Kornimate/medical-research-clean huggingface dataset:
resistant starch in pediatric inflammatory bowel disease (crohn's disease or ulcerative colitis)

Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: the purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf. * enrolled in the main parent study. * new ulcerative colitis diagnosis (mild/moderate) or crohn's disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy. * clinically responsive to induction medical therapy at enrollment (crohn's disease participants with a weighted pediatric crohn's disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points). * ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study. * willing to provide consent/assent for the collection of stool samples. exclusion criteria: * allergy to resistant starch or excipients. * co-existing diagnosis with diabetes mellitus. * treatment with another investigational drug or intervention throughout the study. * current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * inability or unwillingness of an individual or legal guardian to give written informed consent. * requirement for antibiotic therapy as part of standard crohn's disease therapy (i.e. those patients with penetrating disease as manifested by intra-abdominal abscess or perianal abscess). * requirement of oral antibiotics for other conditions (e.g. acne). * participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the rapid assay of an individual's microbiome (rapidaim) evaluation following enrollment. * requirement of therapy other than oral corticosteroid / aminosalicylates for induction therapy. * patients diagnosed with inflammatory bowel disease-unclassified. * refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for crohn's disease standard of care.

Keywords: resistant starch microbiome
4 week treatment with three oral doses of bi 10773 in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: safety and tolerability of bi 10773 in male and female patients with type 2 diabetes secondary objective: pharmacokinetics and pharmacodynamics of bi 10773


Eligibility criteria:
inclusion criteria: * male and postmenopausal or hysterectomised female patients with type 2 diabetes * age \>18 and \< 70 years * bmi \>18.5 and \<40 kg/m2 exclusion criteria: * antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent; * fasted blood glucose \> 240 mg/dl (\>13.3 mmol/l) or a blood glucose level above 400 mg/dl (22.2 mmol/l) postprandially; * hba1c \> 8.5 %
safety and immunogenicity of recombinant hepatitis b vaccines in the neonates

Conditions: Hepatitis; Hepatitis B; Liver Diseases; Digestive System Diseases

Summary: the purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml recombinant hepatitis b vaccines(saccharomyces cerevisiae) in the healthy neonates.


Eligibility criteria:
inclusion criteria: * subjects who are healthy full-term infants after birth, apgar score ≥8; * subjects with a birth weight ≥ 2500g; * subjects' guardians are able to understand and sign informed consent; * subjects who can and will comply with the requirements of the protocol. exclusion criteria: * family history of eclampsia, epilepsy and encephalopathy; * subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis; * subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde; * subjects' parents had a medical history of allergic to combined hepatitis a and b vaccine(hab) or hepatitis b vaccine; * subjects had serious acute and chronic diseases; * with temperature ≧37.1℃; * any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Keywords: recombinant hepatitis b vaccine safety immunogenicity
a randomized, comparative study of hexvix fluorescence cystoscopy and standard cystoscopy in patients with non-invasive bladder cancer

Conditions: Bladder Cancer

Summary: the main objective of the study is to compare the 1-year recurrence rate of hexvix assisted transuretheral resection of the bladder (turb) to standard white light turb in patients with suspicion of non-invasive bladder cancer. the hypothesis is to test whether the 1-year recurrence rate is different with hexvix assisted turb compared to standard white light turb.

the main objective of the study is to compare the 1-year recurrence rate of hexvix assisted transuretheral resection of the bladder (turb) to standard white light turb in patients with suspicion of non-invasive bladder cancer. patients will be followed 4, 8 and 12 months after the initial turb. this follow-up regimen is according to standard clinical practice in denmark. recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether hexvix assisted turb can reduce the early recurrence compared to standard turb

Eligibility criteria:
inclusion criteria: * patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder * above 18 years * written informed consent obtained exclusion criteria: * gross hematuria. (note: gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy). * patient with porphyria. * known allergy to hexyl aminolevulinate hydrochloride or a similar compound. * participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. * pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (iud) during the treatments and for at least one month thereafter). * conditions associated with a risk of poor protocol compliance.

