Kornimate/medical-research-clean huggingface dataset:
randomized, two-arm, non-inferiority study comparing endeavor-resolute stent with abbot xience-v stent

Conditions: Coronary Artery Disease

Summary: the resolute-iii allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. the study is a "real world, all comers" study. primary objective: to compare the medtronic endeavor-resolute (zotarolimus-eluting stent) system with the abbott xience v (everolimus-eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), target lesion revascularization at 1 year in a "real world" patient population.

the resolute-iii allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. the study is a "real world, all comers" study. primary objective: to compare the medtronic endeavor-resolute (zotarolimus-eluting stent) system with the abbott xience v (everolimus-eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), target lesion revascularization at 1 year in a "real world" patient population. study hypothesis: to determine whether the zotarolimus-eluting stent (medtronic endeavor-resolute) is non-inferior to the everolimus-eluting stent (abbott xience v) in terms of the primary endpoint at 12 months after stent implantation.

Eligibility criteria:
inclusion criteria: * minimal age 18 years * symptomatic coronary artery disease * patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines * presence of one or more coronary artery stenosis \>50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents * patient indication, lesion length and vessel diameter according to 'instructions for use' of study stents * patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing ec approved written informed consent. exclusion criteria: * women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating * known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, zotarolimus, everolimus, or contrast material * participating in other trial before reaching primary endpoint * planned surgery within 6 months of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Keywords: drug eluting stents interventional cardiology
physical exam indicated cerclage in twin gestations

Conditions: Twin Pregnancy, Antepartum Condition or Complication; Preterm Birth; Cervical Dilation Premature

Summary: this is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.

twin pregnancies have 58% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. no therapy has proven effective in preventing preterm birth in twins. when cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. cervical dilation is the worst prognostic factor for preterm birth. there are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. the investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.

Eligibility criteria:
inclusion criteria: 1. pregnant women older than 18 years of age 2. diamniotic twin pregnancy 3. cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation exclusion criteria: 1. singleton pregnancy or higher order than twins multiple gestation 2. cervical dilation more than 5 cm 3. amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue 4. more than 24 weeks of gestation 5. multifetal reduction after 14 weeks 6. monoamniotic twins 7. twin-twin transfusion syndrome 8. ruptured amniotic membranes at the time of diagnosis of dilated cervix 9. major fetal structural anomaly 10. fetal chromosomal abnormality 11. cerclage already in place for other indications 12. active vaginal bleeding 13. suspicion of clinical or biochemical chorioamnionitis 14. painful regular uterine contractions 15. labor (progressing cervical dilation) 16. placenta previa

Keywords: cervical cerclage
effect of gynostemma pentaphyllum tea in insulin sensitivity in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: the aim of the present study was to investigate the effects of gynostemma pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients.

in vietnam, traditional herbal medicines have played a major role in the management of diabetes for centuries. gynostemma pentaphyllum (gp) makino (family cucurbitaceae) is a perennial creeping herb growing wild in the mountainous regions of vietnam, china and some other asian countries and was widely used in southeast asian countries as an herbal medicine and being beneficial for the prevention and treatment of diabetes. we have previously published the evidences that gp tea possessed anti-diabetic effect with good safety data in newly diagnosed t2d patients, and had effect on insulin sensitivity. in addition extract of gp had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic zucker fatty rats. so the present study was to investigate the effects of gynostemma pentaphyllum tea in insulin sensitivity in type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * newly diagnosed, drug-naive patients with type 2 diabetes * fasting plasma glucose: 7-11 mmol/l * hba1c: 7-9%. exclusion criteria: * type 1 diabetes * liver and kidney failure

Keywords: herbal medicine; type 2 diabetes; gynostemma pentaphyllum tea; insulin sensitivity;
establishing clinical utility evidence for chronic disease management testing patient study

Conditions: Cardiometabolic Syndrome

Summary: this is a national-level research study of primary care physicians. the purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications.

in the original study protocol (approved on october 19th, 2021), which the investigators are now referring to as phase 1, the investigators measured changes in clinical practice using clinical performance and value (cpvs) vignettes, described below. phase 1 utilized simulated patients to determine clinical variation in the management of chronic cardiometabolic diseases and assessed the impact of the cdmt results on physicians' clinical decision-making. cpvs are qure's scientifically-validated measurement tool, first described in jama, 2000, and now used in scores of scientific investigations. in this research and derivative peer-reviewed publications, qure's cpv studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers. this amendment allows us to ask the same physicians if they change their practice in an actual clinical setting. phase 2 extends the findings from phase 1 by measuring the change in clinical practice using cpvs and securing data on practice patterns from abstracted medical records. the investigators will look for the same changes the investigators found in phase 1 to determine the impact of cdmt on real-world clinical decisions and patient outcomes. the advantage of phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in round 1 who indicated that cdmt would change their practice. these physicians will be given, free of charge, the option of using cdmt on their real patients who share similar medical diagnoses as the cpv simulated patients. phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including, but not limited to, blood pressure control, blood sugar control, and parameters of disease progression

