Kornimate/medical-research-clean huggingface dataset:
evaluation of treatment methods for clinically significant tinnitus

Conditions: Tinnitus

Summary: the investigators propose to evaluate two different approaches to the alleviation of tinnitus symptoms by comparing changes from baseline performance on the tinnitus severity index. they propose to provide an unbiased evaluation of competing methodologies. the design is one in which pairs of prospective subjects are randomly assigned to one of two treatment groups. changes in group performance will be compared for selected measures.


Eligibility criteria:
inclusion criteria: patients with significant tinnitus exclusion criteria:

Keywords: auditory, tinnitus
additional metabolic and vascular effects of exercise in patients on diet-based weight loss programs

Conditions: Obesity

Summary: this study tests the hypothesis that exercise training can confer additional benefit to patients in weight-loss programs in the form of improvements in either metabolic or vascular parameters or both. patients will be randomized to either diet plus conventional physical activity or diet plus a planned exercise training. the interventions will be carried out until the patients lose between 5% and 7.5% of their initial weight. at entry and at the end, all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin, c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and abdominal visceral fat (ct-scan). both groups will be compared.


Eligibility criteria:
inclusion criteria: * bmi\> 30 and \<40 exclusion criteria: * diabetes mellitus * active endocrine disease * active heart disease * active smoking * medical contra-indications for exercise * using anti-obesity drugs

Keywords: obesity exercise diet lifestyle vascular reactivity body composition lipids glucose insulin resistance
comparison of the efficacy of azarga® versus cosopt® in patients with open-angled glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: subjects are dosed twice daily at 9am and 9pm for 12 weeks. the primary efficacy variable is the mean change in intraocular pressure (iop) from baseline to 12 weeks. secondary efficacy variable: % iop ≤ 18 millimeters mercury (mmhg). exploratory endpoint: ocular discomfort scale after first dose.


Eligibility criteria:
inclusion criteria: 1. must be at least 18 years of age. 2. must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye). 3. must have iop considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. 4. must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at visit 1, throughout the study period. 5. must have an iop of between 19 to 35 mmhg in at least one eye (which would be the study eye). 6. for the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone. exclusion criteria: 1. known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the principal investigator. 2. presence of other primary or secondary glaucoma not listed in inclusion criterion #2. 3. any abnormality preventing reliable applanation tonometry in study eye(s). 4. risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment. 5. progressive retinal or optic nerve disease from any cause. 6. use of systemic medications known to affect iop (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to day 1 visit or an anticipated change in the dosage during the course of the study. 7. a condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. 8. participation in any other investigational study within 30 days prior to visit 1.
comparing the effects of sertindole and olanzapine on cognition (serola)

Conditions: Schizophrenia

Summary: cognition is one of the core symptoms of schizophrenia. this study is a head-to-head trial between olanzapine and sertindole with cognition as primary outcome. the design is a 12-week double-blinded randomized controlled flexible dose study.


Eligibility criteria:
inclusion criteria: * anicd-10 schizophrenia diagnosis f20.0-f20.9. * contraception. * a negative pregnancy test for women. * no known allergy to any of the substances in the study medication * baseline qtc \< 450 milliseconds for men and \< 470 milliseconds for women * s-potassium and s-magnesium within normal reference range. * suboptimally treated on current antipsychotic medication * stable dosage of antidepressants and mood stabilizers one month before the inclusion * signed informed consent and power of attorney exclusion criteria: * withdrawal of consent * qtc prolongation \>500 milliseconds during the study * patients with known clinical important cardiovascular disease * significant substance abuse * earlier partial or non-response in treatment or intolerability to sertindole or olanzapine. * calgary depression scale score ≥ 7 * treatment that interferes with the metabolism of sertindole or olanzapine, * oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing * prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period * treatment with an anticholinergic after the first three weeks of the study * somatic illness, as judged by investigator, interfering with cognition * known risk of narrow angle glaucoma * treatment with electroconvulsive therapy (ect) the last three months before inclusion, or treatment with ect in the study period * treatment with clozapine or depot antipsychotics before inclusion

