Kornimate/medical-research-clean huggingface dataset:
a study to assess the effect of a normal vs. high protein diets in carbohydrates metabolism in obese subjects with diabetes or prediabetes

Conditions: Weight Loss; Obesity; Diabetes; Diet, Reducing; Carbohydrates; Protein

Summary: the objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. a dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). subjects are provided with weekly menus and different recipes to use them as part of the diet. monitoring visits with the nutritionist will be performed every 15 days. at the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, hdl cholesterol, ldl cholesterol, apolipoproteins a1 and b, iron, transferring, ferritin, uric acid, glucose, hba1c, insulin, adiponectin and resistin). urine samples are also collected to assess microalbuminuria and ureic nitrogen.


Eligibility criteria:
inclusion criteria: * age: 18-70 years old. * body mass index between 27.5 - 40. * steady weight (± 4 kg) in the last 2 months. * glycated hemoglobin between 6 - 7%. exclusion criteria: * anti-diabetic drugs (oral or subcutaneous) in the last 2 months. * lipid-lowering drugs in the last 2 months. * gouty arthritis in the last 2 years or uric acid \> 735 mg/dl. * presence of uncontrolled endocrinological pathology (including hypothyroidism). * hepatic chronic disease (glomerular filtration rate \< 45 ml/min). * renal, inflammatory or tumoral diseases. * drugs which could interfere in glucose or lipid metabolism such as androgens, corticosteroids (except for those with topic administration) and estrogen replacement therapy. * intake of functional foods with plant sterols in the past 6 weeks. * high alcohol intake (\> 30 g per day). * any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study. * pregnancy or intention of pregnancy during the study.
tamsulosin for thyroid lid retraction

Conditions: Thyroid Eye Disease; Eyelid Diseases

Summary: the purpose of this study is to examine the effect of using tamsulosin for treatment of eyelid retraction as part of thyroid eye disease. the treatment will be offered to all thyroid patients suffering from eyelid retraction who are treated at the thyroid clinic in sheba's ophthalmology department. all patient will receive information about the drug tamsulosin, the possible side effects, and the alternative treatment options for retraction. patients recruited will take 0.4mg/day tamsulosin for 3 months and will have follow-ups at 1 week, 1 month and 3 months to evaluate the retraction status.

thyroid eye disease is a common autoimmune disorder caused by antibodies directed against receptors present in the thyroid cells and extra-ocular muscles and soft tissue of the orbit. the disorder is characterised by enlargement of the extra-ocular muscles, fatty and connective tissue volume. upper lid retraction is the most common sign of the eye disease (present in up to 92%). the causes for retraction are not fully understood. it may be related to inflammation of the levator muscle and the muller muscle, or related to over sympathetic activity causing overstimulation of the muller muscle. upper lid retraction severity can range from very light to severe, with scleral show, eye dryness and even exposure keratopathy. additionally it can have a very significant effect on the patient's appearance (a constant surprised look). treatments for lid retraction include aggressive lubrication and tarsorrhaphy if needed (sewing the eyelids together). the muller is a smooth muscle which elevates the upper eyelid and is sympathetically innervated (alpha receptor). the drug tamsulosin which is a selective alpha1 receptor antagonist is commonly used today for benign prostatic hyperplasia (relaxing the prostate muscle). in this study we would like to test using tamsulosin for treatment of lid retraction caused by thyroid eye disease. we hypothesise that the relaxation of the muller muscle may have a beneficial effect on the retraction.

Eligibility criteria:
inclusion criteria: * thyroid eye disease patients suffering from upper eyelid retraction in one or both eyes exclusion criteria: * pregnant/breastfeeding women * previous eyelid surgery/trauma

Keywords: eyelid retraction tamsulosin alpha receptor antagonist
magic camp for children with hemiplegic cerebral palsy

Conditions: Cerebral Palsy

Summary: the proposed study will test the feasibility and effectiveness of a "magic camp" in children with spastic hemiplegic cerebral palsy (cp). a single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "magic camp" on improving upper limb motor function and health-related quality of life (hrqol) in children with hemiplegic cp.

this project will employ a single group pretest-posttest design to investigate the impact of a "magic camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic cp. after the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks. the primary outcome measures will be unimanual function as measured by the jebsen taylor test of hand function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the children's hand experience questionnaire. secondary outcome measures will include hrqol as measured by the cerebral palsy quality of life questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.

Eligibility criteria:
inclusion criteria: * spasticity with modified ashworth scale grades between 1 and 3; * ability to lift the more affected arm 15 cm above a table surface; * impairment of hand function at levels i to iii of the manual activity classification system * ability to grasp and release light objects with the more affected hand * largely nonuse of the more affected hand in daily activities as determined by the pediatric motor activity log * are interested in learning magic tricks * have the cognitive and social ability to participate in a camp setting; * ability to follow directions in english; and * ability to remember simple sequences of actions to perform magic tricks. exclusion criteria: * severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use * dystonia * severe visual or auditory disorders that prevent learning and carrying out the magic tricks * serious or recurring medical complications * participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months * start muscle relaxant within the last 3 months; or * plan to move to another state within the next 6 months.

