Kornimate/medical-research-clean huggingface dataset:
web-based cbt4cbt for alcohol

Conditions: Alcohol Abuse or Dependence

Summary: the investigators are conducting a randomized clinical trial of our new web-based version of the cbt4cbt (computer based training for cognitive behavioral therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the substance abuse treatment unit (satu). the computer-based training program (cbt4cbt) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

ninety alcohol using individuals seeking treatment at the substance abuse treatment unit (satu) of the connecticut mental health center will be randomized to (1) standard outpatient counseling at satu (typically consisting of weekly group counseling), (2) standard outpatient counseling plus web-based cbt, or (3) web-based cbt4cbt with minimal clinical monitoring. treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. the primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based cbt4cbt retains key characteristics of traditional clinician-administered cbt (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility criteria:
inclusion criteria: * are 18 years of age or older. * are applying for outpatient, non-agonist substance abuse treatment at satu. * meet current dsm-iv criteria for alcohol abuse or dependence. * are sufficiently stable for 8 weeks of outpatient treatment. * can commit to 8 weeks of treatment and are willing to be randomized to treatment * are willing to provide locator information for follow-up. * are fluent in english and have a 6th grader or higher reading level exclusion criteria: * have an untreated bipolar or schizophrenic disorder. * who have a current legal case pending such that incarceration during 8-week protocol is likely. * are physically dependent on alcohol, opioids or benzodiazepines

Keywords: cognitive behavior therapy computer assisted instruction alcohol abuse therapy educational resource design and development
single cohort 4-period study to assess pharmacokinetics of metformin alone and in combination with ranolazine

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of steady-state ranolazine on the steady state pk of metformin in subjects with type 2 diabetes mellitus (t2dm).

the primary objective of this study is as follows: • to evaluate the effect of steady-state ranolazine on the steady state pk of metformin in subjects with t2dm. the secondary objectives of this study are as follows: * to examine the safety and tolerability of metformin when co administered with ranolazine at steady-state in subjects with t2dm. * to determine the steady-state pk of ranolazine in subjects with t2dm receiving metformin.

Eligibility criteria:
inclusion criteria: * males and females, 30 to 65 years old, inclusive * documented history of t2dm * hba1c = 6.5%-10%, inclusive * fasting serum glucose ≤ 270 mg/dl at screening * fasting c-peptide ≥ 1 ng/ml at screening * stable metformin monotherapy (metformin 1000 to 2000 mg total daily dose for at least 4 weeks prior to screening) * body mass index (bmi) = 25 to 40 kg/m2, inclusive, at screening * creatinine clearance \> 80 ml/min at screening * females of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day -1 and must agree to use highly effective contraception methods from screening throughout the duration of the treatment period and for 14 days following the last dose of study drug exclusion criteria: * type 1 diabetes mellitus (t1dm) * use of insulin therapy \< 3 months prior to screening * history of ketoacidosis, ketosis-prone diabetes, or lactic acidosis * clinically significant complications of diabetes * history of hypoglycemia * any non-insulin antidiabetic therapy (other than metformin) \< 2 months prior to screening * any clinically significant cardiovascular event \< 2 months prior to screening * clinically significant, inadequately controlled, or unstable hypertension * hospitalization \< 2 months prior to screening or major surgery \< 3 months prior to screening * history of gastrointestinal disease or surgery that could impact drug absorption * history of substance of alcohol or substance abuse * positive urine drug screen for drugs of abuse * positive alcohol breath test * any other clinically significant existing medical or psychiatric condition or one requiring further evaluation * treatment with selected medications * hemoglobin \< 12 g/dl for males; or \< 11 g/dl for females at screening * active thyroid disease (hypo- or hyperthyroidism) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5x upper limits of normal * qtc interval \> 500 msec at screening * females who are pregnant or are breastfeeding

Keywords: metformin ranolazine type 2 diabetes mellitus
evaluation of scout ds device in the diagnosis of diabetes

Conditions: Type 2 Diabetes

Summary: the primary objective is to identify compare scout ds to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin a1c ≥ 6.0%.

the study will complete up to 330 subjects at the clinical site to evaluate the accuracy of scout ds, random capillary glucose (rcg) and the leicester diabetes risk questionnaire for detecting prediabetes and undiagnosed type 2 diabetes in subjects at risk, but not having a pre-exiting diagnosis of type 2 diabetes. a point of care a1c measurement (siemens dca vantage or axis-shield afinion) will serve as the reference method for defining a positive screen (a1c ≥ 6.0%).

