cyrilzakka/clinical-trials huggingface dataset:
Drinking Extra Water for to Prevent or Decrease Headaches

The purpose of this study is to find out if drinking extra water helps people prevent or relieve headaches and hunger and, if so, what volume of water is most effective and when is it best to drink it?

If participants decide to participate in this trial, they will be asked to drink a specific amount of water at particular times of the day for 14 days. A computer will decide by chance the amount of water they will be asked to drink each day of the trial and the times at which to drink this.

There are different amounts and different times that people will be asked to drink water, this is so that the investigators can find out if there is an optimal volume of water to drink, and a best time to drink water to reduce headaches or hunger. The least amount of water the computer could ask participants to drink is half a glass (that is 4oz or 120ml). The largest volume of water the computer could ask participants to drink would be eight glasses of water a day (a total of 64oz or 2L) spread across the day (that is not all at once). Once the computer has assigned participants to a particular volume and times to drink water, these will remain the same for every day throughout the study.

Participants will be asked to provide some brief information about themselves at the beginning of the study (for example, age, sex, height and whether you exercise, smoke or not). During the study they will be asked to weigh themselves and record this, Their dietary habits and the amount they drink will be kept on a private and confidential page on the study website. They will be asked to fill in \[2\] confidential short surveys about how they feel and their views, one at the start and one at the end of the study.

Eligibility Criteria:
Inclusion Criteria

* Any adult (defined as someone aged 18 or above) for whom advice to drink extra water is not contraindicated.

Exclusion Criteria

General exclusions

* \< 18 years of age
* No personal email address
* Pregnancy
* Ecstasy recreational drug use

Exclusions Health Conditions

* Impaired renal function
* Chronic bowel problems
* Low sodium levels
* Diabetes insipidus
* Schizophrenia or history of psychosis
* Anorexia or bulimia
* Congestive heart failure
* Current chemotherapy treatment

Exclusions Concurrent Medications

* Taking regular non-steroidal anti-inflammatory drugs
* Diuretics (e.g. thiazides, indapamide, loop diuretics), also called "water tablets"
* Anti-depressants: Selective serotonin re-uptake inhibitors (SSRIs), Tricyclic and tetracyclic antidepressants (TCAs),monoamine oxidase inhibitor (MAOIs)
* Anti-psychotics (e.g. haloperidol)
* Anti-convulsants (e.g. sodium valproate, carbamazepine)
* Cancer drugs (anti-neoplastic agents)

Implicit exclusions

* People without internet access
* People who cannot read
* People without the ability to understand the website and informed consent documents
Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE)

The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).


Eligibility Criteria:
There are no specific inclusion and exclusion criteria for this study.

The inclusion and exclusion criteria are those of patients enrolled in the RITUX-PLUS (NCT03154385) and BLISS BELIEVE studies (NCT03312907) including the following inclusion criteria:

* individuals are affiliated to social security
* individuals not be placed under judicial protection, guardianship or curatoship
A Mobile Health Intervention Among Hispanics

Hypothesis: More than 80% of the participants (n=40) will complete the intervention at three month (intervention completion) and the six month follow-up (retention rate as feasibility). More than 70% of the participants will report high overall study satisfaction (acceptability) with the intervention and study.

This pre-pilot will inform intervention and procedural refinements for the pilot.

Hypothesis: Participants who receive the intervention (n=57) will report more skin cancer-related preventive behaviors (e.g., mean of summed score of sun protection behaviors such as use of sunscreen, etc.) at three month and six month follow-up compared to those in the control condition (n=57, who will receive general information about physical activity and nutrition).

Aim 1: The investigator will conduct individual interviews among key stakeholders such as health care providers and community leaders to plan a mobile skin cancer intervention among Hispanics. Data will be collected from individual interviews (n=10-12) among key stakeholders and triangulated with data from a funded pilot grant (focus groups and surveys with Hispanic community members) to gather information regarding Hispanics perceptions and behaviors related to skin cancer and suggestions for a WhatsApp intervention.

Aim 2: Employing a user-centered approach to develop a WhatsApp intervention to promote skin cancer risk-reduction behaviors among Hispanics and encourage engagement in the intervention. Use an iterative qualitative (focus groups with Hispanics, n=32; individual interviews with key stakeholders e.g., health care providers and community leaders, n=10-12) process to incorporate input from Hispanics and relevant stakeholders to develop a mobile WhatsApp intervention that is theory- and culturally-guided.

