Kornimate/medical-research-clean huggingface dataset:
fecal microbiota transplantation for patients with chronic widespread pain

Conditions: Chronic Widespread Pain

Summary: this study aims to explore the effect of fecal microbiota transplantation (fmt) on the clinical symptomatology in chronic widespread pain (cwp), to assess the acceptability, tolerability, and safety of fmt in patients with cwp, as well as explore the effect of fmt on the gut microbiome diversity in cwp. the investigators hypothesize that fecal microbiota transplantation will reduce pain intensity in patients with cwp, is acceptable, safe, and tolerable in patients with cwp, and will achieve change of gut microbiome diversity after fmt treatment.

in this proposed proof-of-concept pilot study, the investigators capitalize an establish chronic pain cohort to explore the effect of fmt in improving the pain symptomology in patients with cwp. this will be a 12-week single-arm prospective interventional study, all study subjects will receive 3 fmt infusions (n =20).

Eligibility criteria:
inclusion criteria: • participants aged ≥ 18 with diagnosis cwp; a modified version of the london fibromyalgia epidemiology study screening questionnaire (lfessq) will be used to screen for the presence of cwp. exclusion criteria: * patients with fibromyalgia, a subgroup with complex neurobiological, behavioural and psychological factors on its pathogenesis, will be excluded.\[8\] this will be based on the american college of rheumatology 2010 when subjects with cwp but with a widespread pain index (wpi) of ≥ 7 and a symptom severity scale (sss) score of ≥ 5 or a wpi between 3 and 6 and an sss score of ≥ 9. * patients have a history of inflammatory bowel disease or gastrointestinal malignancy * patients have previous abdominal surgery (other than cholecystectomy or appendectomy) * patients have depression defined by having a patient health questionnaire-9 (phq-9) score \> 15 * patients have anxiety defined by having a generalized anxiety disorder 7 (gad7) score \> 10 * patients have active infection at the time of inclusion * patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days * patients have any other organic causes that can explain the symptoms of cwp * current pregnancy * confirmed current active malignancy or cancers * pregnancy test negative for all female patients of child-bearing potential (except postmenopausal patients and sterilized patients).

Keywords: gut microbiota fecal microbiota transplantation
a group study on the effects of a short multi-domain cognitive training in healthy elderly italian people

Conditions: Age-related Cognitive Decline

Summary: alongside physiological cognitive ageing, nowadays there is an alarming increase in the incidence of dementia that requires communities to invest in its prevention. the engagement in cognitively stimulating activities and strong social networks have been identified among those protective factors promoting successful cognitive ageing. one aspect regarding cognitive stimulation concerns the relevance of the frequency of an external intervention. for these reasons, the aim of this study was to evaluate the efficacy of a 3-month multi-domain cognitive training program, administered once per week in a group of healthy elderly aged over 60 years old. their results obtained on a series of neuropsychological tests, both pre- (t0) and post-training (t1), were compared with those of a passive control group who did not receive the cognitive training.

participants were assigned to the experimental or control group based on their time of application to the program. both experimental and control group underwent a neuropsychological assessment to investigate different cognitive domains, before and after (\~3 months) the training program. based on the scores obtained during the preliminary neuropsychological assessment, the participants of the experimental training group were divided into small subgroups (ranging from 8 to 12 subjects) to further address individualization of training (i.e. level of difficulty of the exercises proposed). the experimental group attended weekly sessions of the multi-domain cognitive training. each session lasted around one hour and the overall duration of the training was of 3 months, for a total of 13 sessions. to promote improvement transfer to everyday life, some of the exercises proposed were ecological in their nature, in that, they asked participants to solve tasks that recalled everyday situations (such as remembering names or road maps). furthermore, throughout the training, approximately once every two sessions brief psycho-educational interventions were provided.

Eligibility criteria:
inclusion criteria: * age over 60 years exclusion criteria: * negative anamnesis for neurological and/or psychiatric diseases * no suspected cognitive impairment as assessed during the pre-training neuropsychological testing (\>2 pathological scores)

Keywords: healthy cognitive ageing multi-domain cognitive training
the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices

Conditions: Breast Cancer; Health Knowledge, Attitudes, Practice

Summary: this study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of afghan refugee women. the study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination practices scores among afghan refugee women.

purpose: the aim of the research is to examine the effects of simulation-based breast health education on breast cancer awareness and breast self-examination practices of afghan refugee women. methods: the study will conduct with 64 (32 in the intervention group, and 32 in the control group) afghan. the study population consisted of afghan women. the simulation-based breast health education will applied to the intervention group once a week for 8 weeks. no intervention will offer to the control group. data will collected by a socio-demographic questionnaire, breast cancer awareness measure (bcam) and breast self-examination practices checklist.

