cyrilzakka/clinical-trials huggingface dataset:
HIV Medication Adherence in Underserved Populations

The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.

Although antiretroviral therapy (ART) has proven extremely effective in the treatment of HIV and AIDS, the ability to effectively combat the disease is inconsequential when individuals do not take their medication as prescribed and do not attend their scheduled medical appointments. Non-adherence to effective ART and medical visits is widespread in the United States, especially among ethnic minorities. A recent study indicated that patients who miss a medical appointment in the first year of an HIV diagnosis show over twice the mortality rate of patients who attended all visits. This study is developed to investigate the relationship between HIV Associated Neurocognitive Disorder (HAND) and adherence to HIV treatment among traditionally marginalized populations. Participants will be administered a brief neuropsychiatric screener. Participants will be randomly enrolled one of two cognitive rehabilitation programs so they may learn compensatory cognitive strategies to remain treatment adherent, or they will be receive psychoeducation concerning the importance of taking their medications and regularly attending medical appointments. Participants will be tracked and followed-up with regarding their treatment adherence in regular intervals over the course of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult, age 18 and older.
* Able and willing to provide written informed consent.
* Diagnosed as HIV-seropositive by licensed enzyme-linked immunoabsorbent assay (ELISA) or HIV-seropositive by Western blot (WB).
* Diagnosed as HIV seropositive within the last two years.
* Willing and able to provide adequate information for locator purposes.

Exclusion Criteria:

* Under the age of 18.
* Have ever sustained a traumatic brain injury.
* Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process, or otherwise contraindicate participation in the study.
* Have a learning disability where they cannot read or write pass the third grade level.
* Have an active substance dependence diagnosis.
Correlates and Consequences of Increased Immune Activation in Injection Drug Users

The goal of this study is to learn how injection drug use may affect the immune system.

The goal of this study is to learn how injection drug use may affect the immune system. One way to measure this is by looking at the blood and the gut, or gastrointestinal tract at the same time. It is thought that activating the immune system by injection drug use may increase destruction of immune cells in the gut. To test this theory, the investigators are enrolling HIV-negative injection drug users, HIV-negative people who do not use drugs and HIV-negative former injection drug users.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Between the ages of 18 and 55
* Absence of medical conditions that would preclude flexible sigmoidoscopy
* Absence of active opportunistic infection requiring active therapy including antibiotics or anti-neoplastics (note this does not include prophylactic antibiotic therapy)

Exclusion Criteria:

* History of bleeding disorder
* Platelet count below 70,000
* INR\>1.5 or PTT\>2X control
* Active use of anticoagulants or aspirin therapy that cannot be interrupted
* Comorbid diagnosis of inflammatory bowel disease
* Pregnancy, incarceration, mentally disabled individuals
* HIV-1 infection
* Currently on Hepatitis C treatment
Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study

Methamphetamine use has escalated in recent years. Methamphetamine use has also spread throughout the country. Although much information has been gathered on the treatment of cocaine abuse, very little information has been obtained on the treatment of methamphetamine abuse. One of the first steps in developing appropriate treatment is to examine the effects of stopping a particular substance's use on individuals abusing that substance. To date this has not been well studied for people abusing methamphetamine. The purpose of this study is to better understand and develop accurate ways of measuring symptoms associated with stopping the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal symptoms are able to be effectively measured, this will help to develop treatments targeted at alleviating these symptoms. These symptoms are often associated with relapse to use of that substance.

The primary aim of this 4 week observational study is to examine and characterize the withdrawal symptoms experienced by methamphetamine abusers who are recently abstinent from methamphetamine. The period of drug or substance withdrawal is often cited as the time during which risk of relapse use of that substance is very high. Therefore it is highly important to characterize specifically the withdrawal syndrome associated with cessation of methamphetamine use. This study will demonstrate our ability to recruit and work with this methamphetamine dependent population. In addition it will allow for the collection of pilot data to assist in selecting appropriate assessment tools in a submission of an RO1 grant for well-controlled studies characterizing methamphetamine withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Subjects must have a history of methamphetamine use, with recent use verified by a urine toxicology screen positive for amphetamines

Exclusion Criteria:

* Current diagnosis of drug or alcohol physical dependence (other than methamphetamine or tobacco)
* Schizophrenia, or bipolar type I disorder
* Present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that may affect mood ratings
* Current suicidality or psychosis
* Pregnancy: hormonal changes during pregnancy can affect mood which might produce a potential confound if pregnant women were enrolled
Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients

The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500 chronic pain patients is randomized into either an CPSMP intervention group or a control group.

