Kornimate/medical-research-clean huggingface dataset:
multicenter observational prospective study to describe irritable bowel syndrome in the russian federation

Conditions: Irritable Bowel Syndrome

Summary: observational prospective study to describe irritable bowel syndrome in the russian federation

awareness about the disease in russia is extremely low both among doctors and especially among patients. to date there are no data on the prevalence of the disease in russia. this is the first study to show patient profile, main trigger factors and concomitant diseases among patients with irritable bowel syndrome (ibs) in russia. also treatment characteristics for these patients in russia will be measured. this study fills a lack of scientific data about prevalence of ibs and additional information.

Eligibility criteria:
inclusion criteria: * male or female 18-50 y.o * patients suffering from irritable bowel syndrome (abdominal pain and changes in bowel habit) as defined by rome iv criteria and the absence of any relevant structural disease * patient's written authorization to provide data for the program * patients who are able to input him/herself data into patients' part of electronic data capture (edc) exclusion criteria: presence of alarm features: * positive family history of colorectal cancer, inflammatory bowel disease, celiac disease * rectal bleeding in the absence of documented bleeding hemorrhoids or anal fissures * unintentional weight loss * severe anemia (according to local laboratory reference values) * fever (\> 37,5 degree celsius) * night symptoms appearance other: * significant and progressive change in: enlargement of the liver, spleen, lymph nodes; ascites; palpable mass in the abdomen / pelvic * pregnancy or lactation or the inability to use adequate contraception during the study; * other conditions that made the patients participation impossible (by investigator judgment) * previous enrollment in any other clinical study during the course of this study, including participation in a study within 30 days prior to informed consent. * prescribed by health care professional(s) (hcp) and being currently treated or having been treated with spasmolytics within the 3 months prior to entering the study.

Keywords: ibs; irritable bowel syndrome; spasmolytics; mebeverine; duspatalin
feasibility of the lee silverman voice treatment®-big intervention in stroke

Conditions: Chronic Stroke

Summary: evaluate feasibility (acceptability, subject recruitment/retention, willingness to be randomized, and adherence rates) of delivering the lee silverman voice treatment®-big (lsvt®big) intervention with individuals with chronic stroke. evaluate preliminary effect of the lsvt®big intervention on motor function and occupational performance with individuals with chronic stroke.

literature suggests the lee silverman voice treatment®-big (lsvt-big®) program is an effective intervention for individuals with parkinson's disease (ebersbach et al., 2015); however, no literature or research exists on the use of this program as an intervention for individuals with stroke. therefore, this project aims to measure the effectiveness of the lsvt®big program with one individual with a stroke to determine if lsvt®big is a feasible and effective occupational therapy intervention for this population. the lsvt®big program is an intensive program with hands-on treatment sessions 4 days per week for 4 weeks. clients complete home exercises every day that enhance the hands-on treatment and help promote carry-over of skills learned to daily tasks. the investigators have completed two case studies with clients with chronic stroke who demonstrated improved outcomes in upper extremity motor function and occupational performance. the purpose of this study is to test the lsvt®big intervention with a larger clinical population and to demonstrate that lsvt®big is an effective and feasible treatment option for improvement in occupational performance and upper extremity motor function with individuals with stroke.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. diagnosis of first-ever ischemic stroke at least 6 months prior as confirmed by medical records 3. has more than a moderate stroke (nih stroke scale \> 20) 4. can read and write english. to ensure participants can understand instructions in clinic and home exercise sessions exclusion criteria: 1. more than moderate motor deficits (fugl-meyer ue assessment \< 32/66) 2. more than mild cognitive impairment (mini-mental status examination \< 24) 3. more than mild balance deficits (berg balance scale \<45) 4. minimal or no impairments from their stroke (nih stroke scale \< 6) 5. currently receiving occupational therapy or physical therapy services 6. has had more than one stroke

Keywords: upper extremity hemiparesis
ct evaluation of acl anatomical reconstruction

Conditions: ACL Tear

Summary: our research is to evaluate the position and length of femoral tunnel, and to examine whether knee stability and clinical functional outcomes are better while using two-portal or three-portal technique .

arthroscopic anterior cruciate ligament (acl) reconstruction is one of the most often performed orthopedic surgeries . restoration of normal anatomy after acl reconstruction is related to achieve better function and a satisfactory long-term outcomes. the principles for anatomical acl reconstruction are to functionally reestablish the acl to its native dimensions, collagen orientation and insertion sites . the basis for the completion of these principles lies in the correct identification of the insertion sites. the conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal. the 3-portal technique allows interchangeable use of the portals as a viewing and working portals depending on the specific task that is being performed. the internal joint anatomy, as soft tissue remnants and bony landmarks, should guide the placement of the portals in acl anatomical reconstruction and that each of the portals has a specific role during acl anatomical reconstruction . so does the improved visualization through 3-portal technique compared to 2-portal technique have an impact on femoral tunnel position ?

