Kornimate/medical-research-clean huggingface dataset:
blood antioxidant status in chronic hepatitis c patients before and after antioxidant supplementation: a randomized clinical trial

Conditions: Hepatitis C; Oxidative Stress

Summary: the objective of the present study is to evaluate the antioxidant status in the blood of hcv patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin (1000 to 1250 mg) before and after supplementation of vitamins e, c and the mineral zinc (800 mg,500 mg and 40 mg; respectively) during six months.

the who estimated that around 170 million people are infected by hcv, about 3% of the world population. hcv is the leading cause of acute hepatitis and chronic liver disease, which may lead to cirrhosis and hepatocellular carcinoma. the combined therapy with interferon with or without pegylation associated with ribavirin has shown greater sustained virological response than monotherapy with interferon-alpha, however this response still represents around 60% of cases. the mechanisms by which hcv causes cellular damage are not yet well understood, however immune liver damage, direct cytotoxic damage mediated by different viral products and also oxidative stress have been implicated in the pathogenesis of chronic hepatitis c. several studies support that reactive oxygen species (ros) and oxidative stress are involved in the pathogenesis of hepatitis c, despite that increased ros levels in hcv patients might be beneficial by suppressing hcv replication. ros are involved in several diseases and cause oxidative damage to lipids, dna, proteins and carbohydrates.

Eligibility criteria:
inclusion criteria: * without the presence of illnesses associated with systemic diseases, no chronic alcoholism, without hiv coinfection, and were not participating in other studies. * patients with hepatitis c were selected according to the clinical protocol and guidelines for therapeutic hepatitis c viral. * group i - all subjects were negative for hcv, hbv, hiv, hbsag, anti-hbc total, anti-hcv and normal serum transaminases. exclusion criteria: * patients with one of the following laboratory abnormalities were also excluded: leukocytes, neutrophils, platelets, serum creatinine 1.5 times upper limit of normal, elevated thyroid stimulating hormone, alpha-fetoprotein above normal limits, and/or focal lesion on ultrasound performed within 1 month of study entry.

Keywords: antiviral therapy antioxidant therapy hepatitis c virus oxidative stress vitamin e
collaborative cardiac care project

Conditions: Myocardial Ischemia; Angina Pectoris; Coronary Disease

Summary: data from va-funded studies and the broader literature indicate that chronic stable angina (csa) is prevalent, under recognized, under treated and associated with reduced quality of life. there are substantial opportunities for improving care of patients with this debilitating and potentially fatal problem. because primary care providers manage most patients with csa, efforts to improve care must necessarily involve the primary care delivery system. c3p is composed of a set of interventions employing a collaborative care team model, which has been shown to be effective in managing other chronic illnesses in the primary care setting.

objectives of the proposed project are to: 1) ascertain whether a collaborative approach to managing csa in primary care results in better symptom control and quality of life than routine care; 2) assess whether the practice of providers assigned to the intervention group is more consistent with national clinical practice guidelines than that of control providers; 3) assess satisfaction of both patients and providers with this approach to management; and 4) assess marginal cost-effectiveness.

Eligibility criteria:
inclusion criteria: providers: * staff (md, pa, np) or resident (r1, r2) * at least 1 participating patient patients * assigned to participating provider * diagnosis consistent with ihd * 2 visits in past year * frequent angina symptoms (saq freq. score less than 70) exclusion criteria: providers: - no participating patients patients: * cognitive impairment (inability to complete questionnaires and phone interviews) * non-participating provider * life expectancy of less than 24 months

Keywords: outcomes assessment primary health care group process
allogenic bone marrow stem cells transplantation in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: the objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (bmscs) transplantation in patients with liver cirrhosis. the evaluation of the efficacy includes the level of serum alanine aminotransferase (alt), aspartate aminotransferase(ast), total bilirubin (tb),prothrombin time (pt), albumin (alb), prealbumin(pa), precollagenⅲ(pcⅲ), collagenⅳ(ⅳ-c), laminin(ln), hyaluronidase(hn), liver histological improvement before and 1 week to 1 year after transplantation. child-pugh scores and clinical symptoms were also observed simultaneously.


