Kornimate/medical-research-clean huggingface dataset:
a multiple ascending dose study of ro4998452 in patients with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus Type 2

Summary: this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ro4998452 compared to placebo in patients with type 2 diabetes mellitus. successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * type 2 diabetes; * either treated by diet and exercise alone or with metformin. exclusion criteria: * type 1 diabetes mellitus; * uncontrolled hypertension; * clinically severe diabetic complications.
estimation of balance status in hemiparetics

Conditions: Hemiparesis

Summary: although balance evaluation systems test(bestest) is an important balance assessment tool to differentiate balance deficits, it is time consuming and tiring for hemiparetic patients. using artificial neural networks(anns) to estimate balance status can be a practical and useful tool for clinicians. the aim of this study was to compare manual bestest results and anns predictive results and to determine the highest contributions of bestest sections by using anns predictive results of bestest sections. 66 hemiparetic individuals were included in the study. balance status was evaluated using the bestest. 70%(n=46), of the dataset was used for learning, 15%(n=10) for evaluation, and 15%(n=10) for testing purposes in order to model anns. multiple linear regression model(mlr) was used to compare with anns.

the demographics and clinical information of the participants' were recorded. clinical information consists of some basic medical data for the patients. hodkinson mental test was used to assess the cognitive status of the participants if they met inclusion criteria. balance evaluation systems test was used to assess balance status of the participants. feed-forward back-propagation anns was used in this study by employing levenberg-marquardt training algorithm. tangent hyperbolic transfer functions were used in the hidden layer. matlab (version r2017b, mathworks inc, usa) was used in anns modeling. 70% (n=46), 15% (n=10) and 15% (n=10) of the data obtained from the participants were used for training, validation and test in the study, respectively. multiple linear regression (mlr) models also were used to compare with anns. firstly, the anns were modeled for the first aim of the study. we used the data of the five traditional balance tests in the bestest that did not use the real values (the timing or distance), but just the classified values (0-3 points in the bestest) to train anns. five balance tests were functional reach test (cm), one leg standing test for right and left side (sec), 6-metre timed walk test (sec) and timed up and go test (sec). then, we compare the manual total bestest scores with the predicted scores by the anns. secondly, we removed 6 sections of the bestest one by one and modeled with the remaining 5 sections of the test to estimate the total bestest score. after this modeling, we removed each item one by one in the first section and estimated the first section total score. we repeated the process for all the sections of the bestest. statistical analysis

Eligibility criteria:
inclusion criteria: * being aged between 35-65 years, * able to walk independently or with a walking aid, * able to stand at least 1 minute independently, * having single hemiparesis, * getting at least 8 points from hodkinson mental test. exclusion criteria: * having comorbidities affecting their balance, * having communication problems. * patients who cannot comprehend the directions given to them were excluded from the study.

Keywords: hemiparesis; balance; artificial neural networks.
impact of dissection area on the clinical outcome of endoscopic thyroidectomy

Conditions: Thyroid Tumor

Summary: the purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.

to create a working place in the chest wall is an inevitable step of endoscopic thyroidectomy. large subcutaneous area was considered a drawback of endoscopic thyroidectomy. the purpose of this study is to investigate whether subcutaneous dissection area has influence on clinical outcome of endoscopic thyroidectomy, such as post-operative pain, complication rate and post-operative discomfort.

Eligibility criteria:
inclusion criteria: * thyroid nodule diagnosed by ultrasound * willing to undergo endoscopic thyroidectomy exclusion criteria: * conversion to open surgery * unwilling to join the research

Keywords: thyroidectomy invasiveness
extracorporeal immune support system (eiss) for the treatment of septic patients

Conditions: Severe Sepsis and Septic Shock

Summary: the purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.


