Kornimate/medical-research-clean huggingface dataset:
mobility and physical activity in adolescent and young adult cancer patients or survivors at risk for cardiovascular morbidity and frailty, the mobile aya study

Conditions: Central Nervous System Neoplasm; Hodgkin Lymphoma; Malignant Solid Neoplasm; Non-Hodgkin Lymphoma; Sarcoma

Summary: this study attempts to learn more about the activity levels of adolescent and young adult (aya) cancer patients or survivors at risk for cardiovascular morbidity and frailty by using a smartphone application called beiwe. collecting activity level data on aya cancer patients or survivors may help patients achieve better quality of life.

primary objectives: i. to characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end). ii. to characterize patient physical activity over time based upon smartphone sensor data, during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end). secondary objectives: i. to characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and body mass index (bmi). ii. to characterize patient physical activity over time based upon smartphone sensor data during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and bmi. outline: patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.

Eligibility criteria:
inclusion criteria: * patients age 15-39 at the time of study entry * patients must be within 3 weeks of starting anti-cancer therapy * patients must have a diagnosis of hodgkin lymphoma, non-hodgkin lymphoma, sarcoma and have plans to receive anthracyclines or radiation therapy to the chest or * have a diagnosis of a central nervous system (cns) tumor or * have plans to receive a stem cell transplant * patients must have smartphone device and regular access to internet * patients must be english-speaking exclusion criteria: * patients that are a ward of the state
berberine prevent contrast-induced nephropathy in patients with diabetes

Conditions: Diabetes Mellitus; Chronic Kidney Disease

Summary: the number of cardiac angiography and percutaneous coronary interventions (pci) has increased steadily in recent years. this has resulted in the increasing incidence of contrast-induced nephropathy (cin). major risk factors for cin include older age, diabetes mellitus (dm), chronic kidney disease(ckd), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. importantly, dm appears to act as a risk multiplier, meaning that in a patient with ckd it amplifies the risk of ciaki. the aim of this multicenter prospective, randomized, controlled study is to evaluate whether berberine treatment during and after the perioperative period would reduce the risk of cin in a high-risk population of patients with both dm and ckd undergoing coronary angiography or noncoronary angiography, and the influence of such potential benefit on short-term outcome.


Eligibility criteria:
inclusion criteria: * planned diagnostic coronary or peripheral artery angiography * type 2 diabetes mellitus * ckd stages ≥2 * statin naive, or not on statin treatment for at least 14 days * withdrawal metformin or aminophylline for 48h before angiography * total iodixanol volume exclusion criteria: * hypersensitivity to iodine-containing compounds and berberine * ketoacidosis * lactic acidosis * ckd stages 1, 5 (egfr≥90ml/min per 1.73m2 or egfr\<15ml/min per 1.73m2) * stemi * nyha class iv or hemodynamic instability * administration of any iodinated contrast medium within 14 days before randomization * ldl-c\<1.82mmol/l（70mg/dl） * hepatic dysfunction (alt 3 times greater than upper normal limit) * thyreoid insufficiency * renal artery stenosis(unilateral \>70％ or bilateral stenosis\>50％)
exertion2- the weight gain prevention exercise in renal transplant online study

Conditions: Kidney Transplant; Complications; Weight Gain

Summary: the primary aim of this trial is to assess the feasibility of a novel online weight gain prevention resource for new kidney transplant recipients at two london transplant clinics. a previous study conducted by the research team titled 'exertion' provided usability feedback that led to revisions of this online resource in a purposive sample of kidney transplant recipients (n=11) and transplant multidisciplinary team members (n=6).

this current study aims to recruit a sample of new kidney transplant recipients (n=50) from two transplant sites in london. participants will be randomized to either the 12-week kidney transplant specific novel online weight gain prevention resource (n=25) or usual care (n=25). all participants will be assessed at baseline, 12 weeks and 12 months. the primary outcome of this study is feasibility (screening, recruitment, randomization, retention, adherence to the intervention and adherence to the study visits). the research team will also assess the ability to collect measures for a definitive study (body weight, body mass index, body composition, quality of life, self-efficacy, fatigue, arterial stiffness and physical function). a nested qualitative study will capture participant experience at two time points during this 12 month trial. at 3 months semi-structured individual interviews will be conducted in a purposive approximately 6 to 10 of the intervention participants until data saturation is achieved. these interviews will assess the experience of using the online intervention. at 6 months a purposive sample of approximately 16 participants from both groups will complete individual semi-structured interviews to assess the experiences of participating in this trial.

