Kornimate/medical-research-clean huggingface dataset:
evaluation of a pillcam colon bowel preparation regimen in crohn's disease patients

Conditions: Crohn's Disease

Summary: the proposed study is designed to evaluate pillcam regimen in crohn's disease patients, using the pillcam colon system.

1. primary scientific objective evaluate the effectiveness of the pillcam colon 2 prep regimen in cd patients. secondary objective to evaluate safety of the pillcam™ colon 2 procedure in cd patients 2. study hypothesis crohn's disease may be pan-enteric in nature and can affect the small bowel, the colon or both. pillcam colon 2 may be used for visualization of both sb and colon mucosa in crohn's disease patients. however, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire gi track within examination time. 3. the study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in cd patients all end points will be evaluated within 4 months from end of enrollment.

Eligibility criteria:
inclusion criteria: * subject is 18 years of age and above * subjects who are determined by their physician to have active crohn's disease based on at least one of the following tests which were performed in the past 3 months : * colonoscopy * capsule endoscopy of the small bowel or colon * other radiology tests * clinical symptoms with elevated positive inflammatory markers ;esr, crp, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin * proven patency by the agile capsule or another approach deemed clinically acceptable by the investigator, e.g. ct enterography, performed within the 3 months prior to enrollment * subject is able and agrees to sign the informed consent form exclusion criteria: * • subject has dysphagia * subject has congestive heart failure * subject has renal insufficiency * subject has cirrhosis * subject is known or is suspected to suffer from intestinal obstruction * subject has known previous stricture/obstruction of the sb or colon * chronic use of laxatives * subject has a cardiac pacemaker or other implanted electro medical device. * women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception. * subject is expected to undergo mri examination within 7 days after ingestion of the capsule. * subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. * subject has any condition, which precludes compliance with study and/or device instructions. * subject suffers from life threatening conditions * subject is currently participating in another clinical study * subject has known slow gastric emptying time or gi transit time. * subject is allergic or contraindicated to any of the study medications

Keywords: known, active crohn's disease iieocolonic or colonic involvement proven patency of the gi tract
individual placement and support and/or cognitive remediation therapy added to tau in patients with early schizophrenia

Conditions: Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Psychosis

Summary: this study aims to test the hypothesis that addition of individual placement and support (ips) and/or cognitive remediation therapy (crt) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.

this is an assessor blind, randomised controlled trial, employing a factorial design. this trial aims to assess the feasibility of ips, crt or their combination as an add on to treatment as usual. patients with early schizophrenia spectrum disorder will be recruited from major psychiatric units in pakistan. treatment as usual (tau) will comprise of patient's current antipsychotic medication as prescribed by their responsible clinician. patients will be randomised into ips, crt, their combination or tau, according to the 2x2 factorial schedule in the table. a total of 30 participants will be recruited in each cell, giving a total of 120 participants.

Eligibility criteria:
inclusion criteria: 1. male/female patients aged between 18-35 years. 2. diagnosis of schizophrenia confirmed by scid meeting dsm-v criteria for schizophrenia, schizophreniform or schizoaffective psychosis. 3. stable on medication for the past four weeks. 4. in contact with mental health services 5. within 5 years of diagnosis. 6. able to demonstrate the capacity to provide informed consent to take part in this feasibility trial, as assessed by their own clinician. exclusion criteria: 1. active dsm-v substance abuse (except nicotine or caffeine) or dependence within the last three months 2. relevant cns or other medical disorders 3. diagnosis of learning disability.
lmwh to prevent preeclampsia and fetal growth restriction

Conditions: Preeclampsia

Summary: the objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous factor v leiden and g20210a prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.

the objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous factor v leiden and g20210a prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. we also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.

