Kornimate/medical-research-clean huggingface dataset:
use of the modified atkins diet in infantile spasms

Conditions: Infantile Spasms

Summary: infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. the ketogenic diet has been shown to be very effective in these children. the modified atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. modified atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified atkins diet in infantile spasms refractory to conventional treatment (acth, vigabatrin, and anti-epileptic drugs).


Eligibility criteria:
inclusion criteria: 1. age: 6 months to 3 years. 2. presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day. 3. treatment with at least corticosteroid/ acth or vigabatrin and one other aed( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam). exclusion criteria: 1. known or suspected inborn error of metabolism, as evidenced by: clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination and/ or 2 or more of the following biochemical abnormalities high blood ammonia (\>80mmol/l), high arterial lactate (\>2 mmol/l), metabolic acidosis (ph \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests. 2. motivational or psychosocial issues in the family which would preclude compliance 3. systemic illness- chronic hepatic, cardiac, renal or pulmonary disease

Keywords: west syndrome hypsarrhythmia
effect of fermented oyster extract on musculoskeletal biomarkers in relative sarcopenia adults

Conditions: Muscular Sarcoidosis

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the fermented oyster extract on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

previous studies have indicated that fermented oyster extract may have the ability to prevent skeletal muscle atrophy. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the fermented oyster extract on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. the investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 4 and 12 weeks of intervention. fifty-four healthy adults were administered either 1,200 mg of fermented oyster extract or a placebo each day for 12 weeks;

Eligibility criteria:
inclusion criteria: * \<110% of the standard lean body mass as measured using the body composition analyzer * body-mass index (bmi) ranging from 18.5 to 30.0 kg/m2 exclusion criteria: * abnormal liver or renal function (i.e., serum aminotransferase activity \> 60 iu/l and serum creatinine concentrations \> 1.2 mg/dl) * diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dl) * history of fracture during the previous year * uncontrolled hypertension * history of serious cardiac disease such as angina or myocardial infarction * history of gastrectomy * history of medication for psychiatric disease * administration of oriental medicine including herbs within the past 4 weeks evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer
the effect of pre-sacral nerve block on post-operative pain following laparoscopic hysterectomy

Conditions: Gynecology

Summary: 40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to: group a before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22g needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, fipco, egypt)will be administered. while patients randomized to group b will undergo tlh with pre-sacral nerve block.

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to: group a before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22g needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, fipco, egypt)will be administered , then the uterus will be removed, and the operation will be terminated while patients randomized to group b will undergo tlh with pre-sacral nerve block as follows: uterosacral nerve block will be performed before the removal of uterus and the closure of vaginal cuff, and before the removal of trocars from abdominal cavity, insertion of 6-inch 22g needle 2 to 3 cm below the umbilicus, injection of the shp area which situated anterior to l5-s1 vertebral bodies, caudal to the bifurcation of the abdominal aorta with 30 ml 0.25% bupivacaine (marcaine®0.25% , astra zeneca, egypt) will be administered. following the injection of local anesthetic, patient will be placed from trendelenburg position to horizontal position. the we will remove the uterus and trocars , and the operation will be terminated. data will be recorded in a case report form (crf) and statistical analysis will be done.

Eligibility criteria:
inclusion criteria: * women undergoing elective total laparoscopic hysterectomy body mass index less than 29 kg/m2 exclusion criteria: * previous presacral neurectomy * concurrent surgical procedure other than salpingectomy and/or oophorectomy * chronic narcotic consumption inability to provide consent * patients with contraindication to laparoscopic surgery (e.g. severe cardiopulmonary dysfunction). * bleeding tendency (e.g. patient on anticoagulants, platelets disorders) * intra-abdominal adhesions (due to previous abdominal surgery e.g. myomectomy)
a pilot bioequivalence study of pomalidomide

Conditions: Bioequivalence

Summary: pomalidomide capsule were developed to offer an alternative to the marketed formulation, this pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.


