Kornimate/medical-research-clean huggingface dataset:
determination of the minimal clinically important difference after treatment with pantoprazole in patients with symptoms of acid reflux (gastroesophageal reflux disease) (by1023/m3-340)

Conditions: Gastroesophageal Reflux

Summary: gastroesophageal reflux disease (gerd) is a medical condition affecting the stomach and esophagus. gerd occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. gerd is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. proton pump inhibitors such as pantoprazole can relieve symptoms of gerd in a large proportion of patients. of particular interest in gerd is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. therefore, a questionnaire to assess gerd symptoms was developed (request trademark). an important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect. the aim of this study is to determine the minimal clinically important difference (mcid) in patients diagnosed with gerd. during the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (request trademark). endoscopy will be performed at the start of the study. the study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). during the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. the study will provide further data on safety and tolerability of pantoprazole.


Eligibility criteria:
main inclusion criteria: * in general good health other than gastroesophageal reflux disease (gerd) * history of gerd-related symptoms for at least 6 months prior to inclusion into the study * endoscopically confirmed gastroesophageal reflux disease main exclusion criteria: * acute peptic ulcer and/or ulcer complications * systemic glucocorticoids or non-steroidal anti-inflammatory drugs (nsaids) including cox-2-inhibitors on more than 3 consecutive days within the previous 28 days; except regular intake of acetylsalicylic acid in dosages up to 163 mg/day * intake of proton pump inhibitors and histamine 2-receptor antagonists within the previous 14 days * intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents * pregnant or nursing female patients; non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception

Keywords: gastroesophageal reflux gastroesophageal reflux disease pantoprazole
late preterm corticosteroids and neonatal hypoglycemia

Conditions: Neonatal Hypoglycemia; Prematurity

Summary: this is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. the investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.

the use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care. the american college of obstetrics and gynecologists (acog) officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days. since publication of the alps trial, the society of maternal fetal medicine (smfm) published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days. a secondary finding of the alps trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia; the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known, significant hypoglycemia is associated with poor neurodevelopmental outcome. the optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified. the proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age 34 0/7 weeks to 36 5/7 weeks * planned delivery in late preterm period exclusion criteria: * prior course of betamethasone during pregnancy * twin gestation * fetal demise * major fetal anomaly * maternal contraindication to betamethasone * pregestational diabetes * expected delivery within 12 hours of randomization
bioaerosol sampling in suspected pulmonary tuberculosis

Conditions: Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture

Summary: tuberculosis (tb) is transmitted in bioaerosols containing mycobacterium tuberculosis (mtb). mtb-containing bioaerosols are likely related to host infectiousness and central to ongoing tb transmission. no routine diagnostic assay exists to measure mtb in bioaerosols. furthermore, published studies of mtb in bioaerosol samples, have been limited to individuals with sputum-positive pulmonary tb. currently tb diagnosis is based on clinical symptoms and sputum laboratory findings. however, approximately half of all patients commencing tb treatment are sputum negative resulting in a high proportion of presumptive treatments. we therefore propose to use a sensitive sampling protocol to investigate the prevalence of mtb-containing bioaerosols in both sputum-positive and sputum-negative tb suspects.

our pragmatic, parallel-group design is aimed at identifying viable mtb in bioaerosols produced by individuals attending a tb clinic in cape town, south africa. bioaerosol sampling will be performed on all eligible individuals presenting with symptoms indicative of tb and repeated at 14 days if initially positive for viable mtb. participants will be classified into three distinct groups based on the national tb control program (ntbcp) criteria: group a, tb notification with sputum-based laboratory confirmation; group b, tb notification with empiric diagnosis; and group c, individuals not notified. group c individuals with detectable mtb bioaerosol will be monitored until resolution of clinical and laboratory status. collection of bioaerosol specimens will be via two consecutive sampling modalities: (1) direct sampling of a specific respiratory manoeuvre; and (2) indirect sampling following passive respiratory activity and environmental sampling. microscopy. mtb genomes and mycobacterial and host lipids will be detected using droplet digital pcr and mass spectrometry analyses, respectively. the primary objective is to determine the prevalence of mtb bioaerosols in all tb clinic attendees and in each of the mutually exclusive groups a, b and c. secondary objectives are to investigate differences in prevalence of mtb bioaerosol by hiv status, current isoniazid preventive therapy (ipt) use and pre and post initiation of anti-tb chemotherapy.

