Kornimate/medical-research-clean huggingface dataset:
bilateral priming for upper extremity hemiparesis in older adults

Conditions: Stroke, Upper Extremity Hemiparesis

Summary: this study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. the intention is to understand the effects of priming on upper limb training post-stroke.

techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. the purpose of these techniques is to prime the cortex prior to training. the priming techniques previously described in the literature include medication (i.e. amphetamines), transcranial electric or magnetic stimulation, and manipulation of somatosensory input. here, the investigators examine a priming technique which is non-invasive and free of side effects. the technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. a "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. in this project, the investigators intend to compare bilateral upper limb priming with task specfiic training to a health care education website program followed by the same task specific training as the experimental group.this active comparator (health care education) will receive stroke related health education via a website from the american heart association. transcranial magnetic stimulation willl include measurement of transcallosal inhibition persistence from the affected hemisphere to the less affected hemisphere and vice versa ( less affected to affected). the investigators expect the bilateral priming group to have greater changes in transcranial magnetic stimulation measures and greater improvements in behavioral measures at all time points.

Eligibility criteria:
inclusion criteria: * must have survived a unilateral stroke at least six months prior to enrollment * fugl meyer upper extremity score between 22-38. exclusion criteria: * no individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches
dual diagnosis self-help referral

Conditions: Dual Diagnosis

Summary: this project will help counselors in substance abuse treatment programs make effective referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to self-help groups.

background: dual diagnosis (psychiatric and substance use) patients' (ddps) participation in 12-step mutual-help groups is linked to lower relapse and treatment utilization rates. however, under usual referral, many ddps do not attend, or sustain attendance of, substance-focused groups (sfg). ddps may benefit from dual-focused groups (dfgs). objectives: (1) implement and validate procedures to help counselors make effective referrals to dfgs. ddps were assigned to a standard- or intensive-referral to dfg condition to determine the extent to which intensive referral, compared to standard referral, increased patients' mutual-help group participation. (2) determine whether ddps who received intensive referral had better substance use and psychiatric outcomes. methods: ddps entering va outpatient mental health treatment received either standard (n=145) or intensive (n=142) referral. standard referral consisted essentially of the counselor recommending dfg participation. the keys to intensive referral were a dfg orientation and the counselor facilitating direct contact between the patient and a dfg member, and following up on recommendations for mutual help. patients were followed at six months (80%), one year (81%) and two years (80%) to determine whether intensive referral resulted in more dfg and sfg participation, and better substance use and psychiatric outcomes. status: completed.

Eligibility criteria:
inclusion criteria: * dually diagnosed veterans entering outpatient mental health treatment exclusion criteria: * unable to correctly answer the orientation and registration questions of the mini-mental state examination

Keywords: self-help groups referral and consultation
effects of fructose restriction on liver steatosis

Conditions: Nonalcoholic Fatty Liver Disease; Glucose Metabolism Disorders; Endothelial Dysfunction

Summary: nonalcoholic fatty liver disease (nafld) is an emerging health problem as it can lead to end stage liver failure and cardiovascular complications. diet play an important role in the development of nafld. many studies have addressed the effects of added fructose on nafld. to date, little attention has been paid to the effects of a diet devoid of fructose. therefore, the investigators aim to study the effects of fructose restriction on hepatic fat accumulation and vascular function using a double-blind randomized placebo-controlled design.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * body mass index ≥ 28 kg/m2 * fatty liver index ≥ 60 * fructose intake ≥45 grams/day exclusion criteria: * medical history of liver disease * (history of) excessive alcohol consumption (defined as \> 2 units/day for women, and \> 3 units/day for men) * major change in weight and/or physical activity prior to the study * use of glucose lowering drugs * recent illness * pregnancy and/or lactation * contraindications for magnetic resonance imaging * inability to give informed consent protocol change (implemented on july 18, 2018): in order to increase the inclusion of study participants, subjects with an average daily fructose intake \< 45 gram/day will also be eligible for participation. in subjects who have an average daily fructose intake \< 45 gram/day, supplementation of either fructose or glucose (see 'arms and interventions') will be increased to 45 gram/day.

Keywords: fructose diet
comparison of double pad fiber optic device versus conventional phototherapy

Conditions: Neonatal Hyperbilirubinemia

Summary: a randomized study of phototherapy for neonatal hyperbilirubinemia. the intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. both treatments are well known and used. the primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.


