Kornimate/medical-research-clean huggingface dataset:
limb cooling in essential tremor

Conditions: Essential Tremor

Summary: essential tremor (et) is characterized by tremors affecting the arms. the investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with et at three different temperatures; and will measure changes in tremor amplitude after cooling of the upper limb.

once the subject has agreed to participate in the study the following assessments will be performed. three non-pharmacological assessments will be performed at different temperature to the upper limbs. the first will be a baseline assessment with upper limbs maintaining a normal body temperature (96-98°f). the second assessment will be performed with upper limbs at a temperature of 59°f and the third will be performed at a temperature of 80°f for a period of 10 minutes. at the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes. 1. assessments will include the tremor rating scale (trs), handwriting assessment battery (hab) and the functional dexterity test (fdt). 2. the bagnoli and trigno emg systems will record surface emg signals from muscles and accelerometer readings.

Eligibility criteria:
inclusion criteria: * age range 18 to 95 years, * clinical diagnosis of essential tremor for at least a year, * a +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand exclusion criteria: * dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash), * sensory loss in the upper limbs, * known history of sensitivity to cold (i.e., cold urticaria), * known peripheral vascular disease, * raynaud's phenomenon, * scleroderma healthy normal controls will be enrolled through advertisements. all controls will be examined to ensure that they are neurologically healthy. the exclusion criteria for controls will remain same as those for patient subjects.
effects of sucralose on glucose metabolism

Conditions: Glucose Metabolism Disorders

Summary: in this study the effects of sucralose on insulin sensitivity, beta-cell response and appetite regulating hormones will be evaluated.

the consumption of non-nutritive sweeteners has a high prevalence. the effect of non-nutritive sweeteners in both beta-cell function and insulin resistance it is unknown. previous studies performed in animal models and humans with diverse characteristics have shown variable effects of different non-nutritive sweeteners in variables related to glucose metabolism. due to the high consumption of non-nutritive sweeteners it is relevant to know its effect in beta cell-function and insulin sensitivity. in this study the effects of sucralose, a non-nutritive sweetener that is highly consumed in the population, on insulin sensitivity and beta-cell function will be evaluated. 54 participants with normal glucose tolerance, normal weight, and without chronic diseases with a low consumption of non-nutritive sweeteners will be included. the participants will be randomly assigned to consume sucralose or to a control group. during the first visit an oral glucose tolerance test with 75 g of glucose will be performed. fasting and 2-hour glucose will be measured in order to rule-out diabetes, abnormal fasting glucose, or glucose intolerance. during the second visit a three-hour iv glucose tolerance test will be performed administering 0.3 g/kg of glucose and insulin 0.03 u/kg. samples will be taken following the minimal model described by bergman. after this visit, the group assigned to receive sucralose will ingest 15% of the adequate daily intake (adi) of sucralose and the control group will abstain of any non-nutritive sweetener consumption during 14 days. at the end of this period a third visit to repeat the iv glucose tolerance test will be performed. samples will be analyzed measuring glucose and insulin concentrations to evaluate acute insulin response (air), glucose effectiveness (sg), first phase pancreatic response (ф1), and second phase pancreatic response (ф2). in addition, hormones involved in appetite and satiety (leptin, ghrelin, and peptide tyrosine tyrosine) will be quantified at the beginning and end of the intervention.

Eligibility criteria:
inclusion criteria: * both genders * age between 18 and 55 years * body mass index ≥18.5 and \<25 kg/m2 * low consumption of non-nutritive sweeteners exclusion criteria: * diabetes or glucose intolerance * consumption of medications affecting insulin sensitivity (metformin, steroids, hormone replacement therapy, contraceptives) * intestinal disease such as malabsorption or previous intestinal resection * history of bariatric surgery * pregnancy or lactation * weight loss greater than 5% in the previous month

Keywords: sucralose insulin sensitivity beta-cell response appetite regulating hormone
single-dose crossover study to compare the safety and efficacy of flutiform with fluticasone and formoterol concurrently or alone in asthma patients

Conditions: Asthma

Summary: the primary purpose was to evaluate the efficacy of skp flutiform hfa mdi compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.


Eligibility criteria:
inclusion criteria: * subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid exclusion criteria: * smoking history within the last 12 months * no history of respiratory tract infection within 4 weeks * no history or evidence of any clinically significant disease or abnormality

Keywords: mild to moderate asthma
efficacy of educating physical therapists in the treatment of patients with nonspecific chronic low back pain

Conditions: Back Pain

Summary: the aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

the training "update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. after two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each. the study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated. each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). all the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation. clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. all statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using mixed linear models.

