Kornimate/medical-research-clean huggingface dataset:
clinical trial of electroacupuncture stimulation on prevention and treatment of oxaliplatin neurotoxicity

Conditions: Neurotoxicity; Gastrointestinal Neoplasms

Summary: the clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.this trail is randomized controled.patients are diagnosed gastrointestinal cancer based on pathology or cell biology.they are randomized into 2 groups:both groups receive oxaliplatin regimen.the treatment group receives electroacupuncture in addition to the chemotherapy.the control group only receive the same chemotherapy with the treatment group.both group have the same adjuvant therapy.

the clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.this trail is randomized controled.patients are diagnosed gastrointestinal cancer based on pathology or cell biology.they are randomized into 2 groups:both groups receive oxaliplatin regimen.the treatment group receives electroacupuncture in addition to the chemotherapy.the control group only receive the same chemotherapy with the treatment group.both group have the same adjuvant therapy.mainly to study about oxaliplatin into electroacupuncture leads to the influence of the peripheral nerve toxicity.other clinical evaluation includes chemotherapy drug toxicities,quality of life(qol), etc.

Eligibility criteria:
inclusion criteria: 1. age:18-80 ; 2. male and female ; 3. signed the informed consent form; 4. eastern cooperative oncology group(ecog)o-2,life expectancy more than 3 months; 5. indication for chemotherapy,no contraindication; 6. first time chemotherapy or at least 6 months after last chemotherapy and radiotherapy; 7. at least 8 weeks after last biotherapy; 8. surgery:had not received transplantation surgery,at least 2 weeks after last major surgery. exclusion criteria: 1. chemotherapy is contraindicated; 2. having the primary disease can cause the neuropathy; 3. a history of other malignant tumor in recent 5 years; 4. less than 6 months after last chemotherapy or radiotherapy; 5. less than 8 weeks after last biotherapy; 6. being afraid of acupuncture seriously; 7. had received transplantation surgery,less than 2 weeks after last major surgery; 8. other researchers think is not suitable for this clinical trail.
a physical activity program to disrupt sedentary time in older latinos

Conditions: Sedentary Behavior; Cognitive Impairment

Summary: to test the feasibility of an intervention designed to replace sedentary time with physical activity in older latinos, delivered in their homes to improve cognitive function and brain connectivity.

after being informed of the study and potential risks, all patients giving informed consent will undergo a focused phone interviews, followed by screening to determine eligibility. participants that meet inclusion criteria will undergo baseline cognitive function testing via video (following nih toolbox guidelines for remote cognitive function assessment), followed by a one week measurement of sedentary time using a physical activity monitor (actigraphy). at week 0, participants will be randomized into either a physical activity group to break up sedentary time or activity guidelines only in a 1:1 ratio. follow up occurs at 6 weeks using the same measures as baseline.

Eligibility criteria:
inclusion criteria: * no history of major head trauma * ownership of a smartphone * ability to make video calls exclusion criteria: * requires assistive ambulation; * unstable angina, * claudication * severe arthritis, * extreme dyspnea on exertion, * class iii-iv heart failure; * current uncontrolled sustained arrhythmias, * severe/symptomatic aortic or mitral stenosis, * hypertrophic obstructive cardiomyopathy, * severe pulmonary hypertension, * active myocarditis/pericarditis, * thrombophlebitis, * recent systemic/pulmonary embolus (within 3 months); * revascularization procedures within the previous 6 months; * pregnancy

Keywords: sedentary behavior physical activity cognitive health older adults latinos
study to determine the utility of novel technologies and biomarkers to measure human response to rosiglitazone maleate

Conditions: Diabetes Mellitus, Type 2

Summary: insulin resistance (ir) is common in many metabolic disorders and predisposes an individual to type 2 diabetes mellitus (t2dm), the metabolic syndrome and coronary atherosclerosis. non-diabetics with ir are at risk, but can be difficult to diagnose. a major problem with the use of ir as a predictor or marker of disease is the lack of a simple, robust test that can be used to quantify this parameter in a wide variety of clinical situations. the current 'gold standard' methods for measuring insulin sensitivity, such as the hyperinsulinemic-euglycemic (h-e) clamp, are complex, time consuming and costly. alternative, simpler methods, such as the homeostasis model assessment (homa-ir) score, may be less accurate and are not widely accepted.

