Kornimate/medical-research-clean huggingface dataset:
continuation protocol for study using negative pressure to reduce apnea trial

Conditions: Obstructive Sleep Apnea; Sleep Apnea

Summary: the goal of this study is to allow continued access to the aersleep ii system for subjects that have completed the som-029 study until the device is commercially available.

this is a multi-center uncontrolled continuation study designed to mimic real-world use of the aersleep ii system for subjects that have completed the som-029 protocol. subjects will use the aersleep ii nightly at a fixed pressure of -30 cmh2o. internal electronics will record various measures of how the device is being used and how it performs. subjects will have a video visit with the study site approximately every 30 days, and, if the investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. during these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. the investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (osa). data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.

Eligibility criteria:
inclusion criteria: 1. the subject completed study som-029 (supra). 2. the investigator feels that the subject experienced sufficient benefit from aersleep ii to justify its further use. 3. in the investigator's judgement, the subject will be able to understand and comply with all study procedures. exclusion criteria: 1. the investigator feels that, for any reason, the subject's participation may not be in his or her best interest. 2. any condition or circumstance that in the opinion of the investigator is likely to prevent accurate data collection or bias the results. 3. the subject is pregnant or plans to become pregnant during the course of the study.
advanced non-invasive diagnostics in inflammatory bowel disease

Conditions: Crohn Disease

Summary: the purpose of this study is to determine whether non-invasive endoscopic procedures (pillcam colon capsule endoscopy, pcce) and non-ionizing radiological modalities (mr enterocolonography, mrec and ultrasound, us) - offer a sufficiently high diagnostic validity in patients with suspected cd compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

this is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with pcce, mrec and us in patients with suspected cd. ileocolonoscopy serves as the diagnostic gold standard. patients are recruited from 3 centers in the region of southern denmark managing adult patients with inflammatory bowel diseases. each patient goes through a standardized work-up including medical history, physical examination, c-reactive protein, fecal calprotectin, ileocolonoscopy, pcce, mrec and us. all examinations are reviewed and described in a standardized fashion. the radiologists and physicians describing pcce, mrec, and us are blinded to the findings at ileocolonoscopy and the other imaging modalities.

Eligibility criteria:
inclusion criteria: general criterion all of the following: * clinical suspicion of cd * age \> 15 years * negative serologic markers for celiac disease, negative stool culture (or polymerase chain reaction) for pathogenic bacteria and a negative microscopy for intestinal parasites * fecal calprotectin \> 50 mg/kg * signed informed consent clinical criterion diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) associated with one or more of the following findings: (1) c-reactive protein (crp) \>5 mg/l, (2) thrombocytosis (\> 400 x 109/l), anemia (hemoglobin \ 0.5 mmol/l compared to the usual level), (3) prolonged fever (\> 37.5 c for more than 2 weeks), (5) weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal abscess/fistula, or (7) a family history of inflammatory bowel disease. exclusion criteria: * acute bowel obstruction * intake of nsaids or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose aspirin (≤ 150 mg per day) * pregnancy or lactation * alcohol or drug abuse * known gastrointestinal disorder other than inflammatory bowel disease * renal failure defined by a plasma-creatinine above the normal reference range * claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes mrec * interpreter required or inability to understand the oral and written information * colonoscopy contraindicated, performed within 3 months or unwillingness to go through colonoscopy

Keywords: capsule endoscopy crohn's disease magnetic resonance enterography ileocolonoscopy bowel ultrasound diagnostic imaging
effect of weight reduction on immunity

Conditions: Lymphocytes; Weight Loss; Viral Diseases; Immunity; Anti-obesity Agents

Summary: this study included two groups of premenopausal healthy obese women. experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. at baseline and after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.

tcd3 and nkc cd16/56 were decreased significantly. hence this weight loss program impaired viral immunity

Eligibility criteria:
inclusion criteria: * bmi \>=30 * female * healthy * no smoking * not lactating * not pregnant * no medication use exclusion criteria: * pregnancy * any disease * any medication use * iron and zinc deficiency * any supplement use
a multicenter observational study on safety of the herbal medicines at inpatient setting

Conditions: Drug Induced Liver Injury; Drug-Induced Kidney Injury; Herbal Medicine Adverse Reaction

