception throughout the study period.
- Capable of documenting vitals, symptoms, and study product intake daily and
communicating this information to the study team
- Willing to try to minimize alcohol, cannabis, and dairy products during the study
period.
Exclusion Criteria:
1. Any of the following symptoms which, according to the CDC, require hospitalization:
1. Trouble breathing
2. Persistent pain or pressure in the chest
3. New confusion or inability to arouse
4. Bluish lips or face
2. Current use of investigational agents to prevent or treat COVID-19
3. Known liver disease (ALT/AST >3x ULN or diagnosis of cirrhosis)
4. Known renal disease (eGFR < 60 ml/min) or acute nephritis.
5. Uncontrolled hypertension (SBP>140 or DBP>90 while on medications)
6. Allergy to tree nuts
7. Bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed)
8. Pregnant or breastfeeding women
9. Use of Tolbutamide
10. Use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone,
betamethasone, methylprednisolone, prednisone, dexamethasone). Inhaled budesonide is
to be allowed.
11. Use of digoxin
12. Use of Oxacillin
13. Use of Interferon
14. Use of Vincristine
15. Use of Cyclosporine
16. Use of Amiodarone
17. Patients with a past medical history of epilepsy
18. Use of monoamine oxidase inhibitors (MAOI)
19. Use of Methamphetamine within the prior 30 days
20. Use of Cocaine within the prior 30 days
21. Use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital,
rifampicin, theophylline and warfarin
10.
ClinicalTrials.gov; 17/06/2021; TrialID: NCT04940481
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04940481
ABSTRACT
Condition:
Physical ActivityPrimary outcome:
Moderate to vigorous physical activityCriteria:
Inclusion Criteria:
1. are 18 years of age or older;
2. are a full or part-time employee at UC San Diego
3. Prior to COVID-19, you used to commute to La Jolla at least 2 days per week;
4. have lived in the neighborhood selected for the study for at least one year;
5. are able to walk without human assistance;
6. are comfortable reading and writing in English or Spanish;
7. have a reliable phone where you can be reached;
8. spend most of your time in San Diego County;
9. don't plan on moving in the next year;
10. are able to give informed consent and comply with the protocol;
11. are willing to complete all assessments and wear all devices for 7 days at 3 different
time points in the next 2 years.
Exclusion Criteria:
1) pregnant, 2) mental state that would preclude understanding the protocol, 3) medical
condition that would affect physical activity, 4) taking part in another physical activity
related research study, and 5) live or regularly travel outside of San Diego County.
11.
ClinicalTrials.gov; 13/05/2021; TrialID: NCT04898231
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04898231
ABSTRACT
Condition:
Multisystem Inflammatory Syndrome-ChildrenIntervention:
Drug: Infliximab;Drug: Anakinra;Drug: MethylprednisolonePrimary outcome:
Anti-inflammatory treatment regimen lowest rate of second randomizationCriteria:
Inclusion Criteria:
1. An individual aged <21 years presenting with
1. Fever (>38.0°C for =24 hours; may be by subjective report) AND
2. Two or more of the following (from two different systems; e.g. one from cardiac
and one from mucocutaneous):
Cardiac
- Hypotension
- Shock
- Arrhythmia
- Tachycardia
- Left ventricular ejection fraction <55%
- Valvulitis
- Coronary artery enlargement (LAD or RCA Z-score = 2.5)
- Pericardial effusion Gastrointestinal
- Diarrhea
- Nausea/vomiting
- Significant abdominal pain Immunologic
- Lymphadenopathy (unilateral cervical or diffuse) Mucocutaneous
- Bilateral conjunctival injection
- Extremity swelling or erythema
- Rash
- Lip erythema/Strawberry tongue Neurologic
- Altered mental status
- Focal neurological deficits
- Headache
- Meningismus
3. Laboratory evidence of inflammation, including but not limited to, an elevated
C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen,
procalcitonin, D-dimer, ferritin, lactic acid dehydrogenase (LDH), neutrophilia,
lymphopenia or hypoalbuminemia AND
4. No alternative plausible diagnoses based on clinical judgement AND
5. Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or
antigen test; or suspected COVID-19 exposure AND
6. Parent or legal guardian (or self if at least 18 years old) able and willing to
provide informed consent and subject willing and able to provide assent when
appropriate.
