Kornimate/medical-research-clean huggingface dataset:
assessment of distal protection device in patients at high risk for distal embolism in acute coronary syndrome (acs)

Conditions: Coronary Artery Disease

Summary: attenuated plaque ≥ 5mm by intravascular ultrasound(ivus) was reported to be high risk for distal embolism in acute coronary syndrome(acs). the purpose of this study is to assess the effect of thrombus aspiration catheter and distal protection device (filter wire; filtrap™) in the aforementioned subgroup of patients at high risk for distal embolism.


Eligibility criteria:
inclusion criteria: patients who were diagnosed as acs and meet the following criteria. * patients with acute myocardial infarction or unstable angina within 2 months from onset. * patients who have severe coronary stenosis which require pci and in whom attenuated plaque ≥ 5mm (longitudinally) by ivus before pci is observed prior to balloon dilatation and stent deployment. exclusion criteria: * patients who need balloon expansion (including small diameter balloon) for ivus catheter crossing. * patients who were resuscitated after dead on arrival * graft lesion or in-stent restenosis lesion * patients on dialysis or renal failure (cr\>1.5mg/dl). * left main trunk lesion * target vessel size is \ 5mm * ineligible for pci * lactating and (possibly) pregnant woman or having possibility of pregnant * patients who are considered ineligible by the attending physician

Keywords: distal protection device thrombus aspiration coronary artery disease coronary disease acute coronary syndrome
study to determine the potential ddis when the daclatasvir/asunaprevir/bms-791325 three drug antiviral combination tablet (fdc) is coadministered with a cocktail of cytochrome p450 (cyp) probe substrates and transporter probe substrates (digoxin and pravastatin) in healthy subjects

Conditions: Hepatitis C

Summary: the primary purpose of this study is to assess the effect of the daclatasvir/asunaprevir/bms-791325 fixed dose combination (fdc) tablet on the pharmacokinetics of the cocktail cyp and transporter probe substrates and to assess the effect of the dcv 3daa fdc \[dcv 3daa fdc = fixed dose combination formulation of 3 direct-acting antivirals (3daa) (dcv 30 mg, asv 200 mg, and bms-791325 75 mg)\] + bms-791325 75-mg single-agent tablet on the pharmacokinetic (pk) of the cocktail cyp and transporter probe substrates.

ind number: 79,599 and 101,943 primary purpose: other: study is being conducted to investigate the potential drug-drug interactions (ddis) when the daclatasvir/asunaprevir/bms-791325 fdc formulation is coadministered with a cocktail of cytochrome p450 (cyp) probe substrates (caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, and midazolam) and transporter probe substrates (digoxin and pravastatin) in healthy subjects. it is also intended to characterize the pk of daclatasvir (dcv), asunaprevir (asv), bms-791325, and its major metabolite, bms-794712, at steady state.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ecg measurements, and clinical laboratory test results * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive. bmi = weight (kg)/\[height (m)\]2 * men and women, ages 18 to 45 years, inclusive * women must not be of childbearing potential, must not be breastfeeding exclusion criteria: * any significant acute or chronic medical illness * history of important arrhythmias including, but not limited to, ventricular fibrillation, ventricular tachycardia, complete atrioventricular (a-v) block, wolff-parkinson-white syndrome * history of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope * history of heart disease * history of prolonged qt interval or torsades de pointes (tdp) * history of hypokalemia * family history of sudden cardiac death at a young age, tdp, or long qt syndrome * history of asthma, bronchospasm, or sleep apnea * history of rhabdomyolysis * history of a bleeding disorder * history of raynaud's disease * history of peptic ulcer disease or significant gastrointestinal bleed * history of biliary disorders, including gilbert's disease or dubin-johnson disease * current or recent (within 3 months of study drug administration) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
efficacy of adding lower extremity weights on balance in children with ataxic cerebral palsy

