Kornimate/medical-research-clean huggingface dataset:
first line hepato cellular carcinoma (hcc)

Conditions: Hepato Cellular Carcinoma (HCC)

Summary: the purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced hcc who have not received prior systemic therapy.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * histologic or cytologic confirmed diagnosis of hcc. * advanced hcc: disease not eligible for surgical and/or locoregional therapies or progressive disease after surgical and/or locoregional therapies * child-pugh class a * ecog performance status 0-1 * adequate hematologic, hepatic, and renal function exclusion criteria: * prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for hcc * history of active cardiac disease * thrombotic or embolic events within the past 6 months (except hcc tumor thrombus) * any other hemorrhage/bleeding event \>= ctcae grade 3 within 8 weeks except for esophageal or gastric varices * inability to swallow tablets or untreated malabsorption syndrome
a registered cohort study on duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: dystrophinopathy is a term of x-linked recessive genetic disease, including duchenne muscular dystrophy, becker muscular dystrophy, and the x-linked dilated cardiomyopathy. the aim of this study is to determine the clinical spectrum and natural progression of dystrophinopathy in a prospective multicenter natural history study, to assess the clinical, genetic of patients with dystrophinopathy to optimize clinical management.


Eligibility criteria:
inclusion criteria: * beyond 2 years old * diagnosis with duchenne muscular dystrophy, and female carriers, genotypically confirmed * diagnosis should be supported by muscle biopsy, if no genetic confirmation. exclusion criteria: * presence of other clinically significant illness
remote home-based exercise program for strength training in endometrial cancer survivors in rural areas

Conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma; Stage IA Uterine Corpus Cancer AJCC V8; Stage IB Uterine Corpus Cancer AJCC V8

Summary: this clinical trial studies how well a remotely delivered home-based exercise program for strength training works to positively impact endometrial cancer (ec) survivorship for patients with decreased cancer survivorship access. cancer survivors in rural areas face barriers to supportive care, including geographic and environmental barriers to exercise and technology. rural areas in the midwest are underserved in terms of cancer care thus, it is essential to develop and test interventions that are scalable and can reach many individuals including those living in rural areas. remotely-delivered exercise intervention approach allows for cancer survivors who may live far away from their primary treatment center to engage in supportive therapy via exercise interventions delivered in a sustainable context. in addition, historically black, hispanic and native endometrial cancer survivors have shorter survival and less access to survivorship care, so alternative models for healthcare delivery are needed in this underserved group. information gained from this research may help determine whether utilizing a remotely delivered exercise program can positively impact ec survivorship for patients with decreased cancer survivorship access.

primary objectives: i. to develop and tailor a fully remote home-based exercise intervention for ec patients. ii. to test the recruitment and retention and acceptability of a fully remote home-based telehealth exercise intervention in older adult patients that live in rural america and are survivors of early stage, low risk endometrial cancer. iii. to measure the effectiveness of exercise intervention on quality of life in endometrial cancer patients, specifically in the realm of physical functioning. outline: participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study. after completion of study intervention, patients are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * age 50+ * stage ia-ib endometrial cancer * grade 1-2 disease * no recurrence documented * internet access * access to a remote device with a camera such as a computer, smartphone or tablet * \> 1 year but less than 5 years from surgery * primary residence in rural-urban commuting area (ruca) (rural-urban commuting area) codes 4.0 through 10.0 or of american indian, alaskan native, black or hispanic background exclusion criteria: * paraplegia/hemiplegia * no english speaking
evaluate the use of the magnetic resonance spectroscopy in determining if the breast tumor is benign or malignant

Conditions: Breast Tumors

Summary: magnetic resonance spectroscopy (mrs) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. while mrs does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. in this manner, biochemical information elucidated by mrs can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. the aim of mrs is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.

recent in vivo studies have reported successful use of 1h and 31p mrs in differentiating between benign and malignant tumors in breast tissue. these studies demonstrated an increase in the choline metabolite peak that reflects an increase in choline-containing metabolites in 70-80% of breast carcinomas, as compared to 14-18% of benign breast tumors.the objectives would be to determine sensitivity/specificity of mrs in the context of breast ca, we will use normal volunteers to test software and to develop and optimize mr scan sequences prior to or during the testing of target subjects with suspicious breast lesion.

