Kornimate/medical-research-clean huggingface dataset:
evaluating silymarin for chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: to investigate the effect of silymarin, derived from the milk thistle plant, silybum marianum, in preventing and reversing the complications of chronic infection with hepatitis c virus and/or clearing hepatitis c infections.

the objective of this exploratory project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, silybum marianum, in preventing and reversing the complications of chronic infection with hcv and/or clearing hcv infections, thereby generating preliminary results to serve as the basis of a more definitive study. allopathic therapeutic interventions have not proved promising, particularly with the genotype most commonly encountered in egypt and they are prohibitively expensive in the developing world. egypt has the highest prevalence of hcv infection in the world, averaging 15-25% in rural communities. there are limited rigorous assessments of the dietary supplement milk thistle, but there is promise of salutary effect. the specific aims are to evaluate whether silymarin, the extract of milk thistle, can: (1) improves hepatic morbidity in subjects with chronic hcv hepatitis and/or cirrhosis; (2) prevent progression of liver disease in participants who have chronic hcv infections but who have normal liver enzyme levels; (3) help clear hcv infections; and (4) improves these participants' quality of life. participants will be randomly assigned to receive silymarin or a vitamin supplement (below antioxidant levels). participants will be recruited from a cohort of hcv-infected individuals currently enrolled in a large observational study in egypt. participants will receive the supplements daily for 18 months, with measures obtained every six months. measures to be assessed will include: retention in the study, compliance with study assignment, self-described symptoms, alanine aminotransferase (alt) levels, serum collagen markers, abdominal ultrasound, viral load and clearance, and quality of life (sf36 survey). it is hypothesized that silymarin will not lead to clearance of hcv infections but can prevent progression of liver disease in participants with chronic hcv hepatitis and, in some cases, reverse hepatic lesions that are already present, as well as improving the quality of life in individuals who use this dietary supplement. this exploratory project is anticipated to result in successful initiation of larger and more definitive studies of the effect of milk thistle on hcv infection. evidence of beneficial effect of an inexpensive and benign herbal dietary supplement would have great impact on the large global population suffering from chronic hcv infection.

Eligibility criteria:
embolization in hereditary coagulopathies

Conditions: Hemophilia; Embolization; Hemarthrosis; Clotting Factor Deficiency; Synovitis; Arthropathy

Summary: this is a longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the centro de hemofilia hcfmusp, after approval by the ethics and research committee. they will undergo imaging tests (x-rays and magnetic resonance of knee, elbow, or ankle), physical, pain, quality of life and functional assessments (hemophilia joint health score, functional independence score in hemophilia, perimeter, test timed up and go, 30 second sit and stand test, haemophilia - adult - quality of life questionnaire (haem-a-qol), knee injury and osteoarthritis outcome score, eq-5d, numerical rating scale for pain and embolization procedure (superselective embolization of target arteries with spherical microparticles embosphere 100-300 micrometers (biosphere medical, roissy, france), until partial vascular stasis and decharacterization of pathological synovial enhancement. these evaluations will be performed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.

longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the centro de hemophilia do hospital das clinicas, faculdade de medicina da universidade de são paulo, i.e. hc-fmusp), after approval by the ethics and research committee and registry at the clinical trials. patients will be evaluated by imaging (x-rays and magnetic resonance of the affected joint, i.e., knee, elbow, and/or ankle); physical and functional assessments (hemophilia joint health score, functional independence score in hemophilia, perimeter of the affected joint(s), test timed up and go, 30 second sit and stand test, knee injury and osteoarthritis outcome score (koos); quality of life (haemophilia - adult - quality of life questionnaires (haem-a-qol), knee injury and osteoarthritis outcome score (koos), eq-5d; pain measured by numerical rating scale. volunteers will be submitted to embolization procedure (superselective embolization of target arteries with spherical microparticles embosphere 100-300 micrometers (biosphere medical, roissy, france) of the affected joint(s), until partial vascular stasis and decharacterization of pathological synovial enhancement. these evaluations will be performed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.

