Kornimate/medical-research-clean huggingface dataset:
effects of high amplitude and focused tacs on entraining physiological tremor

Conditions: Tremor, Limb

Summary: transcranial alternating current stimulation (tacs) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. while tacs applied over the motor cortex at the general applied amplitude (1 ma) and using patch electrodes has been shown to entrain physiological tremor in healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude tacs and to assess the effect of different electrode montages and stimulation sites in entraining physiological tremor. first, 10 subjects (arm 1) will be stimulated with 2 ma current amplitude applied between saline soaked patch square electrodes and comparison will be done between motor cortex stimulation and peripheral cortex stimulation. then, 10 subjects (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 ma amplitude and comparison will be made between motor cortex and occipital cortex stimulation. three outcome measurements will be measured during the experiments which are: tremor entrainment, phosphene intensity and phosphene threshold.


Eligibility criteria:
inclusion criteria: * above 18 * signed informed written consent exclusion criteria: * pregnancy * history of epilepsy * family history of epilepsy
efficacy and safety of diclofenac sodium topical gel 1% applied four times daily in subjects with acute ankle sprain

Conditions: Acute Ankle Sprain

Summary: the purpose of this study is to evaluate the efficacy of dsg 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years and over.acute sprain of the lateral ankle, grade i-ii, meeting baseline pain intensity level. injury within past 12 hours. exclusion criteria: * pain medication was taken within the 6 hours that precede randomization.during the past 3 months: grade i-iii sprain of the same ankle.during the past 6 months: grade ii-iii sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., marfan's syndrome, down's syndrome, ehlers-danlos syndrome).

Keywords: ankle sprain, soft tissue injury
efficacy and safety of ave1625 as a co-treatment with antipsychotic therapy in schizophrenia

Conditions: Schizophrenia

Summary: ave1625 is a new potent and selective cannabinoid 1 (cb1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia. the main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of ave1625 using a new cognitive battery called measurement and treatment research to improve cognition in schizophrenia (matrics) in schizophrenic patients. the secondary objectives are to measure the efficacy of ave1625 on functional capacity of the patients using a specific scale called university of california san diego performance-based skills assessment 2 (upsa2) and to assess the safety of the compound.


Eligibility criteria:
inclusion criteria: * outpatients with diagnosis of schizophrenia (diagnosed ≤ 35 years of age). * current treatment consisting exclusively of olanzapine, risperidone/paliperidone, quetiapine or aripiprazole monotherapy for at least 2 months. exclusion criteria: * inpatient hospitalization within past 3 months. * residence at the current address \< 3 months due to any instability in the disease. * presence of depressive symptoms. * past history of clinically significant violent behavior. * substance dependence or abuse. * pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: psychometrics schizophrenia
sustaining the reach of a scalable weight loss intervention through financial incentives

Conditions: Overweight and Obesity

Summary: this study seeks to assess how different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving african american patients. this will be done through an innovative research-practice partnership involving primary care, research expertise, and a small business. participants will be randomly assigned to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice. participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk at the clinic.

the proposed study "sustaining the reach of a scalable weight loss intervention through financial incentives: an exploratory randomized trial" seeks to assess how the use of different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving african american patients through an innovative research-practice partnership involving primary care, research expertise, and a small business. the sample will include approximately 200 persons ages 19+ from nebraska medicine or the greater omaha community. the inclusion criteria are (1) age 19+ years; (2) are obese (bmi \>=30) or overweight (bmi \>=25 yet smaller than 30); (3) have internet access. following the completion of an automated informed consent embedded within the program registration using a kiosk placed at the fontenelle clinic, we plan to conduct a 4-arm, pragmatic randomized controlled trial (rct) that will randomly assign overweight/obese patients at the nebraska medicine fontenelle clinic to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice, following the completion of an automated informed consent embedded within the program registration and initial weigh-in. participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk placed at the fontenelle clinic.

Eligibility criteria:
inclusion criteria: * overweight or obese participants who are of 19 years or older and have internet access exclusion criteria: * not meeting the inclusion criteria.

Keywords: financial incentive behavioral economics attrition reach participation retention weight loss
a study of rgt001-075 in adult patients with obesity

Conditions: Obesity

Summary: this study is being conducted to evaluate rgt001-075 to help people who are above a healthy weight range to lose weight. in this study participants will either get rgt001-075 or a "dummy" medicine (placebo). which treatment participants get is decided by chance. participants need to take rgt001-075 or placebo once every day for 12 weeks.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 75 years * have a bmi ≥27 kg/m² and ≤ 45 kg/m² * have had a stable body weight for the 3 months prior to randomization exclusion criteria: * have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity * have a prior or planned surgical treatment for obesity * have or plan to have endoscopic and/or device-based therapy for obesity * have any prior diagnosis of diabetes * have an electrocardiogram (ecg) with abnormalities * have a history of major depressive disorder (mdd) or other severe psychiatric disorders within the last 2 years * have a history of suicide attempt.
mononucleotide autologous stem cells and demineralized bone matrix in the treatment of non union/delayed fractures

Conditions: Non Union/Delayed Fractures

Summary: the study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged nbmc, and ignite® dbm in the treatment of high risk non union/delayed fractures. another objective is to turn this procedure to a standard care protocol in our department .