Eligibility criteria:
inclusion criteria: * patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years. * physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the national council of physical therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study. exclusion criteria: * patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy. * physiotherapists who want to stop the activities for some reason that prevents participation in the study

Keywords: back pain low back pain chronic low back pain
empowerment and mobile technology in the control of cardiovascular risk factors in patients with ischemic stroke

Conditions: Ischemic Stroke; Transient Ischemic Attack; Atrial Fibrillation; Hypertension; Empowerment

Summary: the cardiostroke is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.

atrial fibrillation (af) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (tia). detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. in the cardiostroke trial, the investigators aim to randomize 405 patients with recent ischemic stroke or tia into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ecg monitoring to detect occult af and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). randomization will occur 2:1 into control and intervention groups. the co-primary outcomes include (1) incidence of new-onset af and (2) difference in the mean blood pressure at 12-months.

Eligibility criteria:
inclusion criteria: * ischemic stroke or transient ischemic attack (abcd2 score ≥3) * age ≥40 years * pre-existing or newly diagnosed hypertension * informed consent from the patient or legal representative exclusion criteria: * known high-risk source of cardioembolism * known indication for anticoagulation * contraindication for anticoagulation * pacemaker * non-compliance to study interventions as judged by the investigator * serious condition hampering the study conduct
a first in human study for resistant epilepsy with the vagus nerve stimulation device by synergia medical

Conditions: Drug Resistant Epilepsy

Summary: this is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the nao.vns system.

this is the first clinical investigation with the nao.vns system from synergia medical. up to 10 patients with drug resistant epilespy, who are eligible for vagus nerve stimulation, will be included in two sites. the total duration of the study is expected to be 36 months. study procedures are composed of (i) baseline, (ii) implantation, (iii) titration and (iv) follow-up until 24 months. primary objective is to evaluate safety of the nao.vns system.

Eligibility criteria:
inclusion criteria: 1. ability to understand the informed consent form (icf) and the study procedures and provide written consent or, in case of cognitive impairment, be the legal ward of a person who is able and willing to provide written consent. 2. subjects diagnosed with drug resistant epilepsy (dre) and candidate for vns treatment 3. ability of subjects or, in the case of cognitive impairment, their caregiver, to accurately count seizures and complete seizure diaries. 4. adult subjects, age ≥ 18. 5. willingness of subjects or, in the case of cognitive impairment, their caregiver, to charge the nao.vns system with the smart charger on a weekly basis. 6. subjects' willingness to follow the protocol procedures. for example, subject should have a careful seizure diary completion according to standard of care to ensure 8 weeks of data available by time of implant. 7. female subjects of childbearing age using acceptable methods of birth control (abstinence considered acceptable). exclusion criteria: 1. unstable medical condition likely to precipitate seizures and make it difficult to evaluate efficacy. 2. prior cervical vagotomy. 3. progressive neurological disease. 4. pregnancy. 5. significant cardiac or pulmonary disease under treatment. 6. history of noncompliance for seizure diary completion. 7. prior implant with vagus nerve stimulation device. 8. current active treatment of epilepsy with cerebellar or thalamic stimulation. 9. prior therapeutic brain surgery for epilepsy within the last 6 months prior to nao.vns implantation. 10. receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation. 11. currently receiving another investigational treatment. 12. patient with vocal cord palsy (vcp), including unilateral, whatever the side. 13. diabetic patients and all patients with a known vagal neuropathy. 14. coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor) are allowed). 15. patient currently participating in another clinical investigation, without explicit consent of the sponsor (non-interventional registries are allowed).

Keywords: vagus nerve stimulation
beyond: betaferon/betaseron efficacy yielding outcomes of a new dose in multiple sclerosis (ms) patients

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to determine * whether treatment with betaferon / betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms * whether treatment with betaferon / betaseron (interferon beta-1b) tolerable and more efficacious than treatment with copaxone (glatiramer acetate) 20 mg

this study has previously been posted by berlex, inc. and schering ag, germany. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc., schering ag germany has been renamed to bayer schering pharma ag, germany. bayer healthcare pharmaceuticals, inc.and bayer schering pharma ag, germany are the sponsors of the trial.

Eligibility criteria:
inclusion criteria: * female and male patients * aged 18-55 years * diagnosis of rrms (relapsing-remitting multiple sclerosis), edss score of 0 to 5.0 * treatment-naive to ifnb or copaxone exclusion criteria: * neurological progression at disease onset or between relapses * serious or acute heart diseases * history of severe depression or suicide attempt * serious or acute liver, renal or bone marrow dysfunction * monoclonal gammopathy * known allergy to gadolinium-dtpa, to ifns (interferons), to glatiramer acetate, to human albumin or to mannitol * pregnancy or lactation

Keywords: relapsing multiple sclerosis interferon beta 1b betaferon betaseron
natural history of levodopa-induced dyskinesia (lid)

Conditions: Parkinson's Disease

Summary: levodopa is the main drug treatment for parkinson's disease. levodopa can cause unwanted and uncontrolled movements called dyskinesias (lid). the severity of these movements can range from subtle to extremely debilitating. these movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. current estimates of the occurrence rate of lid range from 12 % to 100% after one year of levodopa treatment. these estimates used reporting mechanisms such as self-report and doctor-reported. these reporting mechanisms are not reliable. we will use an objective measure of dyskinesia in the first 5 years of treatment for parkinson's disease. the purpose of this protocol is to use an objective measure to estimate dyskinesia onset.

