Kornimate/medical-research-clean huggingface dataset:
treatment of steroid refractory gastro-intestinal acute gvhd after allogeneic hsct with fecal microbiota transfer

Conditions: Fecal Microbiota Transplantation

Summary: patients who have a gastrointestinal acute graft versus host disease (gvhd) received a first-line standard treatment of corticosteroids. for patients who do not respond or progress after an initial response have a high mortality. there is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute gvhd. fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.


Eligibility criteria:
inclusion criteria: * patients who develop a first episode of stage 2 to 4 gastro-intestinal acute graft-versus-host (gi-agvhd) with gut predominance (przepiorka d, 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/kg methylprednisolone equivalent dose) (sr gi-agvhd) * age ≥ 18 years old * allogeneic hematopoietic stem cell transplantation (allo-hsct) with any type of donor, stem cell source, gvhd prophylaxis or conditioning regimen * patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic fmt * signature of informed and written consent by the subject or by the subject's legally acceptable representative exclusion criteria: * grade iv hyper-acute gvhd * overlap chronic gvhd * acute gvhd after donor lymphocytes infusion * relapsed/persistent malignancy requiring rapid immune suppression withdrawal * active uncontrolled infection according to the attending physician * other systemic drugs than corticosteroids for gvhd treatment (including extra-corporeal photopheresis). drugs already being used for gvhd prevention (eg. calcineurin inhibitors) are allowed. * absolute neutrophil count \< 0.5 x 10\^9 /l * absolute platelet count \< 10 000 * patient epstein-barr virus (ebv) negative * evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray * known allergy or intolerance to trehalose or maltodextrin * pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female of childbearing potential * other ongoing interventional protocol that might interfere with the current study primary endpoint.
insulin detemir action in cerebro

Conditions: Type 1 Diabetes

Summary: the aim of this study is to test the hypothesis that subcutaneous administration of insulin detemir, as compared to insulin nph, leads to a more pronounced effect on cerebral glucose metabolism and/or cerebral blood flow in brain regions associated with appetite regulation, to account for the reported difference in weight.


Eligibility criteria:
inclusion criteria: * type 1 diabetic patients; * diabetes duration =/\> 1 year; * hba1c \~ 7,5%; exclusion criteria: * recent onset of dm; * bmi \ 35 kg/m2; * t2dm; * history of major heart/renal disease; * severe untreated proliferative retinopathy; * history of recurrent severe hypoglycaemia; * (history of) brain disorders; * alcohol abuse,(history of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants; * current psychiatric disease/treatment; * (history of) eating disorders; * history of severe head trauma accompanied by loss of consciousness; * any endocrine disease not well controlled for at least 3 months; * inability to undergo mri; * visual acuity \< 0.3; * known or suspected allergy to trial product or related products

Keywords: insulin detemir brain glucose metabolism
long-term elobixibat for chronic constipation

Conditions: Chronic Constipation

Summary: in this double-blind comparative study, ajg533 (elobixibat) 10 mg or ajg533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from week 2 of the observation period in the number of complete spontaneous bowel movements (csbm) at week 12 of the treatment period. the primary endpoint was the change in the number of complete spontaneous bowel movements (csbm) from week 2 of the observation period.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic constipation by the "rome iv" criteria for chronic constipation * age: 20 years old or older and up to 85 years old (at the time of obtaining consent) * gender: any gender * outpatients * patients who can obtain written consent * patients who can record their defecation, etc. in the patient's diary at the time of allocation (dosing initiation criteria) * spontaneous bowel movements (sbm)\* not more than 6 times during the 2-week observation period before the start of treatment * patients with no soft or watery stools (bristol stool shape scale 6 or 7) in spontaneous bowel movements during the 2-week observation period before the start of treatment. * patients who have not used concomitantly prohibited drugs or therapies during the observation period. exclusion criteria: * patients with organic constipation or patients with suspected organic constipation. * patients with or suspected of having functional ileus. * patients with or suspected of having an inguinal hernia. * patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection). * patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy. * patients with complications of malignancy. * pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study. * patients with serious renal, liver, or cardiac disease. * patients who are allergic to this study drug. * patients who have previously taken goufis tablets (elobixibat). * patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets). * patients who are participating in another clinical study or who were participating in another clinical study within 4 weeks before consent was obtained, excluding observational studies. * patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.

