cyrilzakka/clinical-trials huggingface dataset:
The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) in Non Hospitalized Patients Infected With SARS-CoV-2

Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.

This is a prospective, double-blind, randomized and placebo-controlled phase II trial to evaluate the safety and efficacy of KIN001 in non-hospitalized patients suffering from COVID-19. Randomization to one of two treatment arms (KIN001 versus Placebo) is at a ratio of 1:1.

Patients will receive treatment for 14 days and followed for another 14 days. The primary outcome is patient reported COVID-19 symptoms, using the FDA questionnaire developed for assessing COVID-19-related symptoms in outpatients.

The trial will be conducted in Switzerland and Germany.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of symptomatic COVID-19 of less than 5 days' duration, with at least 1 point in at least 4 items of the symptom evaluation table, and at least 2 points in at least 2 items, OR a minimum total score of 6 points
2. Diagnosis of COVID-19 confirmed in the last 48 hours by a positive test for SARS-CoV-2 RNA by RT PCR or a rapid validated antigen test (excluding self-test), in a specimen from the upper respiratory tract, the saliva (antigen test), the lower respiratory tract or an expectorated sputum
3. No indication that the patient will be hospitalized in the next 48 hours for COVID-19 related reasons
4. Adult male or female patients aged ≥ 18 years
5. Females must have a negative pregnancy test or must be post-menopausal
6. Able to understand and willing to sign an IRB/IEC approved written informed consent document.
7. Able to understand and be available for daily phone calls to evaluate symptoms.

Exclusion Criteria:

1. Patients with an indication for hospitalization (e.g. SpO2 \<92%)
2. Patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment
3. Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
4. Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP.
5. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), with hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
6. Any use of CYP450 2C8 inducers (e.g. rifampicin)
7. Known or suspected active viral (including HIV, hepatitis B, hepatitis C), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
8. Pregnant or breastfeeding women
9. Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements as determined at the discretion of the investigator
10. Liver enzyme elevation more than 3x above normal in the last 4 weeks or at inclusion
11. Patients who are detained or committed to an institution by a law court or by legal authorities (subject is vulnerable, such as deprived of freedom)
A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.

Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression.

10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4 Patienten.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria: Informed consent Age 18-60 years Chronic HCV infection Non responder (to Peg-IFN alpha2/Ribavirin containing therapy) Elevated ALT Liver biopsy at screening without sings of (pre-)cirrhosis Compensated liver function Absolute neutrophil count \> 1500 / mm3 at screening Hemoglobin \> 10 g/dL at screening Calculated creatinine clearance of \> 60 cc/min at screening Normal TSH at screening

Exclusion criteria: HBV infection Evidence for concomitant liver disease other than HCV hepatitis Evidence for a HCC Alpha-fetoprotein \>20ng/ml Autoimmune Disease ANA \> 1/320, documented in the last 6 months HIV 1/2 infection ALT and AST \>3x ULN, alkaline phosphatase \>2,5x ULN Known hypersensitivity or allergy to Baminercept Other clinically significant concomitant disease states Known or suspected non-compliance to study protocol, drug or alcohol abuse Infections other than HCV hepatitis Clinically important chest x-ray abnormality at screening Body mass index (BMI) \> 30kg/m2 Concomitant systemic immunosuppressive/-modulating therapy Treatment with anticoagulants Receipt of live vaccine within 4 weeks prior to study start Symptomatic hypogammaglobulinemia with history of recurrent infections Subjects with a history of malignant disease Treatment with other investigational products or participation in an interventional clinical trial within the last 3 months Pregnancy or Breastfeeding Inability or refusal to practice a safe contraception
Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product, Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)

Twenty-eight healty subjects were given a single dose of acyclovir tablet or Zovirax® in dosage form 200 mg and 400mg with 240 mL of water. Then the blood samples for acyclovir was drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Eligibility Criteria:
Inclusion Criteria:

* body weight within normal range (body mass index between 18 and 25 kg/m2)
* had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)
* had normal electrocardiogram
* absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

* pregnant women
* nursing mothers
* women of childbearing potential without adequate contraception
* had a history of contraindication or hypersensitivity to aciclovir, or other antiviral or other ingredients in the study products or a history of serious allergic reaction to any drug,
* a significant allergic disease, or allergic reaction; presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease
* presence of any coagulation disorder or clinically significant hematology abnormalities; using any medication (prescription or non-prescription drug, food supplement, herbal medicine)
* particularly the medication known to affect the pharmacokinetics of the study drug
* who had participated in any clinical study within 3 months prior to the study (\< 90 days)
* subjects who had donated or lost 300 ml (or more) of blood within 3 months prior to the study
* who were positive to HIV, HBsAg, and HCV tests
* who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits
* poor venous access; and who smoked more than 10 cigarettes a day
* had a history of drug or alcohol abuse within 12 months prior to screening for this study and who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.

To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/mL at week 48.

To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48.

To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure.

To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.

Eligibility Criteria:
Inclusion Criteria:

* Completed the original 96-weeks of open-label treatment. Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drugs completion. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures related to the second 96-week open-label phase extension.

