Kornimate/medical-research-clean huggingface dataset:
effect of fecal microbiota transplantation in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to investigate if fecal microbiota transplantation (fmt) will result in improvement in clinical outcome in patients with irritable bowel syndrome (ibs).

irritable bowel syndrome (ibs) is the most commonly diagnosed gastrointestinal condition. ibs is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity. several studies have demonstrated that the composition of the gut microbiota in ibs patients is different from healthy controls. fecal microbiota transplantation (fmt) could therefore be a treatment option for ibs patients by exchanging the microbiota of an ibs patient with the microbiota of a healthy donor.

Eligibility criteria:
inclusion criteria: * fulfilled rome iii diagnostic criteria for ibs * moderate-severe disease activity (ibs-symptom severity score ≥175) * able to read and speak danish * normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool exclusion criteria: * other chronic gastrointestinal disease * positive fecal sample with enteropathogenic microorganisms or clostridium difficile * positive screening for hiv, hepatitis b or hcv antibody * surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures) * psychiatric disorder * fecal calprotectin ≥ 50 mg/kg * abuse of alcohol or drugs * medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines * abnormal screening biochemistry * abnormal colonoscopy findings * pregnant, planned pregnancy or breastfeeding females * ingestion of probiotics or antibiotics \< 8 weeks before the inclusion inclusion criteria for donors * age between 18-45 years * past and current healthy * normal weight (bmi between 18,5-24,9 kg/m2) * normal bowel movements (defined as 1-2 per day and type 3-4 at bristol stool form scale) * no medication consumption exclusion criteria for donors * known or high risk of infectious diseases such as hiv, hepatitis a, b or c * positive stool sample for c. difficile toxin, parasites or other pathogens * antibiotic treatment in the past 6 months * abuse of alcohol or drugs * smoking * tattoo or body piercing within the last 6 months * allergy, asthma or eczema * family history of gastrointestinal diseases * participation in high-risk sexual behaviors * born by caesarean section

Keywords: irritable bowel syndrome fecal microbiota transplantation microbiota
effect of eslicarbazepine acetate on the pharmacokinetics of gliclazide in healthy volunteers

Conditions: Epilepsy

Summary: single centre, randomised, open-label, two-way crossover study to investigate whether multiple-dose administration of eslicarbazepine acetate (esl, bia 2-093) affects the pharmacokinetics of gliclazide.


Eligibility criteria:
inclusion criteria: subjects were eligible for the study if they fulfilled all of the following inclusion criteria: * male or female subjects aged between 18 and 45 years, inclusive. * body mass index (bmi) between 19 and 30 kg/m2, inclusive. * healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ecg. * negative tests for hbsag, anti-hcvab and hiv-1 and hiv-2 ab at screening * clinical laboratory test results clinically acceptable at screening and admission to each treatment period. * negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. * non-smokers or who smoke ≤ 10 cigarettes or equivalent per day. * able and willing to give written informed consent. * (if female) not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device. * (if female) negative urine pregnancy test at screening and admission to each treatment period. exclusion criteria: subjects were not eligible for the study if they fulfilled any of the following exclusion criteria: * clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. * clinically relevant surgical history. * history of relevant atopy or drug hypersensitivity. * history of alcoholism or drug abuse. * consumed more than 14 units of alcohol a week. * significant infection or known inflammatory process at screening or admission to each treatment period. * acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. * used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion. * used any investigational drug or participated in any clinical trial within 6 months prior to screening. * participated in more than 2 clinical trials within the 12 months prior to screening. * donated or received any blood or blood products within the 3 months prior to screening. * vegetarians, vegans or with medical dietary restrictions. * could not communicate reliably with the investigator. * unlikely to co-operate with the requirements of the study. * unwilling or unable to give written informed consent. * (if female) pregnant or breast-feeding. * (if female) of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients

Conditions: Renal Impairment; Diabetes

Summary: this study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients


Eligibility criteria:
inclusion criteria: * patients with mild (crcl from 50 to ≤80 ml/min), moderate (crcl from 30 to \ 80 ml/min exclusion criteria: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a dpp-4 inhibitor 30 days prior to baseline, renal transplant history other protocol-defined inclusion/exclusion criteria may apply

Keywords: renal impairment diabetes vildagliptin galvus eucreas
efficacy and safety of idp-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects (301)

Conditions: Atopic Dermatitis

Summary: efficacy and safety of idp-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects

a multicenter, randomized, double-blind, vehicle-controlled, study to evaluate the efficacy and safety of idp-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects

Eligibility criteria:
key inclusion criteria: * male or female at least 2 years of age and older * written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit) * nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for ad or for whom those treatments are not advisable * subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing key exclusion criteria: * females who are pregnant, breast feeding, or who wish to become pregnant during the study period * active cutaneous bacterial or viral infection in any treatment area at baseline (eg, clinically infected ad) * sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations * history of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)
china post-marketing surveillance (pms) study of aldurazyme®

