Kornimate/medical-research-clean huggingface dataset:
a trial of yoga in pediatric inflammatory bowel disease

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: ibd adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face. stress and how stressful events are perceived, may contribute to worsening of disease. complementary and alternative medicine (cam), are used often by pediatric ibd patients and maybe beneficial in decreasing stress and improving quality of life. yoga could be a well suited paring with standard medical therapy to decrease and provide a better sense of control and improve quality of life.

approximately 25% of inflammatory bowel disease (ibd) is diagnosed in the pediatric age group, with the peak age of onset in the adolescent years. ibd adds additional stressors of a chronic disease with unpredictable and potentially embarrassing symptoms to the expected challenges of psychological and social adjustment that teenagers face. various techniques, such as psychotherapy programs and ibd overnight camp experiences, have been studied to decrease psychological distress and improve quality of life. stress, and particularly how stressful events are perceived, may play a role in triggering ibd flares. complementary and alternative medicine (cam), especially mind-body techniques are used often by pediatric ibd patients and may be beneficial in decreasing stress and improving quality of life (qol). yoga may be well suited as an adjunct to conventional ibd therapy to decrease stress, provide a greater sense of bodily control and improve qol. the primary goal of this project is to determine if a structured yoga program, in addition to standard medical therapy, improves hrqol in pediatric patients diagnosed with inflammatory bowel disease (ibd). investigators will also examine if the yoga program improves self efficacy, which is a person's belief about their ability to influence events that affect their lives. disease response and remission rates will be followed as well, in order to stratify hrqol outcomes in the yoga group. patients will each serve as their own control and complete questionnaires at enrollment and at the start and end of the 12 week group yoga class sessions. they will also complete the questionnaires three months after finishing the class sessions. .the program will consist of a live group class session over 12 weeks. baseline and follow-up questionnaires will be used to determine there are changes in qol, self-efficacy, and disease response.

Eligibility criteria:
inclusion criteria: * both males and females patients with ibd * ages 10-17 years * not currently practicing specific mind-body techniques (yoga, pranayama - deep breathing, biofeedback, hypnosis, guide imagery) * diagnosis of ibd exclusion criteria: * other chronic systemic disease ex. rheumatoid arthritis, cystic fibrosis, celiac or chronic neurologic conditions
changes in electromyographic activity in aligner treatment of adult patients with and without nocturnal bruxism

Conditions: Sleep Bruxism; Masseter Muscle Hypertrophy; Grinding Teeth

Summary: the purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients. the aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using bruxoff ® device, before and after the beginning of the therapy. bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep. the plan is to compare treatment with clear aligners for bruxism and non-bruxism patients. the results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.


Eligibility criteria:
inclusion criteria: * acceptance of the treatment plan with clear aligners; * acceptance of informed consent to the study; * subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the american academy of sleeping medicine. * subjects who don't meet the criteria of sleep bruxism by american academy of sleeping medicine in good health. exclusion criteria: * patients with morphological and structural alterations to the temporomandibular joint, e.g. condillary hypertrophy; * medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia; * patients in therapy with myorelaxants or other medicines that affect chewing muscle activity; * patients with pacemakers; * patients with periodontal diseases; * patients with ongoing orthodontic therapy or with prosthetic rehabilitation

Keywords: clear aligners bruxoff electromiograph therapy masseter muscle contraction muscle pain
study of regn4659 in combination with cemiplimab in patients with advanced or metastatic non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the objective of this trial is to study regn4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (nsclc) patients. there are 2 phases of this study: a dose escalation phase and a dose expansion phase.


