Kornimate/medical-research-clean huggingface dataset:
a study of pregnancy outcomes in congenital heart disease

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to determine if a biomarker assay obtained peripartum (1st-3rd trimester and post-partum) in patients with adult congenital heart disease can predict future risk of cardiovascular adverse events and determine if temporal changes in biomarkers levels throughout the peripartum period can provide a better risk prediction compared to samples taken at a single time-point.


Eligibility criteria:
inclusion criteria: * congenital heart disease diagnosis * currently pregnant exclusion criteria: * unable to consent
saline infusion test in hyponatremia

Conditions: Hyponatremia

Summary: observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.

hyponatremia (low plasma sodium concentration) is a common electrolyte disorder among hospitalized patients that can lead to complications such as gait instability, falls and mental changes. both hyponatremia itself and overly rapid correction of hyponatremia may lead to brain damage. there are several underlying causes of hyponatremia that require different treatment strategies. specifically, hypovolemia is treated with fluid infusion while other common causes such as the syndrome of inappropriate diuresis (siad) and hypervolemic conditions need fluid restriction. in clinical practice, it can be challenging to identify the main cause of hyponatremia due to overlapping diagnosis and unreliable diagnostic tools, typically leading to a timely trial and error approach to therapy. a saline infusion test (sit) is often used to diagnose hypovolemic hyponatremia. to our knowledge, the test has never been validated, but relies on the rationale that the sodium concentration will increase more with saline infusion in hypovolemia than in other causes of hyponatremia. typically, one liter of isotonic saline is infused intravenously and an arbitrarily set cut-off for sodium increase is used to indicate hypovolemia. as the response of sodium depends on several factors that affects the renal free water excretion capacity, this measure may not be the most accurate nor the most efficient. another, more direct, approach could be to measure the change in biochemical markers of circulating volume in response to the volume expansion that comes with saline infusion. we will measure several different biomarkers before, during and after a standardized isotonic saline infusion in patients hospitalized with hyponatremia. based on the results, we hope to develop a more precise tool for the differential diagnosis of hyponatremia.

Eligibility criteria:
inclusion criteria: * plasma sodium 120-130 mmol/l * effective osmolality (2 x plasma sodium + plasma glucose) \< 275 milliosmol/l * age \> 18 years exclusion criteria: * intensive care unit (icu) admission * adequate sodium correction rate: \> 4 mmol/l last 24 hours * primary polydipsia: urine osmolality \< 100 mosm/l * hypertonic saline therapy * adrenal insufficiency * severe heart failure: ejection fraction \< 35 % or clinical suspicion of decompensated heart failure * ascites grade 3 (marked abdominal distention and discomfort) * chronic renal failure stage 4 or 5: estimated glomerular filtration rate \< 30 * failure to submit informed consent

Keywords: arginine vasopressin copeptin antidiuretic hormone saline infusion test fluid- and volume regulation renin aldosterone
effects of additional functional strength training on mobility in children with hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy; Mobility

Summary: the randomized control trail was to determine the effects of additional functional strength training on mobility in children with hemiplegic cerebral palsy.

the aim of functional physiotherapy is to train the child by emphasizing him to learn motor abilities. these motor abilities are those that are thought to be though either by children with cerebral palsy or their parents. functional activities are learned by the repetitive practice of goal-oriented tasks in a given functional situation. this approach instead of focusing on normality, it focuses on functionality. in this way, it is very necessary for the child to practice a given task functionally rather than normally.no studies have been done to improve mobility and strength in lower limb in children with hemiplegia cerebral palsy. so for this reason, this study is conducted to investigate the effects of additional functional strength training on mobility in children with hemiplegic cerebral palsy.in this way we can make these children an active participant of the society.

