Kornimate/medical-research-clean huggingface dataset:
early vs. late time-restricted eating in adolescents with obesity (el trea)

Conditions: Pediatric Obesity; Time Restricted Feeding; Time Restricted Eating

Summary: determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (bmi).

in adults, there is growing evidence that early tre is more effective in improving metabolic outcomes than other forms of tre, however it is unclear whether adolescents will be able to adhere to such recommendations. hence, in the present study we propose a 24-week, 2-arm, parallel randomized pilot trial in 100 adolescents (age 13-18 years, all gender expressions, anticipate 65% latino) with obesity, to test the preliminary efficacy of early vs. late tre on glycemic profiles, weight loss, and body composition. we hypothesize that, among adolescents who can adhere to the meal timing recommendations, early tre will result in greater improvement in metabolic endpoints than late tre. we will test the hypothesis with 3 specific aims: aim 1: test the effect of early vs. late tre on glycemic profiles and β-cell function. aim 2: test the effect of early vs. late tre on obesity and body composition, and cardiometabolic risk factors. aim 3: test the effect of early vs. late tre on exploratory outcomes including sleep, physical activity, and dietary intake to explore how meal timing may influence occurrence, timing, and distribution of sleep and movement as well as dietary intake and caloric distribution. this study is the first study evaluating the effectiveness of early vs. late tre in adolescents with obesity at risk for diabetes.

Eligibility criteria:
inclusion criteria: * 12-21 years with obesity (bmi\>95th percentile) * participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods * baseline eating window greater than 12 hours. exclusion criteria: * diagnosis of prader-willi syndrome, brain tumor, or diabetes serious intellectual disability * previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder) * parent/guardian-reported physical, mental of other inability to participate in the assessments * previous bariatric surgery * current participation in other interventional weight loss studies.

Keywords: obesity intermitted-fasting time limited eating
electrical stimulation for the treatment of post-amputation pain using the sprint system

Conditions: Post-Amputation Pain; Phantom Limb Pain; Residual Limb Pain

Summary: the purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. this study involves a device called the sprint system. the sprint system delivers mild electrical stimulation to nerves in the residual limb. the sprint system includes a small wire (called a "lead") that is placed through the skin in the upper leg. it also includes a device worn on the body that delivers stimulation (called the sprint stimulator).


Eligibility criteria:
key inclusion criteria: * at least 18 years old * traumatic lower extremity amputation(s) * healed amputation and healthy residual limb based upon the investigator's evaluation key exclusion criteria: * change of prescribed medications affecting pain within the past 4 weeks * compromised immune system based on medical history * implanted electronic device * bleeding disorder * history of valvular heart disease * confounding central nervous system injuries and disorders * history of recurrent skin infections

Keywords: electrical stimulation neurostimulation neuromodulation post-amputation pain phantom limb pain residual limb pain neuropathic pain amputee pain
study of idalopirdine in patients with mild - moderate alzheimer's disease treated with an acetylcholinesterase inhibitor

Conditions: Alzheimer's Disease

Summary: to establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (acheis) for symptomatic treatment of patients with mild-moderate alzheimer's disease (ad).

the study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. the dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. the dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. dose changes were permitted until week 12 (visit 5).

Eligibility criteria:
inclusion criteria: * the patient has a knowledgeable and reliable caregiver. * the patient is an outpatient. * the patient has probable ad. * the patient has mild to moderate ad. * stable treatment with an achei. * the patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, or be surgically sterile. * the patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, or must have been surgically sterilised prior to the screening visit. exclusion criteria: * the patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than ad. * the patient has a diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) axis i disorder other than ad. * the patient has evidence of clinically significant disease. * the patient's current achei therapy is likely to be interrupted or discontinued during the study. * the patient is currently receiving memantine or has taken memantine within 2 months prior to screening. other inclusion and exclusion criteria may apply.
ivabradine in stage d heart failure patients on chronic inotropes

