Kornimate/medical-research-clean huggingface dataset:
a registration study to evaluate the performance of chiron® riba® hcv 3.0 sia in hcv antibody detection

Conditions: Hepatitis C

Summary: to evaluate the accuracy of the chiron® riba® hcv 3.0 (riba, investigational product) test using known anti-hcv seropositive and seronegative specimens. registration for license application

to evaluate the accuracy of the chiron® riba® hcv 3.0 (riba, investigational product) test using known anti-hcv seropositive and seronegative specimens. to evaluate the effect and applicability of different sample types on riba test results through the tests of the investigational product on serum and plasma collected from the same donors. the specimens with hav igg positive, or hbsag positive, or hev igg positive, or anti-hiv positive will be collected and tested for potential interference in the investigational product when used for testing the specimens infected by viruses other than hcv. this clinical trial is for registration purpose, the study data will be submitted to regulatory authority (sfda) for license application for chiron®riba®hcv 3.0 sia reagent.

Eligibility criteria:
inclusion criteria: * residual serum or plasma specimens after routine clinical testing; fresh specimens or frozen specimens stored at -20°c or lower within 2 years after collection, with sufficient volume (≥0.5 ml) to complete all the study tests ; 2) residual serum or plasma specimen is acceptable; matched serum and plasma with edta, heparin or citrate used as the anticoagulant. the collection and preparation of the specimens should comply with the standard laboratory operation procedures and the instruction for use (ifu). exclusion criteria: * severely hemolytic or turbid specimens; 2) bacterial contaminated specimens; 3) specimens that are improperly collected, prepared, or stored or not in accordance with package insert instructions. elimination criteria: 1. errors arising during testing in which the specimen cannot be repeated shall be excluded; 2. test results that do not pass routine quality control will not be used 3. any specimen in which the case report form has incomplete data, or the case report form is missing the principal investigator's signature will not be used in the study. case report forms with missing data will have an explanation for the missing data and should be signed by the principal investigator. 4. use of unqualified reagents for specimen testing.

Keywords: 1000 residual serum/plasma samples anti-hcv seronegative or seropositive
probiotic supplementation in nafld patients

Conditions: NAFLD

Summary: this study aimed to evaluate the effectiveness of probiotics supplementation (lactobacillus) on nafld fibrosis score.

non-alcoholic fatty liver disease (nafld) is a disease characterized by accumulation of fat (\> 5% of the liver tissue), in the absence of alcohol abuse or other chronic liver diseases. nafld can cause liver inflammation and progress to non-alcoholic steatohepatitis (nash), fibrosis, cirrhosis or hepatocellular carcinoma (hcc). the global prevalence of nafld in adults is estimated to be approximately 25%.the prevalence of nafld increases with increasing body mass index. in 2012 chalasani et al, reported that 67% of overweight and 94% of obese individuals have nafld. there is a consensus regarding increasing worldwide prevalence of nafld and its impact on health, especially the progression to liver cirrhosis and hepatocellular carcinoma. longitudinal studies of nafld have reported an increase in all-cause mortality, cardiovascular mortality, and liver-related mortality , nafld carries a large economic burden and therefore poor health-related quality of life. lifestyle changes (diet and exercise) are the major and first suggestions of the guidelines ,as regard pharmaceutical interventions, agents with potential benefit in nash include thiazolidinediones (tzds), statins although they are well recognized in the treatment of dyslipidemia, their use as a specific treatment for nafld is not well evidenced. there is some data suggest that disruptions in the gut microbiome may play a role in the pathogenesis of nafld and progressions to nash. a probiotic is a live microbial culture or cultured dairy product, which plays an important role in health. probiotics for the treatment of nafld are seemingly a promising treatment option. relatively easy availability, low cost, and absence of serious side effects make probiotics a lucrative choice. liver biopsy remains the gold standard for nafld diagnosis but it is impractical as a diagnostic tool because it is invasive and expensive. nafld fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in nafld.

