Kornimate/medical-research-clean huggingface dataset:
early tips with polytetrafluoroethylene (ptfe) covered stents for acute variceal bleeding in patients with advanced cirrhosis

Conditions: Decompensated Cirrhosis; Bleeding Varices

Summary: the purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (tips) with polytetrafluoroethylene (ptfe) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.


Eligibility criteria:
inclusion criteria: * history of cirrhosis (clinical or by liver biopsy) * admission due to acute bleeding from oesophageal or gastric (gov1 or gov2) varices * child-pugh class c (child-pugh score less than or equal to 13) or child-pugh class b * signed written informed consent exclusion criteria: * patients not fulfilling inclusion criteria * pregnancy or breast-feeding * confirmed hepatocellular carcinoma * creatinine greater than 3 mg/dl * terminal hepatic failure (child-pugh score greater than 13) * previous treatment with tips or combined pharmacological and endoscopic treatment to prevent rebleeding * fundal or ectopic gastric variceal bleeding (igv1 or igv2) * complete portal vein thrombosis or portal cavernoma * congestive heart failure new york heart association (nyha) greater than iii or medical history of pulmonary hypertension * spontaneous recurrent hepatic encephalopathy

Keywords: transjugular intrahepatic portosystemic shunt tips variceal bleeding liver cirrhosis hepatitis b
metabolic effects of enfuvirtide in healthy volunteers

Conditions: HIV Infections

Summary: the metabolic effects of t-20 are not completely known, since the drug is used in combination with other antiretroviral agents. a short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of hiv infection and the concurrent use of other drugs.


Eligibility criteria:
inclusion criteria: * healthy adult males * bmi between 19-24.9 kg/m2 * no active concomitant clinical conditions * negative hiv, hbv and hcv serologies * negative abuse drug urine test exclusion criteria: * prior psychiatric illness * prior dyslipemia * alcohol consumption \> 30g/day * caffeine consumption \> 5 units/day * current smoker * known drug allergies * participation in other drug trials in the previous 3 months * no medications in the previous 30 days
pain satisfaction survey

Conditions: Pain

Summary: the purpose of this study is to survey pain management satisfaction in patients with non-cancer pain.

this is a multi-center, observational study consisting of a one time survey to assess pain management satisfaction for patients with non-cancer pain. the purpose of this study is to develop a large clinical database for the results of the pain management satisfaction questionnaire. all information collected from hospitals will be used to evaluate patient satisfaction of pain management and to improve the quality of life for patients with non-cancer pain observational study - no study drug administered

Eligibility criteria:
inclusion criteria: * patients who have visited out patient department (opd) and who are actively treated for pain exclusion criteria: * patients with cancer pain * patients with known or suspected psychotic disease or mental retardation

Keywords: non-cancer pain pain
tenecteplase versus alteplase before endovascular therapy for ischemic stroke

Conditions: Ischemic Stroke

Summary: patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tpa therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. if the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. the trial is prospective, randomised, open-label, blinded endpoint (probe) design.


Eligibility criteria:
inclusion criteria: 1. patients presenting with acute ischemic stroke eligible using standard criteria to receive iv thrombolysis within 4.5 hours of stroke onset 2. patient's age is ≥18 years 3. intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset. 4. arterial occlusion on cta or mra of the ica, m1, m2 or basilar artery. exclusion criteria: 1. intracranial hemorrhage (ich) identified by ct or mri 2. rapidly improving symptoms at the discretion of the investigator 3. pre-stroke mrs score of ≥ 4 (indicating previous disability) 4. hypodensity in \>1/3 mca territory or equivalent proportion of basilar artery territory on non-contrast ct 5. contra indication to imaging with contrast agents 6. any terminal illness such that patient would not be expected to survive more than 1 year 7. any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 8. pregnant women
efficacy and safety of odevixibat in patients with alagille syndrome

Conditions: Alagille Syndrome

Summary: double-blind, randomized, placebo-controlled, phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in patients with alagille syndrome.

approximately 35 sites will be initiated for this study in north america, europe, middle east, and asia pacific.

