Kornimate/medical-research-clean huggingface dataset:
attain starfix® 4195 lead extraction study

Conditions: Heart Failure; Indications for Lead Removal

Summary: the purpose of this study is to characterize the removability of the attain starfix® model 4195 left ventricular (lv) lead (starfix®). the goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. this study is required by the food and drug administration (fda) as a condition of approval for the attain starfix® model 4195 lv lead.


Eligibility criteria:
inclusion criteria: * subjects with a class i/ii indication and/or physician discretion for left ventricular lead removal * medtronic model 4195 lv lead implanted for at least 181 days at time of extraction, or other medtronic lv lead (non-model 4195) implanted for at least 181 days at time of extraction, or medtronic model 4195 lv lead implanted for 90-180 days * intention to remove the lv lead prior to the extraction procedure * subject is 18 years of age or older * subject (or subject's legally authorized representative) has signed and dated the patient consent form and is willing and able to comply with the protocol exclusion criteria: * none

Keywords: extraction removal lead heart failure
continuous positive airway pressure and oral appliances treatments in mild obstructive sleep apnea

Conditions: Mild Obstructive Sleep Apnea Syndrome

Summary: treatment response of mild obstructive sleep apnea (osa) to continuous positive airway pressure (cpap) therapy and oral appliance (oa) is still controversial. the aim of this study is to evaluate the effect of cpap and oa treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild osa subjects. subjects with mild osa (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35kg/m2 and age between 18 to 65 years will be included. they also must have a minimum mandibular protrusion of 7mm. subjects will be randomly distributed in three groups: group 1 with cpap, group 2 with oa and group 3 will be the control. at baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with cpap for groups 1), epworth sleepiness scale, karolinska sleepiness scale, stanford sleepiness scale, maintenance of wakefulness test, chalder fatigue scale, neurocognitive testing, beck inventories of anxiety and depression, functional outcomes of sleep questionnaire (fosq), whoqol-bref quality of life questionnaire, short form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. sleep hygiene care was offer to three groups. analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.


Eligibility criteria:
inclusion criteria: * both genders; * body mass index lower than 35kg/m2; * age between 18 and 65 years old; * polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm. exclusion criteria: * unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content); * temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp); * excessive use of alcohol and psychoactive drugs; * clinical, neurological or psychiatric decompensated diseases; * others sleep diseases and previous obstructive sleep apnea treatment.

Keywords: continuous positive airway pressure oral appliance mild obstructive sleep apnea syndrome
pharmacogenomics in stroke: feasibility of cyp2c19 testing

Conditions: Stroke; Transient Ischemic Attack (TIA)

Summary: the purpose of this research study is to explore whether genetic testing can offer a personalized and timely approach to assist physicians in making more informed medication decisions for stroke or high-risk transient ischemic attack (tia) patients during their hospital stay.

this is a pilot clinical trial for feasibility

Eligibility criteria:
inclusion criteria: * patients 18-89 years of age * admitted to university of alabama at birmingham (uab) main hospital with symptoms or signs of minor ischemic stroke, or high risk tia * eligible to receive dual antiplatelet load (presented to the hospital within 66 hours of last known well) exclusion criteria: * diagnosis of atrial fibrillation, valvular heart disease, index stroke due to known hypercoagulability (subset of other determined etiology) or large vessel disease (culprit vessel stenosis of ≥50%) * prescribed anticoagulation prior to stroke * treated with intravenous thrombolysis * treated with mechanical thrombectomy * missing nih stroke scale score

Keywords: personalized medicine cyp2c19 minor stroke transient ischemic attack tia
testing of a new scale measuring medical outcomes of dysphagia (mod) in adult patients with swallowing disorders