Eligibility criteria:
inclusion criteria: * 20-65 years, * must be able to speak turkish or dari. exclusion criteria: * breast cancer

Keywords: afghan breast cancer awareness health education
comparison of three approaches of electrode placement to detect changes in motor evoked potentials during spine surgery

Conditions: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Stenosis; Spinal Curvatures; Spondylitis; Spondylosis

Summary: motor evoked potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. this study investigates the utility of three separate quadriceps mep recording approaches over a total of 40 limbs (20 participants).

the long-term objective of this research is to understand how differing recording techniques may enhance the ability to accurately identify clinically relevant changes in motor evoked potentials (meps) during a variety of surgeries where the central motor tracts or lumbar spinal roots are at risk.the specific aims of the proposed research are: 1. using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings. 2. evaluated the variability of amplitude and area between the intramuscular and subdermal recording techniques. the initial focus will be on recording techniques to obtain stable meps in a proximal lower limb muscle, specifically the quadriceps. continuation research may focus on stimulation techniques to facilitate proximal meps and ultimately to improved specificity of mep changes.

Eligibility criteria:
inclusion criteria: * patients must be ≥18 years of age * patients must be undergoing thoracic or lumbar spine surgery where quadriceps mep recording would be the standard of care * patients should have normal preoperative quadriceps strength * patients are capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed exclusion criteria: * patients with ongoing psychiatric concerns would be excluded. * patients who are non-english speakers.

Keywords: intraoperative neuromonitoring motor evoked potential
efficacy and safety of continuous versus intermittent nebulization of salbutamol in acute severe asthma in children under 12 years of age

Conditions: Asthma in Children

Summary: asthma affects around 260 million people globally, causing around 0.5 million deaths annually. pediatric asthma remains a major global public health challenge, significantly affecting the quality of life for many children. therefore, this study was planned to compare the effects of continuous versus intermittent nebulization of salbutamol in the treatment of acute severe asthma (asa) in children visiting the emergency department of a tertiary childcare hospital in south punjab, pakistan.


Eligibility criteria:
inclusion criteria: * children of either gender * aged 2 to 12 years * diagnosed with moderate exacerbation of acute asthma according to british guidelines on the management of asthma, with a clinical asthma score of 8 or more exclusion criteria: * children who were prescribed with other first-line therapy, such as adrenaline or 3% nacl nebulization * presented at imminent risk of respiratory arrest * congenital heart disease * chronic respiratory disease * neurological disorders * children referred from any other hospital with no data available on emergency treatment
novel adjuvants for peptide-based melanoma vaccines

Conditions: Melanoma

Summary: this is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of ctla-4 antibody; tyrosinase, gp100, and mart-1 peptides; and incomplete freund's adjuvant (ifa) with or without interleukin-12 in patients with resected stage iii or iv melanoma.

in the phase i/ii trial, patients with resected stages iii and iv melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/ifa at a dose of 0.5 mg each peptide plus ctla-4 antibody given intravenously, 3 mg/kg, after each vaccination. in the phase ii randomized study, patients are treated with the melanoma peptide vaccine alone, with ctla-4 antibody, or with ctla-4 antibody combined with il-12 at 30 ng/kg with alum. the peptides are tyrosinase 368-376 (370d); gp100 209-217 (210m); and mart-1 26-35 (27l) which are emulsified with ifa. the dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

Eligibility criteria:
inclusion criteria: * diagnosis of stage iii or iv cutaneous, mucosal, or ocular melanoma * completely resected disease or disease-free * hla-a2.1 positive * tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens * at least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy * wbc count at least 3,000/mm3 * granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 9.0 gm/dl * creatinine no greater than 2.0 mg/dl * bilirubin no greater than 2.0 mg/dl * sgot/sgpt no greater than 2.5 times upper limit of normal * ecog performance status 0-1 * have failed alpha-interferons (patients with resected stage iii disease) exclusion criteria: * prior treatment with tyrosinase: 368-376(370d), gp100:209-217(210m), and mart-1:26-35(27l) peptides * steroid therapy or other immunosuppressive medication requirement * major systemic infections (e.g., pneumonia or sepsis) * coagulation or bleeding disorders * major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems * allergic reaction to montanide isa 51 (incomplete freund's adjuvant) * history of uveitis or autoimmune inflammatory eye disease * other active autoimmune disease * positive for hepatitis b surface antigen, hepatitis c antibody, or hiv antibody * pregnant or nursing

