Kornimate/medical-research-clean huggingface dataset:
study of cardiovascular disease and obstructive sleep apnea

Conditions: Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour); Hypertension

Summary: the purpose of this study is to determine if two medicines (allopurinol and losartan) can influence heart and blood vessel health compared to placebo in patients with sleep apnea who are using continuous positive airway pressure (cpap).

the specific aims of this research project are: 1) determine if treatment with losartan, an angiotensin type i receptor (at1r) antagonist, or allopurinol, a xo inhibitor, normalize chemoreflex control of sympathetic outflow and ventilation and improve local vascular regulation and stiffness; and 2) determine if these interventions reduce the severity of sleep disordered breathing and lower diurnal blood pressure.

Eligibility criteria:
inclusion criteria: * males and females between ages of 21 and 65 years * apnea hypopnea index or respiratory disturbance index greater than or equal to 25 events per hour * subjects eligible for cpap or bipap therapy * hypertension by clinical history/diagnosis (may be controlled with non- exclusionary medications) or average blood pressure \> 140/90 mm hg (using last two measurements in prior 12 months - or 1 prior blood pressure and 1 blood pressure at screening) exclusion criteria: * if subject not using cpap, having ahi \> 60 events/hour or oxygen saturation ≤ 65% during sleep * presence of clinical cv disease (coronary artery disease, angina, arrhythmias (subjects with sinus arrhythmias will be reviewed by pi for enrollment), stroke, tia, cor pulmonale, etc.), heart failure, bruits, or diabetes mellitus by clinical diagnosis/history * presence of pulmonary disease that results in significant hypoxemia (resting sao2 \< 88%) * hypertriglyceridemia (triglycerides \>300 mg/dl), diabetes or impaired glucose tolerance (fasting plasma glucose \> 125 mg/dl) * patients taking angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, potassium-sparing diuretics (without accompanying loop/thiazide diuretic), allopurinol, oxypurinol, febuxostat, amoxicillin, ampicillin, azathioprine or mercaptopurine. * patients with chronic kidney disease (serum creatinine \>1.5 mg/dl) or history of significant hyperkalemia (serum potassium \> 5.2 meq/l) with arb therapy * patients with history of angioedema * patients with bilateral,modified radical or radical mastectomies * patients who have a serum potassium \> 5.0 meq/l at the screening visit * female patients who are pregnant (determined by urine pregnancy test) or breastfeeding * patients with active mrsa or vre (vancomycin resistant enterococcus) infection * history of adverse reaction to allopurinol,losartan, or zolpidem\*\* * patients who cannot swallow oral capsules * patients who are hospitalized or who have been recently hospitalized (last 2 weeks) * inability to comply with or complete the protocol or other reasons at the discretion of the investigators

Keywords: hypertension high blood pressure sleep apnea obstructive sleep apnea osa
treatment patients with pulmonary metastasis of liver cancer with apatinib combination with tace: a clinical study

Conditions: Hepatocellular Carcinoma; Pulmonary Metastasis

Summary: this study mainly evaluate the clinical effect of apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.half of participants will receive apatinib and transcatheter arterial chemoembolization (tace) therapy in combination,while the other half will receive tace therapy alone.

apatinib is a vegfr targeting tyrosine kinase inhibitor, which has preliminary demonstrated the efficacy and safety in treatment of advanced hepatocellular carcinoma by phase ii stage research. pulmonary metastasis of hepatocellular cancer is one of the difficulties in clinical practice,because it's not sensitive to systemic chemotherapy.this phase ⅲ study aims to evaluates the efficacy and safety of the apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatocellular carcinoma * refused to sorafenib treatment * have at least one measurable pulmonary lesions * expected survival time ≥ 12 weeks exclusion criteria: * within four weeks before the study received radiotherapy or chemotherapy * with a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)

Keywords: hepatocellular carcinoma pulmonary metastasis apatinib efficacy safety
ophthalmologic safety of long term treatment with pramipexole compared to bromocriptine or other dopamine agonists in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: study to assess and compare the safety of long term oral treatment for parkinson's disease with pramipexole versus bromocriptine or other dopamine agonists, by measuring cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal degeneration, in a matched pair design


