Kornimate/medical-research-clean huggingface dataset:
a study of valcyte (valganciclovir) syrup formulation in pediatric solid organ transplant recipients

Conditions: Cytomegalovirus Infections

Summary: this study will assess the safety and pharmacokinetics of valcyte syrup in pediatric solid organ transplant recipients. the anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.


Eligibility criteria:
inclusion criteria: * patients between 3 months and 16 years of age; * first solid organ transplant (eg, kidney, liver, heart); * able to tolerate oral medication; * females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug; * patients at risk of developing cmv disease (all transplant recipients other than those who are d-r- for cmv). exclusion criteria: * patients who have previously participated in this study; * patients who are participating in another clinical trial (except with the approval of the sponsor); * severe, uncontrolled diarrhea (more than 5 watery stools per day); * pregnant or lactating females.
development of the danish prospective sarcoidosis registry and baseline characteristics of a danish sarcoidosis cohort

Conditions: Sarcoidosis

Summary: development of a danish sarcoidosis registry. characterization of a cohort of sarcoidosis patients with respect to the baseline epidemiological characteristics, comorbidities, radiology, histopathology, diagnostic investigations and treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis * signed informed consent exclusion criteria: * inability or unwillingness to adhere to the study * inability to give informed consent
the prevalence of semicircular canal dysfunction among rehabilitation patients

Conditions: Vertigo; Dizziness

Summary: patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the dizziness handicap inventory, and then will be examined by an ent physician, followed by a video head impulse test (vhit) study.


Eligibility criteria:
inclusion criteria: * over 65 years old * hospitalized at the rehabilitation department exclusion criteria: * blindness or loss of vision which is not corrected using glasses * past cva with neurological remnants * movement disorder * lower body part weakness * limitation in neck movement * vestibular pathology diagnosed in the past 6 months
clinic-based and tele-monitored home-based intervention in patients with knee oa

Conditions: Knee Osteoarthritis

Summary: this study assessed and compared the effects of clinic-based and telemonitored home-based interventions on pain intensity, function and quality of life in patients with knee osteoarthritis (koa). this was with a view to providing evidence for the validation of the effectiveness of home-based intervention on knee osteoarthritis

this study was a quasi-experiment involving forty two patients with koa. they were randomly allocated into two groups equally; clinic-based group (cbg) and telemonitored home-based group (thg). the cbg received exercises to strengthen the quadriceps and hamstring muscles using thera band while thg received same treatment regimen but at home and were monitored on phone by the researcher. the subjects performed four sets of eight repetitions for each of the exercises three days in a week for eight weeks. pain intensity was assessed with quadruple visual analog scale, function was assessed with the western ontario and mcmaster university osteoarthritis index and quality of life was assessed with who quality of life-bref at pretreatment, 3rd week, 6th week and 8th week of intervention. data was analysed with descriptive and inferential statistics. repeated measure anova was used to compare the mean value of variables within the group and between the groups. alpha level was set at 0.05.

Eligibility criteria:
inclusion criteria: * patients diagnosed with osteoarthritis of the knee of not less than six weeks. * patients that have means of communication via mobile telephone. * patients who understands english or yoruba language. exclusion criteria: participants that have any other knee joint diseases. * participants with history of knee joint trauma. * participants with history of knee surgery or arthroplasty

Keywords: knee osteoarthritis pain intensity functioning health related quality of life tele-monitoring
sacral nerve stimulation in improving bladder function after acute traumatic spinal cord injury

Conditions: Spinal Cord Injury, Acute; Neurogenic Bladder; Incontinence; Urinary Tract Infections

Summary: the purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. patients will be assigned to one of these groups at random and followed for one year. the hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.