Eligibility criteria:
inclusion criteria: 1. ages: 18 to 65 2. males- not involved in active military duty. 3. females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hcg urine) within 72 hours of informed consent. 4. subjects must be available for follow-up for 1 year. 5"hard to heal" fracture include the following: a. fracture of the distal third of the tibial bone b. segmental or open (ii, iiia an iiib) fractures of the the tibia or femur diaphysis c.articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss. exclusion criteria: 1. active systemic or local infection. 2. history of malignancy, radiotherapy, or chemotherapy for malignancy (except bcc of the skin) 3. pathological fractures. 4. prior fracture or prior operation in the current fracture

Keywords: subjects sustaining non union/delayed fractures and requiring surgical intervention for treatment
a positron emission tomography (pet) study to examine the brain binding properties of a novel radioactive compound [11c]-pxt012253 in healthy subjects

Conditions: Parkinson Disease

Summary: this study evaluates the usefulness of a pet radioligand to estimate the binding on the mglu4 receptor in the brain. mglu4 has been proposed as a therapeutic target in parkinson's disease.


Eligibility criteria:
inclusion criteria: * healthy subjects age 20-50 inclusive * body mass index (bmi) between 19 and 30 kg/m2 * normal smri scan, performed within 3 months, as judged by the investigator * the subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, ecg, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests * women of childbearing potential and men whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter * a propensity to tolerate confined spaces for prolonged periods * suitability for radial and/or brachial artery blood sampling and cannulation exclusion criteria: * history of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator * the subject has 1 or more clinical laboratory test values outside the reference range, which in the opinion of the investigator are clinically significant * screening supine blood pressure \>=140 mm hg (systolic) or \>=90 mm hg (diastolic), following at least 5 minutes of supine rest. if blood pressure (bp) is \>=140 mm hg (systolic) or \>=90 mm hg (diastolic), the bp should be repeated two more times and the average of the three bp values should be used to determine the subject's eligibility * the subject has a resting pulse \ =100 bpm at the screening visit * the subject has a qtc interval \>430 ms (bazett's or fridericia's correction) at the screening visit or at he baseline visit, as calculated by the ecg equipment and evaluated by the investigator. the ecg may be repeated if any of the values are out-of-range or abnormal * the subject is pregnant or breastfeeding * habitual use of nicotine products and addictive substances * any finding of significance on mri scans as judged by the investigator. * any previous pet measurements for scientific purposes * use of cns active drugs and/or nsaids 1 month prior to the first pet examination * the subject is exposed to significant level of ionizing radiation at work * the subject has undergone any clinical procedures involving significant exposure to radiation (excluding dental x-ray and common x-rays of the chest or extremities) * the subject has received radio labeled material less than 12
assessment of visual performance with virtual reality after cataract surgery

Conditions: Cataract

Summary: the proposed randomized clinical trial aims to compare visual performance, measured using vr simulations, in cataract patients implanted either with bilateral trifocal iol or bilateral monofocal iol with monovision. the hypothesis is that patients implanted with trifocal iol would exhibit superior visual performance, in both daytime and nighttime conditions, compared to those with a monofocal iol with monovision.

cataract surgery provides an opportunity to restore the quality of life by improving vision. while monofocal intraocular lenses (iols) implantation with monovision has been a common approach for cataract surgery, it may result in limited clarity at the intermediate distance and reduced depth perception. the advent of multifocal iols has expanded the possibilities, potentially offering increased visual performance in different ranges of vision. however, the benefits of multifocal iols in everyday activities are not fully understood due to the lack of task-based investigations. to address this gap, a virtual reality-based approach is proposed to simulate daily activities and assess visual performance. this innovative method can provide insights into how multifocal iols enhance activities requiring good binocular vision at varying distances, a capability monofocal iols may lack. a randomized clinical trial is suggested to compare the tecnis synergy multi-focal iol with the tecnis monofocal iol in monovision. unlike its bifocal predecessors, the tecnis synergy iol is trifocal, providing clear vision at near, intermediate, and far distances. the hypothesis is that patients implanted with the tecnis synergy iol will demonstrate superior visual performance in simulated day and night conditions compared to those implanted with monofocal iols and monovision.

Eligibility criteria:
inclusion criteria: * bilateral cataract * regular corneal astigmatism * corneal endothelium cell count \>2000 cells/mm2 * clear intraocular media other than cataract exclusion criteria: * concomitant ocular diseases * irregular corneal aberration * capsular instability * systemic disease that may affect vision * history of other intraocular surgery

Keywords: cataract virtual reality multifocal intraocular lens trifocal intraocular lens monovision
a randomised study of docosahexaenoic acid (dha) in metastatic breast cancer

Conditions: Metastatic Breast Cancer; Progesterone Receptor Positive Tumor; Estrogen Receptor Positive Tumor; HER-2 Negative Tumor

Summary: the aim of this study is to increase, by dha-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived polyunsaturated fatty acids (pufa).