Eligibility criteria:
key inclusion criteria: 1. patients with histologically or cytologically documented squamous or non-squamous nsclc with unresectable stage iiib or stage iv disease 2. combination dose escalation cohorts: treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit. 3. dose escalation cohort c: anti-pd-1/pd-l1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen 4. expansion cohort(s): anti-pd-1/pd-l1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage iii or iv disease. patients must not have permanently discontinued anti-pd-1/pd-l1 therapy due to treatment related ae. patients must have received one line of anti-pd--1/pd-l1 immunotherapy. patients may also have received one line of chemotherapy key exclusion criteria: 1. expansion cohort(s) only: patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime 2. active or untreated brain metastases or spinal cord compression. patients are eligible if central nervous system (cns) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment) for at least 2 weeks prior to enrollment. patients must be off (immunosuppressive doses of) corticosteroid therapy 3. expansion cohort(s) only: patients with tumors tested positive for epidermal growth factor receptor (egfr) and anaplastic lymphoma kinase (alk) gene mutations or ros1 fusions. 4. radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any ae due to radiation 5. patients who received prior treatment with an anti-cytotoxic t-lymphocyte-associated protein 4 (ctla-4) antibody 6. previous treatment with idelalisib (zydelig®) at any time note: other protocol defined inclusion/ exclusion criteria apply

Keywords: non-small cell lung cancer nsclc anti-pd-1 anti-ctla-4 immunotherapy
prospective observation of aortic regurgitation after tavi and progress over time: progress pvl registry

Conditions: Aortic Stenosis

Summary: the purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the acurate neo™ aortic bioprosthesis, and the acurate tf™ transferral delivery system, when used as per ifu.

the primary objective of this post-market registry is to further evaluate the safety and performance of the acurate neo™ aortic bioprosthesis and the acurate tf™ transferral delivery system in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (ifu). examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external core laboratory. these examinations are limited to echocardiography and/or contrast aortography assessments. the secondary objective is to collect adverse events and evaluate them according to the varc-2 consensus document.

Eligibility criteria:
inclusion criteria: 1. patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system as per the instructions for use (patients which are included but treated outside of the approved indication will be followed for safety reasons). 2. patient is willing to participate in the study, provides signed informed consent/data authorization form and authorizes the sharing of data in the registry. patient agrees that anonymized imaging data will be sent to and analyzed by an external core laboratory. 3. the treating physician should ensure the subject will return for all required post procedure follow-up visits. exclusion criteria: 1. patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system as per the instructions for use.

Keywords: tavi transcatheter aortic valve replacement transcatheter aortic valve implant transfemoral access aortic valve regurgitation
trial on delay phenomenon utility in preventing anastomotic leakage after an esophagectomy

Conditions: Esophageal Anastomotic Leak

Summary: this is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. the delay phenomenon will be performed by an arteriographic approach.

subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (ivor-lewis procedure) is a very complex surgical technique. it is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). one of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads to high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports). the most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. there are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve blood perfusion after a period of time. few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. may the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. there aren't any prospective randomized controlled trials to answer this question. for this reason the investigators propose to perform a prospective randomized controlled trial in patients who underwent a subtotal esophagectomy (ivor-lewis procedure), comparing two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated on directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage. we decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. we established a recruitment period of 3 years, in wich we intend to include 60 patients.

Eligibility criteria:
inclusion criteria: * all patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer * 18 or above years old * acceptance and signing the full informed consent exclusion criteria: * absence of pancreatitis * anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..) * refuse to collaborate in the study
drug-drug interaction to study the effect of bms-708163 on pharmacokinetics (pk) of galantamine extended release (er)

Conditions: Alzheimer Disease

Summary: the purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when bms-708163 is administered at the same time.


Eligibility criteria:
inclusion criteria: * healthy men and postmenopausal women exclusion criteria: * gastrointestinal disorders * bleeding disorders * peptic ulcer disease * cholecystectomy * seizure disorder * asthma * chronic obstructive pulmonary disease * urinary tract obstruction * cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes * inability to tolerate oral medication * inability to be venipunctured and/or tolerate venous access
effects of amino acid supplementation on liver lipid content and protein metabolism in obese children

Conditions: Liver Steatosis; Insulin Resistance; Whole Body Protein Metabolism; Body Composition, Beneficial

Summary: the purpose of this study is to assess the effect of an eight-week dietary supplementation with essential amino acids plus arginine on liver and plasma lipid content, whole-body fat oxidation, whole-body insulin sensitivity, whole body protein metabolism, and body composition in obese pre-pubertal children.