Summary: prospective observations on safety of the herbal medicines regarding liver and kidney injuries at inpatient setting of four sites in south korea which are located at each quadrant of the country. in a previous study (pmid 28634823), six women presented liver injuries by herbs and similar findings were also reported. that knowledge has been developed to design the observations of females (19-80 ages) at least 2 weeks' hospitalization with weekly routine lab tests to obtain the occurrence of liver or kidney injuries and the profiles on micro biomarkers throughout the hospitalization period, and then, the follow-up test will be conducted in outpatient setting.

total 500 inpatients will be observed to assess safety of herbal medicines with the balance of 60 to 110 each site. after obtaining the informed consent from patient, blood draw and urine collection are conducted prior to intake of the herbal medicine, blood draw and urine collection are routinely done every week throughout the whole admission period. the primary outcomes are, 1) liver for alanine aminotransferase (alt), rucam (in case of causality assessment when alt≥3 upper normal limit) and new biomarker, mircorna-122 and 2) kidney for urine creatinine, blood urea nitrogen (bun) and new biomarker, neutrophil gelatinase-associated lipocalin (ngal). the secondary outcomes are, 1) liver for aspartate aminotransferase (ast), alkaline phosphatase (alp), gamma glutamyltransferase (γ-gt), total bilirubin and new biomarker, glutamate dehydrogenase (gldh) and 2) kidney for serum creatinine and new biomarker, kidney injury molecule-1 (kim-1). the follow-up will be done by the study doctors based on their decision on the inpatient after discharge.

Eligibility criteria:
inclusion criteria: * female whose age is between 19 and 80 * inpatient expected to stay at least 2 weeks and to intake herbal medicine * who signed voluntarily informed consent. exclusion criteria: * who were short of stay for 2 weeks or stopped intaking herbal medicine * who had problems physically or mentally by investigator

Keywords: safety herbal medicine drug induced liver injury drug-induced kidney injury prospective observation multicenter study
iort-boost-study, prospective observational study for intraoperative radiotherapy of the breast as a boost

Conditions: Adverse Effect of Radiation Therapy

Summary: in this study the investigators observe the investigation, whether the new method for boost-irradiation with the intrabeam device of zeiss germany influences local recurrence, acute and late effects of radiotherapy, overall survival, quality of life and cosmesis.


Eligibility criteria:
inclusion criteria: * women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor \< or = 3.5 cm * written informed consent * ability to cooperate * full legal capability exclusion criteria: * missing written informed consent * lack of compliance

Keywords: observational study intraoperative radiation of breast cancer early and late effects of radiation cosmesis and quality of life
alterra post-approval study

Conditions: Pulmonary Valve Insufficiency; Complex Congenital Heart Defect; Tetralogy of Fallot; Pulmonary Regurgitation; RVOT Anomaly

Summary: this study will monitor device performance and outcomes in subjects undergoing implantation of the edwards sapien 3 transcatheter pulmonary valve system with alterra adaptive prestent in the post-approval setting

this is a single arm, prospective, multicenter post-approval study.

Eligibility criteria:
inclusion criteria: 1. native or surgically-repaired rvot with severe pr 2. clinically indicated for pulmonary valve replacement 3. planned for treatment with the alterra prestent and sapien 3 thv exclusion criteria: 1. inability to tolerate an anticoagulation/antiplatelet regimen 2. active bacterial endocarditis or other active infections

Keywords: alterra prestent sapien 3 pulmonic delivery system transcatheter pulmonary valve replacement transcatheter pulmonary valve implantation
comparison of dexlansoprazole-based triple and rabeprazole-based triple therapies for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: dexlansoprazole mr is the r-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. it is effective for symptom control of patients with gastroesophageal reflux disease. however, its efficacy in the treatment of h.pylori infection remains unclear. this study was conducted to investigate whether the efficacy of single-dose dexlansoprazole mr-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of h.pylori infection.

helicobacter pylori (h.pylori) infect more than 50% of humans globally. it is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (maltoma). h.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. this therapy is also strongly recommended in the treatment of h pylori-related maltoma. in regions with high incidence of gastric adenocarcinoma, eradication of h pylori is advocated as a preventative measure. proton pump inhibitor (ppi) is one of the key medicines in anti-h pylori regimens. it possesses anti-h pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. this study was conducted to investigate whether the efficacy of single-dose dexlansoprazole mr-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of h pylori infection.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female aged more than 20 years. 2. h. pylori-infected outpatients 3. mental and legal ability to give a written informed consent. exclusion criteria: 1. previous h pylori-eradication therapy, 2. ingestion of antibiotics or bismuth within the prior 4 weeks, 3. patients with allergic history to the medications used, 4. patients with previous gastric surgery, 5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), 6. pregnant women.

