Kornimate/medical-research-clean huggingface dataset:
a 3-fold crossover bioequivalence study between glucobay orally disintegrating tablet (odt) and glucobay standard tablet

Conditions: Diabetes Mellitus, Type 2

Summary: to establish the bioequivalence between glucobay odt (orally disintegrating tablet) taken without or with water and the glucobay standard tablet taken with water


Eligibility criteria:
inclusion criteria: * the informed consent must be signed before any study specific tests or procedures are done * healthy male subject * age: 18 to 45 years (inclusive) at the first screening examination / visit * ethnicity: white * body mass index (bmi): above/equal 18 and below/equal 28 kg / m² * confirmation of the subject's health insurance coverage prior to the first screening examination / visit * ability to understand and follow study-related instructions exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor * known hypersensitivity to the study drugs (active substances or excipients of the preparations) * known severe allergies, non-allergic drug reactions, or multiple drug allergies * chronic intestinal disorders associated with distinct disturbances of digestion and absorption * states which may deteriorate as a result of increased gas formation in the intestine (e.g. roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, crohn´s disease, ulcerative colitis, malabsorptions) * fasting blood glucose level outside normal range * impaired glucose tolerance in glucose tolerance test

Keywords: bioequivalence, acarbose, odt
the effects of oxytocin in obese adults

Conditions: Obesity

Summary: this is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.


Eligibility criteria:
inclusion criteria: * 18-45 years old; * bmi greater than or equal to 30 kg/m2 exclusion criteria: * use of drug affecting metabolism, glucose, or appetite (metformin is allowed if dose and weight are stable for at least 3 months); * history of medication changes within 4 weeks of enrollment; * active substance use; * history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease; * hematocrit \>2% below normal; * fasting glucose \> 125 mg/dl or hemoglobin a1c ≥ 7% ; * alt or ast \>2.5 times upper limit of normal; * cr \>1.5 mg/dl; hyponatremia; * pregnancy or breastfeeding; * unwilling to use medically acceptable form of contraception (females only) * follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, paleo, atkins, raw diet, macrobiotic diet) * current smoking or tobacco use

Keywords: weight loss body mass index oxytocin magnetic resonance imaging
rcvr (residual cardiovascular risk) prospective multicenter study

Conditions: Coronary Artery Disease

Summary: the observational study aims to evaluate the long-term effects of residual cardiovascular risk on clinical outcomes following percutaneous coronary intervention (pci). this risk includes thrombotic, metabolic, inflammatory, and procedural factors, which are assessed 1 month after the intervention. the primary question the study seeks to answer is: what residual cardiovascular risk affects long-term clinical outcomes in patients undergoing pci? participants will undergo artificial intelligence-based quantitative coronary analysis after pci and will have comprehensive laboratory tests conducted at 1 month to evaluate residual cardiovascular risk, and then annually for 3 years post-intervention to assess changes in this risk.


Eligibility criteria:
inclusion criteria: * patients who have undergone percutaneous coronary intervention. * patients who have provided written informed consent. exclusion criteria: * under 19 years of age. * pregnant, breastfeeding, or women of childbearing age. * currently has a malignancy or has a history of malignancy within the past 5 years. * life expectancy of less than 5 years.

Keywords: percutaneous coronary intervention
relative bioavailability, pharmacokinetics, safety and tolerability of biil 284 bs in healthy volunteers

Conditions: Healthy

Summary: the objective of the present study is to investigate the relative bioavailability of two biil 284 bs tablets (tablet c and tablet c) in comparison to the wif tablet at a dose of 75 mg following a standard breakfast in healthy male volunteers


