Kornimate/medical-research-clean huggingface dataset:
we beat - heart club fontan wellness project: a virtual resilience promotion and frailty prevention program

Conditions: Fontan Physiology; Frailty; Single Ventricle Heart Disease

Summary: this trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with fontan physiology. there will be two phases for this project. the first phase is the "we beat group wellness education program" and participants will be transitioned into the phase two heart club following phase one. the trial will look at feasibility and acceptability of the program. additional hypothesis include home whether exercise interventions can: * be delivered without any associated serious cardiac events; * will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. * will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. * will result in increased step counts measured monthly from baseline to end of intervention * will improve self-reported quality of life from baseline to post-intervention. * will result in increased patient reported activity level from baseline to post-intervention


Eligibility criteria:
inclusion criteria: * males and females with fontan physiology who are 13 to \<19 years of age at enrollment * own a mobile device capable of installing the university of michigan patient portal application * fluent in english * participant consent or parental/guardian consent and participant assent exclusion criteria: * height \< 130 centimeters * current intravenous inotropic drugs * severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment. * severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment. * history of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms). * inability to complete exercise testing at baseline screening. * noncardiac medical, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results. * suicidality or homicidality in the past 6 months.

Keywords: wellness education exercise program
antirotinib hydrochloride plus whole brain radiotherapy for small cell lung cancer with brain metastases

Conditions: Whole Brain Radiotherapy

Summary: the objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer

this was a single-center, single-arm trail. enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. after radiotherapy, antirotinib was continued until tumor progression. efficacy and toxicity data were collected for evaluation and analysis.

Eligibility criteria:
inclusion criteria: 1. small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to recist criteria. 2. the expected survival time is more than 3 months. 3. intracranial metastases ≤10. 4. adequate organ and bone marrow function. exclusion criteria: 1. patients who have used antiangiogenic drugs within the previous 1 month. 2. non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer). 3. small cell lung cancer with hilar invasion or hemoptysis. 4. patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage. 5. an unresolved acute toxic reaction period higher than grade 2 of ctc-ae(4.0) due to any prior treatment. 6. advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications. 7. patients with life-threatening conditions of other severe and/or uncontrolled diseases.
serplulimab plus bevacizumab and chemotherapy for egfr-mutant metastatic nsclc patients after egfr-tki treatment failure

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of serplulimab plus bevacizumab and chemotherapy in tki-resistant egfr-mutated non-squamous nsclc chinese patients.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent before any trial-related processes; 2. age ≥ 18 years and ≤70 years male or females; 3. has a histologically or cytologically confirmed stage iiib/iiic (american joint committee on cancer \[ajcc\] 8th edition) nsclc that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous nsclc; 4. patients with egfr mutation confirmed by tumor histology or cytology or hematology prior to egfr-tki treatment 5. egfr-tki resistance, confirmed by recist 1.1 6. the eastern cancer cooperative group (ecog) performance score of 0 or 1; exclusion criteria: 1. history of severe allergies to any study drug 2. has previously received the following therapies: anti-pd-1, anti-pd-l1 or anti-pd-l2 drugs or any other stimulatory or inhibitory agents of t cell receptors 3. previous exposure to vegf inhibitor for anti-cancer treatment 4. patients with untreated symptomatic brain metastases. patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease. 5. has received a live-virus vaccination within 28 days of planned treatment start 6. interstitial lung disease or pneumonitis requiring oral or iv glucocorticoids pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
photodynamic therapy with polyhematoporphyrin for malignant biliary obstruction

Conditions: Klatskin's Tumor

Summary: photodynamic therapy (pdt) is a palliative treatment for malignant biliary obstruction. the aim of this study is to assess the feasibility and safety of this technique in the context of a nationwide retrospective analysis.

introduction malignant biliary obstruction is a life threatening condition in patients suffering from primary or secondary bile duct malignancies. palliative therapies aim to prevent complications associated with the obstruction. photodynamic therapy (pdt) aims to reduce the local tumor mass by inducing tumor necrosis after light activation of a photosensitizer during endoscopic retrograde cholangiography (erc). study aims the aim of the present study is to evaluate the feasibility and safety of pdt with polyhematoporphyrin, the photosensitizer most commonly used for pdt in austria, in the context of a nationwide analysis. methods this retrospective study will be conducted at seven austrian referral centers for bilio-pancreatic endoscopy. the study protocol was approved by the internal review board of the medical university of vienna (ek 1448/2012). patients who underwent pdt with polyhematoporphyrin as therapy for malignant biliary obstruction after 2004 will be identified using examination report databases. examination reports and patient charts will be analyzed to assess underlying diseases, oncological co-therapies, intra-procedural adverse events, hospital stay, adverse events within 30 days post intervention as well as 30-day, 90-day, and overall mortality. all patient data will be de-identified using pseudonymization prior to any further processing. descriptive statistics will be used to present the study parameters. survival will be assessed using kaplan-meier statistics and compared between the different underlying tumor entities using the log rank test. cox regression will be used to identify independent predictors of survival. significant factors at univariate analysis will be entered into multivariate testing. p-values less than 0.05 will be considered significant. spss version 23.0 will serve for data analysis.