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease * patients treated consecutively with either pramipexole or bromocriptine (or other dopamine agonists except ropinirole) for at least two and a half years (i.e. 30 months). interruptions of ongoing dopamine agonists treatment for less than one month per year duration are acceptable, however, interruptions within the last 6 months are not acceptable. patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 month treatment * written informed consent in accordance with good clinical practice (gcp) and local legislation exclusion criteria: * patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist (regardless of the duration of treatment with a previous dopamine agonist) * patient treated with ropinirole * patients with any of the following: * patients with a hereditary retinal disease and/or a family history of hereditary retinal disease * patients with a history of drug-induced retinopathies * patients with a history of surgically or laser-treated diabetic retinopathy * patients with atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases (e.g. progressive, supranuclear palsy, multisystem atrophy) * dementia or other disorders that could impair the signing of informed consent * patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the first visit (patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 months treatment duration
a double blinded study to examine the effect of alpha agonist ointment on fecal incontinence in patients with idiopathic fecal incontinence

Conditions: Idiopathic Fecal Incontinence

Summary: the purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.

this is a double blinded cross over study. approximately 40 subjects will be participating in this 4 weeks study. a screening visit will be used to determine eligibility for the study. patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. this will be followed by a second 2 weeks treatment cycle in which: * patients previously treated with alpha agonist will be treated with placebo. * patients previously treated with placebo will be treated with alpha agonist.

Eligibility criteria:
inclusion criteria: * signed written informed consent. * male or female subjects 18 to 65 years of age. * fecal incontinence score over 8. * the patient is able to understand the treatment and is willing to comply with the prescribed regimen. exclusion criteria: - has a clinically significant history or presence of any of the following conditions: * known allergy to the api. * porphyria. * glaucoma. * pregnancy or lactation. * active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities; * type 1 diabetes mellitus; * insulin treated type 2 diabetes mellitus. * renal insufficiency. * liver insufficiency. * malignant disease within 5 years of screening; * has hypertension (sitting blood pressure over 140/90 mmhg at screening) * history of rectal surgery. * history of hiv, hepatitis b, hepatitis. * has used, in the last four weeks, drugs that may affect blood coagulation, such as aspirin (at a dose above 250 mg/day), warfarin, sintrom, enoxaparin, nadroparin, heparin, clopidogrel, ticlopidine. * use of tricyclic or monoamine-oxidase inhibitors. * has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion. * unable to understand the use instruction for the ointment, as judged by the investigator.

Keywords: fecal incontinence alpha agonist
rheumatoid arthritis-associated interstitial lung disease: characterization of lung disease progression

Conditions: Rheumatoid Lung; Rheumatoid Arthritis; Interstitial Lung Disease; Pulmonary Fibrosis

Summary: bertha study´s primary objective is to characterize rheumatoid arthritis-associated interstitial lung disease (ra-ild) progression and to define a combination of biomarkers, genetic and clinical variables capable of identifying patients at risk of ra-ild progression

bertha is a multicentric, observational study that will enroll 100 ra-ild patients to be followed for 2 years. interstitial lung disease (ild) progression will be ascertained by quantitative image analysis and functional parameters. variables associated with progression with be identified. additionally, ra-ild endotypes will be investigated as well as their association with ra-ild progression.

Eligibility criteria:
inclusion criteria: 1. consecutive adult patients (aged \>18 years) meeting ra diagnostic criteria in accordance with acr 2010 2. presence of interstitial lung disease 2.1 ild definition: presence of interstitial alterations in hrct associated to functional derangements and/or symptoms 3. patient agrees with having follow-up visits every 6 months for 2 years exclusion criteria: 1. pregnancy or intending to become pregnant 2. overlap with other diseases that occurs with ild (other collagenoses, vasculitis, inflammatory bowel disease) 3. presence of advanced ild, characterized by: a. dyspnea rated as modified medical research council 4 (mmrc4) on routine visit 4. presence of significant arterial pulmonary hypertension: 1. evidence of right ventricular failure evidence by echocardiography 2. previous right chamber catheterism showing cardiac index \< 2 liters/min/m² 5. significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
immune response regulation and nutritional status of the crohn's disease patients.

