Kornimate/medical-research-clean huggingface dataset:
how quickly can the effects of excessive caloric intake on insulin resistance be reversed?

Conditions: Obesity

Summary: objective: to show that a 1-2 day reduction of caloric intake can reduce the insulin resistance produced by several days of overnutrition. approach: healthy volunteers will be admitted to the clinical research center and undergo a baseline euglycemic-hyperinsulinemic clamp study to assess their insulin resistance. subjects will then start on an overnutrition program for 4 days consisting of 3 meals and 3 snacks containing \~6,000 kcal/24hours. a second clamp study will be performed on day 5 to demonstrate the overnutrition induced increase in insulin resistance. starting on day 5 the subject's caloric intake will be reduced to \~1,000 kcal for 2 days (day 5 and 6). after that on the morning of day 7, a third hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric intake did reduce insulin resistance and the volunteer will be discharged from the clinical research center.

study volunteers will be admitted to the clinical research center at temple university hospital. after an overnight fast, body composition will be determined non-invasively by bioimpedance analysis (4) and a 4 h euglycemic-hyperinsulinemic clamp (using only fda-approved regular insulin) as previously described (5) will be performed during which serum samples will be obtained for measurement of glucose, insulin, free fatty acids, ketone bodies and lipids. oxidative stress ( 6) will be measured by 24 hour urine collections (analyzed for isoprostane content via 8-isoprostaglandin-f2alpha throughout the study period. respiratory gas exchange rates (7) will be determined at hourly intervals (with a metabolic cart (true one, parvo utah) during the clamp studies and once a day on days 2 through 6. after that, (at about 1:00 in the afternoon on day 1) the volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing \~ 6000 kcal/24 h. the main meals (containing \~ 1500 kcal/meal) will be served at \~ 8:00 in the morning (breakfast), 1:00 in the afternoon (lunch) and approximately 7:00 in the evening (dinner), the snacks (\~ 500 kcal/each) at approximately 11:00 in the morning, 4:00 in the afternoon and 11:00 in the night. on days 5 and 6, volunteers will receive 3 meals, each will contain \~333 calories. each morning blood samples will be obtained to measure glucose insulin, free fatty acids and ketone bodies. daily 24 h urine collections will be obtained each day. in the morning of days 5 and 7, all procedures described for day 1 will be repeated. in the afternoon of day 7, the volunteers will be discharged from the hospital.

Eligibility criteria:
inclusion criteria: healthy non-obese men and women - exclusion criteria: subjects with diabetes or a history of obesity surgery or with more than modest health problems -

Keywords: insulin resistance, obesity, caloric intake
genetic association study between gad1 and reelin polymorphisms and gaba/glutamate mrs in bipolar disorder type 1 and healthy controls: specgene project

Conditions: Bipolar Disorder

Summary: background: the pathophysiological mechanisms of bipolar disorder are not completely clarified and several hypothesis have already been formulated including the role of monoamines, gama amino butyric acid (gaba) and glutamate. gaba is the main inhibitory neurotransmitter while glutamate is the main excitatory neurotransmitter. genes that play a role in gaba metabolism and in the activity of gaba neurons are very important to understand the gaba function, once they affect neurodevelopment and its dysfunctions may predispose to neuropsychiatric diseases. the two genes that are going to be study in this project are glutamic acid decarboxylase (gad1) and reelin (reln). the enzyme glutamic acid descarboxylase (gad67) metabolizes glutamate in gaba in the pre synaptic neuronal regions and is coded by the gene gad1. reelin is secretory serine protease with dual roles in mammalian brain: embryologically, it guides neurons and radial glial cells to their corrected positions in the developing brain; in adult brain, reelin is involved in a signaling pathway which underlies neurotransmission, memory formation and synaptic plasticity. magnetic resonance spectroscopy (mrs) studies on bipolar disorder show a number of alterations in cerebral level of gaba and glutamate in different cerebral areas when compared to healthy subjects and other mood disorders. objective: investigate in bipolar patients and healthy controls the association of gad1 and reln single nucleotide polymorphisms(snp) and cerebral levels of gaba/glutamate on mrs. methods: 70 symptomatic bipolar i patients medication free and 70 healthy controls are going to be genotyped for gad1 and reln snps and gaba/glutamate mrs. key words: gad1, gad67, bipolar, gaba, glutamate, reelin, rln, spectroscopy.


