Kornimate/medical-research-clean huggingface dataset:
assess the potential for adrenal suppression and systemic drug absorption following multiple dosing with dfd-06

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the potential of dfd-06 to suppress the hypothalamic-pituitary-adrenal (hpa) axis when applied twice daily for 15 days.

this is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. in the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with dfd-06 (at least 20 completed subjects). in the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with dfd-06 (at least 20 completed subjects). an attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. dfd-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. subjects must have ≥10% body surface area (bsa) treated to achieve maximal use exposure.

Eligibility criteria:
inclusion criteria: * subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively. subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study. * subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at screening. * subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. * subjects with psoriasis involving ≥10% body surface area (bsa), not including the face, scalp, groin, axillae and other intertriginous areas at the baseline visit. * subjects must have an investigator global assessment (iga) grade of at least 3 (moderate) at the baseline visit. exclusion criteria: * subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. * subject has a history of organ transplant requiring immunosuppression, hiv, or other immunocompromised state. * subject has received treatment for any type of cancer within 5 years of the baseline visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the baseline visit. * subject has a history or presence of intracranial hypertension. * subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease
additive effect of ezetimibe upon simvastatin during myocardial infarction

Conditions: Myocardial Infarction

Summary: during acute coronary syndromes (acs), the generation of inflammatory mediators negatively influences arterial wall remodeling and the endothelium-dependent vasomotor function in the coronary and systemic arterial systems. in fact, the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events. the investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during acs. in addition, such statin treatment attenuates the post-discharge endothelial dysfunction of these patients. by inference, it is plausible to hypothesize that these beneficial effects during acs may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe. so far, data is unavailable to verify this assumption. in parallel, data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in liver cells. in this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.


Eligibility criteria:
inclusion criteria: * less than 24 hours after the onset of myocardial infarction symptoms * st-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads * myocardial necrosis, as evidenced by increased ck-mb and troponin levels exclusion criteria: * use of statins for the last 6 months before myocardial infarction

Keywords: myocardial infarction systemic inflammatory activity endothelial function
evaluating a our practice advisory (opa) to optimize hemoglobin a1c (a1c) and thyroid-stimulating hormone (tsh) test orders

Conditions: Physician Workflow; Resource Utilization

Summary: our practice advisory (opa) are essential tools in clinical decision-making. the alerts are designed to guide providers towards evidence-based practices and improve patient outcomes. the focus of this initiative is on hemoglobin a1c (a1c) and thyroid-stimulating hormone (tsh) testing, with the goal of addressing unnecessary repeat testing within a 30-day timeframe, which rarely yields significant new insights. although randomization occurs at the patient level, the primary outcome of this study focuses on provider behavior and decision-making. by focusing on this specific intervention, the study aims to optimize resource use, align test ordering with evidence-based guidelines, and support improved patient outcomes. the results of this evaluation will help refine opas and guide broader strategies for implementing clinical decision support tools across healthcare systems.

the purpose of this quality improvement (qi) initiative is to evaluate the impact of a randomized our practice advisory (opa) intervention on physician ordering behavior of hemoglobin a1c (a1c) and thyroid-stimulating hormone (tsh) tests within a 30-day interval from the prior test. the opa will fire when an a1c or tsh are ordered within 30 days of a prior result (these short-interval tests are widely considered unnecessary) and will ask providers to reconsider the order. this study will evaluate the effectiveness of this intervention by randomizing patients 1:1 such that physicians caring for the patient will either (1) receive the opa or (2) not receive the opa if the providers order a short-interval test. this study is being conducted for a primary qi intent, as the results will (1) dictate if the short-interval opa should be implemented across all patients, and (2) if this short-interval opa should be applied to other labs aside from a1c and tsh. in these ways, the purpose of this study is to directly inform health system operations.

