Kornimate/medical-research-clean huggingface dataset:
compassionate use of omegaven iv fat emulsion

Conditions: Cholestasis; Total Parenteral Nutrition-induced Cholestasis

Summary: this is a compassionate use protocol to use intravenous fish oil infusion, omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).

intravenous lipids are necessary in pn (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. however, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to pn associated liver disease. it is hypothesized that by administering omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of pn-associated cholestasis may be prevented or reversed.

Eligibility criteria:
inclusion criteria: * two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition) * other causes of liver disease have been excluded. a liver biopsy is not necessary for treatment. * the patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily pn, trial of enteral feeding if possible, and the use of ursodiol (i.e., actigall®). exclusion criteria: * documented causes of chronic liver disease other than parenteral nutrition associated liver disease * proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites. * an allergy to any seafood product, egg protein, and/or previous allergy to omegaven® * active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis * impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis * unstable diabetes mellitus or hyperglycemia * stroke, embolism, collapse and shock, recent mi * cholestasis due to any reason other than parenteral associated liver disease * active new infection at time of initiation of omegaven® * hemodynamic instability * the patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).

Keywords: cholestasis parenteral nutrition associated liver disease
safety and efficacy of multiple dosing regimens of bps804 in post menopausal women with low bone mineral density

Conditions: Osteopenia; Osteoporosis

Summary: this study is designed to provide information on the safety, tolerability, pharmacokinetics (pk) and bone biomarker response following multiple bps804 administration in multiple dosing regimens. this information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.

this study was conducted and previously posted by novartis. the record was transferred to ultragenyx in february 2021.

Eligibility criteria:
inclusion criteria: * postmenopausal women (natural or surgically induced menopause) * low bone mineral density (bmd), as defined by a t score or equivalent bmd absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive * body mass index (bmi) must be within the range of 18 to 35kg/m2. subjects must weigh between 45 and 120kg inclusive to participate. * 25-(oh) vitamin d serum level of ≥ 15ng/ml * serum calcium within normal limits exclusion criteria: * subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or history of bell's palsy, cranial nerve disorders, temporomandibular joint and muscle disorders. * subjects who have an increased baseline risk of osteosarcoma: paget's disease of the bone or unexplained and clinically significant elevations of alkaline phosphatase and/or subjects who have received radiation therapy involving the skeleton. * subjects with any known bone diseases other than postmenopausal osteoporosis. * subjects with a history of an osteoporotic fracture (e.g., vertebral fracture, fragility fracture of the wrist, radius, humerus, hip, or pelvis). * subjects who are regularly using or have regularly used agents affecting bone metabolism: * calcitonin, estrogen, serms (raloxifene, tamoxifen, etc.), tibolone progestin, or androgens within the last three (3) months prior to screening. * any oral bisphosphonate, lithium chloride, fluoride or systemic glucocorticosteroids (p.o. or i.v.) where the total dose exceeds 750 mg of prednisone or equivalent within the last year prior to screening. * any previous use of denusomab (proliatm), parathyroid hormone (forteotm), and/or pth analogs, strontium ranelate, or parenteral formulations of bisphosphonates. * current disease(s) known to influence calcium metabolism including hyperparathyroidism, hypoparathyroidism, hypocalcemia or hypercalcemia. * any disease, abnormality or deformation of the spine (e.g., scoliosis, ankylosing spondylitis, osteophytes) or hip (e.g., joint prosthesis) which would preclude the proper acquisition of a lumbar spine dxa (l1-l4) or femur dxa, respectively. other protocol-defined inclusion/exclusion criteria may apply

Keywords: osteopenia osteoporosis low bone mineral density
eeg parameters between remimazolam- and propofol-based anesthesia

Conditions: Cholecystitis, Acute; Gallbladder Neoplasms; Acalculous Cholecystitis

Summary: this is an observational study comparing perioperative quantitative eeg parameters between the conventional propofol/remifentanil and remimazolam/remifentanil. we aim to compare and analyze the differences in eeg patterns during the postoperative recovery in a group that underwent remimazolam and remifentanil-based total intravenous anesthesia(tiva), in comparison to propofol and remifentanil-based tiva


Eligibility criteria:
inclusion criteria: patients aged 19 to 65 years who meet the american society of anesthesiologists (asa) physical status classification 1-3 and undergo laparoscopic cholecystectomy at severance hospital. exclusion criteria: pregnant women, individuals with arrhythmias, emergency surgeries, obesity (bmi \> 30), day-surgery, foreigners, and illiterate individuals.
continuous positive airway pressure (cpap) for primary care

Conditions: OSA

Summary: the objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the general practitioners (gp) for obstructive sleep apnea (osa) patients treated with positive continuous pressure (cpap) vs. usual control by sleep specialists from the sleep unit. methodology: design: randomized comparative study. it will include patients with diagnosis of severe osa that should start treatment with cpap. participating center is hospital universitario araba in vitoria-gasteiz (spain). these patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the general practitioners (gp), once the osa diagnosis has been made and it was indicated the treatment with cpap. patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. primary outcome: to compare the objective cpap compliance treatment in the two study groups, so that use \>= 4h/day is defined as good adherence to the treatment. secondary outcomes: 1)to evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) to determine the numbers of cpap complications, type, severity and duration; 4) to figure-out the level of take care of the cpap machine, substitutions and complements, assistance and technical incidents; 5) cost-effectiveness analysis.


