Kornimate/medical-research-clean huggingface dataset:
water injection colonoscopy vs air insufflation colonoscopy in training the beginners

Conditions: Colon Disease; Rectal Disease; Pain

Summary: water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.

colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice. up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.when training the first-learners, certain dose of sedatives or analgesics was injected; 3.the patients recruited were less. colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.

Eligibility criteria:
inclusion criteria: * patients diagnostic colonoscopy; * subjets able to provide informed consent exclusion criteria: * prior partial or complete colectomy; * patients who decline to participate; * patients with poor bowel preparation; * contraindications of the colonoscopy
caffeine & bodybuilding dehydration ability

Conditions: Caffeine; Placebo

Summary: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (caf) and placebo trial (pl) with a randomized, double-blind study design. the participants chewing either caffeine gum (caf trial, containing 5 mg/kg of caffeine) or placebo gum (pl) for 10 minutes. after rested for 15 minutes, participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight.

the purpose of this study was to investigate the effect of caffeinated chewing gum on dehydration ability in bodybuilding athletes. methods: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (caf) and placebo trial (pl) with a randomized, double-blind study design. the participants chewing either caffeine gum (caf trial, containing 5 mg/kg of caffeine) or placebo gum (pl) for 10 minutes. after rested for 15 minutes, participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. record time from exercise to completion of dehydration, heart rate, hrv, energy expenditure, fat oxidation rate and carbohydrate oxidation rate.

Eligibility criteria:
inclusion criteria: * having won the top 8 places in a national competition, * having no cardiovascular or joint diseases * being an adult male exclusion criteria: * no top 8 finishes at national level * cardiovascular or joint disease, or any other condition that could be impaired by exercise * female and underage participants * previous caffeine allergy
contrast-enhanced ultrasound in follow-up after endovascular aneurysm repair

Conditions: Abdominal Aortic Aneurysm; Endoleak

Summary: x-ray computed tomography imaging (ct) is routinely used in follow-up after endovascular aneurysm repair (evar). contrast-enhanced ultrasound (ceus) has been shown to give accurate information about endoleak after evar. benefits of ceus over ct include less radiation exposure, avoidance of renal function deterioration due to repeated x-ray contrast agent application and decrease in the cost of evar follow-up. this study is designed to investigate if results from literature are reproducible in st olavs hospital in trondheim (norway), to gain experience with the technique and to introduce ceus as an alternative for detection of endoleak in this hospital.


Eligibility criteria:
inclusion criteria: * in follow-up after endovascular implantation of abdominal aortic prothesis exclusion criteria: * none

Keywords: cardiovascular diagnostic technique ultrasound
re-usable respimat® soft misttm inhaler study

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study is to assess patient satisfaction with the inhaler attributes of the re-usable respimat smi (spiriva, striverdi or spiolto) in patients with copd, including patients who are respimat smi-experienced and respimat smi-naïve. this study also aims to examine patient preference for the re-usable respimat smi compared to the disposable respimat smi in respimat smi-experienced patients switching from a disposable to a re-usable respimat smi product at study entry.


Eligibility criteria:
inclusion criteria: patients fulfilling all the following inclusion criteria will be eligible for participation in the study: * provision of signed informed consent prior to study data collection * patient with copd aged 40 years or older * patient prescribed (or already receiving the disposable respimat smi and switched to) one of the following re-usable respimat smi products per the standard clinical practice: spiriva 2.5 microgram inhalation solution; (2) striverdi 2.5 microgram inhalation solution; and (3) spiolto 2.5 microgram / 2.5 microgram inhalation solution * patient unlikely to change their respimat therapy during the 4-6 week observation period (in the opinion of the investigator) exclusion criteria: patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study: * patient using a disposable respimat smi product during the study period * patient who have had a severe copd exacerbation requiring hospitalisation in the immediate 3 months prior to study entry * patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment * visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires * patient not fluent and literate in one of the main languages of the country
exenatide for myocardial protection during reperfusion study

Conditions: Myocardial Infarction

Summary: this study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (pci) for st segment elevation myocardial infarction or heart attack (stemi).

this is a phase ii randomized, double-blind, placebo-controlled study of patients with stemi. those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. we will assess the ability of exenatide to reduce ischemic injury. this study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.

Eligibility criteria:
inclusion criteria: * admission for primary pci for stemi, with enrollment within 12 hours of onset of symptoms. stemi will be defined as typical ecg changes (st segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset lbbb) associated with acute chest pain or an elevation of cardiac enzymes. * antegrade timi 0 or 1 prior to pci in the infarct-related artery * age ≥18 years exclusion criteria: * symptomatic hypoglycemia (serum glucose \<3.3 µmol/l; 60 mg/dl) * diabetes mellitus requiring insulin therapy * diabetic ketoacidosis * coronary anatomy warranting emergent coronary artery bypass graft surgery * mechanical complication of stemi (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation) * need for hemodialysis * malignancy, hiv, or central nervous system disorder * cardiopulmonary resuscitation \>15 min and compromised level of consciousness. * cardiogenic shock * current participation in any research study involving investigational drugs or devices * inability to give informed consent * inability to safely undergo cmri (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia) * women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission * history of pancreatitis * known end stage renal failure or known egfr \<30 ml/min * currently taking exenatide (byetta, bydureon), liraglutide (victoza), or any other glp-1 agonist

Keywords: myocardial infarction percutaneous coronary intervention reperfusion injury exenatide magnetic resonance imaging
lifestyle intervention for treating systemic hypertension in primary care setting

Conditions: Hypertension

Summary: the canadian hypertension education program recommends increased physical activity, adoption of the dietary approaches to stop hypertension (dash) diet, and reduction in sodium and alcohol intake for treatment and prevention of hypertension. objective: to describe patients participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a family medicine primary care setting. design: descriptive study. participants: the study aims to recruit 60 sedentary hypertensive patients to participate in a 6-month randomized-controlled trial. to be eligible, patients must be ≥18 years of age, sedentary (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood pressure measurements \[abpm\]), non-smoker, non-diabetic and without dyslipidemia. intervention: patients are recruited by health care professionals of the family medicine unit and are thereafter randomized to one of four intervention groups: 1) standard medical care (control), 2) improved diet (dash diet), 3) physical activity, or 4) both improved diet and physical activity. patients are evaluated (pre, mid and post intervention), monitored, and educated by the interdisciplinary health care team that includes a physician, a kinesiologist, a nutritionist and a nurse, depending on the intervention group. t-tests and descriptive statistics were used to analyse data. this study will document the efficacy of a primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * sedentary (7-day measured steps/day and self-report) * arterial hypertensive (based on 24-h ambulatory blood pressure measurements \[abpm\]) exclusion criteria: * secondary hypertension * diabetes * dyslipidemia * cardiovascular diseases with complications * smoker

Keywords: hypertension lifestyle clinical trials primary care setting
continued safety and performance of the tivus system

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: the tivus ii is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the tivus™ system consisting of three (3) concurrent cohorts: * tivus™ severe resistant htn cohort * tivus™ moderate resistant htn cohort * tivus™ failed rf therapy cohort


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 and ≤ 80 years of age * for cohort a: documented office systolic blood pressure \> 160 mmhg (\> 150 mmhg for diabetic patients); for cohort b: documented office systolic blood pressure \> 140 mmhg (\> 130 mmhg for diabetic patients); for cohort c: documented office systolic blood pressure \> 150 mmhg (\> 140 mmhg for diabetic patients) * documented 24 hour systolic abpm \> 135 mmhg * adherence to a stable drug regimen * for patients in cohort c only: documented renal denervation procedure with any rf technology 12 months or more prior to screening * suitable renal artery anatomy * male or non-pregnant / non-lactating female * patient understands the nature of the procedure and provides written informed consent * patient is willing and able to comply with the specified study requirements and follow-up evaluations exclusion criteria: * egfr \< 45ml/min/1.73m2 * documented primary pulmonary hypertension * patient experienced \>1 episode of orthostatic hypotension coupled with syncope * documented indicator of a secondary renal hypertension * history of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months * planned major surgery or cardiovascular intervention in the next 6 months * surgery or cardiovascular intervention in the previous 3 months * hemodynamically significant valvular heart disease * severe debilitating lung disease * patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization * patient has a single functioning kidney * documented thrombocytopenia, clotting disorders or aortic aneurysms * moribund patient, or patient with comorbidities limiting life expectancy to less than one year * contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication * concurrent enrollment in another trial * main renal arteries \< 4 mm in lumen diameter or \< 20 mm in length * aorto-renal angle that prevents a safe cannulation of the renal artery * severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure * hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery * any renal artery stenosis \> 50% by visual assessment * any renal artery aneurysm in either renal artery * a history of prior renal artery balloon angioplasty or stenting (for patients in cohort a and b only, also a history of prior renal denervation at any time)
phase 2 study of the safety and efficacy of ldp-02 in mildly to moderately active crohn's patients

Conditions: Crohn's Disease

Summary: the objectives of this study were to assess the safety and tolerability of ldp-02 in patients with active crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of ldp-02 to reduce crohn's disease activity, and to obtain pharmacokinetic (pk) and pharmacodynamic(pd)information for ldp-02 in patients with active crohn's disease.


Eligibility criteria:
inclusion criteria: * age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent. * crohn's disease of at least 6 months' duration. * endoscopic and/or histopathological and/or radiological documentation consistent with crohn's disease obtained preferably within 24 months of screening. * crohn's disease involving the colon and/or the ileum. * cdai score from 220 to 400 (inclusive) at the time of the screening visit. the cdai must have remained between 220 and 400 after the 1-week screening period for the patient to be eligible. * patients may have been receiving oral or topical 5-asa compounds provided the dosage had been stable for at least the 14-day period before the screening visit. patients were to be maintained on the 5-asa compound at a constant dose at least through day 57. exclusion criteria: * patients with evidence of current gi infection (bacterial or parasitic) or significant infection within 45 days of the screening visit. * patients with a serious underlying disease other than crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia. * patients with significantly impaired liver or renal function. this includes those with established chronic liver disease including hepatitis b or c. * patients with the laboratory abnormalities * patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures. * patients with active psychiatric problems which, in the investigator's opinion, may interfere with compliance with the study procedures. * patients who have previously received or who are currently receiving treatment with a monoclonal antibody. * patients receiving any investigational therapy, excluded medications as defined in protocol, or any approved therapy in an investigational protocol within 30 days prior to screening. * patients unable to attend all the study visits or comply with study procedures.
aspiration for pain relief following ankle fracture

Conditions: Ankle Fracture

Summary: this trial will study the effect of hematoma aspiration in patients with acute ankle fractures.


