Kornimate/medical-research-clean huggingface dataset:
emtricitabine given once a day with other anti-hiv drugs in children with hiv

Conditions: HIV Infections

Summary: the purpose of this study is to see if emtricitabine is safe in children infected with hiv and to determine the best dose.

children are placed into 1 of 4 treatment groups based on age: group 1, 3 months to 24 months; group 2, 25 months to 6 years; group 3, 7 years to 12 years; group 4, 13 years to 17 years. they receive baseline evaluations. antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. antiretroviral-experienced patients replace lamivudine with emtricitabine. patients return to the clinic for follow-up visits at weeks 2 and 4 and then every 4 weeks until week 48. safety is evaluated using adverse events, which are reviewed at every clinic visit. clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. after the week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.

Eligibility criteria:
inclusion criteria children may be eligible for this study if they: * are at least 3 months old and no older than 17 years of age. this is the age the child needs to be at the time they begin the study. * are hiv positive. * weigh more than 5.5 pounds. a newborn child must have reached at least 38 weeks of gestation. * have or have not taken anti-hiv drugs. those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. those that have must have been taking anti-hiv drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening. * have a cd4 count of more than 200 cells/mm3. * have written consent from parent or guardian. * are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active. exclusion criteria children will not be eligible for this study if they: * are pregnant or breast-feeding. * cannot follow the visit or dosing schedule or are not available for 1 year. * have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start. * have nerve damage in their arms or legs. * have trouble eating or taking drugs. * have serious diarrhea within 30 days before study entry. * have had any serious illness within 30 days of study screening. any treatment must have been finished 14 days before study entry. * have had an aids-related (opportunistic) disease within 12 months of screening. * are being treated for tuberculosis. * have had pancreatitis. * require certain drugs.

Keywords: hiv-1 drug administration schedule stavudine hiv protease inhibitors ritonavir reverse transcriptase inhibitors anti-hiv agents pharmacokinetics abt 378 emtricitabine
coronary mdcta with iopamidol injection 370

Conditions: Coronary Artery Disease

Summary: determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.


Eligibility criteria:
inclusion criteria: * provide informed consent * at least 30 years of age * weight less than 250 lbs * known or suspected coronary artery disease and suspected to have significant coronary artery stenosis * undergo mdcta scan * undergo coronary angiography within 2 weeks of mdcta scan exclusion criteria: * hx of hypersensitivity to iodinated contrast agents * known or suspected hyperthyroidism or pheochromocytoma * renal impairment * history of coronary artery stent placement or bypass grafts * unstable * pregnant or lactating
a randomised clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment primary biliary cholangitis-autoimmune hepatitis overlap syndrome

Conditions: Autoimmune Hepatitis; Primary Biliary Cirrhosis

Summary: current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(pbc-aih overlap) consists of a combination of prednisolone and azathioprine. however, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. several studies have documented the efficacy and safety of mycophenolate mofetil(mmf) as second-line therapy for pbc-aih overlap. however, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.


Eligibility criteria:
inclusion criteria: 1. patients aged 18-70 years; 2. diagnosed with pbc-aih overlap syndrome according to paris criteria; 3. agreed to participate in the trial, and assigned informed consent; 4. the wbc count ≥2.5x10\^9/l and platelet count ≥50x10\^9/l. exclusion criteria: 1. the presence of hepatitis a, b, c, d, or e virus infection; 2. patients with presence of serious decompensated cirrhosis; 3. patients have a history of glucocorticoid or immunosuppressant medication before enrollment; 4. liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or wilson disease. 5. pregnant and breeding women; 6. severe disorders of other vital organs, such as severe heart failure, cancer; 7. parenteral administration of blood or blood products within 6 months before screening; 8. recent treatment with drugs having known liver toxicity; 9. taken part in other clinic trials within 6 months before enrollment.
brain trauma outcomes in nova scotia study

Conditions: Brain Injuries,Traumatic; Outcome Assessment (Health Care); Craniocerebral Trauma; Emergency Medical Services; Organizational Innovation

Summary: the goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. nova scotia's centralized neurosurgical services and integrated provincial emergency health services provide a rich opportunity to construct a cohesive, integrated data management system. this system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma. retrospective data collection the retrospective arm of the bto study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. investigators continue to analyze this large amount of data and prepare it for publication. prospective data collection patients with a major head injury (initial gcs 3-12), have been considered for enrollment in the bto study.the prospective arm of the bto study has 52 patients enrolled. screening and enrollment was complete on june 30, 2007. these patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. completion of patient follow up will be in june 2009.