Eligibility criteria:
key inclusion criteria: * genetically confirmed diagnosis of alagille syndrome * history of significant pruritus as measured by the albireo observer or patient reported outcome instrument * elevated serum bile acid level key exclusion criteria: * history or ongoing presence of other types of liver disease (eg. biliary atresia, progressive familial intrahepatic cholestasis, hepatocellular carcinoma) * history of liver transplant, or a liver transplant is planned within 6 months of randomization * alt \>10× upper limit of normal (uln) at screening * total bilirubin \>15 × uln at screening * patient suffers from uncontrolled, recalcitrant pruritic condition other than alagille syndrome

Keywords: algs alagille syndrome
effectiveness and cost-effectiveness study of medical nutrition in malnourished patients in spain

Conditions: Malnutrition; Nutrition Disorders

Summary: the present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

cosnut pretends to assess the cost-effectiveness and cost-utility of oral nutritional supplementation (ons) in persons with malnutrition and other clinical conditions. the effectiveness will be evaluated by comparing the intervention group having ons vs a control group only with nutrition advice. the effectiveness and resource use will be collected using quality of life assessment tools, body mass index, change in malnutrition state, number of hospital admissions, medical visits... unitary costs for spain will be extracted from databases and official publications and will be applied to the number of resources used in order to calculate the costs in each of the groups. finally, the incremental cost-effectiveness ratio will be estimated and presented.

Eligibility criteria:
inclusion criteria: * \>18 y * nutritional status b or c (gsa criteria) * presenting one of the following conditions: * cancer patient after surgery, radiotherapy on antineoplastic treatment. * hip fracture * heart failure nyha (new york heart association) iii-iv. * breathing failure gold 3 o 4: fev1 (forced expiratory volume at one second ) \<50%. * renal failure gfr\<30 (glomerular filtration rate ) * participants agreeing the informed consent exclusion criteria: * cancer patients: esophagus, stomach, pancreas and head and neck * hospital admitted patients at the time of recruitment * life expectancy below 3 months * pregnant or nursing women * use of oral nutritional supplements in the three months prior the enrolment * history of allergy to oral nutritional supplements * diabetes mellitus type 1. * participation in any other study at the time of enrolment * cognitive limitations to participate in the study

Keywords: nutritional supplement cost-effectiveness cost-utility
adipose expression of leptin, adiponectin and il-6 and plasma levels of adipocytokines in women with and without polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of pcos. the investigators investigated lean and obese women with and without pcos.


Eligibility criteria:
inclusion criteria: * women with pcos according to the rotterdam criteria exclusion criteria: * other known diseases
can thrombelastography predict blood loss in patients with hip fractures

Conditions: Hip Fracture; Blood Loss

Summary: hip fractures are associated with a large hidden blood loss. that is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. there is currently no viable method of identifying patients at risk of transfusion. the on admission haemoglobin level has been shown to be falsely reassuring . we are conducting a study of 200 consecutive hip fracture patients. thrombelastography (teg) is taken on admission. the results are blinded to clinicians. results will be evaluated at the end of the study, comparing intra-operative and total blood losses with the teg profile of the patient.

hip fractures are associated with a large hidden blood loss. that is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. the total blood loss depends on the type of fracture and associated surgery. extra-capsular fractures treated with an intramedullary nail are thus associated with the largest hidden blood loss with a median of approximately 1500 ml . this hidden blood loss is primarily associated with the trauma and fracture itself and not, as such, with the surgical procedure. postoperative anaemia necessitating transfusion and a haemoglobin level below 8 g per dl, in hip fracture patients, are both associated with an increased mortality controversy remains on the benefits and indications for transfusion in this group of patients. there is currently no viable method of identifying patients at risk of transfusion. the on admission haemoglobin level has been shown to be falsely reassuring . teg has to our knowledge only been used in one previous study of hip fractures. the outcome measure in this study was thromboembolic events. we have not been able to identify any studies on the use of teg, inr, aptt or other tests as predictors of blood loss in hip fracture patients. clinicians would greatly benefit from a tool to predict the at-risk patient on admission. teg has been suggested as such a tool. bolliger et al suggests that teg can be used in goal-oriented algorithms to optimize targeted transfusion therapies in trauma patients or patients undergoing major surgery. we hypothesize that teg can be used for this purpose in patients with hip fracture. these patients can have large blood losses and they sustain the double trauma of a hip fracture and major orthopaedic surgery.