Keywords: schizophrenia antipsychotic cognition
the effect of virtual exercises on glycemic control and body composition in type 2 diabetic patients

Conditions: Diabetes Mellitus Type 2

Summary: this study was conducted to evaluate the effect of exercises with vr goggles in patients with type 2 diabetes. the effect of exercise in virtual reality goggles on glycemic control, body composition, quality of life and psychological status.

for virtual reality applications, a screen will be worn on the user's head that provides a three-dimensional visual image, thus creating a sense of space and depth. blood glucose levels, vital signs and oxygen consumption capacity measurements will be monitored with the smart watch throughout the vr exercise application.

Eligibility criteria:
inclusion criteria: being over 18 years old able to communicate volunteering to participate in the research exclusion criteria: those with psychiatric problems being unconscious

Keywords: diabetes, glycemic control, virtual reality, quality of life
detemir versus nph for type 2 diabetes mellitus in pregnancy

Conditions: Diabetes Mellitus, Type 2

Summary: to determine whether use of detemir compared to neutral protamine hagedorn (nph) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * preexisting type 2 diabetes mellitus requiring medical treatment or * overt diabetes diagnosed prior to 20 weeks of gestation using either hemoglobin a1c (hba1c) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (gct) \>135 mg/dl followed by 100 gct with at least 2 values above thresholds: fasting blood glucose (fbg) \>90, 1 hr \>180, 2 hr \> 155, 3 hr \> 140 mg/dl). * gestational age ≤20 weeks * willing to start insulin therapy or to continue insulin treatment during pregnancy * singleton or twin pregnancy exclusion criteria: * known allergy/prior adverse reaction to nph/detemir * patients \<18y * known major fetal anomalies * diabetic nephropathy (creatinine (cr)≥1.5) * diabetic proliferative retinopathy * patients with type 1 diabetes or gestational diabetes

Keywords: pregnancy
feasability, validty and reliability of inertial sensors

Conditions: Multiple Sclerosis; CVA

Summary: this study has 3 aimes: 1. to investigate the feasibility of using imus (xsens, mvn studio) during functional tasks to assess upper limb kinematics in pwms and stroke survivors. on the one hand, the feasibility of performing the tasks will be investigated . on the other hand, does the xsens give valuable data? 2. to investigate the discriminative validity of kinematic measurements of upper limb movements post-stroke and pwms in comparison with gender and age-matched healthy controls 3. to investigate the test-retest reliability of the kinematic parameters collected during the different functional tasks in pwms and stroke survivors it is a cross-sectional case-controlled observational study, with 3 different groups: 25 persons with multiple sclerosis, 25 stroke patients and 50 healthy controls, matched by age and gender.


Eligibility criteria:
inclusion criteria: inclusion criteria for all participants: healthy controls, pwsms and stroke patients * no orthopedic or neuro-muscular impairments in the upper limb * age \> 18 years * able to understand and execute the test instructions * perceived pain in one of the upper limbs of more than 4/10 (visual analog scale) * able to move a joint (wrist, elbow or shoulder) in the upper limb against gravity without resistance (medical research council) (16). inclusion criteria for pwms: - diagnosed with ms using mcdonald criteria (17) inclusion criteria stroke patients * first- ever single, unilateral (ischemic or hemorrhagic) * at least one month after stroke * no apraxia or hemi spatial neglect exclusion criteria: exclusion criteria for pwms only: * a relapse 3 months before the start of the study * a change of symptomatic medication during the testing period exclusion criteria: - people with predominantly ataxia or tremor are excluded from the reliability part of this study
healthy juntos pilot study

Conditions: Obesity; Activity, Motor; Diet, Healthy; Sedentary Behavior

Summary: the purpose of the study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile phone-based) program to improve physical activity levels and quality dietary intake among hispanic parent-adolescent dyads.