Eligibility criteria:
inclusion criteria: * subjects should have well defined suspicious breast lesion and that will be biopsied * subjects are to include; varied volunteers with different breast tissue with characteristics such as dense breasts, fibrocystic breasts, "small" breasted and "large" breasted women. exclusion criteria: * women of childbearing potential who are not practicing a medically accepted method of birth control should not participate * subjects that are pregnant, breast-feeding, should not be able to participate * subjects having any of the following metallic devices, will be ineligible to participate in the study: pacemaker, prosthesis, artificial heart valve, coronary artery stents, tens (transcutaneous electric nerve stimulator) or other neurological stimulation units and surgical clips.

Keywords: breast diagnostic radiology suspicious breast tumors mri
intervention trial to decrease cardiovascular risk in persons with serious mental illness

Conditions: Cardiovascular Risk Factors; Serious Mental Illness

Summary: this study will determine whether a program where a health coach works with participants on heart healthy behaviors and treatment of risk factors is coordinated with primary care can reduce overall heart disease risk in people with serious mental illness.

the objective of this study is to perform a randomized clinical trial (ideal) to test a comprehensive cardiovascular risk reduction program for persons with serious mental illness. this trial will enroll adult mental health consumers with at least one cardiovascular risk factor and randomize them to the 18-month ideal intervention or control. intervention participants will receive individual cardiovascular risk reduction counseling, coordination with primary care providers to ensure appropriate management of risk factors, and collaboration with mental health staff and social supports to encourage and motivate participants to reach goals. all participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. the primary outcome will be the change in estimated cardiovascular risk from the global framingham risk score.

Eligibility criteria:
inclusion criteria: * ▪ age 18 and older ▪ body mass index at least 25 kg/m2 or one of the following cvd risk factors: * hypertension (sbp\>= 140mmhg or dbp\>= 90mmhg or on antihypertensive medications; * diabetes mellitus (fasting blood sugar\> 125mg/dl or hemoglobin a1c\>6.5 or on a hypoglycemic medication); * dyslipidemia (ldl \>130 mg/dl , hdl\ =200 or on a lipid lowering agent); * current tobacco smoker * able and willing to give informed consent * completion of baseline data collection * willing to accept randomization * willing to participate in the intervention exclusion criteria: * ▪ cardiovascular event (unstable angina, myocardial infarction) within the past 6 months * serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers) * condition which interferes with outcome measurement (e.g., dialysis) * pregnant or planning a pregnancy during study period. nursing mothers would need approval from physician. * alcohol or substance use disorder if not sober/abstinent for 30 days * planning to leave rehabilitation center or clinic within 6 months or move out of geographic area within 18 months * investigator judgment (e.g., for concerns about participant or staff safety)
study of 89zr-dfo-mstp2109a in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to see if a new diagnostic research agent named 89zr-dfo-mstp2109a can show prostate cancer tumors on a pet scan; as well as see how long 89zr-dfo-mstp2109a lasts in the blood when given in small amounts. dfo-mstp2109a is an antibody that works against steap1 - found on the surface of prostate cancer cells. attached to the dfo-mstp2109a is a radioactive material called 89zr, which allows it to be imaged by a pet scanner. the results of this study may help researchers know whether 89zr-dfo-mstp2109a can be used as a diagnostic agent for finding prostate cancer that have steap1 on its surface with a pet scanner. the reason why identifying steap1 on prostate cancer cells is that new therapies are being developed to target steap1 prostate cancer cells.


Eligibility criteria:
inclusion criteria: * to be included in this study, patients should be eligible for enrollment into protocol 11-016 (therapy with the dstp3086s adc) or meet all of the following criteria: * patients meeting the criteria for enrollment on research protocol 11-016 to receive dstp3086s adc (therapeutic adc based on mstp2109a) will be the preferred patients for this study. patients that are to receive dstp3086s will not be injected with dstp2086s until imaging with 89zr-dfomstp2109a is finished, approximately 1 week. * adult male \> 21years of age * visible lesions by either ct, bone scan or mri consistent with metastatic disease * metastatic progressive disease * imaging modalities: * bone scan: new osseous lesion and/or mri or ct: an increase in measurable soft tissue disease or the appearance of new sites of disease. or * psa changes over range of value 26% * patients with histologically confirmed prostate cancer at mskcc * steap1 antigen positive tissue known from prior ihc testing or if steap1 status is not known archival sample will be sent to genentech for ihc. samples need to be positive, when feasible metastatic lesions will be tested preferentially rather than the primary. * performance status of 60 or higher (karnofsky scale) (appendix a) * ability to understand and willingness to sign a written informed consent document * psa levels to be taken within 2 weeks of antibody administration. exclusion criteria: * patients meeting any of the following exclusion criteria will not be eligible for study entry: * previous anaphylactic reaction to human, humanized or chimeric antibody * hematologic * platelets \<75k/mcl * anc \<1.0 k/mcl * hepatic laboratory values * ast/alt \>2.5 x uln * renal laboratory values * bilirubin \>1.5 x uln (institutional upper limits of normal) * egfr \< 30ml/min/1.73m2 * patients with history of hypersensitivity reaction to any component of 89zr-dfomstp2109a, including dfo

