cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic

Hypothesis 1: Mindfulness is a feasible tool for use within a cystic fibrosis (CF) clinic

Hypothesis 2: Participants in the mindfulness intervention will show an increased level of quality of life post intervention with the Mindfulness course

Hypothesis 3. Levels of mindfulness:

Participants in the mindfulness intervention will report increased mindfulness levels post-program completion as compared to pre-program completion

Hypothesis 4. Levels of stress:

Participants in the mindfulness intervention will report lower levels of stress post-program completion as compared with pre-program commencement.

Hypothesis 5. Levels of residual depressive symptoms post-mindfulness intervention program: Residual symptoms of depression are a risk factor for relapse of depression. Post -program participants of mindfulness will purport fewer residual depressive symptoms compared with pre-program.

Hypothesis 6. CF is associated with severe neutrophilic inflammation of the airways. As mindfulness intervention has been shown to modulate immune system it may improve physical aspects of CF including markers of inflammation and markers of lung disease (lung function tests and rate of pulmonary exacerbations) and nutritional state.

The study will be an active interventional program for approximately six months in duration. All participants will initially undergo an initial assessment interview. Personnel trained and certified in mindfulness-based stress reduction (MBSR) will run mindfulness-based groups in 6-8 weekly 1 1/2 hour sessions (the staff group will comprise of 6 sessions and the parents' and patients' groups will be 8 sessions long). Participants will learn and engage in various formal and informal meditation practices during experiential learning of skills, including concentration, mindfulness of thoughts, emotions, feelings and bodily sensations, decentering, and letting go. Each group will include both practical exercises and a psycho-educational component. Daily homework, an essential aspect of the course, will include meditation practices together with exercises designed to integrate application of awareness skills into daily life. On day 0, participants will complete a battery of questionnaires as well as tests of the physical status of CF disease. This battery will be repeated at 8 weeks, and again at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CF clinically and by sweat test and/ or genetic testing and/ or nasal potential difference
2. Treatment with one or more chronic medications or regimes;
3. Willingness by patient or parent to sign consent form;
4. Parents capable of complying with the program requirements including completing self-report questionnaires pre and post intervention completion.

Exclusion Criteria:

1. Having significant developmental delay or a mental health diagnosis of psychosis;
2. Transplant patients;
3. Participation in other interventional studies within 2 weeks of recruitment or during the study period -
Bowens Technique Versus Mulligan Bent Leg Raise Technique in Kabaddi Players

The purpose of this study is to look into how Mulligan's bent leg raise technique and Bowen's technique affect the functional abilities and range of motion of hamstring-tight Kabaddi players. Our goal is to add to the expanding body of knowledge on sports rehabilitation by investigating the efficacy of various interventions and offering evidence-based suggestions for improving the health and performance of Kabaddi participants

Few studies have been conducted to compare bowen's technique and Mulligan bent leg raise technique kabaddi players to enhance hamstring flexibility. Present study will seek to fill this gap by comparing the effects of Bowen's technique with mulligan bent leg raise technique in enhancing hamstring flexibility and functionality. Moreover, this study would ultimately aid coaches in designing effective training program for kabaddi players.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with hamstring tightness.
* Male
* Age between 18 to 30 years.
* 20° to 50° Active knee extension loss with hip in 90° of flexion.
* Full passive range of motion of knee extension (to rule out knee joint pathology)
* Subjects willing to participate in the study

Exclusion Criteria:

* Acute or chronic low back pain
* Subjects if they have any history of lower extremity injury in past 3 months
* Any fracture or surgery done for back, pelvis hip or knee.
* Any neurological symptoms involving prolapsed intervertebral disc or radiating pain.
* Spinal deformity
* Any recent abdominal surgery
Characterization of Early Markers of Choroidal Neovascularization

To this study and identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from "dry" AMD to sight-threatening chorioretinal neovascularization (CNV).

The primary statistical objective of this study is to identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from risk "dry" AMD to sight-threatening chorioretinal neovascularization (CNV) (wet AMD).

Different imaging methods will be used simultaneously and at regular intervals in order to characterize markers or predictors of conversion to sight-threatening CNV will be: CNV (classic or occult) or position of CNV within 2500 µm (\~1.7 disc diameters) of the foveal center, as evidenced by fluorescein angiography.