Eligibility criteria:
inclusion criteria: * previous severe preeclampsia * previous severe fetal growth restriction * heterozygous factor v leiden * heterozygous g20210a prothrombin gene mutations exclusion criteria: * renal disease * chronic hypertension * preexisting diabetes mellitus * homozygosity for factor v leiden * homozygosity for prothrombin g20210a mutation * hyperhomocysteinemia * protein c deficency * protein s deficency * antithrombin deficiency * positive anticardiolipin antibodies * positive lupus anticoagulant

Keywords: low molecular weight heparin preeclampsia fetal growth restriction thrombophilia factor v leiden g20210a prothrombin gene mutation
investigation of the effects of medium cut-off dialyzers versus high-flux dialyzers on clinical and laboratory parameters of prevalent hemodialysis patients

Conditions: Hemodialysis-Associated Pruritus; Malnutrition-Inflammation-Cachexia Syndrome; Restless Legs Syndrome; Anemia of Chronic Kidney Disease; Depressive Disorder

Summary: in this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and esa treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.

the study is designed as a single-center, prospective, observational research. a total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use mco-membrane and the other 25 will use high-flux membrane. the distribution of patients to the high-flux membrane and mco membrane groups will be done randomly (sequentially single-pair number method). then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. at the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month; monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oc for use at the end of the study. automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness. the malnutrition inflammation score will be applied to evaluate the nutritional status (the mis form is given in the appendix) visual analog scale will be used for appetite visual analog scale will be used for uremic pruritus depression scale screening (beck's scale)

Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients * patients continuing the hemodialysis program for at least 3 months * patients over 18 years of age exclusion criteria: * patients with advanced heart failure, malignancy, terminal illness * patients with active infectious disease * acute hemodialysis patients * patients vascular access dysfunction
randomized phase i study of trimetrexate glucuronate (tmtx) with leucovorin (lcv) protection plus dapsone versus trimethoprim / sulfamethoxazole (tmp/smx) for treatment of moderately severe episodes of pneumocystis carinii pneumonia

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate the safety of the combination of trimetrexate glucuronate (tmtx) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (tmp/smx) in patients with aids and moderately severe pneumocystis carinii pneumonia (pcp). to determine the pharmacokinetic parameters of tmtx, leucovorin, and dapsone and of tmp/smx when given to patients with aids and moderately severe pcp.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * empiric therapy for other opportunistic pulmonary infection (tb or fungi) for the first 72 hours of study enrollment only, until presence of suspected pathogens can be confidently excluded. patients must have: * aids. * confirmed diagnosis of pcp. * alveolar-arterial differences in dissolved oxygen \>= 35 mm hg but \< 55 mm hg on room air. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * severe renal or hepatic dysfunction. * serious or life-threatening intolerance to tmp/smx, tmtx, or dapsone. * concurrent pneumothorax. * active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., cryptococcus neoforms, cmv). note: * identification of mycobacterium avium or cmv in sputum or bal fluid does not exclude, since these organisms may be present without causing disease. * pulmonary kaposi's sarcoma. * active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy). * unable to have arterial blood gases on room air obtained at baseline. * unwilling to undergo bronchoscopy, if sputum induction does not reveal pneumocystis carinii. * suspected malabsorption (e.g., ileus or severe diarrhea with \> 6 stools/day). * known absence of g6pd activity. * large volume (1.0 to 1.5 liters) of intravenous fluid (5 percent in water) per 24 hours is medically inadvisable. * unwilling to comply with study design. concurrent medication: excluded: * induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy). * azt, ddi, ddc, d4t, or other antiretroviral therapy. patients with the following prior condition are excluded: prior history of serious or life-threatening intolerance to tmp/smx. (note: * patients with less severe reactions may be included at the discretion of the investigator and primary care provider.) prior medication: excluded: * more than 24 hours of systemic anti-pcp therapy within 2 weeks prior to study entry.

Keywords: trimethoprim-sulfamethoxazole combination trimetrexate pneumonia, pneumocystis carinii leucovorin dapsone drug therapy, combination acquired immunodeficiency syndrome
study of efficacy of metformin in the treatment of acanthosis nigricans in children with obesity

Conditions: Acanthosis Nigricans

Summary: obesity is often accompanied by insulin resistance and/or hyperinsulinemia. acanthosis nigricans (an) is a skin condition commonly present on the neck of obese children. metformin is a useful drug for conditions characterized by insulin resistance.the aim of this study is to compare the efficacy of metformin versus placebo on an lesions of the neck as well as their effects on metabolic and anthropometric variables in a sample of obese children. this is a 12-week randomized, double-blind randomized trial involving obese children with an to receive either metformin or placebo. evaluations will be performed every three weeks. clinical, histological and colorimetric assessments of an lesions will be compared initially and at the conclusion of the study.