Eligibility criteria:
inclusion criteria: * sepsis with at least one organ failure (severe sepsis) or septic shock exclusion criteria: * participation in another study within the last 30 days * earlier participation in this study * pregnancy * bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day) * hemodynamic shock for more than 12 hours (systolic bp \<90mmhg) despite adequate therapy * hiv infection * hcv infection, active

Keywords: septic shock immunoparalysis extracorporeal granulocyte bioreactor plasmapheresis
effect of gluten-free diets on anthropometric and dietary data of healthy eutrophic women

Conditions: Obesity

Summary: the objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on body weight, basal metabolic rate and macronutrient intake. in a crossover double masked model, 30 volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 "placebo" muffins daily for 3 weeks (placebo phase) and the remnant volunteers will take 2 "gluten" muffins for 3 weeks (gluten phase). after one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks.

the objective is to evaluate in eutrophic women the impact of intake of moderate amounts of wheat gluten on body weight basal metabolic rate and possible relation to macronutrient intake. for this, 30 volunteers will kept on a restricted diet in gluten-free foods of 6 weeks. at the first moment, a structured food frequency questionnaire will be applied, as well as a 24-hour food register, to evaluate the average food and gluten daily intake. the volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 3 weeks (placebo phase) and the remnant volunteers will take 2 gluten muffins for 3 weeks (gluten phase). after one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks. during these 6 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. the test food (gluten and placebo muffins) will be produced in the laboratory of dietetic technique of the school of nursing of the federal university of minas gerais and delivered weekly to each volunteer. placebo test foods is a corn-based muffin of about 45g. in the gluten muffins, 10g of corn is replaced by 10g of gluten (corresponding to 7.5g of gluten protein). each volunteer will be instructed to take 2 (placebo or gluten) muffin/day. to evaluate diet adherence and signs and symptoms of intolerances, volunteers will fill a questionnaire weekly, informing about the consumption of the test food, eventual intake of food containing gluten, and the presence of gastrointestinal signs and symptoms such as constipation, diarrhea, nausea or vomiting etc.

Eligibility criteria:
inclusion criteria: * women aged between 18 and 40 * body mass index (bmi) between 18.5 and 24.9 kg / m² * sign of informed consent * absence of associated chronic diseases exclusion criteria: * postmenopausal patients * onset of chronic medication * discontinuance of test food intake for 2or more days * do not attend 2 of the 3 meetings.
the efficacy and palatability of developed polyethylene glycol-based formula for children with functional constipation

Conditions: Functional Constipation

Summary: this study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (peg) in the treatment of children with functional constipation for 8 weeks. besides, we also aim to assess the side effects of a developed peg-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.

total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. they will be randomised in group a or group b. children in group a will receive peg-chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days. children in group b will receive the standard peg formula (forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days. peg-chula and standard peg will be prepared in sachets with similar packaging and appearance labelled a, b, c, d. children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner. parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook. children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. children with poor compliance will be excluded from the study.

Eligibility criteria:
inclusion criteria: children will be enrolled in this study when they meet 2 criteria: * age from 6 months to 18 years old * children are diagnosed with fc according to rome iv criteria exclusion criteria: children will be excluded from the study if they meet any of the following criteria: * having an organic cause of constipation such as anorectal malformations, hirschsprung disease, myelomeningocele, hypothyroidism, etc. * suspected gi obstruction * receiving medication affecting bowel movement * having a history of allergy to peg and stevia.

Keywords: functional constipation children polyethylene glycol palatability
induced physiological ketosis in asthenia and\or decreased tolerance to physical and\or mental exertion

Conditions: Patient Activation

Summary: the purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with liquid technology formula pantrek, in patients with asthenia and or decreased tolerance to physical and\\or mental exertion. pantrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.

it will be double-blind, placebo-controlled study in 88 patients of both sex, aged from 18 to 65. patients will be randomly assigned to one of two groups: placebo or ip group in 1:1 proportion. study instruments: d-fis, moca, tmt, vas, assessment of blood keton concentration before and after first and last administration per os of 25 ml of placebo or pantrek. pantrek will be served in ampuls, 25 ml per ampule. the duration of the study will be 15 days of treatment and 15 days of follow-up observation. patients will be assessed at screening/baseline, after 15 days and after 30 days. the dose regimen: the shot of pantrek, 25 ml, will be administered per os, twice per day, in the morning and in the evening, per se or deluted in 100 ml of water one hour before or after meal.

Eligibility criteria:
inclusion criteria: * informed consent * diagnosis of astenia and/or decreased tolerance to physical and\\or mental exertion * ability of patients to understand assessment procedures exclusion criteria: * intollerance of components of pantrek * participation in other trials

Keywords: physiological ketosis pantrek asthenia physical functioning mental functioning beta-oxibutiric acid
evaluation of cmv/ebv-cmi in haploid hsct

Conditions: Hematopoietic Stem Cell Transplantation; Cytomegalovirus Infections; Epstein-Barr Virus Infections

Summary: the purpose of this prospective, open-label, single arm, single-center study is to evaluate the cytomegalovirus and epstein-barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-hsct) .


