Kornimate/medical-research-clean huggingface dataset:
robotic right hemicolectomy versus laparoscopic right hemicolectomy

Conditions: Colorectal Neoplasms; Colorectal Neoplasms Malignant; Colorectal Neoplasms, Benign; Colorectal Cancer; Colorectal Polyp; Colorectal Adenoma; Colorectal Adenocarcinoma

Summary: robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.

during laparoscopic right hemicolectomy (laprhc) for cancer or polyp, intra-corporeal anastomosis (ica) offers better short-term recovery and decreased incidence of incisional hernia (ih) when compared to extra-corporeal anastomosis (eca). however, because of the technical limitations of laparoscopy, ica has not gained in wide acceptance and eca has remained the standard of care. on the contrary, robotics offers improved suturing capacities and facilitates the realization of ica. therefore, robotic right hemicolectomy (robrhc) with ica may have better short-term recovery outcomes and decreased incidence of ih when compared to the laparoscopic actual standard of care. in a randomized controlled trial, we will compare robrhc with ica with laprhc with eca, in terms of recovery of bowel function (time to first passage of faeces). secondary outcomes will notably include length of stay, incidence of ih, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).

Eligibility criteria:
inclusion criteria: * adult patients requiring elective minimally invasive rhc for ct1-t3 nx m0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure). exclusion criteria: * not scheduled for minimally invasive rhc (refuses surgery and/or planned open approach) * emergency surgery * hereditary colorectal cancer * inflammatory bowel disease * synchronous resection of (an)other organ(s) * synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract) * ct4 * cm+ * history of laparotomy * pregnancy * no anastomosis planned * unable to provide informed consent * no informed consent
diet treatment of patients with ulcerative colitis in remission

Conditions: Ulcerative Colitis

Summary: the study examines the effect of a low fodmap diet in patients with uc in remission but still having gi symptoms (ibs in ibd). 15 patients will be on watchful waiting. 15 patients will be on low fodmap diet. 15 patients with recieve fodmaps in their diet.

patients are randomized to either standard care, low fodmap diet or a normal fodmap diet. run-in on a low fodmap diet, thereafter parallel design where one arm is assign a blinded food supplement with low fodmap content and the other arm is assigned a blinded food supplement containing fodmap. a control group is "watchful waiting". symptom reports, blood, and fecal samples are collected.

Eligibility criteria:
inclusion criteria: * colitis ulcerosa in remission (calciprotectin\<200 and normal sigmoidoscopy) * rom iv criteria fullfilled * stable medical therapy exclusion criteria: * intake of a low fodmap diet within the past 6 weeks prior to baseline * atypical colitis ulcerosa primarily right sided disease and calciprotectin \>50 unless normal sigmoidoscopy * if diarrhea: clostridium difficile infection * lactose intolerance * systemisk or local treatment for cu other than 5-aminosalicylicacid or biological therapy * antibiotics within 6 weeks * pregnancy * activity in uc * coeliac disease * abnormal transglutaminase * eating disorder * special diet preventing the low fodmap diet * other gi disease or other disease explaining symptoms * medication intake explaining symptoms * not able to follow protocol

Keywords: diet low fodmap uc ibs
study of post-operative oxygen consumption following vascular surgery

Conditions: Oxygen Consumption; Aortic Aneurysm; Peripheral Arterial Disease

Summary: to define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).


Eligibility criteria:
inclusion criteria: * patients presenting for major vascular surgery at the royal infirmary of edinburgh exclusion criteria: * patient refusal

Keywords: oxygen consumption aortic aneurysm peripheral arterial disease
pacemaker-based long-term monitoring of sleep apnea

Conditions: Bradycardia

Summary: this is a prospective, non-interventional cohort study. it tests the hypothesis that * pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. * autonomic imbalance defined by an increased periodic repolarisation dynamics (prd) predicts clinical outcome in pacemaker patients. * autonomic imbalance defined by an increased periodic repolarisation dynamics (prd) predicts the occurrence of ahre in sr patients implanted with a dddr pacemaker.

all forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers as well as autonomic imbalance measures will be correlated with the incidence and progression (within 5 years of follow-up) of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, copd, peripheral artery disease, iron insufficiency. in a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.

