Kornimate/medical-research-clean huggingface dataset:
the cooker-bladder trial

Conditions: Diet, Healthy; Urinary Bladder Diseases; Oncogenesis

Summary: the goal of this interventional study is to test the influence of food intake with characteristics of the urinary bladder. the main questions it aims to answer are: * how does food intake modify the characteristics of urothelial cells? * does change of specific diet regimes influence biomarker characteristics in urine? participants will follow specific diet regime for a given time period. after completion of this period biomarker assessment is performed. thereafter the participants follow an opposite diet regime for the same time period with identical biomarker assessment at the end. biomarkers within the participants and between the diet regimes will be compared to investigate the influence of food intake on the urinary bladder.


Eligibility criteria:
inclusion criteria: * no daily medication * no ongoing medical treatment exclusion criteria: * chronic disease * regular medication * not willing to follow diet instructions
dry eye assessment and management study

Conditions: Dry Eye

Summary: the objective of the dream study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.

the study is designed to: * test the hypothesis that omega-3 supplementation is an effective treatment for dry eye disease (ded) in primary clinical trial. * better understand ded by describing and evaluating a comprehensive set of features of ded and treatment over 12 months of observation in a well-characterized group of patients. * determine the effects of extended use and discontinuation of omega-3 through the extension trial.

Eligibility criteria:
inclusion criteria: * greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (same signs must be present at screening and baseline visits): conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), tear film break up time (tbut) less than or equal to 7 seconds, schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes. * ocular surface disease index (osdi) score: 25-80 at screening, 21-80 at baseline. * symptoms of ded for greater than or equal to 6 months. * use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks. * ability to swallow large, soft gelcaps exclusion criteria: * allergic to ingredients in supplements or placebo * contact lens wear * pregnant, nursing, or lactating * current ocular infection, inflammation, or acute allergic conjunctivitis * history of: ocular herpetic keratitis, ocular surgery in past 6 months, lasik surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies * currently on anticoagulation therapy * eyelid abnormalities or extensive ocular scarring * use of epa/dha supplements in excess of 1200 mg per dayi * current use, insufficient washout period, or intent to change specific treatments for dry eye disease
endothelin-1 and methabolites concentrations in mycrodialysis and cerebrospinal fluid in subarachnoid hemorrhage patients

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: endothelin-1 (et-1) seems to be involved in the pathogenesis of cerebral vasospasm after subarachnoid hemorrhage. however measurements of cerebrospinal fluid concentrations (csf) of et-1 are not sensitive enough to predict the development of vasospasm representing the average value throughout the entire cerebral circulation. cerebral microdialysis (md) is a technique able to detect molecule concentrations in a small perivascular area. the investigators performed a prospective observational clinical study to test the hypothesis that md et-1 concentrations should be a sensitive predictor for vasospasm. patients with subarachnoid hemorrhage at high risk for vasospasm according to fisher scale admitted to the icu were consecutively studied. all patients received surgery within 48 hours from the bleeding; md probe was placed in the area at risk for vasospasm after surgery and samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels; et-1 levels in csf and md fluids were measured from admission until day 7. at admission and after 7 days two angiographies were performed to detect the degree and extent of vasospasm, transcranial doppler and neurological evaluation were daily performed. patients were then classified according to the presence of vasospasm in 3 groups: absence of vasospasm (nv), presence of vasospasm (cv), acute neurological deterioration (and).


