Kornimate/medical-research-clean huggingface dataset:
effect of procrit (epoetin alfa) on preventing delayed graft function after deceased donor renal transplantation

Conditions: Delayed Graft Function

Summary: delayed graft function (dgf) is a major complication following deceased donor renal transplantation. the surgical procedure of harvesting a kidney from a cadaveric donor and implanting the kidney into the recipient inevitably causes some amount of injury. while not always clinically significant, anywhere from 10-50% of transplant patients may develop dgf. ongoing research in animal models has demonstrated benefit with administration of erythropoietin. the investigators propose to study the effect of procrit(epoetin alfa) on delayed graft function in subjects undergoing kidney transplantation.


Eligibility criteria:
inclusion criteria: * patients presenting for kidney transplantation * age \> 18 * deceased donor kidney transplant exclusion criteria: * history of thrombosis or hypercoagulable state * receiving coumadin or heparin * hemoglobin \>=14 g/dl * uncontrolled hypertension

Keywords: delayed graft function kidney transplantation
pharmacokinetics, safety and tolerability study of pf-03463275 in healthy male japanese and western subjects

Conditions: Healthy

Summary: this phase 1 study is the first clinical trial in japanese subjects. the study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of pf-03463275 oral controlled release formulation in japanese and western male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years. * body mass index (bmi) of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs). * japanese subjects must have four japanese grandparents who were born in japan. exclusion criteria: * subjects that are genotyped to be pm (poor metabolizer), um (ultrarapid metabolizer), im/em and em/um for cyp2d6 status. * evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Keywords: phase1 pharmacokinetics healthy male japanese schizophrenia
the relationship between atrial fibrillation and frailty in community-dwelling elderly

Conditions: Atrial Fibrillation; Frail Elderly Syndrome

Summary: atrial fibrillation (af) is the most common arrhythmias in clinical practice. research investigating hospitalized patients have indicated there are deleterious effects of af on patients besides the disease burden itself, including longer stay days for hospitalization, higher rates of frailty and increasing mortality rate after discharged in six months. in the community-dwelling research also found that elderly with af have lower cognitive function, physical functional tests score and slower walking speed compared with the health ones. however, there is limited articles investigating the impact of af on community-dwelling elderly, and the relationship between af and frailty is also lack of discussion. according to the aged society and increasing prevalence of af, the relationship between af and frailty in community-dwelling elderly is warranting investigated.


Eligibility criteria:
inclusion criteria: * older than 65 years old exclusion criteria: diagnosed with the following disease 1. cardiovascular diseases: myocardial infarction, peripheral vascular diseases, aortic plaque 2. cerebrovascular disease: stroke, transient ischemic attack, emboli 3. heart failure 4. participants who cannot finish the trial

Keywords: atrial fibrillation frailty status body composition sarcopenia
optometric follow-up after cataract surgery

Conditions: Cataract; Age-related Cataract

Summary: this study will investigate the effectiveness of an optometric follow up of cataract surgery versus an ophthalmic surgeon follow up. it will investigate patient satisfaction,safety and cost.

the study will be a mixed-methods study, including a randomized controlled trial in which participants are randomized after cataract surgery to follow up to be consultant led follow up or conducted by a trained optometrist 4-6 weeks following surgery. all participants will then return 6 months after surgery for an additional follow-up visit with an ophthalmologist other than the operating surgeon with patient healthcare satisfaction (main outcome), cost-effectiveness and safety outcomes being measured. a subset of patients and local clinicians will also take part in a one-time, individual, semi-structured interview. this research will test an alternative model of aftercare for cataract surgeries, which may reduce patient waiting time and inconvenience. in turn, this could help improve patient satisfaction and reduce costs for both patients and the national health service (nhs). participants will be recruited by operating surgeons. the research will take place in the hospital/clinic/optometrists' offices.

