Kornimate/medical-research-clean huggingface dataset:
matched unrelated donor transplant for metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: the purpose of this study is to find out what effects (good and bad) a stem cell transplant from an unrelated donor will have for patients with kidney cancer that has spread to other parts of the body (metastasized).

standard treatment for kidney cancer that has spread to other parts of the body may include immunotherapy (a therapy that uses the body's natural immune system to fight cancer) and cytokines (proteins found in the body). if these treatments are not successful at controlling the cancer then chemotherapy or thalidomide are used. chemotherapy and thalidomide will not cure kidney cancer but they may control the disease in some patients. in some patients, transplants are now proposed for study. stem cells (from bone marrow or the bloodstream) are normally used to treat cancers of the blood, not kidney cancer. since researchers are still learning about using stem cell transplants for kidney cancer, the study is considered a research study. patients participating in this study will receive smaller doses of chemotherapy drugs to prepare them for the transplant than patients who have a standard transplant. this type of transplant is called a "reduced intensity" transplant. a reduced intensity transplant uses the cell-killing activity of the transplanted donor stem cells to attack the recipient's cancer cells. this is called graft-versus-tumor-effect (gvt). previous studies have shown that gvt may be greater if the donor is not related to the recipient.

Eligibility criteria:
inclusion criteria: * diagnosis of metastatic (stage iv) renal cell carcinoma (rcc) predominately clear cell type * prior nephrectomy * available hla-matched (8/8, 7/8) unrelated donor * at least one prior immunotherapy; or immunotherapy + chemotherapy; or targeted therapy, for metastatic rcc. * adequate organ function exclusion criteria: * prior allogeneic stem cell transplantation * rcc with histology other than clear cell type * history or presence of brain metastasis

Keywords: metastatic renal cell carcinoma unrelated donor transplant stage iv clear cell
sexual health in breast cancer patients

Conditions: Breast Cancer

Summary: in the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.

in the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. the objectives are as follows: 1. to characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship. we predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being. 2. to identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate. exclusion criteria: * patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
treatment efficacy for drug abuse and aids prevention - 1

Conditions: Cocaine-Related Disorders; Heroin Dependence

Summary: the purpose of this study is to assess the safety and effectiveness of buprenorphine for treatment of concurrent intravenous heroin and cocaine dependence.


Eligibility criteria:
please contact site for information.

Keywords: opioid addiction cocaine addiction
evaluation of post-discharge surveillance mobile application for surgical site infection

Conditions: Surgical Wound Infection

Summary: objective: evaluate the effectiveness and usability of a mobile application for post-discharge surveillance of surgical site infection as a support system for clinical decision.

introduction: infection of the surgical site (ssi) is one of the main infections related to health care, culminating in financial losses to the health system and high morbidity and mortality, which due to increasingly shorter hospital stays, from 13 to 75% is manifested at home of the patient, requiring health professionals to act more effectively in post-discharge surveillance of this condition. therefore, considering this problem and the constant evolution of technological resources, with the increase in access and use of smartphones by the population, it is pertinent to develop a mobile application for post-discharge surveillance of surgical site infection. objective: evaluate the effectiveness and usability of a mobile application for post-discharge surveillance of surgical site infection as a support system for clinical decision. method: randomized clinical trial to assess effectiveness of a mobile application for post-discharge surveillance of infection of the surgical site. the study will be developed in a large hospital in the city of são paulo and the study participants will be surgical patients. expected results: the mobile application for post-discharge surveillance is expected to collaborate in the early detection of potential cases of surgical site infection, to be able to improve post-discharge surveillance strategies, assist in data management, decision making and actions to prevent infection of the surgical site.

Eligibility criteria:
inclusion criteria: * surgical patients aged 18 to 70 years * conscious, oriented, * literate * have a smartphone compatible with the use of the application * submitted to traditional anesthetic-surgical procedure * classified as potentially contaminated * experience the postoperative period at home exclusion criteria: * patients with visual impairment * physical restriction or communication problems * undergoing surgery with implants * videolaparoscopies or robotics sugery * who already have the diagnosis of ssi at the time of discharge * have been admitted to the intensive care unit in the postoperative period

Keywords: mobile applications patient discharge surgical wound infection public health surveillance perioperative nursing.
evaluation of a low-fluoride anticaries toothpaste

Conditions: Tooth Abnormality

Summary: the purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus ftcp technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). there will be two test legs.