Eligibility criteria:
inclusion criteria: * age over 13 years * person with suspected tb * provision of written, informed consent (parental consent and patient assent for those aged under 18yrs)
the role of oxytocin in acute ischemic stroke reconvalescence: the roxane study

Conditions: Acute Ischemic Stroke

Summary: evidence suggests that oxytocin has a neuroprotective role on a systemic and cellular level in the context of acute ischemic stroke (ais). the investigators therefore hypothesize that high levels of circulating oxytocin measured within the first 72 hours after symptom onset are associated with lower mortality and favorable outcome in acute ischemic stroke.

the preliminary data suggest a possible neuroprotective role of oxytocin via endocrine as well as paracrine effects, underscoring that oxytocin levels in the acute phase of stroke may have a considerable influence on patient outcomes. however, the role of oxytocin in acute ischemic stroke patients has, to our knowledge, never been investigated. if oxytocin really shows a strong associated with functional outcomes after stroke and given the fact that commercially available oxytocin can be safely administered via nasal spray, oxytocin would become an innovative and highly interesting novel therapeutic agent for ischemic stroke patients in the near future. for the roxane cohort the investigators plan to recruit patients with acute ischemic stroke from the university hospital in basel. the study is designed as an observational cohort study, because an observational study is currently at this stage of knowledge (effect of oxytocin in vitro and in vivo (animal models)), the best study design. it harbors minimal harm, but still allows us to adequately estimate the association of oxytocin levels in humans with stroke outcome. if it is possible to establish this association in humans based on results of the planned observation study, the investigators will be able to plan an interventional trial, which may directly beneficially impact clinical outcome of stroke patient.

Eligibility criteria:
inclusion criteria: * rapid onset of a focal neurologic deficit, with signs or symptoms persisting beyond 24 hours and not associated with infection, trauma, or tumor of the brain, severe metabolic disorders, or chronic degenerative neurologic disease; or * the development of an acute focal neurologic deficit persisting \>24 hours in conjunction with brain imaging consistent with acute ischemic stroke. the ct or mri may either show a new infarct or no change from the study performed at entry, i.e., the diagnosis is clinical and does not require ct/mri confirmation. secondary hemorrhagic infarction is permissible. * first blood sample at the stroke unit is taken within 24 hours from symptom onset. exclusion criteria: * patients below 18 years * hemorrhagic stroke or patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e., stroke mimics) * missing informed consent

Keywords: oxytocin blood biomarkers
obesity risk in african american women is determined by a diet-by-phenotype interaction

Conditions: Diet Modification

Summary: the scientific premise of this study is that the high level of obesity displayed by african american (aa) women is due to the ability to secrete large amounts of insulin when sugary foods are consumed. when aa women eat a diet rich in starchy or sugary food (a "high-glycemic" diet that stimulates insulin secretion), the food that is eaten is stored as fat rather than being burned as fuel. the investigators previous research has suggested that aa women have an easier time losing weight and keeping it off when eating a low-glycemic diet. the proposed study will be the first randomized clinical trial to test the effect of high and low glycemic diets for weight loss and weight-loss-maintenance in obese aa women.


Eligibility criteria:
inclusion criteria: * bmi 30-45 kg/m2 * sedentary to moderately active (\<2 hours/wk of moderate, structured, intentional exercise. * normal menstrual cycle exclusion criteria: * history of eating disorder * daily use of tobacco (\>1 pack/wk) * change in weight greater than 5 pounds in previous 3 months * presence of any condition (e.g. pcos) or use of any medication (e.g. glucocorticoid) deemed by the project physician to interfere with study outcomes * applicants will be screened with a standard oral glucose tolerance test. if a participant's 2 hour glucose if \>200, they will not be able to enroll in the study.
effect of motor rehabilitation treatment on amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: ermosla is a multicentric, randomized, controlled trial to compare effects of an "intensive" or "standard" motor rehabilitation treatment on motor disability in people with als

the study is a multicentric, randomized, controlled trial to compare effects of standard versus intensive motor rehabilitation treatment for people with als. eligible patients are going to be randomly assigned to the standard or intensive treatment (controlling for alsfrsr rates at enrollment, age and site of onset). randomization ratio is 1:1. standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one) for 10 weeks for a total of 20 sessions. the program consists of exercises for aerobic endurance, reinforcement at low load and stretching. at the end of the 20 sessions patient and caregiver are going to continue activity with supervision through regular follow up. intensive treatment is characterized by an increased volume of the above mentioned exercises: 5 sessions/week (45 minutes each one) for 10 weeks for a total of 50 sessions. at the end of the 50 sessions patient and caregiver are going to continue activity with supervision through regular follow up. collection and analysis of data recruitment: during the first 18 months of the study. outcome measures: evaluated at t0-t3-t6-t9-t12-t15-t18-t21-t24. rating scales will be administered by a neurologist in singe blind method with respect to the treatment. data collection will be done through an ad hoc case report form and entered into a database on a dedicated website.