Keywords: dexlansoprazole mr rabeprazole helicobacter pylori triple therapy
women share study: reducing sexual risk

Conditions: Alcohol and Substance-Related Mental Disorders; Sexually Transmitted Diseases

Summary: this study will investigate whether bi and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

this study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the bi and technology extenders. at-risk women drinkers (n = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated bi or control (a centers for disease control and prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.

Eligibility criteria:
inclusion criteria: * female * age 18-29 years * meeting niaaa definition of "at-risk" drinking (\>3 drinks on any day in the last 3 months18 and/or \>7 drinks per week) * sexual risk behavior (i.e., last 3 months: vaginal/anal intercourse with \>1 partner; vaginal/anal intercourse with a partner who has other partners; inconsistent condom use; new relationship (under 3 months)) * english speaking * absence of acute intoxication, depression, or suicidal ideation * no plans for relocation exclusion criteria: * male * under 18 years old or older than 29 years old * non-english speaking * suicidal ideation * relocating * clinic provider advising against recruitment in the study * unwilling or unable to provide consent
"livercolor": machine learning in liver photographs

Conditions: Brain Death; Liver Steatosis

Summary: the main goal of this project is to create a machine learning model in order to quantify liver steatosis in liver donor faster, more objective and reliable than histological analysis and surgeons point-of-view.

surgeons (junior and senior operators) from the hbp \& transplantation unit took the pictures. they were taken after the laparotomy and before any type of surgical procedure. for each deceased donor case, a total of 5 pictures were taken: one for the left lobe and another for the right one before undergoing a surgical biopsy, two more (one for the left and one for the right lobe) after the histological analysis, near to the site of the surgical biopsy, and finally, one picture after liver perfusion.

Eligibility criteria:
inclusion criteria: * livers from donor donor brain death with informed consent before inclusion in the study was obtained from all participants or families. exclusion criteria: * age \< 18 years old * donor after cardiac death * split * cholestasis due to a biliary obstruction * total bilirubin levels above 2,5 mg/dl * glutamic oxaloacetic transaminase (sgot)/ serum glutamatepyruvate transaminase (sgpt) levels and gamma-glutamyl transaminase (ggt) levels above 400 u/l * cirrhotic livers

Keywords: machine learning liver donor (dbd) liver steatosis liver pictures liver pool
intensive care unit acquired infections in patients colonized with extended spectrum enterobacteriaceae

Conditions: Ventilator Associated Pneumonia; Bacteremia; Abdominal Infection; Enterobacteriaceae Infections

Summary: worldwide emergence of extended-spectrum β-lactamase-producing enterobacteriaceae (esbl-e) had become a major problem in icu, with at least 10% of incidence at the admission in europe. a systematic rectal swab is used in 70% of french icu to detect intestinal esbl-e carriage the relationship between intestinal carriage and icu-acquired infection is not perfectly known. the investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved. the investigators also collect data about antibiotherapy used to treat these infections.

intestinal carriage of extended-spectrum β-lactamase-producing enterobacteriaceae (esbl-e) had become a major problem in general population, morover in intensive care units. systematic rectal swab for screening is done in 70% of french icu in routine. some studies had show a good negative predictive value of this test for icu-acquired infection (for example ventilator-associated pneumoniae), but a poor predictive positive value. the precise relationship between intestinal carriage and icu-acquired infection is not perfectly known. probabilist antibiotherapy with carbapenem for esbl-e suspected infection are currently recommanded by national and european guidelines, particulary in case of shock or immunodepression. a esbl-e systematic screening-guided strategy for probabilist antibiotherapy could be interesting, and could lead to a carbapenem or a carbapenem-sparing focused antibiotherapy. the investigators conducted a monocentric retrospective observational cohort study in patients with presence of extended-spectrum β-lactamase-producing enterobacteriaceae in systematic rectal swabs to investigate the number of esbl-e related infections, the site of these infections and which species of bacteriae are involved. they also investigate which was the antibiotherapy administered, and investigate what factors lead clinicians to treat the infection with carbapenem antibiotherapy.