Eligibility criteria:
inclusion criteria: * bipolar disorder type i diagnose (dsm-iv criteria) * medication free (4 last weeks) exclusion criteria: * heavy smokers * cannabis use * recent alcohol abuse (14 days)

Keywords: gad1, gad67, bipolar, gaba, glutamate, reelin, rln, spectroscopy euthymic bipolar i patients
effects of a multispecies probiotic on migraine

Conditions: Migraine; Irritable Bowel Syndrome; Headache, Migraine

Summary: the prevalence of migraine is higher in female patients with various intestinal diseases. an explanation could be that migraine is caused by a leaky gut, defined by increased intestinal permeability that permits particles to pass through the gastrointestinal wall. probiotics, may be able to improve intestinal barrier function. objective: to test whether probiotics, as adjucnt therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.

given the significant unmet need for improved therapies that address migraine disorders and concurrent irritable bowel syndrome (ibs), this study seeks to investigate the impact of probiotics on the sequelae of symptoms associated with both migraine and ibs.

Eligibility criteria:
inclusion criteria: * episodic migraine diagnosis for a minimum of 1 year (12-months) * between 3-12 migraine episodes /month * comorbid, symptomatic, irritable bowel syndrome during the screening period * on a steady treatment regimen: preventative and acute migraine medications and therapies unchanged over the last 6 months * access to scripps center for integrative medicine * access to smartphone or computer to complete electronic surveys exclusion criteria: * other gi or hepatic diagnoses (inflammatory bowel disease (ibd), small intestinal bacterial overgrowth (sibo), non-alcoholic fatty liver disease (nafld), elevated liver function tests (lfts) within the last 6 months) * prior gi surgery * prior gi infection in the previous 3-months * antibiotic treatment in previous last 3 months * diagnosed autoimmune disease * current corticosteroids use * morbid obesity (bmi \>40) * took probiotics or probiotic-containing supplements or therapy in the previous 3-months * diagnosis of post-traumatic headache or cervicogenic headache * pregnancy or plans to become pregnant during study participation

Keywords: probiotics headache disorders migraine disorders pain digestive system diseases neurologic manifestations gut-brain axis microbiome functional gastrointestinal symptoms
a study evaluating the effect of etoricoxib and indomethacin in the treatment of acute gout (0663-081)(completed)

Conditions: Acute Gout

Summary: a study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.


Eligibility criteria:
inclusion criteria: * males or females at least 18 years of age who have acute gout.

Keywords: arcoxia
effects of wobenzym® plus in healthy, sportive people after eccentric exercise

Conditions: Muscle Injury; Muscle Soreness; Exercise Induced Muscle Damage

Summary: the aim of the current study is to investigate the therapeutic effect and especially the mode of action of wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eimd) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo.


Eligibility criteria:
inclusion criteria: * subject is able and willing to sign the informed consent form prior to screening evaluations * subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology * not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study * non smoker * men with strength training experience * age: 20-50 years * bmi ≥20 kg/m2 and ≤ 32 kg/m2 * medium concentric strength ability (150-300 nm) exclusion criteria: * relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture. * no intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial * subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2. * for this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening * known hypersensitivity to the study preparation or to single ingredients (e.g. lactose intolerance) * drug, alcohol and/or medication abuse * known hiv-infection * known acute or chronic hepatitis b and c infection * participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial * blood donation within 4 weeks prior to trial start (visit 1) or during trial.

Keywords: muscle soreness exercise induced muscle damage inflammation proteolytic enzymes muscle strength dynamometer
protein s activity in women with unexplained infertility

Conditions: Unexplained Female Infertility

Summary: this study will add: finding out an association between protein s activity and unexplained female infertility. aim: study hypothesis: in women with unexplained infertility protein s activity may be low. study question: in women with unexplained infertility does protein s activity low?. this study aims to assess the activity of protein s activity in women with unexplained infertility. objectives: the main objective of this study is: to determine the prevalence of protein s activity with unexplained female infertility and to compare its prevalence in fertile women among women attending outpatient clinics at ain shams university maternity hospital.

