Kornimate/medical-research-clean huggingface dataset:
a phase 1b study of ppi-461 in patients with hcv genotype 1

Conditions: Chronic Genotype 1 Hepatitis C Virus Infection

Summary: the purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of ppi-461 in patients with chronic hepatitis c virus genotype 1 infection.


Eligibility criteria:
eligibility criteria: * male or female, between 18 and 65 years of age (female patients must be surgically sterile or 2 years post-menopausal and are required to take a pregnancy test) * body mass index (bmi) 18 - 32 kg/m2 * chronically infected with hepatitis c genotype-1 virus * serum hcv rna \> 5 log10 iu/ml * no previous treatment with interferon, peginterferon, ribavirin or any investigational hcv antiviral agents * no history of signs or symptoms of decompensated liver disease * no known history of cirrhosis * no co-infection with hbv, hiv-1, hiv-2 * no history of any medical condition that may interfere with absorption, distribution or elimination of study drug or with the clinical and laboratory assessments in this study * no history of alcohol abuse, or illicit drug use within 2 years prior to screen, or enrollment in a methadone maintenance program (unless he/she has been enrolled in the methadone program for at least 3 months with good compliance, stable psychosocial circumstances, and no known current risks for recidivism)

Keywords: hepatitis c ns5a hcv rna
study to document the effectiveness of dysport in patients suffering from upper limb spasticity (uls) after stroke

Conditions: Post Stroke Arm Spasticity

Summary: the objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of dysport within the reimbursement scheme called "drug programme" funded by polish national health fund (nhf) for patients with post stroke uls. the study is designed to collect data in patients scheduled to receive dysport treatment in a drug programme, based on routine treatment of subject with uls.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age. * a history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital. * post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified ashworth scale - mas ≥ 2) in at least one muscle group. * classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services. * drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation. * written informed consent given by patient before any occurrence of study related procedure. * patient has been already included in a nhf dysport programme. exclusion criteria: * severe dysphagia and respiratory disorders. * pregnancy * myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases). * generalized symptoms of infection * the presence of inflammation within the planned sites of administration. * fixed contractures in the soft tissues and joints. * dementia medium or deep cycle (score on mini mental state examination (mmse) equal to or less than 18 points).
treatment of the postthrombotic syndrome with the oblique stent - topos study

Conditions: Post-thrombotic Syndrome; Iliac Vein Compression Syndrome

Summary: primary objective: to assess the efficacy of the stents (sinus-obliquus stent for the common iliac vein, the sinus-xl flex stent or sinus-venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression. secondary objective: to assess long-term safety of venous stenting


Eligibility criteria:
inclusion criteria: 1. male or female adults aged ≥18 years 2. post-thrombotic syndrome (villalta score \>4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis 3. evidence of venous stenosis in common iliac vein \>50% confirmed by venography (ct or mri) or intravascular ultrasound (ivus) 4. use of sinus-obliquus stent for unilateral common iliac vein stenosis 5. if stent extension is required either sinus-xl flex or sinus-venous stents must have been used for stenoses \>50% confirmed by venography (ct or mri) or ivus in external iliac and common femoral veins exclusion criteria: 1. pregnancy, breast-feeding or birth-giving during the last 30 days 2. life expectancy \<6 months 3. iliofemoral dvt less than 3 months ago 4. permanently immobile patient (wheelchair user or bed-ridden patient) 5. allergy to nitinol 6. patient's target vessel(s) has/have been stented before 7. legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study 8. patients in custody by juridical or official order
a peer support network system construction for the primary caregivers of children with biliary atresia

Conditions: Biliary Atresia Congenital Type 3

Summary: the peer support wechat platform for primary caregivers of children with biliary atresia can provide social support ,help them adopt positive coping styles to face the disease, and reduce negative emotions and caregiver burden.

the primary caregivers of children with biliary atresia have a heavy psychological burden, but there is a lack of supportive research on this population. therefore, this study used a web-based peer support platform to intervene in the primary caregivers of children with biliary atresia to reduce the psychological burden of this population. the study consisted of two parts. first, a literature analysis, semi-structured interviews, and expert validation are used to form a peer support wechat platform for primary caregivers of children with biliary atresia. second, primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in shanghai. primary caregivers who visit the hospital between august 2022 and october 2022 are assigned to the control group and primary caregivers who visit the hospital between january 2023 and march 2023 are assigned to the intervention group. the intervention group receives a peer support wechat platform intervention on top of usual care from the day of surgery to one postoperative month. the levels of negative emotions and caregiver burden are compared between the two groups after the intervention.

