Kornimate/medical-research-clean huggingface dataset:
a study comparing high dose omeprazole infusion against scheduled second endoscopy for bleeding peptic ulcer

Conditions: Peptic Ulcer Hemorrhage

Summary: a prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.

we have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. we found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis. when we look at the studies in the literature employing proton pump inhibitors (ppi) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement. controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. a recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding. we conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.

Eligibility criteria:
inclusion criteria: * all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with forrest type ia, ib, and iia, iib * age 15 - 90 years * written consent available exclusion criteria: * ulcer bleeding not controlled in first endoscopy * bleeding from malignant ulcer or tumor * bleeding from dieulafoy lesion/ angiodysplasia * bleeding from injection sclerotherapy ulcer * patient with asa category 5

Keywords: peptic ulcer hemorrhage omeprazole scheduled second endoscopy
phase i/ii study of azd2171 in combination with paclitaxel/carboplatin in japanese non-small cell lung cancer patients

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the national cancer institute of canada clinical trials group (ncic-ctg) has informed astrazeneca that the br24 phase ii/iii study of cediranib at 30mg in first line non-small cell lung cancer (nsclc) will not continue into phase iii following the planned end of phase ii efficacy and tolerability analysis by the study's data safety monitoring committee. although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into phase iii. as the design of study 040 is similar to that of study br24, astrazeneca has suspended recruitment into study 040.


Eligibility criteria:
inclusion criteria: * having histologically or cytologically confirmed nsclc * patients with previously untreated advanced/metastatic (stage iiib/iv) or postsurgery recurrent nsclc * who performance status 0-1 exclusion criteria: * untreated unstable brain or meningeal metastases * patient with inappropriate laboratory tests values * patient with poorly controlled hypertension

Keywords: non-small cell lung cancer nsclc azd2171 paclitaxel/carboplatin non-small cell lung cancer (nsclc)
sentinel lymph node assessment in ovarian cancer (trsgo-sln-oo5)

Conditions: Ovarian Cancer; Sentinel Lymph Node

Summary: the aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.

systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. however, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. in the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. for preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease. aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.

Eligibility criteria:
inclusion criteria: * patients with early stage ovarian cancer exclusion criteria: * patient who had been administrated chemotherapy prior to surgery * patients who had diagnosed with malignancy other than ovarian cancer. * patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery. * patients who have allergy for the tracers.
the effect of probiotic and prebiotic supplementation on gastrointestinal health in individuals with chronic spinal cord injury

Conditions: Spinal Cord Injury

Summary: the goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints. the main questions this trail aims to answer are: * what are the effects of the supplementation on gastrointestinal symptoms? * what are the effects of the supplementation on gut microbiome composition? * what are the effects of the supplementation on inflammatory serum markers? * what are the effects of the supplementation on gastrointestinal transit time? participants will: * take either the probiotic or prebiotic supplement daily for eight weeks, followed by a four-week "wash-out period" (= no intake of either supplement) and a subsequent eight-week intake of the other supplement. * visit the study center for four appointments, during which various measurements will be performed.


Eligibility criteria:
inclusion criteria (at screening): * age: ≥ 18 years * sex: male and female. * chronic sci (\>1 year post-injury) * individuals with para- and tetraplegia (american spinal cord injury (asia) impairment scale (ais) score a-d) * having significant gastrointestinal complaints, indicated with "yes" at screening and by a giqli questionnaire score below 110 at baseline * signed written informed consent exclusion criteria (at screening): * antibiotic use within the last four weeks before starting the study * major dietary changes within the last four weeks before starting the study, such as initiating a vegan or ketogenic diet * presence of clinically relevant medical conditions, including crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis * intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis * concurrent participation in other clinical trials investigating or potentially affecting gi health * insufficient german language skills to follow the study procedures * pregnancy (anamnestic)

Keywords: probiotic prebiotic gastrointestinal health microbiome dietary supplement
effect of acetazolamide on altitude related illness in patients with respiratory disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (arahe) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (arahe) in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3200 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3200 m. an interim analysis will be carried out when 90 patients will have completed the study or after the first year. the peto's method will be used to correct the p-values.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/fvc \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; osa; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: airway disease bronchitis emphysema altitude prevention acetazolamide
comprehensive strategy to decolonize methicillin-resistant staphylococcus aureus (mrsa) in the outpatient setting

Conditions: Methicillin-resistant Staphylococcus Aureus

Summary: the purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant staphylococcus aureus (mrsa) among those living in the community. we hypothesize that a greater proportion of those who receive intervention will eliminate mrsa carriage compared to those who do not receive any intervention.


Eligibility criteria:
inclusion criteria: * prior mrsa infection (i.e index case) * identified as being colonized with mrsa on initial screen exclusion criteria: * are pregnant or breastfeeding. * have indwelling catheters. * received prior decolonization treatment within last 6 months of enrollment. * have allergy to study medication. * are colonized with mrsa strain resistant to study medication. * have active infection requiring systemic antimicrobials. * are household contacts to index case.