Exclusion Criteria:

* Patients requiring therapy with any of the following: Nephrotoxic agents (aminoglycoside antibiotics, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, oral and IV vancomycin, oral and IV ganciclovir, other agents with significant nephrotoxic potential);Probenecid; Systemic chemotherapeutic agents; Systemic corticosteroids; Interleukin-2 (IL-2); Investigational agents (except on approval by Gilead Sciences); Drugs that interact with efavirenz (astemizole, terfenadine, dihydroergotamine, ergotamine, midazolam, triazolam, cisapride, rifampin, ergonovine, methylergonovine, voriconazole). Administration of any of the listed medications is not allowed throughout the duration of the study period.
* Pregnant or lactating patients.
* Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
* Current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
* Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, if they are not anticipated to require systemic therapy during the study.
* Active, serious infections(other than HIV-1 infection) requiring parenteral antibiotic therapy.
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.
Anxiety About Casual Exposure to Food Allergens

Living with food allergy may result in anxiety and reduced quality of life. Food allergic patients and their families are often concerned about casual exposure with the offending allergen through skin contact or being near the offending food, which is actually very low risk. This concern can limit social activities and increase stress. The aim of this study is to provide a behavioral intervention consisting of having peanut/tree nut allergic patients hold a cup with a peanut or tree nut to which the patient is allergic to and touching it. The goal is to reduce anxiety about casual exposure to food allergens and improve quality of life for patients with food allergies and their families.

The purpose of the present study is to determine if having patients (ages 9-17) who are peanut and/or tree nut allergic, and endorse anxiety/discomfort about non-ingestion exposure, hold and touch their offending allergen in addition to education leads to reduced discomfort for both patient and caregiver compared to education alone. The primary outcome measure is immediate differences in the score obtained on a child-reported scale in response to a question assessing how worried the patient is about the thought of being near or touching peanut or tree nut from pre-intervention to immediate post-intervention when compared between an intervention (education and touching) and a control group (education only). Secondary outcome measures include: difference between and within groups of child-reported scales regarding questions assessing patients worry regarding casual exposure immediately and one month post intervention within and between groups, differences between and within groups on a parent-reported scale regarding parental worry about casual exposure to food allergen immediately and one month post intervention within and between groups, differences between and within groups on a parent-proxy measures regarding child worry about casual exposure to food allergen immediately and one month post intervention within and between groups, improvement in child anxiety and parent-proxy measures of anxiety from pre-intervention to one month post-intervention within and between groups and improvement in parent-proxy measures of quality of life from pre-intervention to one month post-intervention within and between groups.

Eligibility Criteria:
Inclusion Criteria:

* Age: 9 years to 17.5 years
* Patient seen in the outpatient clinic (no inpatients).
* Patient and or caretaker endorses anxiety about being in proximity with or touching peanut
* Patients must have been diagnosed with a peanut and or tree nut allergy

Exclusion Criteria:

* Patients and caregiver(s) without ability to understand the study, as determined by either: a previously diagnosed cognitive disability or inability to repeat the study protocol at the time of consent.
Coconut Sugar Lowers Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults

The goal of this intervention is to determine the efficacy of coconut sap powder (CSP) to lower arterial stiffness and blood pressure in middle-aged and older adults. Participants will be randomized to the CSP arm or Placebo arm of the study. Primary endpoints include: aortic stiffness assessed by carotid-femoral pulse wave velocity, resting brachial and (non-invasive) carotid blood pressure, and carotid stiffness (e.g. Beta stiffness index, Carotid compliance, Elastic modulus, Distensibility).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18-35 kg/m2
* Brachial blood pressure \<140/90
* Nonsmoker
* No known clinical disease, or suggestive signs or symptoms of clinical disease
* Free of alcohol or drug dependence

Exclusion Criteria:

* taking any anti-hypertensive, lipid lowering or other cardiovascular altering medications
* Known allergies to coconut or tree nuts (i.e., cashews, almonds, or pistachios)
* Engaging in vigorous intensity exercise
Population-based Brest Stroke Registry

The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.

The main objective of Brest Stroke Registry is to regroup all confirmed cases of stroke over a defined geographical zone in order to calculate an incidence.

There are three prospective medium-term goals:

- In respect with public health epidemiology:

1. To obtain incidence data and evaluate the regional and international divergences
2. To obtain the mortality data in short and long term. Since the onset of the registry, it has been implemented a study on the mortality of stroke patients of Brest Registry. This study has been realized independently for both types of stroke, i.e. ischemic and hemorrhagic, with different caused mortality. This mortality was studied at medium-term (≤ 28 days) as well as at long-term (\> 28 days). There will be a collaboration project between Public Health Surveillance (InVS), Brest University Hospital and Rennes network on all causes of death.
3. Pharmaco-epidemiology

In clinical terms, the registry offers an opportunity to do an inventory of all current practices (diagnosis, therapies and the subsidiaries) and propose in this manner the best management of stroke. This strategy is in line with the pilot programs deployed by the French High Health Authority (HAS) for improvement of quality and safety of the health care. The bleeding risk associated with anticoagulants and anti-platelet agents in people of Brest as well as that of Dijon and Lille (in collaboration with their respective registry) will be analyzed.

