Kornimate/medical-research-clean huggingface dataset:
single rising dose study investigating the safety, tolerability and pharmacokinetics of spray dried bibn 4096 bs after inhalation administration in healthy male and female volunteers

Conditions: Healthy

Summary: the purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of bibn 4096 bs after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. according to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of bibn 4096 bs (sd i). following implementation of amendment 2, this objective was extended to the second spray-dried inhalation formulation sd ii with and without concomitant administration of lactose


Eligibility criteria:
inclusion criteria: subjects could be included in the study if they met the following criteria: * healthy male or female volunteers * written informed consent in accordance with good clinical practice (gcp) and the local legislation prior to admission to the study * age 21 - 50 years * body mass index (bmi): 18.5 - 29.9 kg/m2 exclusion criteria: subjects were not allowed to participate if any of the following applied: * any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ecg) deviating from normal and of clinical relevance * raw \> 3 cm h2o • s • l-1 or fev1 \<80% of predicted * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system, psychiatric disorders or neurological disorders * history of relevant orthostatic hypotension, fainting spells or blackouts, * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study * use of any drugs which might influence the results of the trial (within 1 week prior to administration of investigational drug or during the trial) * participation in another trial with an investigational drug (within 2 months prior to drug administration or during the trial) * smoker (\>10 cigarettes/day or \>3 cigars/day or \>3 pipes/day) * inability to refrain from smoking on trial days * alcohol abuse (\>60 gram/day) * drug abuse * blood donation (≥100 ml within 4 weeks prior to administration of investigational drug or during the trial) * excessive physical activities (within the last week before the study) * any laboratory value outside the reference range and of clinical relevance * for female subjects: * pregnancy * positive pregnancy test * no adequate contraception e.g. oral contraceptives, sterilization, intrauterine device * inability to maintain this adequate contraception during the whole study period, * lactation period
growth hormone dynamics and cardiac steatosis in hiv

Conditions: Human Immunodeficiency Virus; Lipodystrophy; Cardiac Disease

Summary: cardiac steatosis is increased among individuals with hiv, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. the pathogenesis and treatment of cardiac steatosis is not well understood. the investigators have previously shown that perturbed growth hormone (gh) secretion in hiv contributes to ectopic fat accumulation in the viscera and the liver. moreover, the investigators have found that augmentation of endogenous gh secretion with the fda-approved medication tesamorelin reduces visceral and hepatic fat. in this longitudinal observational study, the investigators will examine patients with hiv and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. the investigators hypothesize that blunted gh secretion in hiv is associated with cardiac steatosis. the investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.


Eligibility criteria:
inclusion criteria: * men and women, ages 40-70 years * documented hiv infection on stable antiretroviral therapy for ≥ 3 months * abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women * indication for tesamorelin per clinical judgment exclusion criteria: * cd4 \ 400 copies/ml * current active aids-defining illness * history or symptoms consistent with heart failure * standard contraindications to mri including severe allergy to gadolinium * glomerular filtration rate (egfr) \< 45 ml/min/1.73 m2 within one month of mri study * use of growth hormone-releasing hormone (ghrh) or growth hormone (gh) within the past 6 months * hba1c \> 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months * change in statin therapy within the past 3 months * chronic corticosteroid use except intermittent topic steroid creams or inhalers * pregnancy or breastfeeding
web-based personal or peer group weight management study

Conditions: Overweight and Obesity; Cardiovascular Risk Factors; Quality of Life; Work Ability

Summary: the pergroup trial aims to investigate whether web-based personal or web-based group counselling weight management program can help to achieve lifestyle changes needed for weight loss and improvement in quality of life and cardiovascular risk factors. the control group is the traditional nurse-lead weight management group counselling.

in this study, efficacy of two web-based weight management systems will be compared to a traditional nurse-lead sessions for weight management. ten nurse-lead group counselling sessions lasting 90 minutes each will be conducted in three groups of 10-14 participants. each session comprise education about healthy diet, psychoeducation and discussions. the web-based group counselling program offers informative weight management system with peer-based conversation possibility. three groups of 10-14 participants who gather together for three nurse-lead sessions in the weeks 0, 5, and 12. the web-based program can be used for a year. the web-based personal counselling program offers informative weight management system with conversation possibility with the nurse for 12 weeks. altogether 37 participants are enrolled and they can use the web-based weight management system for one year. in each intervention arm, intervention and counselling provided by the study nurses last for three months. among all participants, weight loss, cardiometabolic data, information of lifestyle and quality of life will be measured at baseline, after the nurse-lead intervention (three months) and 12 months from the baseline.