Eligibility criteria:
inclusion criteria: * all hip fracture patients admitted through the emergency room (er) at hvidovre university hospital in the study period. exclusion criteria: * hip fracture patients who are transfered from other wards in the hospital do not go through the er and are not included.

Keywords: hip fracture thrombelastography blood loss
the effect of digital storytelling applied to children in preoperative period

Conditions: Child; Preoperative Period

Summary: digital storytelling is the craft and art of exploring different media and software applications to communicate stories in new and powerful ways using digital media. because new digital tools are inexpensive and widely available, digital storytelling tends to be highly personal and at the same time universal. all in all, it is a very powerful form of communication. digital storytelling applications include short (three to five minute) films with pictures, video clips, soundtrack and narration; storytelling performances and talks supported by media slideshows or interactive presentations; and web-based applications, including streaming media, podcasts, and blogs. when looking at the literature, different approaches to using digital storytelling are seen: it is used in the education of health professionals, in academic education, for digital story development and research, and as a therapeutic care intervention. studies on the use of digital stories in the field of health have just begun to gain popularity, and it is noteworthy that the studies in the health services literature are not yet at the desired level and prevalence. healthcare is a unique environment to use digital storytelling intervention as a therapeutic purpose in addition to gaining knowledge in all our activities. using digital stories; it is thought that it will provide significant benefits to parents/children and health professionals by filling the gap in the literature in order to reduce the negative emotional behaviors and anxiety of children undergoing day surgery in the preoperative period, as an informative intervention that can attract the attention of their children while having fun.

the type of study planned is randomized controlled experimental design. the study group is divided into two as intervention and control groups. the intervention and control groups will be selected by simple random sampling method from among the volunteer participants who meet the inclusion criteria. power analysis was performed to determine the sample size. it was observed that the effect size obtained in the reference study (chow et al. 2017) was quite strong (d=0.96). as a result of the power analysis we performed, assuming that a lower level of effect size could be obtained (d=0.8), it was calculated that 80% power could be obtained at the 95% confidence level when at least 52 people (at least 26 people for each group) were included in the study. considering that there may be data losses, the sample size was planned as 72 people (36 people for each group), taking approximately 30% more than the number of samples calculated as a result of the power analysis.

Eligibility criteria:
inclusion criteria: admission to hospital for day surgery having internet access written informed consent from family and volunteers to participate in the study exclusion criteria: children with neurological development and learning problems children with chronic illness who require special medical care no internet access

Keywords: children preoperative period digital storytelling
the effectiveness of tailored messages on the usage of emollient in patients with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: atopic dermatitis is the most common chronic inflammatory skin disease in children and severely affects quality of life (qol) of patients and their parents. the application of topical medications and emollient is the mainstay of the treatment, but complexity of the treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic failure. adequate education about the chronic disease and its treatment was known to improve the treatment adherence. there are a variety forms like generalized information leaflets and video clips for imparting information to patients and individualized tailoring education was considered more effective way to improve patients' adherence. the aim of this study is to determine the efficacy of tailored education in dermatology area, especially the emollient usage in patients with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * a parent of 0-5 year old children with mild to moderate atopic dermatitis * 20 years of age or older * apply emollient for themselves to their children with atopic dermatitis exclusion criteria: * parents of children with severe atopic dermatitis or showing signs of acute infection (oozing, vesicles, edema, redness or pain)

Keywords: behavioral research emollients
campath-1h induction to allow steroid free immunosuppression in pediatric renal transplantation

Conditions: Disorder Related to Renal Transplantation

Summary: the purpose of this study is to determine whether campath-1h induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.


