cyrilzakka/clinical-trials huggingface dataset:
Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.

Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.

The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.

The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.
* Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)
* Patient who has agreed to participate in the study
* Patient with social security coverage.

Exclusion Criteria:

* Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)
* Pregnant or lactating women
* Minor patient
* Major patient under tutorship, curatorship, or deprived of liberty
* Patient unable to understand protocol and / or give express consent
* Patient not affiliated with a social security system or beneficiary of such a scheme
* Patient participating in an intervention-type clinical research protocol likely to modify the evaluations of this protocol
* adults under the protection of justice
Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)

This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least six months
* Fluent in spoken and written English
* Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
* Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period

Exclusion Criteria:

* Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation
* Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
* Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows
* Currently pregnant or plan to become pregnant during participation in the study
Carbon Monoxide Blood and DNA Biorepository

The purpose of this biorepository is to collect blood from patients at the time of CO poisoning and at follow-up visits months to years later. These samples can be used in the future to learn more about how CO damages the heart and brain and whether blood tests could predict which patients will have problems after CO poisoning.

The investigators propose to establish a biorepository for storage of serum, plasma, and DNA collected from patients with carbon monoxide (CO) poisoning. Participants will also be evaluated for clinical outcome. The biorepository will include serum and plasma from CO-poisoned patients drawn at the time of injury as well as from blood drawn at clinical follow-up visits. The biorepository will also bank DNA from these participants.

These specimens can be analyzed in the future to elucidate potential inflammatory and immunological mechanisms that cause brain and heart damage and identify possible biological and genetic predictors of poor outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.).
2. Documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms.

Exclusion criteria:

1. Pregnancy
2. Age \< 18 years
3. Unable to obtain informed consent
4. Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.
5. Anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 18 years of age and may be of any race and either gender.
2. Subjects must not have ever worn contact lenses.
3. Subjects must have normal, healthy eyes.

Exclusion Criteria:

1. Subjects must not use additional lens cleaners.
2. subjects must not have any ocular or systemic disease.
3. Subjects must not have history of ocular surgery/trauma within the last 6 months.
A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.

The purpose of this study is to assess the long-term safety and tolerability of \[S,S\]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial.
* Patients at screening must have a score of \>/=40mm on the pain visual analogue scale.

Exclusion Criteria:

* Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator.
* Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.
The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women

Scientific background:

Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes. In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times higher than Jewish females, respectively. The economic impact of obesity and overweight in terms of illness, disease and lost productivity is estimated to amount to 2-9% of the national health budget in countries with high GDP. Diabetics have medical expenditure that is 2.4 times higher than non diabetics per capita.

Lifestyle modification is an effective tool in reducing morbidity and health care expenditure but despite that most family practitioners usually treat the complications of obesity rather than preventing it.

PACE is a comprehensive health promotion guide in counseling patients to an active healthy lifestyle. PACE is designed to assist the primary health care providers to promote physical activity and dietary changes during routine office visits.

Objectives:

To asses the impact of PACE program on increasing the amount of physical activity, improving clinical and metabolic indices, increasing the documentation of lifestyle indices in the medical records and reducing health care expenditure and utilization.

Working hypothesis:

Implementing a modified PACE protocol can achieve this objectives in Arab women.

Methodology:

The investigators will conduct a structured, multidisciplinary and continuous primary care based intervention, assisted by trained health promoters and applying a locally adjusted PACE protocol.


Eligibility Criteria:
Inclusion Criteria:

* Arab women
* Age range 35-64
* Insured by Clalit Health Services (CHS)
* Residence in the target communities
* BMI \> 30 kg/m2
* Signed informed consent

Exclusion Criteria:

* Failure in any of the inclusion criteria
Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment

The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.

Foot drop is a symptom observed in various pathologies including neuro-muscular pathologies of peripheral or central origin. It is a walking disability, causing a deterioration in the patients autonomy and quality of life.

The current medical strategy focuses on various off-the-shelf or custom made devices, depending on the walking functional impairment and the characteristics of foot deformities.

The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device ankle foot orthosis compared to a standard plastic ankle foot orthosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a foot levator muscles impairment (single or bilateral drop foot) and / or instability of the back of the foot, associated with a deficit of the triceps
* Patient with inability to stand on tip-toe on one foot
* Patient having signed a free and informed consent
* Patient affiliated or entitled to a social security scheme

Exclusion Criteria:

* Patient with fixed varus-equine foot
* Patient with an unstable skin condition (whether or not treated with additional treatment that may change the footwear)
* Patient with a a foot levator muscles impairment with a deficiency of the quadriceps and hamstrings (knee involvement)
* Patient with uncontrolled spasticity
* Patient for whom foot surgery is planned during the study
* Patient with one of the contraindications to the use of carbon medical device, indicated in the instructions for use
* Patient with one of the contraindications to the use of the standard plastic ankle foot orthosis, indicated in the instructions for use
* Patient with orthopedic comorbidities affecting the musculoskeletal system
* Pregnant woman
* Patient with major cognitive impairment incompatible with participation in a clinical trial
* Patient participating in another clinical investigation conducted to establish the compliance of a MD impacting the evaluation criteria
* Patient who cannot be followed for 12 weeks
* Vulnerable patient according to article L1121-6 of the public health code, persons subject to a measure of judicial protection or unable to consent freely
Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)

The combination of the constraint-induced movement therapy (CIMT) method as a complement to hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand use and function in children with hemiplegic CP.