Eligibility criteria:
inclusion criteria: * patients undergoing cataract surgery in 1st or 2nd eye for age-related cataract, in the belfast trust and southern trust * willing to participate and give informed consent. exclusion criteria: * patients judged by operative surgeon to be of high risk of loss of visual acuity in the operative eye (e.g. end stage glaucoma etc.). note that patients with ocular comorbidity and previous surgery will not be routinely excluded, nor will monocular patients. * patients that were not referred by an optometrist.

Keywords: follow up post surgery patient satisfaction optometrist ophthalmologist community care
hormonal influences on diuresis

Conditions: Nocturia; Menopause; LUTS; Diuresis

Summary: the aim of this study was to observe the effect of hormonal treatment (oral or transdermal substitution therapy) on diuresis (salt and water diuresis) and lower urinary tract symptoms (luts) in postmenopausal women


Eligibility criteria:
inclusion criteria: * patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc) exclusion criteria: -
cognitive training intervention and attitudes towards genetics

Conditions: Cognitive Impairment; Hematologic Neoplasms; Hematopoietic Cell Transplant

Summary: a pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (hct) survivors using the cognitive training lumosity program. in addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-hct will be measured.

the investigators propose using an "off-the-shelf" product - lumosity (http://www.lumosity.com/) - an online cognitive training program, to address the cognitive impairment in outpatient hct survivors. the program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, and executive function. training will involve a daily session of 5 training tasks for 12 weeks. each time the patient is logged in for a session, a customized report will be generated by the lumosity program to capture performance information. ideally, targeting the intervention and offering it specifically to those at highest risk (integrating clinical and genetic markers) would ensure efficacy. however, evidence is lacking on whether patients are receptive to communication of individual genetic information and whether provision of such results would lead to enhanced intervention response. to realize the high expectations of personalized medicine, patients' preferences and attitudes need to be thoroughly investigated especially as more information on genetic risk becomes available. the investigators will examine patients' genetic knowledge to determine whether factual knowledge of genetics is essential for understanding genetic risk and for informing treatment decision making in this patient population.

Eligibility criteria:
inclusion criteria: * ≥ 21 years old at time of allogeneic hct performed at uab * outpatient and between 3 and 6 months post hct * english speaking * possess access to an internet-connected home computer exclusion criteria: * history of pre-existing neurological disorder or documented major psychiatric disorder; significant auditory, visual, or motor impairments * participated in neuropsychological intervention within the past 6 months * history of color blindness

Keywords: hematologic cancers hematopoietic cell transplantation cognitive training genetic knowledge genetic attitude adult cancer survivors
a trial investigating the pharmacokinetic (mode of action in the body) and safety profiles of nn1250 (insulin degludec) in subjects with various degrees of impaired liver function and in subjects with normal liver function

Conditions: Diabetes; Healthy

Summary: this trial was conducted in europe. the aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of nn1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.


Eligibility criteria:
inclusion criteria: * subject with normal hepatic function, liver parameters within normal range. not assessed with the child-pugh criteria. or: subject with stable hepatic impairment classified as child-pugh grade a, b or c as assessed by investigator * body mass index maximum 40.0 kg/m\^2 exclusion criteria: * subject with any disease or condition which the investigator feels would interfere with the trial outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * not able or willing to refrain from smoking during the inpatient period
prediction of pep based on the appearance of the major duodenal papilla

Conditions: Post-ERCP Acute Pancreatitis

Summary: this observational, prospective study aims at evaluating how the occurrence of post-endoscopic retrograde cholangiopancreatography (ercp) acute pancreatitis (pep) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ercp. the rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.


Eligibility criteria:
inclusion criteria: * patients with native duodenal papilla; * any indication to ercp +/- biliary sphincterotomy of duodenal major papilla; * patients able to provide a written informed consent exclusion criteria: * ercp performed for disorders unrelated to biliary tract; * previous upper gastrointestinal tract surgery; * presence of a duodenal stricture (either malignant or benign); * presence of a malignant infiltration of the papilla; * concomitant anticoagulant and/or p2y12 inhibitors therapy (clopidogrel, prasugrel, ticagrelor) that precludes the treatment; * inr \> 1.5; * platelets count \< 80000/mm3; * unwillingness to sign written informed consent.
study of pf-00562271, including patients with pancreatic, head and neck, prostatic neoplasms

