Kornimate/medical-research-clean huggingface dataset:
prospective study of benznidazole for chagas' disease children with chronic indeterminate chagas disease

Conditions: Chagas Disease

Summary: this study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate chagas disease in children. all subjects will receive benznidazole and results will be compared to historically to a placebo arm.


Eligibility criteria:
inclusion criteria: * age between 2 years and 18 years (age limits inclusive) * diagnosis of trypanosoma cruzi (t. cruzi) infection by conventional serology based on positive elisa and at least 1 other positive conventional serology test (recombinant elisa or iif) * written informed consent by parent/legal representative and informed assent from patients if \>7 years old when applicable (as requirements may vary by country and by site) * females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment exclusion criteria: * pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment * patient presenting any other acute or chronic health conditions, which in the opinion of the principal investigator (pi), may interfere with the pharmacokinetic (pk), efficacy, and/or safety evaluation of the study treatment * signs and/or symptoms of acute chagas disease * known history of hypersensitivity or serious adverse reactions to nitroimidazoles * history of chagas disease treatment with benznidazole (bzn) or nifurtimox * immunocompromised (clinical history compatible with human immunodeficiency virus (hiv) infection, primary immunodeficiency, or prolonged treatment with corticosteroids or other immunosuppressive drugs) * abnormal laboratory test values (as per protocol-specified ranges) at screening for the following parameters: total white blood cell (wbc) count, platelet count, alanine aminotransferase (alt), aspartate aminotransferase (ast), total bilirubin, and creatinine * abnormal ecg (as per protocol-specified ranges) and/or any chagas disease associated findings * any condition that prevents the patient from taking oral medication * patient is known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal product (imp) * evidence or history of alcohol or drug abuse (within the last 12 months) * any planned procedure that may interfere with highly effective contraception during treatment and within 5 days after the last dose of study treatment * employee of the investigator or trial centre, or family member of the employees or the investigator * any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol
study evaluating the effiacy of a 13-valent pneumococcal conjugate vaccine (13vpnc) in adults

Conditions: Pneumonia, Pneumococcal; Pneumococcal Infections; 13-valent Pneumococcal Vaccine

Summary: the purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.


Eligibility criteria:
inclusion criteria: * male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements. exclusion criteria: * previous vaccination with any licensed or experimental pneumococcal vaccine * residence in a nursing home, long-term care facility, or similar facility * known hypersensitivity to vaccination * immune deficiency or suppression
comparison of everolimus-eluting stent vs sirolimus-eluting stent in patients with diabetes mellitus

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to establish the safety and effectiveness of coronary stenting with the everolimus- eluting stent compared to the sirolimus-eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (bms) implantation as compared with nondiabetics (2). although drug-eluting stent (des) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to bms in diabetic patients (3), presence of diabetes mellitus (dm) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of des (4,5). recently, the relative efficacies of sirolimua-eluting stent (ses) and paclitaxel-eluting stent (pes) in patients with dm have been evaluated in randomized and registry studies (6-10). the present study, essence-diabetes study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (cypher) or everolimus-eluting stent (xience v)

Eligibility criteria:
inclusion criteria: * diabetic patients with angina and documented ischemia or patients with documented silent ischemia * patients who are eligible for intracoronary stenting * age \>18 years, \<75 ages * de novo lesion * percent diameter stenosis ≥50% * reference vessel size ≥ 2.5 mm by visual estimation exclusion criteria: * history of bleeding diathesis or coagulopathy * pregnant state * known hypersensitivity or contra-indication to contrast agent and heparin * limited life-expectancy (less than 1 year) * acute st elevation myocardial infarction on admission * characteristics of lesion 1. left main disease 2. in-stent restenosis 3. graft vessels * hematological disease (neutropenia \<3000/mm3, thrombocytopenia \<100,000/mm3) * hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal * renal dysfunction, creatinine ≥ 2.0mg/dl * contraindication to aspirin, clopidogrel or cilostazol * left ventricular ejection fraction \<30% * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Keywords: stenting, xience v, cypher
study of the efficacy and safety of mk-0476 in japanese pediatric participants with seasonal allergic rhinitis (mk-0476-519)

Conditions: Seasonal Allergic Rhinitis

Summary: this study will evaluate the efficacy and safety of montelukast (mk-0476) in the treatment of japanese pediatric participants with seasonal allergic rhinitis (sar). the primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in sar.