This is an institutional, prospective, observation study to be performed in fellow eyes of patients with evidence of "wet" AMD in other eye. Therefore, patients will have evidence of exudative ("wet") AMD in one eye ( the non-study eye) and non-exudative ("dry") AMD in the fellow eye (the study eye) that is at risk for progressive to exudation "wet" CNV.

Patients will exit the study at the time of developing sight-threatening CNV in the study eye and will be treated at the discretion of the physician.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age over 50 years
* Any race and any sex
* Clinical diagnosis of exudative AM;D in one eye (non-stud eye) and the presence of the following characteristics in the second eye (study eye, eye to be treated):

  * At least 5 or more intermediate (\> 63 µm) or larger soft drusen AND/OR Confluent drusen within 3000 µm of the fovea center
  * Hyperpigmentation

Exclusion Criteria:

* History of medical condition that would preclude scheduled study visits
* History of ophthalmic disease in the study eye other than AMD
* Clinical signs of myopic retinopathy, or refraction higher than -8 diopter power.
* Intraocular surgery in the study eye within 60 days prior enrollement
* Evidence of past or present CNV in the study eye
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery

The purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulation during off pump surgery in patients who require the drug for inotropic support (improved heart function) and the associated hemodynamic variables (vital signs). Levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization, that makes the heart beat more efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing relaxation, an important therapeutic approach of heart failure therapy.

This is a non-randomized trial, and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group. A total of 30 patients will be enrolled into this study, 20 off-pump and 10 subjects on pump. Levosimendan is approved in Europe for the treatment of decompensated heart failure. It improved cardiac function without increasing energy demands. The subject's enrollment ends at Day 7 or day of discharge, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Less than 80 years of age
* ASA Class III-IV
* Scheduled for elective cardiac surgery
* Signed informed consent
* History of heart failure, and/or left ventricular ejection fraction \<50%

Exclusion Criteria:

* Emergency surgery
* Withdrawal of consent
* Uncontrollable ventricular arrhythmias
* Obstructive cardiomyopathy
* Confirmed pregnancy test for women of child-bearing potential
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation

This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.

This study will be a randomized (1:1; PCC vs. plasma), open-label trial of hemostatic therapies during heart transplantation. The goal is to enroll 60 patients. Informed consent will be obtained from patients meeting the inclusion and exclusion criteria before the initiation of any study specific procedures. Eligible patients will be randomized to receive either PCC or plasma transfusion. The efficacy of interventions will be evaluated after 30 minutes of protamine administration. After the heart transplantation, thrombocytopenia and/or hypofibrinogenemia may worsen bleeding associated with vitamin K dependent factor deficiencies. Transfusion of platelets and/or cryoprecipitate is permitted if abnormal laboratory values are observed during the rewarming phase of CPB; platelet count \<100 x 103/µl, and fibrinogen \<200 mg/dl, respectively. Laboratory tests (hematocrit, platelet count, PT, PTT, POC-PT, coagulation factor and inhibitor levels (e.g., factor II, antithrombin), thromboelastometry or thromboelastography, endogenous thrombin generation) will also be obtained at baseline, twice during surgery and at 12-24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent.
* Be at least 18 years of age.
* Patients with or without ventricular assist device (VAD) undergoing heart transplantation
* Patients who have been on warfarin for at least 72 hours before cardiopulmonary bypass procedures for heart transplantation.
* International normalization ration (INR) greater than or equal to 1.5
* Body temperature greater than 35.0 degrees Celsius.
* Blood pH greater than 7.2
* Hemoglobin greater than 7.0 mg/dL.

Exclusion Criteria:

* Treatment with clopidogrel, prasugrel, or ticagrelor within 5 days prior to study surgery.
* Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation.
* Ischemic or thromboembolic events within 6 weeks of study surgery.
* Known allergy/anaphylaxis to prothrombin complex concentrate or albumin.
* Any indication that a potential subject did not comprehend the study restrictions, procedures. or consequences therein an informed consent cannot be convincingly given.
* Patients on respiratory support including extracorporeal membrane oxygenation (ECMO) .
* Life expectancy less than 48 hours.
* Excluded at the discretion of the surgeon based upon surgical safety precautions
Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)

The aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New Haven area.

There are three specific aims of this study. In the first specific aim, two focus group discussions (FGDs) of YMSM will be conducted to assess the feasibility and acceptability of social media intervention. In the second specific aim of the study, a quasi-pre-post experimental study will be conducted to examine the effect of social media intervention on PrEP uptake (primary outcome) and PrEP use intention, HIV testing, PrEP knowledge, self-efficacy and social support (secondary outcome). In the third specific aim of the study, the most important topics around PrEP will be assessed on the Facebook page of the intervention group by conducting a content analysis.

