cyrilzakka/clinical-trials huggingface dataset:
Increasing PrEP With Trans Women in the Deep South

The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.

The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Declaration of willingness to comply with all study procedures and availability during the study
* Age 18 years old or older
* Male sex designated at birth
* Identify as trans woman, woman or another gender identity not associated with being a man
* Desire to use or re-start PrEP
* HIV uninfected
* Speaks English or Spanish
* Live in the New Orleans metropolitan statistical area (which includes 8 parishes)

Exclusion Criteria:

* Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
* Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
* Concurrent or planned enrollment in a research study that provides PrEP
* Unwilling to attend quarterly follow-up visits, which will include survey participation
* Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients

Randomized, double-blind, placebo-controlled pilot study to evalaute viral load in saliva of COVID19+ patients using quantitative PCR, before and after use of active or placebo rinses


Eligibility Criteria:
Inclusion Criteria:

1. Be positive for SARS-CoCV-2 real-time PCR test
2. SARS-CoV-2 patients positive, with home and/or hospitalized care.
3. Have a medical condition that allows them to perform a mouthwash for 1 minute.

Exclusion Criteria:

1. Pregnant.
2. People with impaired lung function who do not allow them to rinse.
3. Patients with antiviral treatment for Covid-19.
4. Patients with diseases that affect saliva, Sjogren's syndrome, and Systemic Lupus Erythematosus.
5. Any cause of immunosuppression (primary or secondary), including HIV.
6. Chronic kidney disease 3b or older, Coronary heart disease, Uncontrolled diabetes (Hb1Ac \>7), Uncontrolled high blood pressure, Uncontrolled thyroid disease, history of cancer less than 1 year
HA35 Moderate Alcoholic Hepatitis (AH) Study

Eligible participants will be asked to take a placebo/treatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection.

Two phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.

Written informed consent will be obtained during the baseline visit (day 1). Patients will given a physical exam and a blood test will be obtained if not in their medical chart. The subjects who meet the criteria after the screening visit will have the following procedures: A. Body composition will be quantified by whole-body dual energy X-ray absorptiometry (DEXA), Bioelectric Impedance Analysis (BIA), chair stands, 3 position balance and hand grip strength by dynamometry. B. Muscle biopsy from the lateral portion of vastus lateralis, about 20 cm above knee, C. Questionnaires, D. Blood collection, E. Collection of stool samples, F. Sugar cocktail administration, and G. Urine collection (24 hour)

After baseline measures have been completed, patients will be randomized in a 1:1 ratio to either standard of care (SOC) + HA35 or SOC + placebo (140 mg/d) for a total of 3 months post enrollment.

The subjects will be recalled after 3 months. The visit and the procedures conducted on day 90 will be similar to the baseline study visit.

Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of alcoholic hepatitis defined as:

* Regular consumption of alcohol with an intake of \>60 g daily or \>420 g weekly on average for men and \>40 g daily or \>280 g weekly on average for women for 6 months or more

AND

* MELD \<21
* Serum total bilirubin \>3 mg/dL
* AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I

OR Histologic evidence of AH.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with gastrointestinal bleeding within 2 weeks
* Active infection (positive blood or ascitic fluid culture)
* Overt encephalopathy
* Renal failure and/or on dialysis
* Medications that alter muscle protein metabolism
* Myopathies
* Other end-stage organ diseases
* Malignancy
* Solid organ or hematopoietic transplantation
* Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol
* History of recent upper gastrointestinal resection within past 6 months
* Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease
* Inability to provide consent
* Creatinine \>2mg/dL
* Platelets \<60,000k/ul
* PT/INR \>1.7
* Presence of pedal edema
* Use of anti-platelet/anticoagulation drugs or medications that interfere with blood clotting
Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects

This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.


Eligibility Criteria:
Key Inclusion Criteria:

* Body weight between 50 to 120 kg and body mass index within 18 to 29 kg/m2 at Screening;
* Current nonsmokers who have not used any tobacco- or nicotine-containing products (chewed or smoked) or replacement products, including, but not limited to, electronic cigarettes, in the 45 days prior to Screening.

