Kornimate/medical-research-clean huggingface dataset:
bowel preparation for magnetic resonance enterography

Conditions: Crohn Disease

Summary: adequate bowel preparation is required for magnetic resonance enterography (mre) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. we present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for mre in patients with crohn's disease (cd).

this is a open label, multicenter, randomized controlled trial. 96 patients are planed to be 1:1 randomized into one of two groups: (1) tube group, mid-gut tubing prior to the mre examination, administer contrast solution through the mid-gut tube; (2) oral group, administer contrast solution orally, mid-gut tubing after the mre examination. the primary outcome measures are: (1) grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention); (2) degree of discomfort before/during/after bowel preparation for mre using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe). the secondary outcome measure is the accuracy of lesion detection through mre confirmed by endoscopy (within 1 month before mre and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring).

Eligibility criteria:
inclusion criteria: * patients with cd need mre examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition); * age ≥ 14 years old. exclusion criteria: * unable to understand or provide informed consent; * had difficulty in swallowing, or dysphagia; * allergic to laxative and/or contrast; * claustrophobia or implanted metal objects or cardiac pacemaker precluding performance of mri; * known or suspected intestinal obstruction or severe stricture.

Keywords: magnetic resonance enterography bowel preparation
pressure support ventilation during laparoscopic and abdominal robotic surgery.

Conditions: Ventilator-Induced Lung Injury

Summary: this study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (psvpro) versus pressure control ventilation - volume guaranteed (pcv - vg) during laparoscopic and robotic abdominal surgery.

the objective of the study to evaluate the possibility and feasibility of using psvpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block. intervention: we plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. all patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation. expected results. psv may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.

Eligibility criteria:
inclusion criteria: * written consent. * men and women aged 18 years or more. * the physical status from asa classification i, ii or iii. * bmi \<= 34.9 kg / m2. * low risk of respiratory complications. * laparoscopic surgery in the pelvis. exclusion criteria: * the physical status from asa iv or v. * bmi\> = 35 kg / m2. * neuromuscular disease. * allergy to anesthetic agents. * operations on two cavities. * operations on the chest cavity.

Keywords: pressure support ventilation anaesthesia lung injury laparoscopic surgery
statin compliance of patients with non-insulin-dependent diabetes

Conditions: Non-insulin-dependent Diabetes

Summary: the diabetic population has an increased cardiovascular risk compared to the general population. hydroxymethylglutaryl-coa reductase (hmg-coa reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia. many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and as secondary prevention, to avoid recurrence. however, compliance to these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. the purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

the diabetic population has an increased cardiovascular risk compared to the general population. the mortality of people with diabetes due to ischemic heart disease is multiplied by 2.2, and when is due to cerebrovascular disease by 1.8 compared to those patients without diabetes. hydroxymethylglutaryl-coa reductase (hmg-coa reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia. statins have been shown to be effective in reducing the risk of cardiovascular events, each 1 mmol decrease in ldl cholesterol reduces the risk of cardiovascular events by 21% at 5 years. many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and for secondary prevention, to avoid recurrence. however, compliance with these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. indeed, the persistence of statin use, one year after its prescription, is estimated at 70% in the general population. however, there are no data in the french population, and in particular on french diabetic patients for whom the cardiovascular risk is increased compared to the general population. the purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

Eligibility criteria:
inclusion criteria: * major patients * with non-insulin-dependent diabetes, taking statins for at least 1 month (to assess compliance) * hospitalized in the diabetology day hospital of the saint philibert hospital * in capacity to answer the girerd test * patient who has been informed and not opposed to the study exclusion criteria: * patient's refusal to participate in the study * patient under guardianship or curatorship

Keywords: non-insulin-dependent diabetes statins compliance
a phase iii study of an otic formulation in acute otitis externa

Conditions: Acute Otitis Externa

Summary: the purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (aoe).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of aoe based on clinical observation and of presumed bacterial origin * a minimum combined score of ≥4 in at least 1 affected ear at the day 1 exam for tenderness, erythema, and edema * other protocol-defined inclusion criteria may apply exclusion criteria: * duration of pretherapy signs or symptoms of aoe greater than four (4) weeks * presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at visit 1 prior to enrollment * clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa * known or suspected ear infection of fungal or mycobacterial origin * prior otologic surgery within 6 months of study entry * seborrheic dermatitis or other skin conditions of the external auditory canal * current or prior history of an immunosuppressive disorder (e.g., hiv positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis * diabetic patients (controlled or uncontrolled) based upon assessment by investigator * any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), downs syndrome, and cranial facial reconstruction\] * any current known or suspected infection (other than aoe) requiring systemic antimicrobial therapy * use of prohibited medications or inadequate washout of any medication listed in protocol * concomitant use of topical or oral analgesics (i.e., nsaids and aspirin products) which may have anti inflammatory effects. patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. use of acetaminophen ("tylenol") is permitted during the trial * other protocol-defined exclusion criteria may apply