Eligibility criteria:
inclusion criteria: * all participants are healthy males * age range from 21 to 50 years * broca-index: within +- 20% of their normal weight * in accordance with good clinical practice (gcp) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study exclusion criteria: * volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values * volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders * volunteers with history of orthostatic hypotension, fainting spells or blackouts * volunteers with chronic or relevant acute infections * volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * volunteers who have taken a drug with a long half-life (\>= 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study * volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study * volunteers who participated in another study with an investigational drug within the last two months preceding this study * volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day) * volunteers who drink more than 60g of alcohol per day * volunteers who are dependent on drugs * volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study * volunteers who have donated blood within the last 4 weeks (\>= 100 ml)
timing of rectal cancer resection after preoperative chemoradiotherapy

Conditions: Rectal Neoplasms

Summary: this pilot study will take place at health sciences north (hsn) in sudbury. patients will be identified and screened for inclusion into the study once referred to a general or colorectal surgeon for resection of their rectal cancer. this may occur before or after preoperative chemoradiotherapy (crt) but randomization will take place after crt.

the main question of this study is whether or not delaying surgery after preoperative crt increases disease-free survival. the standard 6-7 week waiting period will be compared to 10-11 weeks, which was the time-frame identified in the dutch surgical colorectal audit as increasing the likelihood of pcr the most. this trial will also be able to determine if an increased waiting interval increases the rate of sphincter-preservation, local recurrence, and pcr. while similar to the greccar-6 trial, our primary outcome is disease-free survival (a more clinically relevant outcome) and is the first north american clinical trial of this nature. to maximize the utility of this trial, immunohistochemical staining will be performed on pre-crt tumor samples to prospectively validate the scoring system proposed by hur et al. \[28\] the question being whether or not expression of these biomarkers can predict which patients will experience pcr and disease-free survival. the pilot will be constructed as a prospective, open-label clinical trial, with patients being randomized to undergo surgery at 6-7 weeks or 10-11 weeks after completion of preoperative crt. the intention is that once preliminary data is available, other centres in ontario will be recruited. this will not only help answer our research question, but also create a large, prospective database of rectal cancer patients. the primary outcome (disease-free survival) will be assessed at 3 years.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) * t3/4n0m0 or txn+m0 rectal cancer below or at the peritoneal reflection, confirmed on clinical exam, histology, pelvic mri, and ct chest/abdo * patients who have completed a crt protocol for the above tumor at hsn * informed consent given * surgical resection with tme planned exclusion criteria: * metastatic disease * failure to complete preoperative crt * unable to give free and informed consent * unable to comply with the requirements of the study * previous malignancy other than nonmelanoma skin cancer, papillary or follicular thyroid cancer * inflammatory bowel disease * hereditary colorectal cancer
a study to investigate safety, pharmacokinetics (pk) and pharmacodynamics (pd) of bkm120 plus gsk1120212 in selected advanced solid tumor patients

Conditions: Advanced and Selected Solid Tumors

Summary: this is an open label, dose finding, phase ib clinical trial to determine the maximum tolerated dose (mtd) and /or recommended phase ii dose (rp2d) and schedule for the pi3k (phosphatidylinositol 3-kinase) inhibitor bkm120 given in combination with the mek inhibitor gsk1120212 in patients with selected, advanced solid tumors. the focus will be on tumors with ras/raf mutations and on triple negative breast cancer. both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days. cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the mtd. the mtd is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (dlt) in more than 33% of the treated patients.. at least 12 patients will be required at mtd and 6 patients at rp2d level to allow the evaluation of the combination's safety and pharmacokinetics or pharmacodynamics. upon declaration of mtd and/or rp2d, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination. * expansion arm 1 will consist of approximately 15 patients with ras or braf mutant advanced nsclc * expansion arm 2 will consist of approximately 15 patients with ras or braf-mutant ovarian cancer * expansion arm 3 will consist of approximately 15 patients with ras or braf-mutant pancreatic cancer


