Kornimate/medical-research-clean huggingface dataset:
metabolic adaptations to weight loss with and without exercise

Conditions: Obesity; Metabolic Disease; Metabolic Syndrome; Insulin Sensitivity; Insulin Resistance; Weight Loss

Summary: study purpose: the combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. a deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases. although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. this is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. we argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained study summary: 10% weight loss phase - subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). during this, subjects will be randomized into one of two different experimental groups: 1. moderate intensity continuous training (mict) exercise group 2. no exercise (control) group follow-up phase: after completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss. total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).


Eligibility criteria:
inclusion criteria * age: 18-40 * body mass index: 30-40 kg/m2 * weight stable (±3kg for greater than or equal to about 2 months) * no regularly planned exercise/physical activity * women must have regularly occurring menses and must be premenopausal exclusion criteria * ekg abnormalities * evidence/history of cardiovascular disease, diabetes or other metabolic disease * medications known to affect lipid or glucose metabolism * pregnant or lactating * tobacco or e-cigarette use * prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection. * allergies/hypersensitivity to local anesthetics of the amide type (e.g., lidocaine) * history of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics) * anti-coagulant medication (e.g., coumadin, rivaroxaban) and lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure.
long-term treatment effect of diapep277 in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with diapep277 and clinical follow-up, for 2 additional years. the expectation is first to demonstrate that extended treatment with diapep277 is safe and second to evaluate the long-term effectiveness of treatment. only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.


Eligibility criteria:
inclusion criteria: * a patient that participated in previous 461/po and 901 studies and received all doses of study medication, per protocol. * evidence of clinically significant residual beta-cell function demonstrated by mmtt stimulated c-peptide concentrations ≥ 0.20 nmol/l. exclusion criteria: * the patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study. * the subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.

Keywords: type 1 diabetes beta cells immunomodulation immunointervention
feasibility of a whole-food, plant-based diet for patients with low-risk chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia Stage A(0)

Summary: this study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk cll who are undergoing observation. over the course of 8 weeks, participants will attend weekly group cooking classes via zoom lead by a rd. participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention.


Eligibility criteria:
inclusion criteria: * patients who have a diagnosis of low-risk cll according to the modified rai staging criteria for a minimum of 12 months and are currently undergoing observation. * access to a computer or tablet and zoom. exclusion criteria: * have active disease and are currently receiving pharmacologic treatment for cll * have previously received treatment for cll * are currently following a vegan or vegetarian diet * a previous or current diagnosis of disordered eating including anorexia, bulimia, binge eating disorder or avoidant/restrictive food intake disorder. * a diagnosis of type 1 diabetes * a diagnosis of insulin dependent type 2 diabetes * currently pregnant or planning to become pregnant

Keywords: whole-food plant-based diet cll
co-active therapeutic theatre (co-att) for dual-diagnosis patients

Conditions: Mental Health Issue; Substance Use Disorders

Summary: drama therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing. this study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. the study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful). the drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.


Eligibility criteria:
inclusion criteria: * diagnosed with at least one primary psychiatric disorder, and * diagnosed with at least one substance use disorder * both disorders active (i.e., meeting dsm-v criteria for each disorder (i.e., with ongoing psychiatric symptoms and ongoing substance use) * enrolled in the addiction psychiatry treatment program (aptp) at boston medical center (i.e., scheduled for follow-up appointments with therapist and/or psychiatrist in aptp). * currently taking medications and those not currently taking medications exclusion criteria: * incarcerated persons * pregnant women * inability to understand and/or sign informed consent form

Keywords: drama therapy psychiatric symptom severity subjective quality of life overall functioning
preoperative magnetic tracking in breast surgery in france: french medical-economic study.

Conditions: Breast Cancer; Medico-economic Impact; Breast Cancer Surgery

Summary: magneto is a french medico-economic study on preoperative localization in breast cancer surgery. the main objective is to conduct a cost-consequence analysis comparing magnetic clip localization with the use of metallic wires for the preoperative identification of non-palpable breast lesions. the choice of localization method is left to the physician's and center's discretion. the study is non-interventional (with only questionnaires and data collection), prospective, and multicenter, with patient follow-up lasting up to six months after breast surgery.

the magneto study is a non-interventional, prospective, and multicenter study. it includes two cohorts: one using magnetic clip localization and the other using metallic wire localization. patients are enrolled by the surgeon during the preoperative consultation validating the conservative surgery with preoperative localization. the choice of cohort is left to the discretion of the center based on their routine practice. baseline data, including patient and disease characteristics, are collected. depending on the assigned cohort, localization is performed either with a magnetic clip or a metallic wire. a mammogram is then performed to assess the correct positioning of the marker and its distance from the target lesion. at this stage, the radiologist completes a likert scale satisfaction questionnaire. breast-conserving surgery is performed according to the hospital's standard practices. on the day of the procedure, the surgeon also completes a likert scale satisfaction questionnaire. patients complete quality of life (eq-5d-5l) and satisfaction questionnaires at several points throughout the study. postoperative complications are also recorded.