Eligibility criteria:
inclusion criteria: * diagnosys of subarachnoid hemorrhage * angiographic proof of aneurysm * admission within 24 hours from the subarachnoid hemorrhage * presence of an intraventricular catheter and a microdialysis catheter placed either after admission or at the time of the surgery exclusion criteria: * moribund * gcs=3 * denied consent
"endoscopy first" or "laparoscopic cholecystectomy first" for patients with intermediate risk of choledocholithiasis

Conditions: Choledocholithiasis

Summary: the study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated. endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ercp) on demand are performed before laparoscopic cholecystectomy for one arm. intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ercp on demand are administered in another arm.

use of ercp as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. it is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. therefore the best possible patient selection for ercp procedure is needed. at the centre of abdominal surgery of vilnius university hospital santaros klinikos an original prognostic index (vilnius university hospital index (vuhi)) is used for evaluation of risk of choledocholithiasis. it is calculated by formula vuhi = a/30 + 0.4×b, where a - total bilirubin concentration (µmol/l), b - common bile duct (cbd) diameter measured by ultrasound exam. a retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. the intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ercp. endoscopic ultrasound (eus) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. main hypothesis of the trial is that intraoperative cholangiography with ercp on demand can shorten the duration and costs of treatment and avoid diagnostic ercps.

Eligibility criteria:
inclusion criteria: * patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated * intermediate risk for choledocholithiasis (vuhi 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in cbd on ultrasound) exclusion criteria: * pregnancy; * acute cholangitis; * biliary pancreatitis; * acute cholecystitis, degree ii-iii by tokyo guidelines 2013; * anastomosis in upper gastrointestinal tract; * other known cholestatic hepatopancreatobiliary disease; * known or suspected hepatitis of another origin (viral, toxic, etc.); * contraindications for general anaesthesia or surgery; * iv-vi class of american society of anesthesiologists physical status classification; * morbid obesity (body mass index \> 40); * patient's refusal to participate in the study.

Keywords: choledocholithiasis endoscopic ultrasound ercp intraoperative cholangiography common bile duct stone endoscopic retrograde cholangiopancreatography gallstone disease cholelithiasis bile duct obstruction laparoscopic cholecystectomy
a prospective non-interventional multicenter study to evaluate the effectiveness of adalimumab in korean patients with ulcerative colitis (uc) and identify potential predictors of clinical response in routine clinical practice

Conditions: Ulcerative Colitis

Summary: this is a prospective, single country, multi-center study in participants with ulcerative colitis (uc) treated with adalimumab. up to 147 participants are enrolled at approximately 20 sites. the baseline assessment is performed prior to the first dose of adalimumab (visit 1). study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. all participants will have one follow-up for safety approximately 70 days after the last dose of adalimumab.

this is a prospective, single-country, multi-center study in uc patients treated with adalimumab. the prescription of adalimumab is at the discretion of the physician in accordance with clinical practice and label, is made independently from this study, and preceded the decision to offer the patient the opportunity to participate in this study. up to 147 subjects are planned to be enrolled at approximately 20 sites. the baseline assessment is performed prior to the first dose of adalimumab (visit 1). participants are administered adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the korean label. study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. all participants had one follow-up for safety approximately 70 days after the last dose of adalimumab. clinical response is assessed at week 8, and participants with clinical response at week 8 can continue on adalimumab treatment as per korean reimbursement guidelines. clinical response is defined as a decrease from baseline in the total mayo score by at least 3 points and at least 30% with an accompanying decrease in rectal bleeding subscore of at least 1 point or absolute rectal bleeding sub-score of 0 or 1.

Eligibility criteria:
inclusion criteria: * participant must be an adult ≥19 years * participant with active moderate to severe ulcerative colitis with mayo score of ≥ 6 points and endoscopic sub-score of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants. * participant must have tuberculosis (tb) screening assessment in accordance korean reimbursement guidelines. * participants who had started on adalimumab treatment in normal clinical practice setting by their physician. * participant must provide written authorization form to use personal and/or health data prior to the entry into the study. exclusion criteria: * female participants who are pregnant or breast feeding * participant with any contraindication to adalimumab * participant that is participating in other clinical trials

Keywords: adalimumab trough level fecal calprotectin fecal microbiota
a study of lebrikizumab (milr1444a) in adult patients with asthma who are inadequately controlled on inhaled corticosteroids

Conditions: Asthma

Summary: this is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ics).