Eligibility criteria:
inclusion criteria: * age greater than or equal to 45 years or age 18 to 44 years and bmi \> 25 kg/m² with one or more of the following risk factors: * elevated waist circumference, \> 35 inches for women and \>40 inches for men * habitually physically inactive (does not exercise regularly) * has a first-degree relative with diabetes * ethnicity with elevated risk for type 2 diabetes * has delivered a baby weighing \> 9 lb or diagnosed with gestational diabetes * hypertension (≥130/≥ 85 mmhg) or being treated for hypertension * hdl cholesterol level \< 35 mg/dl and/or a fasting triglyceride level ≥ 250 mg/dl or being treated for dyslipidemia with medication * has been previously diagnosed with polycystic ovary syndrome (pcos) * had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs * conditions associated with insulin resistance such as acanthosis nigricans * history of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease exclusion criteria: * under 18 years of age * receiving investigational treatments in the past 14 days * psychosocial issues that interfere with an ability to follow study procedures * conditions that cause secondary diabetes including cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis * diagnosed with any type of diabetes, including type 1 or 2 * taking glucose lowering medications with the exception of metformin * known to be pregnant * receiving dialysis or having known renal compromise * scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. * recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded * current chemotherapy, or chemotherapy within the past 12 months * known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Keywords: screening for type 2 diabetes
muscle atrophy, physical performance and glucose tolerance post stroke

Conditions: Stroke

Summary: stroke, a leading cause of disability in the aging population, increases the risk for diabetes, subsequent stroke recurrence, and cardiovascular disease complications. the downsizing of private and federal health care resources, along with the anticipated increase in stroke rates as our population ages, mandate that alternative strategies be developed to reduce the public health burden of stroke. this pilot study may facilitate our knowledge of the timing of paretic leg muscle atrophy, fiber type shift, and the progression of worsening of glucose tolerance after stroke. knowledge of the skeletal muscle changes occurring in the sub-acute stroke period is essential to create new guidelines incorporating exercise rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the health care of veteran stroke survivors.

the vast majority of cerebrovascular accidents are reported in persons older than 55 years of age and occur in over 780,000 persons each year in the u.s. as our adult population ages, the number of strokes in the united states is anticipated to double, reaching nearly 1.5 million annually by the year 2050. following stroke, patients remain at continued high risk for recurrent stroke with almost a third of them suffering recurrent stroke within 5 years, even despite optimal medical management. age and cardiac disease are among the most important longitudinal predictors of cardiovascular health outcomes and survival after stroke. notably, 75% of chronic stroke survivors have residual disability emphasizing the need for rehabilitation strategies. knowledge of the skeletal muscle changes that occur in the early phases after stroke is essential to create new guidelines which incorporate exercise rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the health care of stroke survivors.

Eligibility criteria:
inclusion criteria: * men or women 21 years of age or older * bmi between 20-50 kg/m2 * presenting within a month after stroke onset with residual hemiparetic deficit * patients must have adequate language and neurocognitive function to participate in testing and give adequate informed consent exclusion criteria: * patients deemed too disabled to participate in physical therapy, or patients with minimal deficits, or patients who fully recovered after their stroke, in which physical therapy is not necessary * unstable angina, chf, severe pad * dementia or untreated major depression * severe receptive or global aphasia * heavy alcohol use defined by greater than 3 oz. liquor, 12 oz of wine or 32 oz of beer daily * muscle biopsy exclusion criteria: * anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted) * bleeding disorder * allergy to lidocaine

Keywords: stroke body composition glucose tolerance
serial assessment of body fat accrual in very preterm infants

Conditions: Infant,Premature; Body Weight; Adiposity

Summary: despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. the study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.

infants in the intervention group will have the information about infant body composition known to the clinicians caring for them (including reference data). infants in the control group will also undergo serial measurements of infant body composition, but this information will not be available to the clinicians. if parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).