Eligibility criteria:
inclusion criteria: * age 18 or above * able to provide written consent * less than 3 months post kidney transplant * access to the internet connected computer, tablet, laptop or smartphone * a body mass index greater than or equal to 18.5 (healthy range) exclusion criteria: * age \< 18 * current pregnancy * unstable medication condition such as uncontrolled angina * participation in a recent structured exercise programme in the last 3 months * bmi of less than 18.5 (classified as underweight) * significant cognitive impairment preventing them from engaging with the online resource * unable to complete the resource in english

Keywords: kidney transplant weight gain prevention behavior change techniques dietary advice physical activity advice
efficacy and safety of obe2109 in subjects with heavy menstrual bleeding associated with uterine fibroids

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Summary: the primary objective of this study is to demonstrate the superior efficacy versus placebo of obe2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

the study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of obe2109 alone and in combination with add-back therapy for the treatment of uterine fibroids. subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Eligibility criteria:
key inclusion criteria: * premenopausal woman at screening. * body mass index ≥ 18 kg/m2. * menstrual cycles ≥ 21 days and ≤ 40 days. * presence of uterine fibroids. * heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method. key exclusion criteria: * the subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study. * history of uterus surgery that would interfere with the study. * the subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided. * undiagnosed abnormal uterine bleeding. * significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.

Keywords: uterine fibroid leiomyomata heavy menstrual bleeding hmb heavy uterine bleeding menorrhagia obe2109 + add-back
older veterans empowered to use regular exercise (overture) ii

Conditions: Quality of Life; Aging

Summary: the purpose of this study is to investigate the practicality of a short-term (8-weeks), home-based digital versatile disc (dvd) chair exercise program among 40 sedentary older black/african american and white/caucasian veterans with three or more chronic health conditions, such as type 2 diabetes, hypertension, and osteoarthritis.

this study will determine the feasibility of a home-based dvd chair exercise program, "sit and be fit." participants will be asked to complete a chair-exercise program monday through friday. each chair exercise session lasts approximately 30 minutes. participants will receive a new dvd player, the exercise dvd, and the necessary exercise equipment to complete each session. the equipment includes a set of 1 pound hand weights, a 10" exercise ball, a small handball, a resistance band, an exercise log, and a satisfaction survey. upon initial enrollment, both groups will receive a baseline health assessment that will include health-related quality of life, subjective well-being, body mass index (bmi), comorbidity, blood pressure, lower body extremity fitness, physical activity, and hand grip strength. excluding health status, all other measures will be completed at post-assessment (the end of week 8 for group a and group b). the intervention group (group a) will receive the equipment after completing eligibility screening, an informed consent, and health assessments. the waitlist control group (group b) will receive the equipment at week 9 after the post-assessment. group b will complete the program through week 16. the waitlist control group(group b) will not receive an additional post assessment at the end of week 16.

