Kornimate/medical-research-clean huggingface dataset:
ticagrelor vs clopidogrel for platelet inhibition in stenting for cerebral aneurysm

Conditions: Cerebral Aneurysm

Summary: part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. to reduce thromboembolic events, dual antiplatelet therapy (apt) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. it could be an option for apt due to more reproducible response with less interindividual variability and reduced monitoring. the aim of this study is to demonstrate the interest of ticagrelor for the dual apt for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.


Eligibility criteria:
inclusion criteria: * unruptured cerebral aneurysm * elective endovascular treatment * stenting required * dual antiplatelet therapy required exclusion criteria: -none
glutamine therapy for hemolysis-associated pulmonary hypertension

Conditions: Pulmonary Hypertension; Sickle Cell Disease; Thalassemia

Summary: the primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (ph) in sickle cell disease (scd) and thalassemia (thal) patients with ph. ph is defined as a tricuspid regurgitant jet velocity (trv) on doppler echocardiography \> 2.5 m/s. we also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-pat technology through nitric oxide (no) generation, leading to changes in biological markers, and clinical outcome. specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and ph in patients with scd and thal.


Eligibility criteria:
inclusion criteria: * established diagnosis of scd (hb ss, sc or sbeta- thalassemia) or thal * ph documented by echocardiography, defined as at trv greater than 2.5 m/s * age greater than or equal to 4 years exclusion criteria: * inability to take or tolerate oral medication * acute crisis or hospitalization within 1 month of enrollment * hepatic dysfunction (sgpt greater than 3x normal) * renal dysfunction (creatinine greater than 2x normal) * allergy to glutamine * pregnancy or breastfeeding * patients on sildenafil (viagra), calcium channel blockers, or amino acid/protein supplements (other therapies acceptable if stable more than 3 months)

Keywords: pulmonary hypertension sickle cell disease thalassemia
drug interaction potential between dolutegravir and simeprevir in hiv/hcv seronegative volunteers

Conditions: HIV; Hepatitis C

Summary: the investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. the investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.

to investigate the potential for drug interactions between simeprevir and dolutegravir, participants will receive each drug alone and the drugs in combination for 7 days. the pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be compared.

Eligibility criteria:
inclusion criteria: * men and women ages 18-60 years * absence of hiv-1 and hcv antibodies at screening, * ability and willingness to give written informed consent before the first trial-related activity. exclusion criteria: * pregnancy * breastfeeding * active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements * participation in any investigational drug study within 30 days prior to study entry * currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results * use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives * concomitant medications other than those listed above must have been discontinued at least 14 days before study entry * currently active dermatitis or urticaria or diagnosis of eczema or psoriasis, * history of significant drug allergy (i.e., anaphylaxis and/or angioedema) * subjects with the following laboratory abnormalities at screening as defined by the 2004 division of aids table for grading the severity of adult and pediatric adverse events ("daids grading table") and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range (uln)); hemoglobin grade 1 or greater (≤ 10.9 g/dl); platelet count grade 1 or greater (≤ 124.999 x 109/l); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/l); aspartate aminotransferase (ast) or alanine aminotransferase (alt) grade 1 or greater (≥ 1.25 x uln); total bilirubin grade 1 or greater (≥ 1.1 x uln), any other laboratory abnormality of grade 2 or above.

Keywords: dolutegravir simeprevir hiv hcv
study of automated care pathway for patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive; Pulmonary Diseases, Obstructive

Summary: this is a fully automated randomized trial with two randomization branch-points. the first is inclusion of disease-specific orders in the admission orders based on a predictive model using real-time data. the second is the use of dynamic orders that are end-user tested rather than static orders designed by a committee. the primary hypothesis is that automatic inclusion of disease specific orders with admission orders will improve adherence to guidelines for patients with copd. the secondary hypothesis is that clinical and operational outcomes will improve, thereby improving value.