Eligibility criteria:
inclusion criteria: * gestational age between 28 and 32 weeks of gestation exclusion criteria: * gastrointestinal or neurologic malformations * terminal illness requiring limited or withheld support

Keywords: premature infants body composition
food addiction and follow-up in subjects with obesity

Conditions: Obesity; Eating Disorders; Food Addiction

Summary: obesity is a chronic disease. its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). these disorders require specific management if you want to achieve a good weight result. the aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.


Eligibility criteria:
inclusion criteria: * obese patients grade 2 and 3 * hospitalized in endocrinology a from january 1, 2017 to january 1, 2018 * over 18 years of age * not objecting to its participation exclusion criteria: * no understanding of french
alk37-005: a study of alks 37 (rdc-1036) in adults with opioid-induced constipation (oic)

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of alks 37 when administered daily for 4 weeks to adults with opioid-induced constipation (oic).


Eligibility criteria:
inclusion criteria: * are at least 18 years of age at time of consent * have a body mass index (bmi)of 19 to 35 kg/m2 at screening * are receiving prescribed opioid medication for the management of chronic, non-cancer pain * meet the criteria of oic * agree to use an acceptable method of contraception for the duration of the study exclusion criteria: * pregnancy and/or currently breastfeeding * clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) * receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction * any gastrointestinal (gi) disorder (other than opioid-induced constipation) or gi structural abnormality known to affect bowel transit, produce gi obstruction, or contribute to bowel dysfunction * use of naloxone, subutex or suboxone, revia, relistor, or entereg starting 15 days before the first study visit following screening until the end of the study * participation in a clinical trial of a pharmacological agent within 30 days before screening
study evaluating the efficacy, safety, and reliability of vardenafil

Conditions: Erectile Dysfunction

Summary: study to investigate the efficacy and safety of vardenafil


Eligibility criteria:
inclusion criteria: * heterosexual males * \>/= 18 years old with ed for more than six months * subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation exclusion criteria: * primary hypoactive sexual desire * history of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * nitrate therapy * other exclusion criteria apply according to the summary of product characteristics

Keywords: erectile dysfunction vardenafil
investigating the efficacy of combining virtual reality-based mirror therapy (vrmt) and transcranial direct current stimulation (tdcs) to improve upper limb recovery in patients with stroke

Conditions: Stroke Rehabilitaion; Stroke

Summary: this study will investigate whether combining virtual reality-based mirror therapy (vrmt) and transcranial direct current stimulation (tdcs) alongside conventional physical therapy (cpt) will significantly improve hand function for patients with stroke compared to using vrmt or tdcs alone.

more than half of stroke survivors suffer from upper-limb dysfunction that persists years after stroke, negatively impacting patients' independence and, therefore, affecting their quality of life. motor rehabilitation is required after a stroke to facilitate motor recovery. more importantly, finding new ways to maximize patients' motor recovery is a core goal of stroke rehabilitation. thus, researchers have explored the potential benefits of using advanced technologies such as virtual reality-based mirror therapy (vrmt) and transcranial direct current stimulation (tdcs) to boost the brain's responses to interventions and maximize the effects of rehabilitation to improve upper-limb recovery post-stroke. however, the potential impact of combining vrmt and tdcs on upper limb functions for patients with stroke has not been explored. therefore, the goal of this study is to investigate whether combining virtual reality-based mirror therapy (vrmt) with transcranial direct current stimulation (tdcs) alongside conventional physical therapy (cpt) will significantly improve hand function for patients with stroke compared to using vrmt or tdcs alone. the participants will be randomly assigned into one of the four groups: (1) the anodal tdcs + vrmt group, (2) the anodal tdcs alone group, (3) the vrmt alone with sham tdcs group, and (4) the cpt with sham tdcs group. all groups will receive cpt as part of the treatment. functional scales will be used before and after the intervention to assess upper motor functions. these measures include the fugl-meyer assessment, wolf motor function test, box and block test, nine-hole pegboard test, and stroke impact scale-16 (sis-16). in addition, physiological measures such as transcranial magnetic stimulation (tms) and task-based fmri.

