Kornimate/medical-research-clean huggingface dataset:
extension study to veg105192 to assess pazopanib in patients with advanced/metastatic renal cell cancer

Conditions: Carcinoma, Renal Cell

Summary: this is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the phase iii renal cell carcinoma study (veg105192) and have progressed on placebo. subjects will receive 800 mg pazopanib once daily. the study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. the primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. the secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. response rates will be collected per investigator assessment (no central review). subjects will have a ct/mri scan every 6 weeks until week 24 and every 12 weeks thereafter.


Eligibility criteria:
inclusion criteria: * progressed from veg105192 study treatment * patient's veg105192 was placebo * baseline has good organ function exclusion criteria: * no brain metastasis

Keywords: renal cell carcinoma pazopanib anti-angiogenic therapy open label
multimodal perioperative pain management

Conditions: Degenerative Spondylolisthesis

Summary: convalescence after lumbar fusion is dependent on pain. in orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery. the objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.

major spine surgery is usually associated with high postoperative pain scores and opioid requirements. epidural analgesia has been reported to be an effective and safe method to control postoperative pain after spinal instrumentation surgery, but the overall effects of pain management on postoperative length of stay and recovery remains debatable. however, in a multimodal approach, including multimodal non-opioid analgesia to control postoperative pathophysiology and rehabilitation, complications and hospital stay have been reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and abdominal surgery and other procedures, when combined with an enhanced recovery program. the aim of the study is to assess the effect and safety of a combined analgesic regimen consisting of local anesthetic, intra-operative and post-operative continuous epidural analgesia and a single dose ketorolac together with a fast track rehabilitation program after 360 degree lumbar fusion for degenerative disc disease and spondylolisthesis \< 2

Eligibility criteria:
inclusion criteria: * degenerative disc disease and spondylolisthesis up to grade 2 at one to the three lower lumbar levels. exclusion criteria: * previous fusion, metabolic bone disease, severe comorbidity or psychological instability.

Keywords: disc disease spondylolisthesis
chinese spondyloarthritis inception cohort (cespic)

Conditions: Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA); Non-radiographic Axial Spondyloarthritis (Nr-axSpA); Axial Psoriatic Arthritis (axPsA); Acute Anterior Uveitis (AAU); Crohn Disease (CD); Ulcerative Colitis (UC); Reactive Arthritis (ReA)

Summary: the chinese spondyloarthritis inception cohort (cespic) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in china on patients with early spa including ankylosing spondylitis (as, also known as radiographic axial spondyloarthritis) and non-radiographic axial spa. the objectives of cespic are to learn about the course of spa during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). cespic has been recently expanded to recruit patients with other forms of spa / conditions associated with spa: reactive arthritis, acute anterior uveitis, crohn's disease as well as with psoriasis / axial psoriatic arthritis.


Eligibility criteria:
inclusion criteria: crohn's disease. acute anterior uveitis. psoriatic arthritis with axial involvement. reactive arthritis. exclusion criteria: infections, malignancies, major cardiovascular events, lower intestinal perforations other adverse events
electromagnetic navigation system versus freehand technique in total hip arthroplasty

Conditions: Hip Osteoarthritis

Summary: a prospective randomized study comparing accuracy and precision of acetabular component placement in total hip arthroplasty with use of novel electromagnetic navigation system versus freehand technique.

patients with hip arthritis, who are to be treated with total hip arthroplasty will be randomized in two groups. patents allocated to study group will get their acetabular components implanted with the help of electromagnetic navigation system. patients allocated to the control group will get their acetabular components implanted with freehand technique. accuracy and precision of implanted acetabular components will be assessed on images obtained by postoperative computed tomography. postoperative inclination and anteversion angles of acetabular components will be measured by the independent technician. results will be statistically analyzed and compared.

Eligibility criteria:
inclusion criteria: * age above 18 years * unilateral surgery * osteoarthritis of the hip * no previous surgery on the affected hip * implantation of the same acetabular component through the same approach * signed informed consent exclusion criteria: * age under 18 years * unwilling to participate * prior surgery on affected hip

Keywords: navigation hip arthroplasty surgical time landmark
the impact of artichoke leaf extract on blood cholesterol: primary study

Conditions: Lipid Metabolism Disorders

Summary: pycrinil® is a purified extract of the artichoke leaf. artichoke leaf extract (ale) has some clinical trial data suggesting benefit in the treatment of cholesterol disorders in several countries, but this effect has not been studied in a u.s. population. the investigators will give ale or a placebo to overweight men and women with low "good" cholesterol to see if ale increases their good cholesterol. the investigators will also make sure that ale is safe.