Eligibility criteria:
inclusion criteria: * subjects should read, sign and date an informed consent form and be fully informed of possible adverse events prior to any study procedures. * subjects should complete the trial according to the regulations. * subjects must agree to take effective contraceptive methods to prevent pregnancy from 2 weeks before screening until 3 months of last dose administration. subjects must agree to avoid semen and blood donation until 3 months of last dose administration. * healthy male volunteers of 18-50 years old. * body mass index (bmi) ranges from 18.0 to 28.0 kg/m2, body weight ≥ 50 kg. * medically healthy subjects with clinically normal neutrophils and platelets within 14 days. * no history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities. exclusion criteria: * smokers (\>3 cigarettes/day) * history of allergic reactions to pomalidomide or thalidomide analogues. any food allergies, which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study. * any history of thrombus or liver, kidney diseases. * history of alcohol abuse (3990 ml beer, 1400 ml wine, 350 ml spirits/week) * recent donation of plasma or significant loss of whole blood (\>400 ml) within 3 months. * subjects have difficulty to swallow or any clinical significant history of ongoing gastrointestinal problems which affect absorption of drugs. * received a prescription medicine within 2 weeks prior to study dosing. * received a non-prescription drugs, traditional chinese medicine, health products within prior to study dosing. * received a special food (dragon fruit, grapefruit or other tropical fruit) or strenuous exercise within 1 week prior to study dosing. regular use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study administration. * any anticipation in other trial within 3 months. * abnormal laboratory tests judged clinically significant. * positive test result for hbsag, hbeag, hbeab, hbcab, hcvab, hiv antibody, syphilis screening antibody. * received a caffeine/xanthine beverages or food within 48 h prior to study dosing. * received an alcohol within 24 h prior to study dosing or positive test result for alcohol screening. * positive test result for drugs of abuse. * other reasons which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.

Keywords: pomalidomide multiple myeloma bioequivalence
reducing stigma and increasing treatment seeking intentions among adolescents

Conditions: Stigma, Social; Mental Health Disorder; Adolescent Behavior; Depression

Summary: depression is a leading cause of illness and disability in teenagers. longer duration of untreated depression (dud) is associated with greater severity, poorer outcome, and cognitive impairment. stigma toward people with depression has been identified as a barrier to seeking help; therefore, reducing stigma toward young people at depressive risk could enhance their receptivity to seeking treatment. social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes. in a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among adolescents with depression. the videos feature adolescent protagonists varied by race/ethncitiy and gender (black girl, black boy, white girl, white boy, hispanic girl, hispanic boy, nonbinary or transgender adolescent) who will share their experiences with depression, challenges, and recovery process. the investigators would like to conduct a randomized controlled trial (rct) to test the efficacy of these tailored videos as compared to a video control condition (which provides information about depression and how to seek help but does not include a personal story) on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, 2 week follow-up, and 4 week follow-up among adolescents ages 14-18 recruited via cloudresearch. the videos will be shown again at 2 week follow-up.

in a randomized control trial (rct) with pre-, post-intervention, and 2 and 4 week follow-up assessments, the investigators aim to test the efficacy of brief social contact video interventions, varying protagonist race/ethnicity, as compared to video control in reducing depression related stigma and increasing treatment-seeking intentions and behavior among adolescents ages 14-18 recruited via cloudresearch, a crowdsourcing platform. the control condition will include a video that will provide information about depression and how to seek help but does not include a personal story. the tailored video interventions will be assigned based on participant demographics and will include adolescent protagonists varied by race/ethnicity and gender (black girl, black boy, white girl, white boy, hispanic girl, hispanic boy, nonbinary or transgender adolescent). videos will be shown at baseline and 2 week follow-up. the investigators hypothesize that 1) brief social contact-based video interventions will reduce stigma towards depression and increase treatment-seeking intentions and behavior compared to video control which provides information about depression and help seeking but does not include a personal story.

