Kornimate/medical-research-clean huggingface dataset:
pk of rivaroxaban in bariatric patients - extension

Conditions: Prophylaxis of Venous Thromboembolism

Summary: aim of this clinical trial is the assessment of rivaroxaban pk/pd parameters in patients 6-8 months after bariatric surgery

weight loss after bariatric surgery can putatively alter drug disposition of rivaroxaban. this may be due to an altered intestinal adaptations several months after the surgical procedure. the aim of this clinical trial is to investigate pharmacokinetic and pharmacodynamic parameters after single application of 10 mg rivaroxaban in patients with prior bariatric intervention (roux-en-y-gastric bypass or sleeve gastrectomy 6-8 months ago). pk/pd parameters will be assessed during 12 hours after application of rivaroxaban.

Eligibility criteria:
inclusion criteria: * patient with past elective bariatric surgery (roux-en-y gastric bypass surgery or sleeve gastrectomy 6-8 months ago) * patient aged 18 years and older * bmi ≥ 35 kg/m2 * women of child-bearing age: willingness of using a double barrier contraception method during the study * written, informed consent exclusion criteria: * intake of oral anticoagulants (phenprocoumon, acenocoumarol, dabigatran, etexilate, apixaban etc.) 4 weeks prior to inclusion in the study * application of parenteral anticoagulants (unfractionated heparin, low molecular weight heparins, heparin derivates (fondaparinux etc.) 4 weeks prior to inclusion in the study * pharmacologic platelet inhibition 4 weeks prior to inclusion in the study * known coagulation disorders (e.g. willebrand's disease, haemophilia) * evidence for deep vein thrombosis or pulmonary embolism in the personal history or in the history of first degree relatives * medical condition that is associated with an increased risk for vte, i.e. active cancer disease, lupus erythematodes chronic inflammatory bowel disease * active, clinically significant bleeding * congenital or acquired bleeding disorder * uncontrolled severe hypertension * active gastrointestinal disease that can potentially lead to bleeding disorder: oesophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel disease * vascular retinopathy * bronchiectasis or history of pulmonary bleeding * prior stroke or tia * hereditary galactose intolerance, lapp lactase deficiency, glucose-lactose malabsorption * severe renal impairment with a creatinine clearance (gfr) of \< 30ml/min * positive pregnancy test, pregnancy or nursing women * high risk of bleeding (e.g. active ulcerative gastrointestinal disease) * known intolerance of the study medication rivaroxaban * concomitant treatment with strong cyp3a4 inhibitors (e.g. ketoconazole, itraconazole, lopinavir, ritonavir, indinavir) * concomitant treatment with an p-glycoprotein inhibitor and weak or moderate cyp3a4 inhibitor (e.g. erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine)
strawberries and knee osteoarthritis (oa)

Conditions: Osteoarthritis, Knee

Summary: the proposed study aims to examine the hypothesis that strawberry supplementation will lower serum biomarkers of inflammation and improve knee function in patients with symptomatic osteoarthritis (oa).

the investigators propose the following two specific aims in a randomized crossover placebo-controlled trial in participants with two or more features of the metabolic syndrome and symptomatic osteoarthritis in this 12-week efficacy study: aim 1: to assess the effects of strawberries on biomarkers of inflammation \[serum levels of c-reactive protein: crp; inflammatory cytokines: interleukin-6: il-6; interleukin 1β: il-1β; tumor necrosis factor-alpha: tnfα\] aim 2: to assess the effects of strawberries on knee function as assessed by overall musculoskeletal examination and pain score (icoap, koos and haq-di).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis * must have waist circumference \>35 inches for women and \>40 inches for men exclusion criteria: * cancer * heart disease * smoking * berry allergy
study of dalotuzumab alone and with ridaforolimus in pediatric participants with advanced solid tumors (mk-8669-062 am1)

Conditions: Solid Tumors

Summary: this is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for pediatric participants with advanced solid tumors. this study will have three parts. part 1 will find a maximum tolerated dose (mtd) and collect pharmacokinetic (pk) data for dalotuzumab alone. part 2 will find an mtd and collect pk data for dalotuzumab in combination with ridaforolimus. part 3 will be an expansion cohort at the recommended phase 2 dose (rptd) found in part 2 to confirm the rptd and look at the potential efficacy of the combination therapy.


