Kornimate/medical-research-clean huggingface dataset:
zgn-440 (beloranib for subcutaneous injection) for treatment of obesity

Conditions: Obesity

Summary: the purpose of this study is to assess the pharmacokinetics/pharmacodynamics (pk/pd), safety, and effectiveness of multiple subcutaneous doses of beloranib (zgn-440).

this protocol is designed to test the safety and efficacy of a drug called beloranib (zgn-440). it is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. the study will provide information on how much zgn-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility criteria:
inclusion criteria: * obese but otherwise healthy females * non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months) * bmi ≥ 30 and ≤ 45 kg/m2 * stable body weight during the past 2 months exclusion criteria: * use of weight loss agents in the past month * history of eating disorder * history of type 1 or type 2 diabetes mellitus * current smokers

Keywords: obese obesity overweight
reference values for gastric emptying

Conditions: Delayed Gastric Emptying

Summary: healthy volunteers will ingest a 13c-octaoate containing test meal and 13c in expiratory air will be followed. normal values will be calculated data of these tests.

this is a clinical study for establishing reference values in a 13c-octanoate breath test and a 13c-sodium acetate breath test. healthy volunteers (n=75) will eat a solid test meal of scrambled eggs and toast containing 13c-octanoate. 13c-content of exhaled air will be measured at baseline and followed for the next 4 hours. one week later, the healthy volunteers (n=75) will drink a standardized nutritional shake (ensure plus vanille, abbott) containing 13c-sodium acetate. 13c-content of exhaled air will be measured at baseline and for the next 4 hours. estimated gastric emptying time will be calculated using established algorithms.

Eligibility criteria:
inclusion criteria: * subjects free of relevant abdominal complaints * written informed consent exclusion criteria: * age under 18 * previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders) * known diabetes mellitus, scleroderma, neurological impairment or other major current disease * subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, ddv-iv-inhibitors, inkretin-mimetica, non-steroidal anti-inflammatory drugs, macrolid antibiotics * pregnancy beyond week 12 (no pregnancy test will be performed) * involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion * known allergy or intolerance against hen egg protein or gluten
a study in healthy men to test how bi 1810631 is taken up in the body when taken with or without food

Conditions: Healthy

Summary: the main objective of this trial is to investigate the relative bioavailability of a single dose of bi 1810631 intended commercial formulation (icf) under fed (test treatment, t) and fasted (reference treatment, r) conditions.


Eligibility criteria:
inclusion criteria: 1. healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests 2. age of 18 to 55 years (inclusive) 3. body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) 4. signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial exclusion criteria: 1. any finding in the medical examination (including blood pressure (bp), pulse rate (pr) or electrocardiogram (ecg)) deviating from normal and assessed as clinically relevant by the investigator 2. repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 bpm 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.
proteomic analysis in paediatric diabetes type 1 (papd)

Conditions: Diabetes Type 1; Proteomics; Diabetic Peripheral Neuropathy

Summary: the aim of the present study is to investigate a targeted proteomic analysis in plasma of children - of greek origin- with type 1 diabetes (dt1) and its correlation with the electrophysiological findings that accompany diabetic peripheral neuropathy. diabetic neuropathy is the most frequent chronic complication in adults with dt1 and rarely appears in childhood. nevertheless, cases of acute mononeuritis have been described at the time of diagnosis of dt1. according to recent reports several biomarkers, including proteomic analysis, have been proposed for the early detection of peripheral neuropathy in children and young adults with t1dm. in the present study the researchers will attempt to investigate the role of biomarkers with targeted proteomic analysis in the plasma of children with dt1 in combination with an electrophysiological study, which includes a nerve conduction study, to detect early diabetic peripheral neuropathy, before the appearance of clinical manifestations.


Eligibility criteria:
inclusion criteria: 1. children with confirmed dt1 under insulin substitution therapy 2. age 5-10 years 3. good glycemic control with hba1c ≤ 7.0% 4. prepubertal patients 5. absence of other diseases 6. signed informed consent of the parents or guardians of patients exclusion criteria: 1. presence of organic cause for neuropathy 2. presence of other chronic disease 3. poor glycemic control 3. medication

Keywords: plasma proteomics children diabetes type 1 nerve conduction
vibrational-proprioceptive resistance exercise training versus neuromuscular electrical stimulation training in elderly people with muscle weakness

Conditions: Muscle Weakness Condition; Therapy Effect

Summary: study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.