Keywords: 89zr-dfo-mstp2109a tracer pet scan 12-178
hypertonic saline dextran in pediatric cardiac surgery

Conditions: Heart Defects, Congenital; Transposition of Great Vessels; Heart Septal Defects, Ventricular; Endocardial Cushion Defects

Summary: the purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.

after major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (cpb). we want to test whether a small infusion of 7.5% nacl in 6% dextran solution before and after cpb reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (il-6, il-8). we also measure extravascular lung water, fluid balance and weight during the first 24 hours post cpb.

Eligibility criteria:
inclusion criteria: * patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (cpb). * age below 17 weeks exclusion criteria: * preoperative: organ failure (other than heart), serum sodium \> 155 mmol/l, central venous pressure \> 12 mmhg * perioperative: core temperature \< 25 ºc on cpb, re-heparinization, re-operation

Keywords: cardiac surgery infant infant, newborn hypertonic solutions saline solution, hypertonic capillary leak inflammation mediators
role of cbc indices in acute lymphoblastic leukemia patients

Conditions: Lymphoblastic Leukemia

Summary: role of cbc indices in acute lymphoblastic leukemia patients to explore the prognostic role of them in prediction the response to induction chemotherapy

role of neutrophil to lymph ratio , lymphocyte to monocyte ratio and platelet to lymphocyte in acute lymphoblastic leukemia adults and pediatric patients to explore the prognostic role of them in prediction the response to induction chemotherapy

Eligibility criteria:
inclusion criteria: * patients newly diagnosed all exclusion criteria: * others malignanices * all on therapy
cost-effectiveness analysis and conditional response to the effect of positional devices in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea of Adult

Summary: the objectives of this study are: * to assess the effectiveness and cost-effectiveness of a vibrating positional device (nightbalance, philips) in the treatment of positional obstructive sleep apnea compared to conventional cpap treatment. * to investigate whether a positional device (nightbalance, philips) avoids supine position after a period of use of the device without actively using the device for a subsequent period of time.

non-inferiority clinical trial open to patients and investigators, multicenter, randomized and controlled to treatment with positional device (pd) and cpap to evaluate the effectiveness of treatment of positional obstructive sleep apnea with a pd (nightbalance, philips) compared to cpap after 6 months of continuous treatment (first phase) and the permanence of such efficacy after subsequent discontinuation of treatment (second phase). an initial respiratory polygraphy will be performed in all patients and the sleep study will be repeated at 6 months with pd and cpap. after its withdrawal, in those patients who respond, the respiratory polygraphy will be repeated at one week and one month.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * signed informed consent. * diagnosis of posa by respiratory polygraphy with the following criteria: * ahi ≥ 15/h or ahi ≥ 10/h and ahi \ 10 * ahi ns \<10/h (\<5/h in mild osa). * ahi is at least twice the ahi in ns * time in supine \>20%. * valid recording time\>4h exclusion criteria: * treatment of osa with cpap or dam in the previous month or treatment with surgery for osa at any time. * presence of other sleep disorders or central sleep apnea (central ahi \>50% of total ahi). * severe cardiovascular, neuromuscular or pulmonary pathology or chronic home oxygen use. * poorly controlled arterial hypertension or refractory arterial hypertension. * condition that makes it difficult or impossible to change position during sleep. * epworth scale score ≥ 16. * professional driver, heavy machinery operator or shift worker. * pregnancy. * treatment with medication that may interfere with alertness or drowsiness such as: sedative antidepressants, hypnotics, opioids, anticonvulsants or central nervous system stimulants.
scleral self-indentation chandelier-assisted peripheral vitrectomy under air rhegmatogenous retinal detachment.

