Kornimate/medical-research-clean huggingface dataset:
enhancing use of hydroxyurea in sickle cell disease using patient navigators

Conditions: Sickle Cell Disease

Summary: multi-phase, patient navigator-based program in the richmond and tidewater regions of virginia to demonstrate: 1. the feasibility of using patient navigators to improve the percentage of children and adult (age 15 and older) patients with sickle cell disease (scd) in scd specialty care 2. the efficacy of using patient navigators to improve hydroxyurea (hu) (re-)initiation and adherence among adult patients with scd eligible for hu (patient navigators may also be known as public health workers.)

the state of virginia, including the virginia department of health and three academic medical centers and one federally qualified health center, plans a two-phase demonstration, first of improvement in the percentage of adults with scd who are in scd specialty care (phase i), then of improvement in adherence to hu of eligible scd adults (phase ii). both phases will use existing academic scd providers, and an innovative, multimodal strategy, featuring specially trained scd patient navigators (pns), that addresses barriers to care and to hu use. in phase i we will demonstrate the feasibility of utilizing pns to overcome patient access barriers to scd care. in phase ii we will test the efficacy of pns for overcoming barriers to acceptance of and adherence with hu therapy. patients will be randomized to a pn arm or to a usual care arm. providers will implement nih guidelines for hu eligibility and prescribing in both arms. all hu eligible patients will be offered hu at each clinical visit. among patients prescribed hu, if a maximum tolerated dose (mtd, defined in end points) has not been reached, providers will dose escalate every 8-12 weeks to mtd, rather than to clinical effect, before declaring treatment success or failure. this project will be critically important and impactful by demonstrating the feasibility of a statewide community-based strategy to assist vulnerable scd adults in obtaining scd specialty care and likely prolonging life, a model that other states could adopt.

Eligibility criteria:
phase i: inclusion criteria: * patient self report of sickle cell disease (genotypes: hb ss, sc, sbothal, sb+thal) * 15 years or older * virginia resident exclusion criteria: -visited one of a pre-selected list of sickle cell specialists in virginia within the last 6 months phase ii: inclusion criteria: * sickle cell disease (scd) patient (genotypes: ss or sbothal) * eligible for hydroxyurea (according to nih guidelines) * 15 years or older * virginia resident exclusion criteria: * pregnancy * enrollment in scheduled chronic transfusion program * scd genotype: hb sc and sb+thal)

Keywords: sickle cell disease hydroxyurea patient navigator community health worker public health worker fetal hemoglobin health services research
effects of ldx on functioning of college students with adhd

Conditions: Attention-deficit/Hyperactivity Disorder

Summary: the purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (adhd). twenty-five college students with adhd from two universities (university of rhode island and lehigh university) completed a within-subject, placebo-controlled research trial. dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).

objective: evaluate stimulant medication on symptoms and functioning for college students with adhd using double-blind, placebo-controlled, crossover design. method: participants included 24 college students with adhd and 26 college students without psychopathology. lisdexamfetamine dimesylate (ldx) examined for adhd participants over five weekly phases (no-drug baseline, placebo, 30, 50, \& 70-mg ldx per day). self-report rating scales of functioning and direct assessment of adhd symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).

Eligibility criteria:
inclusion criteria: * diagnostic statistical manual of mental disorders 4th edition-text revision (dsm-iv-tr) criteria for adhd based on self- and parent-report using questionnaires and clinical interview exclusion criteria: * significant cardiac condition based on medical history and/or physical examination * significant substance abuse based on self-report and toxicology screen at intake * significant symptoms of major depressive disorder, bipolar disorder, or thought disorder based on initial diagnostic interview
fluoroscopic guided interlaminar epidural versus ultrasound guided transforaminal epidural in the treatment of unilateral cervicobrachialgia.

Conditions: Cervicobrachial Neuralgia

Summary: chronic cervicobrachialgia is a public health problem. epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. the interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). however, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). the ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.the aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status (asa) i-iii * chronic unilateral cervicobrachial pain * allowed steroid infiltration exclusion criteria: * pregnancy * lactation * allergy or intolerance to any of the drugs/materials used in this study, * participation in another interventional study * systemic anticoagulation, * infection at the puncture site * patient refusal.

