Kornimate/medical-research-clean huggingface dataset:
gyn onc prehab study

Conditions: Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Surgery; Treatment Adherence; Quality of Life

Summary: patients will be randomized to a unimodal or trimodal prehabilitation program prior to surgery for known or suspected gynecologic cancer.

prehabilitation generally refers to the act of an intervention prior to a known potentially debilitating event. usually taking the form of physical therapy prior to surgery, prehabilitation programs have demonstrated success in colorectal, urological, and surgical oncology cases. patients with a gynecologic oncology diagnosis face an arduous course. their treatment generally involves a major surgery and is often followed by chemotherapy, radiation, or both.the patient population is generally older in life as the average age for an endometrial or ovarian cancer diagnosis is 63. these patients may already have a lower performance status at baseline deeming their treatment course exponentially more difficult to endure. women with gynecologic cancer suffer significant mental duress often living in fear of the high rates of recurrence from some of these malignancies suggesting they may benefit from psychologic support and counseling through their treatment. given the proven success in other surgical disciplines, we believe that instituting prehabilitation programs should be standard of care. patients will be randomized to a trimodal approach (physical therapy, nutritional counseling, cognitive behavioral therapy) versus a unimodal intervention (physical therapy) for a formal prehabilitation program. our primary outcome will be functional return to baseline following surgery with secondary outcomes including items such as quality of life assessments, patient satisfaction, and compliance.

Eligibility criteria:
inclusion criteria: * patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis. exclusion criteria: * non-english speaking patients * surgeries done for palliative intent * poor performance status or other inability to participate in physical therapy
reveal® xt performance trial (xpect)

Conditions: Atrial Fibrillation; Risk of Cardiac Arrhythmias

Summary: the purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the reveal® xt in a clinical setting and to verify overall system performance, r-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.

the study is a prospective, non-randomized, multi-center international post-market study. the study will be conducted at 20-30 centers primarily in europe. the study will be conducted at least in germany, austria, switzerland, the netherlands, and the czech republic. study centers from canada may also participate, depending on the timelines for regulatory approval and commercial release of the reveal® xt in this region. it is expected that between 140 and 200 patients will be enrolled to ensure that at least 47 patients are included to assess the first primary objective and at least 60 patients to assess the second primary objective. the primary objective is to quantify the af detection performance of the device. the patient population will be assessed in two separate cohorts. the first primary objective is to quantify the 24-hour af burden accuracy in patients with more than 1% af burden. the second primary objective is to quantify the detection accuracy of non-arrhythmia in patients with 1% or less af burden.

Eligibility criteria:
inclusion criteria: * patient is willing and able to provide his/her informed consent * patient has been implanted with a reveal® xt * patient fulfills at least one of the following three additional requirements 1. is scheduled for pv ablation or surgical rhythm control intervention, and the pv ablation or surgical intervention can be deferred until study completion or 2. has documented frequent af or frequent symptoms attributable to af or 3. has undergone pv ablation within the last 6 months and still has symptoms attributable to af exclusion criteria: * patient has an implanted pacemaker or icd * patient has persistent or permanent af * patient is allergic to adhesive ecg electrodes * the study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period * patient is participating in another study that is expected to compromise the results of this study * patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study * patient is pregnant

Keywords: atrial fibrillation risk of cardiac arrhythmias loop recorder
neurocognition, lifestyle modification, and treatment resistant hypertension

Conditions: Treatment-Resistant Hypertension

Summary: this application proposes to extend an ongoing nhlbi clinical trial (nct02342808) examining the efficacy of a lifestyle intervention combining the dietary approaches to stop hypertension (dash) diet with caloric restriction and aerobic exercise to lower and control bp in individuals with rh. in the parent trial, participants with rh will be randomized to either: (1) a 4-month adjunctive lifestyle intervention designed to lower bp through exercise and diet (c-life), or; (2) a standardized education and physician advice (sepa) control condition. the current protocol will collect additional assessments of neurocognition (executive function, processing speed, and memory), endothelial function (brachial artery flow-mediated dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in 120 participants at baseline, following completion of the 4-month intervention, and again after one year, in order to examine neurocognitive improvements and their potential mediators.