Eligibility criteria:
inclusion criteria: * weight: ≥ 25 kg * height: ≥ 125 cm * able to record symptoms in a diary * has had allergic rhinitis symptoms \[japanese cedar (jc) pollinosis\] * tested positive for jc pollen specific immunoglobulin e (ige) antibody assay exclusion criteria: * has nasal findings that would interfere with evaluating nasal congestion symptoms * past or present medical history of bronchial asthma * medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by jc pollen exposure
a clinical study of lung-ct cad decision support

Conditions: Lung Cancer; Lung Diseases

Summary: this product is a computer-aided detection software designed to assist clinicians in detecting lung nodules in chest computer tomography. this product receives from pacs, radiology information system or directly from computer tomography scanner. after receiving the image, the product performs image analysis and provides a mark of suspected lung nodules. users can use existing medical image capture and transmission systems or reading software to view these annotations on the workstation. the main purpose of this trial is to verify that when clinicians perform chest ct pulmonary nodule detection, compared to only diagnosis based on chest ct images, whether the "taihao" lung ct decision support system helps to improve the diagnostic efficiency of clinicians. the secondary purpose is to evaluate that when clinicians perform chest ct pulmonary nodule detection, compared to only diagnosis based on chest ct images, whether the "taihao" lung ct decision support system helps to improve the sensitivity, specificity, and image interpretation time (reading time) of clinicians.


Eligibility criteria:
inclusion criteria: * cases of men or women aged between 20 and 89. * at changhua christian hospital or yuanlin christian hospital, expert (qualified for interpretation of chest computed tomography lung nodules) confirms that the original low-dose computed tomography image had pulmonary nodules (part solid nodule, solid nodule, and pulmonary nodules greater than or equal to 3 mm), and verified that it is as a true nodule through follow-up clinical imaging examination or clinical determination, or * at changhua christian hospital or yuanlin christian hospital, the subject has undergone a low-dose lung computed tomography and a physician (qualified for interpretation of chest computed tomography lung nodules) confirmed that there are no lung nodules on the computed tomography scan. exclusion criteria: * the computerized tomography of the lungs and obvious administrative or technical errors. * a physician (qualified for interpretation of chest ct pulmonary nodules) confirms cases with severe infections such as tuberculosis and pneumonia from source report or other medical records. * a physician (qualified for interpretation of chest ct pulmonary nodules) confirms cases with lung fibrosis such as pneumoconiosis from source report or other medical records. * test cases used when training physicians to use the lung computer tomography decision support system.
a prospective, multicenter study on best clinical use of imatinib in the advanced gastrointestinal stromal tumors

Conditions: Advanced Gastrointestinal Stromal Tumors

Summary: open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. patients will be treated for up to 12 months. data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age. 2. histologically documented diagnosis of gist, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach. 3. immunohistochemical documentation of c-kit (cd117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry. 4. at least one measurable site of disease (recist criteria), or other response assessment criteria, as appropriate. 5. performance status 0,1, 2 or 3 (ecog). 6. adequate end organ function. 7. adequate bone marrow function. 8. female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. exclusion criteria: 1. previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing. 2. other primary malignancy with \< 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the steering committee to entail a low risk of relapse. 3. grade iii/iv cardiac problems as defined by the new york heart association criteria. 4. pregnancy, breast-feeding. 5. severe and/or uncontrolled medical disease. 6. known brain metastasis. 7. known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). 8. known diagnosis of human immunodeficiency virus (hiv) infection. 9. previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin-c). 10. previous radiotherapy to ≥ 25 % of the bone marrow. 11. major surgery within 2 weeks prior to study entry.

Keywords: gist imatinib advanced gist
computerized single-session interventions for indian adolescents

Conditions: Well-being; Depression; Anxiety

Summary: the overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for indian adolescents. the investigators will be examining the effects of three interventions on the well-being and mental health of adolescents. the investigators hypothesize that at least one of the three interventions will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.


Eligibility criteria:
inclusion criteria: * attending a participating secondary school * age 12 to 18 * literate in english exclusion criteria: * unable to provide informed consent
early phase clinical trial about therapeutic biological product mix for treating hpv

Conditions: HPV Infection

Summary: conducting an early phase clinical trial to assess hpv antigen presentation therapeutic biological product mix activity that suggests the potential for clinical benefit of hpv patients. 1. treat infection of multiple hpv virus strains via trained immunity. 2. activate human hpv antigen presentation reaction. 3. the human antigen presenting cells (apcs) can treat the hpv virus protein antigens into small peptide fragments, and then clear hpv virus in vivo.

* conducting an early phase clinical trial to assess hpv antigen presentation therapeutic biological product mix activity that suggests the potential for clinical benefit of hpv patients * 20 cervical hpv infection patients * positive testing hpv by standard pcr assay * hpv infection without symptoms * no clinical signs indicative of oncology * tb negative participant is negative igra blood test with tb antigens * 9vhpv vaccine 1.0 ml plus bcg organism 50 mg mix * by the percutaneous route with the multiple puncture device * negative testing hpv by standard pcr assay after percutaneous 21 days * positive igra blood test with hpv protein antigen after percutaneous use 21 days * our trial duration will be 12-week duration.