Eligibility criteria:
inclusion criteria: * board-certified physician currently practicing in either family medicine or internal medicine. * have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years * community/non-academic based practice setting * ≥ 40 patients under care weekly * commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia * patient hipaa authorization form signed upon initial enrollment into the provider's practice * practicing in the u.s. * english-speaking * access to the internet * informed and voluntarily consented to be in the study exclusion criteria: * not a board-certified physician * not practicing in the united states * not informed and voluntarily consented to be in the study.
a study of real-life current standards of care in participants with relapsed and/or refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: the purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (pros) associated with standard of care (soc) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: for period 1, 2 and 3 * have a documented diagnosis of multiple myeloma according to international myeloma working group (imwg) diagnostic criteria * have an eastern cooperative oncology group (ecog) performance status grade of 0 or 1 * must not be pregnant or must not plan to become pregnant within the study period * participants must sign an informed consent form (icf) indicating that he or she understands the purpose and observational nature of the study and is willing to participate. consent is to be obtained prior to the initiation of any study-related data collection * for period 1 and 2: received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (pd) was the best response to the line of therapy * must have documented evidence of progressive disease based on participating physician's determination of response by the imwg response criteria on or after the last regimen. participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible * measurable disease at screening as defined by any of the following: serum monoclonal paraprotein (m-protein) level 1.0 g/dl or urine m-protein level 200 mg/24 hours; or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain 10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio * period 1: received as part of previous therapy a pi, an imid, and an anti-cd38 antibody (prior exposure can be from different monotherapy or combination regimens) * period 2: received as part of previous therapy a pi, an imid, an anti-cd38 antibody, and bcma-targeted therapy (prior exposure can be from different monotherapy or combination regimens) * for period 3: measurable disease at screening as defined by any of the following: serum monoclonal paraprotein (m-protein) level .5 g/dl or urine m-protein level 200 mg/24 hours; or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain 10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio
a single-dose study of the pharmacokinetics of vibegron (mk-4618) in adults with hepatic insufficiency (mk-4618-013)

Conditions: Overactive Bladder

Summary: this study will investigate the pharmacokinetics of a single oral dose of vibegron (mk-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (bmi). participants may be enrolled with mild hepatic insufficiency.

this study is planned to be conducted in two parts. part 1 of the study will include participants with moderate hepatic insufficiency and healthy participants. if part 2 is conducted, part 2 of the study will include participants with mild hepatic insufficiency.

Eligibility criteria:
inclusion criteria for both healthy participants and participants with hepatic insufficiency: * continuous non-smokers who haven't used nicotine-containing products for at least 3 months prior to study drug administration * body mass index (bmi) ≤39 kg/m\^2 * good health based on medical history, physical examination, vital signs, laboratory safety tests, and electrocardiogram (ecg) * females of childbearing potential must be sexually inactive for 14 days prior to study drug administration and throughout study or use acceptable birth control method * females of non-childbearing potential must have undergone an acceptable sterilization procedure at least 6 months prior to day 1 of study or be postmenopausal with amenorrhea for at least 1 year prior to day 1 * non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after study drug administration for participants with hepatic insufficiency only: * diagnosis of chronic, stable, hepatic insufficiency * for part 1 participants: child-pugh scale range from 7 to 9 * for part 2 participants: child-pugh scale range from 5 to 6
effect of music over the tolerance to colonoscopy.