Eligibility criteria:
inclusion criteria: * age related muscle weakness * age between 65-85 years * all inclusion criterias must be fullfilled exclusion criteria: * recent hip or knee endp-prosthesis (within last 2 years), longstanding immobility * body mass index greater than 40 * acute thrombosis in lower extremity (within last 3 weeks) * severe articular effusion * acute infection * known myopathy * relevant neurological diseases with gait disorders (e.g. poly neuropathy, parkinson's disease) * dementia, impaired cognitive abilities * diseases of the vestibular system causing vertigo or impairing balance * symptomatic cardio pulmonal diseases within the last 6 months * not or insufficient treated hypertonia * rheumatic diseases * other relevant functional impairment of the musculo-skeletal system caused by surgery, trauma or degenerative diseases * pain in the lower extremity (vas \> 5) * if one of the above criteria applies the subject will be excluded from the study
protocol for the specified clinical experience investigation on the single use of casodex® tablet 80 mg

Conditions: Prostate Cancer

Summary: to gather information on the safety of monotherapy of casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).


Eligibility criteria:
inclusion criteria: * prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo casodex® tablets monotherapy for not less than 12 months

Keywords: prostate cancer casodex monotherapy
lmwh infusion as anticoagulation for home hd

Conditions: Endstage Renal Disease

Summary: there is a lack of data in the literature about the use of low-molecular weight heparin (lmwh) as anticoagulation for nocturnal home hemodialysis (nhhd). this study aims to evaluate the efficacy and safety of lmwh, administered by infusion method, as compared to unfractionated heparin as anticoagulation for nhhd treatment.

low-molecular weight heparin (lmwh) and unfractionated heparin (ufh) are established systemic anticoagulants for the patients who receive conventional thrice-weekly hemodialysis in absence of significant bleeding risk. for the patients who undergo nocturnal home hemodialysis (nhhd), lmwh is seldom utilized because of the need of an additional bolus injection during a long dialysis treatment, which is impractical as the patients are sleeping during hemodialysis. moreover, there is a potential risk of lmwh accumulation due to its longer half-life. as there is a paucity of data in the literature on the use of lmwh for nhhd treatment, this trial is conducted to assess the safety and efficacy of lmwh, administered by infusion method, in this particular group of dialysis patients.

Eligibility criteria:
inclusion criteria: * prevalent nhhd patients who have received \>1 year dialysis with unfractionated heparin as anticoagulant * age \>= 18 * informed consent available exclusion criteria: * history of intolerance to lmwhs during hd * receiving warfarin or other oral anticoagulant * pregnant patients

Keywords: anticoagulation anti-xa activity low-molecular weight heparin unfractionated heparin
arthroscopic rotator cuff repair: suture anchors versus arthroscopic transosseous fixation

Conditions: Rotator Cuff Tears

Summary: arthroscopic transosseous fixation of rotator cuff tears has become an alternative to arthroscopic suture anchor. this novel technique that allows surgeons to perform a standardized arthroscopic transosseous (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the incidence of shoulder stiffness. the aim of the this study is to compare clinical outcomes of two groups of patients: patients that received an arthroscopic transosseous fixation using the arthrotunneler tunneling device (tornier inc, edina, minnesota) versus patients that received an arthroscopic rotator cuff repair using suture anchors.