Eligibility criteria:
inclusion criteria: * diagnosis of possible, probable or definite als according to the revised el escorial criteria * time from diagnosis \<18 months at screening. * forced vital capacity (fvc)\> 50% at screening * written informed consent patients will be required to take the full dose of riluzole, but not assuming riluzole do not constitute a criterion for exclusion. exclusion criteria: * enrolment in any other clinical trial in the three months prior to screening * tracheostomy or niv for\> 23h/day for 14 consecutive days at screening. * diagnosis of severe neurodegenerative diseases in addition to the als * diagnosis of severe heart disease, current neoplasia, any unstable medical condition that contraindicates an intensive rehabilitation treatment * state of pregnancy or breastfeeding * residency outside emilia-romagna region * lack of multidisciplinary follow-up

Keywords: motor rehabilitation treatment intensive versus standard motor disability
longitudinal studies of blood pressure in the elderly

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to study further the association between blood pressure mortality among those who participated in both the hypertension detection and follow-up program (hdfp) screen and the east boston established populations for epidemiologic studies in the elderly (epese) study.

background: in middle-age, level of blood pressure (bp) is a strong and independent predictor of both total and cardiovascular disease (cvd) mortality. however, among the elderly, recent short-term observational studies, including the east boston established populations for epidemiologic studies in the elderly (epese), have raised the possibility of a j-shaped curve. in a study of short-term mortality, low blood pressures were positively associated with total and cardiovascular disease mortality. however, a further analysis confined to the 2079 (68 percent) of this cohort who were also screened nine years previously for the hypertension detection and follow-up program showed the more conventional positive linear relationship between systolic blood pressure, and no association between diastolic blood pressure and mortality. the observations of higher short-term total and cardiovascular disease mortality at lower blood pressure levels among the elderly could have reflected a particular susceptibility to deleterious consequences of drug therapy for high blood pressure. alternatively, such a finding might have been artifactual, due to survival bias or confounding by co-morbid conditions. design narrative: linking data from the hdfp and the epese studies, the investigators examined change in blood pressure, antihypertensive medication use, and mortality over a 15-year period. with regard to the association between lower blood pressure and increased mortality, they determined whether the relationship previously observed reflected a fall from normotensive levels as opposed to a consistently low blood pressure. with regard to the upper end of the mortality curve, they assessed the effect of antihypertensive drug treatment on mortality as compared to those with untreated hypertension. the latter question had particular public health significance because questions remained about the risk-to-benefit ratio of antihypertensive drug treatment in this age group. furthermore, they also described changes in blood pressure in this population and medication usage patterns over time and correlated type of medication and mortality. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
treatment of uretral stricture with self-catheterization : tolerance evaluation

Conditions: First or Second Uretral Stenosis; Diagnosed With Uretral Fibroscopy

Summary: urethral stenosis has a recurrent character. the clean intermittent self-catheterization can be proposed for repeat stenosis. this study seeks to explore the tolerance of clean intermittent self-catheterization in the evolution of urethral stenosis after urethrotomy.


Eligibility criteria:
inclusion criteria: * men between 18 and 80 * first or second uretral stenosis, diagnosed with uretral fibroscopy exclusion criteria: * not multiple, strength or long stenosis * no previous surgery of the urethra * refusal to participate to the study * inability to perform self-catheterization
impact of vitamin d supplementation on cardiometabolic risk factors [the daily d health study]

Conditions: Vitamin D Deficiency

Summary: the purpose of this research is to determine what supplemental doses of vitamin d may be necessary to raise serum levels to optimal levels and how vitamin d supplementation and changes in vitamin d status impact cardiovascular risk factors in schoolchildren.

research suggests that vitamin d, known mainly for its role in bone health, may have other roles in the body and that vitamin d deficiency may contribute to certain chronic diseases, such as cardiovascular disease. recently, vitamin d has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin d deficiency. most circulating 25-hydroxyvitamin d comes from exposure to uvb rays in natural sunlight. in 2010, the institute of medicine issued new recommendations that daily vitamin d intakes should be increased to 600 iu/day for children ages 1-18. however, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/ml. moreover, more than two-thirds of all children have levels below 30 ng/ml, including 80% of hispanic children and 92% of non-hispanic black children. therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(oh)d due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are latino or african american; and 2) whether serum concentrations of 25(oh)d over 30 ng/ml in children prevent health risks.

Eligibility criteria:
inclusion criteria: * subjects in 4th-8th grade * subjects must attend school where study is being conducted * subject and parent/guardian must give assent/consent to participate in study related requirements * subjects must complete all study visits (baseline, 3,6 and 12 months) * subjects must agree to be blinded exclusion criteria: * subjects taking glucocorticoids * subjects not in 4th-8th grade * clinical diagnosis of cystic fibrosis * clinical diagnosis of kidney disease * subjects currently taking a vitamin d supplement of \>1000 iu/day * subjects diagnosed with irritable bowel syndrome (ibs) * clinical diagnosis of aids * clinical diagnosis of sarcoidosis * clinical diagnosis of epilepsy

Keywords: vitamin d vitamin d deficiency avitaminosis deficiency diseases blood lipids
a post-marketing observational study of tasfygo in participants with unresectable biliary tract cancer with fibroblast growth factor receptor 2 (fgfr2) fusion gene positivity who progressed after chemotherapy

Conditions: Biliary Tract Cancer

Summary: the primary purpose of this study is to investigate the safety of tasfygo.


Eligibility criteria:
inclusion criteria: 1. participants with unresectable biliary tract cancer with fgfr2 fusion gene positivity who are naïve to tasfygo tablet and progressed after chemotherapy. exclusion criteria: not applicable.

Keywords: tasfygo fgfr2 fusion cancer