Kornimate/medical-research-clean huggingface dataset:
microprung : intestinal microbiota analysis in patients with or without hirschsprung's associated enterocolitis

Conditions: Hirschsprung Disease

Summary: hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. the consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. the most common type of hirschsprung disease alters the rectosigmoid (80%). the incidence is around 1/5000 live births. this anomaly requires a surgical ablation of the aganglionic segment. regardless of the surgical complications, patients with hirschsprung disease are exposed to the risk of hirschsprung associated enterocolitis (haec). this variable risk, 4-54%, is responsible to a major part of hirschsprung disease morbimortality. its onset is more frequent during the first two years of life and then decrease with age. its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. this breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of crohn's disease onset. some studies emphasize the role of microbiota in the pathogenesis of haec, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use. the study hypothesizes microbiota is a major factor in haec onset and in their functional bowel problems. considering haec is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. this project is innovative because it will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages. multicentre transversal study. this study has the potential to significantly modify clinical practice for hirschsprung disease patients: a better care for haec and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for haec, prophylactic treatment of patients at high risk of haec.

primary objective : characterize intestinal microbiota in patients with or without haec. secondary objectives : * look for a difference in microbiota composition between patients with or without haec ; * study the evolution with age of the microbiota in hirschsprung disease patients ; * study predominant taxonomic classification elements in both groups.

Eligibility criteria:
inclusion criteria: * patients from 0 to 16 years ; * with rectosigmoid hirschsprung's disease confirmed by rectal biopsies and at surgery; * already operated on, whatever the surgical technique was ; * with a health care insurance; * clear information and signed consent form exclusion criteria: * long segment hirschsprung disease ; * syndromic hirschsprung disease ; * down syndrome.

Keywords: hirschsprung associated enterocolitis (haec)
comparison of home-based exercise programmes for falls prevention and quality of life in older adults

Conditions: Accidental Falls

Summary: this study compares the effects of three home-based exercise programmes in "at-risk to falling" older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. the subjects will be randomized and allocated in three groups. the group a will receive the "test-and-exercise" home-based programme (t\&e), the group b will receive the "otago" home-based exercise programme and the group c (activ-control group) will receive the "helsana" booklet

home-based exercise programmes appear to reduce rate of falls, number of fallers, risk of falling and risk of death and to improve balance, leg strength, function, physical activity and balance confidence in older adults living in the community. the test-and-exercise home-based programme (t\&e) contains 50 tests and 50 exercises to improve balance, strength and ability in older adults. it is especially built for older adults and is based on the concept of self-efficacy and empowerment. the originality of this programme is the evaluation of the difficulty perceived of the balance-exercises. it is delivered on a booklet which investigators had good experience with in our pilot study, with pictures and descriptions of each test and each exercise. investigators also developed a mobile application. this application will be transmitted on a tablet-computer. in addition, the participants will receive cards with pictures of the exercises, to put into a plastic sheet to have an overview of their own exercise programme. this programme will be implemented from especially trained physiotherapists. the otago home-based exercise programme was developed in new-zeeland in the 2000's to prevent falls in older adults. it proposes 22 exercises and walk training. the physiotherapists give an exercise prescription at each home visit. it shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time. the otago home-based exercise programme was developed in new-zeeland in the 2000's to prevent falls in older adults. it proposes 22 exercises and walk training. the physiotherapists give an exercise prescription at each home visit. it shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.

Eligibility criteria:
inclusion criteria: * 65 years old and older, * living in their own home, * having a history of fall in the previous 12 months or perceiving fear of falling (≥ 20 points on fes-i, * being able to walk without auxiliary tools in their home. * signed informed consent exclusion criteria: * having severe vision impairment that do not permit the reading of the exercise-programme booklet and that do not permit the completing of the monthly diaries, * receiving physiotherapeutic treatment with balance learning, * having cognitive impairment (\<25 points on the mini-mental state examination (mmse) of folstein
cemiplimab survivorship epidemiology