Eligibility criteria:
inclusion criteria: children who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center exclusion criteria: children with any other diagnosis other than cp children with fixed contractures children underwent surgery children who received botulinum toxin

Keywords: cerebral palsy functional strength training mobility gmfc gmfm
a long-term safety study of olumacostat glasaretil gel in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: the objective of this study is to assess the long-term safety of olumacostat glasaretil gel, 5.0% in patients with acne vulgaris


Eligibility criteria:
inclusion criteria: * signed informed consent or assent (for subjects under legal adult age) * completed week 12 visit of either drm01b-acn03 or drm01b-acn04 studies. * willing to comply with the protocol. subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol * willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics. exclusion criteria: * abnormal clinically significant findings on physical exam, vital signs or ecg at week 12 visit of either the drm01-acn03 or dmr01-acn04 studies that would make further treatment with olumacostat glasaretil gel contraindicated, as determined by the investigator * any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
heart rate variability, physical activity and exhaustion in the inpatient treatment of stress-related disorders

Conditions: Depression; Burnout; Stress Related Disorder

Summary: the goal of this observational study is to learn about heart rate variability and physical activity in inpatients with stress-related disorder. the main questions to answer are: * whether heart rate variability shows the severity of certain symptoms. * whether physical activity has an influence on heart rate variability and symptoms of stress-related disorder. participants will be asked to take part in 5 examinations during their up to 8-week inpatient treatment: * participate in an interview * measurement of heart rate variability, blood pressure and health of the arteries (pulse wave velocity) * tests of endurance, strength, balance and cognitive abilities * completion of two additional short questionnaires * wearing a 24-hour electrocardiogram * wearing a fitness watch and daily self-assessment of fatigue, mood and tension via an app on participant's mobile phone during their stay.


Eligibility criteria:
inclusion criteria: * diagnosis of an icd-10 depressive episode (f32 or f33) and burnout (z73) without psychotic symptoms * german language skills * mobile phone ownership * age 18-35 years exclusion criteria according to medical history: * comorbid psychiatric disorder, including post-traumatic stress disorder as well as anxiety and panic disorder * current treatment with antiarrhythmic drugs and tricyclic antidepressant medication * factors precluding submaximal endurance test: history of cardiac diseases such as myocardial infarction, stroke and unstable heart failure within the previous six months impairing exercise testing and training, and heart failure (new york heart association functional class iii and iv) * factors severely affecting hrv parameters: type 1 \& 2 diabetes mellitus with clinically proven cardiovascular autonomic neuropathy, chronic obstructive pulmonary disease global initiative for obstructive lung disease stage ≥ iii, ongoing cancer treatment, moderate to severe chronic kidney disease (estimated glomerular filtration rate stage 3a (g3a) or worse (≤ 45 ml/min)), current eating disorders such as anorexia nervosa and bulimia nervosa, excessive drug or alcohol abuse * known pregnancy * suicidal thoughts precluding informed consent

Keywords: stress related disorder heart rate variability physical activity exhaustion inpatient treatment cardiorespiratory fitness
the development of autistic children based on mothers´response in autism behavior checklist

Conditions: Autism; Asperger Syndrome

Summary: the purpose of this study is to evaluate the process of development of autistic children, in a direct and indirect intervention context from mother´s response in autism behavior checklist.

aim: we evaluated the process of development of autistic children, in a direct and indirect intervention context from mother´s response in autism behavior checklist. method: the sample were composed of 11 mothers of children diagnosed with autism (6) and asperger syndrome (5), according to the criteria established by the dsm ivtr (apa, 2002). these children were randomly divided into two groups: six were receiving both direct and indirect intervention (therapy group -tg), and five were receiving exclusively indirect intervention (orientation group - og). we used the autism behavior checklist (krug et al., 1993), adapted to portuguese on three occasions: at the beginning, six months later and 12 months later. this is a list of nonadaptive behaviors (57), in the areas: sensorial, body and object use, language, social and relating.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism or asperger syndrome * age (children) * adherence in the study (at least 70%) exclusion criteria: * others clinical diagnosis

Keywords: autism asperger syndrome
yoga on arrhythmia burden and quality of life in paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: studies in the past have shown that yoga could relieve stress which is the most common trigger for recurrent episodes of atrial fibrillation. breathing exercises in yoga are found to influence the autonomic nervous system (particularly parasympathetic) and thus reduce palpitations. this study hypothesizes that patients with atrial fibrillation might benefit by practicing yoga. yoga may also help to better control heart rate and rhythm when used in combination with usual medical management.


