Kornimate/medical-research-clean huggingface dataset:
a study to evaluate breathing muscle training in cardiac rehab

Conditions: Healthy; Heart Failure

Summary: the purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.


Eligibility criteria:
inclusion criteria - heart failure group: * adult 18 years and older. * english speaking. * has a qualifying heart failure indication for center-based cardiac rehabilitation. inclusion criteria - healthy control group: * adult 18 years and older. * english speaking. * absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. controls will be matched for age and sex. exclusion criteria: * hf patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program. * participants unable/unwilling to provide informed consent. * uremia, history of allergy to iodides. impaired renal function. * creatinine value greater than 1.3 mg/dl (via clinical record within the past 6 months). * diagnosis of liver disease.
alzheimer's in long-term care--treatment for agitation

Conditions: Alzheimer Disease; Psychomotor Agitation

Summary: the purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with alzheimer's disease (ad) and other types of dementia in late life.

although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in alzheimer's disease. because of the success prazosin has had in the treatment of posttraumatic stress disorder, it is thought that it could be used similarly with disruptive agitation. originally designed to evaluate alzheimer's disease patients in nursing homes, the study now includes outpatients. it is a 9-week placebo-controlled trial.

Eligibility criteria:
inclusion criteria: * no age limit * probable/possible alzheimer's disease diagnosis * disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing) * no hypotension * no concurrent use of alpha-1-blockers * no delirium, schizophrenia, mania, psychotic symptoms. exclusion criteria: * cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (av) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension * other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition * exclusionary medications: current treatment with prazosin, other alpha-1-blockers * current enrollment in a separate investigational drug trial * psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. although not formally rated, this improvement is equivalent to a clinical global impression of change (cgic) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient). * psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.

Keywords: double-blind treatment prazosin
phase 2a study of vtx3232 in parkinson's disease

Conditions: Idiopathic Parkinson Disease

Summary: this is a study to understand if taking vtx3232 is safe in participants diagnosed with early stage idiopathic parkinson's disease (pd). approximately 10 patients will take vtx3232 dose a. the study consists of a 30-day screening period (to see if a participant qualifies for the study), a 7-day pre-baseline period, a 28-day open label treatment period (a participant receives active dose a), and a 14-day follow-up period.


Eligibility criteria:
inclusion criteria: * participants must be ≥ 40 years up to 80 years of age, inclusive, at the time of signing the informed consent, with bmi \> 18.5 and \< 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. * diagnosis of idiopathic parkinson's disease between 0 and 60 months prior to screening. * score of 2 or less on movement disorder society-unified parkinson's disease rating scale (mds-updrs) part iv at screening. * have not received prior treatment with deep brain stimulation (dbs). * if receiving treatment with symptomatic pd therapies, treatment must be stable. note: the medical monitor should be contacted with any questions regarding concomitant therapies. * a female participant is eligible if they are of nonchildbearing potential * a male participant sexually active with a woman of child bearing potential is eligible if they agree to use contraception/barrier and refrain from donating sperm during the study and for at least 90 days after the last dose exclusion criteria: * diagnosis of a parkinsonian syndrome other than idiopathic parkinson's disease. * a diagnosis of a significant central nervous system (cns) disease other than parkinson's disease; history of repeated head injury or traumatic brain injury; history of epilepsy or seizure disorder other than febrile seizures as a child. * history of brain surgery.

Keywords: vtx3232 idiopathic parkinson's disease nlrp3 inhibitor zomagen
relation of functional ındependence to balance, exercise capacity, and peripheral muscle strength

Conditions: Functional Independence; Balance; Distorted; Exercise Capacity; Peripheral Muscle Strength

Summary: stroke is one of the leading causes of death worldwide and is among the most important diseases that cause long-term disability in adults. in high-income countries, the incidence of stroke has decreased significantly with increased use of preventive therapies and control of risk factors. stroke has a significant impact on individuals' independence and productivity. walking capacity is limited due to motor control, balance, and muscle strength disorders after stroke. in addition, it was determined that the functional exercise capacity of stroke patients decreased when compared to healthy individuals of the same age. the quantitative decrease in muscle mass due to physical inactivity is accompanied by sarcopenia, which worsens the situation. although the primary impairments affecting gait are muscle strength weakness and loss of coordination, impaired cardiorespiratory fitness can also affect walking performance by limiting endurance. depending on the change in each parameter after stroke, the functional independence and daily living activities of individuals are affected. a correlation was found between balance and functional mobility and the level of functional independence in stroke patients. it has been found that having a good balance function after stroke significantly increases the likelihood of being functionally independent. when the studies in the literature were examined, no study was found that directly showed the relationship between functional exercise capacity and muscle strength in stroke patients. therefore, in our study, we aimed to investigate the relationship between balance, functional exercise capacity, peripheral muscle strength, and functional independence level in stroke patients.


Eligibility criteria:
inclusion criteria: * having had a stroke for the first time at least 6 months ago * being 40 years or older * having a mini-mental test result of more than 24 points * the lower extremity score for brunnstrom is 5-7 * being 3 and above according to the functional ambulation scale * willingness and willingness to work * being able to speak and understand turkish exclusion criteria: * having a different neurological, orthopedic, and rheumatological disease * having a visual or hearing impairment * having uncontrollable cardiopulmonary and unstable chronic diseases * having had a transient ischemic attack or multiple strokes * lack of independent sitting and standing balance
safety and preliminary effectiveness of the barosense articulating circular endoscopic (ace) stapler for plication of dilated post-surgical gastric anatomy

Conditions: Obese

Summary: the barosense articulating circular endoscopic (ace) stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. this study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated roux-en-y gastric bypass (rygb) pouch. the primary objective of this study is to perform an evaluation of the safety of the ace stapler for the treatment of dilated post-surgical gastric anatomy. the secondary objective of this study is to evaluate the preliminary efficacy of the ace stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.


Eligibility criteria:
inclusion criteria: 1. subject, male or female, is age 18 to 60 years of age. 2. subject must be able to understand and be willing to sign an informed consent document. 3. subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. this includes availability of reliable transportation and sufficient time to attend all follow-up visits. 4. subject must be \> 2 years post rygb surgery. 5. subject must have documented records indicating an initial achievement of \> 60% ewl (based on an ideal weight of 25 bmi) at some point after rygb surgery. 6. subject has a bmi at baseline of \> 30 and \< 50. 7. at time of enrollment, subject must have regained at least 35% of the maximum weight lost following rygb, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss. 8. subject must have a stoma diameter of at least 18 mm. 9. subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair. exclusion criteria: 1. subject has a severe eating disorder. 2. investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy. 3. subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments). 4. subject had irreversible or life threatening complications following initial rygb procedure (cardio or respiratory). 5. subject has an ongoing severe complication from their initial rygb procedure (recurrent ventral hernia, pain syndrome, etc.). 6. subject has an intragastric fistula, anastomotic leak, or staple/suture line disruption. 7. subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease. 8. subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. 9. subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (copd), pneumonia or cancer.

Keywords: prior rygb procedure regained weight over time dilated pouch and/or stoma
study to assess efficacy and safety of oglemilast in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will assess the safety and efficacy of a range of oglemilast doses. the study will be 14 weeks in duration. all patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.


Eligibility criteria:
inclusion criteria: * presence of copd as defined by gold criteria (2006); post-bronchodilator fev1/fvc \ 30% and \< 80% predicted * current or former cigarette smoker exclusion criteria: * long-term oxygen use of \> 15 hours a day * symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms) * any copd exacerbations within 30 days prior to study entry or during run-in * history of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months * presence of clinical significant pulmonary disease other than copd

Keywords: airflow obstruction, chronic chronic airflow obstruction chronic obstructive pulmonary disease chronic obstructive airway disease chronic obstructive lung disease copd coad
comparison of the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation: a double-blind, randomized, noninferiority clinical trial

Conditions: Post Operative Sore Throat

Summary: the purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.


Eligibility criteria:
inclusion criteria: * asa i-ii patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation exclusion criteria: * preexisting hoarseness or sore throat, upper respiratory tract infection * steroid therapy or immunocompromised patients * chronic treatment with calcium channel blocker or magnesium * allergy to magnesium sulphate * cormack-lehane grade 3,4 or patients who are expected to difficult intubation * fail to tracheal intubation at first trial * reduced kidney function * diabetes mellitus

Keywords: magnesium, post operative sore throat, prone position, tracheal intubation
definition, quantification, and utility of biomarkers of repetitive brain injury in predicting concussion and other long-term injury risks in patients with atrial fibrillation (concussion af)

Conditions: Cognitive Change

Summary: this is a prospective clinical study designed to evaluate biomarkers of brain injury and dementia incidence and moderate cognitive decline rates in moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management.

a written informed consent will be obtained from atrial fibrillation patients seen at intermountain medical center who meet the study eligibility criteria. following the baseline visit for obtaining informed consent and conduct of baseline procedures, subjects will be required to return to clinic at 6, 12, 18 and 24 months after enrollment. cognitive testing will be performed at baseline and repeated at 24 months. as much as possible, the study follow-up visits will be scheduled at the same time as the patients' regular visits for clinical care. six questionnaires will be administered at the baseline visit and repeated at the 24-month visit. at the time of cognitive assessment, the following will be completed, if not already performed as part of usual standard of care: complete blood count, protime/inr, basic metabolic profile, review of cardiac medications, and review of adverse events and hospitalizations. additional serum tests will be performed on all subjects at enrollment and at the 24-month visit. biomarkers will be drawn at specific intervals (baseline, 6, 12, 18, and 24 months) then on an as needed basis (within 7 days) when treatments for atrial fibrillation that may increase brain injury risk occur.