Eligibility criteria:
inclusion criteria: * admitted in brest icu (medical or surgical) * positive rectal swab for esbl-enterobacteriae screening at the admission or during the icu stay * written consent exclusion criteria: * refusing to participate
single center experience over a decade in living donor liver transplantation for egyptian patients with hepatocellular carcinoma: stretching the limits

Conditions: Recurrence of HCC After LDLT

Summary: within community with high incidence of hcc, stretching the limits could be justified based on tumor characters and its biological behavior

590 egyptian patients underwent ldlt; of them, 172 (32%) patients were transplanted for hcc. twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to non hcc related mortality (n=4). one hundred forty six patients were retrospectively reviewed to determine prognostic factors for recurrence.

Eligibility criteria:
inclusion criteria: * egyptien patients with hcc * patients within milan criteria * patients beyond milan criteria are selected on a case by case basis until 2005. from 2005 , patients beyond milan criteria are subjected to down staging protocol and then reassessed (pre transplantation local ablative therapy either with rfa or tace according to the size and the site of the lesion and we wait for 12 weeks after ablation ,only those with well ablated lesions, decreased afp and no denovo lesions were transplanted). exclusion criteria: * • evidence of macro vascular invasion by ct portography and/or us duplex. * metastatic hcc * general contraindications for lt (ongoing sepsis, other major co morbidities,...). * early postoperative mortality (first1 month). * post transplant mortality during the period of follow up due to any cause other than recurrent hcc (e.g. sepsis, rejection, cardiological or cerebrovascular complications...)

Keywords: ldlt,hcc, microvascular invasion
stereotactic radiotherapy in locally advanced pancreatic cancer with different biological effective doses

Conditions: Treatment

Summary: the aim of this study is to compare the safety and efficacy of sbrt in lapc with different biological effective dose (bed) (60-70gy vs.\>70gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.


Eligibility criteria:
inclusion criteria: * 18≤age≤75 years * cytologically or histologically verified pancreatic adenocarcinoma or clinically diagnosed as pancreatic cancer by multidisciplinary consultation * locally advanced pancreatic cancer (lapc) * sbrt was not preceded by any targeted antitumor therapy * ecog 0-1 * written informed consent according to ich/gcp regulations before registration and prior to any trial specific procedures exclusion criteria: * patients who have previously received related treatment because of pancreatic adenocarcinoma, such as radiotherapy, chemotherapy or focal treatment * patients with severe liver or kidney dysfunction * patients with obstructive jaundice * patients with mass ascites * patients participated in other clinical trials for less than three months * patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, ect * unsuitable to participate in this clinical trial judged by the investigator

Keywords: sbrt locally advanced pancreatic cancer biological effective dose
brain changes in severely depressed patients before and after treatment with electroconvulsive therapy

Conditions: Severe Depression

Summary: electroconvulsive therapy (ect) is a non-pharmacological treatment used in resistant depression whose effectiveness has been demonstrated. however, the brain mechanisms underlying this therapeutic effect remain unclear. many animal studies show a neurotrophic action of ect on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of glial cells. in addition, functional imaging of "resting state" type have shown, among depressed patients after ect, increased functional connectivity . these results were reinforced by the recent work of perrin (2012). in view of this a priori contradictory, it seems appropriate to continue research neuroanatomical correlates subtending neurofunctional processes responsible at the same time improving the clinical depressive. the investigators suggest using an original technique never used in this type of population: functional magnetic resonance imaging (fmri) or multimodal structural-functional. this method will allow us to study the impact of ect on brain structures involved in major depressive disorder: hippocampus.


Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders-v (dsm) diagnosis of major depressive disorder * indication of ect and signing the consent for conducting a ect * right-handed * be of french mother tongue * belong to a social security scheme * sign an informed consent exclusion criteria: * against indication for mri * against indication to anesthesia * processes brain expensive * pregnant woman * refuse to be informed of an abnormality detected during mri * patients holders of stimulation electrodes * presence history of neurological disease * presence history of head injury * mini-mental state examination (mmse) \<15/30 * presence of neurodegenerative disease * patients who have had ect treatment in the last 6 months

Keywords: ect diffusion tensor imaging (dti) fmri