subjects will be divided into one of two groups: (1) pycrinil®/flaxseed oil or (2) placebo/flaxseed oil twice daily with food. the two formulations will be identical in appearance and standardized by indena, s.p.a. patients will be enrolled for a total of 3 months (± 1 week to allow for scheduling flexibility) with a 1 month (± 1 week to allow for scheduling flexibility) first follow-up visit in between enrollment and final visits. at all visits, patients will be asked to monitor for any symptomatic ade. the first follow-up visit will focus on medication compliance (via pill count) and safety assessment (including laboratories). the final study visit will consist of brief clinical assessment (including anthropometrics), completed lifestyle and physical activity assessments, subjective ade reporting, and donated blood and urine for clinical laboratory tests. medication changes are not prohibited during the study period, but must be recorded. medication bottles will be collected at the first follow-up and final visits; pill counts will be performed to assess compliance.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * hdl cholesterol \<40 mg/dl in men or \<50 mg/dl in women * bmi ≥25 kg/m2. exclusion criteria: * patient on statins * triglycerides \>400 mg/dl * low density lipoprotein (ldl) \>190 mg/dl * significant hepatic disease (i.e., documented diagnosis of hepatic cancer, hepatitis, or cirrhosis) * significant renal disease (i.e., most recent glomerular filtration rate \<30 ml/min/1.73 m2) * significant gastrointestinal tract disease (documented diagnosis of malabsorption disorder, gi cancer, or uncontrolled inflammatory bowel disease) * history of transplant * women of reproductive potential not receiving birth control * pregnant/nursing women

Keywords: lipids cholesterol dietary supplements cynara scolymus safety
chronotype, chrononutrition and glucose tolerance among prediabetic individuals

Conditions: PreDiabetes; Diabetes Mellitus, Type 2

Summary: chronotype and chrononutrition, both are emerging research fields in nutritional epidemiology. however, its association with glycemic control in the global population is less clear. a better understanding of how activity/ eating time can influence glucose levels in prediabetic individuals may improve strategies for blood glucose control. the present paper aims to determine the associations of chronotype and chrononutrition with glucose tolerance among prediabetic individuals in malaysia.

this is a prospective longitudinal study named chrono-dmtm, that targets to recruit 166 newly diagnosed prediabetic individuals from the community clinics in malacca, malaysia. respondents will be followed-up for 6 months: (1) baseline (1st oral glucose tolerance test (ogtt)); (2) second visit (at 3rd month); and (3) third visit (2nd ogtt at 6th month). data collection includes sociodemographic and anthropometry measurements (weight, height, body fat, visceral fat, waist and hip circumference). dietary intake and meal timing are collected using the 3-day dietary record while data on sleep pattern, light exposure, chronotype and chrononutrition will be collected using validated questionnaires. physical activity will be captured using a validated ipaq questionnaire and pedometer during periods of wearing continuous glucose monitoring (cgm) sensor. cgm, fasting plasma glucose (fbg), ogtt and hba1c are performed to assess glycemic outcomes.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed prediabetic individuals who have been first seen by clinical dieticians registered under the ministry of health malaysia. 2. malaysian ≥ 18 years old. 3. those who plan to continue prediabetes care at the selected community clinic in melaka. 4. those who can read, write and understand the malay language. exclusion criteria: 1. night shift workers at least 3 times per week. 2. known sleep disorder. 3. pregnant women. 4. those on oral glucose-lowering medications, diabetes supplements, anticonvulsant medications or oral steroids currently or in the last month. 5. those with prior explored to any information regarding time-of-eating/time-of-activity restriction. 6. those with chronic kidney disease. they are excluded as current research lack of evidence to support the accuracy of using 24-hour continuous glucose monitoring system (cgms) (freestyle libre pro, abbott, germany).

Keywords: chrononutrition chronotype glycemic outcomes meal timing
growth chart parameters, risk factors

Conditions: Growth Disorders

Summary: comparison between growth chart parameters and different risk factors which can cause abnormal growth chart parameter

infant growth is defined as a positive change in body size over a period of time, and it is a sensitive predictor of an individuals' health. an inappropriate growth pattern indicates nutritional disorders, chronic and infectious diseases in infants. early growth rate is related to adulthood health, such that it is important to develop the concept of appropriate growth for parents, in other to detect children with abnormal growth rates, as soon as possible .weight and height of preschool children are the most common anthropometric measurements, to investigate a child's growth rate. weight is the simplest and most reliable anthropometric measurement, and may be used as an indicator of childhood infection. on the other hand, height summarizes various measures of nutritional conditions in the first two decades of a human's life. many children younger than 5 years in developing countries are exposed to multiple risks, including poverty, malnutrition, poor health, and unstimulating home environments, which detrimentally affect their cognitive, motor, and social-emotional development.

