Kornimate/medical-research-clean huggingface dataset:
combination of serum measurements of molecular biomarkers and serum protein profiling can be used to predict which patients undergoing prostatic biopsy will be diagnosed with cancer

Conditions: Prostate Cancer; Elevated Prostate Specific Antigen (PSA)

Summary: this is a prospective, serum proteomics study of men who are to undergo prostate biopsy. the purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer on biopsy from men with no cancer on biopsy.


Eligibility criteria:
inclusion criteria: * men aged 18 years or older * have a psa level between 2 and 10 ng/ml * may or may not have an abnormal digital rectal examination * scheduled for trans-rectal ultrasound (trus) guided systematic prostate biopsy as part of routine medical care. all sites (department of urology at suny downstate medical center, brooklyn, the department of urology, new york presbyterian hospital, weill medical college of cornell university, manhattan and the department of urology, kings county hospital) will perform a standardized 14 core biopsy protocol. * signed, informed consent * patient must be able to attend the pre-biopsy blood draw exclusion criteria: * any period of prior/current treatment with hormonal therapy (lhrh agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor) * prior pelvic radiation * a period of less than 6 months prior/current treatment with an alpha-blocker * previous diagnosis of prostate cancer

Keywords: biomarkers - psa, hk2 and solubilized urokinase-receptor forms (su-par) 08-114
optimization of bevacizumab scheduling with chemotherapy for metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

obelics is a two-arm phase 3 trial comparing in mcrc patients (1:1): concurrent administration of bevacizumab in combination with modified folfox-6 regimen (mfolfox-6) or modified oxxel regimen (moxxel), in which bevacizumab is administered the same day as oxaliplatin, (standard arm); and sequential administration of bevacizumab with the same chemotherapeutic regimens, in which bevacizumab is administered 4 days before oxaliplatin at each cycle (experimental arm) oxaliplatin regimen (mfolfox/moxxel) is chosen according to local clinical practice at the beginning of the study.

Eligibility criteria:
inclusion criteria: * histological diagnosis of colorectal adenoma carcinoma * stage iv disease * presence of at least one measurable target lesion (according to recist), and not previously radiated. * age ≥ 18 e ≤ 75 years * ecog performance status 0-1 * life expectancy \>3 months * adequate recovery from surgery, with at least 28 days from surgery to date of pre-study biopsy. * adequate contraception for male and female patients of child bearing potential * informed consent exclusion criteria: * more than one previous line of therapy for metastatic disease * prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,, cetuximab, fluoropyrimidine, folic acid are permitted) * primary tumor that is stenosing and/or that infiltrates the entire thickness of the intestinal wall * regular use of nsaids or aspirin * bleeding disorders or coagulopathy * concurrent anticoagulant therapy * suspected or cerebral metastases (to verify in the presence of symptoms) * neutrophils \< 2000 / mm3, platelets \< 100,000 / mm3, hemoglobin \< 9g/dl * creatinine \> 1.5 times the upper normal limit * got and/or gpt \> 2.5 times the upper normal limit, bilirubin \> 1.5 times the upper normal limit in absence of liver metastases * got and/or gpt \> 5 times the upper normal limit, bilirubin \> 3 times the upper normal limit in presence of liver metastases * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ * congestive heart failure, ischemic coronary events within past 12 months, uncontrolled cardiac arrhythmia * uncontrolled hypertension * active or uncontrolled infection * any concomitant condition that, in the investigator's opinion, would contraindicate the use of any of the study drugs * pregnancy or lactation * central nervous system disorders or peripheral neuropathy \> grade 1 (ctcae v. 4.0) * inability to comply with follow up procedures of the study

Keywords: metastatic stage iv
mucopolysaccharidosis (mps) vi clinical surveillance program (csp)

Conditions: Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy Syndrome)

Summary: the objectives of this program are: to further characterize the natural progression of mps vi disease; to generate and disseminate information on the care and management of mps vi patients to clinical and medical professionals; to provide a resource to physicians and patients by providing information for optimizing patient care based on aggregate data; to characterize the clinical response to long-term naglazyme® (galsulfase) treatment; to further characterize the long-term safety of naglazyme® treatment.


