Kornimate/medical-research-clean huggingface dataset:
improving exercise capacity with tailored physical activity in lymphoma & breast cancer patients undergoing tx

Conditions: Hodgkin Lymphoma; Non-hodgkin Lymphoma; Lymphoma; Breast Cancer

Summary: to provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.

this study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (pai) vs healthy living intervention (hli) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (qol), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bc).

Eligibility criteria:
inclusion criteria: * subjects age 18-85 years old * stage i-iv hodgkin's (hl) or non-hodgkin's lymphoma (nhl) or i-iii breast cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens \[anthracyclines, trastuzumab\]), immuno-therapies (immune checkpoint inhibitors \[ici's\]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion). exclusion criteria: * evidence of covid19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for covid19. * uncontrolled hypertension (systolic blood pressure \>190 mm hg or diastolic blood pressure \>100 mm hg) * a recent history of alcohol or drug abuse * inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion * other exclusions include those with contraindications to mri; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (\>20 pvcs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write english); or moving within 12 mos. of enrollment.

Keywords: physical activity intervention healthy living intervention health-related quality of life
glucose study, spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this research study is to find out how blood sugar levels change during the day and night in people living with spinal cord injuries (sci) and then to compare that with people who do not have a spinal cord injury. as people with sci get older they become more likely to develop health problems, just like everyone else. however, sci increases the risk of certain problems. the amount of time post-sci can also increase the risk of certain problems. this research project will focus on identifying the patterns of changes in blood sugar levels after sci. sugar in the blood is the important source of energy for the body. too much sugar in the blood is known as hyperglycemia and not enough sugar in the blood is known as hypoglycemia. under healthy conditions, the amount of sugar in the blood is automatically regulated so that a steady level is maintained. after sci, however, this automatic regulation is damaged. the likelihood of experiencing too much or too little blood sugar is increased. over time, having too much blood sugar can lead to the development of diabetes. in just the opposite situation, individuals with sci can begin to experience more frequent episodes of too little blood sugar, which can lead to acute emergency situations. the pattern of how blood sugar levels change during a typical 24-hour time period in persons with sci is not known. there may be unknown factors that affect blood sugar levels. in order to find out that information, this study will involve continuously monitoring blood sugar over a 3-day period in a variety of persons with sci. a non-invasive, wireless monitoring system will be attached to the abdomen. this system records blood sugar levels every 5 minutes. the information gathered from this observational study is vital to the understanding of how sci alters the regulation of sugar levels in the blood and to the subsequent medical management of this population.


Eligibility criteria:
inclusion criteria: 1. must be greater than 1 year post-injury. 2. must be 18-65 years of age. 3. must have detectable neurologic impairment resulting from a spinal cord lesion. 4. must not have any current pressure sores. 5. must be cognitively competent and have no concomitant brain damage. 6. must pass a medical examination by the study physician. 7. must be healthy. 8. must not have any physical ailments. 9. must be cognitively competent.
mechanisms of malnutrition in cirrhosis with portosystemic shunting

Conditions: Cirrhosis

Summary: cirrhosis is characterized by loss of muscle as well as fat mass, which increases morbidity and mortality before, during, and after liver transplantation. a common mechanism for the reduced muscle and fat mass in cirrhosis is an increased expression of the tgf (transforming growth factor)beta superfamily member, myostatin, in the muscle and adipose tissue. the present study will examine the expression of myostatin, its receptor and intracellular signaling pathways in the skeletal muscle and mesenteric adipose tissue in cirrhotic patients undergoing liver transplantation as compared to healthy controls undergoing planned abdominal surgery. 16 cirrhotic patients will be identified from the transplant list, and 16 healthy controls from outpatient surgery lists. nutritional assessment will be performed, including anthropometry (triceps skinfold thickness, mid arm circumference), dual energy x-ray absorptiometry (dexa), and bioelectrical impedance analysis (bia). rectus abdominis muscle tissue and omental fat tissue will be harvested in the operating room, and the expression of signaling proteins involved in skeletal muscle protein synthesis will be quantified. the investigator will also quantify the expression of genes involved in lipolysis and lipid synthesis. the investigator anticipates that the expression of myostatin will be higher in the skeletal muscle and adipose tissue of cirrhotics as compared to controls. there will be a reduction in the expression of the signaling proteins that regulate skeletal muscle protein synthesis, as well as the expression of genes regulating lipogenesis. the increased expression of myostatin will also correlate with reduced anthropometric and dexa measurements of lean body mass and fat mass.


