cyrilzakka/clinical-trials huggingface dataset:
ST-segment Elevation as an AF Endophenotype

The purpose of this study is to look for a similarity in people's genes that may help understand which people could benefit from certain drugs for the treatment of atrial fibrillation (AF).

Current drug therapies to suppress AF are incompletely and unpredictably effective and carry significant (albeit generally small) risks of serious adverse effects, including drug-induced long QT syndrome (diLQTS), other forms of proarrhythmia, increased mortality through uncertain mechanisms, and extracardiac toxicity. Identification of clinical and genetic subtypes of AF will permit stratification of therapeutic approaches and thereby facilitate the practice of personalized medicine. Furthermore, limited success of drug therapy and increase in drug toxicity in AF is probably because the arrhythmia represents a final common pathway of multiple initiating mechanisms, including some that are genetically-defined.

Identifying specific intermediate phenotypes ("endophenotypes") associated with defined clinical courses in AF represents a potential method to systematically subtype patients by underlying mechanism and represents a much-needed clinical advance. Clinical endophenotypes that have been studied include atrial fibrillatory rate, prolonged signal-averaged P-wave duration, and biomarker profiles. The endophenotype we will study here is right precordial ST segment elevation, seen not only in Brugada syndrome (BrS) (where it is unmasked by sodium channel blocking drugs) but also commonly in early-onset ('lone') AF and in patients with AF-associated rare variants in genes encoding the cardiac sodium channel α- or β-subunits. Taken together these data suggest the hypothesis to be tested in this study, that variants in multiple genes can culminate in a similar AF-prone substrate by reducing sodium current that can be identified by screening for baseline or manifest right precordial ST segment elevation endophenotype after sodium channel block with intravenous procainamide.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing AF ablation at Vanderbilt or MGH

Exclusion Criteria:

* Patients taking membrane active anti-arrhythmic drugs with sodium channel blocking properties (amiodarone, dronedarone, flecainide, propafenone) at the time of the ablation
* Patients with a history of Brugada syndrome or type 1 Brugada ECG pattern on the baseline ECG
* Patients with a history of drug-induced torsades de pointes
* Patients with a known history of hypersensitivity to procainamide, procaine or related drugs
* Patients with a history of systemic lupus erythematosus and myasthenia gravis
* Patients with a history of second degree AV block (Mobitz type II) or third degree AV block
* Women of child-bearing potential unless post-menopausal, surgically sterile, or have a negative pregnancy test day on the day of procedure
* Patients with dual chamber pacemakers or implantable defibrillators requiring ventricular pacing (uninterpretable ECG)
* Patients unable to give informed consent
To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

To collect clinical response data with the use of ertapenem in approved indications.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 20 years of age or older
* Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
* Patients who required therapy prior to identification of cause of infection

Exclusion Criteria:

* Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
* Patient has an apache ii \> 30.
* Patient has an infection caused by pathogens resistant to ertapenem
* Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
* The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
Minimization of IntraLipid Versus Omegaven

Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises \>100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).

Eligibility Criteria:
Inclusion Criteria:

* infants admitted to neonatal intensive care unit
* severe cholestasis, defined as conjugated bilirubin greater than 35
* receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
* signed consent

Exclusion Criteria:

* hepatitis (TORCH or other viral infection)
* primary liver disease as etiology of cholestasis
* clinically severe bleeding not able to be managed with routine measures
* lethal congenital abnormalities
* congenital heart disease associated with right heart dysfunction
Effects of Kegel Exercises With and Without Myofascial Release in Chronic Pelvic Pain

Study will be a Randomized control trial to check the effects of kegel exercise with and without myofascial release on chronic pelvic pain in females so that we can examine the effect of above techniques on pain, function and quality of life in chronic pelvic pain females.Non-probability convenience sampling technique will be used, subject following eligibility criteria from DHQ Hospital Layyah will be randomly allocated in two groups. Group A participants will be given kegel exercise with myofascial release, Group B participants will be given kegel exercise for 3 weeks. Assessment will be done via, Numeric Pain Rating Scale and pelvic floor impact questionnaire (PFIQ) and functional pelvic pain scale