Keywords: neuropathic cervicobrachial ultrasound-guided transforaminal infiltration cervical interlaminar epidural infiltration cervical chronic pain
teriflunomide for steroid-resistant/relapse immune thrombocytopenia

Conditions: Immune Thrombocytopenia

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

this is a prospective, single-arm, open-label study of teriflunomide in approximately 40 patients with itp who have relapsed or have an insufficient response to prior therapies. teriflunomide is administered as 7 mg orally once daily with dose adjustments for 24 weeks. efficacy and safety outcomes are assessed on scheduled study visits.

Eligibility criteria:
inclusion criteria: 1. diagnosis of primary immune thrombocytopenia (itp) by excluding other supervened causes of thrombocytopenia 2. patients with a platelet count \<30,000/μl or a platelet count \<50,000/μl with bleeding manifestations at the enrollment; 3. patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation; 4. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit; 2. secondary immune thrombocytopenia (e.g. patients with hiv, hcv, helicobacter pylori infection, malignancy, or patients with confirmed autoimmune disease); 3. pregnancy or lactation; 4. pre-existing acute or chronic liver disease, or serum alanine aminotransferase (alt) greater than 2 times the upper limit of normal (uln); 5. current or recent (\< 4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection; 6. have evidence of active tuberculosis (tb), or have previously had evidence of active tb and did not receive appropriate and documented treatment, or have had household contact with a person with active tb and did not receive appropriate and documented prophylaxis for tb; 7. patients who are deemed unsuitable for the study by the investigator.

Keywords: teriflunomide
treatment patterns in gastrointestinal stromal tumors in the community oncology setting

Conditions: Gastrointestinal Stromal Tumors

Summary: this is a retrospective medical record abstraction to evaluate the patterns of care for gastrointestinal stromal tumors (gist) in the community setting. patient demographics and characteristics along with the treatments received will be described. investigators will establish the percentage of patients who undergo surgery, the percentage of patients who are treated with kinase inhibitors as well as in what setting (adjuvant or metastatic) as well as the duration of therapy. physician information will also be collected to assess for differences in treatment based on physician or geographical differences.


Eligibility criteria:
inclusion criteria: * patients diagnosed with gist based on icd-9 code from january 2005 to present will be eligible. this will include current active patients as well as patients who have expired and have medical chart available.

Keywords: gastrointestinal stromal tumors gist tyrosine kinase inhibitors imatinib gleevec suntinib sutent
the comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy

Conditions: Gallbladder Disease

Summary: laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. single incision laparoscopic surgery (sils) was developed with the aim of reducing the invasiveness of conventional laparoscopy. in this study we aimed to compare results of sils cholecystectomy and three port conventional laparoscopic (tpcl) cholecystectomy prospectively

single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. the current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery. total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo sils cholecystectomy group (n = 50) or tpcl cholecystectomy group (n= 50) according to a computer-generated table of random numbers. demographics (ie, age, gender, body mass index (bmi), american society of anesthesiology (asa) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. outcome measures include operative morbidity, operative time, pain score, hospital stay. morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.

Eligibility criteria:
inclusion criteria: * required laparoscopic cholecystectomy for gallbladder disease. exclusion criteria: * american society of anesthesiologists score (asa) more than iii, * patients had prior abdominal surgery, * patients admitted outside working hours with acute cholecystitis, * patients have choledocolithiasis, * pregnancy, * ongoing peritoneal dialysis, * lack of written informed consent.

Keywords: single incision cholecystectomy laparoscopy
work of breathing under extreme hypercapnia induced by ventilation insufficiency

Conditions: Accident Caused by Snow Avalanche

Summary: the aim of the study is to investigate work of breathing of a person in simulated avalanche snow and consequent use of the measured data for judging which one of three simulated scenarios are alike while increasing hypercapnia in the simulated avalanche snow.

the study is a part of a university diploma thesis aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. the investigator is measuring work of breathing in three scenarios: a) 2l air pocket, b) 2l air pocket with resistance compensation and c) no air pocket. the investigator hypothesize that the work of breathing during compensation of air pocket will be alike with no air pocket scenario, thus proving significance of the resistance reduction for survival. the aim of the study is to investigate the effect of work of breathing on gas exchange in subjects breathing into the simulated avalanche snow scenarios.