Eligibility criteria:
inclusion criteria: * documented resistant hypertension (rh). in the absence of a specific rh diagnosis, individuals being treated for two or more weeks with 3 antihypertensive medications of different classes, including a diuretic if tolerated, with clinic sbp ≥ 130 mm hg or dbp ≥ 80 mm hg, will be eligible. individuals being treated with 4 or more antihypertensive medications, including a diuretic if tolerated, with sbp ≥ 120 or dbp ≥ 80 mm hg will also be eligible. * adherent to prescribed medications * overweight (bmi ≥ 25 kg/m2) * sedentary * willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention * informed consent exclusion criteria: * secondary htn, non-adherence to anti-htn medications * severe ckd (egfr \<40 ml/min/1.73m2) * severe ischemic heart disease (ccs class 3 or 4 angina or evidence of ischemia at \<85% heart rate reserve on treadmill testing) * severe heart failure (nyha association class 3 or 4), high grade arrhythmias, severe valvular heart disease * severe asthma or chronic obstructive lung disease * diabetes requiring insulin * musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training * major psychiatric disorder, a history of drug abuse, alcohol consumption \>14 drinks/week * life-limiting comorbid medical condition such as cancer * prior gastric bypass surgery * currently pregnant * cognitively impaired
effectiveness of an electronic training program for orienting and interpreting [18f]flutemetamol positron emission tomography (pet) images

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: to evaluate the effectiveness of an electronic training program for orienting and interpreting \[18f\]flutemetamol positron emission tomography (pet) images.


Eligibility criteria:
inclusion criteria: * subject received a dose of flutemetamol f 18 injection ranging from approximately 185 mbq to approximately 370 mbq. * the subject was classified as one of the following: 1. end-of-life subject who expired and underwent brain autopsy, with histochemical (hc) confirmation of brain amyloid status. 2. subject with known/suspected normal pressure hydrocephalus (nph) who underwent brain biopsy, with hc confirmation of brain amyloid status. 3. elderly healthy volunteer (age ≥55). 4. young healthy volunteer (age ≤40). 5. subject with probable alzheimer disease (pad). 6. subject with amnestic mild cognitive impairment (amci). exclusion criteria: * not applicable

Keywords: alzheimer's disease mild cognitive impairment positron emission tomography (pet) pet images
pms evaluation of safety and efficacy of the mid-c system 5 years post-implantation in ais

Conditions: Adolescent Idiopathic Scoliosis

Summary: the apifix mid-c system is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. the mid-c system is designed to act as an internal brace. a total of 10 patients, who are planned to undrego the mid-c system implantation procedure will be enrolled for the study. a 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the mid-c system.


Eligibility criteria:
inclusion criteria: 1. adolescent idiopathic scoliosis classified as lenke type 1 or type 5 curves; 2. * patients with risser stage 0-1, primary cobb angle between 35-50 degrees (inclusive), or * patients with risser stage 0-1 and good brace compliant but curve progression above 6°, or * patients with risser stage 0-1 that are non-compliant with brace treatment and primary cobb angle between 30-50 degrees or * patients with risser stage 2, primary cobb angle between 40-50 degrees (inclusive) 3. flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; 4. kyphosis angles of ≤ 45 degrees measured from t5 to t12; 5. appropriate candidate for posterior surgical approach; 6. patient has good general health; 7. patient has no known hypersensitivity or allergies to titanium; 8. patient's guardian signs a written informed consent form (icf). exclusion criteria: 1. any type of non-idiopathic scoliosis; 2. any main thoracic deformity that includes vertebral levels and cranial including to t2; 3. cumulative vertebral wedging over the apex of the curve\>15º 4. known history of existing malignancy, or any systemic or local infection; 5. spinal cord abnormalities that require treatment; 6. known neurological deficit (defined as motor grades \< 5/5); 7. known poor bone quality defined as t score -1.5 or less; 8. previous spine surgery that would prevent the successful performance of the mid-c system; 9. active systemic disease, such as aids, hiv, or active infection; 10. active infection or the skin is compromised at the surgical site; and 11. systemic disease that would affect the patient's welfare or overall outcome of the study
peritoneal dialysis vs furosemide for acute kidney injury after cardiopulmonary bypass