Eligibility criteria:
inclusion criteria: * patients with hereditary coagulopathies with arthropathy (i.e., chronic synovitis due to hemarthrosis), with x-ray and mri (documenting synovitis) followed up at the hemophilia center hc-fmusp. exclusion criteria: * patients who do not complete the planned assessments * patients who do not accept to continue with the study.
a study to learn about the study medicine called pf-07799544 in people with advanced solid tumors

Conditions: Melanoma; Glioma; Thyroid Cancer; Non-Small Cell Lung Cancer; Malignant Neoplasms; Brain Neoplasms; Colorectal Cancer

Summary: the purpose of this clinical trial is to learn the safety and effects of the study medicine (pf-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. this study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. all participants in this study will receive pf-07799544. pf-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). depending on the part of the study, participants may also receive another study medicine. * in the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. encorafenib comes as a capsule and is taken once per day. * in the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "braf" will receive pf-07799544 with other study medicines (for example, pf-07799933). participants may receive the study medicines for about 2 years. the study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility criteria:
inclusion criteria: * diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation * disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation * for substudy b, histological or cytological diagnosis of advanced/metastatic melanoma * for substudy c, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to soc, excluding melanoma, * for substudy b and c, measurable disease by recist version 1.1 * for substudy b, evidence of a braf v600 mutation or braf class ii/iii alteration in tumor tissue and/or blood * for substudy c, evidence of a braf founder alteration (non-v600 class ii/iii braf alteration) exclusion criteria: * brain metastasis larger than 4 cm * history or current evidence of retinal vein occlusion (rvo) or concurrent neuromuscular disorder associated with elevated creatine kinase (ck)

Keywords: proto-oncogene proteins b-raf brain neoplasms melanoma carcinoma, non-small-cell lung neoplasm by histologic type crc mapk
immediate mobilization versus 2 weeks cast immobilization after distal radius fracture treated with volar locking plate

Conditions: Distal Radius Fracture

Summary: the aim of this study is to analyze total lenght of the sick leace and functional outcome (prwe) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a drf.

this study is a prospective, randomized, controlled trial. the aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a drf. co-primary outcome in this study will be the total lenght of sick leave and patient-rated wrist evaluation (prwe) 2 months after the operation.

Eligibility criteria:
inclusion criteria: * intra- or extra articular drf (colles, smith, volar barton) * operative treatment justified exclusion criteria: * refusal to participate in the study * open fracture with a severity greater than gustilo grade 1 * patient aged less than 18 or over 65 * patient does not understand written or spoken guidance in local languages * pathological fracture * previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function * ipsilateral fracture in upper extremity * associated fractures of the ulna (except fractures of the psu) * polytrauma

Keywords: distal radius fracture volar plating surgery
therapy with zoledronic acid in patients with multiple myeloma stage i

Conditions: Multiple Myeloma Stage I

Summary: multiple myeloma is a disease of b-lymphocytes producing malignant plasma cells. malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. it is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.


Eligibility criteria:
inclusion criteria * evidence of myeloma according to the criteria of the british columbia cancer agency (for the diagnosis, 2 of the 3 criteria must be met): * evidence of paraprotein in the serum or urine * bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells * radiologically, at least one osteolytic lesion * asymptomatic patients with stage i (durie and salmon) multiple myeloma exclusion criteria: * patients with more than one osteolytic lesion on conventional skeletal radiography * previous treatment with bisphosphonates * bilirubin \> 2.5 mg/dl * abnormal renal function as evidenced by: a calculated creatinine clearance \< 30 ml/minute. creatinine clearance (crcl) is calculated using the cockcroft-gault formula: * crcl= \[140-age(years)\] x weight(kg)/\[72xserumcreatinine(mg/dl)\] x {0.85 for female patients} * patients with other malignant diseases or severe concomitant diseases * potentially fertile patients who are not using a reliable and appropriate method of contraception * pregnancy or breast-feeding * participation in another clinical study with an investigational drug within 12 weeks of study entry * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. * recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants) other protocol-defined inclusion and exclusion criteria may apply.

Keywords: multiple myeloma stage i zoledronic acid progression
beijing percutaneous coronary intervention registry

Conditions: Coronary Heart Disease

Summary: the registry study is to obtain the state of the art of the percutaneous coronary intervention state treatment for coronary heart disease in beijing area of p.r.china in a real world. the data are collected from 48 hospitals in beijing area using an uploading system through internet.