Aim 3: The investigators will evaluate the feasibility and acceptability of this mobile intervention in a single-arm pre-, post-test pilot study among at-risk Hispanics.

Aim 4: Refine the intervention and conduct a pilot RCT (n = 114) using this mobile program among Hispanics at risk for skin cancer and assess the preliminary effects of the mobile intervention at 3-month (intervention completion) and 6-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Self-report as Hispanics
* 18 years or older
* No personal history of skin cancer
* Report more than one skin cancer risk factor
* Do not engage in sufficient sun protection behaviors
* Have not conducted a SSE in the past three months
* Own a smartphone and will be willing to use WhatsApp

Exclusion Criteria:

* Currently being treated for melanoma or nonmelanoma skin cancer
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.


Eligibility Criteria:
Inclusion Criteria:

* For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
* Have at least 1 injectable tumor
* Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
* A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
* Thyroid function laboratory values within normal range

Exclusion Criteria:

* Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
* Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
* Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
* History of solid organ or hematologic stem cell transplantation
* Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
* History of Grade 3 or higher toxic effects during prior treatment with immunotherapy or requirement of anti-tumor necrosis factor (TNF) or anti-interleukin 6 (IL-6) agents to manage AEs from prior treatment with immunotherapy
* History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study

The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Chronic heart failure (NYHA II, III or IV)
* Left ventricular systolic dysfunction (LVEF ≤ 35%)
* Sinus rhythm and resting heart rate ≥ 70 bpm
* Optimal and unchanged CHF medications or dosages

Exclusion Criteria:

* Unstable condition within previous 4 weeks
* Myocardial infarction or coronary revascularisation within previous 2 months
* Stroke or transient cerebral ischaemia within previous 4 weeks
* Congenital heart disease
* Severe valvular disease
* Active myocarditis
* Permanent atrial fibrillation or flutter
Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).


Eligibility Criteria:
Inclusion Criteria:

1. Infection with HIV greater than 6 months in duration
2. Right heart catheterization showing PASP \> 30mm Hg
3. Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment.
4. Ability to participate in follow-up for the duration of the study.

Exclusion Criteria:

1. Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy.
2. Any known pulmonary disease that could potentially cause pulmonary hypertension.
3. A pO2 by pulse oximetry below 90% on room air.
4. Obstructive sleep apnea.
5. Known collagen vascular disease.
6. History of anorexigen use

   * 7. Age less than 18 years old.
   * 8. Other co-morbidities for which the investigators, in conjunction with the primary care provider, believe render the participant with an expected survival of 6 months or less.
Comparison of the Effect of a Non-immersive VRE and CT in Patients With Tennis Elbow

This study investigates the comparative effectiveness of non-immersive virtual reality (VR) therapy and conventional physiotherapy in managing tennis elbow (lateral epicondylitis). Tennis elbow is a painful condition often characterized by chronic pain, reduced grip strength, and limited functionality.

Conventional treatment approaches, including manual therapy and strengthening exercises, have been widely used but may not fully address the long-term rehabilitation needs of every patient. Virtual reality, an emerging tool in rehabilitation, has the potential to enhance patient engagement and adherence by providing an interactive therapeutic environment. Participants will be divided into two groups: one receiving VR therapy and the other conventional therapy, with each intervention lasting six weeks. Outcome measures include pain intensity (VAS), functional disability (DASH), patient satisfaction (PRTEE), grip strength, range of motion (ROM), and adherence rates. This study aims to determine if VR therapy can offer superior benefits over conventional

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 25 to 50 years.
* Patient diagnosis with lateral epicondylitis.
* Patients that a medical doctor will be formally diagnosed to have tennis elbow, that is, lateral epicondylitis.
* Patients who have specific pain and function impairment associated with tennis elbow.
* Patients giving written consent to participate in the study. Willing to participate and provide informed consent.

Exclusion Criteria:

* Patients with neurological conditions whereby they have abnormal functioning of their arms.
* Any previous surgical intervention for tennis elbow The presence of other significant musculoskeletal diseases in the upper extremity Severe cardiovascular or neurological disorders.
Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD

The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 15-30 years.
* Subjects with a DSM-IV diagnosis of ADHD (combined or inattentive subtype) as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
* Subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview.
* Subjects with an ADHD CGI-S of \>= 4 (moderate impairment).