The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors are not health professionals but chronic pain patient themselves. The program is highly structured and manualized.

Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and well-being. Hence we expect the CPSMP to have an effect on various domains.

1. Symptom reduction - lower self-reported pain in the CPSMP group compared to controls
2. Illness perception - the cpsmp group will differ from controls in illness perception and have higher disease related self-efficacy
3. Sickness behavior - the cpsmp group will have fewer sick days and lower health care utilization (estimated by registerbased data)than controls
4. Quality of life - the cpsmp group will report higher life satisfaction and less social isolation than controls


Eligibility Criteria:
Inclusion Criteria:

* Pain in more than 3 months
* Self-reported pain \> 4.99 on 10 point Likert scale
* Age \> 18 years old
* Able to understand, speak, and read Danish

Exclusion Criteria:

* Pain related to conditions that the patient are likely to consider more important than pain itself, e.g. pregnancy, cancer in acute phases
* Drug abuse, psychiatric or physical disease that would prevent participation in weekly sessions
* Drug abuse, psychiatric or physical disease that would disturb completion of group sessions
An Association Between Asthma Severity and Capnography Parameters

Asthma is a common chronic disorder of the airways characterized by periods of reversible airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to become life-threatening events. Severity of asthma exacerbation is assessed through medical history and lung function measurements with Spirometer and requires full cooperation of the patient. Thus, in uncooperative populations or during emergency medical situations the spirometer cannot be used. As an alternative, capnography data has been proposed as an indicator of bronchospasm in asthma. Previous studies found correlations between the capnography parameters and methacholine challenge in asthma patients. However, the relationship between capnography parameters and severity of asthma or severity of asthma exacerbation have not been well characterized. The study hypothesis is that within the clinical population that is invited to do the methacholine challenge, a different waveform pattern in asthma patients will be detected and possibly a correlation between the severity of obstruction and pattern of waveform during the methacholine challenge. In this proposed feasibility observational study, sixty subjects, both men and women, who will be invited to participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, will be recruited to the study. Respiratory information will be recorded using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine® Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the methacholine challenge.


Eligibility Criteria:
Inclusion Criteria:

1. The subject was invited to participate in methacholine challenge for the purposes of clinical assessment, with no relation to this study
2. Age 18-70
3. Ability to sign informed consent form

Exclusion Criteria:

1. Cannot or not willing to have capnography measurement during the entire methacholine challenge
2. Has or had in the past chronic obstructive pulmonary disease (COPD)
Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus

This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.

The present double-blind, randomized and placebo-controlled study will be conducted on type 2 diabetes mellitus patients to evaluate the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving glycemic profiles (fasting blood sugar, glycosylated Hemoglobin, 2 hours postprandial blood sugar, insulin concentration, insulin resistance, and beta-cell function). The study also evaluates systolic blood pressure, diastolic blood pressure, anthropometric variables, lipid profile, C-reactive protein, and renal and liver function tests.

A pilot study with 30 participants will be conducted to estimate the sample size considering 0.05 first type error and a power of 80%. Individuals aged between 18-70 with a diagnosis of type 2 diabetes mellitus based on WHO criteria for at least one year will be enrolled. Participants will be randomized in the placebo or intervention group to receive two capsules per day before lunch and dinner for six months containing 200 milligrams of equally combined extracts of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac. Participants will be followed up with four office visits (t0= baseline, 1=15th day, 2t=3rd month, 3t=6th month) to assess outcomes. Also, the complications and adherence of patients to intervention will be checked every two weeks by telephonic discussion. The analysis will be performed based on the intent-to-treat method.

Eligibility Criteria:
Inclusion Criteria:

* At least one year of diagnosis of type 2 diabetes according to the criteria of the World Health Organization,
* Hemoglobin A1c (HbA1c) \> 7.0% or fasting blood glucose \> 7.0 mmol/L,
* Body mass index (BMI) more than 23 kg/m2 and less than 35.

Exclusion Criteria:

* Comorbidities, including type 1 diabetes, cardiovascular disease, thyroid disease, liver disease, kidney disease, cancer, mental disorders, and the use of drugs related to the aforementioned diseases,
* Pregnancy,
* Patients with a BMI over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months
* A history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, Nettles and sumac and also
* Lactating women
* Regularly consuming cigarettes or alcohol
* Using psychiatric drugs or insulin
* Changing in the medication regimen during the trial period. For example, to start receiving insulin therapy, become pregnant, or no longer follow medication and dietary instructions.
2nd International Survey on Interventional Strategies

The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.

2nd International Survey on Interventional Strategies is a web-based platform.