1. type of study: case control study. 2. study setting: ain shams university maternity hospital: outpatient infertility clinic and outpatient gynecology clinic. 3. study population: the study will include women with unexplained infertility (group 1; cases) and fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions nor history of secondary infertility (group 2; control). group 1: will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic. group 2; another 30 fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions; will recruited from outpatient gynecology clinic as control. according to inclusion and exclusion criteria listed below. inclusion criteria: 1. age: 18 - 35 years old. 2. normal husband's semen analysis, (who criteria): 1. count ≥ 15 million/ml. 2. motility: ≥ 40% 3. morphology: ≥ 4% normal morphology. 3. documented ovulation. 4. normal follicle stimulating hormone, luteinizing hormone, thyroid stimulating hormone, serum prolactin. 5. patent fallopian tubes. 6. normal uterine cavity. exclusion criteria: 1. patients aged less than 18 years or more than 35 years old. 2. secondary infertility 3. presence of male factor infertility 4. anovulatory cycles. 5. tubal block; tubal disease is an important cause of infertility and should be speciﬁcally excluded. 6. medical disorder that might affect pregnancy (e.g.: diabetes, thyroid dysfunction) 7. patients with recurrent abortion.

Eligibility criteria:
inclusion criteria: 1. age: 18 - 35 years old. 2. normal husband's semen analysis, (who criteria): 1. count ≥ 15 million/ml. 2. motility: ≥ 40% 3. morphology: ≥ 4% normal morphology. 3. documented ovulation. 4. normal follicle stimulating hormone, luteinizing hormone, thyroid stimulating hormone, serum prolactin. 5. patent fallopian tubes. 6. normal uterine cavity. - exclusion criteria: 1. patients aged less than 18 years or more than 35 years old. 2. secondary infertility 3. presence of male factor infertility 4. anovulatory cycles. 5. tubal block; tubal disease is an important cause of infertility and should be speciﬁcally excluded. 6. medical disorder that might affect pregnancy (e.g.: diabetes, thyroid dysfunction) 7. patients with recurrent abortion. -
tactile stimulus, music play and virtual reality video watching during non-stress test on maternal anxiety and fetal parameters

Conditions: Fetal Heart Failure; Fetal Movement Disorder

Summary: the research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.


Eligibility criteria:
inclusion criteria: * - not having any risk factors (pre-eclampsia, iugg, premature rupture of membranes, getational diabetes, etc.) during pregnancy * absence of uterine contraction as a result of nst, * no cardiovascular disease diagnosed in the fetus, * being in the 18-49 age group exclusion criteria: * any complications in pregnancy and fetus * refusal to accept the final test

Keywords: nursing fetal health women women health
effect of oral rufinamide and oxcarbazepine on nerve excitability, hyperalgesia, allodynia and flare reaction compared to placebo. a monocenter, randomized, double-blind, cross-over study

Conditions: Healthy Subjects

Summary: untersuchungen über die wirkmechanismen von antiepileptika haben gezeigt, dass durch eine blockierung von spannungsabhängigen natrium-kanälen im nervensystem die schmerzübertragung moduliert werden kann. verschiedene antiepileptika werden in der chronischen schmerztherapie schon lange angewendet (z.b. oxcarbazepinum, trileptal ® bei trigeminusneuralgie oder diabetischer polyneuropathie). in unserer untersuchung wollen wir zwei in der schweiz zugelassene antiepileptika bezüglich ihrer wirkung auf das schmerzempfinden untersuchen. eines dieser medikamente, trileptal® (wirkstoff: oxcarbazepinum), wird schon häufig bei chronischen schmerzzuständen eingesetzt. das zweite medikament, inovelon® (wirkstoff: rufinamid) ist seit mehr als einem jahr in der schweiz zugelassen und wird klinisch vor allem in der behandlung von besonderen epilepsieformen im kindesalter eingesetzt. wir erwarten, dass auch nach gabe von inovelon® die schmerzleitung in den nervenzellen verändert und die lokalen schmerzreaktionen in der haut vermindert werden. * trial with medicinal product


