Kornimate/medical-research-clean huggingface dataset:
preventive effect of probiotics in gdm

Conditions: Gestational Diabetes Mellitus (GDM)

Summary: gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. they will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until oral glucose tolerance test (ogtt) at 24-28th gestational weeks. perinatal outcomes about neonatal weight will be registered.


Eligibility criteria:
inclusion criteria: * pregnant women who meet the high-risk indicators for gdm and agree to participate in this study. 1. included between 12-16 gestational weeks 2. a woman was considered high risk when her pre-pregnancy bmi ≥ 24 kg/m\^2, having family history of diabetes (type 1 or 2), gdm or pcos (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+) exclusion criteria: 1. taking probiotics or prebiotics within the past month 2. have a history of allergies to the drug components or similar drugs in this study 3. having long-term smoking or drinking habits 4. type 1 or type 2 diabetes patients with definite diagnosis before pregnancy 5. diseases in other important organs such as heart, liver, and kidney 6. with clear digestive system diseases 7. multiple pregnancy 8. with mental or cognitive impairments who are unable to complete this study
kinesio taping technique versus virtual reality in patients with chronic shoulder impingement syndrome

Conditions: Impingement Syndrome, Shoulder

Summary: purpose of the study: to compare between the effect of kinesio taping technique versus virtual reality technique in rehabilitation of patients with chronic shoulder impingement syndrome.

rotator cuff disorders are considered to be among the most common causes of shoulder pain and disability encountered in both primary and secondary care, with subacromial impingement syndrome in particular being the most common disorder, resulting in functional loss and disability, of the shoulder. there is a lack of literature about virtual reality exergaming in subjects with orthopedic problems. to reduce ul impairment, new therapeutic approaches, such as constraint-induced movement therapy, robotic arm training, and virtual reality therapy (vrt), have been successfully employed over the last decade. kinesio taping is the increasingly popular method for preventing and treating sports injuries. the tape helps to maintain the joint position, increases the proprioceptive awareness, and assists in removal of exudates thereby reducing pain and improves the muscle function. so as there is lag in literature regarding the best type of treatment for patients with chronic impingement syndrome so this study will be conducted to compare between kinesiotaping and virtual reality and to determine the best treatment for patients with chronic shoulder impingement syndrome (sis).

Eligibility criteria:
inclusion criteria: * 1. patients will be diagnosed with chronic shoulder impingement syndrome (who had supraspinatus tendinitis stage (ii) 2. ages 25-40 years 3. both sexes will be included. 4. patients complaint from limitation in the rom in abduction flexion and external rotation. 5. patient complaint from pain and tendinitis in subacromial area more than 3 in vas. 6. all patients complaint from difficulties in joining adl activities. 7. all patients will assign written consent form. exclusion criteria: subjects with the following criteria will be excluded from the study: 1. shoulder fracture or instability. 2. previous shoulder surgery. 3. arthritis of the glenohumeral or acromioclavicular joints. 4. cervical radiculopathy 5. patients with visual disorders. 6. diabetic patients. 7. balance and coordination disorders. 8. tumor and breast cancer. 9. major trauma.
renal function assessment in critically ill children

Conditions: Iohexol; Pharmacokinetics; Renal Function; Critically Ill Children; Acute Kidney Injury; Augmented Renal Clearance

Summary: identification of renal dysfunction in critically ill children is often delayed due to lack of accurate methods for evaluation of glomerular filtration rate (gfr). the investigators compared gfr measurement by the gold standard technique iohexol plasma clearance with estimated gfr (egfr) based on selected established formulas incorporating the renal biomarkers creatinine, cystatin c and betatrace protein.

acute kidney injury (aki) is a frequent comorbidity of critical illness associated with poor outcome, including prolonged duration of mechanical ventilation, longer length of stay and increased mortality or progression to chronic kidney disease on the long term. the reported incidence of aki in critically ill children and neonates varies widely between 10% and 80% depending on the diagnostic criteria. besides a decline in renal function, also the phenomenon of augmented renal clearance (arc) and in consequence enhanced clearance of renally eliminated drugs, is increasingly recognized in pediatric intensive care patients. hence, accurate assessment of renal function is crucial in the intensive care population to guide therapy. but to date consensus is lacking about the reliability of common gfr estimation methods based on the endogenous renal biomarkers serum creatinine, cystatin c and betatrace protein in critical care patients. the aim of this study is to measure gfr in a reliable way by iohexol plasma clearance and evaluate the agreement between the gold standard technique iohexol plasma clearance and biomarker-based formula to estimate gfr.

