Kornimate/medical-research-clean huggingface dataset:
folfoxiri plus panitumumab in kras and braf wild-type metastatic colorectal cancer

Conditions: Metastatic Colo-rectal Cancer

Summary: the gono-folfoxiri regimen demonstrated higher activity and efficacy compared to folfiri in a phase iii trial. panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and associated with improved activity in kras codon 12-13 wild-type patients. braf and other ras rare mutations have been suggested as additional potential biomarkers for anti-egfr agents in metastatic colo-rectal cancer. the present study aims to demonstrate the feasibility and the activity of the first-line combination of the gono-folfoxiri regimen and panitumumab in molecularly selected metastatic colo-rectal cancer patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal adenocarcinoma; * availability of formalin-fixed paraffin embedded tumor block from primary or metastasis; * kras and braf wild-type status of primary colorectal cancer or related metastasis; * unresectable and measurable metastatic disease according to recist criteria; * male or female, aged \>/= 18 years and \</= 75 years; * ecog ps \< 2 if aged \< 71 years; * ecog ps = 0 if aged 71-75 years; * life expectancy of more than 3 months; * adequate haematological function: anc ≥ 1.5 x 109/l; platelets ≥ 100 x 109/l, hb ≥ 9 g/dl; * adequate liver function: serum bilirubin ≤ 1.5 x uln; alkaline phosphatase and transaminases ≤ 2.5 x uln (in case of liver metastases \< 5 x uln); * serum creatinine ≤ 1.5 x uln; * previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse; * at least 6 weeks from prior radiotherapy and 4 weeks from surgery; * written informed consent to experimental treatment and pharmacogenomic analyses; * magnesium ≥ lower limit of normal; * calcium ≥ lower limit of normal. exclusion criteria: * prior palliative chemotherapy; * prior treatment with egfr inhibitors; * symptomatic peripheral neuropathy ≥ 2 grade ncic-ctg criteria; * presence or history of cns metastasis; * active uncontrolled infections; active disseminated intravascular coagulation; * past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix; * clinically significant cardiovascular disease, for example cerebrovascular accidents (cva) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, nyha ≥ grade 2 chronic heart failure (chf), uncontrolled arrhythmia; * fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception; * subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment; * history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan.

Keywords: ras wild-type braf wild-type
health and health care utilization effects of medical debt forgiveness

Conditions: Health Care Utilization; Depression; Anxiety; Subjective Wellbeing

Summary: the goal of this study is to estimate the direct, causal impact of medical debt on health care utilization, mental health, and wellbeing of patients. the investigators will conduct a survey to measure the impact of the debt forgiveness on health care use, mental health, and wellbeing. the survey will be administered to approximately 17,000 subjects of a recent medical financial intervention. in that prior intervention, a non-profit charity, rip medical debt, purchased and abolished medical debt for a randomly selected about 6,000 (out of the 17,000) individuals. in this current protocol, the investigators will administer the survey, and will compare surveyed outcomes of subjects who received and did not receive the intervention.

this study will estimate the direct, causal impact of medical debt on health care utilization, mental health, and wellbeing of patients. to do so, the investigators will administer a survey to approximately 17,000 subjects of a recent medical financial intervention. in that intervention, a non-profit charity, rip medical debt, purchased and abolished medical debt for a randomly selected about 6,000 (out of the 17,000) study subjects. in this current protocol, the investigators will compare surveyed outcomes of subjects who received and did not receive the medical debt abolishment intervention. because debt abolishment was randomized, comparing surveyed outcomes of treated and control subjects in the cross-section will allow the study to estimate the causal impact of the medical debt abolishment. the survey will measure the effects of medical debt on three sets of outcomes: (i) health care utilization, as measured by medical care visits, prescription drug utilization and adherence, and unmet need for medical care; (ii) mental health, as measured by validated screens for depression and anxiety; and (iii) subjective wellbeing, as measured by self-reported health, forgone consumption, and financial strain. this study would be the first to provide a direct, causal connection between the rising personal debt associated with u.s. health care and the health outcomes of its recipients.

Eligibility criteria:
inclusion criteria: * individuals ages 18 and over who owed medical debt to ffam, a debt collections agency exclusion criteria: * excluded individuals who owed less than $500 in medical debt to ffam * excluded individuals with missing social security numbers

Keywords: health care utilization mental health depression anxiety subjective wellbeing medical debt
identification and evaluation of patients at risk of developing cardiotoxicity after receiving chemotherapy for breast cancer, lymphoma or leukemia

Conditions: Breast Cancer; Lymphoma; Leukemia

Summary: this is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. the study will involve retrospective and prospective evaluations. safety will be assessed through reporting of serious adverse events (saes) related to study procedures.

the aim of this study is to identify and evaluate cardiotoxicity in patients with diagnosis of breast cancer, lymphoma or leukemia scheduled to receive anthracycline-based chemotherapy (cohort a: prospective evaluation); and patients undergoing or having received within the last 5 years anthracycline-based chemotherapy (cohort b: retrospective and prospective evaluations). part a and b will be conducted in parallel. this study also has the objectif of identifying biomarkers of cardiotoxicity including inflammatory response proteins and clonal hematopoiesis.