acanthosis nigricans (an) are lesions affecting localized areas of the skin in persons with obesity and/or hyperinsulinemia. roughening of the skin is related with histological papillomatosis and the skin darkening is due to hyperkeratosis. biochemical mechanisms for developing this hyperplastic lesion involve local cutaneous growth factors. nearly 40% of native american teenagers have acanthosis nigricans, whereas about 13% of african american, 6% of hispanic, and less than 1% of white, non-hispanic children aged 10-19 have clinically apparent acanthosis nigricans. an is a clinical surrogate of laboratory-documented hyperinsulinemia. the aim of this study is to compare the efficacy of metformin versus placebo on an lesions of the neck as well as their effects on metabolic (homa, triglycerides, cholesterol) and anthropometric variables (bmi, waist) in a sample of obese children. this is a 12-week randomized, double-blind randomized trial involving obese children with an to receive either metformin or placebo. evaluations will be performed every three weeks. clinical, histological and colorimetric assessments of an lesions will be compared initially and at the conclusion of the study. burke´s scale, papillomatosis and hyperkeratosis, and the l\* axis of will be used to measure the an improvement.

Eligibility criteria:
inclusion criteria: * signed informed consent from children and parents. * children younger than 18 years. * clinical diagnosis of acanthosis nigricans. * obesity. exclusion criteria: * diabetes mellitus. * neurological diseases. * congenital diseases. * oral treatment for obesity in the last two months. * topical treatment for the last two months.

Keywords: acanthosis nigricans obesity children metformin
a study to assess adverse events and change in disease condition of mesalamine capsules in children aged 5 to 17 years with ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: ulcerative colitis (uc) is a type of inflammatory bowel disease (ibd) characterized by diffuse, continuous inflammation of the colon. this study will assess how safe and effective mesalamine delayed-release capsules are in treating pediatric participants with uc. adverse events and change in disease activity will be assessed. delzicol (mesalamine) is an approved drug being developed for the treatment of ulcerative colitis (uc). study doctors put the participants in 1 of 2 groups, called treatment arms. each group receives a different treatment. around 80 pediatric participants aged 5 to 17 years with a diagnosis of uc will be enrolled in approximately 45 sites in the united states. participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for 30 days. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: - documented history of ulcerative colitis (uc) who have been successfully maintained in remission for at least 30 days prior to the screening visit and are on a stable dose of mesalamine or 5-aminosalicylic acid equivalent. exclusion criteria: - abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ecg), hematology, clinical chemistry, or urinalysis.

Keywords: ulcerative colitis (uc) mesalamine delzicol agn-226474
effect of an endoscopic bite block on mask ventilation

Conditions: Ventilator Lung

Summary: evaluation of effects of an endoscopic bite block on mask ventilation. in the present study, expiratory tidal volume and minute ventilation are measured under same pressure controlled mode in ventilator with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

evaluation of effects of an endoscopic bite block on mask ventilation. in the present study, expiratory tidal volume and minute ventilation are measured under the same pressure controlled mode in ventilator (pressure 15cmh2o, respiratory rate 15/min, i:e=1:1) with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

Eligibility criteria:
inclusion criteria: * patients scheduled for elective surgery under general anesthesia and agree with the purpose of the study exclusion criteria: * patients with diseases or structural abnormalities in the upper airway, wobbly teeth, and limited mouth opening of less than 3.5 cm or those who were at risk of aspiration

Keywords: manual ventilation
effect of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with clozapine

Conditions: Schizophrenia; Clozapine; Exercise

Summary: this prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with clozapine.

the first developed atypical antipsychotic is clozapine. its efficacy has been demonstrated in individuals with schizophrenia who have insufficient response to other antipsychotic therapies; nonetheless, its adverse effect profile is extensive. among the antipsychotic medications now available, clozapine is not utilized as a first-line therapy because of major side effects such agranulocytosis. increased salivation, sleepiness, weight gain, changes in blood pressure (sometimes an increase, sometimes a drop), elevated heart rate, dizziness, exhaustion, constipation, fever, and nocturnal enuresis are common adverse effects of clozapine usage.