Conditions: Dysphagia

Summary: swallowing disorders (dysphagia) are common in adult patients. there is emerging evidence that dysphagia itself can cause adverse medical outcomes. there is a three-fold increased risk for pneumonia in these patients versus similar patients without dysphagia. patients with dysphagia also suffer poor nutrition and dehydration. patients can become so malnourished that it slows their recovery. dysphagia can cause choking when food or liquid enters the lungs. over time, this will cause pneumonia and even death. more acutely, patients fear that their choking will cause them to suffocate and die. over time, patients are embarrassed to be seen choking and thus feel forced to dine alone. these patients report feelings of isolation and depression. to date, there are no practical methods to assess these adverse outcomes of swallowing difficulties in patients. this research will be the first to address this gap. specifically, as part of previous research (phd dissertation by rm, the pi) a new measure of medical outcomes of dysphagia was developed, titled the medical outcomes of dysphagia (mod) scale. the mod consists of 3 subscales that each measure lung, nutrition-hydration or psychological consequences in patients with swallowing difficulties. unlike more expensive and complex tests, the mod has been designed for both in- and outpatients. this research will validate each mod subscale to ensure retention of only items that are reliable and valid for use with patients who have dysphagia due to any disease etiology. the final mod subscales will be the first to allow clinicians to track medical complications in their patients and to ensure that treatment is effective. globally, the mod subscales will direct limited health care resources to the most effective treatments for swallowing disorders.


Eligibility criteria:
inclusion criteria: * adult (18+ years) * any disease etiology, including but not limited to: previous or current diagnosis of head and neck cancer (treatment may include surgery, radiation or chemotherapy, or a combination of more than one), stroke, cervical spine abnormality, brain tumour, cardiovascular surgery, and parkinson's disease * current diagnosis of dysphagia, as determined by a speech language pathologist * english-speaking exclusion criteria: * no dysphagia * cognitive impairment * limited fluency in english
clarix™ 100 & clarix cord 1k for discectomy patients

Conditions: Protruded Disk

Summary: the purpose of the study is to evaluate the efficacy of clarix™ 100 and clarix™ cord 1k as a tissue barrier when used as an annular patch in discectomy patients with low back \& leg pain when compared to traditional discectomy patient outcomes. this will be a 120 patient, prospective randomized study model over a 5 year post-operative period.


Eligibility criteria:
inclusion criteria: * patients between 18 and 90 years of age * patient is able to understand the aims and objectives of the trial and the trial procedures * patient is willing to give written informed consent to the trial * patient is able to follow up with regularly scheduled visits with and phone calls from dr. anderson and his research staff * diagnosed with lumbar protruding disc * suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options exclusion criteria: * participation in clinical trial involving therapy for back pain within 30 days of screening * prior back surgery at the same level * inability to walk independently (adaptive devices such as walkers or canes are allowed) * relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company * receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit * pregnancy or planning to become pregnant during study period * body mass index \>50 * patients with chronic diseases such as crohn's disease, severe renal failure (serum creatinine 2.5 mg/dl or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema * severe anemia, hemoglobin \<8.5 mg/dl * active, local or systemic malignancy such as lung cancer or leukemia * severe hypertension (systolic blood pressure greater than or equal to 200 mmhg or diastolic blood pressure greater than or equal to 100 mmhg) * severe hypoxia, with chronic oxygen or ventilation therapy * history of collagen vascular disease or sickle cell anemia * active rheumatoid arthritis * systemic antibiotic therapy for any indication within 10 days of screening

Keywords: discectomy lumbar discectomy protruding disc
effect of mavacamten treatment on coronary flow reserve in ohcm

Conditions: Obstructive Hypertrophic Cardiomyopathy

Summary: the goal of this observational study is to measure the effect of mavacamten treatment on blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic cardiomyopathy. the main question it aims to answer is: • does mavacamten treatment improve blood flow in the heart muscle? participants will take mavacamten at the direction of their treating physician. participants will complete 2 myocardial positron emission tomography and computed tomography (pet-ct) scans. the first scan will be completed before participants start taking mavacamten. the scan will be repeated after 12 months of mavacamten treatment.

this is a single-arm, before-and-after investigation of the effect of mavacamten therapy on myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of care for ohcm. we hypothesize that 12 months of mavacamten therapy will improve myocardial blood flows as assessed by pet/ct. the investigation will take place at a single site. participants who consent will be prospectively enrolled once mavacamten therapy has been approved by their health insurance/payer. enrolled participants will undergo myocardial pet/ct before starting mavacamten and after 12 months of therapy.