Eligibility criteria:
inclusion criteria: * all children attending primary health care units in assiut governorate aged from one year to five year exclusion criteria: * 1. congenital anomalies 2. chronic diseases (d.m , thyroid dysfunction)
periprocedural myocardial infarction: the role of human neutrophil peptide-1 to 3

Conditions: Coronary Thrombosis

Summary: the aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.


Eligibility criteria:
inclusion criteria: * troponin negative patients * stable angina * unstable angina * positive screening tests exclusion criteria: * troponin positive * technical failure of procedure * hemodynamic unstability
the development and validation of mri-ai-based predictive models for cspca

Conditions: Prostate Cancer

Summary: this study retrospectively included patients who underwent prostate magnetic resonance imaging (mri) and subsequent ultrasound-guided prostate biopsy at peking university first hospital from january 2019 to december 2023, and prospectively enrolls patients from january 2024 to december 2029. clinical information such as age, psa levels, pi-rads scores, and digital rectal examination findings are collected. a well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using mri images. furthermore, prostate-specific antigen density (psad) and transitional zone-based prostate-specific antigen density (tz-psad) are calculated using prostate volume and transitional zone volume. utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (cspca) are developed and validated.

this study retrospectively included patients who underwent prostate magnetic resonance imaging (mri) and subsequent ultrasound-guided prostate biopsy at peking university first hospital from january 2019 to december 2023, and prospectively enrolls patients from january 2024 to december 2029. clinical information such as age, psa levels, pi-rads scores, and digital rectal examination findings are collected. a well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using mri images. furthermore, prostate-specific antigen density (psad) and transitional zone-based prostate-specific antigen density (tz-psad) are calculated using prostate volume and transitional zone volume. utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (cspca) are developed and validated

Eligibility criteria:
inclusion criteria: * the interval between prostate mri and biopsy within 3 months * integrity of related data exclusion criteria: * psa less than 50ng/ml * any treatment for pca prior to either mri or biopsy, including radical prostatectomy, radiotherapy, chemotherapy, and endocrine therapy * previous history of surgical treatment or 5α-reductase inhibitor therapy for benign prostatic hyperplasia * subjects undergoing mri with an indwelling urinary catheter or suprapubic catheter * inadequate quality of mri images

Keywords: clinically-significant prostate cancer artificial intelligence magnetic resonance imaging predictive model
lowering serum uric acid to prevent acute kidney injury

Conditions: Hyperuricemia

Summary: acute kidney injury is associated with a rise in serum uric acid during cardiovascular surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury. we hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for acute kidney injury. the preoperative lowering of serum uric acid will reduce the incidence of acute kidney injury following cardiovascular surgery.

the study will be a prospective, double-blind, placebo-controlled, randomized, clinical trial, initiated and implemented conjointly by the nephrology and cardiovascular surgery departments at shands hospital at the university of florida in gainesville, fl. we propose to study whether lowering uric acid provides significant renal and cardiovascular protection in subjects undergoing cardiovascular surgery. up to 30 patients presenting for elective or urgent cardiovascular surgery with uric acid level \> 6.5 mg/dl and estimated glomerular filtration of 30 - 60 ml/min will be included in the study. patients recruitment will continue until up to 30 patients have completed the study, taking into account expected patient loss due to withdrawal of consent, incomplete study and other reasons. patients will be randomized to a control group or rasburicase group. rasburicase or identical placebo will be administered to each group after randomization. a selected number of patients may undergo additional testing for mechanistic (non-clinical) secondary endpoints.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older, and 2. undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, other cv surgery, and 3. preoperative serum uric acid \> 6.5 mg/dl, and 4. preoperative estimated glomerular filtration rate of \>30ml/min/1.73m2 or higher, but less than 60ml/min/1.73m2 exclusion criteria: 1. prior history of allergy/adverse reaction to rasburicase 2. history of any organ transplant 3. preoperative intra-aortic balloon pump (iabp) 4. known glucose 6-phosphate dehydrogenase (g6pd) deficiency 5. current use of natriuretic peptides

Keywords: cardiac surgery hyperuricemia
study of nu172 as anticoagulation in patients undergoing off-pump cabg surgery

Conditions: Heart Disease

Summary: this is a phase 2, multicenter, open-label, single-arm, sequential cohort study to be conducted in up to 30 subjects. the study will evaluate subjects undergoing primary, elective, off-pump cabg surgery with median sternotomy.