Eligibility criteria:
inclusion criteria: * patients treated who were diagnosed with schizophrenia according to dsm-v criteria by psychiatrist at the turkish ministry of health kartal dr. lütfi kırdar city hospital * using a therapeutic dose of 300-500 mg/day of clozapine, exclusion criteria: * pregnancy
comparison of different transesophageal echocardiography guided thrombolytic regimens for prosthetic valve thrombosis

Conditions: Prosthetic Valve Thrombosis

Summary: despite high mortality and morbidity, the best treatment strategies for prosthetic valve thrombosis (pvt) have been controversial. in this study the investigators wanted to identify the most effective and safe regimen among different thrombolytic strategies.transesophageal echocardiography (tee) guided thrombolytic treatment was administered to 182 consecutive patients with pvt in 220 different episodes (156 women, mean age 43.2±13.06 years) between 1993 and 2009. these regimens included rapid streptokinase (group i, 16 episodes), slow streptokinase (group ii, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-pa) (group iii, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-pa without bolus (group iv, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-pa without bolus (group v, 124 episodes). the study endpoints were thrombolytic success and in-hospital mortality and non-fatal complication rates.

one hundred and eighty two consecutive in-hospital patients with 220 episodes of pvt between 1993 and 2009 were included in the study. the patients were enrolled after informed consent if there was no contraindication, to thrombolysis. the study was approved by the local ethics board. the patient demographics, past medical history, date of the operation, type and make of the prosthetic valve, rhythm disorders, aspirin use, nyha functional capacity, leading symptoms and international normalization ratio (inr) values at the time of admission were prospectively entered into a database.the diagnosis of pvt was verified each time by transesophageal echocardiography (tee) when a patient was admitted with thromboembolism or persistently low inr for the preceding consecutive 3 months and when a transthoracic echocardiography (tte) documented prosthetic valve dysfunction or thrombus. all patients underwent tte and tee examination before and after the thrombolysis sessions. the cross sectional area and the longest diameter of the thrombus were measured on tee recordings

Eligibility criteria:
inclusion criteria: * patients with prosthetic valve thrombosis exclusion criteria: * large left atrial thrombus * recent (\<3 weeks) ischemic stroke * hemorrhagic stroke * early (\<4 days) postoperative period * traumatic accident \<4 weeks * bleeding diathesis † * i̇ntracranial mass * active internal bleed * aortic dissection

Keywords: prosthetic valve thrombosis troia tpa tee
cuff pressure control and evacuation of subglottic secretions to prevent pneumonia

Conditions: Respiratory Failure

Summary: multicenter, cluster randomized, controlled, open-label trial to assess if anapnoguard system can minimize tracheal microaspiration and the risk of ventilator-associated pneumonia when compared to standard treatment

maintaining the endotracheal tube (ett) cuff appropriately inflated plays a crucial role in the management of intubated patients because overinflation may cause tracheal wall damage, ulcerations and stenosis, and underinflation may results in fluid leakage and ventilator-associated pneumonia (vap). during mechanical ventilation, secretions contaminated with oropharyngeal and gastric pathogens pool in the subglottic space (tracheal region between the ett cuff and the vocal cords) and enter the lower airways via microaspiration. subglottic secretion drainage (ssd) reduces the incidence of vap and can be performed intermittently or continuously, with varying efficacy and often causing secondary tracheal mucosa lesions. anapnoguard (ag) ett has three dedicated lines (two suction lines and one sensing/venting/rinsing line) and can be connected to the ag 100 system, a new device which provides high-sensitive capnography of subglottic space and consequent adjustment of cuff pressure, to avoid fluid leakage and overinflation. it also evacuates secretions from the subglottic space by simultaneously rinsing/venting this space using the ett dedicated line. the hypothesis is that ag system may reduce the incidence of microaspiration, bacterial tracheal colonization and consequently the risk of vap when compared to standard treatment (ett with manually performed secretion drainage and cuff pressure control).

Eligibility criteria:
inclusion criteria: * primary intubation with the study ett * expected duration of mechanical ventilation \>48 hours * age older than 18 years exclusion criteria: * invasive mechanical ventilation in the last 14 days, * contraindication for enteral feeding * clinical evidence of inhalation before intubation * pregnancy * enrolling in another study that may interfere with this trial