this is a single-center, single-blinded, 2x2 factorial randomized controlled trial to test both automated order set inclusion and evidence-based order set design with end user testing on order set use and clinical outcomes for adult patients admitted to the hospital with acute exacerbations of chronic obstructive pulmonary disease (copd). first, the investigators will develop a predictive model to identify patients admitted to the hospital with copd exacerbations based on retrospective data, but limited to data that is available in real-time at admission. second, 1,000 admissions to ucsf medical center of adults predicted to have copd by the predictive algorithm will be prospectively block randomized by encounter to automatic inclusion of a copd order set in the admission orders or usual care. providers caring for patients in both arms of the trial can independently search for and use a copd order set. any provider using a copd order set in either arm will also be randomized to see two versions of the order set. the first is a static list of orders, and the second is dynamic, meaning that orders will display only when appropriate. for example, a patient who just had a chest x-ray does not need a routine repeat test. the dynamic order set will show the provider that the x-ray was completed at a specific time and will not display a prompt for a repeat test. providers can, of course, still order anything they deem clinically appropriate, and may choose to order a repeat x-ray for a patient with a change in clinical status. the components of the order set are based on international guidelines from the global initiative for chronic lung disease (gold initiative, a collaboration between the national heart, lung, and blood institute and the world health organization) and a multi-stakeholder working group at ucsf including two hospitalists, two pulmonologists, two transitional care nurse specialists, one advanced practice nurse, one pharmacist, one respiratory therapist, one physical therapist, and one nurse.

Eligibility criteria:
inclusion criteria: * patients 18 years old or greater admitted to the hospital medicine service at ucsf medical center who meet criteria as determined by predictive model to be likely admissions for copd exacerbation. exclusion criteria: * patients admitted to other clinical services at ucsf medical center.

Keywords: informatics copd quality improvement
perspectives of subcutaneous velcade at home of patients with myeloma.

Conditions: Multiple Myeloma

Summary: in the present study, we have trained 10 patients in subcutaneous self-administration of velcade. after their training, patients will alternately receive their treatment in the hospital and at home by self-administration. in keeping with common practice, a nurse contacts the patients by telephone before 9.00 am on the day of treatment to ensure that the patient is physically "fit" to receive the medication and to discuss any side effects. to highlight the advantages and disadvantages of the changed treatment practice from the perspectives of both patients and healthcare professionals, data is collected from two consecutive semi-structured interviews with n = 10 patients and n = 1 focus group interview of the healthcare professionals involved. moreover, time registration of medication administration both at the hospital and in the patients' home is done. the qualitative data will be analyzed via the method of condensation and continual quantitative data will form the basis of a cost-benefit analysis.


Eligibility criteria:
inclusion criteria * patients must have multiple myeloma * patients (or their relatives) must be deemed physically and cognitively suitable and willing for self-administration of subcutaneous velcade * patients must be able to understand and speak danish * patients must have received a minimum of 1 treatment cycle in the outpatient clinic exclusion criteria * lack of willingness to participate in scheduled interviews * patients who are cognitively affected * must not be receiving trial treatment
itch trial: protocol for a randomized, double blind placebo-controlled trial

Conditions: Cerebral Hemorrhage

Summary: intracerebral hemorrhage is increasingly becoming a major burden in the society because of significant morbidity as well as mortality. hematoma volume at the time of presentation as well as hematoma expansion and re-bleed or ongoing bleed further deteriorates the patient making a poor prognosis, however at present no therapy targets this pathological process. though clinical studies do report benefit of using tranexamic acid in spontaneous intracerebral hemorrhage by reducing hematoma expansion rate as well as decreasing ongoing bleed, large randomized controlled trials have not shown any convincing advantage owing to various limitations in their design and methods. however, they uniformly did not find any significant side effect with the use of tranexamic acid. the aim of this study is to test the hypothesis that intravenous tranexamic acid is superior to placebo by reducing hematoma expansion when given within 24 h of spontaneous intracerebral hemorrhage.

patients and methods: data are being collected as patient gets admitted with intracerebral haemorrhage. 154 spontaneous intracerebral haemorrhage patients presenting within 24 hours of ictus or last known well will be taken in the study. outcomes of these patients will be calculated to establish a relationship between hematoma expansion, underlying pathology and outcome of the patients. results: primary outcome i.e. radiological improvement (ct scan): difference between hematoma volume with perilesional edema from baseline and 48-hour post treatment scan, hematoma location, and new infarction. secondary outcomes: neurological impairment (nihss), disability (barthel index), dependency (mrs) on day of discharge. mrs at day 30. cognition (telephone interview cognition score-modified), dependency (mrs) at days 90 and 180. similarly, costs of treatment between two groups, length of stay in hospital and f/u data. also, safety endpoints recorded until day 180: death (cause), venous thromboembolism confirmed by ultrasound, vascular occlusive events (stroke/transient ischemic attack/myocardial infarction/peripheral artery disease), seizures. serious adverse events (aes) in first seven days will be analyzed and calculated.