Eligibility criteria:
inclusion criteria: * at least 18 years old. * stroke patients with unilateral cerebral infarction or hemorrhage, more than three months following the stroke. * adequate cognitive ability to follow instructions (the arabic version of the mini-mental state examination scores \> 24). * modified ashworth scale score \< 3. * fugl-meyer assessment (fma) score of 10-58 indicating moderate-to-severe arm impairment. exclusion criteria: * visual impairment and field defect or hemi-sensory inattention and unilateral neglect. * wernicke's aphasia, or global aphasia, leads to difficulty following instructions. * any contraindication to nibs. * other neurological conditions or participation in another study.

Keywords: virtual reality, mirror therapy, non invasive brain stimulation, tdcs, stroke transcranial direct current stimulation
exploratory study of dipraglurant (adx48621) for the treatment of patients with blepharospasm

Conditions: Blepharospasm; Dystonia

Summary: this study is designed to assess the safety and tolerability of dipraglurant in patients with blepharospasm (bsp) (randomized 1:1:1 to receive dipraglurant 50 mg, 100 mg or placebo) and explore the efficacy of 50 mg and 100 mg immediate release tablets (versus placebo) on the severity and frequency of bsp signs and symptoms using objective measures, clinical ratings and patient reported outcomes.


Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of idiopathic benign essential blepharospasm * must have had prior response to to botulinum toxin (bont) reported on last 2 consecutive injection cycles * last injection of bont at least 8 weeks prior to screening assessments * patient is experiencing features of blepharospasm (bsp) of moderate severity/frequency at study entry. exclusion criteria: * bsp that is known or suspected to be associated with a known cause such as neuroleptic exposure, brain injury or lesion, stroke, parkinson's disease, or related parkinsonisms * history of surgical intervention (e.g., deep brain stimulation) or orbital myectomy for dystonia * disabling eyelid opening apraxia * other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments. * other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study. other protocol-defined inclusion and exclusion criteria may apply

Keywords: blepharospasm dystonia
the impact of physical and mental fatigue on balance

Conditions: Balance

Summary: mental and physical fatigue and overall fatigue will be collected based on fatigue assessment scale while balance data will be obtained by recording mobile sensors in x, y and z directions when mobile placed on cog of the participants.


Eligibility criteria:
inclusion criteria: * patients from 18 to 24 years old exclusion criteria: * free of any mental disorders or major health issues in last year
five-year patency of no-touch saphenous vein grafts in on-pump versus clamp-less off-pump coronary artery bypass surgery

Conditions: Coronary Artery Stenoses

Summary: randomised controlled trials (rcts) have shown high long-term patency for no-touch saphenous vein grafts (ntsvgs), comparable to the internal thoracic artery in on-pump coronary artery bypass grafting (cabg). rcts on patency in ntsvgs in off-pump cabg have not been published yet. orebro university hospital participated in the cabg off- or on-pump revascularization study (coronary, clinicaltrials.gov number, nct00463294) and included fifty-six patients. accordingly, this is a sub-study and the aim was to assess the midterm patency in ntsvgs in clamp-less off-pump versus on-pump cabg at five-year follow-up.


Eligibility criteria:
inclusion criteria: * patients were eligible if they: 1. provided written informed consent; 2. were \>21 years of age; 3. required isolated cabg with median sternotomy; 4. had at least one of the following risk factors: 1. had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index \<0.90), 2. had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%), 3. had renal insufficiency (creatinine above upper limit of normal), 4. were ≥70 years of age, or 5. were between the ages of 60-69 with one of the following: i. had diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome), iii. were a recent smoker (within 1 year of randomization), or iv. had left ventricular ejection fraction ≤35%, or 6. were between the ages of 55-59 with two of the following: i. diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome, iii. were a recent smoker (within 1 year of randomization), or iv. had a left ventricular ejection fraction ≤35% exclusion criteria: * patients were excluded if they: 1. required a concomitant cardiac procedure associated with cabg; 2. had a contraindication to off-pump or on-pump cabg (e.g., calcified aorta, intramuscular left anterior descending artery, calcified coronaries, small target vessels); 3. had a concomitant life-threatening disease likely to limit life expectancy to less than 2 years; 4. were previously enrollment in the coronary trial; 5. required emergency cabg surgery (i.e., immediate revascularization for hemodynamic instability); or 6. required a redo cabg.