Eligibility criteria:
inclusion criteria: * age \> 18, \<65 * rotator cuff tears * patients given written informed consent * bmi ≤ 33 exclusion criteria: * age \> 65, \< 18 * previous surgical intervention * informed consent not accepted * serious comorbidity * diabetes * metabolic disorders * active infections * muscular atrophy * biceps tenodesis
effectiveness of preurodynamic with posturodynamic levofloxacin on the incidence of uti

Conditions: Urinary Tract Infections

Summary: this study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (uti) after urodynamic examination.

this study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (uti) after urodynamic examination. this study uses a randomized single-blind trial design to compare the proportion of posturodynamic uti in the group receiving preurodynamic single-dose levofloxacin with the group receiving three days - once daily of levofloxacin posturodynamic. the target population is patients who undergo urodynamic examination at the rsupn dr. cipto mangunkusumo, siloam asri hospital, and persahabatan hospital during the given time. of the study. the total sample size in this study was determined based on a two-proportion analytical sample calculation formula with type 1 error of 5% and type 2 error of 80%. on the fourth posturodynamic day, urinalysis and urine culture were performed to determine the diagnosis of uti. to analyze the association between uti and the treatment group, the chi-square test was used. results were considered statistically significant if p \< 0.05. the expected results are data on the comparison of the incidence of uti after urodynamic examination in the group given a single dose of levofloxacin and levofloxacin for three days post-examination. the incidence of uti in the group receiving a single preurodynamic dose of levofloxacin compared to the group receiving levofloxacin for three days posturodynamics.

Eligibility criteria:
inclusion criteria: * male/female patients \> 18 years who have indications for urodynamics * willing to participate in research exclusion criteria: * allergy to levofloxacin * history of taking antibiotics in 1 month • pregnant * uncontrolled dm * use a urinary catheter * having a uti before urodynamics, based on clinical symptoms and urine examination results * refuse to participate in research

Keywords: urodynamics antibiotics prophylaxis
safety and efficacy of ft218 in idiopathic hypersomnia (revitalyz)

Conditions: Idiopathic Hypersomnia

Summary: this is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of ft218. ft218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. the study will enroll subjects who are diagnosed with idiopathic hypersomnia. subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. the estimated total duration of study for each subject is approximately 18 weeks, including the screening period.


Eligibility criteria:
inclusion criteria: * primary diagnosis of idiopathic hypersomnia * total ess score at screening \> 11 if not on prior oxybate * average nightly total sleep time of \> 7 hours * may use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to screening, and remain stable until the double-blind, randomized withdrawal visit * females of childbearing potential must use highly effective contraception for 2 months prior to baseline, throughout the study, and for 30 days after the last dose of study drug * males with female partners of childbearing potential must use condoms throughout the study and for 30 days after the last dose of study drug * willing and able to provide informed consent and comply with the requirements of the study exclusion criteria: * pregnant, nursing or lactating females * hypersomnia due to another medical, behavioral, sleep, or psychiatric condition * untreated or incompletely treated sleep apnea in patients with an apnea-hypopnea index (ahi) ≥ 15 by american academy of sleep medicine (aasm) 1a criteria * clinically significant parasomnias * history or presence of seizures, head trauma, succinic semialdehyde dehydrogenase deficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment * history or presence of bipolar and related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders * ongoing or past (within 1 year) major depressive episode * at risk for suicide or history of suicide attempt * if not on oxybate at screening, treatment or planned treatment with any central nervous system (cns) sedating agents during study * current or past substance use disorder (including alcohol or cannabinoids) * excessive caffeine consumption (\> 600 mg/day) * prior treatment with either ft218 or lumryz
prospective bladder cancer infrastructure (probci)

Conditions: Bladder Cancer

Summary: prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the netherlands


Eligibility criteria:
inclusion criteria: * bladder cancer * any stage except ta * 18 years or older * written informed consent exclusion criteria: * no exclusion criteria note: participation in probci does not exclude the patient from participation in other studies.

Keywords: bladder cancer prospective cohort
parental involvement in pain reducing measures

Conditions: Procedural Pain; Preterm Infants; Parents

Summary: this pilot study was conceptualised to determine the feasibility of involving parents via facilitated tucking or observing during painful procedures and to measure change in parental stress and infant pain. an additional purpose of this pilot study was to determine the size of the cohort of preterm infants needed for a larger trial, the time, and resources required for recruitment and data collection.