Eligibility criteria:
inclusion criteria: * body mass index 25 kg/m2 or higher exclusion criteria: * pregnancy * active cancer * acute cardiovascular event less than three months before * untreated thyroid disease * systematic corticosteroid medication * anorexia or bulimia * impaired communication ability
effect of two exercise programs on obese patients

Conditions: Obesity; Hypertension

Summary: the purpose of the study is to compare the effectiveness of two exercise programs (high intensity interval training/hiit and low intensity (lit) long duration training) on decreasing fat mass and preserving lean body mass in obese patients. what the investigators are proposing is that hiit is less effective because it will most likely decrease lean body mass in obese patients, whereas lit decreases fat mass and conserves lean body tissue.


Eligibility criteria:
inclusion criteria: * anyone with a bmi of 25 and above exclusion criteria: * those that cannot exercise
barostim neo system in the treatment of heart failure

Conditions: Heart Failure

Summary: the purpose of this portion of study nct01471860 is to assess the long-term safety and efficacy of the barostim neo system in canadian study participants implanted with the device.

the neo randomized heart failure study is a prospective, randomized, study describing the safety and efficacy of the barostim neo system in the heart failure participants with a left ventricular ejection fraction ≤ 35%. during long-term follow-up, all participants are required to have at least one annual visit. parameters assessed during long-term follow-up visits: * physical assessment * subject medications * serious adverse events

Eligibility criteria:
inclusion criteria: * actively participating in the neo randomized heart failure study. * have signed a revised approved informed consent form for continued participation in this study. exclusion criteria: * treating physician decision that the subject should not continue with therapy.
effect of helicobacter pylori on the availability of vitamin e and c

Conditions: Heliobacter Pylori Infection

Summary: this study argues that h.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants(vit e and vit c) that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer.

it has been postulated that dietary antioxidants may reduce cancer risk by modulating red-ox status, by preventing biological oxidation, and by inhibiting the formation of carcinogen. however, supplementation studies and prospective studies have yielded contradictory results. in the case of gastric cancer, h.pylori infection, which is known to be associated with a higher risk of the disease, results in an increased production of ros \& rns. as a result serum levels of these free radicals increase, exerting a higher demand for dietary antioxidants to neutralize them. the fact that the relation between serum levels of antioxidants and gastric cancer is more consistent than that of dietary intake levels and the disease suggests the possibility of the presence of an intrinsic factor that is altering the true relation between dietary antioxidants and the cancer. this intrinsic factor, this study argues, is the infection with h.pylori. h.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer. the purpose of this pilot study is to investigate the possibility that h.pylori infection alters the bioavailability of the dietary antioxidants: vitamin c, and vitamin e. this project will be done in preparation for an etiologic study of dietary antioxidants and gastric cancer.

Eligibility criteria:
inclusion criteria: * adult , age 18-45 exclusion criteria: 1. smoking 2. body mass index below 18 or above 25. 3. previous treatment for h.pylori infection 4. partial or total gastrectomy 5. history of gastritis 6. currently taking antioxidants supplementation 7. training in an athletic team. 8. drinking more than 3 servings of alcohol/day

Keywords: heliobacter pylori infection reactive oxygen species antioxidants
cycling exercise in mechanical ventilation

Conditions: Muscle Weakness; Mechanical Ventilation Complication

Summary: prolonged critical illness renders survivors with increased long-term morbidity associated with high healthcare costs. muscle weakness and fatigue are reported as the main contributors to long-term poor functional outcomes. emerging evidence for early mobilisation demonstrates reduction in the number of ventilator days and hospital length of stay. it has been demonstrated that daytime motoring (passive and active) can improve functional capacity in intensive care patients. the aim of the proposed study is to evaluate the effect of cycling exercise in patients on mechanical ventilation appointed to weaning process.

this prospective randomized study is being performed at the department of anesthesiology, resuscitation and intensive care (carim) of the university hospital ostrava. all mechanically ventilated patients are followed. at the time of weaning initiation, the randomization into two groups (the study (cycling) and control group) is performed. the physiotherapy will be carried out twice a day in both groups according to the mobility protocol. the cycling exercise is performed only in the study group, once a day. before a patient is released from the icu, a cycling test, dynamometry test will be performed on both groups.