Conditions: Pain; Anxiety

Summary: this study will evaluate the efficacy of music (a very well selected list of songs)on improving the tolerance to the colonoscopy. the patients will be randomly assigned to receive music or not. the authors hypothesis is that music is able to improve the tolerance to colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain experimented during the procedure and a reduction of the administered dose of midazolam during the colonoscopy.

to select the music that will be administered on this trial we will performed as the first part of the study, a two fase pilot study. in the first part, five song belonging to different musical styles (rock, bosa nova, classical music, popular chilean music and new age) will be heard by 40 persons and the main emotion produced by every song will be registered (chosen among a previously defined list of emotions) and then rated using a visual analog scale. thus, we will be able to select the musical style that with more frequency produce "tranquility and/or peace". once this musical style will be selected we generate a set of songs belonging to this style. this set of songs will be validated using again a similar methodology in the second part of the pilot study to be sure that is able to produce the same emotion that the song previously evaluated. the validated set of songs will be the music that will be administered to the patients participating on a multicentric randomized controlled trial where the effect of the selected music over the tolerance to colonoscopy will be evaluated measuring the level of anxiety, the administered dose of midazolam and the intensity of pain experimented during the procedure among another variables on the experimental and the control groups, including 150 patients on each arm.

Eligibility criteria:
inclusion criteria: * adults (over 18 years) * diagnostic colonoscopy * signed informed consent exclusion criteria: * hypoacusia * significant cognitive impairment * hypotension * signs of digestive haemorrhage (other than a small amount of rectorrhagia) * more than moderate intensity of pain before the colonoscopy. * previous colorectal surgery * allergy to midazolam or pethidine

Keywords: colonoscopy music tolerance pain anxiety dose of sedative drugs administered during the procedure
weight management in mothers and adult daughters

Conditions: Overweight or Obese

Summary: the purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for mexican-american women. the study has three specific aims. aim 1: develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from mexican-american mother-daughter dyads. the adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors. aim 2: implement and evaluate a pilot weight management program adapted for mother-daughter dyads. dyads will be randomly assigned to partner-based treatment with or without communication skills training. aim 3: evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.


Eligibility criteria:
inclusion criteria: * female * body mass index of 25-50 kg/m2 * mexican or mexican-american exclusion criteria: * pregnancy or plans to become pregnant in the next year * 5% weight loss in the last 3 months * history of bariatric surgery * serious medical condition or psychological disorder
treatment burden screening questionnaire pilot study

Conditions: Type 2 Diabetes

Summary: the main objective of this study is to develop and evaluate a clinic-based pilot intervention to optimize patient-centered diabetes care for low income patients at risk for low quality diabetes care and poor outcomes.

single arm trial of a brief screening tool to identify areas of treatment burden in patients with diabetes, which will then be used as a tool in a primary care clinician visit discussion. we will assess (primary outcome) the acceptability and feasibility of 1. recruitment and retention processes; 2. screening tool usability; and (secondary outcomes) 3. outcome assessments. data will include systematic tracking of recruitment and retention efforts, baseline and follow-up participant data, post-visit surveys of clinicians and participants, and patient participant qualitative interviews.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, a diagnosis of t2dm, receiving primary care in a participating clinic, and having an in-person clinic visit with a participating trained clinician. exclusion criteria: * cognitive impairment, residing in a nursing home, and pregnancy (to avoid recruiting patients with gestational diabetes).

Keywords: type 2 diabetes treatment burden
promoting early diagnosis of chronic mesenteric ischemia

Conditions: Chronic Mesenteric Ischemia

Summary: cmi is an incapacitating disease and timely diagnosis remains problematic. despite the substantial compensatory capacity of the mesenteric circulation cmi is relatively common, its incidence being comparable to other well-known diseases like crohn's disease. diagnostic tools are needed for two purposes since the exclusion of cmi currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. first, a sensitive test is desirable to rule out cmi and avoid excessive diagnostic investigations. quantification of mesenteric arterial calcification on computed tomography (ct) seems suitable for this purpose, synonymous with the coronary artery calcium score. second, a specific test is required confirming cmi by detection of mucosal ischemia during a meal, when oxygen demand peaks. a breath test, based on the requirement of oxygen to absorb and metabolize 13c-butyrate in the enterocyte, could detect mucosal ischemia objective: facilitating diagnosis of chronic mesenteric ischemia (cmi) using 1) the mesenteric artery calcium score (macs) and 2) mucosal ischemia detection by butyrate breath testing study design: multicentre prospective cohort studies.


Eligibility criteria:
inclusion criteria: * patients with a clinical suspicion of cmi referred to to maagdarm ischemie centrum rotterdam (micr). * patients ≥ 18 years exclusion criteria: * patients who are unable to give informed consent * patients with previous mesenteric artery revascularization * no available ct imaging and contraindications for ct imaging (e.g. pregnancy) * common origin of the celiac artery and superior mesenteric artery * known delayed gastric emptying * known and untreated small intestinal bacterial overgrowth

Keywords: breath test, chronic mesenteric ischemie, calcium scoring