Exclusion Criteria:

* Pregnant or nursing females.
* Subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study.
* Recent history of intravenous drug use, or subjects who have current DSM-IV criteria for abuse or dependence of cocaine, MDA, MDMA, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, PCP, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study.
* Subjects with Mental Retardation or Organic Brain Syndromes.
* Subjects who are psychotic or have a history of bipolar disorder.
* Participants who are taking any psychotropic or anti-SUD medications will be excluded from the study.
* Current DSM-IV diagnosis of major depression, depressive disorders, or anorexia as manifested by clinical interviews.
Behavioral Research of Environment and Air Pollution Through Education

The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study is a pilot randomized control trial comparing the efficacy of a classroom-based intervention to no intervention in helping middle-school students understand and make behavioral decisions about air pollution. This study is designed to evaluate the effectiveness of the classroom-based intervention on knowledge of air pollution, understanding of air pollution sources, and behavioral choices made to reduce both contributions to air pollution and personal exposure to air pollution.

It has been well established that pollution is a racial and economic issue. Low-income areas with populations of predominantly people of color tend to be those with the highest rates of pollution and the largest particulate exposure. Creation of and exposure to this pollution is a key issue for the health of inhabitants of these areas, and of those in the broader surrounding areas. By developing, and assessing the effectiveness of, the investigators hope that the BREATHE study will give the investigators insights into how to better combat this higher exposure and reduce the health risks for those in high pollution areas.

The study will take place in 4 visits over a period of 12 months. The hypothesis is that the classroom-based intervention will be effective in leading to behaviors that will reduce exposure to air pollution.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read, write, and understand English at a middle school level
* Willing to participate in follow up visits

Exclusion Criteria:

* Learning disabilities such as autism
* Moving out of the area in the next 6 months
* Inability to complete the questionnaires
Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "Prevention Care Advocate" intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "Prevention Care Advocate" intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.

This 8-session, multi-component, skills-building intervention adapted from strategies used in prior studies encourages participants to advocate prevention and receipt of primary care services for themselves and their peers. We will employ a randomized experimental design to compare the intervention's efficacy with an attention-control group.

SPECIFIC AIMS Aim 1: To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting. The impact of the intervention on secondary outcomes including the increased use of HIV primary outpatient care and readiness for and entry to drug treatment, will also be evaluated.

Aim 2: To examine whether knowledge, motivation and perceived self-efficacy are impacted by the intervention, and if changes in these variables explain change in the behavioral outcomes of interest.

Aim 3: To determine the extent to which behavioral outcomes are maintained over time.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Sexually active
* Recruited from inpatient/hospital setting
* Crack user

Exclusion Criteria:

* HIV negative
* Not sexually active
* Not recruited from inpatient/hospital setting
* Non crack user
Management of Albuminuria in Hypertensive Diabetics

Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years and older and able to visit the study sites every 3 months
* T2D patients with ongoing anti-diabetic therapy for at least 5 years
* Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP\> 130/80 mmHg)
* Able and agreeing to provide informed consent.

Exclusion Criteria:

* Type 1 diabetes patients
* Ongoing therapy with perindopril,
* Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,
* A history of angioedema related or not to previous treatment with ACEI,
* Impaired renal function defined as serum creatinine levels \> 177 µmol/L, eGFR \<30 mL/min,
* Hyperkalemia or hypokalemia,
* Severe hepatic impairment,
* Use of non-antiarrhythmic agents causing torsade de pointes,
* Pregnant or lactating women, or who are planning to become pregnant,
* Any conditions which may impact on participation according to treating physician.
Clinical Epidemiology of Asthma in An HMO

To provide information on morbidity and health care utilization for asthma for a large, well-defined population over a 20 year period.

BACKGROUND:

Asthma is the second most common chronic respiratory disorder seen by physicians in outpatients, and in 1988 was estimated to be the primary or secondary cause of 9.3 percent of all physician office visits for ambulatory medical care in the United States. Reports citing increased asthma morbidity and mortality in this country and abroad have intensified interest in this disorder. Investigations into possible explanations for these increases, however, have been hampered by the lack of good longitudinal data on the incidence, prevalence, and health care utilization associated with asthma, and by the lack of generally accepted diagnostic criteria for defining the disease.

DESIGN NARRATIVE:

Use of the Kaiser-Permanente Northwest Region data base allowed an examination of the secular trends in the prevalence and incidence of physician-diagnosed asthma and asthma-like disorders in inpatient and outpatient populations over a 20 year period, health care utilization and temporal changes in utilization patterns for asthma, and the natural history of asthma in selected subpopulations. Demographic factors examined were limited to age and sex.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria