Kornimate/medical-research-clean huggingface dataset:
inspiratory muscle training in patients with end-stage renal disease

Conditions: Kidney Disease

Summary: background: patients with chronic kidney disease on hemodialysis may have reduced diffusion capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy. the inspiratory muscle training (imt) appears as an instrument to improve the inspiratory muscle strength, with positive effects on functional capacity and quality of life of kidney patients, however, the effects of imt were not addressed in the specific variables of the respiratory system and to date there are no studies on the use of daily training in this population. objective: to evaluate the effectiveness of daily inspiratory muscle training on respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage renal disease patients. methods: a randomized controlled clinical trial to be developed in cardiopulmonary physical therapy laboratory of the universidade federal de pernambuco (ufpe) during the period from november 2015 to december 2016. the sample is composed of 24 individuals aged 18 and 65, having ckd, to perform hemodialysis for at least twelve months and provide inspiratory muscle weakness. patients will be divided into two groups, the training group will be imt with power-breathe®, load of 50% of mip, duration of three sets of 30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham group will be subjected to the same procedure (duration and frequency), but without load. participants will be assessed before and after intervention through a global assessment form, questionnaire kidney disease quality of life instrument short form - kdqol-sf, diaphragmatic ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.


Eligibility criteria:
inclusion criteria: * have a chronic kidney disease * hemodialysis for a minimum period of twelve months * inspiratory muscle weakness, with mip \<80cmh2o for men and \<60cmh2o for women exclusion criteria: * neurological deficit * chronic lung disease * severe heart disease (unstable angina and acute myocardial infarction) * decompensated diabetes * infectious disease
vitrification for ovarian tissue harvesting

Conditions: Ovary; Anomaly

Summary: increasing interest has emerged concerning ovarian tissue cryopreservation and subsequent transplantation as a potential way of preserving fertility in cancer patients as well as for women who just wish to delay childbearing. as the majority of existing protocols use the slow freezing method, this study aims to test vitrification techniques of ovarian cortex.


Eligibility criteria:
inclusion criteria: * female-to-male transsexuals * gender completing operation * signed informed consent form * willingness to donate ovarian tissue for research purposes * age \>=18 years exclusion criteria: * malignant disease * age under 18 years * refusal to donate ovarian tissue
cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement

Conditions: Aortic Stenosis

Summary: to prove the non-inferiority of tavr-cmr compared to tavr-ct to guide tavr according to clinical efficacy, defined as implantation success based on the varc-2 criteria.

study title: cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement (tavr-cmr). coordinating prinicpal investigator: prof. bernhard metzler, university clinic of internal medicine iii, cardiology and angiology, innsbruck medical university. planned study period: 2017-2023. objective: to investigate, for the first time, the non-inferiority of tavr-cmr to contrast-enhanced computed tomography (tavr-ct) regarding efficacy and safety end-points. design: prospective, randomized, open-label, multi-centre trial. patients (planned): 270 patients. diagnosis / inclusion criteria: symptomatic severe aortic stenosis scheduled for tavr based on a local heart-team decision. methods: patients will be randomized in a 1:1 fashion to receive a predefined tavr-cmr protocol or to receive a standard tavr-ct protocol within two weeks after inclusion. main outcome measure: follow-up will be performed at hospital discharge after tavr and after 6 months. the primary efficacy outcome is device implantation success at discharge. the secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 6 months, as well as a comparison of imaging procedure related variables (see section 5.11.2). endpoint definitions are based on the updated 2012 varc-2 consensus document.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1) 3. typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope 4. patient is evaluated for tavr exclusion criteria: 1. contraindications to perform cmr 2. contraindications to perform ct 3. contraindications for tavr or reduced life expectancy \< 1 year. 4. known hypersensitivity to cmr or ct contrast agents 5. childbearing potential or inability to exclude pregnancy 6. inability to understand and follow study-related instructions 7. severe renal insufficiency requiring renal replacement therapy 8. severe hepatic insufficiency (child-pugh class b or c) 9. post organ transplantation 10. participation in another clinical study
evaluation of humira retention rate in psoriasis patients in daily practice and assessment of work productivity and quality of life

Conditions: Psoriasis

Summary: this observational study will document to what extent in daily clinical practice humira (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up period of 2 years. reasons for interrupting or permanently discontinuing humira therapy and reasons for restarting humira therapy will be noted. an evaluation will be performed of the effect of the disease on quality of life and work productivity.


