Kornimate/medical-research-clean huggingface dataset:
induction study #1 of oral ozanimod as induction therapy for moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: this is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active crohn's disease.


Eligibility criteria:
inclusion criteria: * crohn's disease for ≥ 3 months on endoscopy and on histological exam * inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies * crohn's disease activity index (cdai) score ≥ 220 and ≤ 450 * an average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points * has simple endoscopic score for crohn's disease (ses-cd) score of ≥ 6 (or ses-cd ≥ 4 in participants with isolated ileal disease) exclusion criteria: * has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention * has extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition * current stoma, ileal-anal pouch anastomosis, or fistula other protocol-defined inclusion/exclusion criteria apply

Keywords: crohn's disease crohn disease oral ozanimod moderately active severely active rpc01 rpc01-3201
study of the femtosecond laser system as compared to continuous curvilinear capsulorhexis for cataract surgery

Conditions: Cataract

Summary: the purpose of this study is to evaluate the safety and efficacy of the optimedica femtosecond laser system to perform surgical maneuvers used in the treatment of subjects with cataracts. the safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (ccc) and ultrasonic phacoemulsification.


Eligibility criteria:
inclusion criteria: * able and willing to comply with the treatment/follow-up schedule and requirements * able to understand and provide written informed consent * etdrs (early treatment of diabetic retinopathy study) visual acuity equal to or worse than 20/32 (best corrected) * age between 50 and 80 years old * pupil dilates to at least 7 mm * subject able to fixate * grade 1-4 nuclear sclerotic cataract (lens opacities classification system - locs iii) * axial length between 22 and 26 mm exclusion criteria: * pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding * participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the investigator's careful discretion, as long as not contradictory to any of the above criteria * any condition which, in the investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated * anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via iol master (zeiss). * history of prior ocular surgery * history of ocular trauma * co-existing ocular disease affecting vision * history or current use of alpha-1 antagonist medication (e.g., flomax) * known sensitivity to planned concomitant medications

Keywords: cataract surgery, cataract extraction optical devices, laser
intensive versus minimal surveillance of patients with resected dukes b2-c colorectal carcinoma

Conditions: Colorectal Cancer; Surveillance

Summary: dukes b2-c colorectal cancer patients who had no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for the trial and randomized to two different surveillance programs. these programs differ greatly in the frequency of diagnostic imaging. they have similar schedules of physical examinations and carcinoembryonic antigen (cea) assessments. patients will receive baseline and yearly health-related quality of life (hr-qol) questionnaires. primary outcomes are overall survival and qol.

minimal program for colon cancer: office visit and cea at 4,8,12,16,20,24,30,36,42,48, and 60 months. colonoscopy at 12, and 48 months. liver echography\* at 8, and 20 months. intensive program for colon cancer: office visit, cbc, cea+ca 19.9 at 4,8,12,16,20,24,30,36,42,48, and 60 months. colonoscopy at 12, 24, 36, 48,and 60 months. liver echography\* at 4,8,12,16,24,36,48, and 60 months. chest x-ray at 12,24,36,48,and 60 months. \* abdominal-pelvis c.t., as an alternative to echography, was a 2° level exam only (doubtful results of physical examination or echography; increasing levels of cea; predictable poor sensitivity of echography due to obesity or other anatomic-clinical conditions)

Eligibility criteria:
inclusion criteria: * patients with histologically proven adenocarcinoma of the colon or rectum with dukes astler-coller modification stage b2-c who had been treated with curative intent (radical excision ± adjuvant radio-chemotherapy) . * eligible patients had to be free of known cancer prior to study entry as attested by negative results of endoscopy, liver ultrasonography, chest roentgenography and serum cea level performed \< 4 months before randomization exclusion criteria: * inability to undergo testing (disability, allergy to contrast agents, etc.) and patients geographically not amenable to full follow-up. * patients enrolled onto any other research protocol that requires strict adherence to any specific follow-up practice. * a history of any previous malignancy in the last 10 years (other than carcinoma in situ of the cervix or non-melanoma skin cancer). * no informed consent to participate in the trial according to local regulatory guidelines.