Conditions: Crohn's Disease

Summary: the objective of this study was to evaluate the effect of whey protein (wp) and soy protein (sp) nutritional supplements on nutritional status and disease activity in crohn's disease patients.

the patients were split into two groups: one group was supplemented with whey protein and the other, with soy protein. participants were assessed at three moments: before starting the intervention and after 8 and 16 weeks. the nutritional status and body composition were measured using bioimpedance analysis, anthropometry and albumin and pre-albumin dosages. dietary intake was determined by 24-h dietary recalls. the disease activity was evaluated by crohn's disease activity index, serum cytokines and c-reactive protein dosages.

Eligibility criteria:
inclusion criteria: * crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-tnf-alpha) or azathioprine and anti-tnf-alpha exclusion criteria: * smokers * who were using other medication or nutritional supplements.

Keywords: crohn's disease whey protein soy protein nutritional status activity of disease
flow mediated dilation in response to black tea

Conditions: Vascular Function

Summary: research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. in a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. the current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.

epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. in a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by flow mediated dilation in various populations. the current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.

Eligibility criteria:
inclusion criteria: * males and post menopausal (\> 1 year) females, not on hormone replacement therapy * aged \>18 and \< 65 years * body mass index (bmi) of \>=18.0 and =\<35.0 kg/m2 * hypertension as previously diagnosed by primary care or hospital physician. * if untreated, office bp between 140/90 mmhg and 160/100 mmhg on screening * if treated, a controlled blood pressure (\<160/100) on stable medication for at least 4 weeks exclusion criteria: * tea drinkers: having typically consumed \> 1 cup of black tea per week. * current smoker or has stopped smoking less than 6 months before start of study * self reported alcohol intake of \>21 units/week * established cardiovascular disease other than hypertension * clinically significant arrhythmia * diabetes mellitus * chronic kidney disease \> stage 2 * 10-year cardiovascular risk equivalent to 20% or greater using the qrisk2 calculator * abnormality of laboratory blood tests considered clinically significant * any other significant intercurrent condition/disease

Keywords: flow mediated dilation tea blood pressure
observational study to evaluate short and long-term safety of the absorb scaffold

Conditions: Coronary Artery Stenosis

Summary: the german-austrian absorb register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the absorb (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery disease.

the register collects prospective data regarding the quality of care of this therapy concept including specifically the following objectives: * documentation of all consecutive patients having been treated with the absorb biore-sorbable vascular scaffold system under clinical real-world conditions * documentation of indications, procedural results, and short and long-term outcomes * documentation of the technical performance of absorb implant procedures * collection of safety data, in particular documentation of hospital mortality, major non-fatal complications (especially myocardial infarction, re-pci (percutaneous coronary intervention) or cabg (coronary artery bypass grafting), stroke, thrombosis) * documentation of long-term patient safety marked by mortality and major non-fatal complications (especially myocardial infarction, re-pci or cabg, stroke, thrombosis) at 30 days, 6 months, 2 years and 5 years * gathering of health economics data (capture of direct costs, especially with view to change of medication and outpatient/inpatient hospital services, and indirect costs) pre and post absorb implant * gathering data on the quality of life pre and post absorb implant to document individual qol dimensions as well as qaly (quality adjusted life year) data

Eligibility criteria:
inclusion criteria: * absorb implant scheduled * age 18+ * patients giving consent to keep scheduled follow-ups * signed informed consent exclusion criteria: * none

Keywords: coronary artery stenosis, vascular scaffold, absorb
cognitive remediation in 22q11ds

Conditions: 22q11.2 Deletion Syndrome; Velo-Cardio-Facial Syndrome

Summary: the goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11ds). this study involves a two part approaching including a computerized cognitive remediation program (ccrp, posit science, ca) in combination with a social cognitive training (sct) program. the computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11ds, who have unique needs due to their lower iq and high risk of psychosis in late adolescence and adulthood. the sct is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. a preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.