Eligibility criteria:
retrospective arm cohort 1: ais ≥ 3, head +/- other injuries cohort 2: ais ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1) inclusion criteria: 1.patient treated in at least one facility prior to arrival at qeii. exclusion criteria 1. injured out of province 2. time from injury to 1st facility presentation known to be \> 24 hours 3. time arrival at 1st referring facility to time arrive at qeii known to be \> 24 hours 4. direct ground or air scene transport prospective arm: inclusion criteria: 1. have a head injury requiring hospital admission 2. able to provide informed consent or have next- of -kin able to provide consent on patients' behalf exclusion criteria: 1. unwilling or unable to provide consent

Keywords: brain injury head trauma trauma systems head injury guideline time to tertiary care
the role of an optical probe in thyroid cancer diagnosis: pilot study

Conditions: Thyroid Nodule; Thyroid Neoplasms; Thyroid Cancer

Summary: this study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.

the optical real-time readings will be compared to the histological analysis from the same area. subjects undergoing thyroid surgery for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. after the removal of the thyroid gland, optical readings will be taken from the ex vivo thyroid gland and these same areas will then be analyzed in the usual standard fashion. the reading will then be correlated with the histological results. in addition, if lymph nodes are removed as part of the surgery they will also be tested prior to histological standard processing. all specimens and data will be de-identified.

Eligibility criteria:
inclusion criteria: * subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid goiter with nodules. exclusion criteria: * subjects whose thyroid specimens have been put in formalin

Keywords: thyroid neoplasms optical devices spectrum analysis thyroid diseases
redect 2: renal masses: pivotal trial to detect clear cell renal cell carcinoma with pet/ct

Conditions: Renal Cell Carcinoma; Kidney Cancer

Summary: study wx-20-002 will confirm diagnostic efficacy and safety of a pet/ct scan using iodine (124i) girentuximab performed during the diagnostic work-up in patients with indeterminate ct1-renal masses.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age. 2. presence of indeterminate ct1 renal mass by screening ct with and without contrast or mri with and without contrast (mri only if ct is contra-indicated). 3. negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. 4. recovered from toxicity of any prior therapy to grade 1 or better. 5. able to take oral medication (ki). 6. written informed consent available. exclusion criteria: 1. renal mass known to be a metastasis of another primary tumor. 2. known histology of renal mass (e.g. by biopsy). 3. active non-renal malignancy requiring therapy during the time frame of individual patient study participation. 4. chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to iodine (124i) girentuximab infusion on day 0 or continuing adverse effects (\>grade 1) from such therapy. 5. exposure to murine proteins or chimeric antibodies within the last 5 years. 6. intercurrent medical condition that may limit patient's study participation or compliance. 7. history of autoimmune hepatitis. 8. mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 9. participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment. 10. women who are pregnant or breastfeeding. 11. contraindication to ki intake (see package insert/appendix vi). 12. hyperthyroidism, or grave's disease. 13. contraindication for pet/ct.
forceps vs. snare ivc filter removal

Conditions: DVT

Summary: ivc filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. when no longer indicated, interventional radiologists are consulted for ivc filter removal. currently, many methods for extracting ivc filters exist. two of the most common methods involve using an endovascular snare device or rigid forceps. we intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. this will be compared by evaluating success rates and procedure time.

currently the optimal method for ivc filter retrieval with respect to success rate and fluoroscopic time (i.e. radiation exposure) is poorly understood. both snare and forcep techniques have independently evaluated in literature but have never been compared directly. the proposed study would prospectively assess whether one of these established technique offers an advantage with respect to either of these variables.