Eligibility criteria:
inclusion criteria: male * age: 18-65 years * weight: 50 - 100 kg * height: 155 - 195 cm * signed and dated informed consent exclusion criteria: * contraindications to the class of drugs under study * intellectually or mental impaired subjects * known hypersensitivity to class of drugs or the investigational product * drug abuse * known peripheral neuropathies * diabetes mellitus * chronic alcohol consumption * congestive heart disease * participants of other studies during study period and 30 days prior to study begin * smoker * abnormal electrocardiogram * any regular concomitant medication

Keywords: gesunde probanden
respiratory muscle strength in patients with obesity hypoventilation syndrome (ohs) or with a precursor of the disease

Conditions: Obesity Hypoventilation Syndrome

Summary: using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to * identify potential determinants for the development of obesity hypoventilation * to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients


Eligibility criteria:
inclusion criteria: * patients with bmi \> 30 and obesity-associated hypoventilation stages i - iv * patients with bmi \> 30 and elevated ohs-risk (= obstructive sleep apnea without hypercapnia) * age:18-80 years * capacity to consent exclusion criteria: * any other disease, that causes ventilatory insufficiency * pacemaker, defibrillators or device for deep brain or vagus nerve stimulation * esophagitis, barrett-esophagus, esophageal cancer * acute gastritis and ulcera ventriculi * epilepsy * any medical, psychological or other condition impairing the patient's ability to provide informed consent
dose-effect of hiit on cardiovascular health of children

Conditions: Cardiovascular Diseases Risk; Adiposity

Summary: an adequate physical activity level has important effects on cardiovascular health of children. however, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. high intensity interval training (hiit) has emerged as an effective strategy for improving physical and mental health in children. to note that hiit can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. however, there is no information about the dose of hiit needed to obtain significant effects on cardiovascular health of children. the adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases. school-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.


Eligibility criteria:
inclusion criteria: all school children able to attend the physical education sessions of the school - exclusion criteria: * children with medical condition that limits physical activity

Keywords: hiit nutritional education dose-effect school children cardiovascular adiposity blood pressure fitness
safety, tolerability, and immunogenicity of v419 in healthy infants when given at 2, 4, and 11 to 12 months (v419-008)

Conditions: Bacterial Infections; Virus Diseases

Summary: this study will determine whether participants who receive v419 (pr5i) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. this study will also determine whether the immune response to v419 is similar to that of participants who received a licensed vaccine control. the primary hypothesis is that participants who receive pr5i at 2, 4, and 11 to 12 months have an acceptable response rate to all pr5i-contained antigens at one month after the toddler dose of pr5i.


Eligibility criteria:
inclusion criteria: * healthy infant able to attend all study visits * parent(s)/legal representative are able to read, understand, and complete study questionnaires exclusion criteria: * history of congenital or acquired immunodeficiency * received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids * history of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder * hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines * has any chronic illness that could interfere with study conduct or completion * received any immune globulin, blood, or blood-derived products since birth * received a dose of hepatitis b vaccine prior to study entry * vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof * fever within 24 hours prior to enrollment * received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrolment * has a coagulation disorder * has developmental delay or neurological disorder * participant or his/her mother has a medical history of hepatitis b surface antigens (hbsag) seropositivity * history of haemophilus influenzae type b, hepatitis b, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection

Keywords: combination vaccine diphtheria pertussis tetanus hepatitis b hep b haemophilus influenzae b hib polio poliovirus
cognitive behaviour therapy for patients with ibs

Conditions: Irritable Bowel Syndrome; Constipation; Abdominal Pain; Depression

Summary: irritable bowel syndrome (ibs) affects approximately 10-15% of the adult population. this condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. options for treating ibs include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (cbt). available data on the effectiveness of cbt in ibs patients in israel are scarce. the aim of the present study is to assess effectiveness of cbt as compared with standard therapy for ibs patients in israel the course of cbt consisted of up to six 40 min sessions, and included education about ibs and techniques to reduce focusing on symptoms and to manage stress.standard therapy includs life style modifications. the primary outcome measure was the score on a symptom-severity scale specific to ibs.

symptomatic treatment of patients would not be modified

Eligibility criteria:
inclusion criteria: * age 18-75 * ibs exclusion criteria: * malignancy * known psychiatric disorders

Keywords: obstructed constipation quality of life