local relapses and metastases make breast cancer a deadly disease. a major goal remains the improvement of treatment efficacy, meaning increasing toxicity to tumor tissue, without additional toxicity to non-tumor tissues. the literature indicates that dha sensitizes breast malignant tumors, but not non-tumor tissues, to chemotherapy and to radiotherapy through a variety of mechanisms. dha enrichment of tissues can be achieved through a dietary supplementation of dha-containing oils, such as fish oil, both in experimental animal models or in humans. therefore, this represents an original nutritional approach to increase the activity of anticancer treatments through an enhanced specificity toward tumor tissues.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer requiring first-line taxanes or anthracyclines based chemotherapy * her2 negative, hr positive * life expectancy \> 3 months * ecog performance status \< or = 2 within 15 days before randomization * measurable and/or evaluable disease according to recist criteria 1.1 * age \> or = 18 years and \< or = 80 years * body mass index (bmi)\>17 for patients \ 21 for patients \> 70 years, within 15 days before randomization * hepatic parameters : total bilirubin strictly normal, ast and alt \< or = 3xuln (5 if liver metastases) within 15 days before randomization * signed written informed consent exclusion criteria: * triple negative breast cancer or her2 over expression * symptomatic central nervous system metastases * previous chemotherapy for metastatic breast cancer * obesity with bmi \> 35 within 15 days before randomization * presence of another invasive cancer * uncontrolled cardiac disease or uncontrolled hypertension * milk protein intolerance * known food allergy to fish * women of childbearing potential not using adequate contraceptive measures, pregnant or breast feeding.

Keywords: metastatic breast cancer first-line chemotherapy taxane or anthracycline dha pufa dietary supplementation first-line taxane or anthracycline based chemotherapy
albiglutide glucose clamp study in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with type 2 diabetes mellitus. a single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. the goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.

this is a phase ii, single-site, randomized, double-blind, parallel-group, placebo-controlled, stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with type 2 diabetes mellitus. a single dose of albiglutide or placebo will be given 3 days before employing a stepped hyper- and hypoglycemic clamp. the goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner. in particular, this study is being conducted to ensure that albiglutide does not impair counter-regulatory responses during hypoglycemia.

Eligibility criteria:
inclusion criteria: * historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before screening * hba1c \<10% at screening for subjects who do not require washout of existing oad or \<9% at screening for subjects who do require washout from existing oad * body mass index in range 28 kg/m2 to40 kg/m2 exclusion criteria: * history of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis * history of significant gastrointestinal surgery, * history of significant cardiovascular disease * history of a seizure disorder * documented hypertension or hypotension * use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration. * current hepatic disease or abnormal liver function tests * positive test result for hepatitis b, hepatitis c, or human immunodeficiency virus infection 1 or 2 * history of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men) * female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum * known allergy to any glp-1 analog or excipients of albiglutide, baker's yeast, or insulin * history of type 1 diabetes, * prior exposure to glp-1 agents, including albiglutide * blood donation over 500 ml within 8 weeks before screening

Keywords: glucose clamp hypoglycemia
ultrasound to predict a pediatric difficult airway and obstructive sleep apnea syndrome in children

Conditions: Difficult Airway; Obstructive Sleep Apnea

Summary: this is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (osas) in children.


Eligibility criteria:
inclusion criteria: * children with known or suspected difficult direct laryngoscopy identified by either ent or anesthesiologist. * children with difficult tracheal intubation aged 1 month - 18 years old * children with obstructive sleep apnea aged 1 year - 8 years old exclusion criteria: * parent/ patient refusal to participate in study
telavancin observational use registry (tour)

Conditions: Hospital Acquired Bacterial Pneumonia; Complicated Skin and Skin Structure Infections; Ventilator Associated Bacterial Pneumonia; Gram Positive Infection

Summary: the telavancin observational use registry (tour) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.

this is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. all treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.

Eligibility criteria:
inclusion criteria: -received at least 1 dose of telavancin since january 1, 2015 exclusion criteria: * participation in an interventional research study or clinical trial involving telavancin after january 01, 2015

Keywords: registry
nebivolol for the prevention of left ventricular systolic dysfunction in patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy; Cardiomyopathy; Heart Failure

Summary: the objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with duchenne muscular dystrophy aged 10 to 15 year-old.

a 1.25 mg-test dose will be administrated to assess the treatment tolerance before randomization. a forced titration of nebivolol and placebo will be performed with 2 weeks periods. full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight is\>60kg).

Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy genetically proven * age between 10 and 15 years * left ventricular ejection fraction assessed by radionuclide angiography or echocardiography ≥50% and measured within 3 months * systolic blood pressure ≥80 mmhg * diastolic blood pressure ≥70 mmhg exclusion criteria: * heart rate \<50 bpm * 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction * asthma or bronchospasm * severe peripheral circulatory disease * hypersensitivity to nebivolol or excipients * metabolic acidosis * blood urea \>7 mmol/l * liver transaminases enzymes \>6 fold the upper limit of normal * formal indication for beta-blockade treatment * cardiac treatments except angiotensin-converting enzyme inhibitors * participation to another clinical trial within 3 months

Keywords: nebivolol beta-blockade treatment