Eligibility criteria:
inclusion criteria: * age between18 and 60 * bmi ≥ 25 kg/m2 * sonographic findings of nafld +/- elevated liver enzymes (not more than 2 folds increase). exclusion criteria: * ▪ any evidence of chronic liver diseases including viral hepatitis (b and c), auto immune hepatitis. * history of alcohol drinking. * chronic medication use (drugs that cause elevated liver enzymes, recent antibiotic use or paracetamol use in the last month) * persistent elevation of liver enzymes for 3 months. * history of dm. * history of statin therapy for cardiovascular disease (cvd). * history of recent operation. * history of gastroenteritis or diarrhea in the last 2 week.
a research study to examine the difference between local anesthetics alone and local anesthetics plus steroids in the treatment of chronic headache

Conditions: Migraine

Summary: subjects are scheduled to undergo a greater occipital nerve block (gonb) as treatment for your chronic daily headache (cdh). gonb has been used for many years in the treatment of headaches. the nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. the nerve runs superficially in this area, therefore the drugs are injected just under the skin. the injected drugs block electrical transmission through the nerve, resulting in reduced head pain. there are treatment options for patients receiving a gonb, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. the purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for gonb. we expect to enroll 60 patients into this research study at thomas jefferson university only.


Eligibility criteria:
inclusion criteria: * adult patients, age 18-65 inclusive * patients who have chronic daily headache (15 or more headache days per month) for at least 3 months prior to enrollment in the study. * headache level should be 5/10 or more at time of gon block. * patients should have posterior cervical muscle tenderness at time of nerve block. exclusion criteria: * patients who had surgery or any other invasive procedure in the occipital area. * patients with abnormal sensory findings on examination or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc). * patients diagnosed with cluster headache * patients with skin diseases that may affect skin sensation. * patients who are cognitively impaired. * patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators. * patients who are pregnant or breast-feeding.
long term outcomes of pediatric compartment syndrome

Conditions: Compartment Syndromes

Summary: the goal of this study is to review the etiology, diagnostic criteria, complications and outcome of acute pediatric compartment syndrome identified at the children's hospital of western ontario (chwo) . follow up with patients treated for compartment syndrome by fasciotomy will assist in determining the long term effects of compartment syndrome and surgical procedures on the patient quality of life and return to level of function of the affected limb.

acute compartment syndrome (acs) is caused by elevated pressure within a closed osseofascial compartment, leading to microvascular compromise and cell death. without urgent decompression of the compartment, significant functional impairment and loss of limb may result. compartment syndrome can be difficult to diagnose as there are a wide variety of causes, clinical manifestations, and no reliable objective test. the diagnosis in a pediatric population is further complicated when the patient has a decreased ability to communicate verbally, and/or is non-compliant with physical examination. cs pathophysiology indicates that such an increase in compartmental pressure leads to the loss of microvascular perfusion (ischemia), restricting oxygen and nutrient delivery to vital tissues, ultimately causing the permanent functional and physical loss of the limb. the basic principle of fasciotomy is the full and adequate decompression of the compartment of interest and is performed secondary to compartment syndrome. this can be achieved via a single or double incision approach with both methods appearing to be equally effective in reducing intercompartment pressure (icp). subsequent skin closure and/or coverage is performed only when all muscle groups are deemed viable. however, there are a number of coverage techniques described without a clear systematic approach based on objective outcomes. currently, the only available treatment consists of restoration of blood flow by releasing the pressure by slicing open the skin and connective tissue overlying the muscle in a procedure called fasciotomy. this crude method may result in long-term muscle weakness and disfigurement, and does not treat the ischemic damage already caused by the trauma. pressure release can be achieved via a single or double incision approach with both methods appearing to be equally effective in reducing icp. subsequent skin closure and/or coverage is performed only when all muscle groups are deemed viable. however, there are a number of coverage techniques described without a clear systematic approach based on objective outcomes.