Eligibility criteria:
inclusion criteria: * body weight 40 kg--150 kg * chest radiograph with no evidence of clinically significant abnormality * uncontrolled asthma exclusion criteria: * asthma exacerbation during screening * known malignancy * known immunodeficiency * pre-existing lung disease other than asthma * uncontrolled clinically significant medical disease * current smoker * history of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator * prior allergic reaction to a monoclonal antibody * patients (men and women) of reproductive potential who are not willing to use contraception * pregnancy

Keywords: adult asthma
a multi-center, placebo-controlled study to evaluate nt100 in pregnant women with a history of unexplained recurrent pregnancy loss (rpl)

Conditions: Recurrent Pregnancy Loss; Recurrent Miscarriage

Summary: this is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous nt100 in pregnant women with a history of unexplained recurrent pregnancy loss. approximately 150 participants will be randomised to receive subcutaneous nt100 or placebo.

this is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous nt100 in pregnant women with a history of unexplained recurrent pregnancy loss. approximately 150 participants will be randomised to receive subcutaneous nt100 or placebo. participants will be screened for eligibility, and will begin attempts at spontaneous conception. following randomization and initiation of study drug treatment, participants will visit the study site at specified intervals throughout the study for assessments and blood work. all participants will be monitored for adverse events. all participants who have received at least one dose of study drug will be followed for safety for a minimum of 4 weeks following the last dose of study drug. after delivery, pregnancy outcome information will be obtained.

Eligibility criteria:
inclusion criteria: 1. pre-menopausal female 18-37 years of age at consent, trying to conceive 2. documented history of unexplained recurrent pregnancy loss 3. spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site 4. body mass index (bmi) of 19-35 kg/m2 at consent exclusion criteria: 1. greater than 5 weeks of gestation when presenting for randomisation. 2. known karyotype abnormalities in either the participant or her current male partner 3. uncorrected clinically significant intrauterine abnormalities 4. abnormal vaginal bleeding of unknown cause 5. current diagnosis of infertility in either the participant or her current male partner 6. current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery. 7. any uncontrolled clinically significant medical condition

Keywords: recurrent pregnancy loss recurrent miscarriage miscarriage pregnancy loss repeated pregnancy loss
"comparison of therapist-led and robot-assisted arm therapy in subacute stroke rehabilitation"

Conditions: Stroke; Hemiparesis; Muscle Spasticity; Upper Extremity Dysfunction; Subacute Stroke

Summary: this study aims to compare the outcomes of upper limb motor therapy conducted by a physiotherapist with robot-assisted therapy using the luna emg device in patients in the subacute phase after stroke. additionally, the study will examine the correlation between changes in muscle tone and motor function improvement. the randomized controlled trial will be conducted at the rehabilitation department of the t. marciniak lower silesian specialist hospital in wrocław, poland. two groups (robot-assisted vs. conventional therapy) will perform identical sets of movements with matched repetition counts over a 6-week therapy period. functional improvement will be assessed using fugl-meyer upper extremity assessment (fma-ue), box and block test (b\&bt), eq-5d-5l, and myotonpro measurements.

stroke often leads to upper limb motor impairment, spasticity, and reduced independence. robot-assisted rehabilitation, including devices like luna emg, may increase therapy intensity and patient motivation through feedback and movement intention detection via emg signals. this interventional study includes 50 participants post-stroke, randomly assigned to either robot-assisted therapy (luna emg) or conventional physiotherapist-led therapy. both groups receive standard rehabilitation (75 minutes/day), with an additional 45-minute targeted upper limb training session. sessions are conducted 5 days a week for 6 weeks. muscle tone will be assessed using the modified ashworth scale and biomechanical parameters (stiffness, oscillation) with myotonpro. motor performance will be evaluated using the fugl-meyer assessment (fma-ue) and the box and block test (b\&bt). quality of life and pain perception will also be measured using the eq-5d-5l and a numeric rating scale (nrs). outcome measures will be collected at baseline, after 3 weeks, after 6 weeks of therapy, and 3 weeks post-intervention to evaluate both immediate and short-term effects of the intervention. this study seeks to identify whether robotic rehabilitation offers measurable advantages over traditional methods in early post-stroke recovery.