Eligibility criteria:
inclusion criteria: * age 18-70 years * patients undergoing abdominal surgery (liver transplantation or other surgery) control 1. non liver transplant donor 2. elective abdominal surgery (cholecystectomy, diverticulosis, acute gastrointestinal bleeding in the absence of exclusion criteria) exclusion criteria: * exclusion criteria (all subjects) * average daily alcohol intake \> 20 g in women and \> 30 g in men * diabetes or a fasting serum glucose \> 100 mg/dl * hyper- / hypo- thyroidism * renal disease with serum creatinine \> 1.4 mg/dl * folate or vitamin b12 deficiency * active intravenous drug use * history of bowel surgery or gastric bypass surgery * medications/supplements that affect fat mass or protein mass (creatine, glucocorticoids) * pregnancy * chronic diseases that result in cachexia (renal, cardiac, pulmonary, hematologic, cancer) * hepatocellular cancer exclusion criteria (controls) * evidence of malnutrition as quantified by triceps skinfold thickness, mid arm muscle area and creatinine height index)
systematic transplantectomy versus conventional care after kidney graft failure

Conditions: Renal Transplantation

Summary: our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-hla immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event). observation or investigation method used : the study is : * multicenter * prospective * open * randomized: patients are divided into two parallel groups: * study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. abrupt discontinuation of anticalcineurin two weeks after transplantectomy. corticosteroids: 5mg per day until one month after transplantectomy then stop within one month. * control group: no systematic transplantectomy. antiproliferatives stop at the start of dialysis.anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months. in the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients affiliated to health protection system, social security in france or any similar regimen. * renal transplant patient with end-stage transplantation, regardless of the number of previous transplants. * patient receiving immunosuppressive protocol based on anticalcineurin or mtor inhibitors * patient should have resume hemodialysis within 4 weeks * duration of transplantation more than one year * patient with asymptomatic graft * immunogenic potential residual \>50% (calculated pir during the re-dialysis) * patient not covered by any measure of legal protection. exclusion criteria: * immunogenic potential residual \<50% * graft infection uncontrolled by treatment * active infectious pathology * inflammatory graft * uncontrolled arterial hypertention * inflammatory syndrome of undetermined origin with crp\>50mg/l * fever of unknown origin for more than 8 days t\>38°c * contra-indication to surgery * avk treatment * patient candidate for a living donor within 12 months * monotherapy with calcineurin inhibitors or mtor inhibitors * treatment directed against the humoral response in the 6 months preceding the recovery of dialysis (rituximab iv-ig or high doses) * presence of another transplant (pancreas, liver, heart, lung)

Keywords: renal failure, transplantectomy immunosuppression sensitization
exercise rehabilitation for children with asthma

Conditions: Asthma in Children; Rehabilitation; Exercise

Summary: asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. in addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. by employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. the 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. the study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. the anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients.


Eligibility criteria:
inclusion criteria: 1. diagnosed with bronchial asthma; 2. no acute asthma attacks in the past three months; 3. currently undergoing stable prophylactic treatment for asthma, with no changes in the treatment plan in the past three months. exclusion criteria: 1. suffering from other severe heart, lung, or musculoskeletal diseases; 2. frequent acute asthma attacks or recent hospitalization records; 3. changes in asthma medication treatment plan in the last three months; 4. currently participating in other clinical trials that could affect the results of this study; 5. any medical contraindications, such as severe exercise-induced asthma or other health issues affecting the ability to exercise; 6. severe psychological or behavioral issues that may affect participation in training or adherence to the research protocol.
effects of a 5:2 diet on weight loss and cardiovascular risk factors in obesity

Conditions: Obesity; CVD; Dietary Modification

Summary: a randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk factors of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects.

background: the optimal diet for treating obesity and cardiovascular disease (cvd) risk is still not clarified. could a five plus two diet, a form of intermittent energy restriction lead to good adherence, similar weight loss and reduction in cvd risk factors as a isocaloric continuous energy restrictions in obese subjects. methods: the study is a randomized controlled clinical trial in 120 men and women between 21 to 70 years with bmi (bmi 30-45 kg/m2), stable weight within ±3 kg last 3 months and 1 additional metabolic syndrome risk component. dietary intervention: randomization will be to one of two diet groups. participants in the intervention group will follow av 5:2 diet and participants in the control group will follow an isocaloric continuous energy restriction. primary research question: compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects? secondary research questions compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects. the project consist of to randomized controlled clinical trials.

Eligibility criteria:
inclusion criteria: * men and women between 21 to 70 years. * bmi (bmi 30-45 kg/m2). * stable weight within ±3 kg last 3 months. * 1 additional metabolic syndrome risk component. exclusion criteria: * diabetes if treated with insulin or incretin analogues. * history of bariatric surgery. * use of antiobesity drugs or supplements. * eating disorder. * psychiatric illness that contributes to difficulties with study procedures. * alcohol or drug abuse.
the involvement of the gut hormone gip in the pathophysiology of post prandial hypotension

Conditions: PostPrandial Hypotension

Summary: the present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (gip) in the pathophysiology of postprandial hypotension (pph)

the study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the gip receptor antagonist, gip(3-30)nh2 (nh2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (mmt). eighteen participants, men and women, with mmt confirmed pph will be included in the study.