Eligibility criteria:
inclusion criteria: * 18 years or older * inpatient or observation stays within ucla health system hospitals * hemoglobin a1c (a1c) and thyroid-stimulating hormone (tsh) ordered, and this lab was ordered and resulted within the prior 30 days exclusion criteria: * have an a1c or tsh ordered and do not have a result for one of these labs in the prior 30 days

Keywords: clinical decision support laboratory test optimization resource utilization our practice advisory (opa)
an open label study of the effect of telaprevir in combination with ribavirin and peginterferon on hcv infection in stable liver transplant patients

Conditions: Hepatitis C

Summary: to assess efficacy of telaprevir, pegylated interferon alfa-2a (peg-ifn-alfa-2a), and ribavirin (rbv) for hepatitis c virus (hcv) in a 48-week total treatment duration regimen following liver transplantation.


Eligibility criteria:
inclusion criteria: * male and female participants between the ages of 18 and 65 years * history of orthotopic liver transplantation less than 10 years before the screening visit but no sooner than 6 months before day 1 * taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months * naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response exclusion criteria: * documented cirrhosis after liver transplantation * ascites or hepatic encephalopathy within 6 months before screening * retransplantation for recurrent hepatitis c * treatment for hepatitis c post liver transplantation * history within the past 3 months of: rejection within 3 months or greater than (\>) 1 rejection within 12 months * current treatment with sirolimus or methylprednisolone. low dose prednisone use (\<5 milligram per day) is permitted * history within 3 months of any bacterial infection requiring \>1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush) * history of post transplant lymphoproliferative disease * acceptable laboratory values at screening as specified in the protocol * positive for human immunodeficiency virus 1/2 (hiv1/2) enzyme immunoassay (eia) antibody screen or hepatitis b deoxyribonucleic acid (dna) or hepatitis b surface antigen * history of hepatocellular carcinoma with high risk of recurrence * any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis c * autoimmune-mediated disease * history of acute pancreatitis within 5 years before the screening visit * prior treatment with an hepatitis c virus (hcv) protease inhibitor
atrial fibrillation burden and long-term risk of thromboembolic complications- the fincv-4 study

Conditions: Atrial Fibrillation; Stroke, Ischemic

Summary: this study explores the association of symptomatic episodes of atrial fibrillation (af) occurrence and long-term risk of thromboembolic complications in a retrospective setting.

the study population consists of the fincv-dataset, which includes 7660 acute cardioversions for atrial fibrillation. the electronic patient records of fincv-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. we seek to explore the possible association between the frequency of af paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. data collection is performed by reviewing electronic patient records.

Eligibility criteria:
* primary diagnosis of atrial fibrillation (icd-10 code i48) * cardioversion for acute (\<48 h) atrial fibrillation * \>18 years of age * living within the catchment area of the hospital
promoting adherence to anti-hiv drug regimens

Conditions: HIV Infections

Summary: one of the main causes of treatment failure in hiv infected individuals is lack of adherence to complicated drug regimens. the purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-hiv drug regimens. participants in this study will be recruited from the university of alabama at birmingham (uab) outpatient hiv clinic.

poor adherence to complicated antiretroviral (arv) drug regimens is one of the most pressing behavioral problems in the clinical management of hiv infected persons. recent medical advances have made it possible to maintain tighter control of viral replication, allowing people with hiv to live longer, healthier lives. however, the complexity of arv drug regimens and drug side effects make medication adherence problematic. deviations from the prescribed regimen may allow the virus to resume rapid replication and develop drug resistant mutations that could render the prescribed drugs useless. this study will evaluate the efficacy of a 6-month, theory-based behavioral intervention to enhance adherence to antiretroviral treatment regimens. hiv-related attitudes, depressive symptoms, coping strategies, and social support will also be assessed to examine theoretical assumptions regarding the causal relationship between psychosocial constructs and medication adherence. participants in this study will be recruited from uab outpatient hiv clinic patients who are taking arv medication. participants will be randomized to a standard adherence promotion group or an enhanced adherence promotion group. the enhanced adherence promotion will systematically address specific psychosocial issues associated with medication adherence. participants will be followed for 6 months, and adherence will be evaluated at monthly study visits. pill counts, viral loads, self-reported adherence to arv medication, cd4 count, and genotypic viral resistance will be assessed.