Chronic pelvic pain (CPP), defined as a noncyclical pain lasting for more than 6 months can lead to lower physical performance and quality of life in women. In this study the effects of Kegel Exercise with and without myofascial release in chronic pelvic pain population will be analyzed. This study will be a randomized clinical trial. Kegel Exercise and Myofasical Release would be administered to the chronic Pelvic pain Females. Subjects meeting the predetermined inclusion criteria will be divided into two groups. Assessment will be done using Numeric Pain rating scale (NPR), Pelvic floor Impact Questionnaire (PFIQ) and Functional pelvic pain scale (FPPS). Subjects in one group will be treated with kegel exercise with myofascial release, and the other will be treated with kegel exercise only. Each subject will receive a total 12 treatment sessions, with 04 treatment sessions per week. Measurements will be recorded at start and end of treatment session. Recorded values will be analyzed for any change using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* • Age 25-55

  * Record of CPPS for more than 6 months.
  * Complete gynaecological consultation with necessary workup.
  * Chronic pelvic pain associated with gynaecological issue.
  * Patients who have tenderness upon palpation are included, suggesting that the trigger points are painful.
  * Patient that can't cope with their daily activities

Exclusion Criteria:

* Acute active infection
* Malignancy
* Active pregnancy
* Pudendal nerve entrapment syndrome.
* Not simultaneously partaking in pelvic floor physical therapy.
* No evoked tenderness upon palpation of levator ani sling at examination.
Pseudoexfoliation Syndrome in Myopes

A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.

A retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators Clinic in a period of 2.5 years. Pseudoexfoliation syndrome was found in 255 eyes. There were only 26 cataract myopic eyes with pseudoexfoliation syndrome. Refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (IOL) value done by optical low coherence reflectometry biometer LENSTAR LS 900®. Ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization IOL value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.

Eligibility Criteria:
Inclusion Criteria:

* cataract surgery patients ≥ 40 years old

Exclusion Criteria:

* cataract surgery patients \< 40 years old
Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome

The main purpose of this study is to measure the evolution of hemoglobin A1c level after treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic control and associated moderate or severe obstructive sleep apnea.

Subjects with poorly controlled type 2 diabetes are a high cardiovascular risk group in which a high prevalence of moderate to severe sleep apnea is expected. Studies based on interstitial glycemic measurement demonstrate a reduction in glucose levels when treating sleep apnea with CPAP. Nevertheless, the effectiveness of CPAP in improving glycemic control has been questioned as most studies have failed to demonstrate a reduction in hemoglobin A1c (HbA1C) level over time. Most of these studies have limitations such as a short follow-up or a suboptimal fulfillment of CPAP treatment. We hypothesize that treating moderate to severe sleep apnea with CPAP will improve glycemic control (measured by HbA1C) at 14 weeks in good compliers and that this improvement will be sustained at one year. We aim to test this hypothesis in consecutive type 2 diabetes patients on stable treatment with HbA1c ≥7% in routine outpatient visits in our Diabetes, Nutrition and Endocrinology Unit. After providing informed consent, patients will be screened for sleep apnea by nocturnal oximetry followed by a diagnostic respiratory polygraphy. Those patients with obstructive sleep apnea with an apnea-hypopnea index ≥20 will be invited to enter the study. After a 3-month observation period without any intervention to rule out a potential influence of entering the study on HbA1C levels, patients will be treated with CPAP. HbA1C levels will be measured at baseline, after 14 weeks, and thereafter every 14 weeks until completing one year of treatment. Other endocrine, metabolic and cardiovascular risk variables will be determined at baseline and at 14 weeks of the intervention.

Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes on stable treatment for the last three months and HbA1C ≥ 7%
* Obstructive Sleep Apnea with and apnea-hypopnea index ≥20
* Acceptance of a therapeutic trial with CPAP

Exclusion criteria:

* Race: non caucasic
* Blood level of hemoglobin \<10 in women or \<11 in men or iron defitiency or hemoglobinopathy
* Glomerular filtration rate \< 30
* Habitual sleeping time \<6 hours per night
* Nocturnal work, shift work or unsual sleeping schedule
* Primary severe insomnia or secondary to restless legs syndrome
* Major or non stable psychiatric disorder
* Treatment with corticosteroids
* Chronic respiratory disorders that may require corticosteroids or cause respiratory insufficiency or FEV1/FVC\<0.7 with FEV1\<50 in spirometry
* Predominant nocturnal hypoventilation pattern
* Cardiac failure
* Alcohol abuse
* Active CPAP treatment
* Previous surgery for sleep apnea
* Severe nasal obstruction
* Illiteracy
Assessment of the Psychophysical State During Rehabilitation Treatment With Lokomat

The use of robotic technologies in rehabilitation is an increasingly widespread practice in the health sector: the Lokomat is a medical device intended for walking rehabilitation, consisting of an exoskeleton, a treadmill and a harness that supports the body weight and acts as a safety tool This technology is useful in the rehabilitation of pathologies such as prenatal stroke, brain injury, paraplegia, multiple sclerosis and other motor, orthopedic and neurological problems. During these treatments, the psychological / emotional component of the patient is not properly considered and the success of the treatment remains focused on the motor-rehabilitation level.

The management of subjective-experiential aspects remains in the hand of clinical figures (primarily physiotherapists) who have no tools for objective assessment other than their sensitivity. However, considering the experience is fundamental for the success of the therapy: this happens especially in the pediatric field, where clinical results improve significantly when children start therapy with a relaxed and positive mental state.

The aim of this project is to investigate the rehabilitation experience of patients who perform gait rehabilitation by menas of the Lokomat system, considering the relationship between physiological parameters and moods. Therefore, the main goal is to monitor the patient's psychophysical condition before, during and after the rehabilitation activity, during the different sessions. This will allow describing, with qualitative and quantitative data, the user experience of the patient who undergoes a therapeutic treatment with the Lokomat.


Eligibility Criteria:
Inclusion Criteria:

- patients that need gait rehabilitation treatment according to their clinician

Exclusion Criteria:

* subjects unable to understand and execute simple instructions;
* subjects with skin problems in the wrist area intended for the application of the Empatica bracelet.
Human Skin Test Model in Colostomists

The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent.
2. Be in the age of 45 to 75 years of age both extremes included.
3. Have had a colostomy for at least 1 year.
4. Has a colostomy with a diameter up to (≤) 40 mm.
5. Have mental capacity to understand the study guidelines and questionnaires.
6. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
7. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
8. Have a BMI between 20-30 kg/m2.
9. Are willing to comply with investigation procedures.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Received radio- and/or chemotherapy within the last two months.
3. Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.

   on peristomal skin (injections and oral treatment are accepted).
4. Have dermatological problems.
5. Participating in other clinical studies or have previously participated in this test.
6. Be a daily user of a convex base-plate.
7. Are pregnant or breastfeeding.
8. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)

Evaluation of the effectiveness of a phlebology-oriented spa therapy at 6 months on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs

NEYRAC is a:

* prospective, before/after, cohort follow-up study with repeated measurements
* monocentric study with the dispensation of a 3-week phlebology-oriented spa therapy in Neyrac-les-Bains

Eligibility Criteria:
Inclusion criteria:

* Age greater than 18 years
* Patient with chronic venous insufficiency of the lower limbs (CEAP category C4a, C4b and C4c)
* Patient presenting an indication for a phlebology-oriented spa treatment as the primary orientation. Patients with a dermatological or rheumatological pathology can benefit from a dual orientation spa treatment with a main phlebology orientation
* Patient affiliated to the social security system or such a system
* Available for an 18-day spa treatment and a 6-month follow-up
* For women of childbearing age: effective contraception
* Patient close to a study investigator (excluding teleconsultation) If not patient with access to the necessary equipment to perform a teleconsultation (smartphone, tablet or computer with an internet connection + taking and sending photos of the lower limbs)

Non inclusion criteria:

* Venous surgery or venous interventional therapy within 3 months prior to inclusion or scheduled within the next 3 months
* History of venous ulcer
* Contraindication to spa therapy (immune deficiency, evolving cardiopathy neoplasia, infection, pulmonary tuberculosis, severe renal insufficiency, alcoholic cirrhosis, advanced senility and severe mental disorders)
* Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.)
* Persons suffering from venous insufficiency of the varicose vein type (category CEAP C2) or edema alone (category CEAP C3) or open or healed ulcers (CEAP category C5 and C6)
* Patient who has already undergone a phlebology-oriented spa treatment within the current thermal season
* Subject already included in an interventional clinical research protocol
* Persons referred to in articles L1121-5 to L1121-8 of the "Code de la Santé Publique" (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
A School-based Prevention Intervention to Promote Wellbeing in Preadolescents

This is a field study aiming to evaluate a school-based prevention intervention, Diario della Salute (DDS).