Keywords: stage iii melanoma stage iv melanoma interleukin-12 cancer vaccines antineoplastic agents, combined incomplete freund's adjuvant monophenol monooxygenase mannitol adjuvants, immunologic melan-a protein antigens, neoplasm antibodies melanocyte lineage-specific antigen gp100 ctla-4
impact of medical nutrition therapy and follow-up frequency on metabolic syndrome parameters

Conditions: Metabolic Syndrome; Metabolic Syndrome Obesity; Metabolic Syndrome Parameters

Summary: there is no study that has investigated the effects of medical nutrition therapy and more frequent follow-up via telehealth on metabolic syndrome parameters in patients with mets who have multiple metabolic disorders such as being overweight, prediabetic/diabetic, dyslipidemic and having increased blood pressure. this study was conducted to examine the effects of medical nutrition therapy and increased follow-up via telephone calls on mets-related parameters in individuals with mets.


Eligibility criteria:
inclusion criteria: * individuals with hba1c values \<8.5% * diagnosed with mets by a physician according to the criteria declared by the consensus of the "international diabetes federation task force on epidemiology and prevention, national heart, lung, and blood institute, american heart association, world heart federation, international atherosclerosis society, and international association for the study of obesity" were included. exclusion criteria: * taking anti diabetic agents other then metformin * taking anti hyperlipidemic agents * taking anti hypertensive agents * using food supplements (w-3, chromium, multivitamins) that could affect metabolic parameters, * having kidney failure, * having liver failure, * having immune failure * having chronic gastrointestinal system disease * having cancer * having type 1 diabetes * being pregnant or breastfeeding.

Keywords: metabolic syndrome x abdominal obesity medical nutrition therapy
treatment of elevated arterial pulmonary pressure with inhaled iloprost

Conditions: Persistent Pulmonary Hypertension; Respiratory Distress Syndrome

Summary: the purpose of this study is to determine if iloprost is effective in the treatment of elevated arterial pulmonary pressure in children with ventilator treated respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: * elevated arterial pulmonary pressure * ga \> 24 gw * 24-48 hours of age * ventilator treatment exclusion criteria: * congenital anomalies * severe hypotension
taking account of inobservable periods in longitudinal drug treatment follow-up

Conditions: Drug Exposition

Summary: the question of the inclusion of periods of interruptions and periods unobservable has been studied as part of medico-administrative databases. however, the specificity of the health insurance databases justify the realization of dedicated methodological research. a thorough knowledge of the purpose of these data, how they collect and restitution is an essential prerequisite to carry out this work. one type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis of the comparison between the exposure groups. however, this traditional approach has the major drawback of neglecting the changing nature of drug exposure, and therefore fails to take into account any changes or interruptions doses. approaches to take into account the time dependent variables were developed. these allow to take into account any interruptions. however, as part of study on health databases, sometimes we do not have the status in relation to the exhibition on the entire monitoring period. this is for example the case during hospitalization. the bias generated by the failure to take account of these periods ("non measurable time bias") can be problematic when a long exposure and chronic disorders require hospitalization.


Eligibility criteria:
general inclusion criteria: * beneficiaries of all social security regimen with a minimum of one year of data in general sample of beneficiaries group expose to benzodiazepine : * exposition to at least one benzodiazepine or anxiolytic group antidepressants and anxiolytics and hypnotics non benzodiazepines : * exposition to at least one antidepressants and anxiolytics and hypnotics non benzodiazepines control group : - patient having a medical consultation without prescription of interest exclusion criteria: * non incident patient : patient having a prescription of benzodiazepines, clonazepam, tetrazepam, antidepressants, anxiolytics ou hypnotics non benzodiazepine during the last 12 months before index date

Keywords: benzodiazepines fracture
trend analysis of the service of pediatric palliative care

Conditions: Nursing Caries; Palliative Care; Pediatric Population; Pediatric Cancer; Oncology