a single-center, non-randomized, open-label, comparative study to assess the utility of novel technologies and biomarkers as methods for measuring human pharmacodynamic response to 8 weeks of administration of rosiglitazone maleate 4mg bid in healthy normal or overweight controls, healthy obese subjects and subjects with type 2 diabetes mellitus (t2dm).

Eligibility criteria:
inclusion criteria: * male and/or females aged 18-65 years * females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception. * healthy normal or overweight control subjects or healthy obese subjects or subjects with t2dm. exclusion criteria: * clinically significant past or current medical conditions * clinically significant abnormalities in vital signs or routine laboratory parameters

Keywords: total body water t2dm, healthy obese, insulin resistance, rosiglitazone maleate, glucose disposal, hyperinsulinemic-euglycemic clamp,
health education vs. health education plus physical therapy for low back pain patients

Conditions: Low Back Pain

Summary: the primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in primary care of the spanish national health service. this is a controlled, cluster randomized community trial.


Eligibility criteria:
inclusion criteria: * consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery. exclusion criteria: * inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration; * diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years; * suspicion of fibromyalgia.

Keywords: low back pain, health education, physical therapy
prophylactic antibiotics in endoscopic secondary prevention of gastroesophageal variceal bleeding

Conditions: Cirrhosis, Liver; Hypertension, Portal; Variceal Hemorrhage

Summary: whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of gvb or not is unclear. in this non-inferiority trial, we are aimed to evaluate whether prophylactic antibiotics are essential in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding (gvb). endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding (gvb). however, the value of prophylactic antibiotics in the endoscopic secondary prevention of gvb is still unclear. it's assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding. besides, the surface of intraluminal varices is nonsterile, and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia. as a result, it's rational to use antibiotics prophylactically in the endoscopic sequential therapy of gvb. while giving antibiotics in all patients might cause abuse of antibiotics. in clinical practice now, the prophylactic administration of antibiotics is quite subjective. we observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding, even they have not been administered prophylactic antibiotics. in this non-inferiority trial, we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not, in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

Eligibility criteria:
inclusion criteria: cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form. exclusion criteria: 1. allergy to cephalosporin. 2. the patient is unwilling to sign the informed consent form. 3. already have concurrent infection before the endoscopic operation. 4. already have fever (body temperature \> 37.5 ℃) before the endoscopic operation. 5. have granulocyte deficiency (neutrophil count below 0.5 \* 10 \^ 9/l) before the endoscopic operation. 6. have massive pleural effusion or ascites before the endoscopic operation.

Keywords: gastroesophageal variceal bleeding endoscopic secondary prevention prophylactic antibiotics
pediatric epidemiology of cardiovascular disease risk factors (project heartbeat)

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis

Summary: to conduct a longitudinal, natural history study of cardiovascular disease risk factors in children. growth curves were compared for levels of blood pressure, lipids, cardiac structures and function, and related to physical growth and maturation, nutrient intake, physical activity, body composition, puberty, and smoking.