Eligibility criteria:
inclusion criteria: * histologically/ cytologically confirmed, advanced non resectable solid tumors * measurable or non-measurable, but evaluable disease as determined by recist 1.0 exclusion criteria: * patients with primary central nervous system (cns) tumor or cns tumor involvement. * clinically manifested diabetes mellitus - unacceptable ocular/retinal conditions other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bkm120 ras raf mutations, triple negative breast cancer, pancreatic cancer, pi3k inhibitor, mek inhibitor
lifestyle intervention for osa in adults

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnoea (osa) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, ahi \> 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. the prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. osa has an important negative impact on physical/psychological health and on these patient's quality of life. the gold-standard treatment for osa is the continuous positive airway pressure (cpap). however, cpap compliance is really low, this device requiring a continuous chronic use in order to improve osa and to avoid the relapse. furthermore, it does not address osa risk factors such as obesity and unhealthy lifestyle habits. consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the american academy of sleep medicine (aasm). the objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe osa. the treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. the efficacy of this treatment will be assessed in comparison with cpap, in a short and medium term. this intervention could be considered a good alternative/combined management to the usual treatment of osa (cpap) once its efficacy to reduce and even cure osa symptoms is demonstrated, especially if it is still effective in the long-term.


Eligibility criteria:
inclusion criteria: * previous clinical diagnosis of moderate/severe osa (ahi \> 15) by a healthcare professional. * male patients aged between 18-65 years. * body mass index \> 25 kg/m2. * use of cpap * motivation to participate in the study. * signed informed consent form. exclusion criteria: * sleep disorder other than osa * clinically significant psychiatric, neurological, or medical disorders other than osa * use of prescription drugs or clinically significant drugs affecting sleep

Keywords: obstructive sleep apnea weight loss lifestyle intervention continuous positive airway pressure osa cpap
effect of virtual reality on freezing phenomenon, balance, functional mobility, participation in parkinson's patients

Conditions: Parkinson's Disease; Freezing of Gait

Summary: this study was planned to investigate the use and results of virtual reality applications with specially prepared software for the rehabilitation of freezing phenomenon, which increases the falling anxiety of individuals with parkinson's disease and causes social isolation. individuals over the age of 50 who have been diagnosed with idiopathic parkinson's disease by a specialist neurologist will be included in the study; individuals evaluated in terms of balance, functional mobility, freezing phenomenon, participation, and cognitive status will be randomly divided into two groups receiving conventional treatment and additional virtual reality. after the preliminary evaluation, they will receive 8 weeks of treatment 4 days a week and will be evaluated after the treatment and 3 months after the treatment. in addition to the improvements that will emerge as a result of the treatments within the scope of the study, it is expected that the virtual reality application created with crowd simulation will provide more effective results in improving the parameters. knowing the effects of exercises in crowds, which cannot be performed in the clinic, in the treatment of parkinson's disease patients, whose freezing and freezing-related symptoms are aggravated, especially in crowded environments, will make significant contributions to the field.


Eligibility criteria:
inclusion criteria: * being diagnosed with parkinson's disease by a qualified neurologist (diagnosed with idiopathic pd according to uk brain bank criteria * being between 1-2.5 stages according to the hoehn and yahr staging scale * volunteering to participate in the study * 50 years of age or older * standardized mini mental test score greater than 24 * patients experiencing an on-off period are in the "on" period * not using deep brain stimulation or drug pump * ability to walk independently on level ground (functional ambulation 3 and above according to classification) * having a score of (≥2) on item 3 of the freezing while walking scale exclusion criteria: * being any neurological or psychiatric disease other than parkinson's disease * cardiovascular, vestibular or musculoskeletal disease * dyskinetic movements * having vision problems that cannot be corrected with glasses or lenses * hearing problems that cannot be corrected with a hearing aid * using an assistive device

Keywords: virtual reality rehabilitation
decision-aid on breast cancer screening

Conditions: Breast Cancer

Summary: the present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.

breast cancer is the most common cancer in women. in italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. decision aids are an effective way to support lay people in their decisions about health.

