Kornimate/medical-research-clean huggingface dataset:
seroprevalence of anti-bodies against clostridium difficile toxins and prevalence of asymptomatic carriage of clostridium difficile in ibd patients.

Conditions: Clostridium Difficile; Inflammatory Bowel Diseases

Summary: the objective of this study to evaluate the seroprevalence of anti-bodies against c. difficile toxins a and b and the asymptomatic carriage of c. difficile in ibd patients according to the need and type of immunosuppressive therapy. the ultimate goal is to identify, among ibd patients, those with the highest risk of cdi.


Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosed of ibd, either crohn's disease or ulcerative colitis * age: \>18 and \<65 years * time since diagnoses of ibd ≥ 6 months * present with the criteria included in any of the 4 specified groups in the study population exclusion criteria: * history of documented cdi * active cdi at the moment of study inclusion * any of the following immunosuppressive conditions: hiv infection, liver cirrhosis, ckd stage iv, receiving chemotherapy, transplant (solid organ or hematological), concomitant neoplasia, hypogammaglobinemia.
complement inhibitor eculizumab in clinical islet transplantation

Conditions: Diabetes Mellitus

Summary: this is a dual centre, single arm, exploratory study of the possibility to use eculizumab (soliris) to prevent/reduce destruction of islets of langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant.

this is a dual centre, single arm, exploratory study of the possibility to use eculizumab (soliris) to prevent/reduce destruction of islets of langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. ten patients from 2 centres (uppsala university hospital and karolinska university hospital in stockholm) will be transplanted. the purpose of the study is to investigate if selective complement inhibition by eculizumab combined with standard anticoagulation during and after transplantation can further reduce the extent of early tissue loss after portal infusion of islets.

Eligibility criteria:
inclusion criteria: * patients between 18 to 65 years of age * patients able to provide written informed consent * absent stimulated c-peptide (\< 0.1 nmol/l). this includes also previously islet-transplanted patients with no detectable c-peptide. * patients at fear of severe hypoglycemia * female patients of child bearing potential must have a negative pregnancy test (s-β-hcg) and must be practicing an effective, reliable medical accepted contraceptive regimen while on eculizumab treatment and to study end at 75 days. * patients vaccinated against neisseria meningitides or patients accepting adequate antibiotic prophylaxis exclusion criteria: * body mass index \> 30 kg/m2 * untreated proliferative diabetes retinopathy * recipient of any other concomitant organ transplantation - glomerular filtration rate \< 50 ml/min before first islet transplantation * positive t-cell cross-matching by complement depending cytotoxicity (cdc) * pregnancy or lactating * active ongoing infection, bacterial or viral * unresolved meningococcal disease * known bleeding disorder * known complement disorder * have received any other investigational drug within 30 days before inclusion * history of drug or alcohol abuse within the last year
fetal death in utero in the internship experience of midwifery students : an unavoidable experience?

Conditions: Fetal Death in Utero

Summary: fetal death in utero and the psychological and professional impact it could have on the midwifery student in training. fetal death in utero corresponds to the spontaneous cessation of cardiac activity, from 14 weeks of amenorrhea. for a large proportion of midwifery students, fetal death in utero is a situation encountered in the field. despite the theoretical courses, a student does not expect to encounter this type of situation during the internship: it is delicate for both the supervising caregivers and the student. the purpose of this study is to demonstrate the impact that this situation could have on the midwifery student, both psychologically and in terms of their professional project.

the aim of the research is to highlight the psychological and professional impact of in utero fetal death among midwifery students in strasbourg.

