Kornimate/medical-research-clean huggingface dataset:
sit less, interact and move more (slimm) 2 study

Conditions: Chronic Kidney Diseases; Obesity

Summary: * prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death. * in a previous pilot study funded by nih, it was shown that a sit less, interact and move more (slimm) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained. * therefore, the researchers are currently conducting a follow-up study named sit less, interact and move more (slimm) 2. * this nih funded study is conducted at the university of utah and stanford university. * the purpose of this study is to see if guided resistance training (to improve muscle strength) and semaglutide (fda approved diabetes and weight loss medication that might also improve physical function) can boost adherence to the slimm intervention and reduce sedentary behavior.


Eligibility criteria:
inclusion criteria: * chronic kidney disease epidemiology collaboration (ckd-epi) glomerular filtration rate (egfr) 20 to \<60 ml/min/1.73m\^2 * able to perform resistance training * access to compatible "smartphone" or device (i.e., android, kindle or apple with internet connectivity or mobile network), desktop or laptop exclusion criteria: * type 1 diabetes * history of gastroparesis or paralytic ileus * at baseline, if sedentary time is 25 min/hr or less, measured by accelerometer * potential contraindications to semaglutide such as a history of pancreatitis, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma. * previous bariatric surgery * medical condition likely to limit survival to less than 1 year * anticipated start of dialysis or kidney transplantation within 6 months * any factors judged by the investigator or study team to likely limit adherence to interventions * vulnerable populations- pregnant or incarcerated * enrolled in interventional trials using drugs or devices * not able to undergo informed consent * recent hospitalizations or major interventional procedures done within the past 60 days * known or suspected hypersensitivity to tegaderm * use of any glp-1 receptor agonist within 30 days prior to screening * presently classified as being in new york heart association (nyha) class iv heart failure * daytime use of supplemental oxygen (i.e., prescribed a stationary or portable oxygen system) * presence of metastatic cancer * current use of mobility aid(s) * living in the same household of a participant already enrolled in the study
investigating the effectiveness of tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the effectiveness of tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus. eu-treat (european tresiba audit)


Eligibility criteria:
inclusion criteria: * informed consent will be obtained before any study-related activities. study-related activities are any data collection from the medical records of the patient * age at least 18 years at the time of tresiba® initiation * t1dm or insulin-treated t2dm patients * switched to tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with tresiba® at the time of patient selection * previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to tresiba® * at least one documented medical visit in the first 9 months after tresiba® initiation * minimum available data at the time of tresiba® initiation: age, type of diabetes, hba1c (glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an egfr (estimated glomerular filtration rate )value in the last 12 months exclusion criteria: * previous participation in this study. participation is defined as having signed the informed consent * participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of tresiba® * current participation in another non-interventional study on insulin degludec (tresiba®) * patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving tresiba®
randomized, multicenter trial comparing tvt with tvt-o for treatment of female urinary incontinence

Conditions: Urinary Stress Incontinence

Summary: the tensionfree vaginal tape (tvt) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. the tvt procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. a modification of the tvt procedure called tvt-o (tensionfree vaginal tape obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. the trial compares the tvt procedure with the tvt-o procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.


Eligibility criteria:
inclusion criteria: * history of stress incontinence * indications for surgical treatment * positive cough stress test * urgency score \< 7 exclusion criteria: * prior incontinence surgery * need of concomitant surgery * post void residual urine volume \< 100 ml * urinary tract anomalies * urinary tract infection * more than 3 urinary tract infection within last year * more than grade 2 urogenital prolapse * body mass index \> 35 * radiotherapy of the pelvic region * active malignancy * hemophilia * anticoagulant treatment * neurological disorder or other disease which affects bladder function * anticholinergic treatment * use of duloxetine * do not understand the purpose of the trial * immobility

Keywords: incontinence urinary female surgery complications
riluzole in women with stage i, stage ii, or stage iiia breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. riluzole may help slow the growth of tumor cells. purpose: this phase i trial is studying riluzole in women with stage i, stage ii, or stage iiia breast cancer.