Keywords: randomized clinical trial
health parameters in soccer players and sedentary individuals after consuming a synbiotic

Conditions: Athlete; Sedentary Behavior

Summary: the main objective of this research was to carry out an experimental study, triple blind, on the possible immunophysiological effects of a nutritional supplement (synbiotic, gasteel plus®, heel españa s.a.u.), containing a mixture of probiotic strains, such as bifidobacterium lactis cbp-001010, lactobacillus rhamnosus cncm i-4036, bifidobacterium longum es1, as well as prebi-otic fructooligosaccharides, in both professional athletes and sedentary people. the effects on some inflammatory/immune (il-1β, il-10, and immunoglobulin a) and stress (epinephrine, nore-pinephrine, dopamine, serotonin, crh, acth, and cortisol) biomarkers were evaluated, determined by flow cytometer and elisa. the effects on metabolic profile and physical activity, as well as on various parameters that could affect physical and mental health, were also evaluated via the use of accelerometry and validated questionnaires.

this investigation was a triple blinded, randomized, placebo-controlled pilot study designed to identify the possible differing effects of the synbiotic gasteel plus® supplementation. the participants were professional soccer players of the second division b of the spanish league and sedentary students of the same sex and age range. both study groups were randomly divided into two groups: a control group administered with placebo, and an experimental group administered with the synbiotic. each participant was evaluated at baseline, as well as after the intervention which lasted one month. only in the athletes group did the synbiotic intervention clearly improve objective physical activ-ity and sleep quality, as well as perceived general health, stress, and anxiety levels.

Eligibility criteria:
inclusion criteria: * sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week), * athletes: semi professional soccer players exclusion criteria: * participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods) * presenting injury or illness

Keywords: anxiety immunity inflammation prebiotic probiotic sedentarism soccer stress synbiotic
β-aarc: cohort study for the identification of blood-based biomarkers in a population with subjective cognitive decline

Conditions: Alzheimer Disease; Preclinical Alzheimer; Mild Cognitive Impairment

Summary: the overall (cross-sectional) objective of this study is to detect and describe the profile of ad-related blood biomarkers in a population with scd (including individuals with mci) with the ultimate goal of investigating their capacity to predict underlying ad pathology. longitudinally, the β-aarc_bbrc2021 study fundamentally aims at assessing the ability of ad-related blood-based biomarkers to predict disease progression in the alzheimer's continuum. to achieve these cross-sectional and longitudinal objectives, an exhaustive set of clinical, risk factors, cognitive, mental health and neuroimaging data will be collected, as well as blood and csf samples, from which ad-related fluid biomarkers will be determined. as a secondary objective, we will investigate the efficacy and accuracy of the altoida nmi as a novel digital biomarker for identifying patients with scd or mci that have underlying ad pathology (cross-sectionally) and to test the capacity of the altoida nmi to track disease progression in these popoulations (longitudinally).


Eligibility criteria:
inclusion criteria: 1. cognitively unimpaired persons with scd as well as individuals with mci. 2. to sign the study informed consent form, approved by the corresponding authorities. 3. participation (in-person at the institution or telephonically) of a relative to inform on the participant subjective memory decline and on the clinical interview\*. 4. men and women between 55 and 80 years old 5. memory alteration test (m@t) ≤45 6. good knowledge of the either spanish or catalan language and being literate. exclusion criteria: 1. presence of clinically relevant psychiatric disorder according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-v) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, or any other condition that might impact cognition or performance on cognitive assessments as judged by the investigator 2. parkinson's disease, epilepsy in treatment and with frequent seizures (\> 1 / month) in the last year, multiple sclerosis or other neurodegenerative disease. 3. contraindication to perform an mr scan: claustrophobia, pacemaker, metallic implants, etc. 4. contraindication to lumbar puncture 5. acquired brain injury: history of cranioencephalic trauma with gross parenchymal or extra axial lesion, hemorrhagic ischemic stroke, brain tumors and other aetiologies that can cause acquired brain damage (chemotherapy or brain radiotherapy). 6. investigator's criteria: subjects that show any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and / or in their future permanence in the study.
terminator 2 register

Conditions: Chronic Hepatitis B, HBeAg Negative

Summary: all patients with chronic hbeag negative hepatitis b treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the easl hepatitis b guidelines shall be included in the present study. the aim is to evaluate the clinical outcome (virological relapse, hbsag decline) and associated virological and immunological parameters.


Eligibility criteria:
inclusion criteria: 1. male and female patients with chronic hepatitis b virus infection documented by detectable hbsag. 2. age \> 18 years 3. ongoing antiviral therapy with entecavir or tenofovir (tdf) 4. at least 3 years hbv-dna \< 20 iu/ml (=100 copies/ml) 5. hbeag negative 6. willingness to give written informed consent and willingness to participate and to comply with the protocol. exclusion criteria: 1. hiv infection, persistent hdv-infection, persistent hcv infection 2. history or other evidence of a medical condition associated with chronic liver disease other than hbv associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures). 3. history or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease 4. patients with advanced liver fibrosis and liver cirrhosis (fibroscan \>10.0 kpa) 5. patients with hepatocellular carcinoma 6. history of major organ transplantation or other immunosuppressive conditions 7. history or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study 8. history of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 12 months prior to cessation of antiviral therapy or the expectation that such treatment will be needed at any time during the study -
psychological and psychosocial intervention with war-affected children

Conditions: Stress Disorders, Post-Traumatic; Depression; Anxiety; Conduct; Pro-social Behavior

Summary: the investigators are interested in knowing whether a group-based, trauma-focused intervention (trauma focused cognitive behavioral therapy) is superior to a more general, non trauma-focused, psychosocial intervention (child friendly spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the democratic republic of congo.