Eligibility criteria:
inclusion criteria: * patients from selected 48 hospitals of beijing, p.r.china * patients receiving coronal artery angiography or percutaneous coronary intervention therapy exclusion criteria: * none
multi-modality imaging of ischemia with 18f-fdg pet and cta

Conditions: Myocardial Ischemia

Summary: coronary artery disease results in narrowing of the blood vessels supplying oxygenated blood to the heart muscle. diagnosis in patients with symptoms of chest pain is now quickly done with ct coronary angiography. this x-ray test can show narrowed blood vessels but has limited ability to predict the severity of the narrowings in some cases. we have described a new approach using pet exercise 18f-fdg imaging as a method to image areas of heart muscle not getting enough blood during exercise stress. the 18f-fdg images are co-registered with the ct anatomy from the cta to provide direct evidence of the consequences of the narrowing.

the investigators and others have demonstrated direct imaging of myocardial ischemia using 18f-fluorodeoxyglucose (18fdg) with exercise or dipyridamole stress and positron emission tomography (pet) or single photon emission computed tomography (spect). this approach with "hot-spot" imaging may have greater diagnostic accuracy for ischemia than conventional "cold-spot" myocardial perfusion imaging. recent advances in multi-modality imaging permit fusion of cta images with pet or spect perfusion images and functional assessment of anatomical cad. registration of the 2 data sets can be optimized using the ct acquired with the pet or spect15. 18fdg uptake as a marker for ischemia can be directly related to the coronary anatomy and guide revascularization.

Eligibility criteria:
inclusion criteria: 1. patients with suspected cad referred for cta and found to have moderate cad stenoses and 20 normal volunteers with less than 5% probability of cad. 2. age ≥ 18 years exclusion criteria: 1. inability to undergo stress protocol due to co-morbidities 2. pregnancy

Keywords: radiopharmaceutical 18fdg pet cta multi-modality imaging metabolic imaging of ischemia myocardial blood flow myocardial blood flow reserve
compare the pharmacokinetics of nvp-1205 and coadministration of rosuvastatin and ezetimibe

Conditions: Dyslipidemia

Summary: the purpose of this study is to compare the pharmacokinetics of nvp-1205 and coadministration of rosuvastatin and ezetimibe.

rosuvastatin and ezetimibe(anti-dyslipidemia)

Eligibility criteria:
inclusion criteria: * healthy male subjects age between 19 and 55 signed informed consent exclusion criteria: * subjects have a history of allergy reaction of this drug or other drugs
corneal endothelial cell density in eyes treated with a fluocinolone acetonide intravitreal implant

Conditions: Uveitis, Posterior

Summary: an observational change-from-baseline evaluation of corneal endothelial cell density in eyes treated with a fluocinolone acetonide intravitreal implant

this is a prospective, multicenter, open-label, single arm, observational evaluation of the corneal ecd change from baseline for subjects having the retisert fa drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year.

Eligibility criteria:
inclusion criteria: 1. are scheduled for surgical placement of a retisert fluocinolone acetonide (fa) intravitreal implant in a previously unimplanted eye. 2. are able and willing to comply with all treatment and follow up/study procedures. 3. able and willing to provide informed consent or, for subjects 12-18 years of age, have the ability to understand and provide assent (when applicable) and whose parent/legally authorized representative has the ability to understand and provide written informed consent on the institutional review board (irb) approved informed consent form (icf) and provide authorization as appropriate for local privacy regulations. 4. for female subjects: note: should a subject conceive during the study, the pregnancy should be reported as soon as possible to the study medical monitor and promedica international within 24 hours. the pregnancy will be followed up to term. the subject will continue in the studyregardless if pregnancy is reported on an ae/sae form. if an investigator becomes aware of a post study pregnancy 30 days after the study exit visit while fluocinolone acetonide implant remains in the subject's study eye, then it should be reported as a post-marketing report exclusion criteria: 1. has previously, concurrently or anticipated enrollment in bausch \& lomb study 440, titled, "an observational bilateral evaluation of corneal endothelial cell density in subjects who have had a fluocinolone acetonide implant for at least one year." 2. has severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study, based on the judgment of the investigator. 3. has participated in an ophthalmic drug or device research study within 30 days prior to screening (visit 1, day -30 to -1) in this study 4. is monocular (unable to detect hand motion at 6 feet in 1 eye). 5. has a known corneal dystrophy or corneal transplant. 6. has a history of ocular surgery in the eye scheduled for implant surgery, including laser procedures, within the 30 days prior to screening (visit 1, day -30 to -1). 7. had any type of intraocular drug delivery implant (eg, retisert, ozurdex \[dexamethasone intravitreal implant\]) in the study eye.
characterization of endocarditis to streptococci and impact of the cmi on the future of the patients

Conditions: Endocarditis, Bacterial

Summary: the infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year. this infection is marked with a heavy morbi-mortality.preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. the aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci


Eligibility criteria:
inclusion criteria: * age \> 18 years * endocartitis with steptococci with duke's criteria exclusion criteria: * age \< 18 years * suspiscious endocarditis without duke's criteria
zenith alpha™ abdominal endovascular graft

Conditions: Abdominal Aortic; Aorto-iliac Aneurysm

Summary: the purpose of this study is to evaluate the clinical performance of the zenith alpha™ abdominal endovascular graft for the treatment of abdominal aortic or aorto-iliac aneurysm.