Eligibility criteria:
inclusion criteria: * be a veteran, which will be verified through documentation, such as discharge papers, military identification card, or military photographs * identify as black/african american or white/caucasian; demonstrate proof of age 65+; self-report of three or more chronic health conditions * pass a cognitive screening related to thinking/reasoning/decision making; report less than 30 minutes of daily physical activity * systolic blood pressure lower than 180 * diastolic blood pressure lower than 100 * resting heart rate 90 or lower * three or more chronic health conditions * permission from primary care physician (pcp) * own a sturdy stand-alone chair without arms * own an operable television * willing to be randomized to the intervention or the waitlist control group exclusion criteria: * non-veteran * non-black or african american/white or caucasian * younger than 65 years of age * systolic blood pressure 180 or higher * diastolic blood pressure is 100 or higher * resting heart rate higher than 90 * less than three chronic health conditions * failure to pass a cognitive screening * report more than 30 minutes of daily physical activity * no approval from pcp * no sturdy stand-alone chair without arms * no operable television * unwilling to be assigned to the intervention or the waitlist control group

Keywords: veterans sedentary chronic illness
research evaluating the value of augmenting medication with psychotherapy

Conditions: Depression; Depressive Disorder

Summary: this 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

chronic depression affects approximately 5% of adults in the united states and is associated with significant functional impairment and high health care utilization. the combination of drug treatment and psychotherapy may be most effective in treating depression. this study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication. participants receive an initial trial of antidepressant medication for 8 to 12 weeks. participants who continue to have depressive symptoms are randomly assigned to add cognitive behavioral analysis system of psychotherapy (cbasp) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. assessments are made at 6 and 12 months post-treatment.

Eligibility criteria:
inclusion criteria * major depressive episode * depressive symptoms \> 2 years without remission * hamilton depression scale (ham-d) score \> 20 * fluent in english exclusion criteria * psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder * serious, unstable, or terminal medical condition * axis ii diagnosis of antisocial, schizotypal, or severe borderline personality disorder * previous treatment with cbasp * previous ineffective treatment with 4 of the medication treatments used in the study * substance abuse * pregnancy * not willing to end other psychiatric treatment
reduction of aspiration through cohesive thin liquids (ctl) in patients with mild oropharyngeal dysphagia

Conditions: Dysphagia; Stroke

Summary: the aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

this trial will be a double blind, randomized, crossover, controlled, and interventional trial. each subject will test 6 study samples in a randomized order at 5 ml of volume first then at 10 ml (12 samples maximum). the trial will last a maximum of one hour (a single study visit). the total sample size is 47 enrolled subjects, 33 subjects completed. patients will be females and males aged between 18 and 85 years with mild proven dysphagia.

Eligibility criteria:
inclusion criteria: 1. mild dysphagia as defined by a score between 3 and 5 on the dysphagia outcome and severity scale 2. patients aged between 18 and 85 years 3. ischemic/hemorrhagic cerebral cause (stroke) 4. able to understand french (oral and written) 5. cognitive capacity enough to understand study procedures 6. having health insurance (which in france is " social security") 7. having signed the consent form. exclusion criteria: 1. any swallowing trouble not resulting from the current stroke 2. history of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system 3. any physician diagnosed psychiatric illness 4. patient with a digestive fistula 5. any physician diagnosed food allergy 6. any known allergy to barium or any compound of the contrast product 7. confirmed or suspected perforated and occlusive syndrome 8. pregnant or lactating women 9. major respiratory disease needing oxygen (chronic respiratory insufficiency) 10. subject who cannot be expected to comply with the study procedures, including consuming the test products. 11. currently participating or having participated in another clinical trial during the month preceding the study
effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy: a randomized clinical study

Conditions: Dental Anxiety

Summary: the purpose of this study to evaluate the effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy.

this study evaluated effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy

Eligibility criteria:
inclusion criteria: 1. children aged between 4 to 6 years of both sexes. 2. children with behavior rating score 2,3 or 4 of frankl 's behavior rating scale. 3. children with carious lesions indicated for pulpotomy. 4. restorable primary molars. exclusion criteria: 1. children with special health care needs. 2. children suffering from systemic diseases. 3. unrestorable tooth. 4. extremely uncooperative children.

Keywords: dental anxiety contingent escape positive reinforcement, pulpotomy behavior management
vitamin d supplementation in psychiatric illnesses

Conditions: Obesity; Vitamin D Deficiency; Psychosis; Schizophrenia; Schizoaffective Disorder

Summary: children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (sga) often gain excessive weight during their treatment with these medications. this weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. there is no consensus on the best way to prevent these complications. the investigators' hypothesis is that daily vitamin d supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference.

in this 8-week open label trial, we will enroll 10 subjects who fulfill the inclusion criteria.