Eligibility criteria:
inclusion criteria: * undergone photodynamic therapy as a treatment for malignant biliary obstruction. exclusion criteria: * none

Keywords: photodynamic therapy
genome-wide analysis of lipid-lowering efficacy and drug level of simvastatin and rosuvastatin

Conditions: Hypercholesterolemia

Summary: this study will perform a genome-wide association study (gwas) of the lipid responses to rosuvastatin and simvastatin and plasma concentrations of these two statins in a homogeneous group of han chinese patients.

a gwas will be performed on about 360 han chinese patients with hypercholesterolaemia (which may be familial or non-familial) who have previously participated in a research project on the pharmacogenetics of statins and who have been treated with rosuvastatin and simvastatin to determine the genetic factors that may be related to the reduction in plasma low-density lipoprotein cholesterol (ldl-c) and plasma concentrations of these two statins. the lipid profiles were measured at baseline on no lipid-lowering treatment and after 4-6 week treatment of rosuvastatin 10 mg daily and after treatment with simvastatin 40 mg daily for at least 6 weeks with at least a 4-week washout period between the two treatments. plasma concentrations of these two statins and their active metabolites about 12 hours after administration of statins have been measured by liquid chromatography-tandem mass spectrometry (lc-ms/ms). genotyping for the whole-genome scan will be carried out on the illumina ominiexpress beadchip (illumina, san diego, ca). the samples will be processed using the illumina iscan platform at the li ka shing institute of health science, the chinese university of hong kong (cuhk).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypercholesterolemia (familial or non-familial) * eligible for statin treatment according to local guidelines in the hong kong public hospital system. exclusion criteria: * taking other medication which may interact with the pharmacokinetics or lipid response to statins. * not willing to cooperate with study requirements.

Keywords: statins pharmacogenomics
prospective registration of patient data and quality of life in eye melanoma patients

Conditions: Uveal Melanoma

Summary: proqem is a prospective cohort study among patients diagnosed with uveal melanoma to assess quality of life before and in the first five years after treatment.

proqem is a prospective observational cohort study wherein patients with uveal melanoma are registered at diagnosis and are requested to fill in an array of questionaires before treatment and at 3, 6, 12, 24, 36 and 60 months after treatment. a comprehensive overview of the impact of their disease and treatment on quality of life is obtained by systematic assessment of the psychological impact of the initial diagnosis, eye symptoms, physical, emotional, social and role functioning. in addition, the proqem has a substudy called the proqem-pco (preferences, choices and outcomes) for the subgroup of patients who are eligible for both proton therapy and enucleation. they are invited to participate in research on patient preferences and shared decision-making. the consultations wherein the treatment decision is made are audiotaped and data on perceived shared decision-making, preferences, decision satisfaction and -regret are collected by questionaires at baseline and in the first 36 months after treatment.

Eligibility criteria:
inclusion criteria: * age ≥18 years * clinical or pathological diagnosis of a melanoma of the choroid or ciliary body * no signs of metastasis after staging procedures with at least an x-thorax, blood test and an ultrasound of the liver * treatment by brachytherapy, proton therapy or enucleation exclusion criteria: * none

Keywords: uveal melanoma quality of life shared decision-making patient preferences brachytherapy proton therapy enucleation
a randomized, controlled trial to determine the effects of an exercise intervention on physical activity during chemotherapy for patients with early stage breast cancer

Conditions: Early Stage Breast Cancer

Summary: this study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. one group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 met (metabolic equivalent task) hours per week. the other group will not receive a exercise prescription but their activity will be recorded. the hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.

this is a prospective, randomized, single institution feasibility trial. the efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. the investigators goal is to recruit 120 women and men. assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.

Eligibility criteria:
inclusion criteria: 1. women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks. 2. patients must have recovered from prior surgery. 3. patients must be able to walk unassisted without oxygen 4. patients must complete the physical activity readiness questionnaire with "no" answers to all questions; if patient responds with yes answers, or is over age 69, approval must be obtained from the patient's primary care physician or treating medical oncologist to participate in the study. 5. able to fast for 12 hours for blood work and basal metabolic rate measurement. 6. karnofsky performance status \> or = to 80%. 7. previous or ongoing physical therapy treatments are acceptable. 8. participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials. 9. participants must have a baseline activity level of \< 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the lteq (leisure time exercise questionnaire) for physical activity (completed during screening). exclusion criteria: 1. patients less than 18 years of age. 2. patients with history of acute mi (myocardial infarction) or cva (cerebral vascular accident) within the last 12 months. 3. patients who are oxygen dependent. 4. patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study. 5. patients with a karnofsky performance status of \< 80%. 6. pregnant. 7. unable to read or write in english.