Eligibility criteria:
inclusion criteria: * skeletally immature patients (i.e under 18 years of age) admitted to childrens hospital of western ontario (chwo) between january 2007 and 2017 * diagnosed compartment syndrome development * required surgical intervention in the form of a fasciotomy for compartment syndrome of either the upper or lower extremity exclusion criteria: * 18 years of age or greater * no development of diagnosed compartment syndrome
morphological analysis of the pineal gland in pediatric retinoblastoma patients using magnetic resonance imaging

Conditions: Retinoblastoma; Pineoblastoma

Summary: mri is useful for diagnosing pinealoblastoma in retinoblastoma patients


Eligibility criteria:
inclusion criteria: * diagnosis of retinoblastoma * brain mri available exclusion criteria: * insufficient quality of brain mri

Keywords: retinoblastoma pineoblastoma
a phase 3, randomized, double-blind, placebo-controlled, multicenter study of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis

Conditions: Intravenous Steroid-Refractory Ulcerative Colitis

Summary: to compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (iv) on days 1 and 2 to placebo in subjects with ivsr-uc.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age or older. * diagnosis of uc verified by endoscopy within 60 months prior to consent.

Keywords: ulcerative colitis, uc, intravenous steroid-refractory ulcerative colitis, ivsr-uc
molecular analysis of samples from patients with diffuse intrinsic pontine glioma and brainstem glioma

Conditions: Diffuse Intrinsic Pontine Glioma; Brainstem Glioma

Summary: the purpose of this study is to prospectively collect specimens from pediatric patients with diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in order to characterize the molecular abnormalities of this tumor.

high grade diffuse intrinsic pontine glioma (dipg) accounts for approximately 80% of pediatric brainstem tumors and 10% of pediatric brain tumors, and is the most lethal form of brainstem gliomas in children. there is currently no effective therapy to treat these tumors. we hypothesize that this tumor exhibits unique molecular abnormalities leading to altered rna and protein expression. the aim of this trial is to collect specimens from pediatric patients with diffuse intrinsic pontine glioma including serum, cerebrospinal fluid, urine, brain tumor and other constitutional tissue, during therapy and/or at autopsy. our goal is to study this tissue to characterize the genetic abnormalities that lead to tumor formation in order to identify key molecules as biomarkers which we can target to design and test new and more effective treatments.

Eligibility criteria:
inclusion criteria: * patients of any age with clinical and radiologic diagnosis of diffuse intrinsic pontine glioma * patients with other high-grade gliomas originating in the brainstem * patients with focal gliomas (who grade i/ii) of the brainstem exclusion criteria: * patients with any type of infiltrative low grade (who grade i and ii) or high grade glioma (who grade iii and iv) originating outside the brainstem * patients harboring primary brainstem tumors with other histologic diagnoses (e.g., pnet)

Keywords: diffuse intrinsic pontine glioma dipg childhood brainstem glioma pediatric brainstem glioma brainstem glioma bsg
validity and reliability of thai version of barthel index for hip fracture patients

Conditions: Hip Fracture; Femoral Neck Fracture; Intertrochanteric Fracture

Summary: since an increasing in population age, there was an increasing in geriatric patients. most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. however, barthel index had not been translated into thai language and validated to use in hip fracture patients. the purposes of this study were to translate the barthel index into thai language and to assess validity and reliability of thai version barthel index in hip fracture patients.

since an increasing in population age, there was an increasing in geriatric patients. most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. this index had initially developed to evaluate the self-care of stroke patients which comprised of 10 questions about their basic activity of daily living. barthel index had been well-accepted and widely used. barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. however, barthel index had not been translated into thai language and validated to use in hip fracture patients. hip fractures was usually occured in geriatric patients and there was a trend to increase every year. most of the hip fractures were treated by surgical methods which needed postoperative rehabilitation programs to regain their functions. less than half of the patients with hip fracture could regain their functions to preoperative level. therefore, these patients needed a specific questionnaire to evaluate their functions. barthel index is an uncomplicated questionnaire and can be used to evaluate treatment outcome of the patients. the purposes of this study were to translate the barthel index into thai language and to assess validity and reliability of thai version barthel index in hip fracture patients.

Eligibility criteria:
inclusion criteria: * age at least 50 years old * hip fractures within 2 weeks since injury exclusion criteria: * incommunicable patients * pathological fractures * multiple fractures or multiple trauma * postoperative complications which change postoperative rehabilitation protocols

Keywords: barthel index hip fracture validity reliability
effectiveness of cheek acupuncture therapy for pain control after cesarean delivery

Conditions: Acupuncture Analgesia

Summary: this study investigates whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and explores its mechanisms of action through a prospective randomized controlled clinical trial.

pain control after cesarean delivery, if inadequately managed, can impact the prognosis of the mother and the health of the infant. there is an urgent need to explore safer, more effective, and straightforward non-pharmacological adjunctive interventions to alleviate the pain associated with cesarean section. cheek acupuncture therapy is a green micro-acupuncture treatment that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. to practice the concept of perioperative acupuncture medicine, this study aims to investigate whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and to explore the mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.

