Kornimate/medical-research-clean huggingface dataset:
trial of leptin administration after roux-en-y gastric bypass

Conditions: Overweight

Summary: this is a pilot and feasibility study to examine a novel intervention using leptin in weight-reduced individuals who have undergone bariatric surgery but still remain obese. leptin, a peptide hormone secreted from adipose tissue, is a regulator of food intake and energy expenditure. administration of leptin resulted in profound weight reduction in the few reported cases of obese individuals with genetic leptin deficiency. however, most obese people have increased leptin levels. such individuals are said to be in a "leptin-resistant" state, whereby administration of physiological concentrations of leptin are ineffective at producing significant weight reduction. roux-en-y gastric bypass surgery (rygbp) is more effective than diet alone in producing long-term reduction of body weight. yet even after surgery there is a plateau in weight loss though the individual may still be obese and have or be at risk for obesity related morbidities. the investigators have shown that plasma leptin levels are significantly lower in women after rygbp compared with bmi-matched controls. this state of relative hypoleptinemia or leptin insufficiency suggests that post-rygbp individuals may be in a "leptin-sensitive" state and, thus, would undergo further weight loss when administered doses of leptin that would not normally result in significant weight reduction. this study will examine the effects of leptin administered by self-injection twice per day on body weight and endocrine function. all individuals will received leptin and placebo and different times during the 34 week study period.

metreleptin will be self-administered by subcutaneous injection at 0.05 mg/kg body weight twice per day (i.e. at 8 am and 8 pm). this dose was chosen because it would not be expected to cause substantial weight loss in an obese non-surgical population, nor should it incur any substantial injection site reactions. subjects will receive a demonstration of dose preparation and injection in addition to written instructions with visual aides. after the run-in period, subjects will demonstrate their preparation and injection technique. placebo injections will consist of sterile water equal in volume to that of the metreleptin dose calculated for each individual. subjects will be instructed to continue with their current level of physical activity. at week 16, each subject will cross-over to the alternate treatment for an additional 16 weeks.

Eligibility criteria:
inclusion criteria: * women ages 25-65 years who are 18 months to 15 years roux-en-y gastric bypass * current bmi of 28-50 kg/m2 and a percent total body weight loss from highest pre-surgical weight of \>20% and \<45% * must live in the vicinity of new york city to comply with 11 study visits over 34 weeks * must be willing to self-inject study drug twice per day exclusion criteria: * diabetes * history of plastic surgery

Keywords: roux-en-y gastric bypass leptin bariatric surgery overweight after roux-en-y gastric bypass surgery
the effects of glycine on atherosclerosis and metabolic syndrome-related parameters.

Conditions: Metabolic Syndrome; Dyslipidemias; Diabetes Mellitus; Obesity; Atherosclerosis

Summary: the current study will test the central hypothesis that glycine supplementation in humans improves lipid profile and therefore reduces the risk of atherosclerosis. secondary outcomes including insulin sensitivity and parameters related to metabolic syndrome (mets) will also be measured. furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that glycine via its key biosynthetic pathway involving serine hydroxymethyltransferase 2 (shmt2), is athero-protective by inhibiting sterol regulatory element-binding protein 2 (srebp2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.


Eligibility criteria:
inclusion criteria: * male between the ages of 40-65 years old. * fulfill at least three of the five diagnostic criteria for the metabolic syndrome. * to be able to give their written consent to participate in this study. exclusion criteria: * abnormal liver function tests ≥ 3 times upper limit of normal (uln). * chronic liver disease other than nafld. * previous gastric or small bowel surgery. * abnormal thyroid-stimulating hormone (tsh) level. * known tobacco smoking more than 10 cigarettes per day. * known alcohol consumption more than 2 drink per day. * use of medications that include: insulin or insulin secretagogues, thiazolidinediones, glucocorticosteroids, hormone replacement therapy. * fever \> 38.2 °c in the past 2 weeks. * autoimmune or auto-inflammatory disease. * chronic kidney disease ≥ stage iii. * nephrotic syndrome. * hemoglobin \<12 g/dl. * metal clips or implants that preclude magnetic resonance imaging.
efficacy of intravenous naproksen sodium+codein and paracetamol+codein on postoperative pain on postoperative pain

Conditions: Postoperative Pain, PCA Contramal Consumption

Summary: comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.

patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive iv naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo). the primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia exclusion criteria: * patients, known allergies to any of the drugs used in this study * eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)

Keywords: naproxen sodium+codein, paracetamol+codein,lumbar disc surgery
measuring the effects of touch relaxation painful patients in oncologie nursing

Conditions: Cancer

Summary: measure the impact of touch relaxation on pain communicative patients suffering from chronic pain of cancer origin inpatient oncology. measure over three days the effects on pain anxiety welfare and consumption of analgesics


Eligibility criteria:
inclusion criteria: hospitalized in the oncology department at least 3 days * presenting the cancerous type of pain caused by their disease or treatment * numerical scale pain score = 4/10 * receiving weak and strong opioids * platelet count\> 100 * can receive anxiolytic * adult * patient of both sexes * no other relaxation approaches exclusion criteria: * against indication to touch: wound, bruises, circulatory disorders, diseases psychiatiques * risk of hematoma * numerical scale pain score \< 4/10 * understanding of the difficulties of the french language * no receiving weak and strong opioids
rehabilitation with dual-task exercises to improve balance in patients with parkinson's disease

Conditions: Parkinson Disease (PD), Postural Balance

Summary: the goal of this clinical trial is to learn if a rehabilitative pathway based on dual-task exercise improves balance in patients with parkinson's disease, compared to a traditional rehabilitation program. it will also investigate the reduction of fall risk, and improvement in autonomy and quality of life. the main questions it aims to answer are: * does dual-task exercise improve balance more effectively than traditional rehabilitation in parkinson's patients? * does dual-task exercise reduce the risk of falls? * does dual-task exercise improve patient autonomy in daily activities? * does dual-task exercise enhance the overall quality of life for parkinson's patients? researchers will compare a dual-task exercise program to a standard rehabilitation program. both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. the study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. randomization will be done using dedicated software to ensure unbiased group distribution. participants will: * have a confirmed diagnosis of parkinson's disease (movement disorder society criteria). * be in an early to moderate stage of the disease (hoehn and yahr score \< 3). * be over 30 years old. * be able to provide informed consent. * have a stable medication regimen for at least three months. exclusions include: * hoehn and yahr score ≥3. * severe cognitive or psychiatric disorders (e.g., dementia). * use of interfering medications or treatments. * participation in other clinical trials. * pregnancy or breastfeeding. * need for medication changes during rehabilitation. evaluations will be conducted at baseline (t=0), after rehabilitation (t=1), and at a two-month follow-up (t=2). assessments will include the tinetti balance and gait scales, timed up and go (tug) test, vas pain scale, tampa scale for kinesiophobia, global perceived effect (gpe), barthel index, euroqol-5d-5l, and abc scale. updrs, hoehn and yahr scale, and moca scale will be administered only at baseline (t=0).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of parkinson's disease (movement disorder society criteria). * early to moderate stage of the disease (hoehn and yahr score \< 3). * age over 30 years. * ability to provide informed consent. * stable pharmacological therapy for at least 3 months. exclusion criteria: * hoehn and yahr score ≥ 3. * severe cognitive or psychiatric disorders (e.g., dementia). * use of interfering medications or treatments. * participation in another clinical trial. * pregnancy or breastfeeding. * need for changes in pharmacological therapy during the rehabilitation period.
cardiovascular manifestations in ph-negative mpn

Conditions: Philadelphia Negative Myeloproliferative Neoplasms

Summary: the primary aim of this research is to investigate the clinical and subclinical cardiovascular complications and its relationship with myeloproliferative neoplasms seeking to assess incidence, prevalence and severity in comparison to healthy group and analyze potential risk factors including genetic mutations, inflammatory markers and hematological parameters