Eligibility criteria:
inclusion criteria: * 30 adult subjects (between 18-50 years of age)

Keywords: anti-erosion dental benefits
carbohydrate antigen 125-guided therapy in heart failure

Conditions: Heart Failure

Summary: preliminary data suggest a potential role for monitoring and up-titrate pharmacological therapy of plasma levels of antigen carbohydrate 125 (ca125) following and admission for acute heart failure (ahf). this study will evaluate the effect of a ca125-guided management strategy versus standard therapy on the composite endpoint of 1-year all-cause mortality or readmission for ahf in patients recently discharged for ahf.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * at least 1 admission for ahf, in the last 180 days. * demonstrates functional new york heart association status of class ≥ii at the moment of enrollment. * objective evidence, either during the index admission or at least 180 days before enrollment, of a structural or functional abnormality of the heart at rest, and defined as: n terminal-pro-brain natriuretic peptide \>1000 pg/ml or brain natriuretic peptide \>100 pg/ml or echocardiographic abnormalities congruent with hf diagnosis such as: systolic left ventricular dysfunction (lvef \ 104 g/m2 in women or 116 g/m2 in men); ee'\>15 or significant valvular heart disease (moderate-severe). * a plasma ca125 value \>35 u/ml in a recent test evaluation (at least 30 days before enrollment, and preferably assessed before hospital discharge). * patient must be capable of understanding and signing an informed consent form. exclusion criteria: * life expectancy \<12 months due to other diseases different from hf. * having undergone a cardiac transplantation, coronary revascularization procedure (percutaneous coronary intervention and/or coronary artery bypass grafting) or cardiac valve replacement in the past 3 months. * angina pectoris higher than class ii (canadian cardiovascular society classification). * pregnancy at the moment of enrollment. * valvular heart disease already scheduled for surgical intervention. * severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration. * serum creatinine level \> 3 mg/dl or chronic renal insufficiency on dialysis treatment. * patients receiving resynchronization therapy during the index admission. * significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the screening period, endometriosis, cirrhosis, acute coronary syndrome within 6 months, uncontrolled hypertension, history of human immunodeficiency virus (hiv) infection, or a significant active infection. * participating in another randomized study.

Keywords: heart failure biomarker guided-therapy carbohydrate antigen 125 clinical outcomes.
early intervention to reduce bone loss after spinal cord injury

Conditions: Spinal Cord Injury; Osteoporosis

Summary: after a complete spinal cord injury (sci), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. it has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic sci. through a previous longitudinal study, in which we described rates of bone loss in the first year of sci using peripheral quantitative computed tomography (pqct), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (bmd) in the first 12 months post-sci. as a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and "red-flag" those patients at highest risk of rapidly weakening bones. we propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before bmd reaches dangerously low values. in this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pqct study. for this, we aim to trial a physical intervention, whole body vibration (wbv), that could potentially reduce rates of further bone loss in fast bone losers. vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. if shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with sci.


Eligibility criteria:
inclusion criteria: * motor-complete spinal cord injury (sci) * sci at neurological levels c4 and below * within six weeks of sci exclusion criteria: * recent bilateral fractures in tibia and/or femur * previously diagnosed osteoporosis * pregnancy

Keywords: fractures immobilisation paraplegia tetraplegia
a study of vismodegib (gdc-0449, hedgehog pathway inhibitor) with concurrent chemotherapy and bevacizumab as first-line therapy for metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this was a randomized, placebo-controlled, double-blind study of vismodegib (gdc-0449) added to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (crc), with treatment until disease progression. patients received either folfox (fol=leucovorin calcium \[folinic acid\], f=fluorouracil, ox=oxaliplatin) or folfiri (fol=leucovorin calcium \[folinic acid\] f=fluorouracil, iri=irinotecan hydrochloride) chemotherapy with bevacizumab. the decision of which regimen (folfox or folfiri) to use was made by the treating physician and patient. patients were randomized to receive vismodegib or placebo and were stratified based on the chemotherapy regimen chosen and whether or not response evaluation criteria in solid tumors (recist) measurable disease was present at baseline.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologically confirmed metastatic colorectal cancer (crc) * representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior to entry of study * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate hematopoetic capacity * adequate hepatic function * adequate renal function * use of an effective method of barrier contraception (for women of childbearing potential) * signed informed consent exclusion criteria: * prior chemotherapy for metastatic crc or adjuvant chemotherapy for crc within the prior 6 months * clinically suspected or confirmed cns metastases or carcinomatous meningitis * major surgical procedure within 4 weeks prior to the first day of treatment in this study (day 1) * pelvic radiation within 2 weeks prior to day 1 * wound dehiscence requiring intervention, gastrointestinal perforation, or bowel obstruction * pregnancy or lactation * uncontrolled medical illnesses including the following: infection requiring intravenous (iv) antibiotics, congestive heart failure not controlled with medication, hypertension not controlled with medication * thromboembolic disease * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications

Keywords: hedgehog crc colorectal cancer hedgehog pathway inhibitor
feasibility and effectiveness of a real-time heart team approach in complex cad

Conditions: Cardiovascular Diseases; Coronary Artery Disease; Multidisciplinary Communication

Summary: this study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.

this study is a multicenter, randomized controlled trial. according to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. patients will be randomly assigned to the real-time heart team group and the conventional heart team group by block randomization. the real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. patients who are not randomized will be registered. this study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.