Keywords: elobixibat chronic constipation 12 week complete spontaneous bowel movement
e-cigarettes: dynamic patterns of use and health effects

Conditions: Smoking; Nicotine Dependence

Summary: the proposed research will provide in-depth, longitudinal data, based on real-time reports, which will address key priorities for the fda including, increased understanding of the relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions in combustible cigarette (cc) use, 3) attempts to quit cc use and the success of those attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.

primary aim: characterize e-cig use patterns both acutely and over 2 years and relate them to patterns of cc use (including reduced cc use), nicotine dependence and related variables (e.g., withdrawal suppression), and attempts and success in quitting cc use. investigators will use ecological momentary assessment (ema) to obtain fine grained, real-time data on e-cig and cc use. these data will be used to test the hypotheses that increasing and higher levels of e-cig use, measured in real-time, will be negatively related to cc use, nicotine dependence, and cc withdrawal severity and positively related to cc quit attempts and cc cessation success. secondary aim 1: determine how the use of e-cigs is related to biomarkers of tobacco exposure and cancer risk, and to acute and chronic pulmonary health outcomes. investigators will examine the relation between e-cig use and cancer biomarkers, exposure biomarkers, and pulmonary function. secondary aim 2: identify person factors, contextual variables, and patterns of behaviors and symp-toms that predict e-cig and cc use patterns and key outcomes (e.g., cc cessation, health-related outcomes), and identify variables that moderate relations between e-cig use and such outcomes. investigators will attempt to identify contextual variables and person factors that predict increased e-cig use, decreased cc use (including cessation), reduced nicotine dependence, and significant changes in biomarkers and health outcomes. further, investigators will identify variables that moderate such relations, revealing factors and events that make changes in e-cig and cc use, and associated outcomes, especially likely.

Eligibility criteria:
inclusion criteria: * specific eligibility requirements are: 1. ≥ 18 years old 2. able to read and write english 3. no plans to quit smoking and/or e-cig use in the next 30 days 4. not currently taking smoking cessation medication 5. not currently in treatment for psychosis or bipolar disorder 6. participants must report either that they have: * smoked at least 5 cigarettes per day for the past 6 months and not used e-cigs within the last 3 months ("exclusive smokers") * used nicotine-containing e-cigs at least once a week for the past month and have smoked at least 5 ccs/day for the last 3 months ("dual users"). exclusion criteria: * individuals not meeting any one of the inclusion criteria. those not meeting any one (or more) of criteria 1-5 and either criterion 6a or 6b will be excluded.

Keywords: electronic cigarettes nicotine dependence smoking tobacco use
genotype-phenotype characterization study on genetic diseases with immune and neurological dysfunctions

Conditions: Genetic Diseases; Immune Dysfunction; Neurological Disease; Autoimmune Diseases

Summary: over the past twenty years, prof. yanick crow and his team have developed internationally recognized expertise in genetic pathologies affecting the immune and neurological systems. the pathologies studied have a particularly severe impact on patients' quality of life, with a high mortality rate and a significant risk of occurrence in affected families. these pathologies are rare, and very often under-diagnosed. to date, there is virtually no effective curative treatment. prof. crow's team operates at the frontier between clinical and research work, and from experience, the team knows that patients and families affected by these serious pathologies are often highly motivated to help research into the pathology that affects them. initially, prof. crow's research focused primarily on the study of the genetic disease aicardi-goutières syndrome (ags). however, there is an undeniable clinical and pathological overlap between ags and other forms of disease such as autoimmune systemic lupus erythematosus and many other genetic pathologies - e.g. familial lupus engelure, spondyloenchondromatosis and copa syndrome. this is why research is being extended to all genetic diseases with immune and neurological dysfunctions.