Eligibility criteria:
inclusion criteria: * healthy and fit volunteers, classified as the american society of anesthesiologists class i * without a smoking history exclusion criteria: * tiffeneau index less than 0.70 * any cardiovascular or respiratory condition

Keywords: snow avalanche hypercapnia work of breathing
high-dose proton/photon rt + surgery of sarcomas of the thoracic, lumbar spine/sacrum

Conditions: Mesenchymal Tumor

Summary: the purpose of this study is to test the effectiveness of high dose radiation administered by both proton and photon therapy. radiation is an effective treatment for many types of tumors and it is thought that radiation alone, when given in much higher doses over a shorter period of time, may be more effective in controlling recurrence of sarcoma.

* in this study three types of radiation will be used: standard radiation (called photon); alternative form of radiation called proton beam therapy; and a localized radiation applicator plaque that can be applied to the surface of the dura (the fibrous outer envelope that surrounds the spinal cord and fluid surrounding the spinal cord) at time of surgical removal of the tumor. * radiation treatments (photon and proton) and possibly surgical removal of portions of the tumor with intraoperative radiation delivery to the surface dura with intraoperative radiation delivery will be performed over a period of 12 weeks. as part of the treatment planning process, participants will need two treatment planning ct scans and 2-3 treatment planning sessions. * participants will receive, in total, 39-43 photon/proton treatments.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of malignant mesenchymal tumor of the thoracic/lumbar/spine/sacrum or paraspinal soft tissues involving nerve roots or extending into spinal canal. inter-osseous bone sarcomas are to be managed by wide resectional surgery for patients that are medically operable. * patient tumor status: 1) post biopsy or post resection with gross residual disease 2) post grossly complete resection but with margins positive or very close or tumor spill or cut through * lesion may be primary or recurrent after prior surgery * no clinical, radiographic or other evidence of distant metastasis * fit for the exposure of the affected vertebral segment * life expectancy of greater than 36 months * kps equal to or greater than 70 * 18 years of age or older * declines radical surgery * no prior radiation treatment to the affected spine region exclusion criteria: * pregnancy * disease/conditions characterized by high radiation sensitivity. these include genetic diseases, such as ataxia telangiectasia. major local conditions which are the local tolerance viz., multiple surgical procedures, serious local injuries. * no evident cord/cauda malfunction for causes other than effects of local tumor growth or due to metabolic effects of tumor

Keywords: sarcoma of the thoracic/lumbar/spine/sacrum paraspinal soft tissues proton radiation therapy photon radiation therapy radiation applicator plaque
comparison of brivanib and best supportive care (bsc) with placebo and bsc for treatment of liver cancer in asian patients who have failed sorafenib treatment

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in asian patients who have failed or could not tolerate sorafenib therapy.


Eligibility criteria:
key inclusion criteria: * diagnosis of advanced hepatocellular carcinoma * asian ethnicity * patient has failed ≥14 days of sorafenib treatment * cirrhotic status of child-pugh class a or b with a score of 7 * eastern cooperative oncology group performance status of 0, 1, or 2 * life expectancy of at least 8 weeks * adequate hematologic, hepatic, and renal function key exclusion criteria: * women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy * previous or concurrent cancer that is distinct in primary site * history of active cardiac disease * thrombotic or embolic events within the past 6 months * inability to swallow tablets or untreated malabsorption syndrome * history of hiv infection * prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)
g-csf for the prevention of febrile neutropenia in gynecologic cancer patients

Conditions: Gynecologic Cancer; Myelosuppression Adult; Febrile Neutropenia; Chemotherapy-induced Neutropenia

Summary: this study aims to analyze the effects of long-acting granulocyte colony stimulating factor (g-csf) on the prevention febrile neutropenia (fn) in gynecologic cancer patients. patients all accepted platinum-based chemotherapy 3-4 weeks once per course. the primary end is the incidence of fn in every course of chemotherapy. after the chemotherapy, patients accepted long-acting g-csf and/or short-acting g-csf. the secondary ends include: the incidences of myelosuppression, doses of g-csf and its expenses, visits to outpatient and emergency clinics, adverse events related to g-csf.