This study has gained a particular characteristic since 2012 with emerging new oral anticoagulants (OAC) which have shown less associated bleeding risks compared with vitamin K antagonists (randomized controlled trials).

•In terms of clinical research :

1. Study the impacted consequences of stroke by socio-economic characteristics of the territories in the Pays de Brest
2. Identify short and long term clinical predictors of mortality in patients who have had a hemorrhagic stroke.
3. To identify clinical predictors of mortality in the short and long-term patients with ischemic stroke.
4. To identify genetic predictors of mortality and long-term recurrence of patients with ischemic stroke
5. Identify stroke identification algorithm from existing databases

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic validated for one of the following pathologies:
* Ischemic stroke,
* Non-traumatic intracranial hematoma
* Cerebral venous thrombosis Diagnostic after December 31, 2007 Age \> 15 years on the date of the diagnostic Patient domiciled at the time of the diagnostic in one of the 79 communes defined beforehand

Exclusion Criteria:

* Age ≤ 15 years
* Validated diagnosis (see below, § 4.2.2) of aneurysmal subarachnoid hemorrhage cerebrovascular
* Diagnosis made before 1 January 2008
* Unconfirmed diagnosis
* Patient domiciled outside the previously defined area of residence
Feeding for Accesible, Affordable and Healthy Childhood

The main objective of this study was to evaluate the effectiveness of implementing a healthy eating vs traditional recommendations on the Medkid index of children in primary school. To do so, different companies involved in ALINFA project developed with the assessment of UNAV, CNTA and UPNA, a healthy bi-weekly menu.


Eligibility Criteria:
Inclusion Criteria:

* Adequate cultural level and comprehension of the clinical study from the legal tutors.
* To agree in taking part of the study.

Exclusion Criteria:

* Children presenting clinically relevant gastrointestinal malfunctions or structural anomalies, such as ulcers, chronic inflammatory diseases, etc. Even if they do not follow any pharmacological treatment at the moment of inclusion.
* Children with uncontrolled endocrine disorders.
* Children with any type of tumor/cancer within the last 5 years, or in current treatment.
* Children with any alimentary allergy.
* Children presenting any type of cognitive or psychic disorder
* Parents or legal tutors in which their future collaboration may not be the required, seen from the researchers' point of view.
Ivermectin for Severe COVID-19 Management

In this multicenter study; it was aimed to investigate the effectiveness and safety of ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no mutations which alter ivermectin metabolism and cause side effects.

Patients with severe COVID-19 pneumonia were included in the study. Two groups, the study group and the control group, took part in the study.

Ivermectin 200 mcg/kg/day for five days (9 mg between 36-50 kg, 12 mg between 51-65 kg, 15 mg between 66-79 kg and 200 microgram/kg in \> 80 kg) in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine (2x400mg loading dose followed by 2x200mg, po, 5 days) + favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days) + azithromycin (first day 500mg followed by 4 days 250mg/day, po, total 5 days)- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin.

The mutations in 29 pairs of primers in mdr1/abcab1 gene by sequencing analysis using Sanger method, and the haplotypes and mutations of the CYP3A4 gene that cause the function losing were investigated among the patients who meet criteria and who were included in the study group according to randomization. Mutation screening was done when the first dose of the research drug ivermectin was given, ivermectin treatment was not continued in patients with mutations detected as a result of genetic examination and these patients were excluded from the study.

Patients were followed for 5 additional days after treatment. At the end of the treatment and follow-up period (At the end of 10th day), clinical response and changes in oxygenation and laboratory parameters were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively.

Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;

1. Presence of tachypnea ≥ 30/minute, SpO2 level \< 90% in room air, PaO2/FiO2 \<300 in oxygen receiving patient
2. Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)
3. Mechanical ventilation requirement
4. Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure assessment) score \>2

Exclusion Criteria:

* Patients with the following characteristics were excluded from the study.

  1. Pediatric patients; \<18 years of old
  2. Patients with chronic liver or kidney disease
  3. Pregnant women
  4. Patients with known ivermectin allergy
24-Week Water Aerobics Program for Adults and Older Adults at Different Intensity Levels

This goal of this clinical trial is to verify the best way to do water aerobics with adults and older adults. It wants to answer these questions:

* Is high-intensity water aerobics better than water aerobics performed at moderate intensity?
* Does a 24-week water aerobics program improve muscle strength, body weight, fat mass, triglycerides, cholesterol, blood pressure, and quality of life for adults and older adults?

Participants must:

* Do water aerobics at high or moderate intensity, twice a week for 45 minutes per class, for 24 weeks.
* Be assessed before starting the water aerobics program and after it ends to see if there are gains in muscle strength, body weight, fat mass, triglycerides, cholesterol, blood pressure, and quality of life.

It was believed that all variables would get better after doing water aerobics, no matter the intensity. It was also expected that doing higher-intensity water aerobics would lead to larger gains in all measurements compared to moderate-intensity.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age

Exclusion Criteria:

* taking part in another physical exercise program
* being recently hospitalized
* having severe motor or cognitive problems
* having any medical restrictions on physical exercise