Eligibility criteria:
inclusion criteria: 1. all patients were diagnosed with hemopathy. 2. all patients should have the indication of haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus. 3. all patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study. exclusion criteria: patients with any conditions not suitable for the trial (investigators' decision).
esophageal manometry and impedance study in obese patients before and during anesthesia

Conditions: Obesity

Summary: the purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia. using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. the investigators aim to include 16 obese patients, with bmi \> 35, undergoing laparoscopic gastric by-pass.

Eligibility criteria:
inclusion criteria: * male and female patients * aged 18-60 years * bmi\>35 * asa classification i-iii exclusion criteria: * use of drugs that interfere with esophageal motility * gastro-esophageal reflux disease

Keywords: gastric by-pass surgery
omega-3 fatty acids in adolescent depression

Conditions: Adolescent Depression

Summary: aim. to provide preliminary data about the efficacy of omega-3fa in the treatment of adolescent mdd. to address this aim, a 10-week double blind, placebo-controlled study of omega-3fa, using a flexible dose titration is proposed. primary outcome measures will be: (1) change in the total score of the children's depression rating scale-revised (cdrs-r) at the end of treatment (2) response rate on the clinical global improvement scale (cgi) at the end of 10-week treatment. hypothesis. omega-3fa treatment in adolescents with mdd will result in a significant reduction of cdrs-r total scores, and a significantly higher improvement rate on the cgi at the end of treatment compared to placebo.

title: omega-3 fatty acids in adolescents with depression note: no individual will be advised to terminate ongoing treatment. if adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. however, psychotherapy cannot be initiated at the time of entry into the study. aim: to provide preliminary clinical data about the efficacy of omega-3fa (derived from fish oil) in the treatment of adolescent mdd. a nccam/nih-funded study. summary: informed consent will be obtained from parent/guardian and assent obtained from participant. interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility. routine blood tests and a urine pregnancy test will be obtained. eligible participants will be randomized to receive either omega-3fa or matching placebo (corn oil) for 10 weeks. patients will be seen weekly throughout the trial. dosage will be titrated based on clinical response and side effects. at end of double-blind phase, participants will be referred to a clinician who will be informed of subjects' treatment. depending on treatment received during double-blind phase, post-study treatment options will include treatment with omega-3 fatty acids or an ssri.

Eligibility criteria:
inclusion criteria: * age: 12-19 * depressed with dsm-iv diagnosis of mdd * duration of depressive episode greater than 6 weeks exclusion criteria: * current or past dsm-iv-tr bipolar, schizophrenia, psychosis, pervasive developmental disorder (pdd), and tourette's disorder. * current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic stress, and/or substance-related disorders (other than nicotine). * adolescents who present with current suicidal ideation with intent or plan, or who may pose a danger to themselves. * current antidepressant treatment, or taken within 60 days prior to enrollment * neuroleptics taken within 90 days prior to enrollment

Keywords: adolescents depression fish oil omega-3 fatty acids psychiatry
myofascial trigger point release and paced breathing training for chronic low back pain

Conditions: Chronic Low-back Pain

Summary: a study to explore whether two different treatment approaches, myofascial trigger point release and core stabilization exercises, both with and without additional paced breathing training, can help patients with chronic low back pain (clbp) and whether one of the two treatments is superior.

this is a randomized controlled trial to evaluate the effect of myofascial trigger point release therapy compared to core stabilization exercises, both with and without additional paced breathing training, on patients with chronic low back pain (clbp). the main focus is on changes in pain severity, anxiety and depression, heart rate variability, and use of analgesic medication. outcomes are measured at baseline (pre-intervention), after ten treatments (post-intervention), at three- and at six-month follow-up.