Eligibility criteria:
inclusion criteria: * confirmed primary gynecologic cancer * good performance status * aged 18 years or older * signed an approved informed consents * no immunosuppressive disease exclusion criteria: * not meeting all of the inclusion criteria
establish a "taiwan rare disorder tissue bank", to collect and repost biological samples and disease information from patients with rare disorders

Conditions: Rare Disorders

Summary: even though rare disorders usually have limited case numbers, they have induced huge impacts on patients and their families, and has heavily burdened on our society and healthcare system as well. therefore, it is essential to detect the occurrence of disorders and thus take appropriate measures as early as possible. the preventive goal is based on comprehensive understanding on rare disorders, available diagnostic and therapeutic approaches. however, studies related to rare disorders are often impeded by limited sample sizes and infrequent exchange of research materials among institutes. after referring to foreign experiences, the investigators have noticed that a non-profit tissue bank which can reposit biological samples and thus provide researchers access to samples, may be a solution. through sharing this public asset, the investigators believe not only quantity and quality of rare disorder studies will be improved, the collaboration between various research institutes can also be strengthened afterwards. most important of all, those achievements can ultimately benefit patients, families and the whole society.

investigation plan 1. study period：from 2009 to 2013 2. study population：patients with rare disorders. 3. planned number of subjects： 300\~500 subjects will be included in cmu. 4. inclusive criteria：a patient who is clinically diagnosed as one of rare disorders notified by department of health or our organization. or a patient who is diagnosed as a probable rare disorder case by physicians. 5. exclusive criteria：patients whose physical or mental status is not suitable by the judgment of health professionals. or a patient who is \<20 years old or interdictory, yet without getting the permission from his/her legal representatives. 6. study site： mainly in opd that related to rare disorders. 7. study materials：blood (for plasma, dna and cell line), a questionnaire and a chart review form. tissue samples are acceptable as well. 8. application of collected materials：samples and information will be restored in appropriate manner, and researchers will be encouraged to apply them for biological studies in the field of rare disorders thereafter.

Eligibility criteria:
inclusion criteria: * a patient who is clinically diagnosed as one of rare disorders notified by department of health or our organization. or a patient who is diagnosed as a probable rare disorder case by physicians. exclusion criteria: * patients whose physical or mental status is not suitable by the judgment of health professionals. or a patient who is \< 20 years old or interdictory, yet without getting the permission from his/her legal representatives.
validation of digital chest-x-ray (cxr) to assess lung recruitment in ards

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: lung recruitability is essential for optimal positive end-expiratory pressure (peep) selection in ards patients. it is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. peep contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. peep also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. the gold-standard method for assessing lung recruitability is lung ct scan. for economic and feasibility this technique cannot be used in routine. therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. the measurement of recruited lung volume (vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. it can be done at the bedside. chest-x-ray (cxr) is an interesting option as done in routine in this setting. furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. in a preliminary one-center study we found a significant negative correlation between the amount of vrec and the reduction in lung density measured by digital cxr between 5 and 15 cm h2o peep. in present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.


Eligibility criteria:
inclusion criteria: * intubation and mechanical ventilation in the icu * ramsay score 6 under sedation and analgesia * icu respirator implemented with pressure-volume curve device * age equal to or greater than 18 years * ards defined from the berlin criteria * absence of pneumothorax on the cxr before the study * absence of pleural effusion greater than 500 ml estimated from ultrasonography. * no child-bearing woman * written inform consent signed by the next of kin exclusion criteria: * pneumothorax * pleural effusion greater than 500 ml estimated from ultrasonography * thoracic surgery in the last 3 months * contra-indication to cxr * contra-indication to peep of 15 cm h2o * contra-indication to peep of 15 or peep 15 mandated * pressure-volume curve not feasible * refusal to participate * language barrier of the next of kin * child-bearing woman * person under legal protection

Keywords: ards, peep, lung recruitment, lung recruitability, chest-x-ray, lung imaging, pressure/volume (pv) curve, compliance, respiratory mechanics