Eligibility criteria:
inclusion criteria: * neonatal icterus and total serum bilirubin above threshold for phototherapy. * gestational age ≥ 33 weeks * birth weight ≥ 1800 gr * postnatal age \> 24 hours and \< 2 weeks exclusion criteria: * hemolysis due to isoimmunization * very high or rapidly rising total serum bilirubin
hyperbaric oxygen brain injury treatment trial

Conditions: Traumatic Brain Injury

Summary: the purpose of this innovative adaptive phase ii trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe tbi patients in a subsequent phase iii trial.

preclinical and clinical investigations strongly indicate that hyperbaric oxygen (hbo2) is physiologically active in improving the destructive processes in severe traumatic brain injury (tbi). however, prior to a definitive efficacy study, important information is required regarding optimizing the hbo2 treatment paradigm instituted in terms of pressure and whether nbh enhances the clinical effectiveness of the hbo2 treatment. preclinical investigators working with tbi models have used pressures varying from 1.5 to 3.0 atmospheres absolute (ata). clinical investigators have used pressure varying from 1.5 to 2.5 ata. however, the lungs in severe tbi patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to oxygen (o2) toxicity. working within these constraints, it is essential to determine the most effective hbo2 treatment parameters without producing o2 toxicity and clinical complications. this proposed clinical trial is designed to answer these questions and to provide important data to plan a definitive efficacy trial.

Eligibility criteria:
inclusion criteria: * age 16 years or older and 65 years or younger * present with severe tbi, defined as glasgow coma scale (gcs) of 3 to 8. * marshall computerized tomography (ct) score \>1 in patients with a gcs of 7 or 8 or patients with an alcohol level \>200 mg/dl * ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure or * ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure exclusion criteria: * first hyperbaric oxygen treatment cannot be initiated within 24 hours of injury * gcs of 3 with mid-position and non-reactive pupils bilaterally (4mm) * penetrating head injury * pregnant * pre-existing neurologic disease (e.g. tbi or stroke or neurodegenerative disorder) with confounding residual neurologic deficits * unstable acute spinal cord injury * fixed coagulopathy * severe hypoxia * cardiopulmonary resuscitation performed * coma suspected to de due to primarily non-tbi causes * any contraindications to the study intervention
gwas to identify predictive genetic factors for the success of dietary intervention in the treatment of ibs symptoms

Conditions: Irritable Bowel Syndrome (IBS); Genome-wide Association Study; Single Nucleotide Polymorphisms; Mediterranean Diet; FODMAP Diet

Summary: this is a gwas that aims to identify possible single nucleotide polymorphisms (snps) that are associated with the response in a combined dietary pattern low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and meditteranean diet (med-lfd) in a small group of patients with irritable bowel syndrome (ibs).

irritable bowel syndrome (ibs) is a very common chronic gastrointestinal disorder. several factors seem to contribute to its development, such as psychological stress, intestinal dysbiosis, infections, post-traumatic syndrome and genetic predisposition. regarding the nutritional management of ibs, there are several approaches to alleviate symptoms, such as the low-fructose diet low in fermentable oligosaccharides, disaccharides, monosaccharides and fodmap polyols (lfd), recommendations from the british institute of health and care excellence (nice) and the recently proposed combination of the mediterranean diet and lfd (med-lfd) proposed by our research group. however, genetic background expressed in single nucleotide polymorphisms (snps) appears to influence the response to even dietary interventions. the aim of this gwas is to identify snps that are associated with the negative or positive response to the diet. at the baseline, blood samples will be collected for dna extraction. genotyping will be based on next generation sequencing (ngs) technology to detect genetic factors associated with the effectiveness of the intervention. symptom severity will be measured by the ibs-sss scale. mental health status will be assessed with the hads (hospital anxiety and depression scale) questionnaire. patients will be recruited by the department of clinical nutrition, attikon university general hospital, where the nutritional intervention will be carried out.

Eligibility criteria:
inclusion criteria: * fulfillment of the rome iv criteria for ibs * provision of written informed consent. * commitment of availability throughout the study period. * ibs-sss \> 175 exclusion criteria: * any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity). * pregnancy. * breastfeeding.

Keywords: diet response nutrigenetics
comparison of sensimed triggerfish (tf) 24 hour monitoring of the eye in glaucoma patients before and after trabeculectomy

Conditions: Glaucoma

Summary: a 24 hour profile is recorded using sensimed triggerfish in glaucoma patients before and after trabecuelctomy


Eligibility criteria:
inclusion criteria: * patient must have the willingness and ability to provide signed informed consent * patient is able to comply with the study procedure * patient must be ≥ 18 years old * diagnosis of primary open angle glaucoma (egs criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye * planned trabeculectomy in the study eye * in preparation for trabeculectomy, all preoperative iop lowering medication has been replaced by dorzolamid 20 mg/ml + timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before triggerfish® profile * patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out * visual acuity of 20/200 or better in both eyes * ability of subject to understand the character and individual consequences of the study exclusion criteria: * subjects with contraindications for wearing contact lenses in the study eye * secondary glaucoma in the study eye * history of refractive surgery in the study eye * history of intraocular surgery in the last three months in the study eye * severe dry eye syndrome as judged by the investigator in the study eye * keratoconus or other corneal abnormalities * any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision * conjunctival or intraocular inflammation in the study eye * simultaneous participation in other clinical trials * previous iop-lowering intervention in the study eye * current shift workers (applicable for at least 3 months) * transmeridian flight \< 2 months before screening (6 hours time shift) * subjects with pacemaker
cardiac energetics and function in normal human ageing

Conditions: Left Ventricular Function Systolic Dysfunction; Left Ventricular Function Diastolic Dysfunction; Ageing

