Kornimate/medical-research-clean huggingface dataset:
using telemedicine to improve veteran sleep apnea care

Conditions: Sleep Apnea Syndromes

Summary: obstructive sleep apnea (osa) is highly prevalent in the veteran population given the risk factors of male gender, being overweight, and increasing age. osa is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. while continuous positive airway pressure (cpap) is a highly efficacious treatment for osa, compliance with treatment is suboptimal. because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.

background: obstructive sleep apnea (osa) is highly prevalent in the veteran population given the risk factors of male gender, being overweight, and increasing age. osa is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. while continuous positive airway pressure (cpap) is a highly efficacious treatment for osa, compliance with treatment is suboptimal. because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider objectives: the objective of this proposal is to explore the feasibility and initially evaluate the potential efficacy of a video teleconferencing system for patients with obstructive sleep apnea syndrome (osa) that facilitates patient- centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (cpap). methods: the evaluative aspect of this proposal was designed as a pilot randomized, controlled clinical trial of video teleconferencing (vtc) compared to usual care (uc). the key feature of the video teleconferencing intervention was the use of a telemedicine system that allows for audio/visual conferencing with the patient in their home environment from the start of treatment initialization. the provider is able provide more direct feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. specific inclusion and exclusion criteria included: age \> 18 years; confirmed diagnosis of moderate-severe osa; being newly prescribed cpap therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in english. patients were recruited from the va san diego healthcare system pulmonary sleep clinic. patients were enrolled for a 2-month time period. groups were compared on quantitative and qualitative measures. status: study complete

Eligibility criteria:
inclusion criteria: * diagnosed with moderate to severe sleep apnea * live in san diego county * veteran exclusion criteria: * previous use of positive pressure airway therapy * residence outside of san diego county

Keywords: telemedicine continuous positive airway pressure treatment adherence
a study of renal denervation in patients with treatment resistant hypertension

Conditions: Treatment-Resistant Hypertension

Summary: the purpose of this study is to evaluate the clinical and economic impact of implementation of renal denervation with the symplicity™ catheter system for treatment-resistant hypertension in ontario, canada.

this is a pragmatic randomized trial of renal nerve denervation for treatment resistant hypertension. this is part of a ministry sponsored mars-excite program, to conduct early market health technology assessment, in order to determine appropriateness for provincial funding. we will assess the effectiveness, safety, economic attractiveness and feasibility of implementation of renal nerve denervation for treatment resistant hypertension. this will involve a new model of care which will include a multi-disciplinary team approach to these patients. treatment resistant hypertension is defined as patients with uncontrolled hypertension despite being on optimal doses of 3 or more anti-hypertensive medications. patients will be randomized to either standard treatment or renal nerve denervation and followed for 6 months to determine impact on blood pressure.

Eligibility criteria:
inclusion criteria: * ontario residents * aged 18 and over * diagnosis of treatment-resistant hypertension after assessment and optimization by a hypertension specialist following recommended evaluation and diagnosis as outlined by the american heart association * office systolic blood pressure ≥ 160 mmhg (≥ 150 mmhg for patients with type ii diabetes mellitus) prior to optimization by a hypertension specialist * baseline average systolic 24 hour ambulatory blood pressure of ≥ 135 mmhg after optimization and prior to randomization * prescribed 3 or more antihypertensive medications of different classes, both prior to optimization and at randomization, one of which must be a diuretic (a medication can be counted more than once if it acts on different receptors) * suitable renal artery anatomy based on ct/mri/renal angiography imaging: both renal arteries \> 20 mm in length and \> 4 mm in diameter without significant fibromuscular disease or renal artery stenosis (\>50%) exclusion criteria: * secondary causes of hypertension: 1. primary aldosteronism (secondary to adrenal adenoma) 2. chronic kidney disease: creatinine clearance or egfr \< 45 ml/min/1.73m² (measured on 24 hour urine preferably or mdrd) 3. pheochromocytoma 4. cushing's syndrome 5. aortic coarctation (differential in brachial or femoral pulses, systolic bruit) * type 1 diabetes mellitus * pregnancy

Keywords: treatment-resistant hypertension renal denervation ambulatory blood pressure
a clinical study to evaluate the long-term safety sodium oligomannate capsules (gv-971)

Conditions: Alzheimer Disease

Summary: a clinical study to evaluate the long-term safety of sodium oligomannate capsules (gv-971)

sodium oligomannate (code: gv-971), a marine-derived oligosaccharide after extraction, separation and degradation from algae, can play a role in the treatment of alzheimer's disease by reconditioning the dysbiosis of gut microbiota, preventing peripheral immune cells from invading the brain, inhibiting the inflammatory response in the brain, and targeting protein folding errors in the brain tissue. phase i clinical study shows gv-971 was safe and tolerated in healthy adult volunteers when administered continuously at 1200 mg/dose or 1500 mg/day (750 mg/dose, bid) for 5 days. phase ii and iii clinical studies show that the treatment of gv-971 at 900 mg/day dosage for 36 weeks can significantly improve the cognitive function of patients with mild to moderate alzheimer's disease (ad) and was safe and well-tolerated. sodium oligomannate capsules obtained approval from china's national medical products administration (nmpa) on november 2, 2019, with approval letter number of 2019s00571. this product is a chemical drug with a registration classification of 1.2. it is approved for the clinical indication of mild to moderate alzheimer's disease and the function of improving the cognitive function of patients. the clinical dosage and administration is 3 capsules (450 mg)/time, bid, po. due to the limited number of subjects and observation period of medication in completed gv-971 clinical studies, and the screening of patients with the strict inclusion and exclusion criteria, the adverse reactions and long-term safety of gv-971 cannot be comprehensively observed and recorded. therefore, according to the requirements of the nmpa for the marketing of new drugs, this study is intended to further carry out a post-marketing investigation on expanded population using a design of a 96-week intensive monitoring clinical trial to determine the incidence of known adverse reactions of gv-971 under long-term administration, observe the occurrence of new adverse reactions, analyze the correlation, incidence, severity, and risk factors of adverse reactions/events, and better guide the rational use of drugs in clinical practice.

Eligibility criteria:
inclusion criteria: * subjects eligible for this study must meet all of the following criteria: 1. ≥18 years of age; 2. signed informed consent form; 3. patients receiving gv-971 treatment prescribed by clinicians; exclusion criteria: * a subject may be excluded from participation in the study if any of the following apply: 1. patients who may be allergic to sodium oligomannate capsules as judged by the investigator; 2. female participants who are pregnant or lactating; 3. patients who cannot cooperate to complete the follow-up inquiries; 4. any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
impact of a standing program in a child with spina bifida: a case report

Conditions: Spina Bifida With Hydrocephalus

Summary: the purpose of this case study is to investigate a child with mmc who has significant knee and hip flexion contractures to answer the following research questions: 1) is a home standing program effective in reducing hip and knee flexion contractures in a child with mmc? 2) does a home standing program result in a change in the quality of functional movement? a physical therapist, pt, will administer the peds nrs and goniometric measurements prior to the start of the study and at the end of the study. the pt will also provide the parent instruction on the standing home program with weekly check-ins to ensure the parent and child are able to follow the home program. the home standing program will last 8 weeks. the parent will keep a written log of stander use. the peds nrs scores and goniometric measurements will be compared pre and post intervention. the expected outcome is that the peds nrs scores and hip and knee extension range of motion measurements will improve.


Eligibility criteria:
inclusion criteria: * diagnosis of spina bifida * be able to stand with an assistive device exclusion criteria: * a diagnosis unrelated to spina bifida that limits standing * medical restrictions that contraindicate standing
a phase 1 study of continuous intravenous l-citrulline during sickle cell pain crisis or acute chest syndrome

Conditions: Sickle Cell Disease

Summary: sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from sickling of red blood cells, that can lead to pain or organ complications such as acute chest syndrome. sickle cell disease is associated with low amounts of nitric oxide, a compound important for dilating the blood vessel wall. citrulline is a substance that is known to increase nitric oxide. the goal of this phase i study are to find the highest safe dose of continuous iv citrulline that can be given to individuals with sickle cell disease experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side effects.


Eligibility criteria:
inclusion criteria: 1. sickle cell disease genotypes (hbss, hbs/β0-thalassemia, hbs/β+-thalassemia, hbsc) 2. ages 6 to 50 years old 3. patients with sickle cell disease aged 6 to 50 years old presence of sickle cell pain crisis defined by the presence of pain requiring hospitalization and parental opioid therapy 4. presence of acute chest syndrome defined by the presence of a new cxr infiltrate and any one of the following respiratory symptoms of fever, shortness of breath, wheezing, chest pain, cough or new onset hypoxia. exclusion criteria: 1. presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, etc. 2. severe anemia (hemoglobin \< 5g/dl) 3. history of red blood cell transfusion within the last 30 days 4. systemic steroid therapy within the last 48 hours 5. pregnant (as confirmed by a negative urine pregnancy test) or lactating female 6. alanine/aspartate transferase \>2x upper limit of normal laboratory range for age. 7. subject has the following serum creatinine: * age 6 to 13 years \> 0.9 mg/dl * age 14-17 years 1.0 mg/dl * age 18 years \>1.5mg/dl 8. patients with an inability to give consent will be excluded

Keywords: sickle cell disease citrulline
effects of high-intensity interval aerobic training on balance, walking capacity, and quality of life in patients with sub-acute stroke

Conditions: Stroke, Ischemic; Cerebrovascular Accident

Summary: hemiplegia is one of the most common sequelae of stroke. stroke is the leading cause of disability in adults all around the world. stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. after stroke, impairments in adls and functional status, deterioration in health related quality of life can be seen. the purpose of this study is to determine the effect of aerobic exercise training on balance, walking capacity and quality of life in sub-acute stroke.