Keywords: recurrence of bladder cancer fluorescence cystoscopy
prospective observational study for determination of minimal clinically important difference of allergic rhinitis symptoms due to grass pollen (equinoxe 2)

Conditions: Allergic Rhinitis Due to Grass Pollen

Summary: prospective multi-center study carried out in france involving patients with allergic rhinitis. study in usual care where no specific diagnostic or therapeutic procedure is required. the patients will be asked to fill in questionnaires on a daily and weekly basis.


Eligibility criteria:
inclusion criteria: * male or female patients aged between 6 and 65 years. * patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements. * patient with an grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated). * patients presented for symptomatic management of allergic rhinitis. * patients having symptoms score ≥ 6. exclusion criteria: * patients involved in any other clinical/observational study. * patients unable to fill in the study questionnaires. * patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities. * patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance. * patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
lifestyle heart trial

Conditions: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Hypercholesterolemia; Hypertension; Myocardial Ischemia

Summary: to assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

background: the trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone. design narrative: patients were randomly assigned to an experimental group or to a usual-care group. experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. no animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. the diet contained approximately 10 percent of calories as fat. control-group patients were not asked to make lifestyle changes. coronary angiography was performed at baseline and at one year to assess progression or regression of disease. patients were recruited into the trial between january 1986 and november 1988. the trial was supported prior to april 1989 from various sources other than the national heart, lung, and blood institute. follow-up continued for four years. the study completion date listed in this record was obtained from the query/view/report (qvr) system.

Eligibility criteria:
men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs.
pivotal, clinical study for the accuracy evaluation of the identiclone dx trg assay

Conditions: T-Cell Lymphoproliferative Disorder

Summary: this protocol describes the pivotal accuracy study for the identiclone dx trg assay. the intent of the accuracy study is to demonstrate agreement between the results of the ic trg dx assay and a predicate devise or assay on retrospective and residual de-identified dna extracted from ffpe (formalin fixed paraffin embedded) samples from individuals with suspected t-cell lymphoproliferations. the predicate device will be the lymphotrack dx trg (fr1/fr2/fr3) assays - miseq (lt dx trg-ce-ivd), which is a ce-ivd assay with a similar intended use as the ic trg assay on the same sample type.


Eligibility criteria:
inclusion criteria: 1. de-identified, residual ffpe specimens with a minimum of 8 curls 2. subject age ≥ 18 3. for suspected clonal positive specimens, ffpe specimens of subjects diagnosed (at the time the specimen was drawn) with t-cell lymphoproliferative disease with at least one of the following: 1. icd10 codes: c84, c85.8, c85.9, c86.1, c86.2, c86.3, c86.5, 86.6, c91.5, c91.6, c91.0, c91.z, c91.9, c94, c95, c96, or other t-cell lymphoma diagnosis 2. b. t-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., snomed) 3. mycosis fungoides or sézary syndrome sample are acceptable 4. for suspected clonal negative specimens, ffpe specimens of subjects suspected of t-cell lymphoproliferative disease but diagnosed negative for t-cell lymphoproliferative disease. up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than t-cell lymphoproliferative disease exclusion criteria: 1.ffpe specimens that were fixed using formalin substitute (ethanol, methanol, etc.)
platino-resistance in ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages). patients will receive treatment (platinum based-chemotherapy) according to the standard practices. a prospective database and an associated biological collection will be performed during 5 years: * for each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care. * biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. these samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study). study participation of each patient will be 5 years.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. epithelial ovarian cancer at initial diagnosis (all stages) 3. curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment 4. indication of platinum based-chemotherapy 5. patient affiliated to the french social security system 6. patient must provide written informed consent prior to inclusion in the study and any study-specific procedure exclusion criteria: 1. non-epithelial ovarian tumor, borderline ovarian tumor 2. patient with recurrent disease 3. exploratory surgery not performed at the "institut universitaire du cancer de toulouse - oncopole (iuct-o)" 4. pregnant or breastfeeding women 5. any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures 6. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Keywords: epithelial ovarian cancer platinum based-chemotherapy
a study of atr-101 for the treatment of endogenous cushing's syndrome