Eligibility criteria:
inclusion criteria: * i1. female aged ≥ 18 years; * i2. patient presenting with a unifocal and unilateral lesion of invasive carcinoma or in situ; * i3. indication for first breast-conserving treatment with the need for preoperative localization of the lesion, regardless of the associated lymph node procedure; * i4. patient affiliated with a health insurance system; * i5. non-opposition to the study. exclusion criteria: * e.1. psychological, family, or sociological condition that may potentially compromise adherence to the treatment protocol and follow-up; * e.2. bilateral surgery required; * e.3. patient with metastatic breast cancer; * e.4. multifocal or benign lesions; * e.5. pregnant or breastfeeding patient; * e.6. need for neoadjuvant treatment; * e.7. associated breast reduction procedure; * e.8. patient under guardianship, curatorship, or deprived of liberty.

Keywords: cancer breast cancer breast cancer surgery preoperative localization magnetic clip wire localization health economic study cost-consequence analysis medico-economic
pilot study of 99mtc-mip-1404 spect/ct imaging in men with prostate cancer undergoing prostatectomy and/or pelvic lymph node dissection

Conditions: Prostate Cancer

Summary: this is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. patients receive a single iv dose of 99mtc-mip-1404 (study drug) followed by spect/ct scan 3-6 hours after injection. as standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (plnd) within two weeks of study drug dosing. patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mtc-mip-1404 image data will be evaluated for visible uptake and compared with histopathology.


Eligibility criteria:
inclusion criteria: 1. male aged 21 years or older. 2. ability to provide signed informed consent and willingness to comply with protocol requirements. 3. past biopsy indicating the presence of adenocarcinoma of the prostate gland. 4. participant is deemed to be high-risk with potential for pelvic lymph node involvement. the criteria for high-risk are: * patient has psa value \>10 and clinical stage t2 or higher, and gleason score 8, 9 or 10. * patient has psa value \>20 and clinical stage t2 or higher, and gleason score 5. participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection. 6. have had (within previous 2 months) or will undergo diagnostic ct or mri imaging prior to surgery. 7. have had (within previous 2 months) or will undergo bone scan imaging prior to surgery. 8. participants must agree to use an acceptable form of birth control throughout the study period. participants must use condoms for a period of seven days after each injection, if engaged in sexual activity. exclusion criteria: 1. participants for whom participating would significantly delay the scheduled standard of care therapy. 2. participants administered a radioisotope within 5 physical half lives prior to study enrollment. 3. participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
the effect of a plant sterols-enriched low-fat milk on lipid profile in healthy southern chinese (come-pass)

Conditions: Dyslipidemia

Summary: this is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. half of the participants will consume of 1.5g of plant sterols daily as provided by two servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half will consume placebo low-fat milk.

plant sterols are the naturally occurring functional equivalent of mammalian cholesterol. plant sterols differ structurally from cholesterol by a methyl or ethyl group in their side chains and are not synthesized by the human body. these structural differences render them minimally absorbable in the intestine. it has been consistently reported that dietary incorporation of plant sterols(1.5-2 g/day) reduces serum low-density lipoprotein cholesterol (ldl-c) levels with minimal adverse events. the hypochoelsterolemic effects of plant sterols is explained by an inhibition of cholesterol absorption, which is ascribed to a competition with intestinal cholesterol for incorporation into mixed micelles, although other possible mechanistic explanation have been proposed.

Eligibility criteria:
inclusion criteria: * southern chinese male or female ≥ 18years. * in good general health as evidenced by medical history * have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and discloser of research-related health information, and comply with the study data collection procedures. provide signed and dated informed consent form exclusion criteria: * subject with familial hypercholesterolemia * ingestion of drugs known to interfere with lipid profiles, such as hormone replacement treatment, diuretics, beta-blockers, statin or other hypochoelsterolemic drug treatment * smoking \> 10 cigarettes/day * subject with heavy alcohol intake (alcohol \> 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day) * having milk intolerance or dislike * having major diseases such as diabetes (type i and type ii), renal or liver diseases * subject presenting known allergy or hypersensitivity to milk proteins, soy and peanut * subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product) * subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters * subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial * pregnancy or lactation * anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Keywords: plant sterols low-density lipoprotein cholesterol phytosterols
optical coherence tomography to evaluate ticagrelor and clopidogrel

Conditions: Thrombosis

Summary: a number of 352 patients scheduled for elective percutaneous coronary intervention (pci) with a native coronary stenosis suitable for des implantation and oct imaging are openly randomized 1:1 to either brilinta™ (ticagrelor) or plavix® (clopidogrel bisulfate).

the study is prospectively conducted at 4 high-volume pci center in china with oct expertise. angiographic follow-up and oct imaging with motorized pull-back at 20-36 mm/s are planned in all patients 12 months after implantation of the study stents. oct endpoints are: (1) subclinical intra-stent thrombus, defined as a mass protruding to the lumen with significant attenuation, and respectively (2) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts. the study is powered for oct endpoints, which are likely to reach significance at the level p \< 0.05 even at a follow-up drop-out rate up to 10%.