Eligibility criteria:
inclusion criteria: 1. willingness and ability to provide written informed consent 2. willingness and ability to comply with scheduled visits and study procedures 3. male or female, aged 18-85 years 4. diagnosed with obstructive hypertrophic cardiomyopathy according to presence of a left ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormal loading conditions (e.g., hypertension, valvular, congenital disease) or infiltrative cardiomyopathies. unexplained left ventricular wall thickness of ≥13 mm is sufficient for diagnosis in relatives of individuals with hypertrophic cardiomyopathy or those who are genotype positive. 5. has been prescribed mavacamten consistent with us prescribing information 6. ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation 7. for females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits. exclusion criteria: 1. pregnancy or lactation 2. known hypersensitivity to components of mavacamten or regadenoson 3. prior treatment with mavacamten or aficamten 11. over weight limit for imaging gantry. 12. to minimize the risk of participants undergoing pet/ct with inadequate image quality, participants with left ventricular systolic dysfunction or lung disease will be excluded.
multiple objective particle swarm optimization postural instability gait disorder

Conditions: Parkinson Disease

Summary: sixty patients will be enrolled in this study who are treated for parkinson's disease (pd) with bilateral deep brain stimulation of subthalamic nucleus (stn) or globus pallidus (gp), who have a pre- operative 7 tesla mri including diffusion tensor imaging for tractography and a postoperative head ct for electrode localization, and in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. using their mri and ct, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode. then applying nonlinear (particle swarm) optimization, patient- specific stimulator settings will be designed to maximally or minimally activate specific path- ways. in stn dbs: pedunculopallidal vs. pallidopeduncular pathways. in gp dbs: pallidopeduncular pathways at its origin in gp pars interna (gpi) vs. inhibitory afferents to gpi (from gp pars externa gpe). all stimulation falls within the the fda-approved range for dbs for pd.

patients will undergo on-label dbs for the treatment of parkinson's disease, at stimulator settings different from their usual settings, but within the fda-approved range for this indication, based on patient specific models that identify stimulation settings that most selectively target one pathway over other adjacent pathways. in aim 1 (stn dbs), the comparison will be amongst settings that selectively target pedunculopallidal, pallidopeduncular and subthalamopallidal pathways. in aim 2 (gp dbs), the comparison will be amongst settings which selectively target the pallidopeduncular pathways at its origin in gp pars interna (gpi), inhibitory afferents to gpi (from gp pars externa gpe), and pallidosubthalamic pathway (from gpe). total time, including both test stimulation and off-stimulation time, will be about 6 hours for arm 1, and about 5 hours for arm 2. testing will include quantitative measures of gait, balance, bradykinesia, and rigidity.

Eligibility criteria:
inclusion criteria: * diagnosis of pd * bilateral dbs * directional dbs electrode system * mri, at least 7 tesla, with diffusion tensor imaging, prior to dbs surgery * head ct, at least 1mm cuts, following dbs surgery * at least 3 months since initial activation of the neurostimulator exclusion criteria: * neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements * dementia * prior stereotactic neurosurgery other than dbs for movement disorder * pregnancy

Keywords: deep brain stimulation
the comparison of efficacy between electromagnetic stimulation therapy and electromagnetic stimulation therapy with extracorporeal biofeedback

Conditions: Urinary Stress Incontinence

Summary: the aim of this study is to compare the efficacy between electromagnetic stimulation therapy and electromagnetic stimulation therapy with extracorporeal biofeedback in stress urinary incontinence patient.


Eligibility criteria:
inclusion criteria: 1. female patient with stress urinary incontinence, over 20 2. leakage over 2g in stress pad test 3. capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits exclusion criteria: 1. mixed urinary incontinence which is dominant in urge urinary incontinence. 2. true incontinence 3. overflow incontinence 4. patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline. 5. urinary tract infection found in urine test. 6. patient who had pelvic organ prolapse. 7. patient who had inserted pacemaker. 8. pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period. 9. disorder in neurosystem like stroke, multiple sclerosis, spinal injury, parkinson's disease . 10. patient who will participate in other clinical trial during this study. 11. any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
study of default options in advance directives