Keywords: methicillin-resistant staphylococcus aureus decolonization random allocation outpatient
the safety and effectiveness of clarithromycin plus ethambutol used with or without clofazimine in the treatment of mac in patients with aids

Conditions: Mycobacterium Avium-intracellular Infection; HIV Infections

Summary: primary: to assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated mycobacterium avium complex (dmac). secondary: to determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. to determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.


Eligibility criteria:
inclusion criteria patients must have: * history of hiv seropositivity. * disseminated mac. * positive blood culture for mac within 4 weeks prior to study entry. * consent of parent or guardian if less than 18 years of age. * ability to complete the study. note: * patients with active opportunistic infections other than dmac are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment. exclusion criteria concurrent medication: excluded: * active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels. * active therapy with investigational drugs other than treatment for hiv disease, except with approval of the sponsor. * concomitant terfenadine (seldane or seldane-d) or astemizole (hismanal). * amikacin. * azithromycin. * capreomycin. * ciprofloxacin. * cycloserine. * ethionamide. * gentamicin. * kanamycin. * levofloxacin. * lomefloxacin. * ofloxacin. * rifampin. * rifabutin. * sparfloxacin. * streptomycin. * any other aminoglycosides, quinolones, and macrolides. patients with the following prior conditions are excluded: history of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine. prior medication: excluded: * other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry. * clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.

Keywords: mycobacterium avium-intracellular infection drug therapy, combination ethambutol clofazimine acquired immunodeficiency syndrome clarithromycin
a clinical study with aliskiren alone or in combination therapy with diuretic hctz in venezuelan hypertensive patients.

Conditions: High Blood Pressure

Summary: this is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. the study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. patients will be evaluated every 4 weeks during period 2. treatment will start with aliskiren 150 mg with dose titration to aliskiren 300 mg, and addition of hctz 12,5 mg and 25 if control of bp is not achieved (\< 140/90 mmhg or 130/ 80 mmhg in diabetics patients). all patients who have reached their bp target will be considered as having met the primary endpoint and this visit will be considered as the final visit.


Eligibility criteria:
inclusion criteria: * outpatients, with essential hypertension, stage i-ii, naïve or not controlled with monotherapy. exclusion criteria: * bp\> 180/110 mmhg * pregnant or nursing women * hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month * k \<3.5 meq/l or ≥ 5 meq/l * renal impairment * hypersensitivity to hctz or aliskiren or angioedema due to ace-i or arb * other protocol-defined inclusion/exclusion criteria may apply

Keywords: high blood pressure aliskiren hydrochlorothiazide control rate
treatment of parkinson's disease with a transdermal skin patch

Conditions: Parkinson Disease

Summary: patients with parkinson's disease are missing the chemical neurotransmitter dopamine. this occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. muscle tremors, rigidity of movement, shuffling footsteps, droopy posture, and a mask-like expression on the face characterize parkinson's disease. this study is designed to determine the effects of a new drug, n-9023. the drug acts like dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian symptoms. the goals of this study are to find out whether n-9023 is useful in treating the signs and symptoms of parkinson's disease and to determine the best dose of n-9023 that is safe and effective.

the acute safety and antiparkinsonian efficacy of transdermally delivered n-0923 will be evaluated in patients with parkinson's disease. this dopamine receptor agonist will be administered transdermally under double-blind conditions, in a rising dose paradigm. antiparkinsonian activity will be quantified by means of standard rating scales. possible adverse events will be assessed by appropriate clinical and laboratory tests.

Eligibility criteria:
all patients will carry a diagnosis of parkinson's disease based on the presence of a characteristic clinical history and neurological findings. symptom severity will range from hoehn \& yahr stage ii-iv. males and females between the ages 30-76 are eligible for the study. initial emphasis will be on patients who are taking few or no other medications than levodopa for their parkinson's disease. no presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. no patients with a history of significant cardiac (myocardial infarction within 12 months prior to study, dysrhythmia; qtc intervals greater than 440 msec). no patients who are convulsive, hepatic, or with renal disorders (exceeding the upper limit of normal values for lft's and creatinine respectively). no patients with evidence of other serious medical illness, a history of alcohol or drug abuse, those who have participated in an investigational trial within 28 days prior to study, and pregnant or nursing women or anyone not practicing effective means of birth control.

Keywords: continuous stimulation dose finding skin patch
oral versus intravenous hydration to prevent contrast induced nephropathy

Conditions: Contrast Induced Nephropathy

Summary: the increased risk for contrast-induced nephropathy (cin) in patients with chronic kidney disease (ckd) undergoing coronary angiography (cag) has been established. current and historical data on cin prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. we investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with ckd undergoing cag.

this is a single center study randomizing patients with ckd undergoing cag into 4 groups: 1) intravenous normal saline, 2) intravenous normal saline and intravenous bicarbonate, 3) oral hydration, and 4) oral hydration and oral bicarbonate. the primary endpoint was the occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dl from baseline at 72 hours following exposure to radiocontrast. secondary endpoints include the length of hospitalization and in-house mortality.