Eligibility criteria:
inclusion criteria: * age \> 18 years * icu admission * mechanically ventilated for more than 5 days * indications for starting weaning * informed consent for participation exclusion criteria: * inability to use cycling exercise: trauma or operation of lower limbs, pelvis, open abdomen, non-cooperation (qualitative and quantitative disturbance of consciousness) * encephalopathy (ischemic, traumatic) * extreme obesity (body mass index ≥ 40) * anticipated survival time ≤ 7 days * patient height ≤ 1.5 m * more than 48 hours of mechanical ventilation outside of the department

Keywords: cycling exercise mechanically ventilated patient muscle strength assessment muscle weakness
pediatric philadelphia positive acute lymphoblastic leukemia

Conditions: Leukemia, Pediatric

Summary: the purpose of this study is to determine whether dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (all) * age \>1 year and \< less than 18 years old * induction chemotherapy ≤ 14 days according to institutional standard of care * adequate liver, renal and cardiac function exclusion criteria: * prior treatment with a oncogene fusion protein (bcr-abl) inhibitor * extramedullary involvement of the testicles * active systemic bacterial, fungal or viral infection * down syndrome
efficacy and safety of ilaprazole based bismuth-containing quadruple regimen for the first-line treatment of helicobacter pylori infection

Conditions: Helicobacter Pylori Eradication Antibiotic

Summary: this study compared efficacy and safety of ilaprazole based bismuth-containing quadruple regimen therapy including ilaprazole 5mg, bismuth potassium citrate 220mg, clarithromycin 500mg and amoxicillin cap (amoxicillin) 1000mg bid on the first line eradication treatment of h.pylori. participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be h.pylori positive patients in the biopsy and ubt test. for 14 days, participants treated as esoprazole based bismuth-containing quadruple regimen therapy therapy including esoprazole 20mg, bismuth potassium citrate 220mg, clarithromycin 500mg and amoxicillin cap (amoxicillin) 1000mg bid. after treatment, the healing rate was evaluated in the ubt test and biopsy at 49±5days from the first day dosing.

this study compared efficacy and safety of ilaprazole based bismuth-containing quadruple regimen therapy including ilaprazole 5mg, bismuth potassium citrate 220mg，clarithromycin 500mg and amoxicillin cap(amoxicillin) 1000mg bid on the first line eradication treatment of h.pylori. participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be h.pylori positive patients in the biopsy and ubt test. for 14 days, participants treated as esoprazole based bismuth-containing quadruple regimen therapy therapy including esoprazole 20mg, bismuth potassium citrate 220mg，clarithromycin 500mg and amoxicillin cap (amoxicillin) 1000mg bid. after treatment, the healing rate was evaluated in the ubt test and biopsy at 49±5days from the first day dosing.

Eligibility criteria:
inclusion criteria: * subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be h.pylori positive patients in the biopsy and ubt test. * subject who fully understands conditions of clinical trial. * subject who agrees to participate and spontaneously sign the icf. exclusion criteria: * known hypersensitivity to any component of ilaprazole, amoxicillin and levofloxacin. * subjects who are taking contraindicated medications for experimental and concomitant drug. * patients with abnormal levels in the laboratory tests. * total bilirubin, creatinine\> 1.5 times upper limit of normal. * ast, alt, alkaline phosphatase, bun\> 2 times upper limit of normal. * administrated of ppi, antibiotic medication within 4 weeks prior to commencement of the study. * pregnant and/or lactating women. * reproductive aged women not using contraception. * uncontrolled diabetics. * uncontrolled hypertension. * uncontrolled liver dysfunction.
acupuncture in diabetic peripheral neuropathy

Conditions: Diabetic Neuropathy

Summary: multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.

the study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. neurophysiological testing of the affected nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.