background: both the pathologic precursors of atherosclerosis and the development of its major risk factors -- blood pressure, blood lipids, and cigarette smoking -- are often far advanced before age 20 or within the period from birth or conception through adolescence. in 1990, there was growing interest in understanding these aspects of human biology and in devising appropriate preventive measures. in 1990, knowledge about the risk factors during childhood and adolescence was based mainly on cross-sectional surveys, from which very striking and consistent patterns of change with age were inferred, and from which reference values for screening and management were derived. both growth and sexual maturation influence these patterns strongly, yet these risk factors had only recently been taken into account in 1990, only partially in screening recommendations for blood pressure and not at all for cholesterol. design narrative: subjects were selected by simple random sampling. data were collected on dependent variables including blood pressure, heart rate, echocardiography, doppler flow, blood lipids, and smoking. independent variables included growth, diet and nutrition, electrolytes, physical activity and fitness, personal, family, and social history, and bone age. most observations were recorded at four month intervals. there was a six month pretest recruitment period, four years of cycled measurements and data collection, and six months of analysis and reporting. curves for both velocity and acceleration of growth for attained levels of blood pressure, blood lipids, and smoking were determined as were longitudinal relationships between individual growth curves of blood pressure, echocardiographic measures, physical growth, sexual maturation, body composition, diet, physical activity, and social factors. dr. labarthe has several r03 grants to analyze data from project heartbeat. see also study 4962. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
short-term androgen priming before cos using aromatase inhibitor and hcg during early-follicular-phase gnrh antagonist administration - a randomized controlled trial

Conditions: Infertility

Summary: we want to investigate if early follicular phase downregulation and androgen priming, by use of gnrh antagonist, aromatase inhibitor and hcg before coh in a short protocol, shows signs of improvement compared to standard short antagonist protocol


Eligibility criteria:
inclusion criteria: * indication and wish for ivf/icsi treatment * womens age 20-39 years (both inclusive) * regular menstrual cycle within normal range * body mass index: 18-30 kg/m2 (both inclusive) * negative pregnancy test before treatment * a maximum of 3 earlier ivf/icsi treatments that did not result in pregnancy exclusion criteria: * serious systemic disease * presence of polycystic ovarian syndrome (pcos) * earlier poor response with less than 4 mature follicles * earlier participation in the investigation
randomized phase ii study of ixabepilone alone and ixabepilone plus cetuximab as first-line treatment for female subjects with triple negative locally advanced non-resectable and/or metastatic breast cancer

Conditions: Triple Negative Locally Advanced Non-resectable Breast Cancer; Metastatic Breast Cancer

Summary: the purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor \[er\], progesterone receptor \[pr\], human epidermal growth factor receptor 2 \[her2\] negative) locally advanced non-resectable and/or metastatic breast cancer


Eligibility criteria:
inclusion criteria: * female subjects with triple negative (er, pr, and her2 negative) locally advanced non-resectable and/or metastatic breast cancer * prior adjuvant or neoadjuvant anthracycline-based chemotherapy exclusion criteria: * tumors that are fluorescence in situ hybridization test (fish) positive or immunohistochemistry (ihc) 3+ * neuropathy \> grade 1 * prior systemic therapy for metastatic disease
carboplatin in castration-resistant prostate cancer

Conditions: Prostatic Neoplasm

Summary: open label, non-randomised phase ii clinical pilot study

pilot study of weekly carboplatin in patients with advanced metastatic castration-resistant prostate cancer (crpc) and dna repair defects

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. adult patients with histological diagnosis of adenocarcinoma of the prostate. 3. metastatic castration-resistant prostate cancer (mcrpc) 4. progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (cyp17 inhibitor or a new generation aa like enzalutamide). 5. dna repair defects as per central assessment 6. eastern cooperative oncology group (ecog) performance status (ps) 0 - 2 7. progression of disease by any of the criteria listed here: * psa utilizing pcwg 2 criteria * bone scan * recist 1.1 8. adequate organ and bone marrow function as evidenced by: * haemoglobin ≥8.0 g/dl * absolute neutrophil count ≥1.5 x 109/l * platelet count ≥ 100 x 109/l * ast and/or alt \< 2.5 x uln, in the presence of liver metastases: ast ≥5 x uln, alt \<5 x uln * total bilirubin \< 2.0 x uln (except for patients with gilbert's disease) * creatinine clearance ≥30ml/min 9. patient must agree in the biomarker studies including the fresh tumour biopsies exclusion criteria: 1. contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product carboplatin 2. prior treatment with any prior platinum based chemotherapy, 3. major surgery within 4 weeks prior to planned start of treatment 4. known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids 5. inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant 6. previous enrolment into the current study 7. active secondary malignancy that requires systemic therapy.
a study evaluating the safety and efficacy of beam-201 in relapsed/refractory t-cell acute lymphoblastic leukemia (t-all) or t-cell lymphoblastic lymphoma (t-ll)