Eligibility criteria:
inclusion criteria: 1. all patients presenting to the emergency department with symptom of hemorrhagic stroke within 24 hours from onset of symptom or last seen well. 2. patient who had a follow up exclusion criteria: 1. glasgow coma scale \<8 after resuscitation (as this can lead to biasness; requires surgery) 2. contraindication to tranexamic acid, 3. hemorrhagic stroke secondary to trauma, 4. hemorrhage was caused by coagulopathy

Keywords: double blind randomized trial spontaneous intracerebral hemorrhage tranexamic acid
positron emission tomography (pet) imaging of neuroinflammation in patients with neurological dysfunction after severe acute respiratory syndrome coronavirus 2 (sars cov 2) infection

Conditions: SARS CoV-2 Post-Acute Sequelae

Summary: this clinical imaging study will use the small molecule translocator protein (tspo) ligand, fluorodeoxyglucose(18f)-labeled dpa-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of sars-cov-2 (pasc) . the brain uptake of dpa-714 will be contrasted with healthy subjects.


Eligibility criteria:
inclusion criteria: 1. 18 to 65 years of age 2. healthy volunteer or clinical diagnosis of post-acute sequelae of sars-cov-2 (pasc) 3. high or mixed affinity binder for tspo ligands based on genotyping for single nucleotide polymorphism (snp) rs6971. 4. pasc participants must have been previously infected with sars-cov-2. their neurological symptoms must have been present for at least four weeks prior to the enrollment. 5. healthy control participants must have no neurological symptoms exclusion criteria: 1. contraindication to mri 2. pregnancy 3. lactation 4. individuals who are unable to participate in the imaging portion due to severity of their medical condition 5. chronic infectious disease (e.g. hiv, hcv) 6. viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation 7. diagnosis of cancer, including leukemia 8. blood or blood clotting disorder 9. except for individuals with multiple sclerosis (ms), a diagnosis of autoimmune disease is exclusionary 10. positive urine β-hcg test day of procedure or a serum human chorionic gonadotropin (hcg) test within 48 hours prior to the administration of \[18f\]dpa-714.11. 11currently enrolled in a clinical trial utilizing experimental therapies. 12. currently taking experimental therapies 13. low affinity binder for tspo ligands based on genotyping for snp rs6971. the following exclusionary criteria apply only to pasc patients and healthy controls: 14. self-reported history of moderate or severe traumatic brain injury 15. self-reported history of whiplash injury 16. self-reported history of inflammatory bowel disease (ibd). (individuals with irritable bowel syndrome (ibs) and no signs of inflammation will be allowed to participate.) 17. the following blood test results (at screening) will be exclusionary: 18. rheumatoid factor (rf) =\> 14 intunits/ml, 19. anti-nuclear antibody (ana) \> 1:80, 20. erythrocyte sedimentation rate (esr) \> 60mm/hour, 21.high sensitivity c-reactive protein (hscrp) \> 10mg/l, 22. complete blood count (cbc) results indicating acute infection, anemia, or other condition, 23. t3, t4, or thyroid-stimulating hormone (tsh) levels out of normal range, 24. fasting glucose \> 100 mg/dl, 25. blood chemistry results indicating organ damage or other serious medical condition 26. use of illicit substances within the past 6 months 27. self-reported diagnosis of type i or type ii diabetes 28. healthy controls must not regularly take over-the-counter anti-inflammatory medication, analgesics (except aspirin), or sleep medication
proper extent of maze intercaval lesion

Conditions: Atrial Fibrillation

Summary: it's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the cox-maze procedure. a patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years male or female * scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible * subjects willing and able to provide written informed consent exclusion criteria: * subjects receiving surgery with non-sternotomy access * presence of or history of transvenous pacing leads * subjects receiving a re-do cardiac surgery * subjects with a history of pericarditis * subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it. * any medical condition or finding for which the investigator used medical discretion to determine the subject should be excluded * subject is currently participating in another clinical trial. * subject is unable to provide written informed consent.
vitamin d as a key player in rheumatoid arthritis