Eligibility criteria:
inclusion criteria: * patients admitted to the pediatric or neonatal intensive care unit * 0 - 15 years * for neonates: gestational age ≥ 37 weeks * bodyweight \>2.5kg * intra-arterial and/or intravenous access available for iohexol administration and blood sampling exclusion criteria: * no vascular access in place for iohexol administration and blood sampling * absence of parental/patient consent * known hypersensitivity to contrast media or previous history of adverse reaction after administration of contrast agents * known thyroid dysfunction, or for newborns: mother with known thyroid dysfunction * extracorporeal circuit (haemodialysis, extra corporal membrane oxygenation (ecmo), peritoneal dialysis) * patients with chronic kidney disease or congenital kidney anomalies * preterm neonates (gestational age \< 37 weeks) * body weight \< 2.5 kg * dehydrated newborns (i.e. loss of birth weight ≥ 10%) * planned/expected surgery with extracorporeal circulation within 5 days after inclusion
efficacy of chatbot for irritable bowel syndrome (ibs) patients

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome - Constipation; Irritable Bowel Syndrome - Diarrhoea; Irritable Bowel Syndrome - Mixed

Summary: the goal of this clinical trial is to evaluate the efficacy of an automated chatbot system in improving quality of life, reducing depression and anxiety, and decreasing visceral sensitivity in patients with irritable bowel syndrome. the main research question is: is an automated chatbot as effective for patients with ibs as standard care? participants will be asked to complete online surveys to assess quality of life, symptoms of depression and anxiety, and visceral sensitivity before and after the intervention.

the study consists of three stages: stage 1: patients with irritable bowel syndrome (ibs) who meet the eligibility criteria will be invited to participate in the study. after providing written informed consent, all participants will be asked to complete a set of questionnaires to assess various parameters: 1. irritable bowel syndrome quality of life (ibs-qol); 2. quality of life - short form-36 (sf-36); 3. symptoms of anxiety and/or depression - hospital anxiety and depression scale (hads); 4. state and trait anxiety levels - state-trait anxiety inventory (stai); 5. visceral sensitivity - visceral sensitivity index (vsi); stage 2: participants will be randomized into one of two groups: a chatbot group (intervention) and a standard care group (control). prior to enrollment, both groups will receive a consultation with a gastroenterologist providing information on lifestyle, diet, and treatment. the intervention group will receive the access to a chatbot. at the fourth and eighth week of follow-up participants in both groups will be asked to re-complete the set of questionnaires (ibs-qol, sf-36, hads, stai, vsi). no routine gastroenterologist consultations will be scheduled during the follow-up period. stage 3: results from the questionnaires will be analyzed and used to formulate conclusions.

Eligibility criteria:
inclusion criteria: * adults ≥18 years; * diagnosed with ibs; * signed informed consent. exclusion criteria: * age under 18 years; * pregnant individuals; * patients with cognitive or sensory impairments that hinder understanding of questions in surveys, scales, or instruments used in the study; * patients unable to use a chatbot; * patients currently participating in any other clinical trial or experimental study; * patients with psychotic symptoms; * patients with other conditions that may influence the endpoints of the current study.

Keywords: ibs irritable bowel syndrome chatbot ehealth
live@home.path: innovating the clinical pathway for home dwelling persons with dementia and their families

Conditions: Dementia; Home-dwelling; Caregiver

Summary: this study aims at developing, implementing and evaluating a complex intervention involving learning, innovation, volunteers and empowerment for home dwelling persons with dementia and their caregivers. the investigators hypothesise that a successfully implemented intervention will reduce caregivers burden and be cost-effective.