The survey contains specific questions and dedicated case presentations on two major topics.

The first part queries the characteristics of the participants, including overall experience in interventional cardiology, annual volume of percutaneous coronary intervention (PCI), and duration of experience with quantitative coronary angiography (QCA), intravascular ultrasound (IVUS),optical coherence tomography (OCT), fractional flow reserve (FFR) and non-hyperaemic pressure ratios (NHPR). The survey uses here predefined categories and single-choice questions.

The second part investigates personal strategies for evaluating angiographically intermediate stenoses in the catheterization laboratory. Here, participants are asked to evaluate 5 complete coronary angiograms. All cases are characterised as stable angina without relevant changes on resting ECG. No information about non-invasive testing is known or provided.

Here participants are asked to (1) localise all relevant stenoses by indicating the involved segment; (2) define percent diameter stenosis (%DS) by visual estimate; and (3) determine the significance of the stenosis of interest. In cases of angiographic uncertainty, the preferred diagnostic tool is asked to be selected from the arsenal available in the catheterisation laboratory, namely QCA, IVUS, OCT, FFR or NHPR. Participants are asked to make their decisions assuming ideal world conditions, without considering any financial restrictions or local regulations, but only after the best clinical practice achievable in this virtual catheterisation laboratory.

Eligibility Criteria:
Inclusion criteria

* Interventional cardiologists
* Interventional cardiologists in training
Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.


Eligibility Criteria:
Inclusion Criteria:

* having a diagnosis of an opioid use disorders (OUD) within the past 12 months;
* started buprenorphine (the term we use to refer to all buprenorphine products including buprenorphine/naloxone) treatment within the past 6 months
* at least moderate or greater self-reported pain on average over the past 3 months;
* regular and consistent access to a telephone and willingness to use the phone for study sessions.

Exclusion Criteria:

* buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch
* self-reported pregnancy at the time of study enrollment
* currently living outside of the United States
Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee

It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Diagnosed with osteoarthritis of the knee
* Candidate for an intra-articular injection (single joint, unilateral) of Monovisc® or Cingal® as part of their routine clinical care and in accordance with the locally approved label

Exclusion Criteria:

* Previous intra-articular injection within the last 6 months from enrolment
* Known hypersensitivity to cortico-steroids, hyaluronic acid or any component of Cingal® or Monovisc®
* Infectious, traumatic or neoplasic component of knee pathology
* Surgery of the knee within the last 6 months or scheduled surgery in the next two months from enrolment
* Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned.
* Patients with known bleeding disorders
* Patient currently treated with oral steroids or opioids
* Patients that, in the investigators' opinion, are unlikely to comply with protocol
* Pregnant or nursing women or women who suspect they might be pregnant.
KT on Low Back Pain Patients

This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back pain patients, analysing the electromyography activity of longissimus muscle (median frequency) and the sustained time during a fatigue test (Ito test).

Individuals with low back pain usually have poor back muscles endurance, which may be improved with the application of Kinesio Taping. The aim of this study is evaluate the effect of Kinesio Taping on back muscle fatigue of low back pain patients. Sixty-four women, between 18 to 50 years old, with chronic nonspecific Low Back Pain will attend this study. They will be randomly assigned in four different groups: control group (CG), KT with tension group (KTT), KT no tension group (KTNT) and Micropore® group (MP) and submitted to three evaluations: pre, three and ten days after intervention, analysing the electromyography activity of longissimus muscle and the sustained time during a fatigue test. The variables analysed during the evaluations will be median frequency (MP) slope of longuissimus muscle and sustained time during the Ito test.

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.

Exclusion Criteria:

* Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
* Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
* Fibromyalgia
* Corticosteroid treatment in the previous two weeks;
* Antiinflammatory treatment in the previous 24 hours;
* Contraindications to the use of Kinesio Taping (allergy or intolerance);
* Score of two or less on Visual Analogue Scale of the first day;
* Pregnancy;
* Previous Kinesio Tape therapy on lumbar.
Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.

In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.

The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.

Eligibility Criteria:
Inclusion Criteria:

1. Patents who sign the informed consent forms, and allow to be followed.
2. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
3. Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
4. Patients with age equal or greater than 20 years old regardless of gender.

Exclusion Criteria:

1. The presence of a atrial or ventricular thrombus.
2. Patients who are allergic to or unsuitable for use with the contrast media.
3. Pregnant patients or patients who are unavailable to receive X-ray.
4. Patients with renal insufficiency.
5. Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure.
6. Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
7. Patients with age less than 20 years old or greater than 90 years old regardless of gender.