Keywords: swimmer's ear ear drops ear infection ear pain ear inflammation
a study of comparative formulations of niraparib and abiraterone acetate (aa) in men with prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine the relative bioavailability (rba; period 1) and bioequivalence (be; period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (aa) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mcrpc).

niraparib is an orally available, highly selective poly (adenosine diphosphate \[adp\]-ribose) polymerase (parp) inhibitor, with potent activity against parp-1 and parp-2 deoxyribonucleic acid (dna)-repair polymerases. aa is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/c17,20-lyase (cyp17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. the rationale of the study is to investigate the various strengths and formulations of niraparib and aa plus prednisone or prednisolone (p) in metastatic castration resistant prostate cancer (mcrpc) participants with and without homologous recombination repair (hrr) gene alterations. in participants with metastatic prostate cancer, dna-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. this study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment \[eot\] visit within 30 days after the last dose of study treatment). total duration of study is up to 1.4 years. efficacy, safety, pharmacokinetics (pk), and biomarkers will be assessed at specified time points during this study. participants safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate * diagnosed with metastatic castration-resistant prostate cancer (mcrpc), who in the opinion of the investigator may benefit from treatment in this study * able to continue gonadotropin-releasing hormone analogues (gnrha) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy) * eastern cooperative oncology group performance status (ecog ps) of less than or equal to (\<=) 1 * willing to provide a tumor sample (archival) for determination of homologous recombination repair (hrr) gene alteration status exclusion criteria: * symptomatic brain metastases * prior disease progression during treatment with abiraterone acetate (aa) alone or when combined with a poly adenosine diphosphate (adp)-ribose polymerase inhibitor (parpi). prior discontinuation of treatment with aa or parpi due to aa- or parpi related toxicity. * history or current diagnosis of myelodysplastic syndrome (mds)/ acute myeloid leukemia (aml) * known allergies, hypersensitivity, or intolerance to niraparib or aa or the corresponding excipients of niraparib/aa * any medical condition that would make prednisone/prednisolone use contraindicated
randomized, double blind, 2 way crossover study of csii with, versus without, pretreatment with human hyaluronidase

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (u) of hylenex® (recombinant human hyaluronidase ph20 \[rhuph20\]) injection at the time of infusion set insertion compared to sham injection.


Eligibility criteria:
inclusion criteria: 1. males or females of age 18 to 65 years, inclusive. females of child-bearing potential must use a standard and effective means of birth control for the duration of the study. 2. non-smoking participants with type 1 diabetes mellitus (t1dm) treated with insulin for ≥12 months. nonsmoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests at screening. 3. body mass index (bmi) 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive. 4. glycosylated hemoglobin a1c (hba1c) ≤10% based on local laboratory results. 5. fasting connecting peptide of insulin (c-peptide) \<0.6 nanograms per milliliter (ng/ml). 6. current treatment with insulin \<90 units per day (u/d). 7. current use of rapid acting insulin analog. 8. routine use of csii as the primary route of insulin administration for at least 3 months prior to screening 9. participants should be in good general health based on medical history and physical examination without medical conditions that might prevent the completion of study drug infusions and assessments required in the study protocol. exclusion criteria: 1. known or suspected allergy to any component of any of the study drugs in this study. 2. previous enrollment in this study. 3. use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia. participants taking maintenance doses of blood thinners (for example, coumadin or heparin) will be excluded. 4. use of any long-acting insulin injection within 72 hours of study day 1; participants will continue to refrain from use throughout the duration of the study (phases i and ii). 5. recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator. 6. current addiction to alcohol or substances of abuse as determined by the investigator. 7. blood donation or phlebotomy (\>500 milliliters \[ml\]) within the previous 8 weeks of the screening visit(s) in this study. 8. pregnancy, breastfeeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device \[iud\], oral or injectable contraceptives, or barrier methods). 9. symptomatic gastroparesis. 10. receipt of any investigational drug within 4 weeks of study day 1.

Keywords: type 1 diabetes continuous subcutaneous insulin infusion (csii)
identifying patients with suspicion of infection in the ed who have low disease severity using mr-proadm - pilot study

Conditions: Patients Presenting With Suspicion of Infection to the ED

Summary: emergency departments (ed) are becoming increasingly over-crowded, with patients facing prolonged waiting times. therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ed. the rationale of this ideal study is to provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker mr-proadm. this will be tested in a pilot study first.