Conditions: the Immunomodulatory Effect

Summary: rheumatoid arthritis (ra) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. vitamin d was found to modulate cell growth, function of immune cells and anti-inflammatory action. the aim of this study was to investigate serum vitamin d level and some cytokines and to identify the correlation between vitamin d and these cytokines in ra. methods: totally 60 ra patients without vitamin d supplement were involved in this study. the serum level of vitamin d, interleukin-6 (il-6), il-10, il-35, tumor necrosis factor α (tnf-α) and c-reactive protein (crp) were measure in all patients by enzyme-linked immunosorbent assay (elisa) then they will divided into 2 groups, group i receive vit. d supplementation and group ii will receive placebo and follow up for 3 months.

rheumatoid arthritis (ra) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. vitamin d was found to modulate cell growth, function of immune cells and anti-inflammatory action. the aim of this study was to investigate serum vitamin d level and some cytokines and to identify the correlation between vitamin d and these cytokines in ra. methods: totally 60 ra patients without vitamin d supplement were involved in this study. the serum level of vitamin d, interleukin-6 (il-6), il-10, il-35, tumor necrosis factor α (tnf-α) and c-reactive protein (crp) were measure in all patients by enzyme-linked immunosorbent assay (elisa) then they will divided into 2 groups, group i receive vit. d supplementation and group ii will receive placebo and follow up for 3 months.

Eligibility criteria:
inclusion criteria: * ra patients exclusion criteria: * patients with inflammatory bowel disease patients with any other autoimmune diseases
billroth ii or roux-en-y reconstruction for gj after pd: randomized controlled trial (pauda trial)

Conditions: Malignant Neoplasm of Head of Pancreas

Summary: the aim of the study is to compare the effect of roux-en y reconstruction (study group, dpcda) versus classical child reconstruction (dpcun) in the incidence of vgl in patients for dpc. the hypotesis of the study is that roux-en y reconstruction decreases incidence of dge after pancreaticoduodenectomy.

the pancreaticoduodenectomy (dpc) is the procedure of choice of the tumors of the head of the pancreas, periampullary tumors and intractable inflammatory pathology. the high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery. the most common complication is delayed gastric emptying (dge), defined as the intolerance to solid oral intake by 7th day postoperative. in some severe cases, oral intolerance can occur after the 21th postoperative day. therefore, the patient requires parenteral nutrition and prolonged hospital stay. the aim of the study is to compare the effect of roux-en y reconstruction (study group, dpcda) versus classical child reconstruction (dpcun) in the incidence of vgl in patients for dpc. the hypotesis of the study is that roux-en y reconstruction decreases incidence of dge after pancreaticoduodenectomy. a pilot randomized clinical trial has been designed to compare two surgical techniques for reconstruction of digestive tract after dpc in patients treated in our center. the patients are randomized after tumor resection and before the reconstruction througt computer-generated random numbers using a sealed envelope technique. the primary endpoint is the incidence of dge. secondary endpoints are postoperative morbidity and specific complications as pancreatic fistula, the hospital stay, and postoperative endocrine and exocrine function.

Eligibility criteria:
inclusion criteria: * patients with pancreatic head cancer considered resectable after the extension study * patients suffering from periampullary tumors considered resectable after the extension study * patients suffering from pancreatic inflammatory disease with medically intractable pain * patients who have read the information sheet of the study and signed the informed consent form exclusion criteria: * patients with history of previous gastrectomy * patients with associated resections of other organs, except for the superior portal vein or mesenteric vein * patients with enlargement to total pancreatectomy * patients who has recieved neoadjuvant treatment * patients with plastic peritonitis * patients with liver cirrhosis.

Keywords: pancreaticoduodenectomy delayed gastric emptying roux en-y reconstruction
azd2171 in addition to fulvestrant in patients with advanced breast cancer.

Conditions: Advanced Breast Cancer

Summary: the purpose of this study is to determine whether azd2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.


Eligibility criteria:
inclusion criteria: * written informed consent * females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease * one or more evaluable lesions exclusion criteria: * prior hormonal therapy with fulvestrant * more than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer * prior biologic therapy for abc including anti-vegf agents * radiation therapy within 4 weeks prior to provision of consent

Keywords: advanced breast cancer