Eligibility criteria:
inclusion criteria: 1. significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels\[significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.\] 2. at least 1 significant stenosis in all 3 major epicardial territories supplying viable myocardium; 3. other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations. exclusion criteria: 1. less than 18 years of age; 2. previous history of pci or cabg; 3. admitted for ami, ecg and biomarker detection indicated acute stage; 4. patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment; 5. combined with af or severe arrhythmia; 6. other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization; 7. rejection or exclusion of a revascularization mode (pci or cabg); 8. refuse to participate in the study.
mgc health covid-19 & flu a+b home multi test usability study

Conditions: COVID-19; Influenza A; Influenza B

Summary: the purpose of this study is to evaluate the usability of the mgc health covid-19 \& flu a+b home multi test in home use.

the mgc health covid-19 \& flu a+b home multi test is a lateral flow immunochromatographic antibody assay intended for the simultaneous qualitative detection and differentiation of the nucleocapsid antigen from sars-cov-2, influenza a and/or influenza b directly from anterior nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection within five (5) days of symptom onset. this test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user collected anterior nares swab samples from individuals aged 2 to 13 years. the objective of the study is to determine the usability of the mgc health covid-19 \& flu a+b home multi test in a simulated home use environment. this is an open label study to evaluate the usability of the mgc health covid-19 \& flu a+b home multi test using information from the quick reference instructions (qri).

Eligibility criteria:
inclusion criteria: * an institutional review board (irb) approved informed consent / assent, if applicable, is signed and dated prior to any study related activities. * male and female subjects 2 years of age and older. * subject is willing to provide a self-collected nasal swab sample. (if the subject is under the age of 14, an adult lay user will collect the sample.) * subject agrees to complete all aspects of the study. exclusion criteria: * subject has a visual impairment that cannot be restored with glasses or contact lenses. * subject has prior medical or laboratory training. * subject uses home diagnostics, e.g., glucose meters, hiv tests. * subject has prior knowledge of their current covid-19 or flu infection status.

Keywords: covid-19 flu a flu b influenza
a study of jnj-64619178, an inhibitor of prmt5 in participants with advanced solid tumors, nhl, and lower risk mds

Conditions: Neoplasms; Solid Tumor, Adult; Non-Hodgkin Lymphoma; Myelodysplastic Syndromes

Summary: the purpose of the study is to identify the maximum tolerated dose (mtd) of jnj-64619178 in participants with relapsed/refractory b cell non-hodgkin lymphoma (nhl) or advanced solid tumors and also to identify the recommended phase 2 dose(s) (rp2ds) of jnj-64619178 for nhl and advanced solid tumors (part 1) and to confirm the tolerability of jnj-64619178 in participants with lower risk myelodysplastic syndromes (mds) (part 2).

the study is designed to determine the maximum tolerated dose (mtd) of jnj-64619178, and to select a dose(s) and regimen(s) that may be used in future clinical development. study evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations (disease assessments). adverse events will be evaluated throughout the study. the study is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment phase, and a post treatment follow-up phase. an end-of-treatment visit will be completed less than or equal (\<=) 30 days (+7 days) after the last dose of study drug or prior to the start of a new anticancer therapy, whichever comes first.

Eligibility criteria:
inclusion criteria: * b cell non-hodgkin lymphoma (nhl) or solid tumors, or lower risk mds * at least 1 measurable site of disease for b cell-nhl and solid tumors * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * adequate organ function * women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) at screening and prior to the first dose of study drug. women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug exclusion criteria: * history of, or known, central nervous system (cns) involvement * prior solid organ transplantation * either of the following: a) received an autologous stem cell transplant less than or equal (\<=) 9 months before the first dose of study drug b) prior treatment with allogenic stem cell transplant * history of malignancy (other than the disease under study) within 3 years before the first administration of study drug. exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years * known allergies, hypersensitivity, or intolerance to jnj-64619178 or its excipient

Keywords: lower risk mds low risk mds lower-risk mds low-risk mds intermediate 1 risk mds intermediate-1 risk mds