Eligibility criteria:
inclusion criteria: * age \> 18 years * ability to implant device less than 12 weeks post-spinal cord injury (sci) * presence of acute sci at or above t12 * american spinal injury association (asia) scale a or b * expectation to perform clean intermittent catheterization (cic) personally or have caretaker perform cic exclusion criteria: * inability to perform cic * pre-existing sci * pre-existing progressive neurological disorder * autonomic dysreflexia * prior sacral back surgery * posterior pelvic fracture with distortion of the sacroiliac joint * prior urethral sphincter or bladder dysfunction * chronic urinary tract infections prior to sci * pregnancy at the time of enrollment * presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure * any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure * active untreated infection * traumatic injury to the genitourinary system * prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology

Keywords: spinal cord injury neurogenic bladder electrical stimulation neuromodulation
effect of high-dose pitavastatin on glucose control in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this purpose of this study is to evaluate effect of high-dose pitavastatin on glucose control in patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * patients diagnosed as metabolic syndrome according to national cholesterol education program criteria * patients with hypercholesterolemia who required to start statin therapy exclusion criteria: * overt diabetes * acute coronary syndrome within 2 months * acute cerebrovascular event within 2 months * recent treatment of statin within 1month * recent diagnosed neoplasm * recent diagnosed liver disease * chronic kidney disease * patients with myopathy * pregnant women, nursing mothers, women with possibility of pregnant * patients being adminstered cyclosporine * patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption * patients with treatment cyclosporin
conveen optima urisheaths with collecting bags versus absorbents

Conditions: Urinary Incontinence

Summary: the objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of conveen optima urisheath in comparison with their usual absorbent protection.


Eligibility criteria:
inclusion criteria: * patient over 18 * out clinic patient * patient using absorbent protection for his urinary incontinence * moderate to severe urinary incontinence (1 hour pad test \> 10g) * all kind of stable urinary incontinence * patient able to apply himself the device * patient able to understand the questions * patient having given his informed consent * patient whose overall treatment for his urinary incontinence is not modified during the study exclusion criteria: * patient having a retracted penis * patient having skin problem on the penis * patient using urisheaths * bedridden patient * institutionalized patient * patient with indwelling catheter or under intermittent catheterisation * patient with fecal incontinence leading to the use of absorbent protection * patient suffering of urinary tract infection
transversus abdominis plane block versus quadratus lumborum block for pain management in laparoscopic appendectomy

Conditions: Post Operative Pain; Appendicitis Acute; Surgery

Summary: laparoscopic appendectomy causes postoperative pain. the primary objective of this prospective randomized controlled study is to compare the effect of ultrasound (us)-guided quadratus lumborum block (qlb) on 24-hour cumulative opioid requirements with transversus abdominis plane (tap) block.

168 patients (asa i-ii-iii) between 18 and 65 years of age, who were to undergo laparoscopic appendectomy, were randomized and divided into two groups. 32 patients were dropout for different reasons.(68 patients in each of the tap block and qlb block groups). tap block was performed for tap group and qlb block was performed for qlb group. postoperative analgesia was provided by intravenous tramadol hydrochloride using a patient-controlled analgesia device. 24-hour total tramadol hydrochloride consumption was primary outcome measure.postoperative numeric rating scale values were the secondary outcome measure.

Eligibility criteria:
inclusion criteria: * ages of 18-65 * patients who will undergo laparoscopic appendectomy * asa i-ii-iii patients exclusion criteria: * clinically known local anesthetic allergy * morbid obesity (body mass index\>40 kg m2) * clinically diagnosis of opioid, alcohol and substance dependence * clinically diagnosis of psychiatric disease * coagulopathy * patients with asa iv-v

Keywords: postoperative pain laparoscopic appendectomy transversus abdominis plane block quadratus lumborum block local anesthetic
study of khk 4323 in healthy volunteers and subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: part 1: to investigate the safety and tolerability of intravenous (iv) or subcutaneous (sc) administration of a single dose of khk4323 to japanese or caucasian healthy adult males in a double-blind, placebo-controlled study. part 2: to investigate the safety and tolerability of intravenous (iv) administration of repeated doses of khk4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.