Conditions: Ataxic Cerebral Palsy

Summary: ataxic cp is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. they may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. some also have trouble with depth perception this means being able to accurately judge how close or far away something is


Eligibility criteria:
inclusion criteria: * ataxic cerebral palsy aged 7-13 years exclusion criteria: * any musculoskeletal conditions that affect balance previous surgeries that affecting balance
virtual reality, ice application and self-injection and self-test fair, pain and state anxiety

Conditions: Injection Site Irritation; Fear of Pain

Summary: ai̇m:the aim of this study is to control the fears and anxieties of type 2 diabetics in insulin injection and blood glucose measurement with motivational videos and ice applications to be applied with virtual reality glasses. material and methods: the research is designed as a semi-experimental model with pretest-posttest control groups. the research will be carried out in the endocrine services located in turgut özal medical center in malatya province. the universe of the research will be 2113 type 2 diabetes patients who are being treated in the hospital specified on the specified dates, who are injecting insulin and following blood sugar. according to the analysis of the power, the sample of the research is composed of an experiment effect of 0.5% with bilateral significance level, 95% confidence interval determined with 5% error level, the experiment group to be applied with 80% reality with 80% representation power, and the control group with 80 ice application. will create a total of 240 type 2 diabetes patients.in the collection of the data, the participant presentation form developed by the researcher, diabetes fear of self injecting and self-testing questionnaire-d-fisq, state anxiety scale and vas will be used.

vr is a relatively new human-computer interaction tool in which a person becomes an active participant in a virtual world. sensory cues of vr, especially the precise control of auditory, tactile and olfactory systems, enhances the reality of the virtual environment. as a result, users feel that they can look around and enter the simulated environment. the virtual environment provides sensory information such as visual, auditory, movement, virtual or artificial, and makes the individual feel similar to real life. ice application has been used as a topical pain reliever for centuries. it works through a variety of mechanisms, such as slowing the transmission of peripheral nerve fibers, promoting sensory competition, and reducing the release of inflammatory and nociceptive mediators. ice application is cheap, easily accessible and reaches its purpose relatively quickly to skin anesthesia. apart from these effects, it also reduces pain by activating the door-control mechanism, stimulating the touch receptors and increasing the release of endogenous opioids.

Eligibility criteria:
inclusion criteria: * being literate, * injecting insulin at least twice a day, * following blood sugar at least twice a day, exclusion criteria: * having any psychiatric diagnosis, * communication barriers * the patient has any diagnosis, such as epilepsy, that will trigger seizures. * any diagnosis, such as vertigo, that causes dizziness in the patient.

Keywords: insulin injection fear of injection ice application virtual reality
practice of scuba diving by as many people as possible: effect of medical assessment to provide a suitable and individualised framework for practice (plongée santé)

Conditions: Diving Barotrauma

Summary: the study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the brest university hospital. these people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants. for the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). a relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner. this study aims to analyze the state of health of the service's consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation. the purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").

this is a single-center retrospective study on health data. the methodology includes a collection of data on health and practice of scuba diving, figuring on the medical consultation files and then carrying out a telephone interview of people seen in diving medicine consultation between 01/01/2015 and on 12/31/2018 in the hyperbaric and underwater medicine department of the brest university hospital. one month before the start of these interviews, an information letter on the study is sent by post, giving the possibility of opposing it. the main evaluation criteria are the number of dives carried out since the consultation (and the average number of dives per year of practice), and the number of accidents or incidents during the practice of recreational scuba diving in the framework proposed, during the months or years following the medical consultation the secondary evaluation criteria are the evolution of the chronic pathology, the evolution of health status in general, the number of hours of practice of a physical and sport activity per week, the respect of the technical practice framework recommended.