Summary: normal aging is characterized by altered cardiovascular function. our preliminary data with mr imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension show that age-related cardiac dysfunction is characterized initially by impaired relaxation of the heart (40 - 60 years), and then at \> 60 years altered contraction and impaired myocardial energetics. for the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing stiffness of peripheral blood vessels using an ace inhibitor. this will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.

normal aging is characterized by altered cardiovascular function. our preliminary data with mr imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension show that age-related cardiac dysfunction is characterized initially by diastolic dysfunction (40 - 60 years), and then at \> 60 years altered systolic strains and impaired myocardial energetics. the investigators propose to study the mechanism of these findings in subjects with normal aging without any cardiovascular disease, hypothesizing that increased vascular stiffening contributes to impaired energetics and left ventricular function. for the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing afterload using an ace inhibitor. this will be tested at 2 ages (40-60 and \> 60 years), so that the intervention tests the hypothesis soon after the abnormalities develop (40-60 years - diastolic dysfunction; \> 60 years energetics and altered strains). this will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.

Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 20 and 80 years exclusion criteria: * any cardiovascular condition including hypertension, or on any cardiovascular therapy. * blood pressure \> 150 mmhg systolic, and/or \> 90 mmhg diastolic * claustrophobia * implanted metal prosthesis * chronic renal failure requiring dialysis * diabetes mellitus.

Keywords: energy metabolism ageing left ventricle energetics function
safety and performance of the journey™ ii uni unicompartmental knee system

Conditions: Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee

Summary: this clinical study will evaluate the early to midterm safety and performance of the journey™ ii uni uks in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. clinical, radiographic, health economic and safety outcomes will be evaluated.

to assess the safety and performance of the journey™ ii uni uks in patients with unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative percent implant survival in subjects with the journey™ ii uni uks implanted, compared to a literature reference rate of 91.7% (aoa annual report 2015)12 at 5 years.

Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria for inclusion in the study. 1. unicompartmental, nidjd, including oa, traumatic arthritis, or avascular necrosis. 2. eighteen (18) years of age or older at the time of surgery. 3. skeletally mature in the judgement of the pi. 4. has met an acceptable preoperative medical clearance and is free of (or acceptably managed) cardiac, pulmonary, hematological, infection, or other conditions that would pose an excessive operative risk. 5. willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires. 6. consented to participate in the study by signing the ec-approved icf. exclusion criteria: * subjects meeting any of the following criteria must be excluded from participation in the study. 1. correction of functional deformity. 2. revision procedures where other treatments or devices have failed. 3. treatment of fractures that are unmanageable using other techniques. 4. inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia. 5. body mass index (bmi) \> 40. 6. collateral ligament insufficiency. 7. active infection, treated or untreated, systemic or at the site of the planned surgery or previous intra-articular infections. 8. incomplete or deficient soft tissue surrounding the knee. 9. conditions that may interfere with the uka survival or outcome, including but not limited to paget's disease, charcot disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease. 10. diagnosis of an immunosuppressive disorder. 11. known allergy to study device or one or more of its components. 12. pregnant or planning to become pregnant during the course of the study. 13. subject, in the opinion of the pi, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation
the effects of short-time high-intensity interval training on tissue glucose and fat metabolism in healthy subjects and patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Healthy Volunteers

Summary: the objectives of this study are to investigate the effects of short-time high-intensity interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2 diabetic patients using modern and noninvasive imaging methods positron emission tomography (pet), magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs).


Eligibility criteria:
inclusion criteria: the healthy patients 1. age 40-55 2. bmi 18.5-30 3. fasting plasma glucose less than 6.1 mmol/l 4. normal glucose tolerance test (ogtt) the type 2 diabetic patients: 1. age-, sex-, and bmi-matched with the study subjects in the phase 1 2. in a good treatment balance 3. glycated haemoglobin (hba1c) less than 7.5 mmol/l 4. two hours glucose value in oral glucose tolerance test (ogtt) less than 10.0 mmol/l exclusion criteria: the healthy patients 1. blood pressure \> 140/90 mmhg 2. any chronic disease 3. any chronic medical defect or injury which hinder/interfere everyday life 4. history of anorexia nervosa or bulimia 5. history of rest or exercise-induced asthma 6. previous use of anabolic steroids, additives or any other substrates 7. smoking of tobacco, taking of snuffs, or use of narcotics. 8. significant use of alcohol 9. any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results 10. presence of any ferromagnetic objects that would make mr imaging contraindicated 11. current or history of regular and systematic exercise training 12. vo2max \>40 ml/min/kg the type 2 diabetic patients: 1. any other chronic disease than diabetes 2. blood pressure \> 140/90 mmhg 3. any chronic medical defect or injury which hinder/interfere everyday life 4. history of anorexia nervosa or bulimia 5. history of rest or exercise-induced asthma 6. smoking of tobacco, taking of snuffs, or use of narcotics. 7. any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results 8. presence of any ferromagnetic objects that would make mri imaging contraindicated 9. current or history of regular and systematic exercise training 10. vo2max \>40 ml/ min/kg