the research methodology is classic with regard to many genetic clinical studies, and aims to: * clinically define the phenotypes of these diseases (in this case, genetic diseases with immune and neurological dysfunctions) * identify the gene(s) responsible for each disease * understand how changes in these genes and protein functions cause these diseases. it is possible that this research will ultimately lead to the creation of diagnostic tests (e.g. molecular diagnostic screening tests) and treatments that would be clinically very useful for the patients participating in the project. these discoveries could also improve our knowledge of other more common pathologies, particularly those associated with autoimmunity (e.g. when the body increases an immune response against its own tissues). as a complement to this global research project, prof. crow's team intends to study cell populations from patients with no inflammatory pathology, in order to analyze their basal levels of immune and inflammatory mediator production, as well as to assess their capacity (kinetics and amplitude) to respond to stimuli.

Eligibility criteria:
inclusion criteria * patients : * have / present a family history of genetic disease with immune and neurological dysfunction. * have signed an informed consent form. * unaffected related subjects : * be related to a patient included in this research. * have signed an informed consent form. * control patients * be free of any genetic disease with immune and neurological dysfunction. * have undergone surgery as part of their management * have signed an informed consent form. non-inclusion criteria ✓ be deprived of liberty
chemotherapy for participants with lymphoma

Conditions: Lymphoma, Large Cell, Diffuse

Summary: the primary purpose of this study is to help answer the following research questions: * to assess whether enzastaurin combined with rituximab, gemcitabine and oxaliplatin (r-gemox) can help participants with diffuse large b-cell lymphoma (dlbcl) remain free from disease and thus live longer. * to assess for any side effects that might be associated with enzastaurin and r-gemox . * to look at the characteristics and levels of certain genes and proteins to learn more about dlbcl and how enzastaurin works in the body. * to look at the level of enzastaurin in the body and how long it remains.


Eligibility criteria:
inclusion criteria: * diagnosis of dlbcl or transformed (cluster differentiation 20 \[cd20\]+) indolent lymphoma * relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (sd) obtained in 1st- or 2nd-line. * measurable disease (lymph node greater than 1.5 cm) * adequate organ function * greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (hdc) and autologous stem cell transplant (asct) exclusion criteria: * prior allogeneic transplantation * more than 2 prior anticancer treatment regimens * pregnant or breastfeeding * human-immunodeficiency-virus (hiv)associated lymphomas * brain metastases
dynamic cervical change: prediction of preterm labor in symptomatic patients

Conditions: Dynamic Cervical Change in Preterm Labor Patients

Summary: transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are at risk for preterm delivery. a shortened cervical length has been associated with an increased risk of preterm delivery. dynamic cervical change is visible shortening(\>6mm) of the cervix seen during the ultrasound examination. prior studies have shown that the presence of dynamic change in patients with a shortened cervical length(\ 3cm) and dynamic change did demonstrate an increased rate of preterm delivery. because this was a small sub-group, the present study was designed to obtain a larger sample size for further evaluation. the second focus of this study involves patients with a dilated cervix and whether cervical length adds predictive value to gestational age at delivery. patients presenting to with symptomatic preterm labor(vaginal pressure or uterine contractions), who consent to the study, will undergo the standard evaluation for preterm labor(described in detail below.) the only additional evaluation is a prolonged transvaginal ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during a contraction. null hypothesis: symptomatic preterm labor patients, with normal initial cervical length(\>3cm), who exhibit dynamic cervical change deliver at a gestational age equal to those without dynamic change. alternative hypothesis: symptomatic preterm labor patients, with normal initial cervical length(\>3cm), who exhibit dynamic cervical change deliver at an earlier gestational age than those without dynamic change.


Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18 and 45 years. * intrauterine pregnancy with gestational age between 22 0/7 and 34 6/7 weeks gestation. * presenting with symptomatic preterm labor (e.g. regular uterine contractions, uterine cramping, or pelvic pressure). exclusion criteria: * cervical cerclage * ruptured membranes noted on initial speculum examination * cervical os dilation \>4 cm noted on initial digital examination * known hiv-positive or active hsv(to minimize the risk of perinatal exposure) * presence of multiple genital warts * patients under extreme duress from their uterine contractions

Keywords: preterm labor transvaginal ultrasound dynamic cervical change
study on the treatment of anal fistulas using alofisel versus fat autologous stem cells

Conditions: Crohn Disease; Anal Fistula

Summary: one of the newest and most innovative medicinal approaches is cell therapy. several clinical trials and experimental investigations have looked into the feasibility of treating cd-related fistulas with stem cells. the current indication for alofisel® (active ingredient: darvadstrocel) is the treatment of difficult perianal crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy. this brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (adsc). the supplier mandates that two patients be booked for a single dose of alofisel® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed. only one of the two patients receives therapy; the other serves as the backup patient. by doing this, another "back-up" patient who might receive no care at all is avoided. an developing alternate approach to allogeneic adsc injection for the treatment of complicated anal fistulas in cd is autologous fat injection. in recent years, autologous fat grafts have been the subject of in-depth research. they are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of adscs in adipose tissue. additionally, adscs show strong immunomodulatory and regenerative capacities. we would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of cd.

the trial will be made available to patients who are scheduled for perianal surgery with alofisel® or backup (fat injection). the history and signs of perianal fistula will be noted if the patient doesn't object. two visits that correspond to typical follow-up visits for patients will be noted: visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months after : clinical assessment, mri

Eligibility criteria:
inclusion criteria: * complex anal fistula with the following criteria: - inactive/slightly active luminal crohn's disease under conventional treatment or biotherapy mri has demonstrated effective drainage. maximum of two internal orifices and three external orifices; persists despite internal orifice(s) closing. exclusion criteria: * pregnant or breast-feeding women * patients hypersensitive to the product, bovine serum or any of the excipients of alofisel * vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.
hand in hand. psychological support and counseling to breast cancer patients and their partners

Conditions: Breast Cancer

Summary: this study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care

the intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment. the couples in the intervention group participates i six to eight couple sessions. the sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. the control group receives usual care. the framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. the psychologist focus on the couples ability to feel comfortable and safe in each others presence.

Eligibility criteria:
inclusion criteria: * women newly diagnosed with a primary breast cancer (in the last 4 weeks) * women cohabiting with a male partner in a romantic relationship * patient and partner speaks and reads danish exclusion criteria: * patients having a previous cancer diagnosis * neoadjuvant therapy for breast cancer * previous hospital admission with diagnosed psychotic episodes

Keywords: breast cancer partners couples attachment intervention
investigation of the faecal loss of vedolizumab and its role in influencing serum drug levels, outcomes and response in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (uc). patients with moderate-to-severe uc who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. they will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical uc disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.

primary objective - to determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active uc. secondary objective (s) * to evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab. * to explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and uc disease activity and extent. * to determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of th1/th17 effector memory cd4+ t-cells (the key pathogenic subset in ibd) to the colon in uc.

Eligibility criteria:
inclusion criteria: * aged 18 years or over, either male or female * moderate-to-severe uc, defined as: - sccai \> 5 and, i. a raised fecal calprotectin (\> 59 μg/g) or, ii. a raised crp (\> 5 mg/l) or, iii. endoscopic disease activity mayo 2 or above, evaluated within 6 weeks of study enrollment * commencing vedolizumab treatment * sufficient english language skills to understand the patient information sheet and consent form exclusion criteria: * contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients) * imminent need for colectomy (i.e. colectomy is being planned) * previous ileoanal pouch formation * active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections
the association of pelvic organ prolapse severity and urinary symptoms and sexual function

Conditions: Pelvic Organ Prolapse; Sexual Dysfunction; Lower Urinary Tract Symptoms

Summary: women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. therefore, the aim of this study is to identify the above associations by perineal sonography.

women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. therefore, the aim of this study is to identify the above associations by perineal sonography.

Eligibility criteria:
inclusion criteria: * all patients with lower urinary tract symptoms and will undergo urodynamic studies exclusion criteria: * none

Keywords: pelvic organ prolapse lower urinary tract symptoms sexual dysfunction