Eligibility criteria:
inclusion criteria: part 1: * japanese or caucasian male aged 20 to under 45 years old at the time consent was obtained * bmi ≥ 18.5 to \< 30.0 at time of screening tests part 2: * men and women aged 18 years or older at the time of consent * patients with easi ≥ 16 in pre-administration testing * patients with iga of "3: moderate" or higher in pre-administration testing * patients with bsa ≥ 10% at screening in pre-administration testing "exclusion criteria: part 1: * persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease * persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent * persons who have contracted an infectious disease requiring hospitalization or iv administration of an antibiotic within 6 months prior to obtainment of consent * persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent * persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days) * persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period part 2: * patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. includes but is not limited to the following. severe cardiovascular disease (e.g., class iii or iv according to new york heart association functional classification), poorly controlled diabetes mellitus (hba1c \> 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class b or c according to child-pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc. * patients observed to have one of the following laboratory test abnormalities in screening tests * neutrophil count: \< 1500/μl * serum creatinine: \> 1.5 mg/dl * ast or alt: \> 2.5-fold the upper limit of the reference range * other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial
managing chronic kidney disease in eastern north carolina

Conditions: Chronic Kidney Disease

Summary: the purpose of this program is to educate primary care physicians in four underserved clinics in eastern north carolina about chronic kidney disease.

the division of nephrology within the brody school of medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern north carolina. it is estimated that more than 40 million americans have or at risk for ckd. the estimate for ckd in eastern north carolina is exacerbated by poor access to health care. the mission of the east carolina university center for the study and treatment of kidney disease (ecckd) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with ckd in eastern north carolina.

Eligibility criteria:
inclusion criteria: * primary care clinics in eastern north carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.

Keywords: chronic kidney disease cardiovascular disease hypertension anemia
a study of rovalpituzumab tesirine administered in combination with nivolumab and with or without ipilimumab for adults with extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (sclc).

the study planned to enroll three cohorts with approximately 30 participants in each, including a dose-limiting toxicity (dlt) evaluation phase (the first 12 weeks of any treatment) and an expansion phase. initially, up to 12 participants were to be enrolled into cohort 1 in order to obtain 6 evaluable participants through the dlt evaluation period of 12 weeks. safety data were reviewed by a safety monitoring committee (smc) for each cohort during the dlt evaluation phase before the next cohort opened. once a new cohort was opened, the previously opened cohort was permitted to continue enrolling participants for the expansion phase for a total of 30 participants per cohort. only two of the planned three cohorts enrolled participants in the study based on the smc recommendation after dlts were identified in cohort 2.

Eligibility criteria:
inclusion criteria: * participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (sclc) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic, hepatic, and renal function exclusion criteria: * has active, known, or suspected autoimmune disease * had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (pbd)-based drug

Keywords: cancer extensive-stage small cell lung cancer nivolumab ipilimumab rovalpituzumab tesirine
heart and estrogen-progestin replacement study (hers)

Conditions: Coronary Heart Disease

Summary: the purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.

a randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new chd events (myocardial infarction and chd death) as those randomized to placebo.

Eligibility criteria:
inclusion criteria: * \<75 y.o. * uterus present * postmenopausal * evidence of chd * signed consent exclusion criteria: * mi, cabg, mechanical revascularization within 6 months * serum triglyceride \>300mg/dl * used hormone therapy or estrogen vaginal cream in past 3 months * history of dvt or pulmonary embolism * history of breast cancer or mammogram suggestive of cancer * history of endometrial cancer * abnormal uterine bleeding * pap smear abnormal * sgot more than 1.2 times normal * disease judged to be fatal within 4 yrs * alcoholism, drug abuse * nyha class iv congestive heart failure * uncontrolled hypertension * uncontrolled diabetes * participation in any other investigational study

Keywords: coronary heart disease hormone replacement therapy estrogen postmenopausal women
informing low-acuity emergency department patients of non-emergent resources

Conditions: Emergency Service, Hospital

Summary: the goal of this campaign is to reduce unnecessary visits to a geisinger emergency department (ed)/encourage patients with high acuity visits to follow up with an appropriate geisinger provider. in this campaign, patients will be assigned to receive or not receive outreach following ed discharge that is aligned with the goal. outreach will occur via a text message, as well as information added to the patient's after visit summary, and will includecalls to action to see their geisinger cmsl pcp either in person or virtually. the study will assess whether ed use differs across patients in different outreach conditions. it will also examine whether patients follow through on the message-specific calls to action in the messages differently across conditions.