Eligibility criteria:
inclusion criteria: * age ≥18 years * midwifery student of the strasbourg school of medicine of 3rd year or more * having experienced the discovery of a fetal death in utero in a birth room internship * having participated in the follow-up of an in utero fetal death in the birth room * agreed to participate in the interview and did not express opposition to the reuse of their data for the purpose of this research exclusion criteria: - subject who expressed opposition to participating in the study

Keywords: fetal death in utero
hdr brachytherapy 68-ga-rm2 pet, 68-ga-psma-11 pet &multi parametric mri in prostate cancer

Conditions: Prostate Cancer

Summary: this study is being conducted to determine whether the combination of imaging agents 68-ga rm2 and 68-ga pmsa11 is better at assessing response to high dose rate (hdr) local therapy than standard imaging or biopsy in patients with known prostate cancer (pc)

primary objective: 1. to demonstrate that 68ga-rm2 and 68ga-psma-11 pet/mri can detect additional cancers over mpmri. 2. to demonstrate that 68ga-rm2 and 68ga-psma-11 pet/mri can assess changes in response to treatment and predict progression free survival (pfs) at 24 months.

Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age; * patients must be able to provide informed consent; * histologically proven low-grade or intermediate-grade prostate cancer (pc) * scheduled to undergo targeted local therapy (hdr brachytherapy). exclusion criteria: * inability to lie still for the entire imaging time; * inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.); * any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance; * metallic implants (contraindicated for mri).
inflammatory markers in natural orifice hysterectomies

Conditions: Gynecologic Disease; Inflammation

Summary: the authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (slh) and vaginal hysterectomy (vh). between 2018 and 2019, data obtained from patients in the slh and vh groups were reviewed retrospectively. the preoperative and postoperative hematocrit (hct), hemoglobin (hb), white blood cell (wbc), platelet (plr), and neutrophil-lymphocyte (nlr) ratios and values were compared as well as the demographic characteristics of the patients.


Eligibility criteria:
inclusion criteria: * hysterectomy requirement with any conditions in gynecologic diseases exclusion criteria: * patients with a chronic disease (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases) * the presence of active infection * using of corticosteroid, acetylsalicylic acid, or anticoagulant * cystocele or rectocele repair with mesh

Keywords: inflammation mediators lymphocyte activation natural orifice endoscopic surgery neutrophil activation platelet activation vaginal hysterectomy
observational trial to evaluate hematopoietic stem cell transplantation cmv reactivation

Conditions: Infection

Summary: the purpose of this study is to evaluate the ability of the t-spot.cmv assay to determine immune competence against cmv infection in stem cell transplantation. to determine the utility of the t-spot.cmv assay used before transplantation to determine immune competence against subsequent cmv reactivation and to determine the utility of the t-spot.cmv assay used after transplantation to determine immune competence against subsequent cmv reactivation.

in this prospective, non-randomized, observer-blind observational study, up to 200 patients who meet the study's eligibility criteria will be enrolled at up to 20 study centers. enrollment will be actively managed by the sponsor. blood samples will be collected up to 14 days before transplantation, and then at 2-week intervals for the 6 months after the transplant procedure. study duration: 15 months: 9 months to enroll all patients, with 6 months (182 days) of participation for each patient.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. patients who will undergo one of the following types of allogeneic transplantation: matched related donor, matched or mismatched unrelated donor, haploidentical, or cord blood. 3. patients must be seropositive for cmv prior to transplantation, regardless of donor seropositivity. 4. institutional review board (irb)-approved written informed consent and privacy agreement per national regulation (e.g., health insurance portability and accountability act \[hipaa\] for sites in the usa) must be obtained from the patient or the patient's legally authorized representative prior to any study-specific procedures. 5. patients must be considered suitable for the study by the investigator. exclusion criteria: * 1. patients with a known active cmv reactivation within 1 month prior to enrollment or during the study's pre-transplant screening period. 2. patients who have received any antiviral therapy active against cmv other than acyclovir and valacyclovir (i.e., foscarnet, ganciclovir, valganciclovir, or cidofovir) during the month prior to enrollment. 3. patients who have previously received or are planning to receive a cmv vaccine. 4. patients who are known to be hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) positive. 5. patients who are known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study. 6. patients who are participating in or plan to participate in cmv-related drug or vaccine studies.