Exclusion Criteria:
1. Known immunodeficiency
2. Pre-existing medical condition that precludes receiving one or more of the study
medications (e.g. TB, drug allergy to study medication).
12.
ClinicalTrials.gov; 19/08/2020; TrialID: NCT04538495
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04538495
ABSTRACT
Condition:
Kawasaki Disease;InflammationPrimary outcome:
Collection of clinical data and patient samples from children with MIS-C and KD toCriteria:
Inclusion criteria:
The following patients (age 1 mos. through young adults) will be recruited for this study:
Patients who meet the CDC definition for MIS-C:
- Patients presenting with fever (>38C for >24 h - also by subjective report),
laboratory evidence of inflammation, and evidence of clinically severe illness
requiring hospitalization, with multisystem (>2) organ involvement (cardiac, renal,
respiratory, hematologic, gastrointestinal, dermatologic or neurological); AND
- No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2
infection by RT-PCR, serology, or antigen test; or suspected COVID-19 exposure within
the 4 weeks prior to the onset of symptoms
- Patients who meet the CDC definition for MIS-C and require care in the PICU
Exclusion Criteria:
• All patients with pre-existing major medical conditions will be excluded. This includes
patients with known genetic disorders (e.g. trisomy 21, cystic fibrosis), conditions
requiring continuous medication (e.g. seizure disorder, heart disease), or known immune
disorder (e.g. hypogammaglobulinemia, complement deficiency). Patients with asthma or
atopic dermatitis will not be excluded unless patients have received oral steroids in the
previous week. Obesity is not an exclusion.
13.
ClinicalTrials.gov; 24/07/2020; TrialID: NCT04491227
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04491227
ABSTRACT
Condition:
Covid19;AKI;CKD;ESRD;Transplant;Failure,KidneyPrimary outcome:
AKI incidence;Dialysis requirement;hospital mortalityCriteria:
Inclusion Criteria:
- Patients with confirmed infection with COVID 19
- Patients with Acute Kidney injury (AKI) or Chronic kidney disease (CKD) or need for
dialysis
- Patients receiving Chronic dialysis (hemo or peritoneal dialysis)
- Renal transplant recipients
Exclusion Criteria:
- • Patients < 18 yrs age
14.
ClinicalTrials.gov; 24/04/2020; TrialID: NCT04366050
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04366050
ABSTRACT
Condition:
COVID-19Intervention:
Drug: Ramipril 2.5 MG Oral Capsule;Drug: Placebo oral capsulePrimary outcome:
Composite of mortality or need for ICU admission or ventilator useCriteria:
Inclusion Criteria:
- Age = 18 years
- Willing and able to provide written informed consent prior to performing study
procedures
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
polymerase chain reaction (PCR) test = 5 days before randomization OR Clinical
presentation consistent with COVID-19 infection (fever or cough or shortness of
breath) with positive IgM serology
- Currently hospitalized or in an emergency department
- Peripheral capillary oxygen saturation (SpO2) = 93% on room air at screening
Exclusion Criteria:
- Participation in any other clinical trial of an experimental treatment for COVID-19
(use of hydroxycholoroquine or compassionate use of choloroquine or azithromycin is
allowed)
- Concurrent treatment with other agents with actual or possible direct acting antiviral
activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug/placebo
dosing
- Requiring mechanical ventilation at screening
- Requiring ICU care at admission
- NSAID use within 12 hours of randomization or requiring continued NSAID use during
this trial
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
of normal (ULN)
- Estimated GFR < 40 mL/min
- History of serum creatinine = 2 mg/dl in the previous 28 days
- Systolic BP < 100 mm hg or diastolic BP < 65 mm hg
- Hypersensitivity to ACEI
- History of angioedema
- Outpatient use of ACE inhibitor or Angiotensin II receptor blocker in the last 7 days
- History of renal artery stenosis
- Serum potassium = 5.1 mEq/L
- Pregnancy or breastfeeding
- Use of aliskiren, amifostine, lithium, sacubitril within 7 days