cyrilzakka/clinical-trials huggingface dataset:
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I

Phase 1 - MOST Preparation Phase:

1. To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.
2. Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
3. Demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

In Phase 1, we will enroll 10 participants at each recruitment site (n=20). The purpose of Phase 1 (MOST Preparation Phase) is to allow us to establish and refine procedures at these new sites and document aspects of feasibility, including our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer these components; d) run classes; and e) collect follow-up assessments. Enrollment period for this phase will last approximately 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in methadone maintenance (MMT) or buprenorphine/naloxone (BUP) treatment for \> 3 months
* Plan to continue treatment for next 6 months
* Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
* Aged \> 18
* Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences
* Available at least one of the times study classes are offered.

Exclusion Criteria:

* Currently taking yoga classes or practicing yoga at home once per week or more often.
* Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
* Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
* Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
* Surgery requiring overnight hospitalization planned in the next 3 months
* Pregnancy
* Plan to move out of the area within 6 months.
* Homeless, defined as any time in the past month sleeping in a shelter or on the street.
Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Chronic AD that has been present for at least 3 years before the screening visit;
2. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;
3. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion Criteria:

1. Participation in a prior Dupilumab clinical study.
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;
3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

   * Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
   * Phototherapy for AD
4. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
7. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
8. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;
9. Known or suspected history of immunosuppression;
10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
11. Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Eligibility Criteria:
Inclusion Criteria:

* Chronic intractable pain of the trunk and/or limbs
* Documented history of trunk and/or limb pain of at least 180 days
* Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
* Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
* If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
* Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
* Subject is able to independently read and complete all questionnaires and/or assessments provided in English
* 18 years of age or older when written informed consent is obtained
* Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Exclusion Criteria:

* Unable to operate the Precision Plus system
* Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
* Is a high surgical risk
* Is diabetic
* Is immunocompromised
* Currently on any anticoagulant medications that cannot be discontinued during perioperative period
* Untreated major depression or untreated generalized anxiety disorder
* Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
* Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8
* Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
* Current abuse of alcohol or illicit drugs
* Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
* Subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
* Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator
* Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)
Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes

The main goal of this clinical trial is to determine the effect of flaxseed added to the diet on biochemical parameters and quality of life in patients with Type 2 diabetes mellitus (T2DM). The main questions it aims to answer are:

* Does flaxseed supplementation given to T2DM patients for 12 weeks have an effect on biochemical parameters?
* Does flaxseed supplementation given to T2DM patients for 12 weeks have an effect on quality of life?

Researchers will compare patients with T2DM consume diet added flaxseed to a control group to see if flaxseed effect on biochemical parameters and quality of life.

Participants will:

* Complete the questionnaire, record the 3-day food consumption and be taken the anthropometric measurements at the beginning and end of the study.
* Take diet added 30 g ground flaxseed (intervention group) or only diet (control group) every day for 12 weeks.
* Visit the clinic once every 4 weeks for follow-up.
* Report the dietary adherence and gastrointestinal symptoms on a phone call once every week.

Adult individuals between the ages of 19-65, with a body mass index (BMI) between 20-35 kg/m2, using oral anti-diabetics and not using insulin will be included in the study. Patients with T2DM who agree to participate in the study will be randomly assigned to the intervention or control group using the simple randomization method. Participants will be followed for 12 weeks. Both groups will receive diet as part of T2DM treatment. Subjects in the intervention group will consume 30 g of ground flaxseed per day in addition to their diet. The participants were asked by the researchers through a face-to-face interview technique to determine their demographic characteristics (age, marital status, education level, employment status, income level, etc.), quality of life short form (SF-36) scale, international physical activity questionnaire (IPAQ) and 3-day food consumption record. A survey form questioning consumption records will be applied at the baseline and end of the study. In addition, routinely monitored biochemical parameters of the patients will be recorded from the hospital system at the baseline and end of the study. Anthometric measurements will be taken and recorded by the researcher in accordance with the method. The data obtained will be evaluated in the SPSS package program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2DM by a physician
* Being between the ages of 19-65
* Having a body mass index (BMI) between 20-35 kg/m2
* Using oral anti-diabetics and not using insulin

Exclusion Criteria:

* History of gastrointestinal diseases
* High consumption of nuts, flaxseeds or sesame seeds (more than one serving per day)
* Food allergies or intolerances
* Malignancies
* Renal failure, liver, other endocrine or inflammatory disorders
* Use of lipid-lowering drugs
* Smoking and alcohol use
* Being pregnant or lactating
Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2

The purpose of this study is to evaluate the effectiveness of the use of artificial intelligence in home monitoring in patients with uncontrolled arterial hypertension.

Arterial hypertension (AH) is one of the most important cardiovascular risk factors, accounting for 13.5% of all deaths worldwide. Mobile health technologies have been applied as an important tool to improve patient engagement and blood pressure (BP) control, as an alternative approach to remote monitoring of hypertensive patients. Therefore, it is essential to help patients adopt healthy measures to assist in the daily control of BP.

As the barriers to therapeutic adherence are complex and varied, solutions to improve adherence at the population level should be multifactorial. Therefore, the use of an application elaborated by artificial intelligence adapted to individual needs and customs, can help in improving therapeutic adherence and provide better bp control in patients with uncontrolled hypertension.

Eligibility Criteria:
Inclusion criteria:

1. Primary arterial hypertension in drug treatment with at least 3 classes of antihypertensive drugs in optimized dose
2. Aged between 20 and 65 years
3. Blood pressure of the office ≥ 140 and/or 90 mmHg
4. Facilities to use mobile and apps

Exclusion criteria:

1. Stroke sequelae
2. Cognitive dysfunction
The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea

Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI) and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.