objectives: primary * to evaluate the effects of glutamate receptor blockade with riluzole on cellular pathways important in the genesis and progression of disease in women with stage i-iiia breast cancer by examining components of the mglur1 signaling pathway in the pre- and post-treatment tumor samples to determine if glutamate blockade affects signaling through this pathway. secondary * to determine whether treatment with riluzole affects the proliferation and apoptosis in a manner suggesting a potential for therapeutic effectiveness. * to determine whether treatment with riluzole causes objectively measurable tumor shrinkage. outline: patients receive oral riluzole twice daily on days -14 to 0. approximately 12 hours after completion of riluzole therapy patients undergo standard surgery (i.e., partial or total mastectomy) along with sentinel lymph node biopsy (for patients with node-negative disease) or full axillary dissection (for patients with node-positive disease) on day 0. patients undergo 3-dimensional image assessment at pre- and post-treatment by computerized ultrasound risk evaluation (c.u.r.e.). patients undergo core needle biopsy at baseline and during surgery for biomarker analysis (e.g., mglur1) by ihc, western blotting, and rt-pcr. blood samples are collected for grm1 polymorphism analysis. after completion of study treatment, patients are followed every 6 months for 1 year and then according to standard-of-care thereafter.

Eligibility criteria:
disease characteristics: * diagnosis of adenocarcinoma of the breast * stage i (t1c)-iiia disease meeting the following criteria: * large enough (\> 1 cm) to undergo additional multiple core needle biopsies preoperatively * surgically resectable for cure or palliation without first requiring neoadjuvant chemotherapy * patients who have previously been treated for breast cancer, but are judged to have developed a new primary cancer, rather than a recurrence, are eligible patient characteristics: * ecog performance status 0-1 * anc ≥ 1,000/mm³ * platelet count ≥ 50,000/mm³ * liver function tests ≤ 3 times upper limit of normal (uln) * total bilirubin ≤ 2 times uln * creatinine ≤ 1.5 mg/dl * inr ≤ 25% normal limits * not pregnant or nursing * no known history of hiv or aids * no known history of hepatitis b or c * no history of vertigo or ménière's type of disorder * no history of allergic reaction to riluzole or similar compounds prior concurrent therapy: * no prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancer

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer
pazopanib + vinorelbine in non small cell lung cancer (nsclc) and breast cancer

Conditions: Metastatic Non Small Cell Lung Cancer; Metastatic Breast Cancer

Summary: the purpose of this study is to determine the highest dose of vinorelbine and pazopanib that can be given together without causing severe side effects. also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.

this study involves an investigational drug called pazopanib in combination with the chemotherapy drug vinorelbine. an investigational drug is a drug that has not been approved by the u.s. food and drug administration (fda) for use in the united states. vinorelbine has been fda approved to treat patients with nsclc and breast cancer. pazopanib is a vascular endothelial growth factor inhibitor, which means it may prevent the tumor from growing its own blood vessels thereby interfering with the growth of the tumor. participants in this study will be assigned to one of three groups with each group receiving a higher dose of vinorelbine and pazopanib than the previous group. vinorelbine will be given through a needle in the vein on days 1 and 8 of each 21 day study treatment cycle. pazopanib is a pill which will be taken by mouth every day during the 21 day study treatment cycle.

Eligibility criteria:
inclusion criteria: * age \> 18 years * patients must have diagnosis of breast cancer or non small cell lung cancer * patients must have evaluable disease * women of childbearing potential and sexually active males must commit to the use of effective contraception while on study. * patients must have given signed, informed consent prior to registration on study. exclusion criteria: * patients must not be pregnant and/or lactating. * patients must not be receiving any other investigational agents. * no prior exposure to vinorelbine or other vegf inhibitors as treatment for metastatic disease * patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days * history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine. * patients cannot have received more than 2 prior chemotherapy regimens for lung cancer or 3 prior chemotherapy regimens for breast cancer. this criterion can be discussed further with the study doctor. * must not have uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmic, psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: lung cancer breast cancer
sensory motor lateralization as handwriting intervention in school-based ot

Conditions: Developmental Dysgraphia

Summary: children who attend school-based occupational therapy (sbot) show mixed dominance and a liable decreased in the structural and functional differentiation between the two hemispheres. the lack of right-left disparity has been found to link to mirror invariance, poor spatial organization, fragmentary reversals, and handwriting difficulty. this study intends to find out, whether, sensory motor lateralization (sml), "with" a rightward bias, profits handwriting more than the conventional (con) "without".