Eligibility criteria:
inclusion criteria: 1. age ( 16 - 50 ) . 2. isolated acl tear with or without meniscal inj 3. patient who have undergone acl reconstruction in the last 5 years in arthroscopy and sports injuries unit . exclusion criteria: * 1- age ( \< 16 ) 2- patient with multi ligamentous inj . 3- revision acl tear .
seprafilm® adhesion barrier and cesarean delivery

Conditions: Adhesions; Cesarean Section; Delivery, Obstetric

Summary: a multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of seprafilm® adhesion barrier in reducing adhesion formation in cesarean deliveries. primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).

patients presenting to labor and delivery for delivery will be screened for eligibility. if a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. after the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. at this point, she will be considered a candidate for randomization. if the patient subsequently undergoes a cesarean delivery, she will be randomized to either: 1. group a - placement of seprafilm® prior to abdominal closure 2. group b - routine closure without placement of seprafilm® the chances of being assigned to either group will be equal (i.e., 1:1 randomization). the patient will be blinded with regard to seprafilm placement. the investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. there are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. enrollment in this study is not expected to alter the patient's length of stay. the antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. this study in no way changes or directs the care the patient would receive, except with regard to the placement of seprafilm® adhesion barrier. a short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications. if a patient becomes pregnant again and undergoes a repeat cesarean delivery at a participating institution, the location and severity of adhesions (if any) would be assessed at the time of repeat cesarean delivery. the investigators will extract additional data from the chart including operative times, blood loss, and complications. an evaluation of adhesions would conclude the patient's participation in the study.

Eligibility criteria:
inclusion criteria: * pregnant women who are planning or have the potential to undergo cesarean delivery * age over 18 * able to consent to study exclusion criteria: * planned tubal ligation * known allergy to hyaluronic acid * medical or other serious condition which will interfere with compliance and/or ability to complete study protocol

Keywords: adhesion seprafilm cesarean section
family based interventions: preschool children and parent

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to assess the efficacy of a 2-year family-based weight prevention program in a cohort of overweight preschool children and overweight parent pairs.

background: the proposal targets a population of individuals of great public health importance who are of high risk for weight gain: pre-school children of overweight parents. family-based interventions are both theoretically and functionally reasonable approaches for use with these subjects, and the choice to focus on both increased physical activity and healthier food choices in the context of the family's environment is appropriate. the decision to include weight management outcomes on the parent as secondary endpoint is strategically wise and may provide important insights into the process of weight management. a broad array of data is to be collected and strong justification is provided for the inclusion of each. the study is in response to an initiative issued by the national institute of diabetes and digestive and kidney diseases and entitled "innovative approaches to the prevention of obesity". the resulting grant was later reassigned to the national heart, lung, and blood institute. design narrative: approximately fifty child/parent pairs were recruited and randomized evenly to one of two groups: usual care versus an intervention focused on diet and activity strategies that included weekly group visits (24 weeks), biweekly group visits for parents (12 weeks), monthly group visits for parents (6 months) and quarterly group visits (12 months). cognitive-behavioral therapy was used to guide interventions, which focussed on empowering a parent as the primary medium by which lifestyle changes were made. major data collection at baseline, twelve, and 24 months included measures of weight; food and activity records; activity monitor recordings; biopsychosocial profiles; blood lipids, glucose, and insulin; process measures; parenting behavior; and child behavior. the primary study outcome measure was age- and gender-appropriate changes in bmi (expressed as a binomial response). additional outcomes of particular interest were weight changes in the parent, diet and physical activity levels, parenting skills, and biopsychosocial measures. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
lipid profile in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this study aims to assess the tg/hdl-c ratio in patients with acute coronary syndrome as a novel marker of atherosclerosis.

cross sectional study to: assess triglycerides/high density lipoprotein-cholesterol ratio as a novel atherogenic marker in patients presenting with acute coronary syndrome

Eligibility criteria:
inclusion criteria: * all patients presented with acute coronary syndrome exclusion criteria: * patients less than 18 years * rheumatic heart disease * congenital heart disease
clinical and economic evaluation of neurocognitively-enhanced online cognitive behavioural therapy

Conditions: Depression

Summary: to evaluate the clinical efficacy of online cognitive behavioural therapy supplemented with online neurocognitive remediation therapy to improve mood and cognition, decrease relapse rates and optimise work and occupational functioning.