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures; * men and women 18 years and older;. * established indication to pci according to the guidelines of american heart association and american college of cardiology; * native coronary lesion suitable for drug-eluting stent placement and oct imaging. exclusion criteria: * pregnancy and breast feeding mother; * co-morbidity with an estimated life expectancy of \< 50 % at 12 months; * scheduled major surgery in the next 6 months; * inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; * previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days * cardiogenic shock * previous subacute or late coronary stent thrombosis * known allergy against ticagrelor, or against clopidogrel, or aspirin * history of major hemorrhage (intracranial, gastrointestinal, etc.) * active pathological bleeding * acute or chronic hematologic disorder including a hemoglobin less than 10 g/l or a platelet count less than 10×109/l before procedure * any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis); * neutropenia, * thrombocytopenia; * known acute pancreatitis * arterial aneurysm, arterial/venous malformation and aorta dissection. * culprit lesion within the proximal 10 mm of the right or left coronary artery * saphenous vein grafts * lesion length \> 30 mm * involves a side branch ≥2.0 mm in diameter by visual estimate which requires treatment * in-stent restenotic lesions * thombus-containing lesions

Keywords: percutaneous coronary intervention drug-eluting stent thrombosis
the effect of combining spinal manipulation and dry needling in individuals with low back pain

Conditions: Non-specific Low Back Pain

Summary: the goal of this study is to enroll and randomize 99 participants with non-specific low back pain into a multimodal strategy of treatment consisting of a combination of dry needling (dn) and spinal manipulation therapy (smt), dn only, and smt only, followed by an at home exercise program. all groups will receive their respective treatment twice a week for 2 weeks followed by a 2-week home exercise program. primary outcomes include clinical subjective (oswestry disability index, numeric pain intensity rating) and mechanistic (lumbar multifidus, erector spinae, and gluteus medius muscle activation) measures assessed at baseline, 1, 2, and 4 weeks. timepoints at 2-weeks and 4-weeks will be compared to baseline measures to determine effectiveness of the combination group against the other single treatment groups. exercise compliance will be measured by participants self-reporting adherence to the program by selecting average number of days per week the exercises are completed.


Eligibility criteria:
inclusion criteria: * presence of nonspecific low back pain defined as pain between the twelfth rib and buttocks with or without symptoms into one or both legs * current patient-reported pain rating score greater than 3 based on the numeric pain rating score 0-10 scale * oswestry disability index \> 20% exclusion criteria: * prior surgery to the lumbosacral spine * pregnancy * currently receiving mind-body or exercise treatment for low back pain with a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.) * signs of neurogenic low back pain arising from clinical examination (e.g., positive straight leg raise test, diminished muscle stretch reflex, etc.) * evidence of significant spinal pathology (e.g., spinal fracture, infection, etc.).

Keywords: low back pain spinal manipulation dry needling diagnostic ultrasound oswestry disability index numeric pain rating scale
stereotactic radiosurgery compared to observation in treating patients with brain metastases

Conditions: Metastatic Malignant Neoplasm in the Brain

Summary: this randomized phase iii trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

primary objectives: i. to evaluate benefit of post-surgical stereotactic radiosurgery (srs) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) when compared to surgical resection alone. secondary objectives: i. overall survival, development of distant brain metastases and complications related to treatment. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy. arm ii: patients undergo clinical observation after craniotomy. after completion of study treatment, patients are followed up at 5-8 weeks, every 6-9 weeks for 1 year, every 3-4 months for 1 year, and then every 6 months thereafter.

Eligibility criteria:
inclusion criteria: 1. patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3). 2. patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist. 3. the resection cavity must have a maximum diameter of less than or equal to 4cm. this criteria will be determined by the study radiologist. 4. additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm. 5. patients must be considered candidates for srs within 30 days of surgical resection. 6. patients must have a karnofsky performance scores (kps) of at least 70 at the first post operative visit. patients under 18 years of age must have a lansky performance score of of at least 70. 7. patients must be able to undergo an mri scan. 8. patients must agree to randomization as documented by signing the institutional review board (irb) approved consent form. exclusion criteria: 1. patients who have received prior radiation therapy to the brain for any reason. 2. there is radiographic evidence of leptomeningeal disease prior to study entry. 3. the primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma. 4. for females, if they are pregnant or breast-feeding (the exclusion is made because gadolinium may be teratogenic in pregnancy).