Eligibility criteria:
inclusion criteria * hiv infected * receiving services at uab outpatient hiv clinic * taking antiretroviral medication * able to attend monthly assessment meetings at clinic for 6 months * passing score on mini mental state examination

Keywords: patient compliance adherence treatment experienced
randomized study of adjuvant radiotherapy after curative resection of hcc with narrow margin (raise)

Conditions: Hepatocellular Carcinoma; Radiotherapy; Hepatectomy

Summary: raise is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in hcc patients with narrow margin (≤ 1 cm) after curative resection.

raise trial will recruit 148 patients, and they will be randomized (1:1) to two groups (the surgery group and the surgery-radiotherapy group). random assignment was stratified by the condition of mvi and tumor size. all patients in the surgery-radiotherapy group received intensity modulated radiation therapy (imrt) within 1-3 months after surgical resection. the prescription dose was planned at 50 gray in 25 fractions over 5-6 weeks. the trial is to verify whether adjuvant radiotherapy prolongs recurrence-free survival in patients with a narrow resection margin.

Eligibility criteria:
inclusion criteria: 1. age 18 - 75 years. 2. hcc who underwent r0 resection with pathological confirmation. 3. the narrowest margin is less than or equal to 1 cm. 4. no residual tumors after surgery based on postoperative ct or mr images in 4-6 weeks. 5. ecog ps ≤ 1. 6. child-pugh score 5-7. 7. expected life expectancy ≥ 6 months. 8. blood, liver, and kidney functions meet the following criteria: 1)neutrophil counts ≥ 1.5×109/l; 2)platelet counts ≥ 60×109/l; 3)hemoglobin concentration ≥ 90g/l; 4)serum albumin concentration ≥ 30g/l; 5)bilirubin ≤ 1.5 × upper limit of normal; 6)ast and alt \< 3× uln; 7)extended prothrombin time not exceeding 3s of uln; 8)creatinine \< 1.5× uln. exclusion criteria: 1. preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis. 2. the number of tumors ≥4. 3. pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years. 4. patients with concomitant hiv or syphilis infection. 5. patients with concurrent or other malignancies within 5 years before enrollment. 6. patients receiving allogeneic organ transplantation. 7. patients with severe dysfunction of the heart, kidneys or other organs. 8. participated in clinical trials of other drugs within 12 months before enrollment.
a first in human study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled etd002 in healthy subjects

Conditions: Healthy

Summary: this is a first in human study of etd002 a new drug being developed for the treatment of cystic fibrosis.the study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled etd002 in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * males \& females using suitable methods of contraception or females of non-childbearing potential * consent to study participation * body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2 * vital signs assessments within normal ranges * healthy as determined following physical examination at screening visit * spirometry readings (fev1 and fvc) to be ≥ 80% of predicted value exclusion criteria: * acute or chronic illness detected at screening visit * respiratory tract infection within 4 weeks of the screening visit * use of prescription or otc medication within 14 days of the screening visit * history of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse * smoking or use of tobacco products within 6 months of screening * abnormal blood/urine laboratory screening test results * current, or history of, allergy that may be contraindicated

Keywords: cystic fibrosis
role of doppler ultrasound in severe peptic ulcer hemorrhage

Conditions: Peptic Ulcer Hemorrhage

Summary: the aim of study is to evaluate whether doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.

bleeding peptic ulcer is a life-threatening emergency. endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. currently there is no objective assessment of adequacy of endoscopic therapy. endoscopic doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. a persistent signal after endoscopic therapy predicts recurrent bleeding. the current study proposes to compare assessment of ulcer base using either doppler ultrasound or endoscopists' interpretation of ulcer floors. the trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.