the provision of economically viable and proper care for the growing group of home-dwelling people with dementia (pwd) is one of the most pressing issues in our society. while a cure for dementia is not yet available, professionals and policy-makers highly prioritize the support of caregivers who experience a vast burden. however, there is a lack of high-quality research investigating clinical, social and economic factors that may add beneficial effects. this project aims to develop, test, and implement a complex intervention for pwd, intended to reduce caregivers' burden, which will aid pwd to stay safely, longer and independently at home with dignity and cost-effectiveness. the term informal caregivers' burden may include different meanings for different people and be related to economic burden, depression and anxiety, quality of life (qol), or simply the quality of sleep and recreation. in a stepped wedge, cluster randomized controlled trial, involving primary and secondary health care systems in bergen, bærum and kristiansand the 24-month live@home.path study will be undertaken in a stepped wedge design. the user-inspired and tailored intervention includes a designated coordinator to the pwd and caregiver for 6 months to introduce a complex intervention involving a) learning b) innovation c) volunteers and d) empowerment. qualitative interviews will determine users' values and wishes, and promotors and barriers for successful implementation of the intervention. primary and secondary outcomes on cognitive, emotional and social factors, cost-benefit analyses, and qol of pwd and families will be assessed every 6-month over 2 years. update spring 2020: the covid-19 pandemic severely hampered the implementation of the intervention for the second group. we therefore had to change the design, postponing the intervention in bærum and kristiansand, and delivering the intervention in bergen by phone. in addition, we initiated the pan.dem in the live@home.path trial, collecting data from phone interviews with caregivers on change in health services and neuropsychiatric symptoms, risk perception and restrictions. changes in design approved by ethical committee (rek: 10861).

Eligibility criteria:
inclusion criteria: 1. home-dwelling people with dementia (pwd) equal or above 65 years diagnosed according to national guidelines 2. mini mental state examination score 15-24 3. functional assessment staging test (fast score 4-7) 4. living with a partner, or have regular contact with a caregiver minimum 1 hour/week exclusion criteria: 1. participate in other trials 2. expected survival under 4 weeks

Keywords: learning innovation volunteers empowerment
multisite transcranial direct current stimulation to promote hand function recovery after stroke

Conditions: Stroke

Summary: a novel multisite high definition tdcs (hd-tdcs) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond traditional stimulation which targeting only one region. it showed that the excitability following multisite hd-tdcs was more than double the increase following conventional tdcs. to consider the various lesion site of different stroke survivors. the electrode placements based on personalized lesion profiles and anatomical features can be determined using finite element modeling, with lesion profiles generated from fmri and advanced algorithms calculating the current density to maximize the modulation effect. combining motor network interaction and the new multisite electrode montage may further provide a potential to facilitate stroke recovery.


Eligibility criteria:
inclusion criteria: * first-ever stroke, the duration after stroke exceeds 12 months; * mild to moderate upper extremity motor function deficit, determined by the fugl-meyer assessment of upper extremity (fmaue) scores between 15 and 53; * detectable voluntary muscle semg signal from flexor digitorum (fd) and extensor digitorum (ed); * scored below 3 in the modified ashworh score (mas) of fd and ed; * sufficient cognitive function to follow the assessment and training instructions, determined by mini mental state examination score of more than 21. exclusion criteria: * history of epilepsy, or any other contradictions of brain stimulation; * severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.
improving activity in individuals with cerebral palsy

Conditions: Cerebral Palsy

Summary: individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. this study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.

a lack of physical activity in persons with cerebral palsy is known to have cascading effects on their overall health. despite this recognition, there have been limited attempts to improve the physical activity of this patient population. the overall landscape of this project is that a cohort of persons with cerebral palsy will undergo 8 weeks of physical activity that is guided by behavioral coaching. this study aims to determine the impact of behavioral coaching on 1) the amount of daily physical activity, 2) changes in the sensorimotor cortical activity, 3) changes in laboratory assessments of functional mobility. the participants with cp will initially undergo neuroimaging and a battery of clinical assessments. after completing the baseline tests, the participants will undergo 8-weeks of behavioral coaching where they are encouraged to increase the number of steps they take per-day. after completing the 8 weeks, the participants will repeat the same assessments that were performed at baseline.

Eligibility criteria:
inclusion criteria: * cerebral palsy diagnosis and ambulatory (gross motor function classification score \[gmfcs\] levels between i-iii). exclusion criteria: * no orthopedic surgery in the last 6 months, botulinum injections within the last 6 months, or metal in their body that would preclude the use of meg.

Keywords: cerebral palsy fitbit mobility steps
a trial comparing a prophylactic with a therapeutic platelet transfusion strategy in two groups

Conditions: Myeloid Leukemia

Summary: the purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µl). with the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. this is the first prospective randomized study on this topic.