Conditions: COPD; Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy; Idiopathic Pulmonary Fibrosis; Other Interstitial Lung Disease Without Curative Therapy; Congestive Heart Failure; NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year; Malignancy; Any Stage 3B or 4 Solid Tumor

Summary: default options represent the events or conditions that are set into place if no alternatives are actively chosen. the setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood. this is a 3-armed randomized clinical trial in veterans at high risk for critical illness, assessing the impact of advance directive (ad) forms framed with different default options. the central goals are to assess how default options in ads influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and icu utilization. the investigators hypothesize that setting defaults in real ads will increase the proportion of veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that veterans spend in the hospital and/or icu, without affecting patient satisfaction with end-of-life care planning.


Eligibility criteria:
inclusion criteria: * age \> 18 years * chronic obstructive pulmonary disease (copd) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy and/or * idiopathic pulmonary fibrosis (ipf) and/or * other interstitial lung disease without curative therapy and/or * any stage 3b or 4 solid tumor and/or * congestive heart failure (chf) either new york heart association nyha) class iv or nyha class iii plus 1 hospitalization in the past year * no previously signed advance directive in the medical record * neither listed for nor considering lung or heart transplantation * high anticipated risk for critical illness in the next 2 years based on clinical judgment * interest in thinking about filling out an advance directive exclusion criteria: * diseases for which life-extending medical therapies may be available * inability to speak and/or read english proficiently * new clinic patients meeting the clinic provider for the first time * patients being actively evaluated or already listed for transplants * patients already having an ad * cognitive impairment necessitating proxy consent
a phase 1, first time in human (ftih) study to evaluate gsk3352589, a rearranged during transfection (ret) growth factor receptor tyrosine kinase inhibitor, in healthy volunteers

Conditions: Irritable Bowel Syndrome

Summary: this ftih study is designed to assess the safety, tolerability and pharmacokinetic (pk) of escalating single and repeat oral doses of gsk3352589 in normal healthy volunteers. this is a randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that will have two parts; part a and part b.


Eligibility criteria:
inclusion criteria: * between 18 and 55 years of age inclusive, at the time of signing the informed consent. * healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - history of regular bowel habits * male or female of non-childbearing potential. * capable of giving signed informed consent which includes compliance with the requirements and restrictions. exclusion criteria: * alt and bilirubin \>1.5 x upper limit of normal (uln) (isolated bilirubin \>1.5xuln is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * previous diagnosis of ibs * estimated glomerular filtration rate \<60 millilter per minute per 1.73 square meter (ml/min/1.73m\^2) * current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones) * history of gastroesophageal reflux disease (gerd), dyspepsia, gastrointestinal (gi) bleeding, diverticulitis, diverticular stricture or other intestinal strictures, gi surgery that could affect motility * unwillingness or inability to follow the procedures outlined in the protocol

Keywords: rearranged during transfection
a non-inferiority, multicenter and randomized, multiple-dose study about a treatment to hypolactasia

Conditions: Lactose Intolerance

Summary: the primary objective is to determine the compared clinical efficacy of lactase eurofarma (test drug), showing non-inferiority to lactaid® (comparative drug) in the supportive treatment of lactose intolerance and to assess the safety and tolerance of lactase eurofarma (test drug) in the supportive treatment of lactose intolerance.


Eligibility criteria:
inclusion criteria: * to have participated in the single-dose clinical study (ef099) previously performed, with the clinical response being considered as satisfactory by the investigator * the patient should be a male or female, aged between 18 and 60 years old * have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air * the female patients should agree to use birth control methods during the study participation * to be able to meet the study instructions and all the visits required * to give a free consent to participate in the study and sign the informed consent form (icf). exclusion criteria: * smoking * secondary hypolactasia * gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias * colonoscopy or colon cleaning procedure 4 weeks before the start of study * latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics * diagnosis of hiv, immunodepression of any origin, or cancer under treatment. * diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure), * hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study * incapacity to understand and complete the study questionnaires, including the questions that require the use of the visual analogue scale and icf * pregnancy or lactation * use of alcohol, exceeding 3 doses daily * participation in another clinical study on the last 12 months * patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).