Eligibility criteria:
inclusion criteria: * ao/ota fracture classification 44 * closed fracture * injury within 24 hours of presentation * skeletally mature * able to provide consent to participate in study exclusion criteria: * any concomitant injuries affecting numerical rating scale * soft tissue wounds at aspiration sites that compromise ability to aspirate * patient not able to complete pain medication log * patient not able to participate in follow up
a study of tocilizumab as monotherapy and in combination with methotrexate versus methotrexate in patients with early moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. patients will be randomized to receive either (a) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (b) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (c) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (d) placebo plus methotrexate (7.5-20 mg po weekly). patients in groups c and d who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. anticipated time on study treatment is 104 weeks.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age. * rheumatoid arthritis of ≤ 2 years duration. * disease activity score 28 (das28) \> 3.2. * swollen joint count (sjc) ≥ 4 of 66 joints, tender joint count (tjc) ≥ 6 of 68 joints. * rheumatoid factor (rf) and/or anti-cyclic citrullinated peptide (anti-ccp) positive (if rf and anti-ccp negative \> 1 erosion required at screening). * erythrocyte sedimentation rate (esr) ≥ 28 mm/h or c-reactive protein (crp) ≥ 10 mg/l at screening. exclusion criteria: * previous treatment with tocilizumab. * previous treatment with methotrexate or biologic agent. * rheumatic autoimmune disease other than rheumatoid arthritis (ra). * history of or current inflammatory joint disease other than ra. * functional class iv as defined by the american college of rheumatology (acr) classification of functional status in ra.
fertility in untreated rectosigmoid endometriosis

Conditions: Endometriosis; Bowel Endometriosis; Endometriosis, Rectum; Endometriosis Colon

Summary: several studies investigated the reproductive outcomes after surgical treatment of colorectal endometriosis, mainly segmental colorectal resection. little information is available on the spontaneous fertility of patients with bowel endometriosis. this study aims to evaluate the fertility of patients affected by rectosigmoid endometriosis who did not undergo previous surgical treatment.


Eligibility criteria:
inclusion criteria: * desire of conception * diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (tvs) and magnetic resonance imaging enema (mr-e) exclusion criteria: * previous surgery for endometriosis * diagnosis of hydrosalpinx at imaging * previous conception * abnormal semen parameters of male partners
ci532 - early experience study

Conditions: Sensorineural Hearing Loss, Bilateral

Summary: to evaluate performance outcomes in patients implanted with the cochlear nucleus ci532 electrode array.

to compare speech perception and audiometric outcomes in patients implanted with the cochlear nucleus ci532 electrode array at 3 months postactivation with their best preoperative hearing status.

Eligibility criteria:
inclusion criteria: * medical and audiological candidate for a ci532 cochlear implant per commercially approved, age appropriate, fda indications * post-linguistically deafened * ability to complete age appropriate testing exclusion criteria: * previous cochlear implantation in the ear to be implanted * pre-linguistically deafened (onset of hearing loss at less than two years of age) * ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array * diagnosis of retro-cochlear pathology * diagnosis of auditory neuropathy * unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device * unwillingness or inability to comply with all investigational requirements * additional cognitive handicaps that would prevent participation on all study requirements
effect of metformin, dapagliflozin, combination of metformin and pioglitazone in patients with type 2 diabetes

Conditions: Type2diabetes; Insulin Resistance

Summary: although, a number of drugs are promising treatment strategies for insulin resistance, a critical question arises to which drug benefits patients with type 2 diabetes more from reduced insulin resistance and consequent glycemic control. in this study, we aim to evaluate the effect of metformin, dapagliflozin and the fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) on insulin sensitivity and glycemic control in overweight patients with newly diagnosed type 2 diabetes.


Eligibility criteria:
inclusion criteria: * willing to participate in this present study; * regular diet and exercise; * age 18 to 60 years; * screening glycated hemoglobin (hba1c) \> 9.0%; * body mass index (bmi) ≥ 24.0 kg/m2 exclusion criteria: * other forms of diabetes; * insulin allergy or intolerance of metformin, pioglitazone and dapagliflozin; * renal dysfunction (estimated glomerular filtration rate \< 45 ml/min); * severe liver disease or elevated transaminases (2.5-fold the upper limit); * history of alcohol dependence or drug abuse in the past 5 years; * systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months; * acute infection or stress state 1 month prior to this study; * pregnancy or lactation; * history of diabetic ketoacidosis (dka) within the previous year; * psychiatric disease; * other comorbid serious condition including severe heart and pulmonary disease, heart failure of new york heart association class iv, and tumors.