Eligibility criteria:
inclusion criteria: * a patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the zenith alpha™ abdominal endovascular graft exclusion criteria: * life expectancy less than (\<) 2 years * inability or refusal to give informed consent by the patient or legally authorized representative * unwilling or unable to comply with the study follow-up

Keywords: aneurysm aortic aneurysm aortic aneurysm, abdominal iliac aneurysm vascular diseases cardiovascular diseases aortic diseases
improving prognosis in hiv infection

Conditions: Human Immunodeficiency Virus

Summary: the primary objective of this study is to assess the safety of probiotics in cart-treated immunologic non-responder (inr) patients with chronic hiv infection. the secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cart)-treated inr patient with chronic hiv infection, and ii) investigate differences between cart-treated hiv-infected inr and non-inr patients with regards to gut microbial composition and mucosal barrier function.


Eligibility criteria:
inclusion criteria: * hiv seropositive \>4 years. * continuous combined antiretroviral treatment (cart) \>4 years. * plasma hiv rna \ 3,5 years. * cluster of differentiation(cd)4+ t cell count \ 600 cells/µl) \>3.5 years. * caucasian * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to international committee on harmonization (ich) good clinical practice (gcp), and national/local regulations. exclusion criteria: * plasma hepatitis c (hcv) rna positive. * serum hepatitis b surface antigen (hbsag) positive. * comorbidity of inflammatory bowel disease, coeliac disease or malnutrition. * concomitant use of non-steroid anti-inflammatory drugs (nsaid), corticosteroids, disease-modifying antirheumatic drugs, or other anti-inflammatory pharmaceutical substances. * concomitant use of antithrombotic pharmaceutical substances * regular (weekly) use of any probiotic substance within 3 months prior to inclusion. * use of antibiotics within 3 months prior to inclusion. * deranged liver function (serum albumin \<25 g/l or child-pugh ≥10) * renal failure (estimated glomerular filtration rate (egfr) \<30 ml/min) * heart failure (nyha class ii-iv) * intolerance to milk or phenylalanine * any reason why, in the opinion of the investigator, the patient should not participate

Keywords: hiv probiotics microbiota mucosal immunology gut biopsy
clinical study of combined platelet transfusion

Conditions: Hematologic Diseases

Summary: platelet transfusion is an irreplaceable and important treatment method for clinical prevention and treatment of thrombocytopenia or platelet dysfunction. due to various factors, it is difficult to achieve platelet abo complete homotypic transfusion in clinical practice. when abo-compatible platelets cannot be obtained, plasma-reduced platelets, platelets with low anti-a or anti-b titers are often used in clinical practice to reduce the risk of abo-incompatible platelet-compatible transfusion reactions. the combined platelets prepared in this study can achieve abo primary and secondary side compatible infusion.

combined platelet transfusion is a single-arm, open, prospective, non-inferiority study initiated by researchers. patients with hematological diseases who were admitted to the research unit and applied for platelet transfusion within two years were included in the study after informed consent. when the subjects applied for platelet transfusion during the study period, abo homotype platelet transfusion was preferred. when there was no abo homotype platelet in the inventory, abo primary and secondary side compatible combined platelet transfusion was given. the study period was 2 years, including 15 months of enrollment, 6 months of treatment, and 3 months of follow-up after the end of the treatment period

Eligibility criteria:
inclusion criteria: * 1. aged 18-65 years; 2. disease treatment in the research hospital; 3. applied for platelet transfusion therapy. exclusion criteria: * 1. one month before the start of this study, he participated in other clinical trials of drugs and instruments related to platelet transfusion efficacy; 2. without platelet transfusion indications; 3. only received platelet transfusion in the outpatient department and left the hospital without efficacy evaluation after transfusion; 4. gave up platelet transfusion therapy for any reason after enrollment; 5. transferred or discharged from hospital for any reason before platelet transfusion after enrollment; 6. did not receive combined platelet transfusion during the 6-month treatment period after enrollment