Summary: palliative care has received considerable attention in taiwan in recent years. the relevant research has been widely conducted for palliative care in adult population. however, the research in children population is relatively insufficient. in the limited studies, most of them are the experiences generated from individual institutions. this study is going to retrieve the data from 2008-2017 national health insurance research database, cancer registry database, death registry database and other relevant materials in order to analyze the trends of using pediatric palliative care service, the types of services, the timing of initiating palliative care, and the preference of using palliative care service among different life span in the past decade. in addition, the study will examine the differences of the timing of initiating of pediatric palliative care service and the types of diseases among different characteristics of children and healthcare providers. and the study will discuss how pediatric palliative care services affect medical costs.


Eligibility criteria:
inclusion criteria: individuals died from cancer between 2008 and 2017. exclusion criteria: -
five-year recurrence after lcme

Conditions: Colon Cancer Stage I; Colon Cancer Stage II; Colon Cancer Stage III

Summary: a register-based study is conducted to examine clinical outcomes following a population-based, multi-centred implementation of laparoscopic complete mesocolic excision (lcme) in the central denmark region, denmark.

this study was conducted as a population-based "before-and-after" cohort study following the implementation of lcme in the central denmark region (cdr), denmark, in 2017. the ideal framework (idea, development, evaluation, assessment, long-term) was used for examining the outcome of a training program on the lcme adoption. training programme a lcme training program was conducted from march 2017 to october 2017 in the cdr, inspired by the national english laparoscopic colorectal surgery course. patients this study included all colon cancer patients undergoing a curative-intent bowel resection in the defined timeframe. exclusion criteria comprised: 1) another synchronous colon cancer; 2) metastatic disease at the time of surgery; 3) non-curative procedures or local resections only; 4) danish residency \<10 years preoperatively; and 5) non-colon primary cancer. data sources the dccg database, a national registry of newly diagnosed colon cancer patients, was used to identify the primary cohort. for follow-up data beyond 30 days after surgery, the cohort was linked to the following registries: 1) the danish civil registration system (dcrs), 2) the danish cancer registry (dcr), 3) the danish national patient registry (dnpr), 4) the danish pathology registry (dpr) and the danish pathological data bank (dpdb). outcome the primary outcome was the cumulative incidence of colon cancer recurrence 5 years after surgery. a validated algorithm was used to identify recurrence. the secondary outcome was postoperative complications within 30 days graded by the clavien- dindo classification (cdc) (minor: i-ii, major: iii-v).

Eligibility criteria:
inclusion criteria: * newly diagnosed colon cancer patients. exclusion criteria: 1. another synchronous colon cancer 2. metastatic disease at the time of surgery 3. non-curative procedures or local resections only 4. danish residency \<10 years preoperatively 5. non-colon primary cancer.

Keywords: colon cancer lcme cme recurrence laparoscopic complete mesoclic excision
a trial investigating the effect of semaglutide on hypoglycaemic counterregulation compared to placebo in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. stable is defined as unchanged dose * male or female, age between18-64 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 20.0-35.0 kg/m\^2 (both inclusive) * hba1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive) exclusion criteria: * treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. an exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * blood or plasma donation within the past month or more than 500 ml within the last 3 months prior to first semaglutide dosing
transfer of manualized cognitive-behavioral therapy (cbt) for social phobia into clinical practice

Conditions: Social Phobia

Summary: the study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (cbt) on outcome in routine psychotherapy for social phobia. the investigators will investigate how cbt, specifically the treatment procedures and manuals proposed by clark and wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. private practitioners (n=36) will be randomized to one of two treatment conditions (i.e., training in manualized cbt vs. treatment as usual without specific training). the investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (n=116 completers; n=58 per condition). the study is genuinely designed to promote faster and more widespread dissemination of effective interventions. the following research questions can be examined: (1) can manualized cbt be successfully implemented into routine outpatient care? (2) will the new methods lead to an improvement of treatment courses aned outcomes? (3) will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?


Eligibility criteria:
inclusion criteria: * primary diagnosis of social phobia (scid-i) * liebowitz social anxiety inventory scale (lsas) equal to or greater than 30 * age between 18 and 70 years exclusion criteria: * psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for cluster c (scid-ii) * organic mental disorder * severe medical conditions * ongoing psychotherapy or initiation * psychopharmacological treatment

Keywords: social phobia, cognitive-behavioral therapy, treatment