Eligibility criteria:
inclusion criteria: * patients \> or = 18 years * patient with chronic plaque psoriasis * patient newly initiated on humira * patient compliant with humira summary of product characteristics * patient compliant with belgian reimbursement criteria of humira in plaque psoriasis * patient has signed informed consent exclusion criteria: * patients having any of the contraindications mentioned in the summary of product characteristics humira * patients not willing to sign informed consent

Keywords: multicenter study
study to examine safety, tolerability, and effect on body weight of metreleptin administered in conjunction with pramlintide in obese and overweight subjects

Conditions: Overweight; Obesity

Summary: a randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (sc) injection in obese and overweight subjects.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old. * is obese (body mass index \[bmi\]\>=30kg/m\^2 and \ =27kg/m\^2 and \<30kg/m\^2. * has stable body weight, i.e., not varying by \>3% within 3 months prior to study. * has not been treated over the past 3 months or is currently treated with any of the following medications: oral contraceptives (female subjects); hormone replacement therapy (female subjects); metformin for the treatment of polycystic ovary syndrome (female subjects); antihypertensive agents; lipid-lowering agents; thyroid replacement therapy; selective serotonin reuptake inhibitors (ssris). * is comfortable with having repeated telephone contacts with a lifestyle counselor during the study. * is a nonsmoker (has not smoked for at least 6 months prior to the study). exclusion criteria: * has a medical history (e.g., morbid childhood obesity) and/or physical characteristics suggestive of genetic obesity or syndromatic obesity (e.g., prader-willi syndrome, bardet-biedl syndrome). * is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion) * has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility, \*antidiabetic medications. * has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (symlin®). * has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting. * has had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study. * has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.

Keywords: overweight obesity pramlintide metreleptin amylin
rotigotine patch in subjects with advanced stage, idiopathic parkinson's disease who are not well controlled on levodopa

Conditions: Parkinson Disease, Idiopathic

Summary: male and female patients aged ≥ 30 years with advanced stage idiopathic parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in europe, israel, south africa, australia and new zealand. the purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (spm 962) at an individual patient's optimal dose for a period of 4 months each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months. the study clinic visits will include a medical history and physical exam, ecg, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their parkinson's symptoms. patients who complete the study may enroll in an extension trial and receive active study drug.


Eligibility criteria:
inclusion criteria: * advanced stage idiopathic parkinson's disease exclusion criteria: * well controlled on levodopa

Keywords: advanced stage idiopathic parkinson's disease
effectiveness of aurix therapy in venous leg ulcers

Conditions: Venous Leg Ulcers

Summary: the aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (vlu)n will be treated using aurix and compared to patients receiving undefined usual and customary care (ucc)

recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. while treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. aurix is a platelet-rich plasma (prp) gel used in the treatment of non-healing chronic wounds. the aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, randomized trial in which venous leg ulcers will be treated using aurix and standard of care and compared 1:1 to patients receiving undefined usual and customary care (ucc).

Eligibility criteria:
inclusion criteria: 1. medicare eligible 2. ≥18 years of age 3. proven venous disease 4. the largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) that is located between and including the knee and the ankle 5. for subjects with potentially multiple eligible vlus, the largest ulcer will be selected as index ulcer for study. there must be at least 4 cm between the index ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure) 6. debrided ulcer size between 2 cm2 and 200 cm2 7. subject has received ucc care for ≥ 2 weeks at treating wound clinic 8. demonstrated adequate compression regimen 9. duration ≥ 1 month at first visit 10. subject must be willing to comply with the protocol, which will be assessed by enrolling clinician exclusion criteria: 1. subjects known to be sensitive to aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin 2. presence of another wound that is concurrently treated and might interfere with treatment of index wound by aurix 3. ulcer not of vlu pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) 4. patients on chemotherapeutic agents or any malignancy in the wound area 5. subjects who are cognitively impaired 6. serum albumin of less than 2.5 g/dl 7. plasma platelet count of less than 100 x 109/l 8. hemoglobin of less than 10.5 g/dl 9. subject has inadequate venous access for repeated blood draw required for aurix administration.

Keywords: non healing wound
designing a mobile app for veterans with substance use problems

Conditions: Substance Abuse Problem; Alcohol Abuse; Alcohol Dependence

Summary: the purpose of this study is to increase access for rural veterans to evidence-based, person-centered, individually tailored treatment for alcohol use problems. the primary aim is to evaluate the acceptability and feasibility of using mobile technology deliver treatment for alcohol use disorder. a mobile application will be used replacing the usual setting of clinical visits that accompanies standard face-to-face cbt therapy. the application will be loaded onto an ipod, which will be distributed to each participant that has been found to be eligible to participate.

many veterans returning from iraq and afghanistan experience problems with drinking. there are treatments for alcohol use disorders that can be very helpful, but sometimes it can be hard for veterans to find or participate in the treatments. this can be because of the amount of time the treatments take and the long distance to places where substance abuse treatments are offered. for veterans who live in rural areas, these types of issues can pose even bigger problems. to address these issues, new types of treatments and ways of delivering care are being studied. we have developed a mobile application that will be accessed through the use of a mobile device such as an ipod. the application will contain an application dedicated to the treatment of substance abuse disorders. this application will provide the coping skills and educational information to aide in helping with problems associated with drinking alcohol.