Eligibility criteria:
inclusion criteria: * implanted microport teo sr/dr or borea sr/dr pacemaker device * signed informed consent exclusion criteria: * any contraindication to perform a cardiac ct examination * egfr \< 30 ml/min/1.73 m2 * allergy against ct contrast medium * hyperthyreoism * inability of the patient to understand the study purpose and plan * inability of the patient to perform baseline examinations * pregnancy or breast-feeding; women with childbearing potential * estimated life expectancy below one year
prospective treatment efficacy in ipf using genotype for nac selection (precisions) trial

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to compare the effect of n-acetylcysteine (nac) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (ipf) who have the tollip rs3750920 tt genotype. the study will compare the time to a composite endpoint of relative decline in lung function \[10% relative decline in forced vital capacity (fvc), first respiratory hospitalization, lung transplantation, or all-cause mortality\] the secondary objectives will be to examine the effect of nac on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.

this is a multi-center, randomized, double-blind, placebo-controlled trial of nac or placebo in about 200 participants with ipf with a tollip rs3750920 tt genotype. eligible participants will be randomized in a 1:1 fashion to nac or placebo, stratified by stable concomitant ipf therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. participants will receive 600 mg nac orally or matched placebo to take three times daily for 24 months.

Eligibility criteria:
inclusion criteria: * ≥ 40 years of age * diagnosed with ipf according to 2018 ats/ers/jrs/alat, confirmed by enrolling investigator * signed informed consent * if taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit * confirmed rs3570920 tt tollip genotype exclusion criteria: * pregnancy or planning to become pregnant * women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation * significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure * receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer * supplemental or prescribed nac therapy within 60 days of enrollment * listed for lung transplantation at the time of screening * history of lung cancer * inability to perform spirometry * forced vital capacity (fvc) less than 45% predicted, using the global lung function index (gli) equation at visit 1 * active respiratory infection requiring treatment with antibiotics within 4 weeks of visit 1

Keywords: ipf pulmonary fibrosis n-acetylcysteine nac
post-obturation pain following the use of the ah plus and iroot sp sealers

Conditions: Endodontically-Treated Teeth

Summary: the aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers. in this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. the groups were composed of devital teeth with periapical lesions treated with iroot sp sealer, vital teeth treated with iroot sp sealer, devital teeth with periapical lesions treated with ah plus sealer, and vital teeth treated with ah plus sealer. in single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. radiographs were taken and obturation length was recorded. patients recorded pain scores use of visual analogue scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..

this randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iroot sp, ah plus)

Eligibility criteria:
inclusion criteria: * no systemic diseases * women were not pregnant or breastfeeding status * no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment. * all selected teeth were mandibular molar or mandibular premolar. exclusion criteria: * systemic and/or periodontal disease; * allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs; * requirement for antibiotic prophylaxis * open tooth apex * pacemaker use

Keywords: endodontic postoperative pain iroot sp sealer randomized clinical trial herofill carrier-based obturation
taass-traumeel ointment and gel compared with a topical nsaid in athletes with acute ankle sprain

Conditions: Sprain of Ankle

Summary: the objective of this study is to determine the efficacy of traumeel s (both ointment and gel) compared to another antiinflammatory drug called diclofenac in patients with a sprained ankle.

study objective is the confirmatory proof of efficacy for traumeel® s topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. in addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

Eligibility criteria:
inclusion criteria: * athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female * moderate (30-60 mm) to severe (\>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (vas) on weight bearing, unable to perform normal training / sports activities * 18 - 40 years of age * injury occurred within 24 hours of the first dose of study medication * willing and able to give written informed consent * available for the duration of the study exclusion criteria: * similar injury affecting the same joint within the past 6 months * bilateral ankle injury * bed rest, hospitalization, surgery use of a non-removable rigid cast * clinically important abnormality for screening laboratory tests * debilitating acute or chronic illness * use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting nsaid, cox-2 specific inhibitors, or tramadol * history of sensitivity to any component of the study drugs * unwilling or unable to comply with all the requirements of the protocol * participation in other studies within 4 weeks prior to study entry and or during the study participation * current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result

Keywords: ankle sprain traumeel diclofenac antiinflammatory time to normal function
a modified cuff leak test and reintubation in mechanically ventilated patients

Conditions: Mechanical Ventilation Complication; Weaning Failure; Airway Obstruction

Summary: we hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

the cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. however, there is still no clear and unified cuff leak test operation specification. a cohort study has proposed a modified method. when the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. we hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * oral endotracheal intubation and mechanical ventilation \> 36 hours * fulfilled the weaning criteria exclusion criteria: * the patient has a chest drainage tube and there is persistent air leak * abnormalities of the larynx: such as tumors or vocal cord paralysis * the patient cannot maintain the semi-recumbent position * unconventional weaning, such as awake ecmo, etc * participated in the study during the hospitalization * patients or their relatives refused written informed consent
a study of eptinezumab in pediatric participants with episodic migraine