Eligibility criteria:
conducting an early phase clinical trial to assess hpv antigen presentation therapeutic biological product mix that suggests the potential for clinical benefit of hpv patients. 20 cervical hpv infection patients inclusion criteria: * cervical hpv infection patients * positive testing hpv by standard pcr assay * hpv infection without symptoms * no clinical signs indicative of oncology * tb negative participant is negative igra blood test with tb antigens exclusion criteria: * pregnant * thrombosis * bleeding * allergy * tb positive participant is positive igra blood test with tb antigens * symptoms of hpv infection * clinical signs suggestive of other infection * symptoms suggestive of other infection * clinical signs indicative of oncology * evidence of critical illness

Keywords: hpv antigen presentation apc igra trained immunity innate immune memory cervical
pre-incisional wound infiltration and hypogastric plexus block using ropivacaine in laparoscopic myomectomy

Conditions: Fibroid Uterus; Pain, Postoperative

Summary: the purpose of this study is to evaluate the effectiveness of a comprehensive approach to anesthesia in patients with uterine myoma using pre-incisional infiltration of the anterior abdominal wall and presacral blockade of the hypogastric nerve plexus during laparoscopic myomectomy

on admission, patients will complete the eq-5d quality of life questionnaire to assess the level of problems including pain, anxiety and depression, as well as the level of quality of life in general. the central sensitization inventory (csi-r) is also completed. each patient is randomly assigned to one of three groups on admission: standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics), prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia or prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia. randomisation is done in a 1:1:1 ratio. in the early postoperative period, a questionnaire is administered to patients to determine the intensity and nature of pain: hourly vas value, localisation of pain and conditions of its onset are noted. at discharge, patients fill out the eq-5d questionnaire and the picker questionnaire to assess the patient's impressions of her hospital stay.

Eligibility criteria:
inclusion criteria: * patients with large nodal (≥ 6 cm) and/or multiple uterine myomas who are indicated for surgical treatment in the scope of laparoscopic myomectomy on the basis of the gynaecological department of the pirogov gynecological centre of st. petersburg state university, * age - 18 years and over, * informed consent of patients to participate in the research study exclusion criteria: * conversion to laparotomy, * subserous uterine myoma 'on a pedicle' (type 7 according to figo), * the start of the surgical intervention is after 15.00, * presence of malignant diseases, diabetes mellitus, external genital endometriosis of 3-4 stage, * presence of psychiatric and cognitive impairment in female patients that, in the opinion of the physician, precludes participation in the study, * the need for abdominal drainage, * severe adhesions in the sacral region

Keywords: uterine fibroid laparoscopic myomectomy postoperative pain pre-incisional infiltration hypogastric plexus block eq-5d questionnaire picker questionnaire the central sensitization inventory (csi-r)
palliative care planner (pcplanner)

Conditions: Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Summary: the purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called palliative care planner (pcplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.

interstitial lung disease (ild) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (icu). despite the presence of numerous unmet needs, ild patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (acp) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. to address this important clinical gap, we propose adapting our existing needs-targeted pcplanner (palliative care planner) mobile app platform to the outpatient setting. pcplanner outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.

Eligibility criteria:
inclusion criteria: * patient has diagnosis of idiopathic pulmonary fibrosis * patient has gap (gender, age, physiology) index score ≥ 4 * patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit) exclusion criteria: * patient lacks fluency in english sufficient to complete study surveys * patient is already seeing palliative care or enrolled in hospice * nest score \<10 at baseline t1

Keywords: palliative care advance care planning
arthroscopic assisted open reduction internal fixation versus open reduction internal fixation in ankle fractures

Conditions: Ankle Fractures

Summary: the objective of this study is to compare the functional outcomes of patients with ankle fractures treated by arthroscopic assisted open reduction internal fixation (aorif) versus open reduction internal fixation (orif).

prospective randomized clinical trial evaluating patients with ankle fractures undergoing aorif versus orif participants will be randomized into 2 different surgical groups, one group receiving only orif and the other group receiving aorif. as standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. at the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed rom and to continue non-weight bearing. at the 6 week post-op visit, the patient will begin weight bearing in the boot. in office study visit will occur at these same times. at each visit weight bearing status, return to sports, pain level, aofas and faam will be assessed. one additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the faam.

Eligibility criteria:
inclusion criteria: * closed ankle fractures (44a, 44b, 44c) * ages of 18-65 * men or women, including pregnant women * willing to consent exclusion criteria: * open fractures * other lower extremity injuries/conditions that affects functional outcomes * problems maintaining follow up (homeless, not willing to return for follow up) * prisoners * unable to consent
effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing opcab(off- pump coronary artery bypass surgery)

Conditions: Coronary Artery Occlusive Dissease

Summary: surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. the aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing opcab (off-pump coronary artery bypass surgery). sixty patients, aged 20 to 79 years, scheduled for opcab will be divided into carbohydrate (n=30) and control (n=30) groups. randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). in contrast, patients in the control group consume no food or drink after midnight before their surgery. the primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.


Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo opcab exclusion criteria: * subjects are ineligible if they have dm(diabetes mellitus), * gastroesophageal reflux disease or gastric emptying disorder, * inflammatory bowel disease, * previous treatment for intra-abdominal cancer, * entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage, * cognitive dysfunction, * disabling mental change disorder, * are unable to communicate or speak korean