Eligibility criteria:
inclusion criteria: * must give written informed consent prior to initiation of any study related procedures * male or female subjects at least 18 years of age * subject is accepted for primary, elective off-pump cabg surgery with planned sternotomy without other planned concomitant cardiac surgical procedures * new york heart association (nyha) class iii or less heart failure * available for follow-up assessments exclusion criteria: * prior surgery with median sternotomy * prior cabg surgery * women of childbearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives,barrier methods, or other contraception deemed adequate by the investigator); women who are pregnant or lactating * stroke within the previous 6 months * history of stroke with residual neurological deficit * intracranial neoplasm, arteriovenous malformation or aneurysm * any prior exposure to nu172 * contraindication to unfractionated heparin * refusal to undergo blood transfusion, should it be necessary * symptomatic gout * serum uric acid \>11mg/dl at screening * known bleeding diathesis * known thrombotic diathesis * participation in any study of an investigational device, drug or biologic within 30 days prior to planned surgery * any other disease or condition that, in the judgment of the investigator would interfere with the subject's ability to comply with study procedures and requirements

Keywords: cabg anticoagulant off-pump cabg
the discover trial (diagnosis of infection in stem cell transplant patients over time)

Conditions: Bone Marrow Transplant Infection

Summary: demonstrate that the karius infectious disease diagnostic sequencing assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics


Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients who plan on undergoing an allogeneic stem cell transplant and are admitted to ucsf medical center. exclusion criteria: * inability to provide informed consent and comply with study-related procedures
acceptability of 3d printed breast models as surgical decision aids for breast cancer treatment

Conditions: Breast Carcinoma

Summary: this study is to find out the acceptability of a 3d printed breast model by patients as they consider their surgical treatment options. researchers also want to learn the possible impact of the 3d printed breast model in the patient's decision making process.

primary objective: i. to determine feasibility and explore the acceptability of 3 dimensional (3d) printed breast models as a decision aid in breast cancer treatment decision making. outline: patients complete questionnaire over 5 minutes about difficulties in making decision about breast cancer treatment, then participate in a consultation with regular care doctor and study doctor/study staff using the 3d breast model. patients then complete questionnaires over 5-10 minutes about their opinions on the breast model and different breast surgical treatment options available.

Eligibility criteria:
inclusion criteria: * age 18 or older * women diagnosed with breast cancer * patient is a candidate for surgical management * patient has a surgeon at md anderson cancer center (mdacc) (main campus and/or regional care centers) who has agreed to have the 3d model created * patients with a breast magnetic resonance imaging (mri) performed at the md anderson (at the west houston location as well as main campus) * patient able to speak, read or write english * physician eligibility: breast surgeon exclusion criteria: * pregnant and breast feeding patients
meniscal tear and osteoarthritis risk (mentor)

Conditions: Osteoarthritis

Summary: adults with degenerative meniscal tear receiving arthroscopic surgical management or knee drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this non-interventional cohort study. the aim is to investigate whether measurement of an individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms predicts symptomatic and functional outcome suggestive of osteoarthritis (oa) of the knee.


Eligibility criteria:
inclusion criteria: 1. male or female aged 30-60 years. 2. participant able and willing to give informed consent. 3. clinical assessment demonstrates mechanical symptoms suggestive of meniscal pathology (focal knee pain +/- 1 or more of: catching/locking, giving way, focal joint-line tenderness, effusion, mcmurray's positive) within last 12 months. 4. evidence on clinical mri knee of meniscal tear. 5. participant is either in secondary care or has the potential to be referred to secondary care due to severity of symptoms. 6. patient has failed conservative therapy and elected for surgical arthroscopic treatment, or is due knee drainage/injection for clinical reasons. 7. competency of the english language to complete questionnaires independently. exclusion criteria: 1. pre-existing advanced radiographic oa (kl grade 3-4) of index knee at baseline. 2. evidence of anterior cruciate ligament rupture, or more extensive soft tissue injury. 3. history of an acute knee injury (within 12 weeks), or acutely locked knee 4. known history of inflammatory/septic arthritis of index knee. 5. knee replacement or other non-arthroscopic knee surgery (e.g. high tibial osteotomy) - previous or planned within 1 year of study start. 6. index knee surgery within last 3 months, including meniscectomy. 7. steroid injection to index knee in last 3 months. 8. active other (treated) inflammatory disease or infection. 9. positive pregnancy test. 10. unable to provide blood samples. 11. unable to give informed written consent.

Keywords: biomarker inflammation knee prognosis