Kornimate/medical-research-clean huggingface dataset:
trastuzumab in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

objectives: primary * to evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer. secondary * to analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival). outline: this is a multicenter study. patients receive standard treatment with trastuzumab. blood is collected periodically for pharmacogenetic analysis.

Eligibility criteria:
disease characteristics: * histologically confirmed breast cancer * metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, ct scan, mri scan, or ultrasound) or scintigraphically confrimed * evaluable disease * beginning first-line metastatic treatment with trastuzumab (herceptin®) with or without chemotherapy * primary tumor must overexpress her2 (ihc 3+ or ihc 2+ and fish+ or fish+) * hormone receptor status not specified * no brain metastasis patient characteristics: * menopausal status not specified * life expectancy \> 3 months * able to undergo cardiotoxicity evaluation every 4 months by measuring lvef via an isotopic method or ultrasound with systematic registration * no chronic uncontrolled disease * no heart failure * no respiratory failure or hypoxemia * no history of another primary cancer except for basal cell carcinoma of the skin * no severe uncontrolled infection * no psychological incapacity prior concurrent therapy: * see disease characteristics

Keywords: stage iv breast cancer her2-positive breast cancer
endoscopic sutured gastroplasty with endomina® device versus standard of care in patients with type 2 diabetes and class i obesity: a multi-center, randomized controlled trial

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: the primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class i obesity.


Eligibility criteria:
inclusion criteria: * age between 18-65 years; * recently diagnosed type 2 diabetes (\<= 10 years): * hba1c \< 9%: * under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, dpp4i, glp1-ra, sglt2i, alone or in combination * anti-diabetic therapy stable during the last 3 months before inclusion * bmi between 30-34.9 kg/m² with adaptation for asian population 27.5-32.5kg/m² * must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to randomization treatment, dietary follow up, visits schedule and all study specific procedures); * must be able to understand and be willing to provide written informed consent. exclusion criteria: * contra-indication to the use of endomina® and tapes according to their instruction for use (ifu). * type i diabetes characterized by c peptide \<0.2 nmol/l or presence of anti-gad, anti ia2, anti-znt8 * unstable diabetic retinopathy * severe kidney (stage 4-5), hepatic (child b and c cirrhosis), pulmonary disease or cancer (cancer in the past 5 years); * short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (\<5 years) * contra-indication to endoscopic gastroplasty (...) * impending gastric surgery 60 days post intervention; * participant involved in another interventional clinical study * patients having alcoholic or drug addiction; * patients having a severe mental illness such as psychosis, bipolar disorders, severe, current depression or eating disorder such as bulimia nervosa or binge eating disorder; * person deprived of liberty by judicial order * person under guardianship or curatorship
avacen treatment method and postprandial blood glucose

Conditions: Postprandial Hyperglycemia

Summary: a double-blind crossover randomized controlled trial to investigate the effects of the avacen device on postprandial blood glucose. the avacen device creates negative pressure around the hand while heating the palm. two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. each subject will use each of these three devices during the first hour of a 2-hour oral glucose tolerance test on separate visits. subjects arrived in the morning following an overnight fast. fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 2-hour oral glucose tolerance test.


Eligibility criteria:
inclusion criteria: * healthy individuals exclusion criteria: * diagnosis of diabetes, diabetes medication, hypertension medication
chronic obstructive pulmonary disease (copd) dual therapy burden of illness

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the main purpose of the study is to assess the burden of illness for, copd using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, fluticasone/salmeterol flut/sal; advair) or umeclidinium/vilanterol (umec/vi; anoro) to support global initiative for chronic lung disease (gold) category b recommendations. the study will use a health plan recruitment strategy and subject's will be recruited using optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (modified medical research council dyspnoea scale \[mmrc\] and copd assessment test \[cat\]), and demographic and sociodemographic characteristics. a total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month baseline period for analysis. pharmacy and medical claims data, will be used to calculate all-cause and copd-related health care utilization and costs, treatment patterns, and baseline clinical characteristics. the study duration is estimated to be of 12-months.


Eligibility criteria:
inclusion criteria: * \>=2 international statistical classification of diseases and related health problems (icd)-10-cm diagnosis codes for copd at least 30 days apart during the 12 month period prior to sample identification. * diagnosis codes j40-j44 will be included. * \>=1 pharmacy claim for umec/vi or flut/sal single-inhaler dual therapy during baseline. * age \>= 65 years. * self-reported health care provider diagnosis of copd. * self-reported prescription for flut/sal or umec/vi. * 12 months of continuous enrollment during the baseline period. * ability to complete the study survey in english. exclusion criteria: * \>=2 icd-10-cm diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification. * claims for both umec/vi and flut/sal in the 6 months, closest to sample identification. * claims for triple therapy (inhaled corticosteroid \[ics\] + long-acting antimuscarinic \[lama\] + long-acting beta-agonist \[laba\] during the baseline period. * evidence of lung cancer diagnosis and/or treatment

Keywords: cohort chronic obstructive pulmonary disease observational gold claims health plan recruitment
a retrospective, observational, multicenter, study to collect clinical safety and performance data on polymaille®c

Conditions: Abdominal Vascular Surgery; Peripheral Vascular Surgery; Vascular Prothesis; Aneurysm Abdominal; Aneurysm; Peripheral; Obliterative Arterail Disease

Summary: purpose of the study is to describe safety and performance of polymaille® c from a minimum of 200 subjects will be evaluated. a minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral). follow-up at least 1 year follow-up after surgery until a maximum of 5 years. polymaille®c vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.