Eligibility criteria:
inclusion criteria: * under 18 years of age, * witness to a violent event involving a real or perceived direct threat to life, * ability to attend a 3-week intervention exclusion criteria: * psychosis, * mental retardation, * inability to understand swahili, * severe emotional \& behavioral problems that made group participation impossible

Keywords: trauma-focused cognitive behavior therapy war-affected children post-traumatic stress symptoms psychosocial distress
diffusion tensor and functional connectivity imaging in pediatric epilepsy: imaging/histology correlation

Conditions: Intractable Epilepsy

Summary: to determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.

to determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children. all enrolled children will undergo standard preoperative and postoperative mri imaging, plus a 15 minute set of functional connectivity and diffusion tensor sequence with no additional sedation. this imaging data will be stripped of identifiers and be processed to provide both quantitative analysis, resting state functional connectivity changes and three dimensional modeling of white matter tracts adjacent to epileptogenic foci. this study is being done to determine if diffusion tensor and functional connectivity magnetic resonance imaging are helpful to better understand and diagnose intractable epilepsy in children.

Eligibility criteria:
inclusion criteria: * children diagnosis with intractable epilepsy exclusion criteria: * no intractable epilepsy
the effects of dexlansoprazole for the treatment of throat-related reflux

Conditions: Laryngopharyngeal Reflux

Summary: recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. as dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (lpr) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. it is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.

the aim of the study is to compare outcomes, based on rsi-based symptomatic improvement and pharyngeal probe results, after lpr patients are treated for two months with once-daily (qam) kapidex versus placebo.forty patients with pharyngeal ph probe-documented lpr and an elevated reflux symptom index (rsi) (≥14) will be enrolled into a double-blinded placebo controlled study. twenty patients will receive kapidex once daily, while twenty receive placebo. patients will return at two months for evaluation with repeat rsi documentation and repeat pharyngeal ph probe testing. student t-test will be used to determine if the change in rsi and ph-probe results differs between the study and placebo group.

Eligibility criteria:
inclusion criteria:patients with an abnormal restech ph probe study and also have an rsi of 14 or greater will be invited to participate in the study exclusion criteria:known intolerance or allergy to proton pump inhibitors, hypersecretory conditions (zollinger-ellison), self-reported anxiety/depression (shown to affect rsi),16 history of laryngeal irradiation, or have been on twice daily proton pump inhibitors (ppi) therapy for greater than 2 months without symptomatic relief (with an rsi ≥14)

Keywords: laryngopharyngeal reflux, acid reflux, throat reflux
effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer.

this is a prospective observational study design. a total of 45 patients with newly diagnosed esophageal cancer will be recruited from the mackay memorial hospital. all tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test).repeated measure anova will be used for analyzing difference of parameters among various time points.

Eligibility criteria:
inclusion criteria: * newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty exclusion criteria: * inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy

Keywords: respiratory muscle strength diaphragmatic surface electromyography functional capacity
repeatability and feasibility of infant spirometry

Conditions: Prematurity

Summary: this is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. a flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. the study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. the equipment is made by volusense norway as, and marketed under the name floright. the equipment is owned by volusense norway as during the study period.


Eligibility criteria:
inclusion criteria: * being a term born and preterm born babies exclusion criteria: * being in an unstable clinical condition

Keywords: repeatability of measurements
reliability and interest of circulating tumor dna in endometrial cancers.

Conditions: Circulating Tumor DNA; Endometrial Cancer

Summary: the recent histo-prognostic molecular discoveries of the tcga (the cancer genome atlas) have shed new light on the classification of endometrial carcinomas. after carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with pole mutations, the "hypermuted" group with microsatellite instability (msi), the "low number of copies" group, and the "high number of copies" group). this histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date. the main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cdna in patients with endometrial cancer during treatment.


Eligibility criteria:
inclusion criteria: * histologically proven endometrial adenocarcinoma type i or type ii. * with recent abdomino-pelvic imaging, less than 3 months old. * tumor tissue sufficiently exploitable for research (\> 20% of tumor cells) * informed consent signed by the patient after clear and fair information about the study. * free patient, without tutorship, curatorship or subordination. * patient benefiting from a social security scheme or benefiting from it through a third person. * patient not opposed to participating in the study. exclusion criteria: * histologies other than adenocarcinoma (sarcoma, leiomyosarcoma) * linguistic or mental refusal or incapacity to understand and / or sign the informed consent * patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection. * pregnant and / or lactating women