up to thirty-two obese pre-pubertal children will be recruited for this study. up to sixteen will be boys and up to sixteen will be girls. the study will be a double-blinded, placebo-controlled trial using a randomized, but counter-balanced design. this will ensure equal numbers in the two groups that the children are randomized to, for each sex. the control group will receive placebo and the intervention group will receive essential amino acids plus arginine. the supplements (essential amino acids plus arginine, and placebo) will be given in the form of a drink twice a day for a total of 8 weeks. both the participants and the investigators will be blinded to group assignment. the primary endpoints of this study are to assess the effect of essential amino acids (eaa) plus arginine supplementation on lipid and protein metabolism. for this, liver lipid content, hepatic apoptosis, plasma lipids, apolipoprotein b-100 (apo b-100) levels, hepatic fatty oxidation, whole body insulin sensitivity, body composition and whole body protein turnover. will be compared between the intervention and placebo groups.

Eligibility criteria:
inclusion criteria: * healthy boy or girl * age 7-10 years of age and tanner stage no greater than stage 1 * bmi ≥ 95th percentile * not participating for more than 1 hour/week in a regular physical activity program exclusion criteria: * tanner stage greater than stage 1 * having known chronic illnesses/disorders that may independently affect study outcome measures: type 2 or type 1 diabetes mellitus, neurologic (e.g. epilepsy), neurobehavioral (e.g. attention deficit disorder and hyperactivity, adhd) endocrine, hepatic, autoimmune, cardiac and renal disorders. also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids * taking permanent medications: thyroid hormone replacement therapy, inhaled/oral steroids, insulin, metformin, anabolic drugs (growth hormone replacement therapy and oxandrolone) anti-lipid medication, blood pressure medication, adhd medication (methylphenidate, amphetamines, atomoxetine)

Keywords: protein kinetics liver steatosis
reliability of an objective measurement to assess lumbar spine motion in healthy controls and in low back pain patients

Conditions: Reliability, Validity of Measurement to Assess Lumbar Spine Motion; Comparison of Healthy Subjects and Low Back Pain Patients

Summary: main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. the data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. in addition we compare the results of the motion measurements with disability and pain questionnaires such as the roland morris, oswestry disability index and the brief pain inventory.


Eligibility criteria:
inclusion criteria: * older than 18 years, informed consent, sufficient german skills \ 31days of low back pain in the last 90 days (low back pain group) exclusion criteria: * neurological disorder (including multiple sclerosis, stroke, parkinson´s disease), current pain \>= 4 (nsr)/intake of analgesic in the last 24h/ previous low back surgery (control group), inability to perform choreography (lbp group)
chronicity dependence of a balance training in adults post-stroke

Conditions: Stroke, Postural Balance, Virtual Rehabilitation

Summary: the level of stroke chronicity has been proposed as an influential variable related to functional balance. however, little is known about the effect of this variable on the effectiveness and maintenance of gains of physical therapy interventions on balance. the objective of this study is to determine the influence of time since injury on the rehabilitation of balance after stroke. participants will be assigned to a least (6-12 months), a moderate (12-24 months), or a most chronic (\> 24 months) group. all the participants will train for 20 one-hour sessions, administered three to five times a week, combining conventional physical therapy exercises and customized exercises interfaced on a balance board that promotes the training of the ankle and hip strategies. participants will be assessed before, after the intervention, and one month later with a posturography test (sway speed and limits of stability) and clinical scales (berg balance scale, functional reaches test, 30-second sit-to-stand test, timed up and down stairs test, stepping test, timed up-and-go test, and the 10-meter walking test).