Eligibility criteria:
inclusion criteria: * patients diagnosed with paroxysmal atrial fibrillation ages 25-80 exclusion criteria: * advanced malignancy or severe co-morbid conditions such as severe heart failure and with life expectancy less than 1 year * pregnant women * unmedicated or uncontrolled high blood pressure * a past history of pneumothorax * severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse * carotid stenosis * history of psychosis or substance abuse * history of epilepsy * glaucoma * history of total hip replacement * ablation within 3 months of the start date of study * patients who have not seen a cardiovascular physician in the last year

Keywords: atrial fibrillation, yoga
therapeutic intervention effects of rtms on children with autism spectrum disorder

Conditions: Autism

Summary: autism spectrum disorder (asd) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (rrb). the unclear pathogenesis of asd, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. as a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (tms) has been used more and more in the interventional treatment of autism. the current project aims to explore the influence of tms on brain plasticity in autism by using tms for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.

autism spectrum disorder (asd) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (rrb). the unclear pathogenesis of asd, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. as a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (tms) has been used more and more in the interventional treatment of autism. the current project aims to explore the influence of tms on brain plasticity in autism by using tms for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. investigators conduct a randomized, double-blind, controlled tms trial and collect the participants' stool samples and sequence the gut microbiome before the first magnetic resonance imaging(mri) scan. besides, investigators collect brain imaging data, eye movement data and clinical scale score before and after tms trial to explore the changes of tms treatment on clinical behavior and brain plasticity and provide guidelines for the intervention and treatment of autism.

Eligibility criteria:
inclusion criteria: * age range from 2 to 8 years old. clinical dsm-iv diagnosis of autism. exclusion criteria: * subjects with other neurodevelopmental diseases subjects with contraindications to mri.

Keywords: autism brain plasticity transcranial magnetic stimulation magnetic resonance imaging eye movement gut microbiome
respiration and applied tension strategies to reduce vasovagal reactions to blood donation

Conditions: Syncope, Vasovagal

Summary: for a number of years, researchers have examined the effects of the muscle-tensing technique, applied tension (at), on blood donation-related vasovagal symptoms and donor retention. at was developed originally to reduce symptoms and avoidance behaviour in people with strong fears of blood and needles (phobics). it was based on the idea that exercise-related increases in blood pressure might be able to counteract the effects of stimuli that lead to a decrease in delivery of blood to the brain. at was adapted for non-phobic blood donors and significant reductions in self-reported vasovagal symptoms and the need for nurse-initiated treatment as well as increases in donor retention were observed in some groups. that said, individual response to at is quite variable. this is probably related to recent research indicating that exercise-related maintenance of heart rate and blood pressure plays only a minor role in reducing vasovagal symptoms. rather, at appears to be working at least in part by regulating breathing and reducing the possibility of hyperventilation. pilot results suggest that a novel intervention aimed specifically at breathing may be more effective and reliable than traditional at. to evaluate this idea, 408 blood donors at mobile clinics in colleges and universities will be assigned randomly to four conditions. in brief, 5-minute preparation sessions using a notebook computer, donors will either learn a respiration control technique to avoid hyperventilation, at, both, or neither. as a manipulation check and also a means of examining mechanisms of the interventions, e.g., the possibility that at may work by regulating breathing and co2, participants will wear non-invasive portable capnometers while they are giving blood. outcome will also be assessed by self-report of vasovagal symptoms, observational data, and number of return visits to a blood clinic in the following year verified by the provincial blood collection agency, héma-québec. as a secondary aim, the research will examine possible moderating effects of pre-donation anxiety and sex. the development of simple, effective approaches to reduce vasovagal symptoms during blood donation has the potential to improve the blood donation experience and blood donor retention as well as encourage people who have never given blood to consider the procedure. it will also improve medical and dental care more generally given the use of needles in so many procedures.

see above.