Eligibility criteria:
inclusion criteria: * participants of age 3 to 17 years for part 1 of the study and age 6 to 17 years for parts 2 and 3 of the study * histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma, that have progressed despite standard therapy or for which no effective standard therapy is known. * measurable or non-measurable disease for parts 1 and 2; measurable disease for part 3 * parts 2 and 3: must be able to swallow tablets * performance status: lansky play scale ≥70 for children \<10 years of age; karnofsky score ≥70 for children ≥10 to \<16 years; or eastern cooperative oncology group (ecog) status 0-2 for patients age 16 and older * adequate organ function * for females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication * participants of reproductive potential must agree to use (or have their partner use) adequate contraception throughout the study, starting with visit 1 through 30 days after the last dose of study drug exclusion criteria: * currently receiving any other investigational agents or using any investigational devices * leukemia * previously received dalotuzumab or other igf-1r inhibitors for part 1 * history of allergic reactions attributed to compounds of similar chemical or biologic composition to dalotuzumab or ridaforolimus * persistent acute toxicity from previous therapy ≥grade 2 (excluding alopecia, neuropathy, or hearing loss) * uncontrolled intercurrent illness despite adequate therapy * pregnant or breastfeeding * for parts 2 and 3: requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome p450 (cyp3a) * poorly controlled type 1 or 2 diabetes
effect of mosapride on gut transit in patients with chronic constipation or constipated irritable bowel syndrome and healthy subjects

Conditions: Constipated Irritable Bowel Syndrome; Chronic Constipation; Healthy

Summary: effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * functional constipation or constipated irritable bowel syndrome patients according to rome iii criteria exclusion criteria: * intolerable or hypersensitive to mosapride * known parkinson's ds * cardio- or cerebrovascular disease within 3 months * malignancy requiring surgery or chemotherapy or radiation within 5 years * history of gi surgeries except hernia repair, appendectomy, primary closure due to perforation * refractory diabetes mellitus/hypertension/thyroid diseases * symptomatic heart failure, renal failure, arrhythmia

Keywords: mosapride
heme home transfusion program

Conditions: Leukemia; Myeloma; Myelodysplastic Syndromes; Hematologic Malignancy; Hematologic Diseases; Lymphoma

Summary: this research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, heme-hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies.

lack of access to blood transfusions is a key barrier to timely hospice use for patients with blood cancers. refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding. transfusions palliate these symptoms and improve quality of life (qol); yet, most hospices do not provide access to transfusions. patients are thus faced with the agonizing choice of preserving access to vital palliative transfusions versus accessing quality home-based hospice care. patients with blood cancers and their caregivers report that transfusions are vital for their quality of life, and that access to transfusions is a key factor in deciding whether to opt for hospice care. the study team has thus developed a new model of care (heme-hospice) that provides access to palliative home transfusions to patients with hematologic malignancies who are enrolled in hospice. the purpose of this study is to determine whether access to heme-hospice versus usual care improves hospice enrollment rates, quality of life (qol), mood, and end-of-life healthcare utilization for patients with hematologic malignancies as well as qol and mood of their caregivers. this study is a cluster randomized trial in which hematologic oncologists will be randomly assigned to access to heme-hospice versus usual care. participants in this study will have access to heme-hospice or usual care based upon the strategy to which their hematologic oncologist has been assigned.

Eligibility criteria:
inclusion criteria for patient participants: * diagnosis of a relapsed/refractory hematologic malignancy * age ≥ 18 years * receipt of primary oncologic care at dfci (at least 2 outpatient visits in 12 months prior to enrollment) * has received at least one red blood cell (rbc) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a severe transfusion reaction * patient resides within catchment served by care dimensions hospice * physician-estimated prognosis of six months or less inclusion criteria for caregivers: * identified informal caregiver of enrolled patient with hematologic malignancy * age ≥ 18 years exclusion criteria for patient participants: * age \< 18 years * already enrolled in hospice * resides in nursing home or assisted living facility * history of previous serious adverse transfusion reaction exclusion criteria for caregivers: -age \< 18 years

Keywords: leukemia myeloma myelodysplastic syndromes hematologic malignancy hematologic diseases lymphoma
inspiratory muscle training in wheelchair basketball players