Conditions: Heart Failure NYHA Class IV

Summary: ivabradine, a selective inhibitor of the if current in the sinoatrial node, provides heart rate reduction and leads to a reduction in heart failure hospitalizations. for this reason, the american college of cardiology (acc) and the american heart association (aha) guidelines provide a class iia recommendation for ivabradine in stable heart failure patients with lvef 35% and new york heart association (nyha) class ii-iii symptoms who are on a beta blocker at maximum tolerated dose with a resting heart rate of 70 beats per minute or greater. while ivabradine leads to improvement in outcomes in stable nyha class ii-iii chronic heart failure patients, its role in class iv, stage d heart failure, and cardiogenic shock is less clear. ivabradine's effect on acute cardiogenic shock has been evaluated by two recent studies. in the modify trial, a randomized control study evaluating ivabradine in patients with multiorgan dysfunction, the addition of ivabradine did not result in significant heart rate reductions or other positive clinical outcomes. however, a small prospective trial demonstrated a significant decrease in heart rate and nt-probnp with the addition of ivabradine in patients with acute cardiogenic shock on dobutamine. while few data investigate ivabradine's role in acute cardiogenic shock, it has yet to be studied in heart failure patients on long-term inotropic therapy. inotropes such as dobutamine and milrinone result in tachycardia and may lead to ventricular arrhythmias. moreover, patients on chronic inotropes are typically off beta blockers and have few pharmacological options available to help reduce heart rates. ivabradine may have a role in decreasing heart rate and improving outcomes in patients on chronic inotropes. given the benefits of ivabradine in stable chronic heart failure patients, we plan to perform a study investigating the role of ivabradine in nyha stage d patients on home inotropes. our primary objective is to analyze changes in two cardiac biomarkers, nt-probnp and high-sensitivity troponin. our secondary outcomes include changes in noninvasive echocardiographic hemodynamics, changes in arrhythmia burden, and heart failure symptom modification based on 6-minute walk test results.


Eligibility criteria:
inclusion criteria: * nyha stage d heart failure on 2 weeks of consecutive iv dobutamine or milrinone * followed at ummc outpatient heart failure clinic or admitted to advanced heart failure inpatient service and planning to follow up at ummc outpatient heart failure clinic exclusion criteria: * patients who are already on ivabradine * patients who are not willing to follow-up with ummc outpatient heart failure team
investigating racing thoughts in patients with insomnia disorder

Conditions: Insomnia Disorder

Summary: cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. however, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. the aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the racing and crowded thoughts questionnaire. specifically, the researchers seek to address three related goals: the comparison of rctq scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of rctq scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.


Eligibility criteria:
inclusion criteria: * major subject from 18 to 70 years old) * with a diagnosis of chronic primary insomnia according to the criteria of icsd-3 * subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship or guardianship * subject under safeguard of justice * patient with secondary insomnia (osa, circadian rhythm disorder, severe restless legs syndrome, bipolar disorder, add +/- h) * subject under psychotropic treatment other than hypnotics * incomplete data concerning the main endpoint

Keywords: insomnia hyperarousal rumination racing thoughts
natural history study in pediatric patients with stxbp1 encephalopathy with epilepsy

Conditions: STXBP1 Encephalopathy with Epilepsy

Summary: this is a prospective, non-interventional, longitudinal study designed to characterize the natural history of stxbp1 related encephalopathy with epilepsy, in participants ≤ \<5 years of age.


Eligibility criteria:
inclusion criteria: * male or female, \> 1 day to ≤ 5 years of age at the time of informed consent. * diagnosed with seizure disorder * presence of a stxbp1 gene mutation. historical documentation is sufficient to support eligibility for the study. confirmatory testing will be obtained at baseline and performed by a clia certified laboratory * written informed consent provided by a parent or legal guardian exclusion criteria: * history of prior gene therapy treatment * current enrollment in an interventional study or has received an investigational drug within 30 days or fewer than 5 half-lives prior to screening visit, whichever is longer * treatment with any antisense oligonucleotide therapy within 6 months prior to screening and anticipate remaining on treatment throughout the study * the presence of a confirmed mutation in a gene other than stxpb1 that is known to contribute to a neurodevelopmental disability * presence of a significant non-stxbp1 related central nervous impairment/behavioral disturbance that would confound the scientific rigor or interpretation of results of the study * history of prematurity (defined as gestational age \<35 weeks), interventricular hemorrhage, structural brain deficit or congenital heart disease * requires mechanical ventilation or non-invasive respiratory support such as continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap) at the time of informed consent

Keywords: stxbp1 epilepsy seizures epileptic encephalopathy genetic diseases, inborn
study of stereotactic body radiation therapy in patients with intact pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this purpose of this study is to determine the highest tolerated dose of stereotactic body radiation therapy (sbrt) and also to determine the appropriate dose for intact pancreatic cancer.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. the cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma). * patients must have measurable radiographic disease.patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease. * patients may receive any number of cycles of chemotherapy prior to treatment with sbrt, but not within 2 weeks of the first fraction of rt. * age \> or = 18 years. * eastern cooperative oncology group (ecog) performance status \ or = 60%) * life expectancy of greater than 3 months. * patients must have normal organ and marrow function. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * concurrent investigational therapy delivered over the period of treatment or observation (28 days post-rt) for dose limiting toxicity. * prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment. * pregnancy. * primary disease \> 7.5 cm in largest diameter as measured by ct or mri. * gross extension of tumor into the lumen of the duodenum. * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before rt or 6 months after rt.