Conditions: Cushing Syndrome

Summary: this is a phase 2 multicenter, randomized, double-blind, placebo controlled study of atr-101 to evaluate the efficacy and safety of orally-administered atr-101 in adults with endogenous cushing's syndrome. following wash-out (if needed), all eligible subjects will enter an open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if the subject does not meet randomization criteria).it is anticipated that the overall duration of the study per subject will range from approximately 16-22 weeks.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of endogenous cushing's syndrome * baseline ufc 1.3 to 10 × upper limit of normal (uln) * if previous pituitary surgery, participants must be at least 3 months since surgery at the time of screening * bmi between 18 and 60 kg/m2, inclusive exclusion criteria: * pseudo-cushing's syndrome, cyclic cushing's syndrome or current iatrogenic cushing's syndrome * candidates for surgical treatment of cushing's syndrome, unless surgery is not anticipated to occur during the study * normal late night salivary cortisol or 24-hr urine free cortisol * radiotherapy of the pituitary within 6 months

Keywords: endogenous cushing's syndrome atr-101 cs
a long term roll-over study to investigate the efficacy and safety of adalimumab given long-term to patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis


Eligibility criteria:
inclusion criteria: * completion of a previous d2e7 study * subject is in good health (investigator discretion) with a recent stable medical history exclusion criteria: * former enrollment in this trial (de018) * subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study * female subject who is pregnant or breast feeding or considering becoming pregnant.
a study in china evaluating the safety and efficacy of adding sitagliptin to stable therapy with sulfonylurea with or without metformin in participants with type 2 diabetes mellitus (t2dm) (mk-0431-253)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (t2dm). the primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin a1c (hba1c) in t2dm participants on sulfonylurea alone or in combination with metformin.


Eligibility criteria:
inclusion criteria: * has t2dm * is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks * has a visit 1/screening hba1c between 7.5% and 11.0% * is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication exclusion criteria: * has a history of type 1 diabetes mellitus or a history of ketoacidosis * has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue * has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin * is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months * has undergone a surgical procedure within 4 weeks or has planned major surgery during the study * has a medical history of active liver disease * has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder * has a diagnosis of congestive heart failure with new york heart association class iii - iv cardiac status * has a systolic blood pressure ≥ 160 mmhg or a diastolic blood pressure ≥ 90 mmhg * has human immunodeficiency virus (hiv) * has severe peripheral vascular disease * is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks * has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) * is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication * is a user of recreational or illicit drugs or has had a recent history of drug abuse
study on the correlation between nat2(n-acetyltransferase2) gene polymorphism and crcl(creatine clreance) and the efficacy and safety of levosimendan in patients with severe heart failure

Conditions: Heart Failure; Levosimendan; Efficacy; Safety

Summary: 1. to evaluate the efficacy and safety of levosimendan in the treatment of heart failure ; 2. guide patients to apply levosimendan individually and establish a dose adjustment program.

the efficacy and safety of levosimendan in chinese patients with different acetylmetabolites and crcl(creatine clreance) were re-evaluated after marketing. the population pharmacokinetics of different populations was studied, and the patients were guided to apply levosimendan individually and establish a dose adjustment program.

Eligibility criteria:
inclusion criteria: * 18-80 years old * patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and lvef(left ventricular ejection fraction) \< 50 %, and were judged by the physician to need and agree to use levosimendan to maintain hemodynamic stability * sign informed consent exclusion criteria: * chronic heart failure and new york heart association ( nyha ) class i \~ ii * complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh c ), severe renal insufficiency ( crcl \< 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan * patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan * during hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue * received positive inotropic drug 2 treatment in the last 30 days * lack of serum creatinine, brain natriuretic peptide or brain natriuretic peptide precursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days before using levosimendan ) data * pregnant and lactating women

Keywords: severe heart failure levosimendan nat2(n-acetyltransferase2) gene polymorphism crcl(creatine clreance)
ocular signs and symptoms in glaucoma patients switched from latanoprost to preservative free tafluprost eye drops

Conditions: Ocular Hypertension; Open-Angle Glaucoma

Summary: the purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (xalatan) to preservative free tafluprost eye drops.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. * evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.
nasonex (mometasone furoate nasal spray) in adenoids hypertrophy in children (p04367)

Conditions: Adenoids

Summary: to document the short term \& long term effect of treatment with nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae).


Eligibility criteria:
inclusion criteria: * 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy \> 50% of posterior choanae. exclusion criteria: * adenoids hypertrophy \< 50% of posterior choanae recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.