Conditions: Respiratory Muscles; Breathing Exercises; Athletic Performance; Athletes; Aerobic Capacity

Summary: investigate the effects of inspiratory muscle training on the physical performance and cardiorespiratory variables of wheelchair basketball players.

the respiratory system has been touted as a limiting factor of physical performance during high intense physical exercises. this limitation is related, among other things, with the fatigue of respiratory muscles. the fatigue of these muscles during physical exercise generates many physiological reflex activation culminating in reduced blood flow to the limb muscles, resulting in decrease in muscle performance. researchers showed that the inspiratory muscle training (imt) is able to generate improved of athlete's physical performance. however, when it comes to wheelchair athletes there are still divergent views on the effects of imt on the physical performance. thus, this study aims to evaluate the effects of imt on the physical performance and cardiorespiratory variables of wheelchair basketball players. for this purpose, the investigators will select 40 wheelchair basketball players of both genders. the participants will be allocated blindly and randomly into two groups that differ by the proposed interventions. in imt group, the participants will be submitted to a imt program with inicial load of 50% of maximal inspiratory pressure (mip); the sham group will be submitted to a simulated imt with load of 15% of mip. all participants will pass through the same evaluation procedures before and after the interventions, so that the investagators can evaluate the benefits generated by the imt on the physical performance and cardiorespiratory variables of wheelchair basketball players.

Eligibility criteria:
inclusion criteria: * training wheelchair basketball for more than one year. exclusion criteria: * cardiovascular or respiratory disease. * motor or cognitive impairments that influencing the results of evaluations. * smoking.
peri-conceptional or pregnancy exposure of vaccination and the risk of adverse pregnancy outcomes

Conditions: Vaccine Adverse Reaction

Summary: uing data from a population based cohort in china, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., hpv/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)

we will develop a vaccination cohort by linking population-based pregnancy registries (i.e., represent) with population-based vaccine databases. the researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. this study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. poisson regression based on propensity scores will be used to estimate the relative risk. to ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.

Eligibility criteria:
inclusion criteria: * all pregnant women in xiamen who registry in our database. exclusion criteria: * pregnant women who were lost to follow-up. pregnant women exposed to related factors of known congenital malformation.

Keywords: vaccine birth defect adverse pregnancy outcomes
comparison of delta-shaped and billroth ii after tldg

Conditions: Gastric Cancer

Summary: to compare the safety and feasibility of delta-shaped anastomosis and billroth ii anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(tldg).

methods: 78 consecutive patients who underwent tldg in first hospital of jilin university between october 2012 and december 2014 were enrolled in this study . all patients were divided randomly into two groups:delta-shaped anastomosis group (ds group) and billroth ii anastomosis group (b-ii group), and the patients in ds group underwent delta-shaped anastomosis after tldg, and the patients in b-ii group underwent billroth-ii anastomosis after tldg.outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

Eligibility criteria:
inclusion criteria: * carcinoma located in the lower 1/3 of gastric body or antrum of stomach * diagnosed by endoscopy ,endoscopic ultrasonography and abdominal ct scan * diameter of the tumor \<3cm * no pyloric obstruction exclusion criteria: * diameter of the tumor ≥3cm * associated with obstruction, bleeding, emergency surgery or surgical intervention * tumor with extensive metastasis * patient had previously undergone gastrostomy

Keywords: totally laparoscopic gastrectomy laparoscopic distal gastrectomy intracorporeal anastomosis delta-shaped anastomosis billroth ii anastomosis gastric cancer
phenylephrine dose and mode of administration for spinal anesthesia induced hypotension

Conditions: Complications; Cesarean Section; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Summary: three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.

phenylephrine will be administered in one of 3 regimens: intermittent bolus of 50 mcg, intermittent bolus of 100 mcg, or continuous infusion of 100 mcg/min. the infusion will contain either phenylephrine or normal saline (placebo). subjects who are randomized to receive a bolus dose will receive placebo in the infusion. subjects who are randomized to receive the phenylephrine infusion will have normal saline (placebo) in the bolus syringe. baseline blood pressures will be obtained prior to surgery and then maintained using these drugs. blood pressure and heart rate will be monitored as usual standard of care. continuous cardiac output and hemodynamic monitoring will be obtained using cnap (tm) or similar (equivalent) monitoring device. blood pressure will be maintained at 90-120% of baseline utilizing infusion and/or bolus with the 3 regimens.