Eligibility criteria:
inclusion criteria: * clean base ulcer with severe upper gib (defined as melaena, hematochezia, hematemesis, and/or gross blood in ng lavage), and any one of the following: 1. sbp ≤ 90mmhg; p of ≥110 bpm; or orthostatic changes with sbp drops 20mmhg or p increases 20 bpm; or, 2. transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or, 3. a documented hct drop of at lest 6% from baseline. * endoscopically confirmed bleeding from gu, du, pyloric ulcer, or anastomotic ulcer * pt can either have primary or secondary acute ugi haemorrhage exclusion criteria: * bleeding site from lesion other than gu, du, pyloric or anastomotic ulcer * there is more than one type of significant bleeding lesion * documented hx of cirrhosis / portal ht * esrf requiring any form of dialysis * expected or persistent (\>24hrs) coagulopathy with inr\> 1.5 * platelet count is under 50000/mm3 * aspirin user / plavix \[clopidogrel\] user * if the ulcer is neoplastic * cannot obtained consent * age \< 18 or is pregnant * severe comorbid of which life expectancy \<30 days

Keywords: peptic ulcer hemorrhage doppler ultrasound
novolet® acceptance study within the hospital practise in indonesia

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the novolet® system used in a hospital environment.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * type 2 diabetes * likely to be hospitalised and require insulin therapy
immunogenicity and reactogenicity study of boostrixtm (dtpa) and boostrix-ipv (dtpa-ipv)

Conditions: Acellular Pertussis; Tetanus; Diphtheria

Summary: this purpose of the study is to evaluate the immunogenicity and reactogenicity of boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of boostrix-ipv followed by two doses of td vaccines (ditanrixtm adult, tedivaxtm), as compared to three doses of licensed td vaccines in adults.


Eligibility criteria:
inclusion criteria: * only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study * a male or female adult \>= 40 years of age * written informed consent to be obtained from the subject prior to study entry * no history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * subject should not be pregnant or plan to become pregnant. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * pregnant or lactating female * female planning to become pregnant or planning to discontinue contraceptive precautions * previous vaccination with a meningococcal-conjugate vaccine, prevenar™ or other experimental conjugated pneumococcal vaccines * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * any confirmed or suspected immunosuppressive or immunodeficient condition

Keywords: dtpa td ipv
minimum effective volume for selective trunk block

Conditions: Musculoskeletal Diseases or Conditions

Summary: the objective of this study is to identify the minimum effective dosage of a mixture of two local anaesthetic drugs called 'levobupivacaine' and 'lignocaine with epinephrine" used to produce an effective ultrasound guided selective trunk block for surgical anaesthesia of the upper limb.

ultrasound is widely used for brachial plexus block (bpb) and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks. since majority of the innervation to the upper extremity, including the shoulder, arises from the three trunks (superior, middle and inferior) of the brachial plexus, so targeted injections of the individual trunks of the brachial plexus under ultrasound guidance will produce surgical anaesthesia of the entire upper extremity (c5-t1). principal investigator refers to this novel technique "selective trunk block" (setb) and the preliminary experience with setb for surgical anaesthesia of the entire upper extremity has been very encouraging. currently there are no data describing an optimal dose or volume of local anaesthetic for setb. the aim of this study is to identify the minimum dosage of 1:1 mixture of 'levobupivacaine' and "lignocaine with epinephrine" required to produce effective surgical anaesthesia in at least 90% of patients presented for upper limb surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-iii scheduled to undergo elective upper extremity surgery involving the proximal humerus to distal hand or surgery involving any combination of these regions. exclusion criteria: * patient refusal * pregnancy * skin infection at the site of block placement * history of allergy to local anaesthetic drugs * history of bleeding tendency or with evidence of coagulopathy * pre-existing neurological deficit * pre-existing neuromuscular disease.

Keywords: selective trunk nerve block