Keywords: motor training for cerebral palsy
the association between kristeller maneuver and pelvic floor trauma after vaginal delivery

Conditions: Labor Complication; Avulsion

Summary: we want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (lam) injury.

we will recruit women immediately following their first vaginal delivery. women who underwent kristeller maneuver will be recruit as cases. for each case, a control (no fundal pressure) will be recruit matched by bmi, second stage duration and birthweight. all women will be invited to undergo a postpartum 3d transperineal ultrasound (tpus). the main outcome measure will be the presence of lam avulsion at 3d tpus. tpus results will be compared between cases and controls.

Eligibility criteria:
inclusion criteria: * first delivery * term pregnancy (37-41w) exclusion criteria: * instrumental vaginal delivery * multifetal pregnancy * previous vaginal or cesarean delivery * refused consent and uncooperative patient for effective valsalva maneuver * handicap in lithotomy position * women without regular and active contractions * epidural analgesia

Keywords: kristeller maneuver,lam avulsion,3d transperineal ultrasoun
impact of adalimumab on patient-reported outcomes in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: to evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe ulcerative colitis (uc) patients.


Eligibility criteria:
inclusion criteria: * patient must voluntarily sign and date a patient authorization. * patient must be ≥ 18 years of age. * patient must have confirmed diagnosis of uc. * patient must have: 1. a mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or 2. a mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr. * patient must have been prescribed adalimumab as part of his treatment by his treating physician. * if the patient was previously treated with vedolizumab or any anti-tnf agent (except adalimumab), an appropriate washout has taken place as per routine practice. exclusion criteria: * patient has previously received adalimumab. * patient has previously used infliximab or any anti-tnf agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction. * patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, kock pouch, or ileostomy for uc or planned bowel surgery. * patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of crohn's disease. * patient with other tumor necrosis factor (tnf) immune-modulated disease. * patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. * a female patient is pregnant or breast-feeding. * patient is currently participating in another prospective study including controlled clinical trials and observational studies

Keywords: real-life effect adalimumab patient reported outcomes (pro) moderate to severe ulcerative colitis (uc) ulcerative colitis (uc)
efficacy and safety of eupasidin-s tab.(eupasidin-s) in gastritis patients

Conditions: Acute Gastritis; Chronic Gastritis

Summary: the purpose of this study is evaluate the efficacy and safety of eupasidin-s tab. in gastritis patients.


Eligibility criteria:
inclusion criteria: 1. age is 19 years old and over, men or women 2. patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms 3. patients with one or more erosions found by gastroscopy 4. patients who voluntarily signed written informed consent may participate in the study exclusion criteria: 1. patients with peptic ulcer and gastroesophageal reflux disease 2. patients with gastrointestinal malignant tumor or surgery related to stomach resection 3. patients with thromboembolism and coagulation disorder 4. patients with significant cardiovascular, pulmonary, heptic, renal primary disease 5. patients with abnormal laboratory result at screening * aspartate aminotransferase(ast), alanine aminotransferase(alt), creatinine \> upper limit of normal range x 2 * white blood cell(wbc) \< 4,000/mm3 * platelet \< 50,000/mm3 6. patients administered with h2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks 7. history of allergic reaction to the investigational product 8. women either pregnant, breast feeding or possible to pregnant without contraceptive method 9. use of other investigational drugs within 3 months prior to the study 10. patients that investigators consider ineligible for this study
fmri and central sensitization in chronic knee osteoarthritis. a pre and post tkr study

Conditions: Osteoarthritis; Pain; Postoperative Pain; Surgery

Summary: painful osteoarthritis (oa) is the 4th largest cause of disability in the uk. preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (tkr). the assessment of the brain's response to noxious stimuli using non-invasive functional mri (fmri) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in oa. fmri may help explain why up to 20% of patients undergoing tkr surgery develop persistent post-operative pain. to test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and oa patients using a novel fmri cuff algometer. assessment of outcomes in terms of pain and function will be performed 6 months post tkr surgery


Eligibility criteria:
inclusion criteria: * oa group unilateral knee oa no previous knee surgery able to give informed consent age \> 40 years - healthy volunteers group no oa or knee pain able to give informed consent age \> 40 years exclusion criteria: -oa group major medical, psychiatric, neurological cx other chronic pain condition (fibromyalgia) contraindications to mri active cancer neuropathic drug treatment -healthy volunteers group pregnancy lower limb pain or previous knee surgery contraindications to mri active cancer major medical, psychiatric, neurological condition

Keywords: osteoarthritis pain postoperative pain
effectiveness of 68ga-psma pet/mri for improving the detection of cspca in lesions with pi-rads score 3

Conditions: Prostatic Neoplasms

Summary: the purpose of this study was to explore the effectiveness of 68ga-psma pet/mri for improving the detection of cspca in lesions with pi-rads score 3. this study is a prospective, observational study, single-center research. after recruiting patients who are suspected prostate cancer with a mpmri pi-rads version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68ga-psma pet/mri will be performed. lesions will be reaccessed based on pet/mri findings and compared with the pathological results.