Eligibility criteria:
inclusion criteria: * non-pregnant females * adult patients (age 18 years and older) * referred to interventional radiology for ivc filter removal * ivc filter implanted less than 6 months with the procedure being performed at ucmc by current ir staff. * cook celect filter or argon medical option elite exclusion criteria: * patients with outside hospital filter placement * filters other than cook celect or argon medical option elite * implantation period \>6 months * evidence of coagulopathy (inr \ 50k) * clotting disorder * central venous occlusion * prior filter placement/removal.

Keywords: ivc filter, filter removal, filter retrieval
transcutaneous electrical acupoint stimulation for non-small cell lung cancer patients

Conditions: Non-Small Cell Lung Cancer; Lung Cancer

Summary: to investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.

lung cancer is the malignant neoplasm with the highest incidence and mortality in china as well as worldwide. non-small cell lung cancer (nsclc) accounts for 80%-85% of all lung cancer cases. chemotherapy is the preferred treatment method for nsclc, but many patients cannot tolerate the adverse reactions of chemotherapy. among the most common and most severe adverse reactions is bone marrow suppression. the more serious the bone marrow suppression, the higher the direct medical cost of chemotherapy. literatures showed acupuncture was used to treat patients with chemotherapy-induced bone marrow suppression. in this study, the effect of percutaneous electrical stimulation of acupoints including dazhui (du14), geshu (bl17), zusanli (st36), sanyinjiao (sp6), and hegu (li4) will be investigated, compared with the medication group treated by oral administration of prophylactic agents, and the control group received routine nursing care on chemotherapy-induced bone marrow suppression in patients with lung cancer.

Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer(nsclc) * age between 20 and 75 years * chemotherapy naive after diagnosis * gp regimen as treatment * an expected survival of more than 12 weeks based on a score equal to or greater than 60 points on karnofsky performance status (kps) scale * the ability to understand and speak mandarin exclusion criteria: * diagnosis of a hematological system tumor * mental illness * bone marrow suppression prior to chemotherapy * pregnancy

Keywords: acupuncture electrical stimulation of acupoints chemotherapy diyu shengbai pian nursing care
evaluation of sequencing of anthracyclines and taxanes for locally advanced her2-negative breast cancer

Conditions: Breast Cancer

Summary: phase iii randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced her2-negative breast cancer.

multicenter, phase iii, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. the treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. the chemotherapy regimen will follow the institution's routine, which includes the use of ca in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. the rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines.

Eligibility criteria:
inclusion criteria: * female participants, with at least 18 years old on the day of signing the free and informed consent; * invasive breast carcinoma stage iii (rh positive) or iib/iii (rh negative), according to tnm 8th edition; histologically confirmed diagnosis of invasive breast carcinoma (with any histology), her-2 negative; * the participant (or legally acceptable representative, if applicable) provides written informed consent for the study; * the participant must agree to use a contraceptive as detailed in appendix b of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment; * have a functional capacity according to the eastern cooperative oncology group (ecog) from 0 to 2. the evaluation of the ecog must be carried out within 7 days before the inclusion date. * have adequate organic function. the samples must be collected within 60 days before the start of the study treatment; * have adequate cardiac function as assessed by echocardiogram or muga performed up to 60 days before the start of treatment under study. exclusion criteria: - individuals who do not meet the inclusion criteria above-mentioned.
evaluating the safety and efficacy of the alphavac multipurpose mechanical aspiration (mma) f1885 pe for treatment of acute pulmonary embolism

Conditions: Pulmonary Embolism; Acute Pulmonary Embolism

Summary: to evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the alphavac multipurpose mechanical aspiration (mma) f1885 pe in a prospective trial of patients with acute intermediate-risk pulmonary embolism (pe).