Eligibility criteria:
inclusion criteria: * child was diagnosed with biliary atresia congenital type 3 and required kasai portoenterostomy ; * providing primary care for the child; * use a smartphone and have access to the internet; * normal communication ability; * volunteering to participate in the study. exclusion criteria: * existing or previous mental illness; * presence of severe anxiety (sas ≥ 70 points) or depressive mood (sds ≥ 70 points); * children with comorbidities other than biliary atresia; * refusal to cooperate.
my team of care: a pilot randomized controlled trial of an online communication tool for collaborative care

Conditions: Neoplasms; Communication

Summary: this project will pilot and test a new online communication tool, loop, developed within a research framework with participatory and user-centred design. this pilot trial focuses on advanced cancer as an example of complex care. cancer care involves many healthcare providers, spanning hospital to home. there is no organized way for them to communicate. loop is a practical tool for ongoing collaboration in the patient's actual team of care that engages patients. the study will answer the questions: does loop improve communication efficiency, engage patients and family physicians, and show early benefits in quality and health care costs?


Eligibility criteria:
inclusion criteria: 1. patients with stage iv cancer, or patients with stage iii cancer and poor prognosis as determined by a physician (\>3 months but \<2 years) 2. eastern cooperative oncology group (ecog) performance status score ≤2 3. each patient must have at least two healthcare providers, including an attending oncologist or palliative care physician 4. patient and, if applicable, family caregiver must be ≥18 years of age 5. literacy and language capacity and competency to provide informed consent 6. patient or caregiver must have access to a computer and the internet exclusion criteria: 1. patients without the capacity to participate in use of the online tool, and do not have a caregiver who can engage in use of the tool on their behalf 2. participants without the capacity to participate in evaluation of outcome measures, including, but not limited to, online and paper-based multiple-choice questions, checklists, and visual analogue scales, and do not have a family caregiver who can complete outcome measures 3. a potential candidate for or currently receiving hormone therapy for breast or prostate cancer 4. patients with a prognosis of \<3 months as determined by attending physician 5. patients with impaired mental status as previously assessed by a physician or judged by research staff using the bedside confusion scale 6. it has been determined that the patient is participating in another study precluding them from taking part in this study, as determined by an agreed-upon algorithm, tracked and managed by study coordinators

Keywords: chronic disease continuity of patient care patient engagement cost effectiveness analysis user-centred design interdisciplinary health team medical informatics patient-centred care
integrated community-clinical linkage model to promote weight loss among south asians with pre-diabetes

Conditions: Pre Diabetes; Weight Loss

Summary: the proposed study will inform efforts to prevent diabetes and promote weight loss in a high-risk population and generate a reproducible, scalable, and sustainable model for use with other insurer groups and clinical settings that work in immigrant populations with a high burden of chronic disease.

the study "integrated community-clinical linkage model to promote weight loss among south asians with pre-diabetes" aims to test the effectiveness and assess the implementation process of an integrated intervention to support weight loss for south asian patients at-risk for type-2 diabetes mellitus (t2dm) in primary care settings. the integrated intervention involves: 1. an electronic health record (ehr) intervention for primary care providers (pcps) utilizing embedded alerts to increase screening and identification of south asian patients at-risk for t2dm with bmi \>23 kg/m2 and registries to track outcomes: and 2. registry-driven community health worker (chw)-led health coaching for patients. using a stepped-wedge design, we will implement the study in 25 new york city pcp sites enrolling 2,840 south asian patients at- risk for t2dm. 3. provider surveys (n=40) to capture data on satisfaction with workflow before and after intervention, information sources for ehr-chw initiatives before and after intervention, acceptability of and satisfaction with the integrated ehr-chw intervention, and barriers and facilitators of point-of-care use of the tools. 4. key informant interviews (n=35) with physician champions at each site and/or administrator of each site, health first representatives, and chws. at baseline, the interviews will be incorporated into the workflow analysis to assess current satisfaction and usage of ehr and health coaching. at follow-up, the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated ehr-chw intervention, fidelity to the interventions, and to solicit recommendations for the replication and scalability of the intervention to other sites and insurer organizations.

Eligibility criteria:
inclusion criteria: * self identify as south asian; * are at least 21 years of age and younger than age 75, * had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months; * have a bmi of \>23; and * have incident pre-diabetes as determined by hba1c test (last a1c test date in the last 12 months). exclusion criteria: * patients under the age of 21 and older than 75 will be excluded. * individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded. * pregnant women and all visits with an obstetrician gynecologist are excluded. * no children or vulnerable subjects will be enrolled in this study.
study to assess the efficacy and safety of sitagliptin added to the regimen of patients with type 2 diabetes mellitus with inadequate glycemic control on metformin (0431-189)

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: after 24 weeks of treatment, to assess the a1c-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus * patient is 30-78 years of age on the day of signing informed consent * patient is currently on metformin therapy (1500 mg/day) * patient is a male or a female who is unlikely to conceive, as indicated by at least one yes answer to the following questions: a) patient is a male. b) patient is a surgically sterilized female. c) patient is a postmenopausal female 45 years of age with \>2 years since last menses. d) patient is a non-sterilized premenopausal female and agrees to use an adequate method of contraception to prevent pregnancy throughout the study starting with visit 1 and for 14 days after the last dose of study medication * patient understands the study procedures, the alternative treatments available, the risks involved in the study and voluntarily agrees to participate by giving written informed consent * patient has an a1c of 6.5 % - 11.0% exclusion criteria: * patient has a history of type 1 diabetes mellitus or history of ketoacidosis
carboplatin plus vincristine in treating children with retinoblastoma

Conditions: Retinoblastoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.

objectives: i. estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (cbdca) and vincristine (vcr) every 3 weeks for 24 weeks. ii. assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. iii. estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery. outline: all patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years. projected accrual: a total of 25 patients will be accrued for this study within 4.5 years.