Eligibility criteria:
inclusion criteria: * ages 14-18 * english speaking * us residents exclusion criteria: * age less than 14 or greater than 18 * non-english speaking * non-us resident
early haemodynamic optimization using preload dependence during septic shock = ehoss-1

Conditions: Septic Shock

Summary: haemodynamic optimization is of paramount importance in septic shock, but is really consensual and standardized during the first 6 hours of treatment. haemodynamic treatment including fluid loading management, vasoactive treatment and oxygen transport optimization is mainly based on expert recommendations or non-randomized trials. recently, preload dependence indexes such as pulse pressure variation have been shown to be more accurate to predict fluid responsiveness than static indexes such as filling pressures. however, whether using preload dependence indexes changes septic shock prognostic remains to date unknown. the aim of this non-blinded randomized controlled trial is to assess whether haemodynamic optimization using preload dependence indexes and pulmonary thermodilution 1. reduces septic shock duration assessed by administration duration of vasoactive treatment (primary end point), 2. reduces regional hypoperfusion assessed by arterial lactate, 3. reduces lung hydrostatic oedema linked to excessive fluid loading (assessed by pao2/fio2 ratio and extravascular lung water). 4. reduces organ dysfunction (assessed by the sofa score), icu stay and 7 and 28 day mortality control group is managed with an algorithm using filling pressures to drive haemodynamic treatment.


Eligibility criteria:
inclusion criteria: * age over 18 years * and fulfilment of two of four criteria for the systemic inflammatory response syndrome * and systolic blood pressure no higher than 90 mm hg (after a crystalloid-fluid challenge of 25 ml per kilogram of body weight over a 30-minute period) * and documented or suspected infection exclusion criteria: * delay between first observation of hypotension and inclusion above 12 hours * pregnancy * acute coronary syndrome * acute cerebral vascular event (\< 1 month), * contraindication to central venous catheterization in the superior vena cava territory * contraindication to femoral arterial catheterization * active haemorrhage * burn injury * trauma * requirement for immediate surgery (\< 6 hours) * acute pulmonary oedema of cardiogenic origin * do-not-resuscitate status, or advanced directives restricting implementation of the protocol. * informed consent not obtained from the patient or surrogates * patient already included in another therapeutic trial * patient previously included in the same therapeutic trial

Keywords: septic shock randomized controlled trial preload dependence pulmonary thermodilution
fuji type vii sealant versus resin based sealant. a clinical trial

Conditions: Dental Caries

Summary: purpose: to evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. materials and methods: using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3m espe) and glass ionomer sealant (fuji). the study comprised of 120 government school children of 7-9 years age group. the glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. they were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.


Eligibility criteria:
inclusion criteria: * children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study. exclusion criteria: * molars with developmental anomalies, hypoplastic teeth were promptly excluded
efficacy of imipramine for treatment of patients with esophageal hypersensitivity/ functional heartburn

Conditions: Gastroesophageal Reflux Disease

Summary: esophageal hypersensitivity/functional heartburn are common among non-erosive reflux disease (nerd) patients who do not response to proton pump inhibitors. whether tricyclic antidepressant improves nerd patient's symptoms remains unknown aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life


Eligibility criteria:
inclusion criteria: * patient with typical reflux symptoms (heartburn and/or regurgitation) more than 3 times per week in at least last 3 months * age more than 18 years * upper gi endoscopy showed no esophageal mucosal breaks * mii-ph monitoring was not showed abnormal both acid and non-acid reflux * symptoms was not improved after received standard dose proton pump inhibitor for at least 1 month exclusion criteria: * history of thoracic, esophagus, or stomach surgery * severe esophageal motility disorder eg. achalasia, scleroderma, autonomic/peripheral neuropathy/myopathy * patient who was indicated to receive proton pump inhibitor * pregnant women * patient who was allergy to imipramine * patient who received tricyclic antidepressant or ssri with in 3 month of enrollment
ultrasonographic monitoring of response to infliximab in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Ultrasonography; Infliximab

Summary: to evaluate the predictive value of clinical, functional (haq), laboratory and us variables in relation to disease activity and radiographic outcome in patients with ra who start treatment with remicade at 24 weeks.