Eligibility criteria:
inclusion criteria: * aged 16\~65 years. * serum hbsag positive for over six months. * ultrasonographic evidences of cirrhosis exclusion criteria: * history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. * prothrombin time is over 30s. * cirrhosis caused by other reasons except hbv infection. * severe problems in other vital organs(e.g.the heart,renal or lungs). * liver tumor on ultrasonography, ct or mri examination. * pregnant or lactating women. * imaging evidences of vascular thromboses.

Keywords: abmsc allogenic bone marrow mesenchymal stem cells liver cirrhosis transplantation
passive heat therapy for people with copd

Conditions: COPD; Cardiovascular Diseases

Summary: people with chronic obstructive pulmonary disease (copd) often develop high blood pressure and heart disease due to their sedentary lifestyle and difficulty exercising. the investigators will test if heating can mimic the health benefits of exercise by monitoring the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. the patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.

people with copd are at higher risk of developing cardiovascular disease (cvd). while exercise training is a potent therapy for cvd, people with copd have a low tolerance for exercise due to dyspnea and premature muscle fatigue. thus, there is a need to develop more effective strategies to improve cvd risk in people with copd. a novel way to reduce blood pressure and enhance arterial health is with passive heat therapy (pht). an acute 45-min bout of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood pressure in healthy older adults, suggesting that pht could have similar hypotensive and anti-atherosclerotic effects as exercise. augmenting leg blood flow with pht may also have functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance. no study to date has looked at the acute and chronic hemodynamic and vascular responses to pht in people with copd, nor whether it can acutely or chronically improve exercise tolerance.

Eligibility criteria:
inclusion criteria: * non-smoking individuals * \>40 years of age * stable (exacerbation free for \>6 weeks), moderate-to-severe copd (post bronchodilator fev1/fvc \<lower limit of normal and fev1 z-score \<2.51) exclusion criteria: * performing structured exercise training (i.e. pulmonary rehabilitation) * have advanced cardiac or cerebrovascular disease (i.e. a history of heart failure, previous stroke or myocardial infarction) * have uncontrolled hypertension (\>160/95 mmhg at rest) * have hypotension (\<110/60 mmhg) * are taking beta blockers * regularly (\>1/week) have hot baths (\>30 min) or use a hot tub or sauna. exclusion criteria for exercise outcomes: * have resting blood pressure \> 150/95 mmhg * on supplemental oxygen for hypoxemia. * musculoskeletal pain that limits their ability to perform stationary cycling.

Keywords: passive heat therapy pulmonary rehabilitation cardiovascular health
study of the efficacy of two doses of ferrlecit in the treatment of iron deficiency in pediatric hemodialysis patients

Conditions: Anemia

Summary: this was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.


Eligibility criteria:
inclusion criteria: * male or female pediatric end-stage renal disease (esrd) patients. * predetermined tsat and serum ferritin levels * receiving chronic hemodialysis therapy with an identified need for repletion iron therapy. * receiving a stable epoetin (epo) dosing regimen. exclusion criteria: * receipt of any form of iron supplements during the 4 weeks prior to the first ferrlecit® dosing. * blood transfusion. * hypersensitivity to ferrlecit®. * significant inflammatory conditions.

Keywords: iron deficiency anemia in pediatric hemodialysis
a study of skb264 versus investigator's choice chemotherapy in patients with unresectable recurrent or metastatic triple-negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: the aim of the study is to evaluate the efficacy and safety of skb264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (tnbc) whose tumors do not express programmed cell death ligand 1 (pd-l1) or in patients with pd-l1 positive tumors who received prior anti-programmed cell death 1 (pd-1)/pd-l1 inhibitor in early setting

this is a randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of skb264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic tnbc whose tumors do not express pd-l1 or in patients with pd-l1 positive tumors who received prior anti-pd-1/pd-l1 inhibitor in early setting.

Eligibility criteria:
key inclusion criteria: 1. histologically and/or cytologically confirmed tnbc. 2. de novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent. 3. no prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease. 4. participants whose tumours are pd-l1-negative, or participants whose tumors are pd-l1 positive and have relapsed after prior anti-pd-1/pd-l1 inhibitor for early-stage disease. 5. at least one measurable lesion per recist v1.1. 6. eastern cooperative oncology group (ecog) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization. 7. a life expectancy of at least 3 months. 8. eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator. 9. adequate organ and bone marrow function. key exclusion criteria: 1. active second malignancy. 2. uncontrolled or clinical significant cardiovascular disease. 3. history of noninfectious pneumonitis/interstitial lung disease (ild) that required steroids or has current pneumonitis/ild. 4. active infection requiring systemic therapy within 2 weeks of randomization. 5. active hepatitis b or hepatitis c virus infection. 6. human immunodeficiency virus (hiv) positive or history of acquired immunodeficiency syndrome (aids); known active syphilis infection. 7. known hypersensitivity to skb264 or its excipients. 8. previously received trop2-targeted therapy or topoisomerase 1 inhibitors. 9. prior treatment with the same investigator's choice chemotherapy (except taxane). 10. pregnant or lactating women.
the effects of sacroiliac joint manual therapy on autonomic nervous system and lower abdominal pain in women in their 20s with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves. the sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea. in this study, by applying spinal manual threapty threapty to the sacroiliac joint in women in their 20s with primary dysmenorrhea, we tried to present an effective treatment method by evaluating the function of the autonomic nervous system and confirming the occurrence of pain in the lower abdomen.


Eligibility criteria:
inclusion criteria: * women between the ages of 20-29 * regular menstrual cycle (24-32 days) * those who have had symptoms of primary dysmenorrhea for at least 1 year * those who have lower back pain symptoms related to menstrual pain of 5 or higher on the visual analysis scale (vas) * the body mass index is between 20-30 * positive reaction to gillet test exclusion criteria: * pelvic inflammatory disease * uterine fibroids, polycystic ovary syndrome. those with gynecological findings such as endometriosis * those who have used an intrauterine contraceptive device * those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
videolaryngoscopy compared to direct laryngoscopy

Conditions: Pulmonary Aspiration of Gastric Contents

Summary: videolaryngoscope (macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room

video laryngoscopy (vl) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using vl in failed tracheal intubation (nap 4 report). vl has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (icu) and emergency department (ed). this is a proposed comparison study of a vl, use in patients with a high risk for pulmonary aspiration and requiring tracheal intubation. an national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the mcgrath® mac versus conventional laryngoscope in adult patients under general anesthesia.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * capacity to consent * present written informed consent of the research participant exclusion criteria: * age \<18 years * existing pregnancy * lack of consent * inability to consent * difficult airway / defined indications for awake intubation * participation in another study

Keywords: airway management videolaryngoscopy adverse events
a study of ro5185426 in previously treated melanoma patients with brain metastases

Conditions: Malignant Melanoma

Summary: this open-label study will assess the safety and efficacy of ro5185426 in previously treated metastatic melanoma patients with brain metastases. patients will receive ro5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * metastatic melanoma (stage iv, american joint committee on cancer) with braf mutation (cobas 4800 braf v600 mutation test) * brain metastases for which surgical resection is not a treatment option * patients must have failed at least one previous treatment for brain metastases * requiring corticosteroids for symptom control * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * increasing corticosteroid dose during the 7 days prior to study entry * previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix * concurrent administration of any anticancer therapies other than those administered in the study * clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
rainbow extension study

Conditions: Retinopathy of Prematurity (ROP)

Summary: the purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (rop) in the core study crfb002h2301 (nct02375971)

this was a multicenter, open-label extension study where the visual acuity (va) assessment at the child's 5th birthday visit was performed. the study had 2 distinct periods (epochs). treatment with study ranibizumab (either as retreatment after ranibizumab had already been injected in the same eye or as switch ranibizumab treatment from study laser therapy administered in the core study) was permitted for eligible eyes with recurrence/worsening of rop up to and including week 40 from the baseline visit in the core study (epoch 1). the remainder of the extension study up to the 5th birthday visit (epoch 2) was observational, with no study treatment planned to be administered. in the core study, patients were randomized to 1 of the 3 treatment arms (ranibizumab 0.2 mg, ranibizumab 0.1 mg, and laser). treatment arm assignment and patient identifier in the extension study remained the same as in the core study.

Eligibility criteria:
inclusion criteria: * signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements * the patient successfully completed the core study h2301, as defined by providing assessments at the visit 112 (the last scheduled visit in the core study) or, if appropriate, at the last of the additional assessment visits as per protocol in h2301, whichever was latest * the patient received study treatment in both eyes at baseline of study h2301 exclusion criteria: * patient had a medical condition or personal circumstance which precluded study participation or compliance with study procedures, as assessed by the investigator * patient had been discontinued from the core study h2301 at any time

Keywords: open-label, long-term, extension study, intravitreal ranibizumab, laser ablation therapy, retinopathy of prematurity, preterm infants, rainbow
phase ii study of epirubicin, cisplatin and capecitabine (ecx) versus cisplatin and capecitabine (cx) for advanced gastric cancer (agc)

Conditions: Advanced Gastric Cancer

Summary: recently, 3-drug (ecx) and 2-drug (cx) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (agc). the objective of the study is to evaluate the safety and activity of ecx and cx combination chemotherapy given as first-line therapy for agc.


Eligibility criteria:
inclusion criteria: * aged 75 years or less * adenocarcinoma of stomach * advanced, metastatic, or recurrent * no prio chemotherapy for advanced disease * adequate performance status * adequate major organ functions exclusion criteria: * severe comorbid illness or active infections * pregnancy or lactating women * gi obstruction or malabsorption syndrome
rna and heat shock protein biomarkers in radiation-induced fibrosis in breast cancer

Conditions: Breast Carcinoma; Fibrosis

Summary: the purpose of this study is to seeking a molecular signature of pathological radiation induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two groups of patients distinguished by their individual radiosensitivity. the signature will integrate recent insights in terms of alternative splicing of mrnas and level of expression of non-coding rnas, particularly long non-coding rnas, snrnas, snornas and micrornas. in each group each expression patterns of candidate hsp proteins potentially predictive of pathological radiation induced fibrosis (hsp27, hsp70, αβ crystalline) in the serum and on cell culture will be characterized.


Eligibility criteria:
inclusion criteria: * women * age ≥ 18 and \<70 years old * non metastatic disease * ecog performance status 0 or 1 * chest size ≤ 110 cm et bra size \<d * absence of reconstructive breast surgery * patient able to undergo blood samples (haematological conditions allowing blood sample) * non-evolving carcinological disease * absence of systemic inflammatory disease (other than scleroderma) or diabetes * no inflammatory ou infectious flare on biopsy site at the time of inclusion * invasive or in situ breast carcinoma * ability to provide an informed written consent form * affiliation to a social security system then stratification into two groups : group 1 : radio-sensitive patients * post-operative radiotherapy completed at least 6 months ago and * radiation induced dermal and/or soft tissue toxicity (dermatitis, fibrosis, atrophy) rated \> 2 (ctcae v4.0 scale) group 2 : radio-tolerant (control) patients * post-operative radiotherapy completed more than 4 years ago and * radiation induced dermal and/or soft tissue toxicity (dermatitis, fibrosis, atrophy) rated ≤1 (ctcae v4.0 scale) . exclusion criteria: * age \ 70 years old * evolutive cancer / metastatic disease * chest size \> 110 cm et bra size ≥ d * previous reconstructive breast surgery * ecog performance status \> 1 * systemic inflammatory disease or diabetes * inflammatory ou infectious flare on biopsy site at the time of inclusion, very significant ulceration in the treated breast * anemic patients * use of oral anticoagulants * pregnant or likely to be in 6 months * patients deprived of liberty or under supervision * non-affiliation to a social security system

Keywords: skin biopsy radiotherapy rna biomarker hsp biomarker exon junction array gene expression radiosensitivity prediction