Sleeping in prone position could be effective in the management of obstructive sleep apnea (OSA) by reducing the gravity effect on the upper airway and hence collapsibility. Pure prone positioning (PPP) consisted of a pillow mounted on a table designed to keep the subjects sleeping prone with the head extended in line with the body.

Eligibility Criteria:
Inclusion Criteria:

* Patients were enrolled to the study among one hundred and eighty-four consecutive patients who were admitted to our sleep center with 6 beds in a tertiary care hospital, during 3 months period. Of these, 36 patients with mild to moderate OSA (AHI=5-30 events/h) were invited to participate in the study based on the selection criteria, and 29 patients with mild to moderate OSA on their baseline PSG, (17 males, 12 females) gave informed consent and participated in the study.

Exclusion Criteria:

* Patients having BMI\>35 and/or abdominal and/or trunkal obesity that may hinder prone sleeping , upper airway pathology (nasal polyp, nasal turbinate hypertrophy, chronic sinusitis, nasal septum deviation, upper airway infection, Mallampati score and tonsil size grade of IV), any other concomitant sleep disorder (narcolepsy, periodic leg movement syndrome, insomnia, sleep related hypoventilation-hypoxemia and central sleep apnea syndrome), psychiatric disorder such as panic disorder, heart failure and coronary artery disease were not included in the study.
Health Technology to Improve Exercise in axSpA

Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
* Have access to email and a smart phone device (Android or iOS operating systems)
* Enrolled in the SPARCC Research Program
* Passes pre-participation health screen

Exclusion Criteria:

* Non-English speaking
* Not enrolled in the SPARCC Research Program
* Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)
Study on the Efficacy and Mechanism of METTL3 Peptide Inhibitors in Enhancing Anti-tumor Immune Response by Reshaping the Tumor Microenvironment

This study aims to validate the accuracy and clinical value of METTL3 as a biomarker for predicting immune therapy response in patients with urinary tract tumors through observational studies.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with urinary system tumors through pathological examination;
2. Meet specific clinical stages and surgical treatment standards;
3. Intraoperative tissue resection meets the sample testing standards;
4. The patient is willing to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Not meeting the specific clinical stage and not receiving surgical treatment;
2. Abnormal mental behavior;
3. Intellectual disability;
4. Age under 18 years old or over 75 years old;
5. Low understanding and communication skills.
The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants

Background:

Each year, more than half a million babies are infected with HIV by mother-to child transmission in developing countries. Many of these babies get sick and develop HIV disease (AIDS) at a very young age. Exposure to other infectious diseases may influence this early progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS.

Objective(s) and Hypothesis:

The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare:

* The percentage of babies who progress to HIV disease
* Blood markers of HIV disease (the amount of virus and protective white blood cells in the body)
* The body's immune response to BCG vaccine and other childhood vaccines
* The percentage of children who develop BCG scarring, BCG vaccine complications and tuberculosis.

Potential Impact:

BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease.


Eligibility Criteria:
Inclusion Criteria:

* Maternal HIV status verified
* Study consent
* Uncomplicated singleton pregnancy with delivery planned at local health facility
* Resident in study area

Exclusion Criteria:

* Active tuberculosis or tuberculosis contact in mother
* No consent
* Planning to move out of study area
* Not planning on delivering at local maternal obstetric unit
* Not planning on attending local baby clinic
Enfamil NeuroPro Study

This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.

This study is a randomized, double-blind, parallel-group study comparing breast milk to Enfamil Infant and Enfamil NeuroPro formulas. The central hypothesis of the study is that the addition of milk fat globule membrane and2'-Fucosyllactose (2'-FL) to infant formula plays a role in shaping the microbiota in a manner similar to the microbiota of breastfed infants. To test this hypothesis, the investigators will explore longitudinal changes in the fecal microbiome from birth to 4 months of age in infants fed breast-milk, standard Enfamil Infant formula or Enfamil NeuroPro formula. Fecal samples will be collected at birth, and then monthly for 4 months. At the time of last collection one serum sample will be collected. The investigators will analyze basic growth parameters, fecal microbial community analysis by metagenomics, fecal metabolome by untargeted metabolomic analysis, and fecal and systemic indicators of inflammation and intestinal barrier function.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants with parental consent
* Parents are able to provide informed consent; own a smart phone and are able to fill out weekly digital questionnaires.

Exclusion Criteria:

* Prematurity (\<= 36 weeks gestational age)
* Babies born through c-section
* Any health issues identified at the first postpartum screening
* Use of both breast milk and formula
* Use of donor breast milk
* Parent unwillingness/inability to avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to the child for the duration of this study
Sex or no Sex: That is the Question.

This study aims to evaluate the impact of sexual intercourse and orgasm in the 72 hrs following embryo transfer of blastocysts on the clinical pregnancy rate.

An impact on sexual activity and a decrease in the frequency of intercourse has been observed in infertile couples. In couples who undergo assisted reproductive technology (ART), sexual relations have an additional component that can condition them, such as the fear of influencing the outcome of the cycle.

The usual practice in ART cycles has evolved towards a preference for blastocyst-stage embryo transfer, both in fresh in vitro fertilization (IVF) cycles and in frozen embryo transfer (FET) cycles.

The investigators consider it important to elucidate whether coital intercourse after embryo transfer (ET) has an impact on the clinical pregnancy rate after the transfer of blastocyst-stage embryos.

It is proposed to carry out an observational, prospective study, in which women with a heterosexual sexual relationship are included, who carry out an embryo transfer, in a FET cycle in the Dexeus Woman Reproduction Medicine Service and who agree to participate in the same.

Eligibility Criteria:
Inclusion Criteria:

* Women with a heterosexual sexual relationship
* That they carry out an embryo transfer, in a FET cycle

Exclusion Criteria:

* Exclusion criteria are not foreseen