Eligibility criteria:
inclusion criteria: * age 18-90 * first-ever ischemic or hemorrhagic stroke within 6 weeks prior to enrollment * stable medical condition * fugl-meyer assessment for upper extremity (fma-ue) ≤ 94 * mini-mental state examination (mmse) ≥ 23 * signed informed consent exclusion criteria: * fixed contractures in upper limb * mas ≥ 3 in any upper limb muscle * severe vision/hearing problems * severe dysphagia or respiratory issues * myasthenia or myasthenic syndrome
health-related quality of life in crohn's disease participants with complex perianal fistula before and after treatment

Conditions: Crohn Disease; Inflammatory Bowel Disease; Gastrointestinal Diseases; Intestinal Diseases

Summary: the purpose of this study is to assess the impact of treatment (medical and/or surgical) on health-related quality of life (hrqol) in participants with crohn's disease (cd) and complex perianal fistula (cpf), by the quality of life in patients with anal fistula questionnaire (qolaf-q), at 12 months after treatment initiation in routine clinical practice.

this is a prospective follow-up post-authorization observational study of participants with cd and cpf. the study will provide real-world data on how cpf treatments in cd participants affect their hrqol. the study will enroll approximately 300 participants. all participants will be enrolled in one observational cohort. this multi-center trial will be conducted in spain. the study will collect data from a routine medical practice visits for cd participants with cpf and an application that will be designed ad hoc and will passively record participant's data. the overall duration of this study will be approximately 31 months. participants will be followed up at months 6 and 12 post-treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosed with cd and cpf (defined as a fistula meeting any of the following criteria: high location \[high intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric\], multiple external openings, perianal abscess, anal stenosis, or proctitis). 2. has tried and failed at least one prior treatment for cpf. 3. starting a new pharmacological or surgical treatment for cpf. exclusion criteria: 1. diagnosed with indeterminate/unspecified type of inflammatory bowel disease (ibd). 2. diagnosed with ulcerative colitis. 3. diagnosed with fistula other than cpf (example rectovaginal). 4. treated with darvadstrocel or other stem cells-based therapies within the eligibility period. 5. previous fecal incontinence. 6. lost to site follow-up for reasons other than death. 7. participates or plans to participate in any interventional clinical trial. 8. non fluent in spanish.

Keywords: drug therapy
a clinical trial to evaluate the safety and tolerability of tqb3911 tablets in patients with bcr::abl fusion gene positive leukemia

Conditions: Chronic Myelogenous Leukemia

Summary: phase i clinical trial to explore the safety, tolerability, and initial efficacy of tqb3911 tablets in bcr::abl fusion gene positive leukemia.


Eligibility criteria:
inclusion criteria: * the subjects voluntarily joined the study, signed the informed consent, and had good compliance; * age: ≥18 years old (when signing the informed consent); eastern cooperative oncology group performance status (ecog ps) score: 0-2; expected survival of more than 3 months; * during the screening period, the patients were identified as chronic myelogenous leukemia-chronic phase (cml-cp) or accelerated phase (ap) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination; * chronic myelogenous leukemia (cml) patients who are intolerant to tyrosine kinase inhibitors (tki) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure) * the main organs function well * female subjects of reproductive age should agree to use contraceptives (such as iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period. exclusion criteria: * had or was currently suffering from other malignant tumors within 5 years before the first medication * combined with active central nervous system leukemia * major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment * previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block * acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication * history of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia * patients with cml-cp who have achieved complete cytogenetic response (ccyr) * received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation * use of drugs that may have caused qt prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period