Eligibility criteria:
inclusion criteria all patients must meet the following criteria to qualify for enrollment in the csp: * patient or patient's parent or legal guardian, if child is under 18 year old or is unable to consent, has provided a signed patient information and authorization form. * patient has laboratory results confirming a diagnosis of mps vi disease based on detection of deficient arsb activity (on fibroblasts, leucocytes or dried blood spots)and/or abnormality on the arsb gene. * patient is willing to undergo general assessments to establish baseline data or permits physician to enter assessment data recorded prior to csp entry if available in the patient's medical records. general assessments include: urinary gag level, urinary protein level, serum sample for antibody levels, height, weight, and patient history.
fob in hsct and leukemia patients with acute respiratory symptoms and pulmonary infiltrates

Conditions: Pulmonary Infiltrate New

Summary: pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant (hsct) and leukemia patients. bronchoalveolar lavage (bal) is frequently used to evaluate new pulmonary infiltrates in this population, however utility is limited by a historically low diagnostic yield for infection. in an effort to improve diagnostic yields, this study will complete a fiberoptic bronchoscopy (fob) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to initiating new antibiotic therapy. to further improve detection of microbiological pathogens, the study will utilize pcr testing with rapid turnaround time to detect atypical pneumonia (m pneumoniae, c. pneumonia, legionella species, and respiratory viruses) and aspergillosis.

proper diagnosis and prompt treatment favorably impacts survival in the post transplant setting, but is often difficult and frequently results in inappropriate or late therapy. low yields may be linked with empiric antibody therapy begun prior to the procedure, delayed time to procedure, procedure technique, the presence of graft versus host disease (gvhd), neutropenia, and diffuse infiltrates (as opposed to localized infiltrates or focal masses and nodules). one recent study found that early fobs (less than or equal to 4 days between detection of pulmonary infiltrates and fob) were 2.5 times more likely to establish a diagnosis of pneumonia compared to late examinations. delaying this procedure(greater than 5 days between detection of pulmonary infiltrates and fob) was associated with drug resistant organisms, polymicrobial infections, and worsened patient prognosis.

Eligibility criteria:
inclusion criteria: * autologous or allogeneic stem cell patients with new acute respiratory symptoms or pulmonary infiltrates * leukemia patients with new acute respiratory symptoms or pulmonary infiltrates thought to be unrelated to disease exclusion criteria: * patients unwilling to undergo fob * patients unable to undergo fob due to clinical status * patients unable to undergo fob within 8 hours of radiographic report of pneumonia * patients unable to wait until completion of fob to implement antibiotic changes * adults unable to provide informed consent

Keywords: pulmonary infiltrates stem cell transplant leukemia
phase i study of dasatinib (bms-354825) and capecitabine for women with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: the purpose of this study is to learn about the safety and efficacy of dasatinib in combination with capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline


Eligibility criteria:
for additional information, please contact the bms oncology clinical trial information service at 855-216-0126 or email mycancerstudyconnect@emergingmed.com. please visit www.bmsstudyconnect.com for more information on clinical trial participation. inclusion criteria: * female with advanced breast cancer previously treated with a taxane and an anthracycline * no pleural or pericardial effusion * not receiving anticoagulants
turning dysfunction after stroke: assessment and intervention

Conditions: Stroke; Walking, Difficulty; Balancing Interference

Summary: the study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.

this study has two parts. the first part is a cross-sectional observatory study.eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). the second part is a randomized controlled trial. stroke participants are randomly allocated into trunk exercise and control groups. trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. turning performance, trunk control and motor function are evaluated before and after training session.

Eligibility criteria:
inclusion criteria: * age between 20 and 80 years old * survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study * able to walk independently over a distance of 10 m without walking aids or orthoses * able to provide informed consent and follow instructions. exclusion criteria: * having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment * having cognitive problems with a mini-mental state examination score less than 24 or aphasia that could prevent subjects from following instructions.
25-hydroxyvitamin d levels in patients with periodontitis (stage iii)