myeloproliferative neoplasms (mpns) are a group of hematological disorders characterized by clonal proliferation of stem cells leading to excessive production of blood cells. the primary types include polycythemia vera, essential thrombocythemia, and primary myelofibrosis. they share a common characteristic in that they lack the philadelphia chromosome. patients with mpn face an elevated risk of various clinical cardiovascular complications including arterial and venous thromboembolism, hypertension and heart failure. this increased risk can be attributed to several factors including, chronic inflammation, hyperviscosity due to increased blood cells count and genetic mutation like jak2 v617f which plays a pivotal role in disease pathogenesis. while clinical cardiovascular events in mpn patients are well-documented, subclinical manifestations such as subclinical atherosclerosis, pulmonary hypertension, left ventriclar hypertrophy, diastolic dysfunction and arrhythmia are often overlooked. these subclinical changes may significantly contribute to morbidity and mortality but are not routinely assessed in clinical practice. non invasive modalities such as electrocardiography, echocardiography, carotid doppler ultrasound and limb doppler ultrasound can provide vulnerable tools for early detection of these cardiovascular manifestations. so understanding the relationship between myloproliferative neoplasms and incidence and severity of cardiovascular complications is crucial. this knowledge can enhance risk assessment, improve patient care and outcomes and facilitate targeted interventions.

Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of myeloproliferative neoplasms of one of the following: * essential thrombocythemia (et) * polycythemia vera (pv) * primary myelofibrosis (pmf) * adults aged 18 years and older. * who accept to participate in the study in assiut university hospital. exclusion criteria: * patients with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) will be excluded. * patients who have experienced a myocardial infarction, stroke, heart failure, hypertension, or significant cardiovascular event before diagnosis of mpn * patients with severe comorbid conditions that could confound results, such as: * severe renal or hepatic impairment * active malignancies other than mpn * pregnant or lactating women should be excluded due to potential risks associated with cardiovascular evaluations. * at age group below 18 years old. * who refused to participate in the study.

Keywords: cardiovascular manifestations
a study to evaluate the pharmacokinetics, safety, and pharmacodynamics of olpasiran in participants with normal renal function and participants with various degrees of renal impairment

Conditions: Renal Impairment

Summary: the primary objective of this study is to evaluate the pharmacokinetics (pk) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.


Eligibility criteria:
inclusion: * male participants or female participants of nonchildbearing potential between 18 and 75 years of age (inclusive) at the time of screening. * body mass index between 18 and 40 kg/m\^2 (inclusive) at the time of screening. * eligible participants classified based on established need for renal replacement therapy and egfr at screening. assignment will be based on egfr at screening. 1. group 1 (normal): egfr ≥ 90 ml/min and no history of renal disease. 2. group 2 (mild): 60 ≤ egfr ≤ 89 ml/min. 3. group 3 (moderate): 30 ≤ egfr ≤ 59 ml/min. 4. group 4 (severe): 15 ≤ egfr ≤ 29 ml/min without dialysis. 5. group 5 (kidney failure): egfr \< 15 ml/min and dialysis patients (off-dialysis). 6. group 6 (kidney failure): egfr \< 15 ml/min and dialysis patients (on-dialysis). exclusion: * active liver disease or hepatic dysfunction, defined as aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of normal. * clinically significant hyperkalemia (defined by serum potassium concentration as \> 5.5 meq/l for groups 1 to 4, \> 6 meq/l for groups 5 and 6) at screening or check-in. * history of hypersensitivity, intolerance, or allergy to any drug compound, or other substance, unless approved by the investigator (or designee) and in consultation with the sponsor. * female participants with a positive pregnancy test at screening or check-in. * participant has received a dose of an investigational drug within the past 30 days or 5 halflives, whichever is longer, prior to check-in. participants in group 1 only (participants with normal renal function) are excluded if: • a history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile at screening or check-in. participants in groups 2 to 6 (participants with varying degrees of renal impairment) are excluded if: • a change in disease status within 30 days of screening, as documented by the participant's medical history, deemed clinically significant by the investigator.

Keywords: olpasiran renal impairment normal renal function amg 890
psychosocial outcomes and contralateral prophylactic mastectomy (cpm)

Conditions: Breast Cancer

Summary: the goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer. researchers want to use what is learned from this study to help future patients with breast cancer to be more informed when making treatment decisions.