10 to 30% of school children suffer handwriting difficulty. many of them are eventually referred to sbot for remedial intervention. among these children, 70% show mixed dominance in their hand and/or leg use, and a likely functional and structural interhemispherical asymmetry reduction. this would make them right-left symmetrical. learning, thus, may be challenged, because people who are right-left balanced would not have a consistent reference point to process the learning materials regularly in any pre-determined directions. they are, thus, prone to suffer mirror invariance, fragmentary reversal errors, and handwriting difficulty, especially with the fast and accurate construction of asymmetrical letters from memory. to enhance right-left disparity, dispel mirror invariance, and facilitate the automatized handwriting, sml preferentially belabors one's right eye, ear, hand and leg in therapy, that would greater engage the left hemisphere for its acclaimed vantages over learning. this study investigates, whether sml, wielding such a rightward bias, profits handwriting greater than con.

Eligibility criteria:
inclusion criteria: * any special or regular education students with individualized education plans (ieps), ot mandates, and handwriting goals. * has intelligence quotient (iq) equal to or above 60. * ambulatory. * proficient in english, and fluent in naming, identifying, and accessing the sequence of letters in the alphabet. * the students who attend physical therapy (pt), adaptive physical education (pe), and any other programs are included, if the programs being provided are skill-, theme-, or task-oriented, not involving any muscle strengthening activities. exclusion criteria: * all are excluded, if the study candidates have any medical condition(s) that would prohibit them from the full physical participation in school.

Keywords: developmental dysgraphia ambidexterity outcome study
diagnosis of adenomyosis using ultrasound, elastography and mri

Conditions: Endometriosis; Adenomyosis

Summary: comparison of transvaginal ultrasound, transvaginal ultrasound elastography and mri for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards


Eligibility criteria:
inclusion criteria: * dysmenorrhea * dyspareunia * non cyclic lower abdominal pain * hypermenorrhea * menometrorrhaghia * pain while compressing the uterus during gyn exam * patient wants to participate * patient will receive hysterectomy exclusion criteria: * patient declines to participate * contraindications against mri * contraindications against ultrasound * minor * cannot give informed consent * no hysterectomy planned

Keywords: adenomyosis endometriosis mri elastography ultrasound hysterectomy
the effectiveness of paracetamol versus ibuprofen in management of patent ductus arteriosus in preterm neonates

Conditions: Patent Ductus Arteriosus in Preterm Infants

Summary: this study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates. the study is being conducted at department of nursery (special care baby unit) and neonatal intensive care unit (nicu), kth, peshawar. neonates diagnosed with patent ductus arteriosus (pda) in the special care baby unit (scbu) and neonatal intensive care unit (nicu) were enrolled in the study after obtaining ethical approval and informed consent from caretakers. the babies received routine care according to departmental policies. for pda management, participants were randomly assigned to group a, receiving oral paracetamol (panadol, 15 mg/kg every 6 hours for 3 days), or group b, receiving oral ibuprofen (brufen, 10 mg/kg followed by 5 mg/kg after 24 and 48 hours). paracetamol was defined as a selective cox-2 inhibitor, while ibuprofen was a non-selective cox inhibitor, both working by inhibiting prostaglandin synthesis. procedures were supervised by a consultant pediatrician, with continuous patient monitoring. treatment effectiveness, defined as complete pda closure on echocardiography, was assessed at the end of the study.


Eligibility criteria:
inclusion criteria: * neonates of gestational age more than 30 weeks and less than 37 weeks * neonates with birthweight of ≥1250g * neonates with postnatal age of 48-96 hours * neonates having one of the following echocardiographic criteria: a duct size \&gt; 2mm, a left atrium-to-aorta ratio \&gt;1.4, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition to clinical signs of patent ductus arteriosus exclusion criteria: * gestational age less than 30 weeks and more than 37 weeks * presence of major congenital abnormalities * right-to-left ductal shunting * life-threatening infection * grade iii or grade iv intraventricular hemorrhage * platelet count of \&lt;60000/mm3 * hyperbilirubinemia requiring blood transfusion * persistent pulmonary hypertension
a study to evaluate safety, pk and pd of fdl169 in cystic fibrosis subjects

Conditions: Cystic Fibrosis

Summary: this is a multicenter, randomized, placebo-controlled, dose-escalation study. enrollment is planned to occur at approximately 14 global sites. approximately 24 subjects with cf.

this is a multicenter, randomized double-blind, placebo-controlled dose-escalation and parallel-arm, dose-ranging study. enrollment is planned to occur at approximately 14 global sites. approximately 24 subjects with cf who are homozygous for the f508del-cftr mutation will be enrolled in two cohorts.