Eligibility criteria:
inclusion criteria: 1. female and male adolescents whose primary caregiver self-identifies as hispanic 2. adolescent is between the ages of 12-15; 3. adolescent lives with an adult primary caregiver willing to participate; 4. both parent and adolescent have smartphone/mobile device with internet access; 5. adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener; 6. adolescent does not meet physical activity guidelines as determined by responses on a validated two-item screener and self-reports engaging in \>2 hours/day of screen time (proxy for overall sedentary behavior) using three items. exclusion criteria: 1. adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range); 2. adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification; 3. adolescent has a diagnosed developmental delay that would interfere with understanding program materials; 4. parent or adolescent has a diagnosed medical or psychiatric condition and is currently taking medications that would interfere with changes to physical activity or diet (e.g., adolescent is diagnosed with attention deficit hyperactivity disorder and is currently on stimulant medication); 5. family is planning to move out of the south florida during the study follow-up period

Keywords: hispanic family digital health obesity prevention physical activity nutrition
a study to test the safety and efficacy of sitagliptin compared to glimepiride in patients with type 2 diabetes on a stable dose of metformin (0431-803)(completed)

Conditions: Type 2 Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Non-Insulin-Dependent

Summary: a study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. this study will also see if this treatment is safe and tolerable.


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosed with type 2 diabetes * on a stable dose of metformin of at least 1500 mg per day exclusion criteria: * history of type 1 diabetes * pregnant * hiv positive * on a weight loss program or medication * has a history of blood disorder, certain cancers, heart, liver or kidney disease

Keywords: type 2 diabetes mellitus non insulin dependent
effect of exercise on vitamin d in obese

Conditions: Obesity; Vitamin D Deficiency

Summary: the aim of the current study was to investigate the effect of exercise-induced lipolysis on vitamin d status in obese children. two types of exercises that have different effects on lipolysis were used. lipolysis was assessed via monitoring the level of plasma level of the free fatty acids and glycerol. vitamin d was assessed through 25 (oh)d plasma levels.

vitamin d status was monitored through 25 (oh)d levels, and the lipolysis status via the plasma level of the free fatty acids and glycerol immediately after the exercise. all subjects who participated in the study were under supervision for controlling the fat contents and vitamin d in their food for one week prior to the exercise. the subjects fasted eight hours before the exercise. all the exercises were performed between 9 am and 11 am.

Eligibility criteria:
inclusion criteria: * body mass index percentile equal to or greater than the 95th percentile * all did not receive strength or balance training or involvement in competitive sports emphasizing muscular strength. * all participants had balance deficiency and mobile flat foot. * 25(oh) d was ranged from 10-20ng/ml exclusion criteria: * injury to the lower limb required medical care. * deformity of or surgery in the lower limb. * visual impairment, or neuromuscular disorders. * engagement in obesity treatment programs, three months prior to the study. * epileptic fits * thyroid medications * autoimmune disease * take calcium or vitamin d3 supplements, medications for osteoporosis
a study of the bioequivalence of 70-mg alendronate and 70-mg alendronate in combination with 5600 iu vitamin d (mk0217a-253)

Conditions: Osteoporosis

Summary: this study will evaluate the bioequivalence of alendronate in combination with vitamin d compared to alendronate alone and the bioequivalence of vitamin d in combination with alendronate compared to vitamin d alone. this was an open-label, randomized, 2-part, crossover study. each participant participated in one part of the study only (i.e., each participant participated only in part i or only in part ii). participants entered the study sequentially within each part of the study. a washout of at least 12 days separated each treatment period within each part of the study.


Eligibility criteria:
inclusion criteria: * male or nonpregnant female age 18 to 85 years * female of childbearing potential on appropriate method of contraception and not nursing * body mass index (bmi) less than or equal to 30 kg/m2 * subject is in good health exclusion criteria: * mental or legal incapacitation * received bisphosphonate treatment within 3 months of enrollment. * unable to sit or stand upright for at least 2 hours * unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration * unwilling to limit alcohol consumption to no more than 2 drinks per day * unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent. * unwilling to refrain from smoking during the study
collection of raw data of thermal imaging for the purpose of developing a device for early detection of breast cancer

Conditions: Breast Cancer

Summary: collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve real imaging's device ("ri3.0") capabilities , which will assist in early detection of breast cancer.