Keywords: breast cancer, exercise
a phase 1 study of nov1601(chc2014) in adult subjects with solid organ malignancies

Conditions: Phase 1; Solid Tumor, Adult

Summary: this study is a first-in-human (fih) study which is required to understand the pk characteristics, mtd, and safety profile of nov1601(chc2014) in subjects with solid organ malignancies.

this is the first-in-human, phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, pk, and clinical activity of nov1601(chc2014) in subjects with solid organ malignancies. the primary goal of the study is to determine the rp2d of nov1601(chc2014) in adult subjects with solid organ malignancies. dose escalation will follow a 3+3 design and will be based on prior cohort review. there will be 2 branches of the dosing schedule, once a day(qd) and twice daily(bid).

Eligibility criteria:
inclusion criteria(partial): * pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease * at least one evaluable or measurable lesion should be present and identified according to response evaluation criteria in solid tumors(recist) version 1.1 or response assessment in neuro-oncology(rano) * relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable * patients with primary central nervous system(cns) tumors or metastasis, if they have been neurologically stable * symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment * stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study * subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(c1d1) without symptom aggravation exclusion criteria(partial): * prior high-dose chemotherapy requiring hematopoietic stem cell transplantation * history or evidence of suspicious leptomeningeal disease * previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule * indwelling percutaneous drainage of bile and chest tube * evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks

Keywords: tropomyosin receptor kinase solid organ malignancies
desmopressin for bleeding related to low body temperature

Conditions: Hypothermia Induced Impairment of Primary Haemostasis

Summary: to study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers exclusion criteria: 1. any known platelet or coagulation disorder. 2. pregnant or lactating women. 3. known chronic liver or renal disease. 4. coronary artery, carotid artery or peripheral artery disease 5. recent history of taking antiplatelet drugs, anticoagulants or herbal preparations. 6. smoker or alcohol user 7. mentally incapable of providing informed consent 8. students or junior staff members who had direct working relationship with the pi
extended pouch roux-en-y gastric bypass study

Conditions: Morbid Obesity

Summary: morbid obesity is an increasing medical problem in the western countries. it's related to comorbidities as diabetes mellitus, hypertension, osas, arthrosis and hypercholesterolemia. the roux-en-y gastric bypass (rygb) is an effective surgical therapy for morbidly obese patients. a part of these patients will have disappointing results, and have weight regain on the long term. some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity. the objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing rygb-surgery. we hypothesize that the restrictive/extended pouch results in more weight reduction. the study design is a prospective, randomized control trial. the patients will be randomized in 2 groups: a standard rygb (normal pouch) and restrictive/extended pouch rygb.


Eligibility criteria:
inclusion criteria: patient eligible for bariatric surgery according fried guidelines primary gastric bypass * bmi 35 - 40 with a comorbidity * or bmi \> 40 exclusion criteria: * exclusion criteria for bariatric surgery (fried guidelines) * patients with language problems that interveins to follow medical advises * genetic diseases that intervens to follow medical advises * chronic bowel diseases * nephrologic (mdrd \<30) of liver diseases (ast/alt more than twice the norm) * pregnancy

Keywords: bariatric surgery roux-en-y gastric bypass
effects of selexipag in adults with raynaud's phenomenon secondary to systemic sclerosis

Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis

Summary: the primary objective of the study is to determine the activity of selexipag on raynaud attack frequency in subjects with raynaud's phenomenon (rp) secondary to systemic sclerosis (ssc).


Eligibility criteria:
key inclusion criteria: * signed informed consent prior to any study-mandated procedure. * male and female subjects aged 18 years and above with a history of recurrent multiple weekly rp attacks secondary to ssc. * women of childbearing potential must agree to use a reliable method of birth control. key exclusion criteria: * known moderate or severe hepatic impairment (i.e. child-pugh c). * known hypersensitivity to selexipag or drugs of the same class, or any of their excipients. * subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit. * subjects who have received a phosphodiesterase type 5 (pde-5) inhibitor within 1 week prior to the screening visit. * any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: calcium channel blockers, nitrates or nitric oxide donors, era's, alpha-blockers, antithrombotic agents, nsaids (occasional use allowed), angiotensin converting enzyme (ace) inhibitors, beta-blockers, clonidine, systemic corticosteroids, fluoxetine. * severe renal insufficiency (at randomization). * any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

Keywords: systemic sclerosis raynaud's phenomenon