with your verbal permission, you may have been asked to complete a questionnaire about your surgical treatment preferences for breast cancer as part of initial screening for this study. this takes about 5 minutes to complete. if you agree to participate in this study, during the same visit you will complete a questionnaire about your background, such as your education level, marital status, and family history of cancer. this should take about 3 minutes to complete. you will also be asked to complete a questionnaire about your surgery decisions and your feelings about those decisions at the following times: around the time you enroll in study before your surgery, and again about 1, 6, and 12 months after the surgery is completed. this questionnaire should take about 30-40 minutes to complete each time. you may complete this questionnaire at the clinic or you may complete it at home. if you chose to complete the questionnaire at home, you will be given a postage-paid envelope to mail it back to the study staff. length of study: after you complete all of the questionnaires, your participation in this study will be over. this is an investigational study. a total of up to 345 participants will be enrolled in this study. up to 245 will take part at md anderson and up to 100 will take part at kelsey-seybold.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed ductal carcinoma in situ (dcis) or stage i-iii sporadic unilateral invasive breast cancer 2. age 18 or older 3. able to speak, read, and write english. 4. spouse/partner: married or living with patient for a year or more 5. spouse/partner: age 18 or older 6. spouse/partner: able to speak, read, and write english exclusion criteria: 1. patients with previous breast cancer 2. prior history of prophylactic mastectomy 3. known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., brca1, brca2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer

Keywords: breast cancer contralateral prophylactic mastectomy questionnaires surveys psychosocial
developing and evaluating effectiveness of a reinstatement tutorial

Conditions: Problem Gambling

Summary: this study will compare a computerized tutorial to a brochure in terms of their education impact of people who wish to end voluntary self-exclusion. voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. the centre for addiction and mental health (camh), in cooperation with ontario lottery and gaming (olg), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. the goal of this study is to determine if this new computerized tutorial decreases the harm of gambling experienced by gamblers who are reinstated. for example, are they less likely to relapsing to problematic levels of gambling.

voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. currently there are over 10000 people in the program. although some self-exclusion programs place a permanent ban on the individual, others offer the possibility of reinstatement after a period of time. many problem gamblers actually do change their minds about self-exclusion and wish to return to gambling. centre for addiction and mental health (camh), in cooperation with ontario lottery and gaming (olg), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. the goal of this study is to evaluate an the intervention to determine its impact on problem gamblers who is reinstated from relapsing to problematic levels of gambling. the content for the tutorial will be informed by camh, will be developed for land based gambling, and also adapted for online gambling as well.

Eligibility criteria:
inclusion criteria: * people currently in the voluntary self-exclusion program who wish to be reinstated (allowed back into the casino to gamble). exclusion criteria: * people who are not currently in the voluntary self-exclusion program
trial to compare the sherpapak™ device vs cold storage

Conditions: Organ Transplant

Summary: the investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts. there are two methods of organ preservation. the first method is the use of cold storage. with this method, the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. this is the usual method for transporting donor hearts. this is also known as "standard of care." the second method is the use of the sherpapak™ cardiac transport system. with this method, the donor heart is kept at a steady, consistent temperature throughout transportation. this method is not typically used for transporting donor hearts. the study will include up to 20 people in total.

this is a randomized study and has 2 study groups. participants will be randomly assigned to a group in a 1:1 ratio. * 50% chance of receiving a donor heart using the sherpapak™ method, or * 50% chance of receiving a donor heart using the cold storage method. the research team will analyze data from the medical records from the heart transplant and clinic visits up to 30 days after the heart transplant. participants will be in the study for about 30 days.

Eligibility criteria:
inclusion criteria: * any sex/gender, 18 years of age or older listed for primary heart transplant. * subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent or consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research. * signed: 1) written informed consent document and 2) authorization to use and disclose protected health information * subjects must receive and accept a non-local donor offer (from northern california, arizona, nevada or farther geographies) exclusion criteria: * re-do heart transplant * multi-organ transplant
breast cancer and resilience in couple

Conditions: Breast Neoplasms; Quality of Life

Summary: this is a prospective pilot study examining the couple's dyadic attitudes from diagnosis to 24 months later when one member is affected by illness and the adaptive strategies the couple employs when stressful events occur.

the patients taking part in the study and their partners are examined from the time of the woman's breast cancer diagnosis up to 24 months later with the help of questionnaires and a focus group in order to understand the couple's coping strategies.

Eligibility criteria:
inclusion criteria: * woman diagnosed with stage 1, 2 or 3 breast cancer * age\> 18 years (patient and partner) * the partner must have lived with the woman for at least 6 months at diagnosis and treatment * patients under treatment at the radiotherapy clinic * subjects available and able to answer questionnaires, interviews, and / or participate in focus groups * informed consent exclusion criteria: cognitive deficits and / or inability to comply with the provisions of the study

Keywords: breast cancer quality of life resilience depression