Conditions: Lymphoblastic Lymphoma; T-Cell Lymphoblastic Leukemia/Lymphoma; Lymphoblastic Leukemia

Summary: this is a phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of beam-201 in patients with relapsed/refractory t-all or t-ll. this study consists of phase 1 dose-exploration cohorts, phase 1 dose-expansion cohort(s), a phase 1 pediatric cohort (will enroll patients ages 1 to \< 12 years), and a phase 2 cohort.


Eligibility criteria:
key inclusion criteria: 1. ages 18 to ≤ 50 years. 2. ages ≥ 1 year to \< 18 years, after health authority approval. 3. t-all/t-ll that is cd7-positive (defined as at least 20% of blasts positive for cd7 by flow cytometry or immunohistochemistry based on assessment of the study site's clia \[clinical laboratory improvement amendments of 1988\] certified facility) in second or greater relapse, first relapse post-transplant relapse, or chemotherapy-refractory disease. specifically: 1. second or greater relapse or post-transplant relapse, defined as: * bm with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening after second documented cr; or * flow cytometric confirmation of relapsed t-all of at least 0.1% after second cr documented to have been mrd negative \< 0.1%; or * any detectable relapsed disease post-allogeneic hsct with flow cytometric confirmation of t-all of at least 0.1%; or * biopsy confirmed evidence of relapsed t-ll on lymph node biopsy after second cr; or * any detectable disease post-allogeneic transplant with biopsy confirmed evidence of t-ll on lymph node biopsy 2. refractory disease, defined as: * primary refractory t-all or t-ll, defined as failure to achieve cr after induction chemotherapy, per investigator assessment and based on biopsy-confirmed evidence of residual t-all or t-ll; or * relapsed, refractory disease, defined as \> 5% bm blasts or biopsy-confirmed evidence of residual tll after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a cr note: patients with mixed phenotype acute leukemia with t-cell dominant phenotype may be enrolled if the aforementioned criteria are met. 4. eligible for myeloablative conditioning for and allogeneic hsct based on the investigator's assessment with an available donor identified by a fact accredited transplant center. key exclusion criteria: 1. cns involvement meeting any of the following criteria: cns-3 disease, progressive cns involvement despite therapy, cns parenchymal or cranial nerve lesions on imaging. 2. clinically active cns dysfunction or known history of irreversible neurological toxicity related to prior antileukemic therapy. 3. receipt of prior cd7 targeted therapy. 4. systemic antileukemic therapy intended to induce or maintain remission within 14 days prior to completion of screening.

Keywords: lymphoblastic leukemia lymphoblastic lymphoma base editing car-t
study to demonstrate equivalent efficacy and to compare safety of biosimilar etanercept (gp2015) and enbrel

Conditions: Chronic Stable Plaque Psoriasis

Summary: the purpose of this study is to demonstrate equivalent efficacy of gp2015 and enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to pasi 75 response rate at week 12.

the purpose of this confirmatory safety and efficacy study (gp15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of gp2015 and enbrel (eu-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between gp2015 and enbrel on efficacy, overall safety, and immunogenicity. since only eu-authorized enbrel was utilized in this study, the use of the term "enbrel" throughout this report describes eu-authorized enbrel only.

Eligibility criteria:
inclusion criteria: * men or women at least 18 years of age at time of screening * chronic plaque-type psoriasis diagnosed for at least 6 months before baseline * moderate to severe psoriasis as defined at baseline by: * pasi score of 10 or greater and, * investigator´s global assessment score of 3 or greater (based on a scale of 0 - 4) and, * body surface area affected by plaque-type psoriasis of 10% or greater * chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator. exclusion criteria: * forms of psoriasis other than chronic plaque-type * drug-induced psoriasis * ongoing use of prohibited treatments * previous exposure to etanercept * active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept other in-/exclusion criteria may apply