Conditions: Vitamin D Deficiency; Periodontitis

Summary: periodontitis; is an inflammatory disease of tissues characterized by bone destruction around the teeth. vitamin d plays an important role in several inflammatory diseases by promoting the expression of inflammatory cytokines such as interleukin il-1, il-6, and il-1β, which are directly related to periodontal attachment loss and bone demineralization. these facts suggest that vitamin d may be associated with periodontal disease. many studies have been conducted on the relationships between serum 25-hydroxyvitamin d (25(oh)d) levels, periodontal disease, and tooth loss. however, as far as we know, there is no study on the relationship between periodontitis and free and bioavailable 25 (oh) vitamin d. in our study, over the age of 35; two groups will be formed, consisting of 40 healthy and 40 periodontitis individuals. serum total 25 (oh) d level and vitamin d binding protein level will be analyzed by elisa method, and bioavailable 25 (oh) d level will be calculated using total 25 (oh) d and vitamin d binding protein levels. the aim of this study; to evaluate the total, free and bioavailable 25 (oh) vitamin d levels of patients with periodontitis by comparing them with healthy controls, and to investigate whether bioavailable 25 (oh) d plays a role in the pathogenesis of periodontitis or can be a simple marker of disease activity in the light of these findings.


Eligibility criteria:
inclusion criteria: * without systemic disease, * had a least 14 teeth exclusion criteria: * individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months, * individuals with an allergy to any ingredient used in the study, * smokers, * pregnant or breastfeeding women, * using vitamin d, * individuals diagnosed with obesity

Keywords: total 25(oh)d bioavailable 25(oh)d free 25(oh)d periodontitis
ultrasound guided nerve block for hip fracture pain management at emergency department

Conditions: Hip Fractures; Pain, Acute; Ultrasound Therapy; Complications

Summary: the main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.

determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today. ultrasound becomes an accessible tool at emergency departments and orthopedic surgeons are increasingly interested its clinical use. this clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.

Eligibility criteria:
inclusion criteria: * low energy hip fracture exclusion criteria: * don´t meet inclusion criteria * present any other synchronic fracture. * drug allergy for drugs used for nerve blocking * skin infection at injection site. * contraindication due to comorbidities. * pathologic fractures. * cognitive impairment * do not give his consent.

Keywords: hip fractures pain ultrasound nerve block
comparison of stent-related symptoms between anti-reflux stents and standard dj stents in children with urolithiasis

Conditions: Urolithiasis; Child, Only

Summary: the aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the children's hospital affiliated with zhejiang university school of medicine, by comparing them with conventional stents.

ureteral stents are crucial adjunctive devices following urolithiasis surgery, serving to support the ureter and facilitate urine drainage. however, the application of these stents can lead to complications such as urinary tract infections, lumbar pain, and bladder irritative symptoms, which significantly impact the quality of life in pediatric patients. novel designs, such as anti-reflux stents equipped with valves, have been optimized to enhance unidirectional urine flow while effectively preventing retrograde urine flow. it is anticipated that these designs could alleviate symptoms of lumbar pain and urinary tract infections, thereby improving the postoperative recovery quality in children. current adult studies suggest that anti-reflux stents might reduce urine reflux but may also be associated with significantly stronger urinary symptoms. to date, there have been no pediatric studies reported on the efficacy of anti-reflux stents. the aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the children's hospital affiliated with zhejiang university school of medicine, by comparing them with conventional stents.

Eligibility criteria:
inclusion criteria: 1. a definitive diagnosis of urinary tract stones by ct scan, with indications for ureteroscopic lithotripsy (url), percutaneous nephrolithotomy (pcnl), laparoscopic/open stone extraction with or without robotic assistance, or combined endoscopic lithotripsy, and no contraindications; 2. age is less than 18 years old; 3. for preschool children, the informed consent form is signed by the parents; for school-age children, the informed consent form is signed by both the parents and the child themselves. exclusion criteria: 1. a history of recurrent bladder irritative symptoms or urinary tract infections; 2. severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study; 3. stent placement surgery within the past 3 months; 4. recent use of medications that may interfere with the study results, such as solifenacin; 5. stent removal surgery performed at an external medical facility.
baricitinib for steroid-resistant/relapse immune thrombocytopenia

Conditions: ITP; Immune Thrombocytopenia

Summary: single-arm, open-label, single-center study to evaluate the efficacy and safety of baricitinib for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (itp).

the investigators are undertaking a prospective trial of 20 adults with itp in china. baricitinib is administered as 4 mg po. daily. safety outcomes and efficacy outcomes are assessed on scheduled study visits (primary endpoint defined as durable response at 6-month follow-up).