Key Exclusion Criteria:

* Past or present diseases, which as judged by the Investigator, may affect the outcome of this study;
* Any condition or situation that, in the opinion of the Investigator, would prevent proper evaluation of the safety or efficacy of the study treatment according to the study protocol;
* History of hypersensitivity or allergy to moxifloxacin or any other study treatment or history of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.
Study on the Difference of Plasma microRNA Expression in Patients With Genetic Susceptibility to Mental Disorders

Schizophrenia (Schizophrenia,Sc), biphasic affective disorder (Bipolar disorder,BPD), major depression (major depressive disorder,MDD), anxiety disorder (Anxiety disorder,An) and other mental disorders have obvious family aggregation, with heritability of 60 -90%. This kind of common mental illness seriously affects the psychosomatic health and quality of life of patients, and places a great mental and economic burden on the society and family. At present, the diagnosis of mental illness is mainly based on clinical symptoms. With the development of molecular biology, genomics has become a new way to study mental illness. MicroRNA (miRNA) is a class of eukaryotic endogenously non-coding single-stranded RNA, which can regulate gene expression by binding to specific mRNA or regulating the protein translation process of specific mRNA. MiRNA widely exists in plasma and serum, and the type and quantity of miRNA in plasma and serum change with different physiological and disease conditions. It is reported that the expression profile of miRNA in brain tissue of schizophrenia is significantly different from that of normal subjects. In addition, the study found that the specific miRNA detected in peripheral blood can directly reflect the condition of the disease, which may use miRNA in peripheral blood as a clinical biological marker. In order to detect the expression of various miRNA in plasma, high throughput miRNA chip detection has become the first choice for primary screening. In this study, the investigators intend to detect the difference of miRNA expression in peripheral blood of different types of schizophrenia by high throughput miRNA chip, and analyze the correlation between them. It is hoped to provide the basis for the diagnosis and occurrence and development of clinical psychotic patients.


Eligibility Criteria:
Inclusion Criteria:

Meet the diagnostic criteria of DSM- V (see attached page for details); there is no history of blood transfusion within 1 month.

Exclusion Criteria:

Physical and nervous system diseases such as brain trauma; history of mental illness such as mental retardation; history of alcohol abuse and drug abuse.
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids

The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Adult females between 18 and 47 years.
* Have a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids.
* Must have uterine fibroids.
* Agreement not to attempt to become pregnant during the trial.
* Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited .
* Ability to complete a daily Participant diary and study procedures in compliance with the protocol.
* Have a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits.
* A Body Mass Index (BMI) between 18 and 45 inclusive.
* Menstrual blood loss \> 80 milliliters (mL) by alkaline hematin assay.

Exclusion Criteria:

* Post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
* Pregnant or lactating or is attempting or expecting to become pregnant during the entire study period.
* Received an investigational drug in the 30 days prior to the screening for this study.
* History of Polycystic Ovarian Syndrome (PCOS).
* Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, Dihydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study.
* Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months.
* Use of Gonadotropin Releasing Hormone (GnRHas) (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months).
* Has an Intra Uterine device (IUD) in place.
* Known or suspected carcinoma of the breast or reproductive organs.
* Recent history (within past 6 months) of alcoholism or drug abuse.
* Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.
Study of Ovum Donors After Donation

To explore the attitudes and reactions of ovum donors prospectively after ovum donation and to follow their medical histories.

Although several studies have explored donor's reactions and experiences up to a year post donation, no study has explored how donor attitudes and reactions change over time. Currently, there is no long-term data available to describe donor's feelings and reactions to their donation. Consequently, programs have no guidance to counsel prospective donors about whether donors' attitudes change towards their own participation, contact with any offspring, or concerns about the donation. In addition, just as ovum donors' initial health histories were shared anonymously with the recipient(s), any updated information gathered in this study would be shared anonymously with the recipient(s) or offspring should they request those updates.

Eligibility Criteria:
All anonymous egg donors are eligible for participation.
Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

The purpose of this study is to examine the effect of memantine and buprenorphine on opioid abusing behavior, to determine the effect of memantine and buprenorphine on early relapse and to evaluate the tolerability of memantine co-administrated with buprenorphine. The study seeks to determine if combined treatment of memantine and buprenorphine may provide shorter-term treatment for opioid dependence.

Opiate dependence is an increasing problem among young adults (18-25 years old) whose rates of current use of illicit drugs are generally high (19.7 %)according to data from the 2007 National Survey on Drug Use \& Health (Substance Abuse and Mental Health Services Administration 2008). Young adults start using heroin around this age range, and more recently have had increasing rates of prescription-type drug use. Given that young adults with opiate dependence who are seeking treatment are relatively treatment naïve, have a shorter period of addiction, and are more likely to choose buprenorphine over methadone, developing short-term buprenorphine treatment alternatives to long-term methadone agonist treatment is needed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18-25 years old
* Opioid dependence as evidenced by signs of opiate withdrawal, self-reported history of opioid dependence for a consecutive 12 month period and positive urine for opioids

Exclusion Criteria:

* Current diagnosis of other drug or alcohol dependence (other than opiates, cannabis or tobacco)
* Serious medical illness (e.g. major cardiovascular, renal, endocrine, hepatic disorder)
* Current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder and participants with suicidal or homicidal thoughts
* Women who are pregnant, nursing or refuse to use a reliable form of birth control or refuse monthly pregnancy testing
* Screening liver function tests (SGOT or SGPT) greater than 3 times normal
Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients

The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.