Eligibility criteria:
inclusion criteria: * subjects with a breast abnormality (identified by mammography, ultrasound, mri and/or a clinical examination) requiring a biopsy. exclusion criteria: * subjects who have had a mammography, ultrasound, and/or mri examination performed on the day of the study, prior to being "imaged" by ri3.0. * subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study. * subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study. * subjects who have undergone a mastectomy. * subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident). * subjects with prior breast reduction surgery or breast augmentation surgery. * subjects who have a fever on the day of their biopsy. * subjects who are pregnant. * subjects who are breast-feeding.
imfinzi/imjudo uhcc japan pms _ japan post-marketing surveillance (pms) study

Conditions: Unresectable Hepatocellular Carcinoma

Summary: this investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (hcc) treated with the combination therapy of imjudo 25 mg, 300 mg and imfinzi intravenous infusion 120 mg, 500 mg or with imfinzi monotherapy under actual use in the post-marketing setting.

this investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (hcc) treated with the combination therapy of imjudo 25 mg, 300 mg and imfinzi intravenous infusion 120 mg, 500 mg or with imfinzi monotherapy under actual use in the post-marketing setting. the investigation will be conducted as one of the additional pharmacovigilance activities in the japan risk management plan of imjudo and imfinzi in compliance with the ministerial ordinance on good post-marketing study practice (gpsp ordinance) and for the purpose of application for reexamination under article 14-4 of the act on securing quality, efficacy and safety of products including pharmaceuticals and medical devices.

Eligibility criteria:
inclusion criteria: all patients who receive imjudo and imfinzi combination therapy or imfinzi monotherapy for their unresectable hcc. - exclusion criteria: -
addition of acetaminophen in standard pda management

Conditions: Patent Ductus Arteriosus

Summary: patent ductus arteriosus is a common morbidity in preterm infants and management of pda varies among neonatologist. the investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (pda) closure after completion of a first treatment course.


Eligibility criteria:
inclusion criteria: * infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight \< 1000 grams * hemodynamically significant pda as defined by any of the following: 1. increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the pda 2. hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (map) at least 2-3 mmhg below the infants' post menstrual age) 3. signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination) * echocardiographic criteria: 1. ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5 exclusion criteria: * no enteral feedings * pda-dependent congenital heart disease * prior treatment with prophylactic indomethacin * prior pda treatment with any medications * suspected or diagnosed acute necrotizing enterocolitis (nec) or spontaneous intestinal perforation * abnormal liver enzymes (alt \> 60 iu/l and ast \> 60 iu/l) * platelets count \< 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding * major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect * prior enrollment to other interventional clinical study where pda is an outcome variable
treatment of moderate ischemic mitral regurgitation in patients with coronary artery disease

Conditions: Coronary Artery Disease; Ischemic Mitral Regurgitation; Angiotensin Receptor/Neprilysin Inhibitor

Summary: this study aims to evaluate the effect of angiotensin receptor/neprilysin inhibitors (arni) on improving ischemic mitral regurgitation (imr) in patients with coronary artery disease undergoing isolated coronary artery bypass grafting (cabg) through a randomized controlled clincial trial.


Eligibility criteria:
inclusion criteria: 1. fully informed and voluntarily signed informed consent; 2. received cabg and moderate imr was diagnosed on two consecutive preoperative transthoracic echocardiography (according to 2021 esc/eacts guidance standards ) exclusion criteria: 1.symptomatic hypotension and/or a sbp \ 5 mmol/l at screening; 4.history of angioedema or unacceptable side effects while receiving ace inhibitors or arbs; 5.patients receiving mitral valve intervention at the same time, or have participated in other clinical trials, or are unwilling to participate in this study.

Keywords: coronary artery disease ischemic mitral regurgitation angiotensin receptor/neprilysin inhibitor