Eligibility criteria:
inclusion criteria: 1. age 18-85 years 2. history of pph-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion 3. informed consent exclusion criteria: 1. not fulfilling the pph diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories 2. treatment with antihypertensives 3. treatment with snri (serotonin and noradrenalin reuptake inhibitor) or treatment within three months before screening visit 4. allergy or intolerance to ingredients included in the mixed meal 5. any ongoing medication that the investigator evaluates would interfere with trial participation 6. any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses 7. anaemia (haemoglobin below normal range \<7.3 mmol/l for women and \<8.3 mmol/l for men) 8. moderate to severe loss of kidney function (estimated glomerular filtration rate (egfr) \<45 ml/min/1.73 m2) at screening 9. known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (alt) \> three times the upper limit of normal at screening 10. any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial 11. alcohol/drug abuse as per discretion of the investigators 12. pregnancy or breastfeeding 13. participation in any other clinical trial during study period 14. mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator

Keywords: postprandial hypotension glucose-dependent insulinotropic polypeptide gip gip receptor antagonist gip(3-30)nh2
early albumin resuscitation during septic shock

Conditions: Septic Shock

Summary: objective: to determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients. design: prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center. setting: 27 intensive care units (icu) in france coordinator: pr j.p. mira and dr j. charpentier - cochin hospital- paris patients: 800 patients could be included during the first 6 hours of their septic shock.

the primary outcome: mortality during the 28 day period after randomization. the secondary outcomes: evaluation of sofa score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections. the albuminemia of all patients is requested before the treatment until day 4 post treatment. the treatment is: vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days. the first patient will be in july 2006, the last patient expected is on july 2009.

Eligibility criteria:
inclusion criteria: * over 18 years old * septic shock \< 6 hours * agreement of patients exclusion criteria: * allergy to albumin * weight \> 120 kg * non septic shock * burned * cirrhosis * albumin perfusion 48 hours before randomization * pregnant women * cardiac dysfunction new york heart association (nyha) 3 or 4 * patients with therapeutic limitation

Keywords: septic shock
pharmacokinetics of ap214 acetate in patients undergoing cardiac surgery

Conditions: Cardiac Surgery; Coronary Artery Bypass Grafting; Valve Surgery; Aortic Root or Ascending Aortic Aneurysm Repair Surgery

Summary: the purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of ap214 in patients undergoing cardiac surgery. ap214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.


Eligibility criteria:
inclusion criteria: 1. has signed the trial-specific informed consent form. 2. patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity. 3. patients undergoing cabg, valve(s), cabg/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery. 4. cleveland clinic renal score ≥ 2 (higher than average risk for aki). 5. ef ≥ 30%, evaluated within 2 months prior to screening visit. exclusion criteria: 1. cardiac surgery to be performed "off pump" without cardiopulmonary bypass. 2. circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery. 3. confirmed or suspected endocarditis. 4. requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure. 5. receiving aprotinin during the trial, from screening to day 90. 6. having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery. 7. active peptic ulcer disease and gastritis. 8. hemoccult positive stools, hematological, bleeding, and coagulation disorders. 9. receiving dopamine at renal doses (2-4 mcg/kg/min), from screening to day of surgery. 10. s-creatinine greater than 2.1 mg/dl. 11. known or suspected hypersensitivity to the investigational medicinal product. 12. known or suspected hypersensitivity to ondansetron or other selective 5-hydroxytryptamine 3 (5-ht3) receptor antagonists. 13. current participation in any other interventional clinical trial. 14. previously dosed with ap214. 15. use of investigational medicinal products within the previous 6 months. 16. body weight above 140 kg. 17. history of any organ transplant. 18. women who are of childbearing potential, pregnant, or breast-feeding. 19. current abuse of alcohol or substance, according to the investigator's medical judgment. 20. has a mental incapacity or language barriers precluding adequate understanding of trial procedures. 21. is considered by the investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.

Keywords: cardiac surgery coronary artery bypass grafting valve surgery aortic root or ascending aortic aneurysm repair surgery acute kidney injury
yogic breathing and ibs

Conditions: IBS - Irritable Bowel Syndrome

Summary: adults with irritable bowel syndrome (ibs) are being randomized to a yogic breathing or control condition. participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. ibs symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.


Eligibility criteria:
inclusion criteria: * must have a formal diagnosis of ibs and not be enrolled in any other clinical trials. exclusion criteria: * 1) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease
prevention of contrast induced nephropathy in oncology patients with sodium bicarbonate

Conditions: Radiographic Contrast Agent Nephropathy

Summary: contrast induced nephropathy is a rising cause of acute renal failure in all patients. a study published in jama 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. the investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \>18 years old, with a gfr \ 30 ml/min/1,73m2 by mdrd formula and/or diabetic patients. in the group 1 the patients will receive a solution with 154 meq/l of a sodium bicarbonate, 3 cc/kg/h at 1 hour before the injection of contrast and 1 cc/kg/h during and 6 hours before the injection. the primary end point will be the rise of 25% or more in creatinine or dialysis needed.


Eligibility criteria:
inclusion criteria: * \> 18 years old * cancer diagnosis * gfr \ 30 ml/min/1,73m2 by mdrd formula or diabetic * ct with contrast exclusion criteria: * dialysis needed * uncontrolled hypertension * changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure * recent exposure to radiographic contrast agents (within previous two days of the study) * administration of dopamine, mannitol , fenoldopam or n-acetyl cystein during the intended time of study

Keywords: contrast nephropathy bicarbonate prevention