Exercise based computer games can facilitate high volume complex task practice, enhance feedback of movement and increase motivation of participants. Those effects are difficult to achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller which a player can use to directly control a game through body movement without the need for handheld controllers. Using Kinect to capture movement is a feasible way to help patients who have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming language for kids from the MIT Media Laboratory. It is easy to use for game designing. Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This means that game programs can be designed with motion control. The aims of this study were to i) develop exergames by using Scratch and Kinect system for training upper extremity function in patient with stroke; and ii) to test the game's feasibility and effects in a group of patient with chronic stroke.

This program will be done within two years. During the first year, investigators will design several exergames which are suitable for training upper extremity function in patient with stroke. Investigators will have several experts meetings, involved by physiatrists, occupational therapists and engineers to design the game. When a prototype game is created, investigators will invite two to four patients with stroke to pilot test the game. The game design will be completed till patients and therapists satisfy the design.

During the 2nd year, investigators will test the feasibility and effects of the exergames by doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will randomize participants to experiment or control group. All participants will receive PT and OT training as routine. The additional intervention either exergames or conventional OT will be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment
* 3 months post stroke
* Impaired arm motor function at Brunnstrom stage 3-5
* Age 18 years or older

Exclusion Criteria:

* severe cognitive impairment defined as \< 20 on Mini Mental State Examination
* visual disorders or neglect limiting the ability to comply with treatment regimen
* orthopedic problem or other neurological diagnosis that makes the UE dysfunction.
Pupillometry Use & Professional's Inspection : Leveling Subjectivity

This prospective, non interventionneal, mono-centric study aims to evaluate the accuracy and quality of pupil assessment among three different groups: senior physicians, anesthesiology residents, and nurses. Pupil assessment is a critical component in anesthesia and emergency medicine, providing essential information about a patient's neurological status and response to medications.

This study aims to assess if there is a significant differences in the accuracy and reliability of pupil evaluations between senior physicians, residents, and nurses when compared to the gold standard of pupillometry, an objective and precise measurement technique.

The study will involve a series of assessments where each participant will evaluate patients' pupils under controlled conditions. The results will be compared against the measurements obtained from pupillometry to determine how closely each group aligns with this standard.

By identifying any discrepancies in pupil assessment skills among the different professional groups, we hope to highlight areas for improvement in training and practice. Ultimately, this research aims to enhance patient care by ensuring that pupil evaluations are performed accurately and consistently across all levels of healthcare providers.

The findings from this study could lead to improved training protocols and potentially influence guidelines for pupil assessment in clinical practice, contributing to better patient outcomes in anesthesia and emergency settings.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in Intensive Care
* Patients who gave their consent to participate to the study, or, if incapable of giving their consent, for whom their designated trusted person has provided their consent.

Exclusion Criteria:

* Aged under 18 years
* Undergoing ocular surgery
* Unable to evaluate both pupils
* Not affiliated with a social security scheme
a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:

1. ME-NBI is useful in distinguishing EGC from other gastric lesions
2. ME-NBI is useful in further differential diagnosis among EGCs.


Eligibility Criteria:
Inclusion Criteria:

* patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.

Exclusion Criteria:

* advanced gastric cancer or any other malignancy;
* patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
* inability to provide informed consent;
* inability to provide histology of resected specimens after endoscopic treatment or surgery.
Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.

Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic cardiomyopathy, with ischemic myocardial scar
* Sustained monomorphic ventricular tachycardia
* Age \> 18 years
* Prior ICD implantation

Exclusion Criteria:

* VT storm
* NYHA functional class IV
* Additional indication for antiarrhythmic drug therapy
* Contraindication for both study drugs (amiodarone and sotalol).
* Uncontrolled myocardial ischemia.
* LV thrombus.
* Non-ischemic VT substrate.
* Contraindications for anticoagulation.
* Prior substrate ablation in the previous 6 months
* Cr \> 2.5 mg/dL
* Mitral AND aortic mechanical valvular prosthesis
Platelet Function With Various Storage Techniques

Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.

Subjects will undergo administration of antiplatelet drugs and then will receive platelets stored in a variety of methods. Platelet function will be measured serially.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects

Exclusion Criteria:

* Pre existing antiplatelet drugs