Eligibility criteria:
inclusion criteria: * patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study: patient has a minimum of 1-year post-operative follow-up data available, or complete data to death exclusion criteria: * patients who have objected to the collect of their data.
auxiliary device to alleviate soldiers' backload

Conditions: Physiological Strain of Weight Bearing.

Summary: combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability. the auxiliary device- "minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. as a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.


Eligibility criteria:
inclusion criteria: * healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use. * lack of any acute disease during 2 weeks prior the study. * subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks. exclusion criteria: * rectal temperature above 39 celsius degrees. * hr above maximal hr ( calculated as 220-age) * the subject's will to stop the test. * the researcher's/doctor's judgment.

Keywords: weight bearing physiological load
study to evaluate the efficacy and safety of ilaprazole 10 mg in prevention nsaids associated peptic ulcer

Conditions: Peptic Ulcer

Summary: to demonstrate the non-inferiority of ilaprazole 10 mg to the active control in prevention of nsaids-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by week 24

not provided

Eligibility criteria:
inclusion criteria: 1. adult males and females aged 19 years or older on the day of informed consent 2. subjects requiring continuous treatment or receiving treatment with nsaids 3. subjects with at least one of following peptic ulcer risk factors at the time of screening 4. subjects who have provided voluntary informed consent for the study participation after the study is explained exclusion criteria: 1. subjects with gastroesophageal varices, esophageal stricture or ulcerous stenosis, gastrointestinal bleeding or perforation, esophageal dysplasia and else based on the screening egd results. 2. subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder 3. subjects with confirmed history of malignancy within 5 years prior to screening 4. positive human immunodeficiency virus (hiv) antigen/antibody at screening
study to evaluate the safety and pharmacokinetics of single doses of asp2151 in healthy male subjects and the effects of food

Conditions: Herpes Genitalis; Herpes Zoster

Summary: the objective of this study is to evaluate the safety and tolerability of single rising doses of asp2151 under fasted condition in healthy male subjects. the study will also evaluate the pharmacokinetics (pk) of a single dose of asp2151 under fasted versus fed conditions in healthy male subjects.

study will be divided into two parts. part 1 will evaluate the safety and tolerability of asp2151 single rising doses in groups a-h in fasted condition and to determine the maximum tolerable dose (mtd) if possible. part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and pk of a single dose of asp2151 in two treatment cycles. the wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of asp2151, as determined in part 1 of the study.

Eligibility criteria:
inclusion criteria: * body weight between 60 and 100 kg, and bmi between 18 and 30 kg/m2 inclusive exclusion criteria: * known or suspected hypersensitivity to asp2151 or any components of the formulation used * any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug * any clinically significant history of genital herpes symptoms and/or herpes zoster symptoms in the 3 months prior to admission to the clinical unit * any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic * abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: pulse rate \ 90 bpm (beats per minute); mean systolic blood pressure \ 140 mmhg (millimeter of mercury); mean diastolic blood pressure \ 95 mmhg * regular use of any prescribed or otc (over the counter) drugs in the 4 weeks prior to admission to the clinical unit or any use of such drugs in the 2 weeks prior to admission to the clinical unit * any use of drugs of abuse within 3 months prior to admission to the clinical unit * history of smoking more than 10 cigarettes per day within 3 months prior to admission to the clinical unit * history of drinking more than 21 units of alcohol per week within 3 months prior to admission to the clinical unit * donation of blood or blood products within 3 months, prior to admission to the clinical unit * positive serology test for hbsag (hepatitis b surface antigen), hav igm (hepatitis a virus), anti-hcv (hepatitis c virus) or anti-hiv (human immunodeficiency virus) 1 and 2 * not willing or able to swallow size 00 capsules

Keywords: safety of asp2151 phase 1 pharmacokinetics healthy male subjects tolerability food effect of asp2151
the effect of yoga on sleep and quality of life in epilepsy patients

Conditions: Epilepsy

Summary: determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives. therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients.

yoga is an ancient hindu practice with documented therapeutic effect in western countries and means perfect control of the body, emotions and mind. it consists of breathing exercises, asanas (posture), relaxation and meditation exercises. through breathing exercises, various postures, and meditation in yoga, the connection between mind and body is established and a balanced health is assisted.