Keywords: cytomegalovirus reactivation in stem cell transplant
cognitive flexibility training in persistent pain

Conditions: Chronic Pain

Summary: to determine whether participation in a cognitive training program over a training period of five weeks improves cognitive flexibility in patients with chronic hip, knee, and back pain.

this project is a single-center prospective, randomized study to assess whether cognitive flexibility can be improved through training on a lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain; and whether changes in cognitive flexibility will correlate with perceived pain scores.

Eligibility criteria:
inclusion criteria: * adults age 18 to 70 with chronic hip, knee, or low back pain for \>3 months * documented moderate to severe chronic pain * english as a primary language * access to a computer at home and an email account exclusion criteria: * diagnosed alzheimer's or documented severe cognitive impairment * lack of email/lack of basic computer skills * has undergone an interventional pain procedure within one week prior to enrollment * are scheduled to undergo a pain procedure during the five weeks of complete cognitive training
the efficacy and safety profile of capsaicin 8% patch versus 5% lidocaine patch in males with diabetic neuropathy

Conditions: Diabetic Nerve Problems; Diabetic Neuropathy; Diabetic Complications Neurological

Summary: the study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. assessment of analgesic effectiveness was assessed by observing any change in the numeric pain rating scale (nprs) score, average daily pain brief pain inventory (bpi) for painful diabetic peripheral neuropathy (bpi-dpn q4) and patient global impression of change (pgic). assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

the aim of the present study was to compare the efficacy and tolerability of using lidocaine 5% patch to 8% capsaicin patch in south asian male patients with diabetic neuropathy. assessment of analgesic effectiveness was assessed by observing any change in the numeric pain rating scale (nprs) score, average daily pain brief pain inventory (bpi) for painful diabetic peripheral neuropathy (bpi-dpn q4) and patient global impression of change (pgic). assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Eligibility criteria:
inclusion criteria: * males aged 40 - 60 * type 2 diabetes of \>10 years duration * symptoms of peripheral neuropathic painpresent by scoring on diabetic neuropathic score (minimum score 1) exclusion criteria: * diabetic foot ulcer * deformed or contracted foot * neurological complications * presence of neurological disease * presence of cardiovascular or peripheral vascular disease, * usage of topical analgesics or implanted medical device six weeks prior to the study
safety & efficacy of canakinumab (acz885) in patients with frequent flares for whom nonsterodial anti-inflammatory drug (nsaids) and/ or colchicine are contraindicated, not tolerated or ineffective

Conditions: Gouty Arthritis

Summary: the purpose of this pivotal phase iii study is to support the registration of canakinumab for the indication of gout in china, a replicate of global studies cacz885h2356 \& cacz885h2357 by demonstrating in patients with frequent flares of gout for whom nsaids and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.


Eligibility criteria:
inclusion criteria: * meeting diagnosis criteria for acute arthritis of primary gout. * start of acute gout flare within 5 days prior to study visit 1 * history of ≥ 3 gout flares within the 12 months prior to study start * evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either nsaids and/or colchicines exclusion criteria: * requirement for administration of antibiotics against latent tuberculosis (tb), e.g., isoniazide * refractory heart failure (stage d). * unstable cardiac arrhythmias or unstable symptomatic coronary ischemia * secondary gout, chemotherapy induced gout, lead induced gout and transplant gout * rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis other protocol-defined inclusion/exclusion criteria may apply

Keywords: gout inflammatory gout acute gout
trial comparing metal versus plastic stents for preoperative biliary decompression