Eligibility criteria:
inclusion criteria: * people who asked for a medical advice for the diving practice in a consultation in the hyperbaric and underwater medicine department of the brest university hospital from 2015/01/01 to 2018/12/31 exclusion criteria: * refusal

Keywords: scuba diving medical fitness sport for health
efficacy and safety of arbaclofen placarbil in subjects with spasticity due to multiple sclerosis

Conditions: Multiple Sclerosis

Summary: to evaluate the efficacy of three doses of xp19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (ms).


Eligibility criteria:
inclusion criteria: 1. has multiple sclerosis (ms) based on poser or mcdonald criteria (all subtypes of ms will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria). 2. maximum ashworth score scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors. 3. expanded disability status scale (edss) rating between 3.0-8.0 inclusive. 4. if a subject is on disease modifying ms treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study. 5. spasticity disability rating of 2 or higher at baseline. 6. willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis). exclusion criteria: 1. spasticity due to neurological disorder other than ms or other conditions that may confound the assessment of spasticity. 2. subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities. 3. subjects who have suffered an acute relapse of ms (as determined by the investigator) within 90 days prior to screening, or have had more than 1 relapse within the year prior to screening 4. botulinum toxin injection within 6 months of screening or has current residual associated side effects at screening. 5. subjects receiving concomitant medication from more than one of the following three drug classes: (antiepileptic drugs, tricyclic anti-depressants and opioids) 6. subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits * gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day * amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day * opioids ≤ 30 mg morphine equivalents per day. 7. evidence of unstable or severe systemic illness, including but not limited to: cardiovascular disease (e.g., chronic ventricular arrhythmia, unstable angina or chf), respiratory disease (e.g., sleep apnea, copd requiring oxygen therapy or hospitalization in last year), endocrine disease, hepatic disease (e.g., chronic active hepatitis), renal disease, or immunodeficiency.
mobile tele-rehabilitation solution for obese patients.

Conditions: Obesity

Summary: published data indicate that rehabilitation in obese patients can result in a loss of body fat and weight that is correlated to improved physical and psychological condition and reduced morbidity and mortality. the ivestigators hypothezise that the use of a mobile telerehabilitation solution will encourage the patient to adopt behavioral modifications allowing a reduction of fat mass

obesity is one of the most important public health care problems worldwide and is associated with increased morbidity and mortality and high healthcare costs. not all obese patients have the same metabolic risk. it is pejorated in case of increase in the fat mass (fm) and especially when it predominates at the visceral abdominal level. clinical trials have established the efficacy of lifestyle and behavioral interventions in obesity. the recent development of telerehabilitation is a promising approach that has only been the subject of pilot studies therefore, the investigators aim to test the effects of 3 months of telerehabilitation solution on fat mass evaluated by impedance analysis. the telerehabilitation program telemouv includes physical activity sessions with low intensity endurance training targeted at the level of maximal oxidation, nutritional monitoring, therapeutic education tools and motivational support patients with bmi \> 30 kg/m² will be randomized for the intervention. the investigators also will analyse the effects of the solution on different anthropometric, metabolic,cardiovascular and psychological parameters, and on rest and exercise metabolism. moreover, we will assess behavioural changes in physical activity and nutrition at the end of the study, patients in the control group will be able to benefit from the telemouv solution in an ancillary study with a follow-up of three months. for a alpha threshold of 5% and a study power of 90%, the study should include 22 patients in each group. taking in account a possible 10% of dropout the study will need to include 25 patients by randomized arm to demonstrate an effect.

Eligibility criteria:
inclusion criteria: * body mass index \> 30 kg/m² * age 20-65 years exclusion criteria: * unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric) * no internet access at home
north american study for the treatment of refractory ascites (nastra)

Conditions: Ascites; Liver Cirrhosis

Summary: the nastra clinical trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (tips) is superior to high volume paracentesis (total paracentesis, tp) for the treatment of refractory ascites due to cirrhosis. only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.