Conditions: Retinal Detachment

Summary: the investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final logmar bcva; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. self-indentation enables complete trimming of the vitreous base without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with less need for chandelier shift than with non-indentation approach.

retrospective cohort study. one hundred and thirty eyes of 130 participants with primary rhegmatogenous retinal detachment were identified. all the participants had undergone a chandelier-assisted peripheral vitrectomy under air. scleral self-indentation had been used in 68 eyes (study group) (indentation group), while non-indentation had been used in 62 eyes (comparison group) (non-indentation group). outcome variables included: trimming-induced retinal breaks (tirb), retinal redetachment rate, final logmar bcva, and intraoperative complications.

Eligibility criteria:
inclusion criteria: - rrd with postoperative follow up \> 3 months, without pvr, or with pvr a-b exclusion criteria: * rrd with less than 3 months of postoperative follow-up, * rrd with proliferative vitreoretinopathy grade c (pvr c), * rrd with uveitis, * rrd with choroidal detachment, * giant retinal tears, * retinal dialysis, * myopic macular hole rrd, * traumatic rd, * children \< 16 years old, * the later vitrectomy (if vitrectomy had been performed for rrd in both eyes)

Keywords: scleral indentation chandelier light air vitrectomy rhegmatogenous retinal detachment
effects of glucosamine and chondroitin sulfate supplementation in addition to resistance exercise training and manual therapy in patients with knee osteoarthritis

Conditions: Osteoarthritis; Osteoarthritis, Knee

Summary: osteoarthritis (oa) is one of the most common joint disorders, affecting not only the joints but also the surrounding muscles, which become weak. resistance exercise reduces pain and improves function in patients with oa of the knee. nonsteroidal anti-inflammatory drugs (nsaids) are widely used by patients with oa to reduce pain and thereby maintain the ability to perform daily activities. however, there is accumulating evidence for a negative effect of nsaids, thus many patients with oa are treated with dietary supplementations such as glucosamine and chondroitin sulfate, and some studies show a beneficial effects on cartilage and pain. however, their effect on oa symptoms and cartilage remains controversial. thus, it is important to investigate whether a potentially beneficial effect of glucosamine and chondroitin sulfate with resistance exercise and manual therapy in patients with knee oa.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis for at least 3 months * knee pain no more than 8/10 * grade iii or less on radiograph (kellgren classification) exclusion criteria: * malignancy * any additional inflammatory disorders * infection * knee trauma * lower limb fracture * lumbar radiculopathy or myelopathy * knee surgery or replacement * intra-articular steroid therapy in the last 2 months

Keywords: chondroitin sulfate resistance exercise strength training manual therapy glucosamine joint mobilization
genetic trial to study diarrhea in patients with stage iii colon cancer who are receiving chemotherapy

Conditions: Colorectal Cancer; Diarrhea; Neutropenia

Summary: rationale: genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects. purpose: genetic study to determine how genes affect the severity of diarrhea in patients with stage iii colon cancer who are receiving chemotherapy.

objectives: * determine whether the presence of a 7 allele at the ugt1a1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage iii colon cancer after treatment with irinotecan, fluorouracil, and leucovorin calcium. * determine whether polymorphisms in the ts enhancer and/or mthfr gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium. * determine whether polymorphisms in ugt1a1, ts, mthfr, cyp3a4, or cyp3a5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan, fluorouracil, and leucovorin calcium. outline: patients are stratified according to prior therapy (irinotecan, fluorouracil, and leucovorin calcium vs fluorouracil and leucovorin calcium) and prior toxic effects (grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea and grade 2 or lower neutropenia). patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. genotyping assays are performed to determine ugt1a1 promoter genotyping, ugt1a1 coding polymorphisms, ts promoter polymorphisms, and mthfr polymorphisms.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iii adenocarcinoma of the colon * enrolled on calgb-89803 and must fall into 1 of the following categories: * received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following: * grade 3-4 diarrhea * grade 4 neutropenia * grade 1 or lower diarrhea and grade 2 or lower neutropenia * received fluorouracil and leucovorin calcium and experienced at least 1 of the following: * grade 3-4 diarrhea * grade 1 or lower diarrhea and grade 2 or lower neutropenia patient characteristics: age * 18 and over

Keywords: adenocarcinoma of the colon stage iii colon cancer diarrhea neutropenia