Eligibility criteria:
inclusion criteria: * 18 to 75 years of age. * ischemic stroke that occurred in the recent 3 months. * who can walk independently or by using assistive device. * have a minimum chedoke mcmaster stroke assessment (cmsa) leg impairment score of 3 but less than 7. exclusion criteria: * patients were excluded from the study if they have a stroke that occurs more than 3 months. * hemorrhagic stroke. * if resting blood pressure more than 160/100 even after taking medications * have by-pass surgery in recent 3 months. * other musculoskeletal problems which restrict the patient's ability to do aerobic activity.

Keywords: cerebrovascular accident treadmill training high-intensity interval training walking capacity.
nanoscope cost analysis study

Conditions: Meniscal Tear

Summary: the study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using nanoscope versus conventional arthroscopy in a traditional operating room (or) setting


Eligibility criteria:
inclusion criteria: 1. subject requires simple partial posterior or mid-body meniscectomy. 2. subject is 18 - 60 years of age. 3. subject body mass index (bmi) is 35 or lower (bmi ≤ 35). 4. subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits. 5. confirmed meniscal injury by physical exam as per standard of care. 6. normal mechanical alignment; \< 5° varus and \< 7° valgus, of the affected knee by clinical assessment or x-rays as per standard of care exclusion criteria: 1. subject requires complex repair or anterior meniscectomy. 2. subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear. 3. current bilateral knee injury. 4. insufficient quantity or quality of bone. 5. blood supply limitations and previous infections which may retard healing. 6. congenital ligamentous hypermobility defined by beighton score 4 or 5. 7. locked knee or haemarthrosis. 8. subjects that are skeletally immature. 9. advanced osteoarthritis; kellgren lawrence ≥ 2 10. fracture of the lower extremities within 6 months prior to screening. 11. previous surgery on the affected knee within 12 months prior to screening. 12. sensitivity to silicone, polyester, nylon, fd\&c blue no. 2 dye and beeswax. 13. other concomitant disease that would interfere with study outcomes. 14. subject is included in a vulnerable population (child, prisoner, etc). 15. conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period. 16. subject is requesting or receiving worker's compensation related to the knee injury. -
the hypoalgesic effect of spinal manual therapy

Conditions: Back Pain

Summary: to study the immediate effect of spinal manual therapy on pain perception in normal subjects

is this effect only local or is it also noticed away from the stimulated area? how long does it last? is there a dose/response phenomenon?

Eligibility criteria:
inclusion criteria: healthy students who volunteer from murdoch university - exclusion criteria: * contraindication to spinal manual therapy
prevention of suicidal behaviour with telemedicine techniques

Conditions: Suicide, Attempted

Summary: this is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt. the hypothesis is that the implementation of this program is associated with reduced rates of suicide reattempts in these patients and also with delayed reattempts in them.

justification: suicide is a global public health concern and is the leading cause of avoidable death in the basque country (spain). the use of telemedicine techniques applied to high risk patients has shown to be useful in the prevention of suicide and suicidal behavior. objectives: to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in patients who recently attempted suicide. design: this is a multicenter, prospective intervention study, non-randomized and with control group. method: a sample of adults discharged from 2 general hospitals after a suicide attempt are enrolled in a telephone follow-up program which is added to their usual treatment (tau). the program consists of 5 short calls made by nurses during 6 months. the calls are intended to: 1) assess the risk of suicide in that moment, 2) improve patient's adherence to treatments, and 3) provide general psychoeducation guidelines. the control group is composed of patients discharged from a third general hospital after a suicide attempt. these receive tau but are not enrolled in the telephone follow-up. evaluation: all patients are followed during 12 months. main outcome measures include the percentage of patients that make a second attempt and the average time to reattempt. patients sign and informed consent.

Eligibility criteria:
inclusion criteria: * adult patients discharged from a general hospital after a suicide attempt and who live in the same health sector as the hospital. * the suicide attempt must have been made within 24 hours prior to the appointment in the emergency service. exclusion criteria: * patient with severe cognitive difficulties and in general any self-injury in which the patient does not understand the meaning or potential consequences of such behavior. * patients in which a regular telephone contact is not possible. * patients in which the psychiatrist who evaluates the case deems inappropriate their inclusion. * patients who remain hospitalized 6 months after the attempt.