Eligibility Criteria:
Inclusion Criteria:

* Biologically male or transgender man
* Self-identification as gay or bi-sexual
* Resident of greater New Haven area
* Willing and able to use Facebook during the span of the study

Exclusion Criteria:

* • Women will not be included in the study

  * Under the age of 18 and over the age of 29
  * Unable to provide informed consent
  * Verbally or physically threatening to research staff
Vitamin D Supplementation and Pregnancy Outcomes

Groups (group 1 receives 1000 IU vitamin D and group 2 receives 2000 IU vitamin D) through a random allocation. It is necessary to mention that all cases in each group could be able to receive the current supplementation during pregnancy (Folic acid, iron and multivitamin and calcium). This study aimed to evaluate the efficacy of two doses of vitamin D supplementation (1000 and 2000 IU/d) during pregnancy on maternal and newborn vitamin D status and metabolic profile including lipid profile (serum concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), glucose homeostasis (fasting glucose, insulin, insulin resistance (HOMA-IR)) and inflammatory and oxidative stress (OS) markers and pregnancy outcomes including gestational diabetes, preeclampsia, preterm delivery, abortion, cesarian section, and also anthropometric data and apgar score of infants compared with placebo.

In this randomized controlled trial, 84 pregnant women aged at 18-40 years with gestational age of \<12 weeks will be recruited and divided into 2 groups.

Demographic, socioeconomic and lifestyle data as well as blood samples and urine samples will be collected at baseline and in the last month of pregnancy. Moreover the cord blood will be collected at birth.

Fasting blood glucose, insulin resistance (HOMA-IR), insulin, lipid profile (serum concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), inflammatory (IL-1β, IL-6, TNF-α, hs-CRP) and oxidative stress markers (MDA, TAC), calcium:creatinine ratio are going to be evaluated at the beginning and in the end of the interventional period in pregnant women. Inflammatory (IL-1β, IL-6, Tumor Necrosis Factor (TNF-α), hs-CRP) and oxidative stress markers (MDA, TAC) will be determined in cord blood as well.

Eligibility Criteria:
Inclusion Criteria:

* maternal age of 18-40 years,
* gestational age of 12 weeks or less,
* singleton pregnancies,
* mothers supposed to have normal pregnancy and not having preexisting diseases like hypertension, or cardiac, renal, hepatic, autoimmune , rheumatoid arthritis and digestive disease, or endocrinological disorders including diabetes (type 1 or type 2 diabetes), parathyroid disorders, and thyroid disorder,
* not receiving dietary supplements including vitamin D (\>600 IU/d), or omega-3 within the past 3 months before the intervention,
* not taking medications that could potentially influence vitamin D metabolism,
* willingness to participate in the study.

Exclusion Criteria:

* Participants who do not meet the inclusion criteria,
* those who diagnosed to have fasting blood sugar (FBS)\>92 at first blood sampling and/or blood pressure \> 140/90 mmHg at the first visit,
* using extra vitamin D3 supplement and/or omega-3 and/or other medications that could potentially influence vitamin D metabolism,
* fetal anomaly,
* poor adherence to the study protocol,
* unwillingness to continue the intervention.
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults

The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.


Eligibility Criteria:
Inclusion Criteria, Healthy adults:

* If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests.
* In good health with normal laboratory results
* Willing to comply with study restrictions, study schedule, and can be reliably contacted

Exclusion Criteria:

* Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.
* current use or likely requirement for medications with potential for liver injury or effect immune system
* History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease
* History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C
HEMAGO Monitoring and Impact on the Occurrence of Complications During Pregnancy in Sickle Cell Patients

Sickle cell disease is the most common monosemic genetic disease in the world and affects approximately 32,000 people in France. In recent years, improvements in the management of this pathology have led to a steady increase in the life expectancy of sickle cell patients.

Women with sickle cell disease are increasingly likely to have one or more pregnancies.

Several studies have shown that these pregnancies are marked by maternal morbidity due to acute sickling crises, thromboembolism, infection, chronic end-organ dysfunction, or pre-eclampsia (PE), while neonatal outcomes may be intrauterine growth retardation (IUGR), preterm delivery, small infants for gestational age, stillbirth, and neonatal death.

