cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray

Hydrogen peroxide is produced physiologically by oral bacteria and plays a significant role in the balance of oral microecology since it is an important antimicrobial agent. In the epithelial cells, the enzyme superoxide dismutase catalyzes a reaction leading from hydrogen peroxide to the ion superoxide. The induced oxidative stress stimulates a local innate response via activation of the toll-like receptors and the NF-κB. Those kinds of reactions are also activated by viral infections. Virus-induced oxidative stress plays an important role in the regulation of the host immune system and the specific oxidant-sensitive pathway is one of the effective strategies against viral infections. Therefore, nose/mouth/throat washing with hydrogen peroxide may enhance those local innate responses to viral infections. The investigators hypothesised that a treatment with a mouth wash and a nasal spray containing a diluted solution of hydrogen peroxide may accelerate the negativisation rate of a positive PCR swab test for SARS-CoV-2 (COVID-19).


Eligibility Criteria:
Inclusion Criteria:

- recent positive SARS-CoV-2 PCER swab test

Exclusion Criteria:

- severe Covid19 disease
Trial of Vitamins Among Children of HIV-infected Women

The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation on reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.

An increasing body of evidence supports the efficacy of single and, more recently, multiple micronutrient supplementation in reducing morbidity and mortality in susceptible populations. For example, we recently completed a multiple micronutrient supplementation trial in HIV-positive Tanzanian women that showed a significant reduction in pre-term birth, fetal loss, and low birthweight. In children, we and others have also demonstrated the beneficial effects of vitamin A supplementation in reducing diarrheal disease and mortality. Our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. Children born to HIV-infected women are at risk of multiple micronutrient deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. In addition, these children, if HIV-infected themselves, are at significantly higher risk of death due to infectious illnesses compared to their non-infected peers. In this study, we propose to study the efficacy of micronutrient supplementation in reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.

Eligibility Criteria:
Inclusion Criteria: Singleton, live born infants born to HIV-infected women Exclusion Criteria: Infants with multiple congenital abnormalities
An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay

This study evaluates the effect of written and oral information in a primary health care setting on 1) patients referred to specialised examination for Lyme neuroborreliosis, 2) delay from patient symptom debut to treatment for Lyme neuroborreliosis, and 3) number of Borrelia serology tests from primary health care.

Lyme neuroborreliosis is among the most common neuroinfections in northern Europe. Residual symptoms after treatment are a frequent problem in Lyme neuroborreliosis, and an association between the delay from symptom debut to antibiotic treatment has been established. In a previous study on Funen Island, Denmark, the delay from day of symptom debut to treatment for Lyme neuroborreliosis patients was 24 days. This considerable treatment delay did not change in the 20 years study period.

In the Danish health system, the general practitioners are the first medical professionals to see the majority of patients. They can refer patients to the hospital for further examination if indicated. Many general practitioners use Borrelia burgdorferi antibodies (igM/IgG) as a screening tool when they suspect Lyme disease or see patients with uncharacteristic symptoms. This is unfortunate, as the rash Erythema Migrans, the most common Borreliosis manifestation in Europe, is a clinical diagnosis. Only around 50% of patients have positive antibodies at time of Erythema Migrans diagnosis. Lyme neuroborreliosis is diagnosed based on symptoms and the results from the cerebrospinal fluid, and cannot be diagnosed based on serology, which only delays the time to diagnoses and treatment. The Danish guidelines on Lyme borreliosis therefore discourage general practitioners from using Borrelia serology.

In the before mentioned study from Funen Island, several patients described multiple contacts to their general practitioners, where the symptoms of Lyme neuroborreliosis were not recognized. The cardinal symptom of radicular pain was associated with a longer delay than many of the less common symptoms of Lyme neuroborreliosis.

Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of \> 4.6/100.000
* Patients with a postal address on Funen and a positive Borrelia intrathecal antibody test (diagnostic for lyme neuroborreliosis) performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
* A Borrelia IgM/IgG serology ordered from Primary Health Care and performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020

Exclusion Criteria:

* Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of \< 4.7/100.000
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with genotype 1b chronic hepatitis C

Exclusion Criteria:

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs antigen in the test
A Comparison of Dynamic Vision & Balance Between College Athletes & Controls

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."

Eligibility Criteria:
Inclusion Criteria:

* California State University Northridge athletes
* Participants are able to give consent to participate in the study
* Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
* Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
* Sampling of convenience on a volunteer basis

Exclusion Criteria:

* Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
* The initial 6- condition BESS score is \>20 errors
* The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.
Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias


Eligibility Criteria:
Inclusion Criteria:

* All patients who meet the requirements for a Gastric Bypass at Køge Hospital.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
* Patients who converted to open surgeon
Evaluation of Peer Group Connection - Middle School

The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is:

Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse?

Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).

Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th or 7th grade); post-intervention (spring semester of 6th or 7th grade); four months post-intervention (fall semester of 7th or 8th grade); and sixteen months post-intervention (fall semester of 8th or 9th grade).

Eligibility Criteria:
Inclusion Criteria:

* Be enrolled at a middle school participating in the study
* Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
* Provide parental consent and student assent to participate in the study
* Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.

Exclusion Criteria:

- Repeating the middle school transition year (6th or 7th grade)
Protective Effects of L-arginine During Reperfusion by Femoropopliteal Bypass for Lower Limb Ischemic Syndrome in Humans

The symptoms and severity of arterial disease is secondary to perfusion deficit. The specific alteration of the mitochondrial function of ischemic skeletal muscle plays an important role, and therapeutic enhancing mitochondrial function are associated with a clinical improvement with increase in the walking distance of the patient.

In severe ischemia, reperfusion required is accompanied by a deleterious episode through a worsening of endothelial dysfunction (impaired pathway of nitric oxide (NO)), majorant alteration of cellular energy and the hormonal and inflammatory responses. This is reperfusion syndrome, which can lead to grave consequences. Our goal is to limit mitochondrial and endothelial dysfunction (increased by the reperfusion) by stimulating the NO pathway by in situ addition of its precursor, L-arginine. Our working hypothesis is that this cellular improvement will be accompanied by an increase in systolic pressure index and an improvement in the walking distance.

Method: This is a trial with direct individual benefit, comparative, randomized, prospective, single-center, double-blind, versus placebo.

2 groups of 30 patients with severe lower limb ischemia requiring femoropopliteal bypass revascularization participate in the study. The control group (placebo isoosmotic saline) will be compared to the treated group (femoral arterial infusion of 2 g L-Arginine for 30 min).

Heart rate, blood pressure and body temperature will be monitored continuously. The gastrocnemius muscle is biopsied before and 30 minutes after revascularization to analyze mitochondrial respiration and its control. Both femoral and brachial concomitant venous samples will judge the importance of muscle damage (lactate, muscle enzymes) and released mediators (cytokines, NO and endothelin) on the local and general.

Main clinical implications: L-arginine supplementation in atherosclerotic patients requiring femoropopliteal bypass to limit the initial deleterious effects of reperfusion and improve their walking distance and therefore their quality of life. Then extending this treatment to other patients with peripheral arterial disease.

Eligibility Criteria:
Inclusion Criteria:

* atherosclerotic patient with peripheral arterial disease stage 2-4 Leriche and Fontaine classification
* requiring surgical revascularization by femoropopliteal bypass
* above 18 years old

Exclusion Criteria:

* active infectious disease
* severe heart disease
* chronic renal insufficency
* pregnant women
* women of childbearing age and with no effective contraception for at least three months
Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD

This is a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Adult Onset Still's Disease (AOSD). Interim analysis (IA) data at Week 28 and 48 from this study supports a registration submission of canakinumab in the indication of Adult still's disease (ASD) in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study. Parent's or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \< 20 years of age
* Japanese male and female participants aged ≥ 16 years
* Confirmed diagnosis of AOSD as per Yamaguchi criteria (Yamaguchi M, 1992) with an onset of disease ≥ 16 years of age. Yamaguchi criteria requires at least five criteria, including two major criteria and no exclusion criteria
* Active disease at the time of baseline defined as follows
* Fever (body temperature \> 38°C) due to AOSD for at least 1 day within 1 week before baseline
* At least 2 active joints (tender or swollen)
* CRP ≥ 10 mg/L

Exclusion Criteria:

* Pregnant or nursing (lactating) female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/ mL) at screening visit.
* History of significant hypersensitivity to study drug or to biologics.
* History/evidence of active macrophage activation syndrome or disseminated intravascular coagulation prior to 6 months of enrollment.
* With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator compromises the articipant and/ or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
* With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including participants with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
* Participants with absolute neutrophil count \< 1500/mm3 at screening.
Immune Interactions in Severe Asthma

This research study is being done to learn more about severe asthma by comparing people with severe asthma to those with milder forms of asthma and people without asthma, at baseline and over time. Individuals are being asked to join a research study to help understand the differences in the lungs and blood of participants with severe asthma compared to those with milder asthma and healthy individuals, as well as differences in overall health. Investigators also want to determine whether these differences predict asthma-related and biologic outcomes over 1 year of follow up.