objectives in this pilot study, the aims were to determine the feasibility of whether pain behaviour in extremely and very preterm infants and perceived parental stress change when parents are involved in pain reducing measures, either actively, performing facilitated tucking or passively, observing the intervention, in comparison to the involvement of nurses only. in addition, the infant's pain reactivity and parental stress over three time points of measurement was of interest. methods extremely and very preterm infants in need of subcutaneous erythropoietin were randomly assigned to the two intervention groups. the intervention encompassed that one parent of each infant was involved during the painful procedure: either parents executed facilitated tucking themselves or stood by, observing the procedure. usual care involved that nurse executed facilitated tucking. all infants received 0.5ml of 30% oral glucose solution via cotton swab before the painful procedure. infant pain was observed with the bernese pain scale for neonates (bpsn) and measured with the skin conductance algesimeter (sca) before, during, and after the procedure. parents' stress levels were measured before and after the painful procedure on the infant, using the current strain short questionnaire (cssq). feasibility of a subsequent trial was determined by assessing recruitment, measurement and active parental involvement. quantitative data collection methods (i.e., questionnaires, algesimeter) were employed to determine the number of participants for a larger trial and measurement adequacy. qualitative data (interviews) was employed to determine parents' perspectives of their involvement.

Eligibility criteria:
inclusion criteria: * premature infants born at the nicu concerned * born between 24 0/7- 32 0/7 weeks of gestation, birthweight (bw) \<1250g * infant in need of s.c. erythropoietin * parents fluently speaking and writing in german * written informed consent by parents exclusion criteria: * premature infant with an umbilical artery ph measurement \<7.00 or asphyxia * premature infant with life threatening malformations of the central nervous system * premature infant with intracranial haemorrhage (even if not present at the start of the study) * premature infant with any surgical intervention * parents with substance abuse (i.e., methadone, heroin, etc.), as mentioned in the electronic patient documentation (epd)

Keywords: pain stress preterm infants parents
clinical disease activity with long term natalizumab treatment

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (flair) lesions over time in approximately 300 relapsing-remitting multiple sclerosis (rrms) participants with regular mri follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the czech republic; and 2) approximately 70 participants from belgium. the secondary objectives of this study are as follows: brain volume change by various measures; changes in the number and volume of magnetic resonance imaging (mri) lesions; no evidence of disease activity (neda) with and without brain volume change.

natalizumab will not be provided to participants by biogen as a part of this study. participants will remain on natalizumab therapy as prescribed by their physician.

Eligibility criteria:
key inclusion criteria: * diagnosis of rrms. * continuous treatment with natalizumab of ≥24 months. in case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected. * ≥1 mri scan of sufficient quality for reliable measurement. * baseline mri scan ≤6 month prior to natalizumab treatment acquired. * ≥1 mri scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months. * edss ≤ 6.5. key exclusion criteria: * anti-natalizumab antibody detection. * prior treatment with alemtuzumab. * prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: rrms mri
ivabradine in hemodialysed patients with increased heart rate

Conditions: High Heart Rate

Summary: a significant association between resting heart rate (hr) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease. cardiac disease is the leading cause of death among hemodialysis (hd) patients a recent study reported that the 48-hr mean hr is an independent predictor of cardiovascular events in normotensive hemodialysis patients. ivabradine, a pure hr lowering agent,acting on if current inhibition has proven beneficial antianginal effects and mortality reduction linked to hr reduction in ischemic patients. aim: to evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis hr (\> 80 bpm)


Eligibility criteria:
inclusion criteria: * dialysis patients * sinus rhythm * pre-dialytic heart rate \> 80 bpm exclusion criteria: * atrial fibrillation/atrial flutter * heart failure * valvular disease

Keywords: heart rate dialysis esrd ivabradine
indocyanine green fluorescence imaging in prevention of colorectal anastomotic leakage

Conditions: Colorectal Cancer; Colorectal Neoplasms; Gastrointestinal Cancer; Gastrointestinal Neoplasms; Diverticulosis, Colonic; Gastrointestinal Disease

Summary: this is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.


Eligibility criteria:
inclusion criteria: * all consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study. * of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold). exclusion criteria: * emergent patients * patients with proven diverticular abscess and colonic fistulas are excluded * patients with planned open surgery are excluded.

Keywords: colorectal surgery anastomosis anastomosis leak fluorescence imaging