Conditions: Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma

Summary: the objectives of the study are: * to describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (q3w) for treatment of patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) cutaneous squamous cell carcinoma (cscc) and patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) basal cell carcinoma (bcc) in real-world clinical settings * to evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (iraes), infusion related reactions (irrs), and treatment related serious adverse reactions (tsars) in patients with advanced cscc and patients with advanced bcc receiving cemiplimab treatment in real world clinical settings * to describe patient experience, including patient reported quality of life (qol) and functional status, and clinician reported performance status in a real-world setting for patients with advanced cscc and patients with advanced bcc * to describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced cscc and patients with advanced bcc undergoing treatment with cemiplimab * to describe patients who receive cemiplimab as treatment for cscc or bcc in a real-world setting * to describe real-world use patterns of cemiplimab for cscc and bcc * to investigate the long-term effects and effectiveness of cemiplimab in patients with advanced cscc or advanced bcc * to describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced cscc or advanced bcc, regardless of etiology, per available data * to describe the effectiveness of cemiplimab after prior exposure to radiation therapy for cscc per available data * to describe the effectiveness of cemiplimab as a first-line (1l) or later systemic treatment in patients with advanced cscc, regardless of etiology, per available data * to describe the effectiveness of cemiplimab in patients with advanced bcc based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior hedgehog inhibitor (hhi) usage


Eligibility criteria:
key inclusion criteria: * eligible for treatment with and prescribed cemiplimab for advanced cscc or advanced bcc in accordance with approved prescribing information as described in the protocol key exclusion criteria: * receiving cemiplimab for an indication other than advanced cscc or advanced bcc * any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study * patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up) note: other protocol defined inclusion/exclusion criteria apply

Keywords: locally advanced cscc (lacscc) metastatic cscc (mcscc) locally advanced bcc (labcc) metastatic bcc (mbcc)
the effect of glp-1 agonists versus ocs on reproductive disorders and cardiovascular risks in overweight pcos

Conditions: Polycystic Ovary Syndrome (PCOS); Overweight; Obesity

Summary: polycystic ovary syndrome (pcos) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. glp-1 receptor agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. this study aims to evaluate the effect of metformin-glp-1 receptor agonist combination versus metformin-diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (pcos) patients.

groups: experimental treatment: metformin-glp-1 receptor agonist therapy. regular treatment: metformin-oral contraceptive(oc) therapy. time point: initial treatment; post-treatment (4w); post-treatment (8w); post-treatment (12w); assess reproductive functions and cardiovascular risk factors.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pcos according to the rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism. * participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks. * participants were advised not to change physical activity or dietary habits during the study period. all subjects were overweight/obese \[body mass index (bmi) \>=24 kg/m2 or waistline\>=85cm \]. * all subjects had normal thyroid-stimulating hormone and prolactin levels. exclusion criteria: * smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions. * age below 18 yr or over 50 yr. * postmenopausal. * uncontrolled hypertension (blood pressure \>=160/100 mm hg). * preexisting ops or glp-1 agonists supplementation * alcohol intake greater than 20 g/d, or pregnancy. * signs of liver or renal failure or active liver disease (alt \> 2.5× the upper limit of normal values). * plt\<60\*10\^9/l,hb\<100g/l, smoking, alcohol use. * the patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

Keywords: polycystic ovary syndrome (pcos) overweight obesity glp-1 agonist oral contraceptives (ocs) metformin reproductive disorders cardiovascular risk factor lipid metabolism
safety and effectiveness of apixaban compared to warfarin in patients with non-valvular atrial fibrillation (a type of irregular heart rhythm) at higher chance of bleeding

Conditions: Non-valvular Atrial Fibrillation

Summary: * the purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (nvaf) patients at higher chance of bleeding using a japanese nation-wide administrative claims database. * atrial fibrillation (af) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots. * an anticoagulation therapy is a critical treatment to prevent thromboembolism in nvaf patients. * apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with af in phase 3 clinical trial. * previously we have shown that bleeding risks as well as stroke/se risks are less in real world clinical practice in japan compared to warfarin. however there are limited apixaban data for japanese nvaf patients with high bleeding risk(s). * this study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in japanese patients with nvaf who has higher chance of bleeding


Eligibility criteria:
inclusion criteria: * diagnosed with atrial fibrillation (af) anytime in the baseline period or on the index date, also have definitive diagnosis of af anytime in the baseline period, on the index date, or post-index period. * prescribed apixaban or warfarin on or after the day of af diagnosis. the first observed prescription will be used to identify the patient's index date and treatment cohort * no use of the any oral anticoagulants (oacs) during the baseline period (the 180 days before the index date) * age of 18 years or older on the index date exclusion criteria: * having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period * having a procedure of prosthetic heart valve during the baseline period * having a cardiac surgery procedure record during the baseline period * having a diagnosis of venous thromboembolism during the baseline period * having a hemodialysis during the baseline period * female patients with pregnancy during the baseline and follow-up period * patients prescribed apixaban other than approved daily dose (\ 10 mg) * patients prescribed oacs during baseline period
intraoperative ultrasonographic localization of pulmonary nodules in vats

Conditions: Ultrasonography

Summary: this study is conducted to explore the feasibility and value of intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (vats).

the study is designed as a single center prospective trial. the participating center is department of ultrasound, shanghai chest hospital, shanghai jiao tong university, china. the study is expected to enroll 200 patients. the feasibility and value of intraoperative ultrasonographic localization of pulmonary nodules in vats will be explored. the accuracy rate of localization will be evaluated using gray scale mode and elastography mode. intraoperative ultrasonographic localization will be performed using an ultrasound system (hi vison ascendus), which is equipped with a 5-10mhz mechanical probe (eup-ol531).