Conditions: Head and Neck Neoplasm; Prostatic Neoplasm; Pancreatic Neoplasm

Summary: phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (fak) inhibitor pf-00562271 in patients with positive positron emission tomography \[pet\] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. screening consists of a fluorodeoxyglucose positron emission tomography \[fdg-pet\] and tumor imaging, medical history, physical examination, eastern cooperative oncology group \[ecog\] performance status, blood draws, a pregnancy test for female patients of childbearing potential. treatment consists of pf00562271 tablets continued until progression of disease, unacceptable toxicity, or patient request. evaluations for bioactivity are measured by serial fdg-pet and blood tests for biomarkers related to fak and pyk2 kinase activities.


Eligibility criteria:
inclusion criteria: * pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic malignancies who have tumor appropriate for serial biopsy. * adequate organ function, including bilirubin less than 1.5 x uln, and \[eastern cooperative oncology group\] ecog performance status of 0-2. exclusion criteria: * clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent cyp 3a4 inhibitors, and history of clinically significant cardiac or pulmonary disorders.

Keywords: pancreatic neoplasm head and neck neoplasm prostatic neoplasms; focal adhesion kinase phase 1 pharmacodynamics fdg-pet
rifaximin 3 times/day (tid) for non-constipation irritable bowel syndrome (ibs)

Conditions: Non-Constipation Irritable Bowel Syndrome

Summary: to evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of ibs symptoms.


Eligibility criteria:
inclusion criteria: * confirmed ibs diagnosis per rome ii criteria for diagnosis of ibs. * colonoscopy within 2 years as part of ibs diagnostic evaluation. * has active symptoms of non-constipation ibs at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency. exclusion criteria: * symptoms of constipation. * history of other gastrointestinal diseases. * type 1 or 2 diabetes. * lactose intolerance not controlled by lactose-free diet.

Keywords: diarrhea rifaximin ibs abdominal pain bloating
predictive and prognostic markers for treatment outcomes in prostate cancer patients

Conditions: Prostate Cancer

Summary: the study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.

this is a single-center single-arm translational study where patients with prostate cancer who are about to receive definitive treatments will be invited to participate the study. after signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study to identify potential metabolite and protein markers that are able to predict responses (including efficacy and side effects) to definitive treatments. all subjects who have received varied treatment before the study can not be recruited.

Eligibility criteria:
inclusion criteria: 1. subjects who have histopathologically confirmed prostate adenocarcinoma. 2. subjects who age 30 years to 100 years 3. subjects who agree to undergo the any of the following four treatments, including radical prostatectomy, definitive prostate radiotherapy, systemic chemotherapy, and androgen deprivation therapy for prostate cancer. 4. subjects who understand and will comply with the entire study procedures, consent to donate his spot urine (once for 50 ml) for urine metabolomics and proteomic profiling, and agree with subsequent collection and analysis of his clinical information including results of biopsy and the details of treatments and outcomes. (note: subjects will be told that the urine metabolomics and proteomics results will not be revealed to them.) exclusion criteria: 1. subjects who have other cancers that have not been curatively treated or are disease-free for only 3 years or less. subjects who have other genitourinary cancers (urothelial, renal cell, etc) are not allowed no matter what the disease-free duration is. however, subjects who have been curatively treated and are disease-free for 3 years or longer are allowed to be enrolled. 2. subjects who have severe organ function impairment which may significantly alter general cell metabolism or proteomics profiles determined by the investigators, such as cre \> 3.0, hba1c \> 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases. 3. subjects who have significant infection or inflammation within 8 weeks of the biopsy. 4. subjects who are taking medicine(s) that may, deemed by the investigators, substantially affect cell metabolism and proteomics profiles. 5. subjects who have a life expectancy less than 12 months.

Keywords: prostate cancer prostatectomy prostate radiotherapy chemotherapy immunotherapy biomarkers metabolomics proteomics urine
impact of opioid free anesthesia on outcome after hip arthroplasty by direct anterior approach.