this is an open-lable, single arm study of the ultrasonographic monitoring of response to infliximab in patients with rheumatoid arthritis. approximately 120 subjects will be enrolled. subjects will receive infliximab 3mg/kg intravenous infusion at 0, 2, 6 week, and then repeated every 8 weeks until 24 weeks. the efficacy assessment is observed by acr response, haq, das28, sharp scores and us assessment at 0,2，6,14, 22, and 24weeks and ultrosonographic and radiographic assessments are conducted at 0, 6,and 24weeks. subjects will be followed for aes and saes up to 8 weeks following the last study treatment administration (see section 6). the end of study is defined as the time the last subject completes the 24 weeks visit.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years, male or female and who are capable of providing informed consent, which must be obtained prior to any study-related procedures. 2. those who have a definitive diagnosis of ra based on the criteria of american college of rheumatology in 1987 and have moderate to severe disease (das28 more than 3.2). 3. patients using oral corticosteroids, must have been on a stable dose of prednisone 10mg/day or its equivalent for at least 4 weeks prior to screening. if currently not using corticosteroids the patient must have not received corticosteroids for at least 4 weeks prior to screening. 4. patients using dmards, must have been on a stable dose for at least 12 weeks prior to screening. if currently not using dmards the patient must have not received dmards for at least 12 weeks prior to screening. 5. if using nsaids or other analgesics for ra, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. exclusion criteria: 1. patient who has a known hypersensitivity to human immunoglobulin proteins or other components of infliximab. 2. patient who suffers from systemic inflammatory disease whose signs and symptoms are expected to affect the evaluation of the study drug. 3. patient who has a history of receiving infliximab or any other biologics. 4. patient who has stage iv ra. 5. patient who has had or is on live viral or bacterial vaccinations within 4 weeks to study entry. 6. patient who ever suffered from chronic or recurrent infection, including but not limited to: chronic kidney infection, chronic thoracic cavity infection (eg. bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drain or dermal infected wound.
contrast-medium induced nephrotoxicity in patients undergoing coronary angiography - iodixanol versus iopromide

Conditions: Chronic Renal Insufficiency; Coronary Angiography

Summary: in the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. in that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. the investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (iocm), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (locms) in high-risk patients. we compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric locm, in patients with renal impairment.

Eligibility criteria:
inclusion criteria: * patients who undergo coronary catheterization * creatinine clearance rates ≤ 60 ml/min using the cockcroft-gault formula exclusion criteria: * pregnancy or lactation * having received contrast media within 7 days of study entry * emergent coronary angiography * acute renal failure or end-stage renal disease requiring dialysis * history of hypersensitivity reaction to contrast media * unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation * multiple myeloma * parenteral use of diuretics * use of n-acetylcysteine * use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
the efficacy of leukotriene inhibitor in adult patients with moderate sars-cov-2 symptoms (covid19)

Conditions: Moderate Covid19

Summary: there is an urgent need to explore therapeutic options for sars-cov-2 in order to face the pandemic. the selected intervention was based on that zafirlukast will have dual effect; first it will block the virus replication through inhibiting the covid19 helicase that is involved in virus replication and secondly by reducing the inflammation through antagonizing the leukotriene receptor. the purpose of this study is to evaluate the clinical efficacy and safety of leukotriene receptor antagonist in the treatment of moderate cases of covid-19 patients.


Eligibility criteria:
inclusion criteria: 1. age of 18 years or above 2. diagnosed with covid-19 by pcr confirmed sars-cov-2 viral infection. 3. able to sign the consent form and agree to clinical samples collection 4. moderate symptomatic covid-19 patients, (any or all of the followings: fever or cough or sob) 5. admitted to the hospital (outside the icu) 6. patients had to be enrolled within 10 days of symptoms onset. 7. willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: 1. asthmatic patient using antiasthma medications 2. being in the hospital or in home isolation for more than 72 hours before the start of the study drug. 3. known sensitivity/allergy to the study drug 4. pregnancy 5. patient refused 6. chronic liver disease 7. severe mental disorder 8. unstable patients requiring icu admission 9. participating in other clinical trial