Eligibility criteria:
inclusion criteria: * scheduled for cesarean delivery age \>/=18 years of age \>/= 37 weeks ega asa status i-iii exclusion criteria: * allergy to medications used in the study non-english speaking

Keywords: cesarean section hypotension phenylephrine
sorafenib plus vitamin k1 versus sorafenib in advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: 60 patients of radiological, biopsy proven advanced hcc (hepatocellular carcinoma) patient will be randomized into two groups. cases group will receive sorafenib plus vitamin k and control group will receive sorafenib plus placebo


Eligibility criteria:
inclusion criteria: * age 18 to 70 years * child a and b cirrhosis with hepatocellular carcinoma * biochemical, radiological, histological evidence of advanced hepatocellular carcinoma diagnosed as stage c and stage d with serum bilirubin \<5 mg/dl according to bclc staging system * hcc with portal vein thrombosis * unresectable cancer, as assessed carefully by individual experts * no recent active treatment like surgery, radiofrequency ablation, trans arterial chemo embolization, radiotherapy, chemotherapy (within the past 6 months) exclusion criteria: * patients with end-stage hepatocellular carcinoma (stage d, bclc)with poor performance status * child c cirrhosis with hcc (hepatocellular carcinoma) * hcc with acute decompensated state of cld - gi bleed, increased jaundice, he, sbp (spontaneous bacterial peritonitis) * acute febrile illness * pregnancy or lactation
study on the efficacy of speed-feedback therapy for elderly people with dementia

Conditions: Dementia

Summary: the purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects adl and qol.

dementia is a syndrome caused by diseases of the cerebral parenchyma, and it is a state in which cognitive functions, including attention, memory, thinking, comprehension, judgment, and computation, are diminished. because of the mental symptoms, problem behaviors, and decreased activities of daily living (adl) it is also recognized as a major social problem. however, rehabilitation of elderly people with dementia is still at the trial-and-error stage, and establishing a method of rehabilitation is an urgent task. in 2004, the authors devised and created a training method that integrates exercise therapy with feedback therapy to treat the cognitive dysfunction of elderly people with dementia. to do so the authors introduced speed-feedback therapy with a bicycle ergometer as a feedback therapy intervention. the results of a preliminary study of the efficacy of this method in improving cognitive dysfunction in 17 elderly persons with dementia showed improvement in cognitive dysfunction, and their attentiveness also improved, suggesting that the impaired attentiveness may have improved in response to treatment by this method and, as a result, have led to improvement of cognitive dysfunction. however, it became clear that it would be necessary to further improve and develop the system, and to demonstrate its efficacy in a controlled trial and verify associations between improvement of cognitive dysfunction and improvement of the adl of dementia patients and their quality of life (qol).

Eligibility criteria:
inclusion criteria: 1. 65 years of age or older 2. diagnosed with dementia by a physician 3. mini-mental state examination score of 23 points or less 4. capable of participating at least once a week for 6 weeks in succession exclusion criteria: 1. management of a medical risk required 2. impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis 3. never having been on a bicycle, and incapable of pedaling well

Keywords: cognitive impairment, ergometer, speed-feedback therapy
study of expectorant activity of oral n-acetylcystein (nac) in patients with stable chronic bronchitis

Conditions: Chronic Bronchitis

Summary: this is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate the effects of three different doses of n-acetyl l-cysteine (nac) and placebo on patient safety and on physical and transport properties of expectorated sputum. patient sumptoms, quality of life and exacerbation will also be followed as well as pulmonary function testing and functional exercise capacity. we hypothesized that a prolongeed course of oral nac favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute exacerbations.


Eligibility criteria:
inclusion criteria: * smokers (past or current,20 pack years) with diagnosis of chronic bronchitis * expectorate sputum daily * fev1 of 40-70% * understand and fill out questionnaire daily exclusion criteria: * other investigational within 30 days * change in smoking habit within 6 months * pulmonary diagnosis other that chronic bronchitis * significant renal, cardiac, hepatic or endocrine diseases * psychiatric disorder or evidence of alcoholism or drug abuse within year

Keywords: chronic bronchitis n-acetylcysteine (nac) quality of life mucus