Eligibility criteria:
inclusion criteria: 1. patients who are older than 18 year-old. 2. chest ct shows pulmonary nodule suspected to be malignant that need to undergo vats. 3. patients who have good compliance and sign informed consent. exclusion criteria: 1. patient with severe asthma and pulmonary fibrosis. 2. refusal of participation. 3. severe cardiopulmonary dysfunction and other indications that can't receive vats.

Keywords: intraoperative ultrasonographic localization pulmonary nodules video-assisted thoracoscopic surgery
the effect of acute ketone monoester supplementation on glucose oxidation during exercise

Conditions: Exercise Metabolism

Summary: the purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. in a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. the main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.


Eligibility criteria:
inclusion criteria: * 18-50 years of age * trained cyclist/triathlete (vo2peak \> 55 ml/kg/min for males and \>48 ml/mg/min for females) * healthy as per medical history and investigator's/physician's judgement * having given written informed consent exclusion criteria: * use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. chronic use of gastric acid suppressing medication, statins, corticosteroids) * smoking * diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. diabetes mellitus) * diagnosed musculoskeletal disorders * adhering to a carbohydrate restrictive diet * participation in another study at the same time * blood donation in the 2 months before the first experimental trial * plasma donation in the 2 weeks before the first experimental trial * males: vo2peak \<55 ml/min/kg body mass * females: vo2peak \<48 ml/min/kg body mass * females: pregnancy
outcomes in a comparison of manual penetrating keratoplasty and the intralase® enabled keratoplasty

Conditions: Keratoconus

Summary: to compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old, with keratoconus and corneal transplant indication exclusion criteria: * exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40
efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (adt) in patients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (adt) in patients with mdd


Eligibility criteria:
inclusion criteria: * patients who have provided consent prior to any specific procedure * meet the the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd) * have a minimum score of 20 on 17-item hamilton depression (hamd-17) rating scale at visits 1 and 2 exclusion criteria: * patients who do not meet dsm-iv-tr criteria for mdd

Keywords: mdd major depressive disorder
safety and effect on quality of life/work productivity of humira in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the agil study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in germany, with a focus on the impact of therapy on employment-related outcomes.


Eligibility criteria:
inclusion criteria: * moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs * inclusive methotrexate * moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before; in case of incompatibility with methotrexate, humira can be used as monotherapy. exclusion criteria: * hypersensitivity against the drug or one of the other ingredients * active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) * moderate to severe cardiac insufficiency

Keywords: work productivity long-term observation humira quality of life rheumatoid arthritis
descriptive study of receptive fields in lower limb amputees

Conditions: Lower Limb Amputation Below Knee (Injury)

Summary: it has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically. this clinical trial aims to investigate the reliability in detecting these receptive fields as well as their incidence and changes over time. further it aims to evaluate the acute effect of a stimulating system ("phantom stimulator" (cort x sensorics, spaichingen, germany)) on selected gait parameters measured tough a gait analysis system ("oprtogait" (microgate, bolzano, italy)) as well as on phantom sensations measured through a questionnaire.

it has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically. a receptive field is defined as skin area anywhere on the same side of the body as the amputation, which when stimulated by others, causes phantom sensations in the amputated extremity. this clinical trial aims to investigate the reliability in detecting these receptive fields as well as their incidence and changes over time. further it aims to evaluate the acute effect of the stimulating system ("phantom stimulator" (cort x sensorics, spaichingen, germany)) on selected gait parameters measured tough a gait analysis system ("oprtogait" (microgate, bolzano, italy)) as well as on phantom sensations measured through a questionnaire.

Eligibility criteria:
1. inclusion criteria for descriptive study: a. lower limb amputation (independently of side or height of amputation) 2. inclusion criteria for phantom stimulator: 1. receptive fields present at testing day 31 (last regular assessment of the receptive fields) 2. lower limb amputation below the knee (if both sides the system is applied to the dominant side). 3. exclusion criteria: 1. implanted devices (defibrillator or pacemaker) 2. pregnancy

Keywords: amputation phantom pain gait analysis