Eligibility criteria:
inclusion criteria: 1. male or female 65 to ≤ 95 years of age 2. ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures 3. af documented by electrocardiogram, ambulatory event monitor, telemetry, or medical records within 12 months of enrollment 4. ability to complete a mini-mental status evaluation 5. ability to independently comprehend and complete a quality of life and dementia questionnaires 6. willing and able to comply with the follow-up visits, tests, and schedule of evaluations exclusion criteria: 1. have a history of any form of dementia 2. have a life expectancy less than 24 months 3. participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study 4. other conditions that in the opinion of the principal investigator and/or sub-investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial 5. the principal investigator and/or sub-investigator(s) determine(s) that the subject is not eligible for participation in this research study
efficacy and safety of dapagliflozin, added to therapy of patients with type 2 diabetes with inadequate glycemic control on insulin

Conditions: Type 2 Diabetes

Summary: this study is being carried out to see if dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin


Eligibility criteria:
inclusion criteria: * type 2 diabetes * patients with hba1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 iu of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs exclusion criteria: * type 1 diabetes * treatment with more than two additional oral antidiabetic drugs * moderate and severe renal (kidney) failure or dysfunction

Keywords: dapagliflozin efficacy safety add on to insulin oral antidiabetic type 2 diabetes
out-patient wake therapy, light therapy and sleep phase advance for depression

Conditions: Unipolar Depression

Summary: depressed patients miss a night of sleep (wake night), then sleep at predetermined times ending at their desired sleep time. beginning the morning following their wake night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.

nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the morningness-eveningness questionnaire (measuring "morningness" and "eveningness") and determine the time patients want to sleep. patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. beginning the morning following their wake night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. in additional, daily telephone check ins occur during the first week following the wake night both to be sure the patient is following the protocol and to obtain symptom ratings. saliva to be measured for melatonin is collected prior to and following sleep adjustment.

Eligibility criteria:
inclusion criteria: * major depressive disorder or persistent depressive disorder or unspecified depressive disorder * physically healthy * patients over age 60 need primary care physician's approval, electrocardiogram and mini mental status examination exclusion criteria: * medically unstable condition * bipolar disorder * current (past six months) substance use disorder * significant suicide risk * need for hospitalization * history of psychosis

Keywords: depression melatonin light therapy wake therapy chronobiology
copper concentration & histopathologic changes in liver biopsy in participants with wilson disease treated with alxn1840

Conditions: Wilson Disease

Summary: the main objective of the study is to evaluate the change in liver copper (cu) concentration following 48 weeks of treatment with alxn1840 in adult participants with wilson disease (wd) who have been previously treated for at least 1 year with standard of care (that is, trientine, penicillamine, or zinc). in the treatment period, efficacy and safety of alxn1840 will be assessed at week 48.

participants who complete the 48-week treatment period will be offered the opportunity to continue their treatment in a 48-week extension period that will offer additional time for evaluation of long-term efficacy and safety of alxn1840. there will be no liver biopsies during the extension period.

Eligibility criteria:
inclusion criteria: 1. diagnosis of wd by leipzig criteria ≥ 4 or by historical test results. 2. continuous treatment for wd with penicillamine, trientine or zinc for at least 1 year prior to screening. 3. body mass index \< 30 kilograms/meter squared. 4. able to cooperate with a percutaneous liver biopsy. 5. willing and able to follow protocol-specified contraception requirements. 6. capable of giving signed informed consent. exclusion criteria: 1. decompensated cirrhosis or model for end stage liver disease score \> 13. 2. modified nazer score \> 7. 3. clinically significant gastrointestinal bleed within past 3 months. 4. alanine aminotransferase \> 2 × upper limit of normal. 5. history of bleeding abnormality or known coagulopathy, including platelet count \< 100,000, and international normalized ratio for prothrombin time ≥ 1.5. 6. participant unwilling to accept blood products, if required. 7. marked neurological disease requiring either nasogastric feeding tube or intensive inpatient medical care. 8. hemoglobin less than lower limit of the reference range for age and sex. 9. participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease 5) or creatinine clearance \< 30 milliliters/minute. 10. lymphoma, leukemia, or any malignancy within the past 5 years. 11. current or chronic history of liver disease not associated with wd.

Keywords: copper alxn1840 histology liver biopsy
efficacy and safety of gsp 301 nasal spray in children (aged 6 to under 12 years) with seasonal allergic rhinitis (sar)

Conditions: Seasonal Allergic Rhinitis (SAR)

Summary: study to evaluate the efficacy, safety and tolerability of gsp 301 nasal spray (ns) compared with placebo ns in pediatric subjects (aged 6 to under 12 years) with seasonal allergic rhinitis (sar).


Eligibility criteria:
inclusion criteria: 1. male and female subjects aged ≥6 to \<12 years 2. clinical history of sar (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen) 3. demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening 4. a 12-hour rtnss value ≥6 out of a possible 12 for the morning assessment at screening 5. signed informed consent/assent form (subject and parent/caregiver/legal guardian) exclusion criteria: 1. females of childbearing potential or pregnant 2. plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period. 3. history of anaphylaxis and/or other severe local reaction(s) to skin testing 4. history and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip 5. subjects with an active pulmonary disorder or infection. 6. subjects with posterior subcapsular cataracts or glaucoma

Keywords: gsp 301 nasal spray for the treatment of seasonal allergic rhinitis