Eligibility criteria:
inclusion criteria: 1. patients are classified as american society of anesthesiologists (asa) physical status i to iii. 2. scheduled for elective cesarean delivery under spinal anesthesia. 3. patients are aged between 19 to 45 years old. 4. patients have provided written informed consent. exclusion criteria: 1. local skin infection at the acupuncture sites in the cheek area. 2. cases where spinal anesthesia fails and general anesthesia is required. 3. patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure. 4. patients who have used opioid medications at least 6 months prior to surgery. 5. patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments. 6. patients with a history of psychiatric illness.

Keywords: cheek acupuncture therapy acupuncture cesarean delivery pain control postoperative pain management
project connect online: an internet-based intervention for women with breast cancer

Conditions: Breast Neoplasms

Summary: this randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (pco plus condition) versus sharing with family and friends only (pco condition) in a sample of women with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * women at least 18 years of age; * first diagnosis of stage iv breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis; * ability to complete the intervention and assessments in english; and * willingness to attend in-person pco workshop; exclusion criteria: * male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses); * local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and * use of a personal website to post cancer-relevant material in the past six months

Keywords: women
apvo436 phase 1b/2 study in patients with newly diagnosed aml

Conditions: Acute Myeloid Leukemia (AML)

Summary: a multi-center, open-label, dose-finding study of five dose levels of apvo436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, cd123+ aml.

phase 1b consists of 28-day cycles of treatment in five sequential cohorts. in cycle 1 (c1) only, to reduce the risk of crs, each cohort will receive 4 priming doses of apvo436 respectively. apvo436 will be given in combination with venetoclax and azacitidine. for c1d15 and all doses in each subsequent cycle, cohorts will receive apvo436 at the determined cohort dose level. apvo436 dosing will be administered by a 4-hour intravenous (iv) infusion.

Eligibility criteria:
inclusion criteria: * 1. age ≥18 years. 2. patient must have confirmation of aml based on 2016 world health organization (who) criteria and not been previously treated. 3. patients must have cd123-positive aml as confirmed by local flow cytometry (or immunohistochemistry \[ihc\]). confirmation at diagnosis is acceptable. 4. patient must be considered ineligible for induction therapy defined by at least one of the following: 1. ≥75 years of age 2. eastern cooperative oncology group (ecog) performance status of 2 or 3 3. cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) 4. pulmonary disorder (e.g., dlco ≤65% or fev1 ≤65%) 5. creatinine clearance 30-45 ml/min based on cockcroft-gault or modified of diet in renal disease (mdrd) formular 6. hepatic disorder with total bilirubin between 1.5 and 3 times the uln 5. patient must have a projected life expectancy of ≥12 weeks exclusion criteria: 1. patient has received treatment with the following: 1. a hypomethylating agent, venetoclax, and/or chemotherapeutic agent for aml, myelodysplastic syndrome (mds), chronic myelomonocytic leukemia (cmml), or myelodysplastic/myeloproliferative neoplasms (mps/mpn) 2. car-t cell therapy or history of allogeneic hematopoietic stem cell transplant (hsct) 3. experimental therapies for mds or aml 2. patient is currently participating in another interventional research study. 3. patient has history of mpn including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (cml) with or without bcr-abl1 translocation, or aml with bcr-abl1 translocation. 4. patient has acute promyelocytic leukemia. 5. patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or iv) steroid therapy \>10 mg methylprednisolone daily or its equivalent 6. patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose). 7. patient has known active cns involvement with aml. patients who received intrathecal chemotherapy for prophylaxis of aml in the cns prior to enrollment may enroll in this study. 8. creatinine clearance \<30ml/min based on cockcroft-gault or mdrd formular. 9. bilirubin of \>3xuln in the absence of gilbert's syndrome. 10. ast and/or alt \>3 times the uln.

Keywords: acute myeloid leukemia