Eligibility criteria:
inclusion criteria: * women aged 45-69, according to the target age of the screening centres involved; * new invited women in mammography screening programme. exclusion criteria: * none

Keywords: breast cancer screening mammography decision-aid informed choice national cancer screening program
expression of tuberculosis in the lung

Conditions: Tuberculosis

Summary: the purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis (tb) and in healthy control persons who are exposed to mycobacterium tuberculosis in households of patients with tb or who are unexposed.

background: m. tuberculosis infects a third of the world's population, and tb is the leading cause of morbidity and mortality due to a single infectious agent. however, only 5% to 10% of m. tuberculosis-infected subjects without an underlying immunodeficiency develop disease during their lifetimes. therefore protective immunity is induced in the majority of subjects. understanding correlates of protection against m. tuberculosis in humans is needed to better direct efforts in the development of antituberculosis vaccines. design narrative: patients are treated according to good clinical practice; however, no study medications are given as part of the research study. this study involves a one-time bronchoalveolar lavage and venipuncture to obtain immune cells for laboratory studies of immune responses.

Eligibility criteria:
inclusion criteria: * tb patients who are 18 to 65 years old * clinical and radiographic signs and symptoms consistent with pulmonary tb * start date of antituberculous chemotherapy less than 10 days prior to procedures * sputum smear positive for acid fast bacilli * drug-sensitive, culture-confirmed growth of m. tuberculosis from sputum * willing to provide informed consent for participation in bronchoalveolar lavage and venipuncture studies exclusion criteria: * tb patients who have hiv-1 coinfection * history of any chronic medical condition requiring daily medication (including diabetes mellitus, hypertension, chronic infections, renal or cardiac failure, and peptic ulcer disease) * history of asthma or upper or lower respiratory tract infection within 2 months of the study * hemoglobin level less than 10g/dl
developing and examining evidenced-based hiv testing messages

Conditions: HIV/AIDS

Summary: the goals of this study are to: 1. develop a hiv test message tailored for african american women. a generic non-tailored message will be developed as well for comparison. a third group will be included that will not be exposed to any message at all. 2. test the effectiveness of both messages on reported future intentions to get tested for hiv and hiv test behavior at 3 month follow up.

african american women have the highest risk and prevalence of hiv infection among women of all racial/ethnic groups in the united states. many of the current hiv infections among young adult african american women remain undiagnosed. the established benefits of routine hiv testing, the limitations of safer sex programs, and the gap of research related to increasing hiv testing as prevention necessitates the need for future research that specifically targets mechanisms to increase hiv testing. higher rates of hiv testing can decrease rates of hiv transmission, as individuals who are knowledgeable of their status are less likely to transmit the virus. the current literature is sparse on factors related to hiv testing among young adults and has largely only examined demographic and sexual behavior correlates of hiv testing. additionally, no studies have developed evidence-based health messages to promote hiv testing specifically among african american young women, despite their high risk of hiv infection and the importance of hiv testing. thus, the proposed study will intend to identify factors related to hiv testing beyond the demographic and sexual risk level through formative research. these identified factors will be included as important elements in the development of hiv testing messages to motivate increased hiv testing. an enhanced message (culturally tailored) and a knowledge only message will be developed and tested.

Eligibility criteria:
inclusion criteria: * self-identified black or african american women exclusion criteria: * women who have never had sex, are married, or are pregnant/attempting to become pregnant
effects of family work shop for children with developmental delays: a randomized trial

Conditions: Development Delay

Summary: to identify the therapeutic effects of short-term family-centered work shop for children with developmental delays

1. the family work shop has a total of 6 weeks, with 6 families in one course. 2. two hours per session, one time per week. aims; 1. assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life. 2. assess the family strain by work shop for parents of children with developmental delays.

Eligibility criteria:
inclusion criteria: * 18 m/o to 36 m/o children with developmental delays, under regular rehabilitation programs exclusion criteria: * less than 18 m/o and older than 36 m/o failed to obtain written informed consent

Keywords: family work shop