Diario della Salute (DDS) is a school-based prevention intervention based on the following theories:

1. social-cognitive theory (Bandura, 1977; 1986)
2. theory of multiple intelligences (Gardner, 1987)
3. emotional intelligence theory (Goleman, 1997)
4. theory of planned behavior (Ajzen, 1991)
5. transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).

DDS is composed by:

1. tools for children and their parents on health and social and emotional well-being issues:

   1. a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
   2. a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
2. five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.

Assignment of schools to study arms (DDS intervention vs. no intervention) will be cluster-randomized. Schools will be matched by number of students and average socioeconomic status. In some study areas schools will not be allocated by chance, but they will be analyzed separately from other schools.

Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol, physical activity and diet) will be before and after the intervention. Pre and post surveys will be linked through an anonymous code (Galanti, 2006).

Eligibility Criteria:
Inclusion Criteria:

* schools providing consensus to study participation

Exclusion Criteria:

* schools involved in structured prevention programs with similar objectives
Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks.

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks; the safety of the compound are also evaluate. The Investigators examine lipid profile, glucose, liver and renal function at baseline, as well as after 4, 8 weeks of intervention. Thirty adults were administered either 1.8 L of drinking water using a tumbler that emits far infrared rays at room temperature or drinking water using a sham-tumbler each day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 19 years and older

Exclusion Criteria:

* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than twice the highest reference value
* serum creatinine ≥ 1.5 mg/dL)
* uncontrolled diabetes mellitus (a fasting glucose of \>160 mg/dL)
* uncontrolled hypertension (BP \> 160/100 mmHg)
* severe gastrointestinal symptoms
* alcohol abuser
* pregnant or lactating women
* allergic to the ingredient involved
* cardiocebrovascular diseases or any cancer during the six months prior to study
* smoker
Determining How Indoor Lighting Affects the Brain Health of Older Adults

The goal of this randomized, cross-over, single-site trial followed by an exploratory third intervention is to understand how indoor lighting affects different measures of brain health in older adults living in independent living residences. This is a community based study occurring in a local senior living facility. The main question this study aims to answer is:

- How does the quality of ambient indoor lighting an older adult is exposed to affect measures of brain health, such as sleep quality, physical activity, cognitive function, and social engagement?

Participants will be exposed to three different indoor lighting conditions for 4 weeks each while performing the following tasks:

* Wear a smartwatch throughout the study to measure sleep quality and physical activity
* Wear a small, wearable light sensor to measure light exposure during waking hours
* Perform cognitive assessments throughout the study to detect any changes between each of the lighting conditions
* Complete self-report of surveys to assess independence, social engagement, sleep quality, and mood

Results from these tasks will be compared within and between subjects to assess whether the different lighting conditions affect these different measures of brain health.


Eligibility Criteria:
Inclusion Criteria:

1. At least age 60;
2. Able to wear wearable devices throughout the study;
3. Willing to have their lighting in their kitchen and dining areas changed and controlled for the study;
4. Willing to have environmental sensors placed in their residence;
5. Willing to provide contact information about their primary care provider (PCP); and
6. Able and has capacity to provide informed consent (score \> 14.5 based on UBACC consent capacity form).

Exclusion Criteria:

1. Is legally blind
2. Previously renovated their living units and no longer have the standard lighting installation offered by the Senior Living Facility;
3. Currently spend or plan to spend most of their day outside of their residence during the study (i.e., would not experience the indoor lighting intervention for the majority of the study);
4. Plan to travel to a different time zone during the study; or
5. Plan to be away from their residence for more than a week during the study.