Eligibility criteria:
inclusion criteria: 1. veteran of the armed forces 2. are part of the primary care - mental health (pc-mh) 3. reside in a rural community, as defined by the us census bureau 4. score greater than or equal to 8 on the alcohol use disorder identification test (audit) 5. meet diagnostic criteria for alcohol abuse or dependence as assessed by the mini international neuropsychiatric inventory (mini) according to the diagnostic and statistical manual (dsm-iv) 6. age 18 and older to participate. - exclusion criteria: 1. have conditions that threaten your safety (e.g., active suicidal intent, current uncontrolled psychosis or bipolar disorders in the past month as assessed by the mini). 2. veterans with a diagnosed concurrent substance dependence (other than nicotine) and more than mild risk of alcohol withdrawal based on a score of greater than 8 on the clinical institute withdrawal assessment of alcohol (ciwa-ar) will be excluded. -

Keywords: alcohol alcohol abuse alcohol dependence veterans
markers of vascular aging and coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". they often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, ptmd) that can accumulate in tissues and be responsible for deleterious effects. the specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated. this project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that ptmd could therefore constitute relevant biomarkers in this specific clinical situation. to explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. the concentrations of ptmd assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed. this should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.


Eligibility criteria:
inclusion criteria: * acute coronary heart syndrome * included during hospitalization, usual cardiologic follow-up planned in reims university hospital exclusion criteria: * \<18yo
telehealth-education-based program for military caregivers of injured service members with head injuries

Conditions: Traumatic Brain Injuries

Summary: the primary purpose of this research is to evaluate the impact of a telehealth-based, cognitive behavioral therapy (cbt) intervention (problem-solving training: pst) for adult informal military family/friend caregivers of oif/oef service members with a deployment-related tbi.

traumatic brain injury (tbi) has gained increasing attention in american society as it is now considered the "signature injury" of the operation iraqi freedom/operation enduring freedom (oif/oef) campaigns. the chronic changes that often occur in the wake of tbi along with possible physical injuries may run a chronic, unremitting course, imposing great strain and distress upon family members who often assume a caregiver role with little preparation and no formal training for these wounded service members as they reintegrate back into civilian life post-deployment. unfortunately, research has not adequately addressed the unique long-term needs of informal military caregivers of deployed service members with tbi (i.e., family members/close friends).

Eligibility criteria:
inclusion criteria: * age ≥ 19 years old * meets study project definition of a military caregiver * documentation or determination of an oif/oef deployment related tbi * service member will have presented to a veterans administration medical center (vamc) or military medical center * english-speaking * has access to a telephone for the administration of measures and/or intervention calls * has no significant cognitive or communication problems that might significantly interfere with adequately understanding information or talking on the telephone which will be determined by the clinical judgment of the person consenting the participant. exclusion criteria: * has a life-threatening or other serious disease that impacts the ability to participate for the duration of the project * no determination or documentation of a deployment-related tbi related to oif/oef for the injured service member * has a severe hearing impairment that impedes communication and standardized implementation of the intervention and telephone follow-up * formal caregiver * caregiver does not want to participate
covid-19 risk stratification

Conditions: Coronavirus; Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Summary: the investigators seek to derive and validate a clinically useful risk score for patients with coronavirus disease 2019 to aide clinicians in the safe discharge of patients.

the investigators a-priori plan the following analysis: 1. derivation and retrospective validation. * select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 beginning march 1, 2020 until approximately 1000 patients are included. * use 75% of this cohort to develop a simple risk-score that prognosticates a patient's suitability for discharge (no supplemental oxygen, no intensive care unit, and no death). use multivariable logistic regression with forward selection informed by clinical judgement to choose variables a priori that emphasizes readily available data and easy calculation for use at the point of care. * use 25% of this cohort to retrospectively validate the risk-score. 2. prospective validation. * select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 as soon as the derivation cohort in step 1 is assembled. include approximately 250 patients. * use this sample to prospectively validate the risk-score developed in part 1.

Eligibility criteria:
inclusion criteria: * positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 * age 18 and older exclusion criteria: * none
the effects of a water based exercise programme and a land based exercise programme on women experiencing pregnancy related pelvic girdle pain

Conditions: Pregnancy Related; Pelvic Girdle Pain

Summary: this study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with pelvic girdle pain (pgp) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.

this study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with pelvic girdle pain (pgp) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme. twenty-three participants with diagnosed pgp, recruited at st george's hospital london, were randomised into two groups (water or land exercise). each group received, four, once-weekly exercise sessions on land or water. exercise effects on pgp were measured using a variety of outcome measures. outcomes were assessed at baseline and post four weeks exercise.

Eligibility criteria:
inclusion criteria: participants were over eighteen years old, over twelve weeks pregnant and able to speak english. exclusion criteria: participants were excluded from the study if they had uncontrolled blood pressure, placenta praevia, pre-eclampsia, obstetric cholestatsis, uncontrolled asthma, unstable respiratory or cardiac conditions, had open skin wounds or mrsa

Keywords: pregnancy pelvic girdle pain hydrotherapy quality of life physical therapy