Eligibility criteria:
inclusion criteria: * age 18 years or older at time of ct initiation * signed informed consent * patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects) * planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline * left ventricular ejection fraction (lvef) ≥50% pre-chemotherapy * the participant is willing to undergo cmr scans and all other required study procedures exclusion criteria: * known cardiomyopathy and/or lvef \<50% * known heart failure * history of myocardial infarction (mi) * clinically significant cardiac valvular disease * clinically significant pericardial effusion * allografted subjects * contraindications to cmr testing (cohort a \& prospective evaluation for cohort b): * pacemakers, other metallic implants or severe claustrophobia * weight \> 135 kg * patients with a history of previous allergic reaction to gadolinium * patients with history of seizure * renal insufficiency (egfr of \< 45ml/min/1.73m2 using the mdrd equation) * pregnant or breastfeeding women
immune reconstitution after allo-hsct and blinatumomab

Conditions: Leukemia, Lymphoid

Summary: the goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (r/r all) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-hsct). the main question it aims to answer is: • effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation. participants will undergo immune repertoire sequencing(ir-seq) before blinatumomab treatment, 6 months and 1 year after transplantation. researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if tcr or bcr expression differs.


Eligibility criteria:
inclusion criteria: 1. aged 16-65 years old 2. kps score \> 60 or ecog score 0-2 3. diagnosed as b-all, a) disease status \> cr1 at the time of transplantation; patients beyond cr1 or induction failure could be free of minimal residual disease (mrd). b) any residual disease, defined as \>0.01% leukemic cells by flow cytometry, bcr-abl transcript ≥ 1 in 10000 by pcr, or high-risk genetic abnormality 4. neutrophil count ≥0.5×10\^9/l and platelet count ≥20×10\^9/l 5. creatinine clearance ≥30ml/min; alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; total bilirubin ≤3 times the upper limit of detection 6. the first initiation of berintuzumab therapy was within 60-100 days after transplantation 7. without evidence of active acute graft-versus-host disease (agvhd) exclusion criteria: 1. with serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc 2. with clinically uncontrolled active infection 3. patients with central nervous system involvement before transplantation 4. poor graft function (pgf) occurred after allo-hsct 5. patients with second allogeneic transplantation
effect of the negative pressure therapy dressing compared with hydrogel dressing.

Conditions: Wound Infection, Surgical

Summary: the objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (pico ®) in the prevention of surgical wound infections (ssi) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "aquacel surgical".

negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed. negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy). all these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs. today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.

Eligibility criteria:
inclusion criteria: * undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy. * who signs informed consent after agreeing to participate in the microbiological study. exclusion criteria: * patients undergoing emergency cardiac surgery that does not time to randomization and/or coding. * patients with immunocompromised haematological diseases. * patients who are allergic or present some hypersensitivity to the dressing or excipient. * patients who are participating in another experimental study. * patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.
natural killer cells and polycythemia vera (vaquez's disease)

Conditions: Polycythemia Vera

Summary: natural killer cells (nk) are pivotal cells of innate immunity, that sense defective expression of hla class i molecules and are complementary to specific cytotoxic t lymphocytes. a defect in nk cell cytotoxicity has been described in some hematopoietic malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. this defect is at least partially linked to a decreased or absent expression of some activating nk cell molecules, more particularly the so-called natural cytotoxicity receptors (ncrs) nkp30, nkp44 and nkp46. some old publications have demonstrated defective nk cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia vera). the investigators more particularly focused their attention on polycythemia vera (vaquez's disease), a myeloproliferative disease characterized by the recently describet mutation v617f of the jak2 tyrosine kinase. the investigators will precise the mechanisms leading to this cytotoxicity defect, the investigators also will evaluate the implication of v617f mutation on nk physiology, and will study the interactions between nk cells and hematopoietic progenitors.


Eligibility criteria:
inclusion criteria: * polycythemia vera * treatment by therapeutic bleedings * no cytotoxic treatment during the previous six months exclusion criteria: * no polycythemia vera * no treatment by therapeutic bleedings * cytotoxic treatment during the previous six months

Keywords: treatment by bleedings
taxxel: taxotere and xeloda in esophageal cancer

Conditions: Cancer of the Esophagus; Gastric Cardia Carcinoma

Summary: this is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of taxotere in combination with xeloda which is dose escalated during the first phase of the study (modified fibonacci design) and fixed during the second phase. the primary objective of the phase 1 part is to define the dose recommended for the phase ii part of the study. the primary objective is to determine the response rate.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia. * inoperable metastatic disease * performance status (who) of 0-2 * measurable disease. * adequate hematological, liver and renal function. * signed informed consent. exclusion criteria: * cns metastases * symptomatic peripheral neuropathy equal to or greater than nci grade 2. * other concomitant serious illness or medical condition. * past or current history of malignant neoplasm other than oesophageal carcinoma. * \<18 years of age. pregnant or lactating patients.
perioperative family updates reduce anxiety and improve satisfaction

Conditions: Family Members; Anxiety; Satisfaction

Summary: this study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.


Eligibility criteria:
inclusion criteria: * patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures exclusion criteria: * age under 18 * non-english speaking patients or families * patients with families that would not be waiting in the hospital during the perioperative period
comparison of soy-milk and cow milk consumption on inflammatory factors, cardiovascular factors ,renal factors, fibrinolytic indice and oxidative stress among type-2 diabetic patients with nephropathy stage 1 and 2

Conditions: Inflammation; Oxidative Stress; Fibrinolytic Markers; Blood Pressure and Cardiorenal Risk Factors

Summary: soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(dn).most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with dn and there are few data about relationship of soy milk consumption and health effect in patients with dn . therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. this was a cross-over randomized clinical trial which was conducted in isfahan among diabetic nephropathy patients. patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.


Eligibility criteria:
inclusion criteria: * adults with (\>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had gfr more than 90 ml/min ) exclusion criteria: * exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women * changing dosage of oral hypoglycemic agents * insulin therapy * lipid-lowering medications * use of hormone replacement therapy * alcohol and cigarette consumption;allergy or intolerance to soybeans or milk * presence of breast malignant and avoid of advisory diet
study to evaluate the efficacy and safety of abt-450/ritonavir/abt- 267 (abt-450/r/abt-267) in japanese adults with genotype 2 chronic hepatitis c virus (hcv) infection

Conditions: Hepatitis C Virus

Summary: this is a phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. the purpose of this study is to evaluate the efficacy and safety of abt-450/r/abt-267 co-administered with weight-based rbv for 12 or 16 weeks in adult chronic hcv genotype 2-infected treatment-naïve and interferon (ifn) treatment-experienced subjects with and without compensated cirrhosis.


Eligibility criteria:
inclusion criteria: * chronic hcv-infection prior to study enrollment * screening laboratory result indicating hcv genotype 2 infection * subject has plasma hcv ribonucleic acid (rna) level greater than 10,000 iu/ml at screening * voluntarily sign an informed consent exclusion criteria: * co-infection of hepatitis b virus (hbv), human immunodeficiency virus (hiv) and any hcv genotype other than genotype 2 * prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir * any cause of liver disease other than chronic hcv-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease * clinically significant laboratory abnormalities * uncontrolled clinically significant disease, disorder or medical illness

Keywords: japanese hepatitis c treatment naive treatment experienced genotype 2 ombitasvir paritaprevir ritonavir ribavirin viekirax combination tablets
effects of individualized exercise training in patients with peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the study is designed to investigate individualized exercise training effects on arterial function, walking ability and quality of life in subjects with peripheral arterial disease post surgery.


Eligibility criteria:
inclusion criteria: * peripheral arterial disease post surgery \> 1 month * no discharge of surgical incision * intermittent claudication post invasive treatment exclusion criteria: * necrosis * above/below knee amputee * other conditions might affect peripheral vascular elasticity

Keywords: peripheral arterial disease walking ability quality of life exercise training
study of efficacy and safety of canakinumab in japanese patients with sjia

Conditions: Systemic Juvenile Idiopathic Arthritis

Summary: this was a phase iii study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in japanese patients with systemic juvenile idiopathic arthritis (sjia). interim analysis (ia) data at week 28 and 48 from this study supported a registration submission of canakinumab in the indication of sjia in japan.


Eligibility criteria:
inclusion criteria - confirmed diagnosis of sjia as per international league against rheumatism (ilar) definition (petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an onset of disease \< 16 years of age: arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following: rash due to sjia, lymphadenopathy, hepatomegaly/splenomegaly, serositis * active disease at the time of baseline defined as follows: * at least 2 joints with active arthritis * documented spiking, intermittent fever (body temperature \> 38°c) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose * c-reactive protein (crp) \> 30 mg/l(3 mg/dl) (normal range \< 10 mg/l(1 mg/dl)) * negative tb screen (chest x-ray and t-spot test) exclusion criteria: * with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of human immunodeficiency virus (hiv) infection, hepatitis b and hepatitis c infection. patients with resolved/previous hepatitis b infection (a negative hbs antigen, but a positive anti-hbs antibody and/or anti-hbc antibody). * with underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation. * with neutropenia (absolute neutrophil count \< 1500/mm3) at screening.

Keywords: acz885 canakinumab juvenile rheumatoid arthritis (jra) chronic systemic inflammatory disorder painful joints inflammation of the synovial membrane auto-immune rheumatoid disease reactive rheumatoid arthritis systemic juvenile rheumatoid arthritis (sjra) japanese patients