Conditions: Obstructive Jaundice; Pancreatic Cancer

Summary: compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

covered self expandable metal stents (csems) are three times larger in diameter than 10 fr plastic stents. when compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for csems. the investigators hypothesize that placement of csems would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. patients with pancreatic cancer and mass in the head of pancreas causing jaundice. 2. patients 19 yrs of age and older 3. serum bilirubin \> 2mg/dl 4. ct: no evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin). exclusion criteria: 1. karnofsky score \< 60 2. prior (ercp or ptc) attempts at biliary decompression for the same indication 3. tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1l/day) 4. ongoing or planned neoadjuvant therapy 5. cholangitis at presentation or coagulopathy needing reversal medication 6. post-surgical anatomy 7. multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum 8. failed ercp's (definition: inability to deploy a biliary stent thereby requiring a ptc or surgery).
fascial manipulation in patients with hip osteoarthritis

Conditions: Osteoarthritis

Summary: the study will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. the fascial manipulation provides a deep pressure of specific points of the muscle fascia. the aims of this treatment are the improve of pain before the surgery and the improve of functional performance after the surgery.


Eligibility criteria:
inclusion criteria: * patients age 40-80, with primary coxarthrosis waiting for total hip arthroplasty that complain a pain measured by numeric rating scale ≥ 5 and that live in bologna exclusion criteria: * arthroplasty revision or substitution. patient with cognitive deficiency and severe comorbidity (rheumatic, neurological or cardiovascular pathology)
efficacy and safety of selumetinib in adults with nf1 who have symptomatic, inoperable plexiform neurofibromas

Conditions: Neurofibromatosis 1; Plexiform Neurofibroma (PN)

Summary: a global study to demonstrate the effectiveness of selumetinib in participants with nf1 who have symptomatic, inoperable plexiform neurofibromas.

this is a randomized, double-blind, placebo-controlled, 2 arm multicentre, global phase iii study to assess the efficacy and safety of selumetinib compared with placebo in adult participants with nf1 who have symptomatic, inoperable pn.

Eligibility criteria:
key inclusion criteria: * adults ≥ 18 years at enrollment with diagnosis of nf1 with symptomatic, inoperable pn * at least one inoperable target pn measurable by volumetric mri analysis * chronic target pn pain score documented for minimum period during screening period * stable chronic pn pain medication use at enrollment * adequate organ and marrow function key exclusion criteria: * confirmed or suspected malignant glioma or mpnst (low grade glioma, including optic glioma not requiring systemic therapy or radiation therapy are exempt from this exclusion) * history of malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence * clinically significant cardiovascular disease, including inherited coronary disease, acute coronary syndrome within 6 months prior to enrollment, uncontrolled angina, symptomatic heart failure, cardiomyopathy, severe valvular heart disease, abnormal lvef and uncontrolled hypertension * ophthalmological findings/conditions including intraocular pressure \> 21 mmhg, rped/csr or rvo * prior exposure to mek inhibitors

Keywords: neurofibromatosis type 1 nf1 plexiform neurofibroma (pn) pns selumetinib mek inhibitor
effect of acetazolamide on right ventricular function at rest in patients with respiratory disease at altitude

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at acute altitude exposure in patients with copd.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at rest in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3200 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3200 m. right ventricular function will be assessed by transthoracic echocardiography.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/fvc \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; osa; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: right ventricular function echocardiography obstructive airway disease emphysema acetazolamide altitude
rapid analysis of infections by spectrometry of exhaled breath

Conditions: Respiratory Tract Infections; Hematologic Diseases

Summary: to quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.


Eligibility criteria:
inclusion criteria: * age ≥ 18y at start of study * one of the following diagnoses: * de novo, refractory or relapsed aml/mds receiving intensive chemotherapy * de novo, refractory or relapsed all/t-lymphoblastic lymphoma receiving intensive chemotherapy * aplastic anemia requiring atg therapy * any patient admitted for either autologous hematopoietic stem cell transplantation. transplantation may not have been performed at time of enrolment. * any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission. * written informed consent obtained from the patient exclusion criteria: * hematological disease beyond the specified inclusion criteria * signs of active respiratory infection * if previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).
to demonstrate the relative bioavailability study of loratadine 10 mg tablets

Conditions: Allergy

Summary: to demonstrate the relative bioavailability study of loratadine 10 mg tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antihistamine