nearly all parkinson's disease (pd) patients eventually develop abnormal and unwanted movements (dyskinesias; lid) caused by the gold standard treatment, levodopa. the severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. current estimates of the prevalence of lid widely range from 12 % to 100% affected after one year. the purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated parkinson's disease patients. all participants will complete seven overnight visits at the octri inpatient unit over 5 years. during the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. a levodopa iv infusion will occur from 0900 to 1100.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * at least 21 years of age * levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study. exclusion criteria: * unable to stand for 1 minute intervals * sensory deficits in the feet * significant cognitive impairment * unstable medical or psychiatric conditions (including hallucinations) * history of dopamine receptor blocking medications (haldol, orap, zyprexa)

Keywords: parkinson's disease dyskinesia movement disorders
physical activity pathological gamblers

Conditions: Gambling Disorder

Summary: gambling disorder (gd) is defined as the recurrent and persistent act of betting which leads to clinical impairments,. the latest edition of the diagnostic and statistical manual of mental disorders (5th edition) conceptualizes gd as a behavioral addiction due to the similarities between gd and substance addictions in clinical presentation, association with personality factors, genetic transmission and treatment options. previous studies found potential benefits of physical activity in treatment of addictions in general and gd in particular, such as reducing desire to play, betting and depressive and anxious symptoms.

detailed description: the purpose of this study is to investigate the effects of regular physical activity controlled and supervised in the treatment of gambling disorder with focus on gambling severity, psychiatric comorbidity and impulsiveness. patients will undergo physical activity either running (experimental) or stretching (control) groups,. physical activity sessions will be lead by a physical educator., both groups will receive treatment for psychiatric comorbidities and cognitive behavioral psychoeducation.

Eligibility criteria:
inclusion criteria: * five or more diagnostic criteria for pathological gambling specified in the diagnostic and statistical manual of mental disorders 4th edition (dsm-iv-tr - apa, 2000); * at least four years of formal education; * able to perform physical activity; * non-pregnant. exclusion criteria: * clinical pathology that demands urgent care such as hospitalization in another service; * any cardiorespiratory, musculoskeletal, or clinical condition that could prevent the practice of aerobic activity, established in clinical evaluation prior to randomization; * psychotic disorder that may undermine validity of responses to the self-report scales administered; * condition which affects the central nervous system and seriously impairs cognitive functions, as a disorder oligophrenia; * diagnosis of moderate to severe depression that compromises engagement in physical activity.
18f-florbetaben pet amyloid imaging in case of intermediate csf biology for the diagnosis of alzheimer's disease : a pilot study

Conditions: Amyloid PET Imaging

Summary: the diagnosis of alzheimer's disease (ad) is based on clinical and neuropathological criteria. some patients have a contributive csf biology to determinate a high level risk of ad (tau + phospho-tau ratio increased and ab42 / decreased aβ40), but others have an intermediate csf biology (tau and/or phospho-tau increased but ab42 ratio / normal aβ40) and are unclassifiable. 18f-florbetaben (neuraceq®), a radioisotope in positron emission tomography (pet), selectively binds to amyloid plaques, with high detection sensitivity (98%). detection of amyloid plaques by pet imaging separate patients according to the criteria of dubois, as with ad and allow them to benefit a cholinesterase inhibitor treatment. if negative, the diagnosis of ad can be excluded with a high level of confidence to prevent initiating unnecessary treatment, expensive for the community. this is the first imaging study of amyloid plaques targeting population whose diagnosis of ad is uncertain according to the csf biology. the aim of this study is to describe the results of amyloid pet in case of intermediate csf biology and to separate patients as ad or not according to the criteria of dubois


Eligibility criteria:
inclusion criteria: * major subjects who have given their consent to participate in the study. * patients with suspected ad and whose csf markers give intermediate results (csf punction less than 6 months): meaning tau and/or phospho-tau increased and ab42 / aβ40 normal (ab42 / aβ40 \> 0.07). * non-indication to perform a pet 18f-florbetaben. * affiliation to the french social security . exclusion criteria: * patients under guardianship. * inability to perform a pet 18f-florbetaben (agitated patient, confused, ..). * pregnancy, lactation.
the effect of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: aim: to investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * the patients included in this study were the ones who were newly diagnosed with type 2 diabetes mellitus exclusion criteria: * presence of thyroid disorders, positive thyroid autoantibodies and usage of medications affecting thyroid hormones such as amiodarone, lithium were accepted as exclusion criterions

Keywords: the purpose of study was investigated the effect of metformin on thyroid hormone metabolism in euthyroid patients with type 2 dm. the results revealed significant decreases in tsh and ft4