Conditions: Episodic Migraine

Summary: the main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine (with or without aura) according to the international classification of headache disorders, 3rd edition (ichd-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the screening visit. * during the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache ediary (≥23 of the 28 days) following the day of the screening visit. * during the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the ediary. exclusion criteria: * history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min). * history of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system. * current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the screening visit. participants with a lifetime history of psychosis and/or mania are excluded. * any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance. other inclusion and exclusion criteria may apply.
analytical evaluation of the endotest® diagnostic

Conditions: Endometriosis; Diagnosis

Summary: this is an interventional with minimal risks and constraints (riph 2 in france), prospective, longitudinal, non-randomized, multicenter study. the present study will allow us to evaluate multiple factors assessing the endotest® diagnostic accuracy and its possible limitations. to characterize the endotest® diagnostic, the following parameters will be evaluated: * repeatability: the verification of the invariability of its results without condition changes, * circadian cycle: whether the circadian cycle affects the determination of the signature, * intermediate fidelity: the verification of the invariability of its results with an operator change, * interferences: the impact of different interferences on its results, * stability: the possible modification of its results depending on the samples conditions of storage. the acts and procedures performed in this research will be divided into three visits: * inclusion visit: performance of 4 endotest® diagnostics (3 at the visit and 1 at home) by the 60 included subjects, * "circadian cycle" visit: performance of 17 endotest® diagnostics (14 at the visit and 3 post-visit at home) by 6 subjects selected after evaluation of the results of the inclusion visit, * "repeatability-intermediate fidelity-interference-stability" visit: realization of 17 endotest® diagnostic by 10 or 16 subjects, depending on the results of the impact of the circadian cycle on the saliva signature. these subjects will be selected according to the results of the inclusion visit, excluding those who participated in the circadian cycle visit.


Eligibility criteria:
inclusion criteria: * subject aged 18 years to 43 years, * subject having dated and signed the consent form, * subject affiliated to the french health system, * subject able to return for a full day for the rest of the study, * subject whose diagnosis of endometriosis has been established with certainty or definitively ruled out. non-inclusion criteria: * pregnant subject, * subject with an acute or chronic infection (viral hepatitis, hiv...), * subject with history of hypersensitivity or allergy, * subject with a personal history of cancer, * subjects with significant difficulties in reading or writing the french language, * subject unable to comply with the study and/or follow-up procedures, * subject who has objected to the collection of her data, * subject participating in an interventional study or in the exclusion period of an interventional study. exclusion criteria: * pregnant subject, * subject with acute or chronic infection (viral hepatitis, hiv...), * subject unable to comply with study and/or follow-up procedures (including absence of outside salivary sample after the inclusion visit), * subject participating in an interventional study or in the exclusion period of an interventional study.

Keywords: endometriosis diagnosis saliva sample repeatibility circadian cycle interferences stability
remedy, biodegradable peripheral stent registry

Conditions: Peripheral Arterial Disease

Summary: this is a prospective multicenter registry to evaluate safety and performance of the remedy, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. patients will be followed for a period of 1 year.


Eligibility criteria:
inclusion criteria: * patients with symptomatic leg ischemia requiring treatment of sfa artery or proximal popliteal artery located within the following parameters: * 1 cm from the femoral bifurcation in the sfa * 3 cm from the proximal margin of the intercondylar fossa * rutherford-becker category 2-5. in patients with bilateral lesions, the highest rutherford category limb should be treated. only 1 leg can be included. * single lesion which can be covered by one stent. * target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate) * a patent popliteal artery free from significant stenosis (\>50%) with at least one patent vessel runoff as confirmed by baseline angiography * signed informed consent. exclusion criteria: * pregnancy * previous stenting of target lesion * acute ischemia * untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis. * significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy * known intolerance to study medications or contrast agents.

Keywords: biodegradable stent, pad
a clinical trial of transcatheter aortic valves in dialysis patients (japan)

Conditions: Aortic Stenosis

Summary: a single arm, prospective, open, non-randomized, japanese multicenter trial to evaluate the safety and effectiveness of the edwards sapien 3 transcatheter heart valve system (model: 9600tfx) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. data will be collected from all patients for up to five years following the index valve replacement procedure.

Eligibility criteria:
inclusion criteria: * patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation. * patient has senile degenerative aortic valve stenosis * patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months. * patient has appropriate aortic valve annulus size measured by tee or 3d-ct. exclusion criteria: * patient has evidence of an acute myocardial infarction (mi) within 30 days prior to the index procedure. * patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve. * patient has severe aortic valve regurgitation. * patient has severe mitral valve regurgitation. * patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary. * patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.