Eligibility criteria:
inclusion criteria: * written informed consent * age between 20 and 70 years * lbp at least once a week during the last three months * pain intensity rated at least 4 on an 11-point scale (0=no pain, 10=worst pain imaginable) * muscular pain during flexion, extension and lateral flexion exclusion criteria: * acute hernia * acute local or generalized inflammation * neurological disorders such as multiple sclerosis, parkinson's disease, hemiplegia * fibromyalgia * radicular symptoms (lasègue's sign, weakness of foot dorsiflexion muscle, needles or tingling in the legs) * paraspinal tumors or metastases * cancer under chemo- or radio-surgical treatment or requiring such during the next 12 months * leg prostheses * rheumatic, cardiovascular or chronic pulmonary condition precluding 45-minute physical therapy (contraindication declared by a physician) * severe depression or severe anxiety currently requiring psychotherapy and/or pharmacotherapy * suicidal tendencies * drug abuse or addiction * pregnancy existing or planned during the study period

Keywords: chronic low-back pain myofascial trigger point release core stabilization exercises paced breathing training pain severity anxiety heart rate variability
testing the cog-fun aging program for older adults with subjective cognitive decline

Conditions: Subjective Cognitive Decline (SCD); Subjective Cognitive Impairment; Subjective Memory Complaints

Summary: the goal of this clinical trial is to learn if the cog-fun aging program helps older adults with subjective cognitive decline (scd) manage memory challenges and improve their daily lives. the main questions it aims to answer are: * does the program help participants better understand their cognitive challenges in daily life? * do participants report using more effective strategies to manage their memory difficulties? * does the cog-fun aging program reduce negative emotions and self-perceptions related to scd? researchers will compare participants who complete the cog-fun aging program with those who do not to determine the program's effectiveness. participants will: take part in a 10-week program with weekly sessions. learn about scd and how it affects daily life. practice and monitor strategies to manage memory difficulties.


Eligibility criteria:
inclusion criteria: * experiencing memory changes and feeling concerned about them * a score of 23 or higher on the moca (montreal cognitive assessment) * ability to speak and understand hebrew sufficiently to participate in a hebrew-speaking group exclusion criteria: * a self-reported health condition that significantly impacts functioning (e.g., uncontrolled diabetes, severe heart/lung disease) * residing in a medical institution or nursing home * currently participating in another scd treatment

Keywords: negative self perceptions cognitive mistakes occupational experience occupational therapy subjective cognitive decline health promotion intervention
metformin for the prevention of episodic migraine (mpem)

Conditions: Migraine

Summary: the investigators will evaluate the safety and efficacy of metformin for preventive treatment of migraine in a randomized, double-blind, placebo-controlled, crossover trial.

this will be a single-center, double-blind, randomized, placebo-controlled, crossover study. the investigators will enroll 40 subjects. subjects will be recruited from the outpatient mayo headache clinic, mayo women's health clinic, mayo community internal medicine, and the mayo clinic- arizona state university neurology clinic. the headache clinic employs 6 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with migraine. before study enrollment, patients will undergo a 2-hour oral glucose tolerance test to confirm the absence of diabetes mellitus. subjects will then keep a headache diary for 4 weeks to establish baseline characteristics, including number of migraine days per month, number of moderate to severe headache days per month, and number of days per month of acute medication use. the 4-week baseline period will be followed by 2 treatment periods of 12 weeks each, separated by a washout period of 4 weeks (total study duration, 32 weeks). for the 12-week treatment periods, subjects will receive either metformin 500mg twice daily or matching placebo twice daily. subjects will have 7 study visits. routine laboratory studies and a pregnancy test will be performed at enrollment and week 20. abnormal kidney or liver function will exclude subjects. pregnancy will exclude subjects. general and neurologic examinations will be performed during 3 of the 7 visits. at each visit, subjects will receive medication for the period until the next visit. a headache diary will be used for the trial. for every day that the subject has a headache of any type, she or he will record headache characteristics, associated features, and medications used.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years 2. a diagnosis of migraine with or without aura for \>1 year according to the international classification of headache disorders-iiib exclusion criteria: 1. a diagnosis of diabetes mellitus or polycystic ovarian syndrome 2. overuse of acute migraine treatments 3. failure to respond to 3 or more classes of preventive drug treatments 4. change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase 5. significant somatic or psychiatric disease 6. known alcohol or other substance abuse 7. pregnant or breastfeeding.
her2-positive breast cancer registry

Conditions: HER2 + Breast Cancer

Summary: the goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in her2-positive breast cancer.


Eligibility criteria:
inclusion criteria: * stage i-iv her2-positive breast cancer exclusion criteria: * none

Keywords: breast cancer registry her2+ her2 positive