Conditions: Mucopolysaccharidosis I

Summary: this is a single treatment arm study that is open-label to be conducted in chinese participants with mps i. trial objectives are to evaluate the safety and tolerability of aldurazyme in chinese mps i participants, and to evaluate the efficacy of aldurazyme on the percent change of urinary glycosaminoglycans (ugags) from baseline to week 26. the study will also evaluate the effect on ugag level and liver volume (hepatomegaly) after 26 weeks, with aldurazyme treatment in chinese mps i participants. treatment duration will include: 2 weeks of screening, 26 weeks of treatment and 1 week of follow-up period. during the treatment period, weekly visits are designed to accommodate weekly administration of aldurazyme (laronidase).

study duration for each participant will be a total of 29 weeks which will include 2 weeks of screening, 26 weeks of treatment period and 1 week of follow-up period.

Eligibility criteria:
inclusion criteria: * chinese participants have a documented diagnosis of mps i confirmed by measurable clinical signs and symptoms of mps i and fibroblast or leukocyte idua (iduronidase) activity \<10% of normal. * participants have to be able to stand independently and walk a minimum of 5 meters in 6 minutes. * a female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: * is not a woman of childbearing potential (wocbp). * or * is a wocbp and agrees to use an acceptable contraceptive method during the intervention period and at a minimum until 7 days after the last dose of study intervention. * a wocbp must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within the screening period before the first dose of study intervention. * if a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. in such cases, the participant must be excluded from participation if the serum pregnancy result is positive. * contraceptive/barrier method is not applicable for male participants. exclusion criteria: * prior tracheostomy or bone marrow transplantation or hematopoietic stem cell transplantation. * have a plan to undergo bone marrow transplantation or hematopoietic stem cell transplantation within half a year after enrollment. * received an investigational drug, or device, other than aldurazyme, within 30 days prior to study enrollment. * received an investigational gene therapy. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Keywords: clinical trial enzyme replacement therapy mucopolysaccharidosis i laronidase
evaluating mass spectrometry and intraoperative mri in the advanced multimodality image guided operating suite (amigo) in breast-conserving therapy

Conditions: Early Stage Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II

Summary: the purpose of this study is to investigate the use of intra-operative magnetic resonance imaging (mri) and mass spectrometry (ms) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.

this research study is a phase ii clinical trial investigating the use of intra-operative mri and ms in breast cancer surgery. phase ii clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "investigational" means that the intervention is being studied. prior research has shown that intraoperative mri and ms are two types of tests that are feasible to use during cancer surgery and may be able to guide therapy. in this study, we are evaluating the accuracy of intra-operative mri and ms in determining whether or not all cancer tissue was removed during breast surgery.

Eligibility criteria:
inclusion criteria: * patients must be female * participants must have a pre-operative standard mammogram with or without ultrasound. these may be performed at outside institutions. * participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. if biopsy was done at an outside hospital, pathology will be reviewed at bwh/dfci. * participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for bcs, and the ability to undergo standard radiation therapy post-operatively). * patient must meet standard mri guidelines and be able and willing to undergo mri * age ≥18 years and \< 75. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * participants with a known brca 1 or 2 mutation. * participants with known li-fraumeni or cowden's disease. * participants with prior mantle radiation. * participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin. * participants who are pregnant. * participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy. * participants with known active collagen vascular disease. * participants with prior history of ipsilateral breast carcinoma. * patients who have biopsy confirmed multi-centric disease. * participants who have documented contra-indications for contrast-enhanced mri, including but not limited to renal failure. * participants who exceed the weight limit for the surgical table at amigo, 350 lbs or who will not fit into the 70 cm diameter bore of the mri scanner at amigo or the 60 cm diameter bore of the pre-procedure imaging mri scanner.

Keywords: early stage breast cancer breast conserving surgery breast cancer stage i breast cancer stage ii
ruxolitinib in myelofibrosis patients in lombardy, italy

Conditions: Myelofibrosis

Summary: the ruxorel-mf observational study includes patients with primary and post-essential thrombocythemia/post-polycythemia vera myelofibrosis (mf) being treated with the oral jak1-/jak2-inhibitor ruxolitinib in a "real world" setting. patients are treated according to current indications in italy (i.e., primary and secondary mf patients with intermediate-1, intermediate-2, and high risk ipss (international prognostic scoring system) scores and symptomatic splenomegaly and/or systemic symptoms). patients are treated at facilities pertaining to the regional hematology network of lombardy (rete ematologica lombarda) in italy. efficacy data, data related to infectious and vascular events, data related to second primary malignancies, data regarding disease progression/transformation, and molecular information in relationship to ruxolitinib treatment will be collected and analyzed.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * diagnosis of primary myelofibrosis diagnosis according to the who 2016 classification or post-essential thrombocythemia/post-polycythemia vera myelofibrosis according to the iwg-mrt 2008 classification * patients with an intermediate-1, intermediate-2, or high risk score according to the ipss (international prognostic scoring system) * patients treated with ruxolitinib in accordance with current indications in italy * patients eligible or ineligible to hematopoietic stem cell transplant or who have already undergone a hematopoietic stem cell transplant exclusion criteria: * diagnoses other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis * patients treated with ruxolitinib having a platelet count at treatment initiation \<50 x10\^9/l * patients treated with ruxolitinib for conditions other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis

Keywords: myelofibrosis ruxolitinib real world data
carpal tunnel syndrome: case reports and analysis - ultrasound imaging and pathomechanics of median nerve compression

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome is caused by compression of the median nerve at the wrist. the hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.

two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. they subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. the carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.

Eligibility criteria:
inclusion criteria: * patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome. * normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing. exclusion criteria: * patients excluded if nerve testing was not consistent with carpal tunnel syndrome. * normals excluded if nerve testing demonstrated any median nerve abnormality.

Keywords: carpal tunnel syndrome median nerve ultrasound electrodiagnosis normal subjects
deep-sea fish oil for prevention of acute radiation-induced esophagitis

Conditions: Radiation Toxicity; Esophagitis; Esophageal Cancer

Summary: purpose：to observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (arie). methods and materials：a total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned (1:1) to treatment or control group. in the treatment group, 1g deep-sea fish oil was oral administrated prophylactically twice a day，the control group was blank control. the clinical efficacy of deep-sea fish oil on prevention of arie was evaluated by comparing the differences in the occurrence time, the grade and incidence of arie. additionally, the change in nutritional status was also investigated. hemanalysis, liver function, kidney function changes， and adverse reactions were compared before and after treatment to evaluate the safety of deep-sea fish oil.

radiotherapy is an important treatment for esophageal cancer, and acute radiation-induced esophagitis (arie) is the most common complication during radiotherapy. the present study was conducted to investigate the clinical efficacy of deep-sea fish oil in the prevention and treatment of arie, and to evaluate the effects of deep-sea fish oil on patients' nutritional status, quality of life, pain management, and the effect on the treatment. this is a prospective, single-center, randomized controlled clinical study. the present study has been registered in the chinese clinical trials registry (chictr2200056847). the present study intends to continuously enroll 120 patients with esophageal cancer who are to receive radiotherapy, and randomly divide the enrolled patients into two groups. one group receive treatment of deep-sea fish oil and the other group is blank control. the differences of arie occurrence, arie degree, pain degree, and the changes of the inflammatory index were compared.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, ≤70 years old, gender is not limited; 2. histological or cytological evidence of esophageal, lung, or breast cancer; 3. ecog score of 0-2, no swallowing pain or severe dysphagia before radiotherapy; 4. liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy; 5. pg-sga score \<9; 6. not pregnant or breastfeeding; 7. the subject must understand and sign the informed consent 8. have reading comprehension ability and can complete the questionnaire with medical assistance; 9. those who voluntarily participate in the study and sign the informed consent letter in person. exclusion criteria: 1. prior radiation therapy; 2. patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function; 3. pregnant or lactating female patients; 4. suffering from severe mental illness and poor compliance; 5. other cases deemed unsuitable for inclusion by the researchers.

Keywords: fish oil acute radiation-induced esophagitis esophageal cancer prevention
cross-linked volume-stable collagen matrix versus connective tissue graft at implant site.

Conditions: Edentulous Alveolar Ridge Atrophy; Soft Tissue Augmentation At Dental Implants

Summary: recent data suggested that an adequate volume of keratinized tissue (kt) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance. the aim of this rct is to test the volume-stable collagen matrix (vcmx) vs the connective tissue graft (ctg) for peri-implant soft tissue augmentation during implant uncovering.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * no systemic diseases or pregnancy. * self-reported smoking ≤10 cigarettes/day. * no probing depths ≥5 mm * full-mouth plaque score (fmps) and full-mouth bleeding score (fmbs) ≤15% (measured at four sites per tooth). * single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering. * need of soft tissue augmentation for aesthetic purpose and/or functional reasons * no previous soft tissue augmentation procedure at experimental site. exclusion criteria: * general contraindications for dental and/or surgical treatments * concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy * inflammatory and autoimmune disease of oral cavity * history of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years * radiotherapy of head area * disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants) * any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease) * untreated acute periodontal disease * patients who smoke more than 10 cigarettes/day will be excluded from the study * diabetes * allergy to the collagen * pregnant or lactating women * women of child bearing age, not using a highly effective method of birth control * participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start