Keywords: pancreatic cancer stereotactic radiation
a trial to learn if odronextamab is safe and well-tolerated and how well it works compared to rituximab combined with different types of chemotherapy for participants with follicular lymphoma

Conditions: Follicular Lymphoma (FL)

Summary: this study is researching an experimental drug called odronextamab, referred to as study drug. the study is focused on participants with previously untreated follicular lymphoma (a type of non-hodgkin lymphoma or nhl). this study will be made up of two parts: part 1 (non-randomized) and part 2 (randomized - controlled). the aim of part 1 of the study is to see how safe and tolerable the study drug is when given alone. the aim of part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for nhl). standard of care means the usual medication expected and used when receiving treatment for a condition. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * how the study drug affects quality of life and ability to complete routine daily activities.


Eligibility criteria:
key inclusion criteria: 1. diagnosis of cluster of differentiation 20\^+ (cd20\^+) fl grade 1-3a, stage ii bulky or stage iii / iv 2. need for treatment as described in the protocol 3. have measurable disease on cross-sectional imaging documented by diagnostic imaging computed tomography (ct) or magnetic resonance imaging (mri) 4. eastern cooperative oncology group (ecog) performance status of 0-2 5. adequate bone marrow function and hepatic function key exclusion criteria: 1. central nervous system (cns) lymphoma or leptomeningeal lymphoma 2. histological evidence of transformation to a high-grade or diffuse large b-cell lymphoma 3. waldenström macroglobulinemia (wm, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma 4. treatment with any systemic anti-lymphoma therapy 5. infections and allergy/hypersensitivity to study drug or excipient note: other protocol defined inclusion/exclusion criteria apply

Keywords: non-hodgkin lymphomas (nhls) indolent nhl b-cells nhl (b-nhl) follicular lymphoma odronextamab
paced electrogram feature analysis (pefa) for ablation targeting in ischaemic ventricular tachycardia

Conditions: Ischemic Ventricular Tachycardia (VT)

Summary: canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (icd).

paced electrogram feature analysis is employed to elucidate vt isthmus sites and target type i sites for ablation to prevent recurrent vt/vf. the trial hypothesis is: catheter ablation employing pefa will, in comparison to published data, reduce the composite outcome of death at any time, appropriate icd shock, ventricular tachycardia storm or treated sustained ventricular tachycardia below the detection rate of the icd or incessant vt for patients with prior myocardial infarction and sustained ventricular tachycardia or fibrillation.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * ischaemic heart disease and prior myocardial infarction (using the international definition of mi: q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) * eligible for catheter ablation as standard of care * implantable cardioverter defibrillator exclusion criteria: * unable or unwilling to provide consent * both mechanical aortic and mitral valve * lv thrombus, * nyha class iv heart failure symptoms * contraindication to heparin * survival limited to \<1 year in estimation of attending care team, * prior vt ablation exclusion to standard of care vt catheter ablation procedure such as * active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic st segment changes demonstrated on ecg) or another reversible cause of vt (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have ccs functional class iv angina. note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia. * non-ischaemic cardiomyopathy because of reduced ablation success and pefa has not been examined in the context of a non-ischaemic cardiomyopathy
study of grazoprevir (mk-5172) + elbasvir (mk-8742) + ribavirin in participants with chronic hepatitis c who failed prior direct-acting antiviral therapy (mk-5172-048)

Conditions: Hepatitis C Virus

Summary: in this study, participants with hepatitis c virus (hcv) genotype 1 (gt1) who failed prior direct-acting antiviral (daa) therapy will receive grazoprevir (mk-5172) + elbasvir (mk-8742) + ribavirin (rbv) to evaluate sustained virologic response (svr) using this drug combination.


Eligibility criteria:
inclusion criteria: * documented chronic hcv gt1 infection (with no evidence of non-typable or mixed genotype) * absence of cirrhosis, or cirrhosis with these criteria: metavir f4, or fibroscan with result \>12.5 kpa, or fibrosure® (fibrotest®) score of \>0.75 + aspartate aminotransferase (ast): platelet ratio index (apri) of \>2- prior regimen containing an approved daa (boceprevir, telaprevir, simeprevir, or sofosbuvir), pegylated interferon, and/or rbv * participants of reproductive potential must agree to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations exclusion criteria: * received any hcv regimen containing a daa with the exception of boceprevir, telaprevir, simeprevir, or sofosbuvir in combination with pegylated interferon and/or rbv * evidence of decompensated liver disease or cirrhosis * co-infected with hepatitis b virus or human immunodeficiency virus (hiv) * history of malignancy \<=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or under evaluation for other active or suspected malignancy * evidence of hepatocellular carcinoma (hcc) or under evaluation for hcc * currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study * clinically-relevant drug or alcohol abuse within 12 months of screening * pregnant, breast-feeding, or expecting to conceive or donate eggs or sperm from at least 2 weeks prior to day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations * male participant whose female partner (s) is/are pregnant * organ transplants (including hematopoietic stem cell transplants) other than cornea and hair * poor venous access * history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease) * hemoglobinopathy, including, but not limited to, thalassemia major * any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial * evidence or history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis