Kornimate/medical-research-clean huggingface dataset:
china q cohort study

Conditions: End Stage Renal Disease on Dialysis; Peritoneal Dialysis; Hemodialysis

Summary: the burden of end-stage kidney disease (eskd) is increasing worldwide. although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat esrd patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (hd) and the remainder receive peritoneal dialysis (pd). this distribution of dialysis modality, however, varies widely by health jurisdiction. for instance, more than 97% of dialysis patients are treated with hd in japan, but more than 50% treated with pd in mexico. evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between pd and hd due to patients enrollment issue.more importantly, for most health care systems, such as united states, united kingdom, australia, indonesia and china, pd is less expensive than hd. it is possible, then, that a greater global utilization of pd might improve access to renal replacement therapy in less advanced economies. the investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (hrqol) with pd versus conventional in-center hd in incident eskd patients. a total of 1082 eskd patients were randomly assigned to pd or conventional in-center hd, and 235 patients enrolled in stage 1 with complete measures of the "burden of kidney disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. however, this trial was designed to evaluate quality of life between pd and hd and all patients were follow-up 48 weeks. therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . our primary objective is to evaluate the association of dialysis modality (pd and hd) with all-cause mortality in eskd patients. the investigators also explore the impact of pd and hd on major cardiovascular event composite (mace), a composite outcome of mace and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of rrf, hemoglobin, and other biochemical parameters.


Eligibility criteria:
inclusion criteria: * adult (age ≥ 18 years old) peritoneal dialysis or in-center hemodialysis patient who have been recruited in previous china q study and who enrolled in surind study with complete measures of the "burden of kidney disease" at both baseline and 48 weeks. * will and able to provide the informed consent form (icf). exclusion criteria: * patients have stopped dialysis due to kidney function recovery or kidney transplantation. * patients refuse to provide consent.
vaccination in methotrexate treated rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: to estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.

patients suffering from rheumatoid polyarthritis have an increased risk to develop an infection compared to general population, with a more important mortality risk because pneumococcus is considered as one of the major pathogenic agents. antipneumcoccal vaccination is recommended to patients suffering from chronic inflammatory rheumatism treated with immunosuppressants. methotrexate is a long term treatment used in first intention for rheumatoid polyarthritis. a recent study shows a decrease of efficacity of antipneumoccal vaccination for patients suffering from rheumatoid polyarthritis treated by methotrexate. the tested hypothesis will be the presence of better vaccinal protection for patients suffered from rheumatoid polyarthritis after 1 month between antipneumococcal vaccination and the initiation of methotrexate. the objective is to compare immunologic response for antipneumococcal vaccination between patients who are vaccinated in the same time of initiation of methotrexate and patients who are vaccinated 1 month before the beginning of the treatment.

Eligibility criteria:
inclusion criteria: * adult (\>18 yeas old) suffers from rheumatoid arthritis considering acr/eular 2010 criteria * rheumatoid arthritis considering 3,2\<das\<5,1 * patient did not treat by long term treatment or has stopped a treatment by sulfasalazine, hydroxychloroquine or methotrexate for at least 3 months * patient has never treated by biotherapy * patient has never vaccinated against pneumococcal * patient has signed study consent form exclusion criteria: * patient has ever treated by leflunomide or has treated previously by leflunomide (last 3 months) * patient is currently treated by methotrexate or has treated previously by methotrexate (last 3 months) * contraindication to methotrexate: renal insuffisance, alcoolic, chronic hepatisis, infectious condition, aids, hematological failure (cytopeny), pregnancy, obesity, diabet, respiratory disease, gastric ulcer * contraindication to corticotherapy * pregnancy or pregancy wish * nursing * absence of oral contraception for women of childbearing age * patient of age protected by law et deprived of liberty * subject who refuses to be vaccinated against pneumococcis agent * previous history of vaccination allergy (anaphylactic shok, quincke oedema...) * gluten hypersensivity or intolerance * other vaccination during the last month before inclusion * ig perfusion during the last 3 months period before the study inclusion or during the study duration * patient currently treated by anticoagulant or has not been stopped for at least 48h before the study inclusion or hemostasis failure which is contraindicated with muscular injection * participation with an other clinical trial

Keywords: antipneumococcal vaccination methotrexate treatment
study of bictegravir/emtricitavine/tenofovir alafenamide in hiv-1 infected naïve patients using test and treat stategy rapid-initiation model of care: bic-now clinical trial (bic-now)

Conditions: HIV Infections

Summary: the goal of this study is to analyze in treatment-naïve hiv patients the antiviral activity, using a test and treat strategy, in real life of bic/ftc/taf. secondary, this study aims to evaluate outcomes for implementation of the evidence based test and treat strategy.


Eligibility criteria:
inclusion criteria: 1. hiv-1 infected adults (\>17 y.o.) 2. antiretroviral-naïve. 3. be able to comply with protocol requirements and instructions. 4. subject or the subject's representative capable of giving signed informed consent exclusion criteria: 1. women who are breastfeeding or plan to become pregnant during the study. 2. patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending. 3. patients with anticipated need to change the art before study ending.

Keywords: hiv test and treat implementation
greater trochanter epiphysiodesis in hip pathology

Conditions: Orthopedic Disorder

Summary: one of the most common problems in the treatment of pediatric patients with various disorders of the hip joint is the formation of deformity of the proximal femur, such as abnormal growth of the greater trochanter, which causes it to be positioned high in relation to the femoral head. this condition is called "relative overgrowth of the greater trochanter" (rogt).


Eligibility criteria:
inclusion criteria: * emerging deformities of the proximal femur with a high position of the greater trochanter, in which its apex was located above the center of the femoral head but below its superior pole; changes in the structure of the femoral neck, accompanied by its shortening; functioning growth zone of the greater trochanter at the time of intervention; and patients without surgical treatment history exclusion criteria: * hip dislocation upon examination; patients with varus deformity of the femoral neck (neck-shaft angle \<120°), patients with complications of surgical interventions, trauma, rickets, and rheumatoid arthritis; and patients with neurological disorders and refusal to participate in this study
the impact of antimicrobial treatment for asymptomatic bacteriuria in renal transplant patients

Conditions: Urinary Tract Infection; Bacteriuria; Renal Transplantation

Summary: the investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (uti) or progression of renal impairment in patients during the first year after transplantation.


Eligibility criteria:
inclusion criteria: * patients who are ≥1 month and ≤ 12 months after renal transplantation. * positive urine culture defined as ≥ 105 colony forming units (cfu) per milliliter of a known single pathogen. exclusion criteria: * any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney * active infections in another site * leucocytosis (wbc \>18.000k/micl) or leucopenia (wbc \< 3.000 k/micl) * elevation of serum creatinine of more than 15% of its baseline level * obstructive or other urological complications following transplantation as known foreign device (stent/double-j-cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization * pregnant or lactating women. * candidates to invasive urologic procedures. * inability to return for regular follow up. * previous enrollment in this study. * patients who incapable of giving informed consent.
an investigational study of esk-001 in participants with normal renal function and participants with mild, moderate, and severe impaired renal function

Conditions: Renal Impairment

Summary: this a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (pk) of study drug (esk-001) in healthy volunteer participants, and participants with mild, moderate, and severe renal impairment.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.)

Eligibility criteria:
key inclusion criteria for all participants: * body mass index between 18.0 and 40.0 kg/m2 key inclusion criteria for participants with renal impairment: * diagnosis of chronic, stable renal function in the 6 months prior to dosing, as determined by the investigator, based on medical history or egfr, and not requiring dialysis key exclusion criteria for all participants: * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed). key exclusion criteria for participants with normal renal function: -significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee. key exclusion criteria for participants with renal impairment: - history of any uncontrolled or unstable hepatic, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.
bronchoscopic closure of bronchopleural fistulas with occlutech figulla asd n occluder device

Conditions: Bronchopleural Fistula

Summary: the purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.


Eligibility criteria:
inclusion criteria: * patients over 14 years old * bronchopleural fistulas exclusion criteria: * clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress) * immunosuppressed patients * acute intense inflammatory process in fistula edge * suppurative pleural cavity infection

Keywords: bronchopleural fistula bronchoscopy
bioequivalency study of 5 mg pilocarpine tablets under fasting conditions

Conditions: Dry Mouth

Summary: the objective of this study was the bioequivalence of a roxane laboratories' pilocarpine tablets, 5 mg, to salagen® tablets, 5 mg (mgi pharma) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to pilocarpine or any comparable or similar product.
a study of camrelizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (tnbc)

Conditions: Triple Negative Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 \[pd-1\] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (tnbc). participants will be randomized in a 1:1 ratio to arm a (camrelizumab +chemotherapy) or arm b (placebo + chemotherapy).


Eligibility criteria:
inclusion criteria: * ecog performance status of 0-1. * early or locally advanced, histologically documented tnbc (absence of her2, er, and pr expression). * tumor stage: ii-iii. * adequate hematologic and organ function. * must be willing to use an adequate method of contraception for the course of the study. exclusion criteria: * has a history of breast cancer. * has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months. * has received prior therapy with an anti-programmed cell death protein 1 (anti-pd-1), anti-programmed death - ligand 1 (anti-pd-l1), or anti-pd-l2 agent or with an agent directed to another co-inhibitory t-cell receptor (e.g., cytotoxic t-lymphocyte-associated antigen-4 \[ctla-4\]. * has a diagnosis of immunodeficiency or autoimmune diseases. * has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment. * severe pulmonary or cardiac disease. * known active hepatitis c virus, or known active hepatitis b virus. * history of organ or bone marrow transplantation. * pregnant or breast-feeding women.
immune reconstitution in hiv disease (irehiv)

Conditions: HIV Infection

Summary: the aim with this study is to provide immunotherapy with vitamin d and phenylbutyrate to treatment-naive hiv infected patients to induce important antimicrobial defence mechanisms and decreased inflammation.


Eligibility criteria:
inclusion criteria: adult patients \>18 years not subjected to haart. hiv-1 infected patients with cd4 t cells counts \>200 cells/ml. detectable plasma viral loads \>1000 copies/ml. exclusion criteria: patients on haart or other antimicrobial drugs (including bactrim). antimicrobial drug treatment in the past month. patients with medical contra-indication for biopsy such as bleeding tendencies. hypercalcaemia (serum calcium \> 3,0 mmol/l) identified at baseline. pregnant and breast feeding women. any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Keywords: hiv cholecalciferol sodium phenylbutyrate antimicrobial peptides immune response inflammation
mechanisms of improved wound healing and protein synthesis of insulin and metformin

Conditions: Insulin Resistance; Hypermetabolism; Hyperglycemia

Summary: massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. insulin and metformin have demonstrated anabolic activity with minimal associated side effects. however, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. we hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.

metformin treated patients will be compared to control patients. both groups will receive insulin therapy for blood glucose \>180mg/dl. insulin will be titrated according to hospital sliding scale. the use of insulin or metformin will benefit burned children by improving muscle protein build-up, speeding wound healing and reversing growth arrest, improving the immune response, and positively affecting long-term rehabilitation. the results of this study may initiate a change in standard of care as it is found that simply the reduction of blood glucose by metformin, improves patient outcomes as metformin can be administered without the added complication of hypoglycemia.

Eligibility criteria:
inclusion criteria: * patient age 10-19 * primary diagnosis of ≥ 20 total burn surface area burn (tbsab ) exclusion criteria: * decision not to treat due to burn injury severity * known history of aids, arc, hiv * pregnancy * previous diagnosis (pre -burn) of renal failure, liver disease or hepatic dysfunction- serum creatinine \>1.5mg/dl for males and \>1.4mg/dl for females, after fluid resuscitation (clinical definition of kidney damage) * pre-existing type 1 diabetes mellitus * pre existing type 2 diabetes mellitus and receiving treatment * allergies to metformin * acute or chronic acidosis (lactic or any other metabolic type) and renal failure

Keywords: burn
topotecan and paclitaxel in treating patients with recurrent or metastatic cancer of the cervix

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

objectives: * determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel. * determine the feasibility and toxicity of this regimen in these patients. outline: patients receive paclitaxel iv over 3 hours on day 1 and topotecan iv over 30 minutes on days 1-5. filgrastim (g-csf) is administered on days 6-14. treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 weeks. projected accrual: a total of 25 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment * measurable disease or evaluable disease patient characteristics: age: * 18 to physiological 60 performance status: * ecog 0-2 life expectancy: * greater than 2 months hematopoietic: * wbc greater than 3000/mm3 * platelet count greater than 100,000/mm3 hepatic: * bilirubin less than 1.5 times normal * sgot/sgpt less than 1.5 times normal renal: * bun less than 1.5 times normal * creatinine less than 1.5 times normal * creatinine clearance greater than 50 ml/min other: * ineligible for other high priority national or institutional study * not pregnant or nursing * hiv negative * no prior malignancy except nonmelanoma skin cancer * no serious medical or psychiatric illness preventing treatment or informed consent prior concurrent therapy: biologic therapy: * not specified chemotherapy: * greater than 4 weeks since prior chemotherapy * no greater than 2 prior chemotherapy regimens * no prior taxane or camptothecin endocrine therapy: * no concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes) radiotherapy: * greater than 4 weeks since prior radiation therapy * no concurrent radiation therapy surgery: * greater than 4 weeks since prior surgery

Keywords: recurrent cervical cancer stage ivb cervical cancer stage iva cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma
a trial to compare the laser treatment (slt vs. alt) in glaucoma patients

Conditions: Glaucoma

Summary: lasers are important therapy in glaucoma. they are a pivotal point in treatment between medical and surgical care. over the last 10 years a new laser has emerged as the usual laser treatment: selective laser trabeculoplasty (slt). slt works as well as the older laser used: argon laser trabeculoplasty (alt). however slt has many theoretical benefits over alt including causing less damage to the tissue it affects. one of the potential patient centered benefits of this laser is that it may be repeatable. it is even possible that the old laser alt may be useable after an slt treatment. this study aims to uncover whether repeat laser is possible after slt and if so which laser is more effective (alt vs slt). the potential of repeating laser therapies may delay surgical treatment and its complications. also understanding which laser to use will help eye doctors know how to treat their patients at this point of the disease.


Eligibility criteria:
inclusion criteria: * over age of 18 yo. * oag including pigmentary dispersion syndrome and pseudoexfoliation * oag has been treated with 360 degrees of slt * two sighted eyes, * willing to participate after being informed of and reading the patient information material. exclusion criteria: * narrow angle glaucoma * previous glaucoma surgery * eye surgery expected in the next 12 months * severe corneal disease * on or anticipated steroid in 6 months * pregnant or breast feeding

Keywords: glaucoma laser slt alt