Eligibility criteria:
disease characteristics: newly diagnosed retinoblastoma bilateral or multifocal unilateral disease in children under age 10 unilateral, multifocal tumors less than 5 dd in children under age 2 no metastatic disease disease evidenced by ophthalmoscopic/imaging exam, ultrasound, ct, or mri fundus drawings and photographs required patient characteristics: age: 10 and under performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: not specified

Keywords: intraocular retinoblastoma
prediction and prognostic analysis of liver abscess formation after transcatheter arterial chemoembolization for hepatocellular carcinoma (chance 2407)

Conditions: TACE; HCC - Hepatocellular Carcinoma; Liver Abscess

Summary: liver abscess is a rare but serious complication of hepatocellular carcinoma after tace, with an incidence of less than 1% reported in previous literature. studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. in recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that tace combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. however, these studies are single-center reports with small sample size and low level of evidence. therefore, it is of great clinical significance to explore the risk factors of liver abscess after tace and build a prediction model by using multi-center and large sample data. the formation of liver abscess after tace means a large range of tissue liquefaction necrosis. there are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. in previous studies, orr in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. the effect of specific abscess formation on tace efficacy of liver cancer remains to be determined. therefore, the second research focus of this project is to explore the effect of liver abscess formation after tace on prognosis of liver cancer.


Eligibility criteria:
inclusion criteria: 1. case group inclusion criteria: 1. time period of inclusion: 2009-2023 (15 years) 2. patients with hcc diagnosed by clinical or pathological criteria according to the national health commission guidelines for the diagnosis and treatment of primary liver cancer who underwent tace after surgery and developed postoperative liver abscess. 3. appendix: diagnostic criteria for liver abscess after tace: condition 1: ct images show typically low-density lesions with or without air and fluid levels condition 2: * positive blood culture * percutaneous drainage or aspiration is purulent or culture-positive * symptoms of infection such as fever/chills, accompanied by elevated inflammatory markers such as white blood cell count, c-reactive protein, or procalcitonin. 2. control group inclusion criteria 1. patients with hcc without liver abscess who underwent tace in the same center within the week of treatment in the case group. - exclusion criteria: 1. clinical and follow-up data were incomplete 2. loss to follow-up
aff008e: observational phase 1b follow-up extension study for patients with parkinson's disease after immunization with affitope® pd01a

Conditions: Parkinson's Disease

Summary: aff008e is set-up to assess the long term effects of the 4 pd01a vaccinations that have been applied during aff008 with regard to safety as well as immunological-, radiological and clinical activity. accordingly, during aff008e, no further vaccine dose will be applied. instead, patients who were participating in aff008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. this is offered to patients who received pd01a vaccinations but also to the patients who served as controls in aff008. thus, aff008e will ensure standardized and controlled management of individuals who have received pd01a as part of aff008, the phase i study analyzing for the first time in humans this first in class candidate.


Eligibility criteria:
inclusion criteria: * written informed consent signed and dated by the patient * participation in aff008 exclusion criteria: * history of questionable compliance to visit schedule; patients not expected to complete the clinical trial * participation in the active treatment phase of another clinical trial except aff008 within 13 weeks before visit 1 and for the whole study duration
single dose pravastatin pharmacokinetics in pediatric peritoneal dialysis patients

Conditions: End Stage Renal Disease

Summary: many children with end stage renal disease develop hyperlipidemia. hmg-coa (3-hydroxy-3-methylglutaryl-coenzyme a) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. however, we do not know how pravastatin is metabolized in patients on dialysis. this study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.

this is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. the study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (ccpd). pravastatin dosing will be 10 mg in all subjects. blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. safety evaluations will include adverse events (aes), physical examination, vital signs, and clinical laboratory evaluations.

Eligibility criteria:
inclusion criteria: 1. patients from 12 months to 18 years of age. 2. patients with end stage renal disease who receive continuous cycling peritoneal dialysis. 3. signed informed consent 4. physical exam demonstrates no abnormalities that would make this study medically hazardous to the subject. - exclusion criteria: 1. any clinically significant unstable medical condition or chronic disease other than those associated with esrd. 2. any clinically significant illness within 10 days or receiving single-sdoe of study medication 3. history of rhabdomyolysis 4. clinically significant liver disease or history of malabsorption or previous gastrointestinal surgery that could effect drug absorption or metabolism. 5. clinical laboratory abnormalities: aspartate aminotransferase (ast), alanine aminotransferase (alt), creatine phosphokinase(cpk) \> 2.5 times upper limit of normal; hemoglobin \< 8.5 g.dl. 6. known hypersensitivity to pravastatin 7. unwilling to have blood samples drawn 8. has taken a hmg-coa reductase inhibitor in the last week -

Keywords: pravastatin, peritoneal dialysis, pediatric patients