This study will obtain human lung samples by bronchoscopy from a range of asthmatics and healthy controls to address questions related to the mechanisms for the development of the complex immune processes observed in the lungs. Samples will be evaluated for Type-1, Type-2 and Interleukin-27 (IL-27) expression (and their downstream signatures). In addition, these samples will be evaluated for the presence or absence of Interleukin-10 (IL-10) as a counter regulatory pathway. These pathways will be directly evaluated in epithelial brushings and bronchoalveolar lavage (BAL) cells, as well as BAL fluid. Broad gene expression profiling (Ribonucleic acid (RNA)-sequencing) will also be performed to determine the range of immune-inflammatory markers present in these severe asthmatics. Investigators will specifically address the Signal Transducers and Activators of Transcription (STAT) signaling pathways, particularly STAT-1 and STAT-3 to determine the pattern of activation and downstream responses to develop new therapies. Additionally, in a subset, investigators will compare targeted and untargeted gene expression as obtained from bronchoscopic samples with expression obtained from clinically performed video assisted thoracoscopic (VATS) biopsies of very severe systemic corticosteroid dependent patients. The ultimate goal of this studies is to determine whether a predictive biomarker panel can be identified in the less invasive bronchoscopic samples which predict the findings seen on VATS biopsy.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Non-smoker
* Asthmatic subjects must also demonstrate forced expiratory volume in 1 second (FEV1) bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤16 mg/mL (Historical methacholine data from previous National Institutes of Health (NIH) trial will be allowed)

Exclusion Criteria:

* Greater than 10 pack year smoking history (none in the last year)
* Vocal cord dysfunction, cystic fibrosis or chronic obstructive pulmonary disorder
* Other lung disease, or any coronary artery disease, hypertension, diabetes or renal failure that is not well-controlled.

Healthy Controls only: Pre-bronchodilator FEV1/Forced vital capacity (FVC) \<0.70 or an improvement in FEV1 of more than 12% following 4 puffs of albuterol.
Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril

Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice.

Type of the program: multicenter, observational, uncontrolled, open program. The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities.Each doctor includes four patients. It is planned to include not less than 1920 patients in total.

Multicenter observational open program. Assessment of the efficacy and tolerability of the fixed-dose combination of bisoprolol/perindopril in patients with arterial hypertension and stable CAD in daily clinical practice (STYLE)

Study objectives and purposes:

Primary endpoints:

* efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP
* efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina

Secondary endpoints:

* impact on the quality of life of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice
* adherence to bisoprolol/perindopril FDC therapy in patients with HT and stable CAD in everyday practice The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities. Each doctor includes four patients. It is planned to include not less than 1920 patients in total.

Milestones of the program:

FSI - November, 2018 LSLV- January, 2019 Database Lock - February, 2019 Statistic Report- May, 2019 Clinical Study Report- January, 2020

Eligibility Criteria:
Inclusion Criteria:

* Stable CAD, defined as stable angina pectoris of class 1-3 by CCS (Canadian Cardiovascular Society) classification;
* Previously or newly diagnosed essential hypertension
* Age 18 to 79 years old;
* Informed consent of the patient for participation in the program;
* Decision of the doctor to prescribe bisoprolol/perindopril FDC before the inclusion in the program in accordance to the instruction for use.

Exclusion Criteria:

* Stable angina pectoris, class 4;
* History of myocardial infarction or cerebrovascular event within the past 3 months;
* Unstable angina within the past 6 months;
* Chronic heart failure classes 3-4 (NYHA);
* Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus;
* Any serious decompensated concomitant diseases requiring the regular medical therapy;
* Inability to understand the essence of the program and follow the recommendations;
* Contraindications to beta-blockers or ACE inhibitors using;
* Participation of the patient in other trials in the present time or within 30 days before the start of observational program.
Observation of Physiotherapy Treatment Sessions - Exploring What Happens in Physiotherapy for Patients After Stroke.

This is the first phase of a study that will investigate the effects that different approaches to physiotherapy have on the expression of associated reactions. During this phase, current practice among neuro-physiotherapists will be explored in relation to: the learning strategies used in stroke rehabilitation, the common interventions used in gait re-education, and the strategies adopted for the assessment and management of associated reactions.

Associated reactions are unintended and involuntary arm movements, normally seen as bending of the wrist and elbow, that may occur after stroke when a person is doing something effortful such as walking.

The objectives are:

* To provide an insight into the learning strategies used by physiotherapists during the re-education of walking, including the verbal dialogue that takes place and any preferences (overt or subconscious) adopted for one type of learning strategy.
* To develop and refine a description of what is meant by the term "gait re-education"
* To provide an insight into how therapists currently manage associated reactions

This phase of the study will explore these objectives using direct non-participation observation of a number of physiotherapy treatment sessions. This will provide an insight into the nature of the therapy that takes place for retraining walking(e.g. the types of exercises commonly used) and the nature of the learning strategies frequently adopted, including the amount and content of explicit verbal instruction and feedback that is provided to patients.

Eligibility Criteria:
* has suffered a stroke
* is currently receiving active rehabilitation that includes gait re-education
* is exhibiting upper limb deficits
* is able to provide informed consent.