Keywords: suicide, attempted prevention telemedicine
gpiag and leicester asthma and dysfunctional breathing (glad) study: a randomised controlled study

Conditions: Asthma; Respiratory

Summary: breathing retraining supervised by a physiotherapist will result in improvements in the quality of life and asthma control of patients treated for asthma in the community with symptoms suggestive of dysfunctional breathing. to investigate the effects of breathing retraining on clinical and physiological parameters of asthma control, to identify the characteristics of patients who benefit, to perform a health economic evaluation.

objectives: * to assess the effect of breathing retraining on asthma-related health status, asthma control and objective indices of asthma severity (bronchial hyper-reactivity (bhr), sputum eosinophilia and nitric oxide production) in patients with symptomatic asthma. * to compare the relationship between symptoms of dysfunctional breathing (nijmegen questionnaire screening score), changes in asthma-related health status and other parameters resulting from breathing retraining * to explore the relationship between dysfunctional breathing, baseline asthma symptoms, treatment and asthma-related quality of life. * to estimate the cost effectiveness of the breathing retraining intervention

Eligibility criteria:
inclusion criteria: * asthma diagnosis in medical records * age 17-70 yrs. * one or more prescription for asthma medication in previous 12 months * impaired asthma related quality of life (aqlq score \<5.5) exclusion criteria: * copd * unstable or under-treated asthma at enrollment.
dia_central:t2d treatment pattern in central europe

Conditions: Diabetes Mellitus, Type 2

Summary: this is a non-interventional study using existing data including medical chart review.


Eligibility criteria:
inclusion criteria: 1. written informed consent prior to participation 2. female and male patients age ≥ 18 years 3. patients with t2d diagnosis 4. patients who have been newly initiated (first ever use) with empagliflozin or other sodium glucose transporter 2 inhibitor (sglt2i), dipeptidyl-peptidase 4 inhibitor (dpp4i) or glucagon-like peptide 1 agonist (glp1a) between september 2018 and december 2018 (study index date 1) 5. patients have been naïve to treatment with empagliflozin or other sodium glucose transporter 2 inhibitor (sglt2i), dipeptidyl-peptidase 4 inhibitor (dpp4i) or glucagon-like peptide 1 agonist (glp1a) at study index date 1 exclusion criteria: 1. patients age \< 18 years 2. patients with diagnosis of other types of diabetes than t2d 3. patients who do not provide written consent to the terms of the study
search for noninvasive markers of "graft injury" in pediatric and adult patients with congenital heart disease undergoing cardiac transplantation

Conditions: Congenital Heart Disease (CHD); Heart Transplant Patients; Adult Congenital Heart Disease; Pediatric Congenital Heart Disease

Summary: this clinical tissue-based, drug-free, single-center, longitudinal study aims to validate a new diagnostic method, namely, to evaluate whether plasma levels of circulating donor free dna in the recipient's blood (dd-cfdna: donor-derived cell free dna), in patients undergoing orthotopic heart transplantation, can be predictive of the presence of acute myocardial rejection with the same sensitivity as immunohistochemical analysis on endomyocardial biopsy specimen, the current gold standard for the diagnosis of acute cell-mediated myocardial rejection, in a population consisting of pediatric patients and adult patients with congenital heart disease undergoing orthotopic heart transplantation.

to achieve the study objective, approximately 20 patients of all ages, both pediatric and adult with congenital heart disease and undergoing orthotopic heart transplantation, followed at our center will be enrolled. whenever a patient enrolled in the study undergoes endomyocardial biopsy, either as part of surveillance of acute myocardial rejection or for clinical suspicion of rejection, concomitantly a blood sample will be taken and analyzed for the presence of dd-cfdna. in patients with biopsy evidence of acute rejection, a new dd-cfdna sampling will be performed approximately three months after treatment at the next clinical follow-up. the data collected for each patient will be both baseline anthropometric data and imaging and laboratory variables collected in the normal follow-up provided by clinical practice, as well as data related to the endomyocardial biopsy result and those related to blood sampling for donor dna.

Eligibility criteria:
inclusion criteria: * adult patients with congenital heart disease undergoing cardiac transplantation at our center or other centers, followed in follow-up at our center (unit of pediatric cardiology and developmental age, irccs azienda ospedaliero-universitaria di bologna) * pediatric patients undergoing cardiac transplantation at our center or other centers but followed in follow-up at our center * obtaining informed consent from the adult patient or parent/guardian in case of minor exclusion criteria: * failure to obtain informed consent from the adult patient or parent/guardian in case of minor