Eligibility criteria:
inclusion criteria: * molecular/cytogenetic confirmation of 22q11ds exclusion criteria: * intelligence quotient \<60 * diagnosis of psychosis * pregnancy * home location does not permit participation in small groups

Keywords: cognitive remediation social cognition
laparoscopic versus robot-assisted left-sided pancreatectomy for benign and pre-malignant lesions (diploma-3)

Conditions: Pancreatectomy; Distal Pancreatectomy (DP); Pancreatic Neoplasms; Pancreatic Adenoma; Pancreatic Cyst; Pancreatic Cystadenoma; Surgery; Minimally Invasive Surgical Technique; Minimally Invasive Distal Pancreatectomy; Minimally Invasive Surgery

Summary: the diploma-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.


Eligibility criteria:
inclusion criteria: * age at least 18 years; * indication for elective left-sided pancreatectomy, either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease); * both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team; * fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist; * written informed consent exclusion criteria: * suspected pancreatic ductal adenocarcinoma; * tumor or cyst larger than 8 cm; * required resection or ablation of organs other than pancreas and spleen; * tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava); * pregnancy; * body mass index \>40 kg/m2; * participation in another study with interference of study outcomes

Keywords: pancreas surgery left-sided pancreatectomy distal pancreatectomy minimally invasive surgery robot-assisted pancreatectomy left pancreatectomy robotic pancreatectomy laparoscopic pancreatectomy
development and validation of a disability severity index for cmt

Conditions: Charcot Marie Tooth Disease

Summary: it is necessary for outcome measures to accurately reflect the state of health of a person in order for clinical trials to show benefit. the most commonly used outcome measure for charcot marie tooth disease (cmt) is the cmt neuropathy score, which uses cutoffs of points designated as mild (0-10 points), moderate (11-20) or severe (21-36). these terms are arbitrary. this study is looking to base mild, moderate, and severe on what both people affected with cmt and those who provide for people with cmt consider appropriate.


Eligibility criteria:
inclusion criteria: * patients with cmt ages 8-100, * health care professionals who take care of patients with cmt. * eligible patients will be patients that have joined the inc rdcrn contact registry. these will be patients or guardians with known or probable inherited neuropathies. * eligible health care professionals who participate in the care of patients with inherited neuropathies (physicians, genetic counselors, physical and occupational therapists etc.) attending the 4th international cmt consortium to be held in potomac maryland june 29-july 1, 2011. exclusion criteria: * does not read or speak english.

Keywords: cmt
overweight and obesity in preschoolers

Conditions: Obesity; Overweight

Summary: obesity interventions in early childhood are recommended as they have been proven to be more effective than interventions later in life. the overall aim of this study is to assess the effectiveness, feasibility, and acceptance of an overweight and obesity intervention in socially disadvantaged families. participants will be families with children aged 2-6 years (n = 300) with overweight or obesity and will be recruited from three sites: stockholm, sweden (n = 100); timisoara, romania (n = 100); and mallorca, spain (n = 100).

the proposed randomized controlled trial has five specific aims: specific aim 1: to determine the effectiveness of a 10 week parent-only group support program focusing on evidence-based parenting practices followed by a mobile health (mhealth) component for 6-months (n = 150) compared to standard care (n = 150) for overweight and obesity in pre-school children (change in bmi z-scores after 9 months primary outcome). specific aim 2: to determine if the intervention can improve body composition (waist circumference), child eating behaviour, physical activity, and parental feeding practices in comparison to the control group. specific aim 3: to assess reversibility of the molecular signatures of obesity following the intervention through epigenetic markers in white blood cells (methylation) and analyzing the role of the gut hormones. specific aim 4: to assess and validate child food intake with metabolic markers in urine. specific aim 5: to evaluate the feasibility of recruitment (facilitators and barriers), attrition and acceptability, as well as patient and caregiver satisfaction to the intervention.

Eligibility criteria:
inclusion criteria: * 2 to 6 year old children with overweight or obesity according to international cut-offs. * children who have no other underlying medical condition(s). * parent(s) who have the ability to communicate in swedish (for the swedish part), romanian (for the romanian part), and spanish (for the spanish part). exclusion criteria: * parent(s) not owning a smartphone compatible with the ministop app.

Keywords: children obesity treatment family mhealth