depression is the most prevalent mental disorder with high relapse rates. direct costs to europe represent 1% of its total economy. following usual treatment, mood improves or fully recovers but cognitive deficits often persist, preventing full return to normal social function. these deficits worsen with repeated depressive episodes and are a significant predictor of relapse. preventing depression relapse remains one of the biggest therapeutic challenges in the field. while effective short-term therapies, such as cognitive behavioural therapy (cbt), exist, all are associated with high relapse rates. online neurocognitive remediation therapy (oncrt), by its potential to rehabilitate impaired cognition in depression, offers an innovative solution to this mental health problem. this trial aims to test the effectiveness and cost-effectiveness of neurocognitively enhanced online cbt to improve mood and cognition in depression, optimise everyday functioning and prevent depression relapse over six months follow-up, using a randomised active-control parallel-groups research design. individuals presenting with at least mild depression (n=134) are randomly assigned to one of two treatment allocations: online cbt (ocbt) or neurocognitively enhanced online cbt (ocbt+oncrt) for 20 one-hour sessions over 5 weeks (i.e., four weekly sessions). before randomisation and within a week of the final allocated session, mood, attention, memory and planning abilities will be assessed. all participants will be then followed for six-months to determine if the mood and cognitive benefits of the ocbt+oncrt are maintained with the passage of time compared to the control group (ocbt alone). standard measures of daily functioning (e.g., work ability, occupational function) and economic cost-effectiveness data will be obtained at the same time points. demonstrating the oncrt effectiveness as an adjunct to cbt will contribute towards optimising connected healthcare solutions for depression.

Eligibility criteria:
inclusion criteria: * scoring a minimum of 14 on the bdi-ii, * internet access * computer access * english-speaking fluency exclusion criteria: * scoring less than 14 on bdi

Keywords: online cognitive behavioural therapy online neurocognitive remediation memory sustained attention everyday occupational function economic evaluation
recab-asa; treatment of recurrent abortion with aspirin

Conditions: Abortion, Habitual

Summary: the aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. the treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. the study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.


Eligibility criteria:
inclusion criteria: * recurrent abortion (≤ 3 consecutive abortions in first trimester) * unknown etiology after work-up * willingness to be randomized exclusion criteria: * previous participation in the study * known cause of recurrent abortion, requiring specific management * age ≥ 40 * bmi above 35 * ivf pregnancy if the reason for ivf was recurrent spontaneous abortion * ongoing treatment with aspirin for other reason * sjoegren syndrome

Keywords: recurrent pregnancy loss, habitual abortion
assessment of cholangio-pancreatoscopy for the diagnosis and the treatment of biliary and pancreatic diseases

Conditions: Lesions of Biliary or Wirsung Ducts; Biliary Tract Diseases; Common Bile Duct Diseases; Pancreatic Duct Disorder

Summary: the biliary and pancreatic tumors are rare but the prognosis is pejorative. it was difficult to have histology of these tumors as the samples taken during ercp were performed under " blind " radiology control. so the diagnostic accuracy was insufficient. the arrival of a new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. however this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost. a new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability. the purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years * patients with biliary duct stenosis with undetermined etiology * patients with pancreatic duct stenosis with undetermined etiology * patients with pancreatic duct distension with undetermined etiology * patients with biliary or pancreatic gallstones after failure to endoscopic treatment exclusion criteria: * patients with haemorrhagic disease or hemostasis and coagulation disorders (tp \ 40 sec. and platelets \< 60000/mm3). * patients treated with anticoagulant or platelet aggregation inhibiting drugs that could not be temporarily interrupted. * patients with biliary duct diameter \< 3 mm * patients with pancreatic duct diameter \<3 mm
consumption of chocolate in pregnant women.

Conditions: Preeclampsia

Summary: the purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.

although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. this is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia. the primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. this 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.

Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18 and 40 years. * presence of uterine diastolic notches measured by uterine artery doppler between 10 and 14 weeks. exclusion criteria: * hypertension requiring medication. * currently or previously use of medications interfering with glucose or lipids metabolism. * use of supplements or natural health products that interfere with blood pressure. * consumption of 1 or more alcohol drink per day. * allergy or intolerance to nuts or chocolate.

Keywords: randomized double blind trial cocoa flavonoids endothelial function blood pressure pregnant women preeclampsia uterine artery flow pulsatility index
worksite wellness within long-term care facilities

Conditions: Worksite Health Promotion; Lifestyle Risk Reduction; Cardiovascular Diseases; Occupational Stress; Healthcare Workers

Summary: the goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. we also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.

this is a cluster randomized control trial (staff n=246 and resident n=180) implemented in six long-term care worksites. three sites will be randomized to the whhip-plus \& ffc and three sites will be randomized to the education-only. the intervention occurs over 12 months and measures will be collected at three timepoints. we will test treatment fidelity as well as if our intervention improves life's simple 7 scores and reduces stress levels among long-term care workers and increases physical activity among residents.

Eligibility criteria:
staff inclusion criteria: 18 years or older; able to understand and speak english; employed by the facility; passed the evaluation to sign consent resident inclusion criteria: 55 years or older; able to understand and speak english; resident of the facility; passed the evaluation to sign consent no exclusion criteria for staff or residents
long-term follow-up of subjects with transfusion-dependent β-thalassemia (tdt) treated with ex vivo gene therapy

Conditions: Transfusion-dependent Beta-Thalassemia

Summary: this is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (tdt) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. after completing the parent clinical studies (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. no investigational drug product will be administered in this study.


Eligibility criteria:
inclusion criteria: * provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s) * treated with drug product for therapy of transfusion-dependent β-thalassemia in a bluebird bio-sponsored clinical study exclusion criteria: * there are no exclusion criteria for this study