Eligibility criteria:
inclusion criteria: aml project * inclusion in studies of the dsil or osho group for aml * aml m3/m3v can be included only when in complete remission * age 16 - 80 years * written informed consent autologous project * aml and all patients in first or second remission * low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma * conditioning regime: tbi 8-12 gy/cy 120 or beam or bu/cy or melphalan 140-200mg/m2 or a similarly intensive chemotherapy regime * age 16 - 65 years exclusion criteria: aml project * known refractoriness to platelet transfusion * known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing * known plasmatic coagulation disorder * patient unable to give informed consent autologous project * known refractoriness to platelet transfusion * known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing * known plasmatic coagulation disorder * patient unable to give informed consent * patients with pulmonal or cerebral lesions due to infection or neoplasm * patients with al-amyloidosis

Keywords: proof of safety and cost effectiveness of the new therapeutic platelet transfusion strategy
reiki as a complementary therapy: a pilot study

Conditions: Hematologic Malignancy

Summary: this research is being done to test whether a complementary intervention, reiki therapy, can provide added benefits to the standard patient care. reiki is method for stress reduction that uses hand positions over and/or on the body to help people relax. we are studying the effect of a 15-minute reiki application compared to an intervention of nursing presence without reiki. we hope to find if reiki can assist in relieving stress, and improving patient outcomes. in the future we would like to offer complementary interventions as an adjunct to our standard care for patients.

this pilot study is designed to test if a complementary therapy, reiki, has an effect on physiological and subjective measures of stress. this is a 2-arm randomized pilot study of the use of reiki therapy prior to a stressful event with a convenience sample of 40 participants who are newly diagnosed hematologic malignancy patients on the inpatient service who will experience bone marrow aspirate post induction chemotherapy. reiki therapy is a non-invasive complementary therapy that can be used in addition to the standard of care. the intervention group will receive a 15-minute reiki session and the control group will receive 15 minutes of nursing presence. each study arm includes a brief item questionnaire to rank subjective measures of pain, anxiety, and energy; saliva biological markers related to stress-reduction; and measures of blood pressure, heart rate, and respirations. the intervention group will receive a 15-minute intervention performed on the inpatient unit prior to the bone marrow aspirate procedure. data will be collected from patients both before and after the intervention and before and after the bone marrow aspirate. we will collect saliva samples from the control group and baseline data including subjective measures of pain, anxiety and energy and measures of blood pressure, heart rate, and respirations. the study nurse will maintain presence in the control participant's room for 15-minutes after the initial measures. our research hypothesis is that there will be a change in the response to one or more parameters of physiological or subjective measures for those patients receiving a reiki intervention when compared to those receiving standard of care plus the nurse presence in room. the null hypothesis is there will be no difference in response between the groups.

Eligibility criteria:
inclusion criteria: * patients 18 and older admitted to hospital * speak english * able to give consent will be included. exclusion criteria: * patients who are under 18 * non-english speaking * unable to consent * pregnant women * unwilling to join the study will be excluded * intensive care unit (icu) patients and those patients scheduled to receive conscious sedation will be excluded. * each patient may join the pilot study only once
endothelial function study before cardiovascular surgery

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Obstructive Sleep Apnea Syndrome (OSAS)

Summary: the aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (copd) and/or obstructive sleep apnea syndrome (osas) on the endothelial function, before cardiovascular surgery, compared to non copd non osas patients undergoing also a cardiovascular surgery, by an observational physiological study. an interim analysis will be performed when 100 patients will be included.

secondary objectives of this clinical trial : * to evaluate the effect of copd and/or osas on the systemic inflammation, insulin-resistance and oxydative stress, in comparison with non copd non osas patients. * to evaluate the effect of copd and/or osas on the inflammation and oxydative stress of the adipose tissue, in comparison with non copd non osas patients. * to validate the stop-bang questionnaire in patients undergoing a cardiovascular surgery

Eligibility criteria:
inclusion criteria: * men or women between 18 and 80 years old * patient with planned coronary artery bypass graft surgery * patient with planned peripheral vascular surgery * patient with aortic surgery exclusion criteria: * patient with aortic or mitral valvular replacement * patient with emergency peripheral valvular surgery * patient with emergency coronary artery bypass graft surgery * patient with evolutive malignancy disease * pregnant or lactating women * patient with inadvisable bronchodilator (used for functional respiratory) exploration

Keywords: copd patients osas patients cardiovascular surgery endothelial function