Eligibility criteria:
inclusion criteria: * male or female subjects with a confirmed diagnosis of cf defined as a sweat chloride value ≥60 mmol/l by quantitative pilocarpine iontophoresis or two cf-causing mutations,documented in the subject's medical record or confirmed at screening. * age 18 and above on the date of informed consent. * weight ≥40 kg. * homozygous for the f508del-cftr mutation. genotyping to be confirmed at screening. * ability to perform a valid, reproducible spirometry test with demonstration of a forced expiratory volume in 1 sec (fev1) \>40% of predicted normal for age, sex and height. * screening laboratory tests with no clinically significant abnormalities that would interfere with the study assessments (as judged by the investigator). * subjects who are sexually active must agree to follow the study's contraception requirements. exclusion criteria: * an acute upper or lower respiratory tract infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to day 1. * major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to screening. * impaired renal function or known portal hypertension. * history of prolonged qt and/or qtcf (fridericia's correction) interval (\>450 msec) or qtcf \>450 msec at screening. * history of solid organ or hematological transplantation. * history of alcohol abuse or drug addiction (including cannabis, cocaine and opiates) during the past year, (as judged by the investigator). * use of ivacaftor or lumacaftor, within 4 weeks of day 1 * any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for cf or for cf-related conditions within 4 weeks prior to day 1. * ongoing immunosuppressive therapy (including systemic corticosteroids). * hemoglobin \<10 g/dl. * abnormal liver function, at screening. * abnormal renal function at screening. * ongoing participation in another clinical study or prior participation without appropriate washout (minimum of 10 half- lives or 30 days, whichever is longer) prior to screening visit.

Keywords: cystic fibrosis
ns-050/ncnp-03 in boys with dmd (meteor50)

Conditions: Duchenne Muscular Dystrophy

Summary: this is a phase 1/2 study of multiple-ascending dose (mad) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of ns-050/ncnp-03 administered once weekly to ambulant boys with dmd, who have a dmd exon deletion amenable to exon 50 skipping.


Eligibility criteria:
inclusion criteria: * male ≥ 4 years and \<15 years of age; * confirmed dmd exon deletion in the dystrophin gene that is amenable to skipping of exon 50 to restore the dystrophin mrna reading frame; * able to walk independently without assistive devices; * able to complete the ttstand without assistance in \<20 seconds; * stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study. other inclusion criteria may apply. exclusion criteria: * evidence of symptomatic cardiomyopathy; * current or previous treatment with anabolic steroids (e.g., oxendolone, oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug; * currently taking another investigational drug or has taken another investigational drug within 3 months prior to the first dose of study drug; * surgery within the 3 months prior to the first dose of study drug or planned during the study duration; * having taken any gene therapy. other exclusion criteria may apply.
a comparative safety and activity study with ferroquine associated with artesunate versus amodiaquine associated with artesunate in african adult patients with uncomplicated malaria

Conditions: Malaria

Summary: the primary objective is to assess the safety of different doses of ferroquine with artesunate (as) in adult african patients with uncomplicated malaria. the secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.

the study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. patients remain hospitalized 4 days.

Eligibility criteria:
inclusion criteria: * body weight between 50 kg and 90 kg with body mass index \>18 kg/m² * presence of body temperature ≥ 37.5°c or history of fever within the last 24 hours * monoinfection with plasmodium falciparum and parasitemia within the 100 to 200,000/microl exclusion criteria: * hypersensitivity to quinoleines or artesunate * history or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information * splenectomized patients * laboratory parameters outside normal ranges * presence of hbs antigen, anti-hcv antibodies and anti-hiv 1\&2 antibodies * cardio vascular and electrocardiogram parameters outside normal values * presence of criteria of complicated malaria * permanent vomiting * previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including st john's wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially cyp3a and 2d6 main substrates * positive results on urine drug screen for anti-malaria agents (aminoquinolines) * history of drug or alcohol abuse (alcohol consumption \> 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol) * intention to use herbal medicine during the study period * immunization injection within last 15 days the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: malaria