Eligibility criteria:
inclusion criteria: 1. stable serum creatinine levels of at least 1.1 mg/dl or estimated creatinine clearance less than 60 ml/min 2. scheduled for diagnostic, elective cardiac angiography exclusion criteria: 1. serum creatinine levels \>8.0 mg/dl 2. change in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours 3. preexisting dialysis 4. multiple myeloma or other myeloproliferative disease 5. current chf or recent history of flash pulmonary edema 6. current myocardial infarction 7. symptomatic hypokalemia 8. uncontrolled hypertension (treated systolic blood pressure \>200 mmhg or diastolic blood pressure \>100mmhg) 9. exposure to radiocontrast within 7 days the study 10. emergency catheterization 11. allergy to radiographic contrast 12. pregnancy 13. administration of dopamine, mannitol, fenoldapam, or n-acetylcysteine during the time of the study 14. severe copd 15. serum bicarb \> 28 16. sodium \<133

Keywords: contrast induced nephropathy percutaneous transluminal coronary angioplasty chronic kidney disease prevention equivalence
the long-term retention rate and influence factors of individualized treatment of vedolizumab in ulcerative colitis

Conditions: IBD (Inflammatory Bowel Disease)

Summary: the drug retention rate of vedolizumab for ulcerative colitis decreases with time. this study analyzed the long-term drug retention rate and its influencing factors in patients with moderately to severely active ulcerative colitis treated with vedolizumab.

vedelizumab is a humanized monoclonal antibody that specifically recognizes α4β7 heterodimer, selectively blocks the interaction between mucosal addressin cell adhesion molecule-1 (madcam-1) on intestinal blood vessels and α4β7 integrins on the surface of lymphocytes, inhibiting the migration of lymphocytes to the gastrointestinal mucosa and thus exerting anti-inflammatory effects. the regimen of vedolizumab therapy for the treatment of ulcerative colitis is intravenous vedolizumab (300 mg) at weeks 0, 2, and 6 for induction therapy, followed by intravenous vedolizumab (300 mg) every 8 weeks for maintenance therapy. this study analyzed the long-term drug retention rate and its influencing factors in moderately and severely active uc patients treated with vdz, aiming to provide a more precise and personalized treatment plan for uc patients before initiating vdz therapy, and to better predict drug efficacy as well as retention rate.

Eligibility criteria:
inclusion criteria: 1. diagnosed with moderate to severe ulcerative colitis 2. receiving treatment with vedolizumab exclusion criteria: 1. combination therapy with other biological agents, small molecule drugs, immunosuppressants or hormone therapy. 2. combination of active tuberculosis, clostridium difficile infection, cytomegalovirus infection, ebv infection, etc. 3. combined with malignant tumors or autoimmune diseases (such as dry syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc.). 4. combined with serious cardiovascular and cerebrovascular diseases or liver and renal insufficiency. * loss of visit or clinical data ≥30% during the follow-up period.

Keywords: ulcerative colitis vedolizumab drug retention influencing factors
contact force sensing and pulmonary vein isolation

Conditions: Paroxysmal Atrial Fibrillation; Catheter Ablation

Summary: introduction - pulmonary vein isolation (pvi) is the cornerstone of paroxysmal atrial fibrillation (af) ablation. recurrences remain, however, not infrequent and are mainly due to pvs reconnection. in this setting, all procedural means able to improve the quality of tissue lesions are welcome. study hypothesis - a continuous sensing of contact force (cf) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for pvi. methods - prospective observational non-randomized monocentric study. patients with paroxysmal af receive pvi following standard ablation procedures (linear antral catheter ablation guided by carto 3 system, biosense webster, inc.) using either a new irrigated rf ablation catheter that provides tip-to-tissue cf information (thermocool smarttouch catheter, biosense webster, inc.) (cf group), or a non-cf irrigated catheter (thermocool sf or ez steer thermocool catheter, biosense webster, inc.) (control group). overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. all procedures is performed by the same experienced operator, not blinded to the catheter used. except for cf information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. patients are discharged from hospital free of antiarrhythmic therapy. patients are enrolled in a specific follow-up plan. primary endpoints -(1) proportion of pvi after exclusive anatomic approach, (2) proportion of patients free of af after 12-month follow-up.


Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal atrial fibrillation despite at least failure of one anti-arrhythmic drug * age 18-75 yrs * first catheter ablation exclusion criteria: * left ventricle ejection fraction at echocardiography \<50% * history of heart surgery

Keywords: atrial fibrillation paroxysmal contact force radiofrequency catheter ablation pulmonary vein isolation recurrence follow-up