Eligibility criteria:
inclusion criteria: * consecutive patients presenting to the ed with suspicion of infection * age ≥18 years * written informed consent obtained exclusion criteria: * recent major trauma or surgery * end stage renal failure requiring dialysis * terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure * patients those source of infection always requires hospital admission or never requires hospital admission. * patients who cannot be discharged for other than medical reasons * patient participates in any other interventional clinical trial * patients with active intravenous drug use * pregnant or lactating women * patients who are institutionalized by official or judicial order * dependents of the sponsor, the cro, the study site or the investigator
optimizing abiraterone therapy

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: the purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. furthermore to explore the relation between biomarkers and treatment response and drug exposure.


Eligibility criteria:
inclusion criteria: * patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated * age ≥18 years * feasible to collect blood samples from * life expectancy of \> 6 months * measurable disease * able and willing to give written informed consent prior to screening and enrollment exclusion criteria: * other anticancer therapies * potent cyp3a4 inducers * herbal medicine that could interfere with abiraterone exposure
the study of skeletal muscle blood flow in becker muscular dystrophy

Conditions: Muscular Dystrophy

Summary: this pilot study tests the hypothesis that the medication nitric oxide extract from beetroot juice improves blood flow to the skeletal muscle during exercise. the investigators will use cutting edge technology with contrast enhanced ultrasound to visualize the microvascular blood supply to the forearm. animal studies have shown reversal of muscle damage with improved delivery of blood to the exercising muscle. this research aims to understand the mechanism of action of this medication in a way it has never been studied before. the results may help benefit individuals with muscular dystrophy in the future.

the subjects are asked to perform a graded hand-grip exercise while blood flow to the skeletal muscle is visualized by contrast enhanced ultrasound. this is done at baseline and after taking the study agent.

Eligibility criteria:
inclusion criteria: * healthy man, aged 18 to 45 years, currently taking no medication. or * clinical diagnosis of becker muscular dystrophy (bmd), aged 18 to 45 years, and currently taking no medication. exclusion criteria: * hypertension, diabetes, heart failure, liver disease * ecg evidence of prolonged qt interval

Keywords: becker muscular dystrophy skeletal muscle blood flow ultrasound
a novel technique for gall bladder fundus retraction in single incision laparoscopic cholecystectomy

Conditions: Gallbladder Diseases

Summary: the investigators describe a novel technique for gb fundus retraction.

few methods are available for gall bladder (gb) retraction in silc to replace the usage of ancillary ports imitating retraction from conventional technique, e.g. trans-parietal stitches mini-loop retractor , a kirschner wire . this technical note describes a novel way to retract the gall bladder fundus.

Eligibility criteria:
inclusion criteria: * all cases underwent single incision cholecystectomy exclusion criteria: * none
the sapheon closure system feasibility study

Conditions: Venous Insufficiency of Leg

Summary: this is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the sapheon™ closure system for the treatment of incompetent saphenous veins.

venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. the primary objectives for this clinical study are to 1. demonstrate the safety of the sapheon™ closure system for the treatment of incompetent saphenous veins, 2. demonstrate the early and late efficacy of the sapheon™ closure system for the treatment of incompetent saphenous veins, and 3. demonstrate the satisfactory performance of the sapheon™ closure system device components.

Eligibility criteria:
inclusion criteria: * males or non-pregnant females ≥21 years of age but \<76 years of age. * venous reflux disease in the gsv diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging. * candidate for surgical closure of a segment of the gsv. * ceap classification of c2, c3 or c4. * ability to walk unassisted. * life expectancy of at least 18 months. * weight \>110 lbs. (50 kg). * ability to attend follow-up visits. * ability to understand the investigational nature of the treatment, and to provide written informed consent. exclusion criteria: * previous surgical procedure (surgical, thermal, or chemical ablation) associated with the venous segment to be treated. * diameter of index vein (supine) \ 12 mm in any segment. * tortuous gsv, which in the opinion of the investigator will limit catheter placement. * local or systemic infection. * insulin dependent diabetes. * leg obesity impairing the ability to gain access to the treatment leg, and/or apply sufficient compression for treatment. * documented history of superficial or deep thrombophlebitis. * varicosities secondary to pelvic or abdominal tumor. * significant arterial insufficiency; demonstrated by absence of ankle pulse. * known sensitivity to the cyanoacrylate (ca) adhesive or positive reaction just prior to surgery (by injecting a small peripheral vein with the agent). the study surgeon will judge the need for the injection and the subject's reaction to the injection on clinical grounds. * formal duplication of the saphenous trunk in the index vein (accessory gsv segments allowed). * hypercoaguable state. * presence of incompetent perforators in the treatment length. * history of right ventricular failure. * significant femoral or popliteal vein insufficiency. * bmi \>35 * additional procedures in the treatment leg likely required within the six months after the investigational procedure. * current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment. * other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent safe participation or otherwise render the subject ineligible for the study.