Eligibility Criteria:
Inclusion Criteria:

* active wrist extension/dorsiflexion of at least 20;
* MACS 1-3;
* GMFCS 1-2;
* enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence.

Exclusion criteria:

* seizures;
* severely increased muscle tone; or hemi arm to good;
* orthopedic surgery on the upper extremity;
* botulin toxin injections within the past half year to the upper extremity;
* inability to understand instructions or cognitive/behavior/concentration.
The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.

This study will assess the impact of Vitamin D supplementation on hypertensive patients with Vitamin D deficiency, it will also investigate the relationship between serum Vitamin D, irisin levels, blood pressure, and heart rate variability (HRV) in hypertensive and normotensive individuals.

It is hypothesized that a decrease in blood pressure and an increase in HRV will be noted in the hypertensive treatment group (subjects on supplemental vitamin D) in comparison to the hypertensive control group (placebo) upon vitamin D supplementation.

In a prospective study conducted on 160 participants, 80 hypertensive and 80 normotensive individuals, assessing correlations between Vitamin D, irisin, blood pressure, and HRV, hypertensive vitamin D deficient participants will be recruited in a randomized controlled trial. In this clinical trial, 60 hypertensive participants with Vitamin D deficiency will receive either Vitamin D supplementation (25,000 IU weekly) or a placebo for 8 weeks (30 participants in each group).

Outcome measures include systolic and diastolic blood pressure, HRV, serum Vitamin D, and serum irisin levels before and after supplementation.

The aim is to explore the potential role of Vitamin D and irisin in regulating blood pressure and improving HRV, potentially offering preventive measures for hypertension management.

Eligibility Criteria:
Inclusion Criteria:

Hypertensive: Adult individual diagnosed with hypertension by a specialist (at least two systolic blood pressure readings above 140 mmHg or diastolic blood pressure readings above 90 mmHg, measured by a qualified professional following American Heart Association guidelines) managing hypertension through medication adherence, and regularly attending heart clinic appointments, with no other systemic diseases.

Control: Healthy adult individuals without hypertension or a history of other systemic diseases who volunteer and participate in the study, which will be recruited from relatives, friends, colleagues or patient accompanies. - (\*Note: The healthy participants were included in the first part of the study before starting the clinical trial)

Exclusion Criteria:

* 1. Hypertensive individuals who have heart failure and other cardiac or systemic diseases or with recent cardiovascular events.

  2. Secondary hypertension 3. Hypertensive patients who require medication change during the course of the study.

  4. Individuals on Lipid-lowering agents (e.g. simvastatin). 5. The use of other medications affecting blood pressure is not part of the study protocol.

  6. Any subjects on regular supplemental vitamin D or receiving multi-vitamins regularly with vitamin D content of more than 880 IU, one month before recruitment.

  7. Individuals with a BMI over 35 or less than 18 kg/m2. 8. Subjects with a significant change in lifestyle, for example, exercise, weight change, or on a specific dietary regimen during or in the previous four weeks of the study.

  9. Subject diagnosed with neoplasm, or inflammatory or autoimmune diseases 10. Pregnant or lactating female
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between 21 and 55 years of age(inclusive).

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).
Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application

The purpose of this study is to examine therapeutic efficacy of categorical language fluency smartphone game application in mild cognitive impairment and mild Alzheimer's dementia.

The Categorical Language Fluency Smartphone Game Application was developed based on the semantic distance training, which was effective in improving categorical language fluency of mild cognitive impairment and mild Alzheimer's dementia. 10 patients with mild cognitive impairment and another 10 patients with mild Alzheimer's dementia were recruited to examine therapeutic efficacy of the application.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 55
* Confirmed literacy

  * Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
  * Diagnosed to possible or probable Alzheimer's dementia by NINCDS-ADRDA and Clinical Dementia Rating(CDR) of 1 or below.

Exclusion Criteria:

* Evidence of delirium, confusion
* Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
* Evidence of severe cerebrovascular pathology
* History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
* History of substance abuse or dependence such as alcohol
* Presence of depressive symptoms that could influence cognitive function
* Presence of medical comorbidities that could result in cognitive decline
Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions

The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child).


Eligibility Criteria:
Inclusion Criteria:

* Must be a patient at University of Texas Physicians Greens Clinic or University of Texas Physicians Pediatric Primary Care in Houston, Texas
* BMI\>85th percentile
* reside within a 10-mile radius of a Brighter Bites school
* Medicaid recipients or low-income uninsured
* parents must be able to read and write in English or Spanish to complete surveys

Exclusion Criteria:

* currently participating in Brighter Bites
* a family member/sibling currently participating in Brighter Bites
* child is currently attending a school that offers Brighter Bites
Analgesia in Laparoscopic Cholecystectomy

The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.

Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU).

Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes.

Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead.

VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery.

The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
* Scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Patients with chronic pain and/or on analgesics for the last month,
* Patients with central nervous, kidney and liver disease, or allergy to local anesthetics
Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

This study will evaluate combination chemotherapy for patients with extensive stage small cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.

Upon determination of eligibility, all patients will be receive:

* Irinotecan + Carboplatin + Imatinib

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Small cell lung cancer with extensive stage disease confirmed by biopsy
* Measurable or evaluable disease
* Ability to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney
* No active brain metastasis.
* No previous chemotherapy or radiation therapy
* Give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Limited stage disease (includes IA, IB, IIA, IIB, and IIIA)
* Active brain metastasis
* Age \< 18 years old
* History of a prior malignancy within three years
* Women pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.