Eligibility criteria:
inclusion criteria: * having been diagnosed with epilepsy for at least six months, * does not have any disease that causes insomnia and does not use sleeping pills * have not participated in a similar regular exercise program in the last 6 months, * seizures are under control, * do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given exclusion criteria: * epilepsy patients who do not agree to participate in the study

Keywords: yoga sleep quality life
assessment of the accuracy of pet/mr in detection and monitoring response of bone metastases

Conditions: Bone Metastases

Summary: the great promise of pet/mr for assessment of skeletal metastatic involvement is derived from the extensive experience with stand- alone mr, but initial data on the use of pet/mr for assessment of bone pathology indicate that pet/mr introduces unique issues that should be addressed when determining its role in this clinical scenario. in this study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline pet/ct prior to treatment. baseline studies and follow up studies of the patients referred post treatment, will be reviewed. the main goal of the study is to asses the accuracy of pet/mr in detection and monitoring response of bone metastases.


Eligibility criteria:
inclusion criteria: 150 patients having metastatic skeletal involvement on baseline pet/ct prior to treatment exclusion criteria: 1. age \<18. 2. pregnant or breast feeding patients.
effects of the low-level laser therapy (lllt) on muscle strength (ms) of the patients with kidneys failure (kf)

Conditions: Chronic Kidney Failure

Summary: the low-level laser therapy (lllt) has been used in many inflammatory disorders. more recently the lllt was associated with an improvement in the muscle strength and endurance. but, these effects were described only in health or athletic individuals. in this randomized and controlled clinical trails, the investigators will study the effects of lllt on muscle strength of the patients with kidneys failure on long time hemodialysis treatment. additionally, investigators will explore three different intensities up the muscle strength.

this study will be conducing in a large hospital that is reference in kidneys disorders treatments. 16 patients will be randomized for placebo, 4j, 6j, or 8j low-level laser therapy (lllt). the maximal voluntary contraction (mvc) will be test by handgrip test before and after de lllt. one-week interval between the lllt will gave to reduce the influence between the treatments. moreover the endurance test will be use to evaluate the muscle oxidation impact of the lllt.

Eligibility criteria:
inclusion criteria: * chronic kidney failure, * long time hemodialysis treatment (\>18 months) exclusion criteria: * any health disturbance that can reduces the handgrip test performance beyond to the produced by the chronic kidney failure.
ultrasound guided bilateral pectoral nerve block versus bilateral transverse thoracic plane block in pediatric patients undergoing corrective cardiac surgeries requiring cardiopulmonary bypass via median sternotomy

Conditions: Ultrasound; Pectoral Nerve Block; Transverse Thoracic Plane Block; Pediatric Patients; Corrective Cardiac Surgeries; Cardiopulmonary Bypass; Median Sternotomy

Summary: this randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (pecs) versus transversus thoracic muscle plane block (ttpb) in pediatric patients undergoing corrective cardiac surgeries.

good perioperative analgesia in cardiac surgical patients helps early recovery, ambulation, and early discharge from the intensive care unit (icu). traditional use of nonsteroidal anti-inflammatory drugs (nsaids) and opioids associated with adverse effect commonly used for pain control postoperative. the transversus thoracic muscle plane block (ttpb) is a recently advised regional anesthesia method that provides analgesia to the anterior chest wall and was initially introduced by ueshima et al. in 2015 . the pectoral nerves (pecs) block has evolved to be two different types: pecs i and pecs ii. in pecs i block, anesthetic is injected in the interfacial plane between the pectoralis major and minor muscles at the 3rd rib, blocking the lateral and medial pectoral nerves. the pecs ii block, which was also developed by blanco in 2012. the pecs block has been well established for its use in breast surgery for the adult population. , however, there has been a recent push in the last couple of years to find more about other uses for these types of blocks, especially in cardiac surgeries.

Eligibility criteria:
inclusion criteria: * age: 6 months - 7 years. * gender: both sexs . * risk adjustment for congenital heart surgery (rachs) ii and iii. * patients undergoing cardiac surgeries requiring cardiopulmonary bypass with midline sternotomy incision. exclusion criteria: * patients whose parents or legal guardians refuse to participate. * preoperative mechanical ventilation. * patients in coma, mental retardation, neurological disease, or on drugs affecting the behaviour. * preoperative inotropic drug infusion. * (bleeding disorders (drug induced i.e., coumadin; or genetic e.g. hemophilia; or acquired e.g. disseminated intravascular coagulation \[dic\]), coagulopathy: partial thromboplastin time (ptt) \> 40 seconds, international normalized ratio (inr) \> 1.4, platelet count \< 100x10⁹. * known or suspected allergy to any of the studied drugs. * severe pulmonary hypertension (mean resting blood pressure in pulmonary arteries is above 70mmhg). * cardiopulmonary bypass time more than 90 minutes. * local infection. * significant renal impairment (creatinine more than 1.2mg/dl) * aortic cross-clamp time more than 45 minutes. * total time from induction till intensive care unit (icu) transfer more than 4 hours and 30 mins.
school-based approaches to help pre-teens manage asthma

Conditions: Asthma

Summary: this random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, african american students in middle schools in detroit, mi. the goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. outcomes of interest are symptom experience, quality of life, self-management, and school grades.

background: to date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. interventions to reach low income minority populations are particularly needed. design narrative: if only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys. additional primary outcomes listed in the protocol include: asthma related quality of life, disease management behavior and academic performance. secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.

Eligibility criteria:
children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in detroit, michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on naepp guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.