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) after cardiopulmonary bypass (cpb) in infants is common and associated with poor outcomes. peritoneal dialysis (pd) and furosemide have been used to attain negative fluid balance due to aki induced oliguria, but have not been compared prospectively. the investigators will prospectively compare outcomes of infants with oliguria after cpb randomized to pd vs. furosemide with the hypothesis that infants receiving pd have superior outcomes.

background: acute kidney injury (aki) is a common postoperative complication after heart surgery with cardiopulmonary bypass (cpb). multiple studies have demonstrated that patients with aki have worse clinical outcomes, such as longer ventilation times and increased length of stay, which is thought to be secondary to associated oliguria and subsequent fluid overload. studies suggest that early renal replacement therapy (rrt) via peritoneal dialysis (pd) may prevent fluid overload and therefore be a superior management to diuretic (i.e. furosemide) administration. however, there is no published evidence to suggest superiority or laboratory data available to guide decision making. objective: our primary objective is to determine if early institution of pd improves clinical outcomes compared to administration of furosemide in post-operative cardiac infants with acute kidney injury. we hypothesize that early initiation of pd will improve clinical outcomes. we will determine if these clinical outcomes will be better among good responders of furosemide compared to poor responders. we will determine if postoperative ngal concentrations are predictive of poor response to furosemide. design / methods: the study will be a single-center randomized clinical trial among neonates undergoing cardiac surgery with cpb with planned placement of a pd catheter due to risk of aki. if patients demonstrate oliguria within the first postoperative day, they will be randomized to early pd or trial of furosemide. clinical and laboratory data will be collected and compared between groups.

Eligibility criteria:
inclusion criteria: * age less than 6 months of age; * undergoing cardiothoracic surgery with cpb; * planned placement of pd catheter per institutional standard of care criteria. exclusion criteria: * pre-existing chronic kidney disease stage 3 or above (correlating with estimated gfr\<60 ml/min/m2, which will be calculated using routine preoperative serum creatinine value using the modified schwartz equation). * known history of allergy to furosemide.

Keywords: acute kidney injury aki cardiopulmonary bypass
a one-year trajectory of depression status changes in older adults with mci and sd: a longitudinal cohort study

Conditions: Mild Cognitive Impairment; Subthreshold Depression; Older Adults

Summary: the purpose of this study is to investigate the one-year trajectory of changes in depression status in older adults with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. this one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in older adults, and their depressive status was assessed using the geriatric depression scale (gds). follow up monitoring of depression status at 6 and 12 months. obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). by studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state markov model with time and state discreteness is constructed, namely: state 1 (normal); state 2 (subthreshold depression); state 3 (mild depression); state 4 (moderate depression); state 5 (severe depression). deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states.


Eligibility criteria:
inclusion criteria: 1. age: ≥ 60 years old 2. meets the diagnostic criteria for mild cognitive impairment and subthreshold depression 3. having basic comprehension and verbal expression skills 4. voluntarily participate in this study and sign an informed consent form. exclusion criteria: 1. diagnosed as depression patients, including patients with organic mental disorders and patients with a history of depression related mental disorders 2. cognitive impairment caused by other diseases (such as neurological and psychiatric disorders, metabolic disorders, poisoning, infections, etc.) 3. severe heart, liver, and kidney diseases 4. serious chronic diseases and complications, such as congestive heart failure, hypertension, diabetes and other diseases with serious complications