Eligibility criteria:
inclusion criteria: * age ≥ 50 and ≤ 65 years old * chronicity \> six months * fairly good cognitive condition defined by scores in the mini-mental state examination above 23 * ability to walk 10 meters indoors with or without technical orthopaedic aids. exclusion criteria: * impaired comprehension that hinder sufficient understanding of the instructions defined by mississippi aphasia screening test scores below 45 * unilateral spatial neglect * ataxia or any other cerebellar symptom * severe auditory or visual impairments * motional or behavioural circumstances that impede adequate collaboration.
effect of night-time and full-time splinting for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome is a common compression neuropathy of upper extremities. its usual symptoms are pain, numbness and tingling of fingers, which tend to be worse at night. splinting the wrist with an external orthosis is usually a first-line treatment provided to most people with mild to moderate disease. the fincross trial (randomized cross-over trial) aims to assess the effect of night-time and full-time splinting in comparison with no-treatment. it also aims to identify possible subgroups of people who would benefit from splinting, as well as assess if positive response to splinting is associated with subsequent lower need of surgery. the trial will recruit 110 people with carpal tunnel syndrome in finland. each participant will undergo all three treatment periods in a randomised order: 1) splinting at night-time for six weeks, 2) splinting both day and night for six weeks; and 3) be assessed under a six weeks long control period of no-treatment. each treatment period will be separated with a three-week washout period. therefore, the whole treatment sequence for each participant lasts 24 weeks after randomization. the participant will be followed-up to 1 year after the randomisation. additionally, the participants will get instructions for self-administered stretching exercises to perform throughout the study. all participants will be asked to avoid any intervention administered or supervised by medical personnel (such as structured supervised exercises, manual therapy, steroid injections, surgery, etc.).


Eligibility criteria:
inclusion criteria: 1. clinically confirmed carpal tunnel syndrome (cts) of any severity level (diagnostic criteria: numbness, pain or paraesthesia in the median nerve distribution area of wrist and fingers), 2. symptom duration of cts for at least 3 weeks, 3. no previous corticosteroid injection or surgery during last 6 months, 4. aged 18 years or older, 5. able to complete self-report questionnaires electronically, 6. able to understand finnish, 7. willing to join the study and follow the study protocol instructions, 8. sign informed consent. exclusion criteria: 1. nerve root or plexus disorders that might be causing cts mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders), 2. other neurological condition affecting the function of the hand such as multiple sclerosis, previous nerve injury, 3. active rheumatoid arthritis or any other active inflammatory joint disease affecting the hand, 4. thenar muscle atrophy, 5. untreated hypothyroidism, 6. known allergy to any of the splint materials (self-reported by patient), 7. long term treatment (over 4 months) for cts with no response, 8. any other known reason that could prevent from participation for the study time.

Keywords: carpal tunnel syndrome splinting no-treatment cross-over trial
effects of carnipure® tartrate on postprandial endothelial function and recovery

Conditions: Healthy Volunteers; Recovery; Endothelial Function

Summary: investigation of 4 weeks supplementation with carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.


Eligibility criteria:
inclusion criteria: * healthy men and women between 25 and 45 years * body mass index (bmi) between 20 and 30 kg/m² * non-smoker * physically active 1-2 times per week exclusion criteria: 1. competitive athlete or performance of high intensity training 2. vegan 3. nutrition with high portion of meat (\> 3 times meat per week). 4. injury at the finger 5. history or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.) 6. known allergy to ingredients of study preparation 7. disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome) 8. hypo/ hypertension or taking anti hypo/ hypertension medication 9. untreated thyroid dysfunction 10. atherosclerosis or other relevant musculoskeletal diseases/ injuries 11. anemia (women: hb \<11 g/ dl; men: 12.5 g/ dl) 12. eating disorder 13. present or recent use of drugs and dietary supplements that affect the endothelial function, re-covery or lipid status 2 months before or during the study (e.g. l-carnitine, arginine, omega3 fa, polyphenol rich supplements (e.g. opc, cacao, etc) antihypertensive drugs, anti hyperlipidemic drugs, regular intake of protein-shakes etc.) 14. subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b. 15. female patients that are pregnant or nursing 16. night shift worker 17. donation of blood or similar blood loss within the previous 30 days before screening; 18. participation in a clinical trial with an investigational product within 30 days before screening 19. known alcohol abuse or drug abuse 20. known infection of human immunodeficiency virus (hiv) or hepatitis b or c 21. known lactose intolerance, dairy protein allergy or allergy to nuts