Conditions: Hip Arthropathy

Summary: all patients with a first anterior arthroplasty, give their informed consent to be randomized to control or study protocol. control means no high steroid dose, opioids for anesthesia; paracetamol, nsaids and opioids as analgesia. study protocol means methylprednisolone 125 mg and opioid free anesthesia followed by paracetamol, nsaids and if needed opioids as escape.

study group means for anesthesia: 1. high dose corticoids pre-operative: 125 mg methylprednisolone. (medrol) pre incision and 24h postoperative 2. ofa using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg). 3. avoid opioids post-operative by using multimodal non-opioid analgesics after ofa. avoid epidural to allow rapid mobilization. all patients get tranexamic acid 1 g (2 amp exacyl 500mg) before and 1 g after surgery. it act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) try to give continuous deep neuromuscular block (nmb) with a post titanic count (ptc) \< 3 by continuous infusion and monitoring of nmb. intravenous fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation \< 20% to reduce wound edema. the pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml ropivacaine 0,2% (max dose 3 mg/kg) + additives (adrenaline 2,5 cc) (ropivacaine: max 3 mg/kg)

Eligibility criteria:
inclusion criteria: * arthroplasty by anterior approach exclusion criteria: * allergy or impossible to use any of the drugs included * revision procedure * major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission
enhancing performance of cognitive behavioral therapy for insomnia with an integrative mobile platform

Conditions: Primary Insomnia; Depressive Disorders With Insomnia

Summary: cognitive behavioral therapy for insomnia (cbt-i) has been proven as an effective intervention for the non-pharmacological treatment of insomnia. this study hypothesizes app programs of smart phone would enhance the compliance and performance of behavioral intervention of cbt-i. during a 3-year study period, 3 app modules, including electronic sleep diary along with message reminder system, social persuasion system and tai-chi practice system will be tested subsequently for their efficacy.

this study comprises 3 parts which are designed as an open-label, active-control study. in each year, the participants in the experimental arm receive app-assisted cbt-i. in the first year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. the subject number in each arm is 20. participants in each arm receive a 6-week standard cbt-i. in the experimental arm, the participants use electronic sleep diary and message reminder to record sleep pattern. in the active-control group, the participants use traditional paper-pencil sleep diary instead. in the second year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. the subject number in each arm is 20. participants in each arm receive a 6-week standard cbt-i. in the experimental arm, the participants use app with function of social persuasion to encourage each other. in the active-control group, no social persuasion is given beyond the treatment sessions. in the third year, participants with comorbid depressive disorder and insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. the subject number in each arm is 20. participants in each arm receive a 6-week standard cbt-i. in the experimental arm, the participants use app module that provides a multi-media assisted tai-chi video to practice tai-chi. in the active-control group, a traditional tai-chi teaching digital video disc is provided to help the participants practice tai-chi.

Eligibility criteria:
first and second year: inclusion criteria: * 20 and more years old * meet diagnostic and statistical manual-iv diagnostic criteria for primary insomnia exclusion criteria: * not current smart phone users third year: inclusion criteria: * 20 and more years old * meet diagnostic and statistical manual-iv diagnostic criteria for depressive disorders (major depressive disorder or dysthymic disorder) * mild to moderate severity of depression (beck depression inventory: 13 and more but less than 29) * mild anxiety symptoms (bexk anxiety inventory: less than 10) exclusion criteria: * with high suicide risk * not current smart phone users

Keywords: insomnia comorbid insomnia cognitive behavioral therapy
collagenase is a common treatment of mcp and pip joint contractures in dupuytrens disease

Conditions: Dupuytren Contracture

Summary: to evaluate the effect of collagenase clostridium histolyticum treatment at the department of orthopaedic surgery at horsens regional hospital after minimum one-year follow-up (fu).


Eligibility criteria:
inclusion criteria: * dupuytrens disease * xiapex treatment exclusion criteria: - demens/other psychiatric diseases