Keywords: mild cognitive impairment subthreshold depression older adults
subcutaneous lavage in cesarean section

Conditions: Surgical Site Infection

Summary: the goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection. intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section. the main questions we aim to answer are: does subcutaneous antiseptic washing reduce the rates of surgical site infection? does antiseptic washing improve scar healing? does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases? researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce participants will: consent to participate in the trial visit the postpartum clinic 30 days after surgery


Eligibility criteria:
inclusion criteria: * pregnant women undergoing cesarean delivery exclusion criteria: * pregnant women undergoing vaginal delivery
bd-covered stent for benign esophageal strictures: a safety and feasibility study

Conditions: Benign Esophageal Stricture

Summary: a non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae

a non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. the follow-up will be 6 months form implantation. after 3 months a control endoscopy will take place to evaluate stent and degradation process.

Eligibility criteria:
inclusion criteria: * subjects of both genders * age ≥ 18 years * appropriate cultural level and understanding of the study * willingness to participate voluntarily in the study and give written informed consent * refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or savary bougie, not complicated by or malignancy. * ability to undergo periodic endoscopic follow-up. exclusion criteria: * pregnancy or breastfeeding * simultaneous participation in another clinical study * life expectancy of less than 12 months * malignant esophageal stricture * stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter * undergone an esophageal stent implantation before.
clinical evaluation of florbetapir in primary progressive aphasia

Conditions: Primary Progressive Aphasia; Alzheimer Disease; Dementia

Summary: the purpose of this research is to better understand how dementia affects activity in different parts of the brain.

this study is being done to examine the usefulness of positron emission tomography (pet) imaging with florbetapir f 18 as a biomarker in the identification of amyloid-ß peptide (aß) in the brain. amyloid-ß peptide (aß) accumulates in the brains of patients with alzheimer's disease. florbetapir f 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a pet camera. the development of biomarker and imaging studies that track the development of ppa and reflect the change in people's bodies may help other people who have a similar medical problem in the future.

Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can tolerate the pet scan procedures exclusion criteria: * clinically significant cardiovascular disease * clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances * pregnant * breastfeeding * women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. * history of relevant severe drug allergy or hypersensitivity * patients who have received an investigational medication under an fda investigational new drug (ind) protocol within the last 30 days.

Keywords: alzheimer's disease dementia primary progressive aphasia neurocognitive disorders speech disorders
cell therapy in dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: the purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

this protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class iii or iv of the new york heart association. the primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. secondary endpoints will evaluate the alteration in nyha functional class, mortality rate, physical capacity (by ergoespirometry), life quality (minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant. hypothesis: the main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.

Eligibility criteria:
inclusion criteria: * diagnosis of dilated cardiomyopathy according to who criteria * syndromic heart failure in functional class iii or iv of the nyha * enrollment and continuous follow-up in cardiac out-patient clinic * adequate medical therapy after optimization therapy * echocardiogram with an ejection fraction equal to or less than 35% by simpson's rule exclusion criteria: * valvular diseases, except functional mitral or tricuspid reflow * coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - lad, cx, rc) in one or more arteries * serologic diagnosis for chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism * sustained ventricular tachycardia * abusive use of alcohol or illicit drugs * pregnancy * use of cardio toxic drugs * any co-morbidity with impact in life expectancy in 2 years * renal function compromised (creatinine above 2 mg/dl)

Keywords: dilated cardiomyopathy stem cells therapeutics randomized controlled trials
raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer

Conditions: Lung Cancer

Summary: the goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. the main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer. the bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.


Eligibility criteria:
inclusion criteria: * patients who plan to undergo bronchoscopic biopsy or ebus-tbna * visible intratracheal lesions under bronchoscope * non-visible lesions suspected of lung cancer exclusion criteria: * the patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc * the patient has no definite diagnosis