Eligibility criteria:
inclusion criteria: * participants must be a single-organ recipient (kidney only) * participants who are receiving their first living donor or deceased donor transplant exclusion criteria: * participants who are recipients of hla-identical living-donor renal transplants * participants with a pra value \> 10% within 30 days prior to the transplant * participants who have received a multi-organ transplant * participants who are who are positive for hepatitis c, hepatitis b surface antigen or hiv * participants who have received an investigational drug within 6 weeks of study entry * participants who have a previous history of, or who currently have, malignancies and/or lymphoma * participants who have received corticosteroids within three months of transplantation * participants who are 3rd transplant recipients * female participants who are pregnant or lactating. fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study

Keywords: living or deceased donor renal transplant recipient
a study to evaluate the efficacy and tolerability of topical therapies for the condition of plaque-type psoriasis

Conditions: Plaque-Type Psoriasis

Summary: the purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.

this study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. subjects will be randomized to only one of the two therapies for treatment throughout the study.

Eligibility criteria:
inclusion criteria: * body surface area (bsa) affected with psoriasis between 4% and 20% . * target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the psoriasis grading scale for target lesion. * elbow and/or knee plaque-type psoriasis with a psoriasis global assessment of mild or moderate (2 or 3). * definitive diagnosis of elbow and/or knee plaque-type psoriasis. * capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed. * male or female, 18 years of age or older at the time that the consent form was signed. * able to complete the study and comply with study instructions. * female subjects of childbearing potential must have had a negative pregnancy test. sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception. exclusion criteria: * use of any emollient applied to psoriasis plaques treated with the study medication during the study. * other serious skin disorder or any chronic medical condition that is not well controlled. * female subjects who are pregnant, trying to become pregnant or lactating. * any major illness within 30 days prior to the baseline visit. * received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.

Keywords: psoriasis
domperidone in refractory gastroparesis

Conditions: Gastroparesis

Summary: the primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.


Eligibility criteria:
inclusion criteria: * male or female * age 18 and older * symptoms or manifestations secondary to motility disorders of the upper gi tract. these include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy. * patients must have a comprehensive evaluation to eliminate other causes of their symptoms. this includes a history and physical examination. a recent (within 3 years) evaluation of the upper gi tract with either upper endoscopy or upper gi radiographic series. baseline blood tests suggested are electrolytes, magnesium, and prolactin level. * patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including: * increased prolactin levels * breast changes * extrapyramidal side effects * cardiac arrhythmias including qt prolongation (increased risk with the drugs listed in the appendix) exclusion criteria: * history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and torsade des pointes. patients with minor forms of ectopy (pacs) are not necessarily excluded. * clinically significant bradycardia, sinus node dysfunction, or heart block. prolonged qtc (qtc\>450 milliseconds for males, qtc\>470 milliseconds for females) * clinically significant electrolyte disorders. these include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities. * gastrointestinal hemorrhage or obstruction. * presence of a prolactinoma (prolactin-releasing pituitary tumor). * pregnant or breast feedings female. * known allergy to domperidone
topical tripterygium wilfordii gel for moderate activity rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: tripterygium wilfordii hook f (twhf), a traditional chinese herb, is widely used in china for treating rheumatoid arthritis (ra), but limited only for elderly ra patients because of its reproductive system toxicity. the investigators are inspired by chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make twhf topically in order to get an effective and safe treatment for active ra patients.


Eligibility criteria:
inclusion criteria: * documented diagnosis of rheumatoid arthritis, as defined by the american rheumatism association 1987 revised criteria. * documented diagnosis of damp-heat syndrome according to traditional chinese medicine. * patients, men and women, must age from 18 to 65 years old. * patients must have moderately active ra based on the criteria of the das-28 score from 3.2 to 5.1. * if patients are receiving disease-modifying anti-rheumatic drugs (dmards), then the doses should have been kept stable for at least 12 weeks. * if patients are receiving non-steroidal anti-inflammatory drugs (nsaids) or orally chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks. exclusion criteria: * skin allergies or broken skin; * taking twhf agents, glucocorticoids and biological agents; * female patients who are pregnant, breast-feeding or planed to be pregnant; * subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.

Keywords: rheumatoid arthritis tripterygium wilfordii hook f double-blinded randomized controlled trial tripterygium administration topical