Eligibility criteria:
inclusion criteria: * \>= 18 years of age * geisinger ed visit rated as low acuity (l4 or l5) * discharged from geisinger ed in past 24 hours exclusion criteria: * cannot be contacted via the communication modality being used in the study (i.e., sms), due to insufficient/missing contact information in the ehr or because the patient opted out * admitted to hospital * already included in intervention in past 365 days
biomarkers for prognosis of ambulatory chronic heart failure patients

Conditions: Heart Failure

Summary: biomarkers representing distinct biological domains including neurohormonal, inflammatory, metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in combination provide prognostic information on mortality in heart failure patients with preserved or impaired systolic function.

upon enrollment in the study, troponin i (ctn i), bnp, norepinephrine, plasma renin activity, aldosterone, high-sensitivity c-reactive protein (hs-crp), tumor necrosis factor-alpha (tnf-alpha), interleukin-6 (il-6), soluble receptor of interleukin 2 (sil-2r), leptin, prealbumin, free malondialdehyde, 15-f2t-isoprostane and protein-bound nitrotyrosine were measured in stable ambulatory, non diabetic, elderly heart failure patients. patients were followed up until death or study termination (31st january 2009).

Eligibility criteria:
inclusion criteria: * symptomatic congestive heart failure lasting at least six months * reduced exercise tolerance * impaired or preserved left ventricular ejection fraction * cardiomegaly exclusion criteria: * acute infection * rheumatoid or other autoimmune diseases * primary cachectic states (cancer, thyroid disease, severe liver disease) * severe chronic lung disease * neuromuscular disorders * myocardial infarction within the previous 20 weeks * diabetes mellitus * chronic renal failure (serum creatinine level \> 2.0 mg/dl, \>177 micromol/l)
safety, tolerability and pharmacokinetics of morab-003 in subjects with advanced ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this study is to establish the safest dose of morab-003 in subjects with advanced ovarian cancer. morab-003 is an antibody directed to an antigen on the surface of ovarian cancer cells.


Eligibility criteria:
inclusion criteria: 1. female subjects, ≥18 years of age, with a histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal adenocarcinoma, with or without elevation of ca 125, confirmed at the department of pathology, memorial sloan-kettering cancer center. 2. subject must have disease, as defined by response evaluation criteria in solid tumors (recist) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by ca-125, radiologic, or pathologic studies conducted within 4 weeks prior to study entry. 3. subject must have failed at least a standard (platinum-containing) chemotherapy regimen and be considered platinum refractory or resistant. 4. life expectancy ≥3 months, as estimated by the investigator. 5. karnofsky performance status ≥70%. 6. subjects must be surgically sterile, postmenopausal, or using an effective form of contraception. 7. subjects undergoing treatment with other medications must have been on a stable medication regimen for at least 30 days prior to study day 1. 8. laboratory and clinical results within the 2 weeks prior to study day 1 as follows: absolute neutrophil count (anc) ≥1.5 x 109/l platelet count ≥100 x 109/l hemoglobin ≥10 g/dl serum bilirubin ≤2.0 mg/dl aspartate transaminase (ast) ≤2.5 x upper limit of normal (uln) alanine transaminase (alt) ≤2.5 x uln serum creatinine ≤2.0 mg/dl amylase ≤1.5 x uln lipase ≤1.5 x uln 9. spirometry indicating a fev1 of \>79% of predicted. 10. subject must be willing and able to provide written informed consent. exclusion criteria: 1. known central nervous system (cns) tumor involvement. 2. evidence of other active malignancy. 3. active asthma or other chronic lung disease. 4. clinically significant heart disease (e.g., congestive heart failure of new york heart association class iii or iv, angina not well controlled by medication, or myocardial infarction within 6 months). 5. ecg demonstrating clinically significant arrhythmias (note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal svt, are eligible). 6. active serious systemic disease, including active bacterial or fungal infection. 7. chronic inflammatory bowel disease. 8. chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment. 9. breast-feeding, pregnant, or likely to become pregnant during the study. 10. active hepatitis or hiv infection. 11. subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or documented haha. 12. subjects with large ascites (≥500 cc based on results of most recent ct scan).