Eligibility criteria:
inclusion criteria: * males over 18 years old suspected for prostate cancer * serum psa between 4ng/ml and 20ng/ml in recent two months * mpmri pi-rads version2 scores 3 in recent two months * willing to undertake prostate biopsy * no evidence of non-cancerous factors interfere psa level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride) * ecog 0-1 exclusion criteria: * history of prostate biopsy or other operations * history of prostate cancer associated treatment * contraindications for mri or pet examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min) * not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)
effect of exercise training on the function of hdl-cholesterol, endothelial function and endothelial progenitor cells in patients with coronary artery disease (hercet-study)

Conditions: Coronary Artery Disease

Summary: patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (hdl)-cholesterol levels or hdl-cholesterol with modified vasculoprotective properties. the purpose of the present study is to characterize the quality of hdl-cholesterol in patients with coronary artery disease and normal blood hdl-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of hdl-cholesterol in these patients. additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.


Eligibility criteria:
inclusion criteria: * coronary artery disease * normal hdl-cholesterol levels in blood: * \> 40 mg/dl (1.03 mmol/l) in males * \> 50 mg/dl (1.29 mmol/l) in females exclusion criteria: * type 1 or 2 diabetes mellitus * acute coronary syndrome * unstable angina pectoris * myocardial infarction during the last 8 weeks * therapy with niacin * active infections * ventricular arrhythmias * systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 95 mmhg * cancer * pregnant or lactating * alcoholism

Keywords: coronary artery disease hdl-cholesterol endothelial function endothelial progenitor cells normal blood hdl-cholesterol level
bronchoprotective effect of arformoterol in children with exercise-induced bronchospasm (eib)

Conditions: Exercise-induced Bronchospasm

Summary: it is our primary hypothesis that pretreatment with arformoterol will provide superior protection against eib in children with mild-moderate asthma compared to placebo added to the current asthma regimen. our secondary hypothesis is that nebulized arformoterol has comparable protection against eib compared to inhaled formoterol by dry powder inhaler.

this study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks. fifteen children 12-17 years of age with asthma and eib, regardless of current asthma therapy will be eligible for this trial.

Eligibility criteria:
inclusion criteria: * children 12-17 years of age * physician diagnosed asthma for at least 6 months * long term controller medication for at least 4 weeks if any being used * females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study * eib diagnosed by a positive exercise challenge at screening * forced expiratory volume in 1 second (fev1) greater than 70% of predicted at screening visit exclusion criteria: * history of cardiac dysfunction * inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry) * upper respiratory infection in the last 4 weeks * severe exacerbation, use of oral steroids, or hospitalization in the last 3 months * chronic (greater than 2 weeks) use of a long acting beta agonist (laba) * pregnancy or lactation * history of paradoxical bronchospasm with any beta-agonist * obesity defined as bmi greater than 30 kg/m2

Keywords: asthma exercise induced bronchospasm prevention eib children
anorectal manometery in pediatric chronic refractory constipation

Conditions: Chronic Constipation

Summary: anorectal manometry and high-resolution anorectal manometry (hram) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. in high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

primary objective: to assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence. secondary objective: to determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. to assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. to assess the effect of elimination of cow milk products in patient with chronic refractory constipation.

Eligibility criteria:
inclusion criteria: 1. children and adolescents aged from 4 to 16 years. 2. participants fulfilling rome iv criteria for the diagnosis of functional constipation. at least 2 of the following present at least once per week for at least 1 month: * 2 or fewer defecations in the toilet per week * at least 1 episode of fecal incontinence per week * history of retentive posturing or excessive volitional stool retention * history of painful or hard bowel movements * presence of a large fecal mass in the rectum * history of large-diameter stools that may obstruct the toilet the symptoms cannot be fully explained by another medical condition (hyams et al., 2016). 3. participants who have chronic refractory constipation. chronic refractory constipation (crc) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire. 5-the participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: * participants who have anorectal malformation * participants who have neurological disease affecting lower limbs * has a history of hypersensitivity or allergies to lubiprostone
effect of chlorhexidine skin cleansing on skin flora

Conditions: Skin Diseases, Infectious

Summary: given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

this study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. the study takes place in the special care nursery at dhaka shishu hospital in dhaka, bangladesh.

Eligibility criteria:
inclusion criteria: * infant admitted to special care nursery at dhaka shishu hospital less than 48 hours chronological age * parental consent must be obtained exclusion criteria: * infants being admitted for major surgical procedure which is attended by high rate of infectious complications * sepsis * clinically-evident skin infection * generalized skin disease * structural defect of the skin involving greater than 5% of the body surface * with a major congenital anomaly * with a known immunodeficiency

Keywords: skin cleansing bangladesh skin flora newborn infectious disease chlorhexidine