Consequently, monitoring pregnancies in sickle cell patients represents a complex medical challenge due to the risk of potentially serious maternal and fetal complications. Multidisciplinary follow-up is then crucial to monitor and manage these possible complications.

The double hematologist-obstetrician consultation program (HEMAGO) offers complete and adapted close follow-up, in order to minimize the risks for the mother and the unborn child.

This study aims to evaluate the impact of this HEMAGO monitoring on the various maternal and obstetric complications by comparing the outcome of pregnancies of patients who were followed before the implementation of this device to patients who were followed in the frame their pregnancy through this program.


Eligibility Criteria:
Inclusion Criteria:

* sickle cell disease female
* followed up for at least one pregnancy in the maternity of Croix-Rousse Hospital, Femme Mère Enfant Hospital and Lyon Sud Hospital

Exclusion Criteria:

* Minor woman
Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback

A key component of effective offender treatment is an initial assessment of risk factors followed by feedback to facilitate problem awareness and engagement in appropriate treatment and/or behavior change. Feedback regarding areas of high risk, however, can be experienced as threatening.

The investigators propose to develop, fine-tune, and pilot-test a computerized system for risk assessment and feedback, including evaluation of a brief pre-feedback prosocial values affirmation exercise (Cohen \& Sherman, 2014) aimed at decreasing defensiveness and increasing inmates' willingness to access and process risk-relevant information and to utilize post-release treatment resources, thereby reducing post-release substance misuse, HIV risk behavior, and criminal recidivism. Participants will be 170 jail inmates nearing release into the community - 20 pilot participants and 150 study participants randomly assigned to one of three conditions: (1) Values Affirmation + Personalized Risk Feedback; (2) Personalized Risk Feedback only; (3) Control. The baseline and risk assessment, values affirmation manipulation, and personalized risk feedback will be presented via touch-screen computers, requiring minimal training to administer. Analyses will assess:

1. The feasibility of utilizing a computerized system to assess and share risk information with jail inmates, including a brief values affirmation exercise to reduce defensiveness;
2. The acceptability of this approach from the perspectives of jail staff and inmates themselves;
3. The impact of the intervention on observed proximal outcomes (mechanisms of action), such as time spent viewing feedback, electing to print a copy of informational and treatment resources, and consequent changes in perceptions of risk, treatability, etc.;
4. The impact of the intervention on key post-release outcomes including engagement in relevant treatment services, substance misuse, HIV risk behaviors, re-offense and re-arrest;
5. The links between proximal outcomes (MOAs) and key post-release outcomes;
6. Potential moderators of treatment effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Sufficient proficiency in spoken English to understand computer-assisted assessments and feedback
* post-sentencing with a sentence (i.e., less than 12 months) likely to be served out at the jail (vs. a state or federal prison) and likely to be released into the community. The invitation to participate will be timed so treatment is delivered toward the end of incarceration (within one week of release) to minimize decay of effects, and to capitalize on the motivational value of the up-coming release.

Exclusion Criteria:

* Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)
Advanced Footwear Technology in Federated Athletes

Background. Athletics is one of the sports modalities with the greatest growth in the number of federative licenses in our country. In the last five years, the use of footwear with Advanced Footwear Technology (AFT) has become widespread in order to increase athletic performance.

Objective. To analyze the risk of injury in athletes using Advanced Footwear Technology as well as the sporting, sociodemographic and anthropometric variables that influence this risk.

Method. Ambispective cohort study. Ninety-five athletes competing in events longer than 800 meters will be recruited. The primary variable will be the number of injuries, muscular and tendon, of lower limbs in the last 3 athletic seasons. Secondary and modifying variables will be: age, sex, weekly training load with and without AFT, weekly training frequency, completion of a complementary toning program and foot size. Potential confounding variables will be body mass index, main training surface and commercial footwear models used. The analysis will calculate the risk of injury in these athletes and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders.

Expected results. To calculate the risk of injury as a function of sport, sociodemographic and anthropometric variables. Identify


Eligibility Criteria:
Inclusion Criteria:

* Athletes competing in events longer than 800 meters; iii) athletes who have not undergone previous musculoskeletal surgery in the seasons under study.
* Federated in the Federación de Atletismo del Principado de Asturias (Asturias Athletics Federation).
* Athletes who have not undergone previous musculoskeletal surgery in the seasons under study.
* Who were federated at least one year before the study period.

Exclusion Criteria:

* Athletes who do not use AFT devices.
* Athletes with a muscle or tendon injury at the time of the study.