Eligibility criteria:
inclusion criteria: 1. males/females between the ages 10 through 18 years, 2. subjects with diagnostic and statistical manual of mental disorders-fourth edition (dsm-iv)\[62\] axis 1 diagnosis who are on treatment with sga. these conditions include schizophrenia, schizo-affective disorder, and psychosis, 3. subjects who have gained 10% of their pre-drug body weight while receiving the following sgas: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. subjects could be taking other psychotropic agents, but only one sga, 4. all subjects will be able to take the prescribed vitamin d by mouth, 5. all subjects will have a 25-hydroxyvitamin d level of \< 32 ng/ml, 6. all subjects must reside in an in-patient psychiatric facility. exclusion criteria: 1. pregnant or lactating women, 2. patients with mental retardation (intelligence quotient \< 50), 3. subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases, 4. subjects with known history of parathyroid disorder, 5. subjects with acquired or congenital disorders of vitamin d metabolism, 6. subjects on calcium and vitamin d replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol, 7. subjects taking any weight loss medications, such as orlistat, and sibutramine, 8. subjects on medications that might affect glucose levels, such as insulin or metformin.

Keywords: psychiatric illnesses vitamin d deficiency obesity
the reduced insulinotropic effect of a continuous infusion relative to a bolus injection of gip

Conditions: Type 2 Diabetes

Summary: in patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic polypeptide (gip) has lost its insulinotropic activity, but more so after continuous versus bolus administration. the design was a two-way crossover design comparing repeated bolus injection and continuous infusion of gip under hyperglycaemic clamp conditions. patients were age- gender- and weight-matched with type 2 diabetes, first degree relatives of such patients, and healthy subjects. investigators performed a: 1. oral glucose challenge; 2. hyperglycemic clamp (8.5 mmol/l) with two repeated gip bolus administrations (50 pmol/kg body weight at 30 and 120 min); and 3. hyperglycemic clamp with continuous administration of gip (2 pmol.kg-1.min-1 from 30-180 min). to answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic action of gip, investigators studied type 2-diabetic patients, their first-degree relatives, and healthy controls under hyperglycaemic clamp conditions with two gip bolus injections 90 min apart, and compared this to a continued intravenous infusion of gip.


Eligibility criteria:
inclusion criteria: * exclusion of pregnancy * exclusion of impaired glucose tolerance or type 2 diabetes in metabolical healthy subjects * current diagnosis of type 2 diabetes according to the guidelines of the german diabetes association (ddg) ( kerner et al . 2001) in subjects of diabetes group * fasting glucose ≤ 150 mg/dl * body-mass-index ≥ 20 kg/m² * written consent exclusion criteria: * type 1 diabetes * impaired glucose tolerance or type 2 diabetes in metabolical healthy subjects * ketone bodies urine diagnostics at least ++ * acidosis * fasting blood glucose \> 150 mg/dl * body-mass-index \< 20 kg/m² * no written consent * pregnancy or unsafe contraception in women before menopause * active malignancy * angina as current, unsolved clinical problem * inadequately treated or untreated arterial hypertension ( \> 160 mmhg systolic and / or \> 95 mmhg diastolic ) * infection / fever \> 37.5 ° c * treatment with glucocorticoids * insulin therapy within the last three months * anemia with a hemoglobin level \< 12 g/dl * liver function limitations * renal impairment ( serum creatinine \> 1.5 mg/dl ) * alcohol or drug abuse * participation in clinical trials in the last 3 months * inability or unwillingness to comply with the requirements of the protocol * known hypersensitivity to gip

Keywords: glucose-dependent insulinotropic polypeptide (gip) glucagon-like peptide 1 (glp-1) incretin insulin secretion tachyphylaxis