Eligibility criteria:
inclusion criteria, among others: * diagnosis of diabetic peripheral neuropathy in diabetes mellitus type 2 * males and females aged \>18yrs \< 70yrs * minimum overall complaints of minimum 40mm on a visual analogue scale (vas) * completed titration of pain medication against diabetic peripheral neuropathy * pathological nerve conduction velocity and amplitude of n. suralis ( \<42meter/second and or \< 6 mikrovolt) exclusion criteria, among others: * very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles * neuropathy due to other reasons such as borrelia infection, hiv, hereditary, alcohol toxic, or related to history of neurotoxic drugs. * severe peripheral artery disease fontaine stage iv * ulcers or gangrenous lesions of the feet

Keywords: acupuncture peripheral neuropathy diabetes mellitus type ii neurophysiology nerve conduction velocity
cnksr2 natural history study

Conditions: Developmental Dysphasia; Epileptic Encephalopathy, Childhood-Onset; X-Linked Intellectual Disability

Summary: this prospective natural history study is being conducted to define the electroclinical, neurodevelopmental, and behavioral characteristics of cnksr2 epilepsy aphasia syndrome (eas) and intellectual disability (id) in children aged 6 to 21 years old with cnksr2 mutations. the data collected from this study will serve as an external control to eventual clinical trials examining precision medicine investigational therapeutics that aim to improve the seizure burden and neurodevelopmental outcomes in patients with cnksr2 eas/id.


Eligibility criteria:
inclusion criteria: 1. age between 6 and 21 years (inclusive) at time of consent. 2. confirmed cnksr2 mutation, as demonstrated by genetic testing and confirmed by the investigators. 3. confirmed intellectual disability or developmental delays, as defined by the american academy of pediatrics (moeschler, j, et al. 2014). exclusion criteria: 1. known pathogenic or clinically suspected mutation in a seizure-associated gene besides cnksr2. 2. confirmed mutation in a gene besides cnksr2 that is known to increase the severity of the seizure phenotype. 3. known central nervous system structural abnormality confirmed by imaging scan of the brain that is not consistent with the clinical phenotype of cnksr2 eas / id.

Keywords: x-linked intellectual disability eses csws cnksr2 epilepsy language disorder
anticoagulant utilization pattern

Conditions: Atrial Fibrillation

Summary: this study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a united states commercial insurance database.


Eligibility criteria:
inclusion criteria: * a recorded diagnosis of atrial fibrillation * initiation of oral anticoagulant medication * congestive heart failure, hypertension, age \> 75, diabetes mellitus, prior stroke or transient ischemic attack, vascular disease, age 65-74, sex category (cha2ds2-vasc) score \>=1 * at least 18 years of age on the date of anticoagulant initiation exclusion criteria: * patients with missing or ambiguous age or sex information * patients with documented evidence of valvular disease * patients with less than 12 months enrolment in the unitedhealth research database preceding the first dispensing * patients with prior use of any oral anticoagulant
renal assist device (rad) for patients with renal insufficiency undergoing cardiac surgery

Conditions: Renal Insufficiency; Acute Kidney Injury

Summary: the study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the juxtaflow system (also known as the juxtaflow renal assist device (rad)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

the bipass-aki study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (csa-aki), and, subsequently, overall poor outcomes. patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative egfr between 15-60 ml/min. participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. participants will receive implantation of the juxtaflow catheters following completion of the their cardiac surgery while remaining under anesthesia. treatment with the juxtaflow system will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.

Eligibility criteria:
inclusion criteria: 1. candidate cardiac surgical patients 2. elective or urgent on-pump coronary artery bypass grafting (cabg) and/or valvular surgery 3. age 22 to 85 years 4. egfr \< 60 ml/min/1.73m2 5. signed informed consent exclusion criteria: 1. end-stage renal disease (receiving hemodialysis or glomerular filtration rate \<15 ml/min/1.73m2) 2. planned off-pump surgery 3. any patients with high-grade proteinuria (i.e., urine protein concentration \> 300 mg/dl) 4. pregnancy 5. any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals 6. current or planned treatment with an investigational drug (ind), device (ide), or other investigational intervention within 3 months prior to or during participation in this clinical trial

Keywords: cardiac surgery associated acute kidney injury (csa-aki) renal compromise kidney disease cardiopulmonary bypass renal assist device (rad) cardiac surgery