Eligibility criteria:
inclusion criteria: * healthy volunteer blood donors. exclusion criteria: -
early clinical evaluation of 18f-ly3546117 in tumor imaging

Conditions: Neoplasms; Neoplasms Malignant

Summary: immuno-oncology (io) therapies have revolutionized cancer therapy and are becoming the standard of care for many cancers. monitoring how well io therapies work against cancer is difficult due to the complexity of the immune system and the fact that an immune response may initially increase, rather than decrease, the size of a tumor. an early response marker would be beneficial to determine which patients should remain on a given treatment or combination of treatments, and which patients should seek other treatment options. 18f-ly3546117 is a radiolabeled tracer that binds to a specific protein (granzyme b) that is found in the human immune system and is thought to trigger programmed cell death. it is thought that imaging granzyme b activity in tumors and elsewhere in the body using a positron emission tomography (pet) scan will allow doctors to monitor the progress of io therapy.


Eligibility criteria:
inclusion criteria (cohort 1): * at least one imageable tumor greater than or equal to 15 mm in the longest diameter * confirmed diagnosis of cancer with a high likelihood of response to immuno-oncology therapy (melanoma or non-small cell lung cancer, or other malignancies with sponsor approval) and planned mono- or combination therapy with immuno-oncology therapy * life expectancy of greater than 6 months inclusion criteria (cohort 2): * at least one imageable tumor greater than or equal to 15 mm in the longest diameter or a tumor assessable by pet in the opinion of the radiologist * received treatment with an immune checkpoint inhibitor with evidence of response * life expectancy of greater than 6 months exclusion criteria: * subjects who plan to receive chemotherapy or radiation therapy during study participation * prior history of failed immune checkpoint inhibitor therapy * subjects who require steroid or other immunosuppressive medications within 2 weeks of the pet scan. * females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using effective methods of contraception. females of childbearing potential must not be pregnant or breastfeeding at screening and agree to avoid becoming pregnant for 24 hours following study drug administration. * females and males must agree to refrain from sexual activity or to use effective contraceptive methods for 24 hours following study drug administration and during study participation

Keywords: cancer imaging
evaluation of the management of diabetic foot ulcers by telemedicine on the number of hospital days in diabetic patients

Conditions: Diabetes Mellitus; Ulcer Foot

Summary: the telepied project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary. it is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot. patients included in the conventional group will be followed according to the usual practice patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator. the patient will be visited by the referring nurse every 15 days. during these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. this visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life. every patients will be followed for one year (12 months).


Eligibility criteria:
inclusion criteria: * patients over 18 years * diabetic patients with foot ulcer * patient who agreed to participate in the study and sign free and informed consent * patient affiliated to a social security scheme exclusion criteria: * pregnant woman * patient deprived of liberty by a judicial or administrative decision or a person subject to a legal protection measure * patient already involved in another clinical trial protocol

Keywords: telemedicine
open label trial of rivastigmine patch in subjects with mild to moderate stage ad having coexisting svcvd

Conditions: Alzheimer Disease; CVA (Cerebrovascular Accident)

Summary: rivastigmine, an acetylcholinesterase inhibitor which has been approved by fda \& hsa, is authorized for use in the treatment of mild to moderate dementia of the alzheimer's type. in this trial, the investigators will be studying the effectiveness of rivastigmine in subjects with ad and cerebrovascular disease.


Eligibility criteria:
inclusion criteria: * age between 50-85 years * diagnosis of dementia of the alzheimer's type according to the national institute of ageing-alzheimer's association criteriah * mri brain (with t2 or flair sequences) performed within a 12 month period from time of recruitment demonstrating the presence of wmh of ≥2 on the fazekas scale (score range of 0-3 wherein a score of 1 indicates mild wmh, 2 indicates moderate wmh and 3 indicates severe wmh).i * clinical dementia rating score of 1-2j * mini-mental state examination (mmse) scores of 12-26 inclusivek * english or mandarin speaking, literate participants exclusion criteria: * severe neurological, psychiatric or systemic disease which in the opinion of the clinician could interfere with trial assessments * the use of any investigational drugs, new psychotropic or dopaminergic agents, cholinesterase inhibitors or anti-cholinergic agents during the 4 weeks prior to recruitment * known skin allergy or previous allergic reaction to rivastigmine patch