Eligibility criteria:
inclusion criteria: * cirrhosis as documented by biopsy or clinical/laboratory parameters with * tense symptomatic ascites and need for paracentesis (10 l) within last 2 months and * failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy) exclusion criteria: * causes of ascites other than cirrhosis and portal hypertension * terminal liver failure * portal vein thrombosis * congestive heart failure * acute renal failure * active encephalopathy * alcoholic hepatitis * pregnancy

Keywords: refractory ascites paracenteses
mineral water for prevention of renal stones

Conditions: Calcium Oxalate Urolithiasis

Summary: the investigators would like to assess if the intake of high bicarbonate mineral water would not only increase total fluid intake but will also be able to give patients the additional benefit of correcting the urinary abnormalities which may predispose them to stone formation.

the life time risk of developing nephrolithiasis is about 10-15% in the western world, but can be as high as 20-25% in the middle east. evidence suggests that the incidence and prevalence of kidney stones is increasing globally which represent a significant economic burden. besides the lack of hydration, the most common metabolic abnormalities associated with calcium stones are hypercalciuria, hypocitraturia and hyperoxaluria. in addition, low urinary ph from consumption of non-dairy animal protein has been associated with reduced urinary citrate and increased uric acid stones which form a nidus for subsequent calcium oxalate precipitates. dietary modification is the first line approach in the treatment of idiopathic calcium oxalate (caox) nephrolithiasis. general advice includes adequate hydration, avoiding oxalate-rich foods, and consumption of an adequate amount of calcium. adequate hydration is an easy and effective way of preventing stones. siener et al found in healthy men, consumption of mineral water rich in magnesium and bicarbonate resulted in favourable changes in urinary ph, magnesium and citrate excretion (inhibitors of caox stone formation). our pilot study in 10 young and healthy surgical residents also revealed similar results after drinking bicarbonate rich mineral water for 1 week. in this study, the investigators compared the effect of drinking bicarbonate rich mineral water with plain water on urine biochemistry in a prospective randomized study in patients with known caox stones. the investigators hypothesize that the intake of bicarbonate rich mineral water, particularly at meal times, reduces stone risk via reduction in urinary oxalate through increased intestinal oxalate binding with dietary calcium. other potential benefits of mineral water include increased urinary stone inhibitors like magnesium, citrate and alkalinisation of urine.

Eligibility criteria:
inclusion criteria: * patients with proven calcium oxalate (caox) stone (caox \>50% by infrared spectroscopy) from jan 2018 to aug 2019 in singapore general hospital * all stone formers had suffered spontaneous passage or surgical removal of a urinary calculus during the study period. exclusion criteria: * presence of urinary tract infection * severe cardiovascular insufficiency * previously diagnosed causal metabolic disease such as hyperparathyroidism, renal tubular acidosis, primary hyperoxaluria, wilson's disease, cushing disease, osteoporosis and malignant diseases. * pregnant women * chronic intestinal diseases * history of previous bowel resection * participation in competitive sports

Keywords: mineral water disease prevention 24h urine analysis
cymbalta for fibromyalgia pain - predictive value of small fiber changed

Conditions: Fibromyalgia

Summary: subjects with fibromyalgia who respond to duloxetine have specific nerve fiber characteristics. this can be used to predict which future patients will respond to duloxetine.

subjects will have skin biopsies taken and evaluated for specific pathologies. all subjects will undergo a treatment period with duloxetine. the analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.

Eligibility criteria:
inclusion criteria: treatment arm * fibromyalgia diagnosis * female * over the age of 18, under the age of 70 * understands english * not pregnant/planning to become pregnant exclusion criteria: * no major psychiatric disorders * no major unconrolled systemic diseases which may require hospitalization in the next 6 months * pregnant inclusion criteria: control arm * female * over the age of 18, under the age of 70 * understands english * not pregnant/planning to become pregnant exclusion criteria: control arm * no major psychiatric disorders * no major unconrolled systemic diseases which may require hospitalization in the next 6 months * pregnant

Keywords: fibromyalgia duloxetine cymbalta pain peripheral nerve biopsy predictive