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form. * 18 years of age and older. * clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. * diagnosis of pulmonary embolism detected from computed tomography angiography (cta). * right ventricle to left ventricle (rv/lv) ratio of 0.9 or higher. * systolic blood pressure (sbp) of 90 mmhg or higher * heart rate of 130 beats per minute (bpm) or less prior to the procedure. * deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment. exclusion criteria: excluded from the study if he/she meets any of the following exclusion criteria * may be pregnant as determined by a positive pregnancy test or who are breastfeeding. * has any contraindication to systemic or therapeutic doses of heparin or anticoagulants. * has used thrombolytics (tpa) in the past 30 days of baseline cta. * has pulmonary hypertension with peak pulmonary artery pressure (pap) \> 70 mmhg. * fraction of inspired oxygen (fio2) requirement \>40% or \>6 liters per minute (lpm) to keep oxygen saturations \>90% * hematocrit \<28% within 6 hours of the index procedure. * platelets count \< 100,000/µl. * serum creatinine \>1.8 mg/dl. * international normalized ratio (inr) \> 3 * has undergone a major trauma within the past 14 days of the index procedure and have injury severity score (iss) \> 15. * presence of cancer requiring active chemotherapy. * known bleeding diathesis or coagulation disorder. * has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure. * history of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, heparin-induced thrombocytopenia (hit) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%. * known anaphylactic reaction to radiographic contrast agents that cannot be pretreated. * requires vasopressor after fluids to keep pressure ≥ 90 mmhg. * with left bundle branch block. * has intracardiac lead in the right ventricle or atrium. * evidence such as imaging or other that suggests the subject is not appropriate for this procedure. * has life expectancy \< 90 days. * dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ecmo). * participation in another investigational study
repetitive transcranial magnetic stimulation in the treatment of obsessive compulsive disorders

Conditions: Obsessive Compulsive Disorders

Summary: objectives.-repetitive transcranial magnetic stimulation (rtms) is a non-invasive stimulation methods that became widely used as therapeutic tools in neuropsychiatric research. the aim of this study is to evaluate the therapeutic impact of different frequencies of repetitive transcranial stimulation (1hz, 10hz) in ocd patients. material and methods; forty five patients of ocd were participated in the study. all patients fulfilled the diagnostic criteria of dsm-iv-tr. the mean age of the patients was 27.1+4.5 years. each patient was subjected to the following: yale-brown obsessive compulsive scale (y-bocs), hamilton anxiety rating scale (ham-a), and clinical global impression - severity scale (cgi-s). the patients were randomly classified into three equal groups using closed envelop: 1st group received 1 hz rtms at 100% of the rmt, 2nd group received 10 hz rtms with intensity of 100% of the rmt and 3rd group was sham group received the sham stimulation with a total 2000 pulses every day for each group for 10 sessions. follow up of the patients using the same previous scales after the end of sessions and 3 months later.


Eligibility criteria:
inclusion criteria: * all patients fulfilled the diagnostic criteria of dsm-iv-tr exclusion criteria: * patients with comorbid psychiatric disorder .
myotonometer analyses of muscles in multiple sclerosis patients with dysphagia

Conditions: Multiple Sclerosis; Dysphagia; Swallowing Disorder; Deglutition Disorders; Muscle Tonus

Summary: multiple sclerosis is a chronic inflammatory autoimmune neurological disease characterized by the destruction of myelin in the central nervous system, grey matter and axonal loss. the prevalence of neurogenic dysphagia in this group of patients is estimated to be more than 30%. the aim of this study was investigating of masseter, orbicularis oris, sternocleidomastoid muscles' viscoelastic properties in ms patients with and without swallowing problems.

the aim of this study was investigating of masseter, orbicularis oris, sternocleidomastoid muscles' viscoelastic properties in ms patients with and without swallowing problems. it carried out that myotonometric assessment of muscles in multiple sclerosis patients with dysphagia and comparison of these properties.

Eligibility criteria:
inclusion criteria: 1. being diagnosed with mc donald's multiple sclerosis (ms) in accordance with 2010 criteria, 2. being between the ages of 18-45. exclusion criteria: 1. having psychological, orthopedic and other neurological disorders, 2. pregnancy, 3. having had an attack in the last 3 months, 4. application of botulinum toxin in the last 6 months.