Eligibility criteria:
inclusion criteria: 1. primary immune thrombocytopenia (itp) confirmed by excluding other supervened causes of thrombocytopenia 2. patients with chronic low platelet count (\<30,000/μl) for 6 months who have failed at least one treatment for chronic low platelet count 3. patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 4. patients with a platelet count \<30,000/μl or a platelet count \<50,000/μl with clinically significant bleeding symptoms at the enrollment 5. over 18 years old 6. willing and able to provide written informed consent, and agreeable to the schedule of assessment exclusion criteria: 1. secondary immune thrombocytopenia (e.g. patients with hiv, hcv, helicobacter pylori infection or patients with confirmed autoimmune disease) 2. active or a history of malignancy 3. pregnancy or lactation 4. current or recent (\<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection 5. a history of symptomatic herpes zoster infection within 12 weeks prior to screening 6. active or chronic viral infection from hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) 7. have evidence of active tuberculosis (tb), or have previously had evidence of active tb and did not receive appropriate and documented treatment, or have had household contact with a person with active tb and did not receive appropriate and documented prophylaxis for tb 8. have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled 9. myocardial infarction (mi), unstable ischemic heart disease, stroke, or new york heart association stage iv heart failure 10. a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data 11. any of the following specific abnormalities on screening laboratory tests: 1) alt or ast \>2 x uln, or total bilirubin ≥1.5 x uln 2) hemoglobin \<9 g/dl, or total white blood cell (wbc) count \<2,500/µl, or neutropenia (absolute neutrophil count \<1,200/µl), or lymphopenia (lymphocyte count \<750/µl) 3) egfr \<50 ml/min/1.73 m\^2
post-cesarean pain control via continuous infusion of ropivacain et diclogenac into the wound versus intathecal morphine

Conditions: Cesarean Section

Summary: the goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).


Eligibility criteria:
inclusion criteria: * single, normally progressing pregancy * term \> 36 weeks amenorrhea * bmi between 20 and 25 kg/m\^2 before pregnancy * height between 55 and 90 kg * cesarean section by joel-cohen or pfannenstiel techniques * patient has signed consent * patient has social security coverage exclusion criteria: * multiple pregnancy * pathological pregnancy: hypertension (\>140/90 mmhg found during the pregnancy), pre-eclampsia, gestational diabetes * term \< 36 weeks amenorrhea * non-pregnancy related maternal pathology (insufficiency) * obesity (bmi \> 25 kg/m\^2 before pregnancy) * height \ 180 cm * weight \ 90 kg * patient refuses to sign consent * surgical technique other than joel-cohen or pfannenstiel * hepatic insufficiency (prothrombin \< 60%) * contra-indications for rachianesthesia: infection, hemostasis problems (platelets \ 40s) * allergy to local anesthestics * patient is participating in another study, or has participated in another study within the last 6 months * patient is under any type of guardianship

Keywords: cesarean section pain ropivacain diclofena morphine
the clinical impact and outcomes of interventional endoscopy procedures

Conditions: Gastrointestinal Diseases

Summary: the main purpose of the protocol is to collect and evaluate performance data after patients undergoing various interventional endoscopy procedures performed at h. h. chao comprehensive digestive disease center (cddc).

in general, the outcome data includes clinical management, hospitalization, and complications; to determine costs associated with endoscopy procedures; to determine performance data including technical success, procedure time, rate of repeat interventions; to compare endoscopy performance and outcome data collected at university of california, irvine (uci) and results from other institutions previously published in the literature. additional parameters might be collected for specific interventional endoscopy procedures.

Eligibility criteria:
inclusion criteria: * subjects who are 18 years of age or older * subjects who are scheduled for a procedure at the h. h. chao comprehensive digestive disease center (cddc). exclusion criteria: * subjects who are not 18 years of age or older * subjects who are scheduled for a procedure at the h. h. chao comprehensive digestive disease center (cddc).

Keywords: gastroenterology endoscopy, digestive system endosonography endoscopic retrograde cholangiopancreatography gastrointestinal endoscopy