Eligibility criteria:
inclusion criteria: * men and women over 18 years old. * patients with osa diagnosis performed in the sleep unit * written informed consent signed. exclusion criteria: * previous cpap treatment for osa diagnosis * psycho-physical inability to complete questionnaires * presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome * patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases) * a medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.

Keywords: osa cpap treatment primary care efficacy
combination of glinides with premixed insulin

Conditions: Type 2 Diabets Mellitus

Summary: combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. twelve weeks after administration of the glinides, they are discontinued. hba1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * who undergoes twice daily injection of premixed insulin * whose hba1c is more than 6.5% and less than 8.0% exclusion criteria: * whose change of hba1c is more than 1.0% during 12 weeks observational period

Keywords: glinides premixed insulin combination therapy glycemic control
month 30 & 42 extension studies of crd-004 primary study

Conditions: Herpes Zoster

Summary: the safety and immunogenicity of the gsk324332a vaccine has been evaluated up to month 12 post-vaccination in the primary study. in the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the gsk324332a vaccine. this protocol posting deals only with objectives \& outcome measures of the extension phase at months 30 and 42. no new recruitment will be done in these extension phases of the primary study. no vaccines are administered in this phase of the study.

all subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine gsk1437173a. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007. further details on the primary study can be found on our gsk study register (https://www.gsk-studyregister.com/advanced-search) by searching on the gsk study identifier 101501.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study; * subjects who successfully completed the primary study and who did not receive varilrix in the primary study; * written informed consent obtained from the subject; * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period; * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed; * administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the influenza vaccine, which can be administered 1 week preceding the first study procedure; * previous vaccination against hz, except the study vaccine administered in the primary study; * history of hz (shingles); * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination; * administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.

Keywords: gsk biologicals varicella zoster virus (vzv) intracellular cytokine staining (ics) vaccine cell mediated immunity (cmi) herpes zoster (hz) shingles
a study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy

Conditions: Primary Membranous Nephropathy

Summary: this study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (pk) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pmn).


Eligibility criteria:
inclusion criteria: * diagnosis of primary membranous nephropathy (pmn) according to renal biopsy prior to or during screening * screening urinary protein-to-creatinine ratio (upcr) \>= 5 g/g from 24-hour urine collection after best supportive care for \>= 3 months prior to screening or screening upcr \>= 4 g/g after best supportive care for \>= 6 months prior to screening * egfr \>= 40 ml/min/1.73m\^2 or qualified endogenous creatinine clearance \>= 40 ml/min/1.73m\^2 based on 24-hour urine collection during screening * other inclusion criteria may apply exclusion criteria: * participants with a secondary cause of mn * pregnancy or breastfeeding * evidence of \>= 50% reduction in proteinuria during the previous 6 months prior to randomization * severe renal impairment, including the need for dialysis or renal replacement therapy * type 1 or 2 diabetes mellitus * receipt of an excluded therapy, including any anti-cd20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening * significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation * known active infection of any kind or recent major episode of infection * major surgery requiring hospitalization within the 4 weeks prior to screening * current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening * intolerance or contraindication to study therapies * other exclusion criteria may apply
evaluation of youcontrol-afib, a mhealth application for persons with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is being done to establish the feasibility of performing a clinical trial using a mhealth application named youcontrol-afib designed to improve the cardiovascular health of persons with atrial fibrillation. the study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.

primary objective * to effectively recruit participants for a clinical trial and obtain user feedback on the mhealth app using the mobile app rating scale and focus group sessions. secondary objectives * to evaluate the impact of the youcontrol-afib mhealth app (pilot version, 3 months of use) on physical activity in persons with atrial fibrillation. * to obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mhealth application. * to obtain user feedback on the mhealth app using the mobile app rating scale and focus group sessions.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent document * willing to comply with all study procedures and be available for the duration of the study * smartphone capable of pairing with a fitbit sense 2 and fitbit app (apple ios 15 and higher or android 10 or higher) * paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ecg) or other clinical grade monitoring * body mass index (bmi) greater than 27 exclusion criteria: * history of permanent atrial fibrillation * left ventricular ejection fraction (lvef) less than 45 percent * myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months * moderate to severe valve disease * inability to participate in a structured exercise program due to musculoskeletal disease * already participating in a structured exercise program or achieving guideline directed physical activity * planned surgery or procedure during the next three months that limit ability to engage in physical activity

Keywords: physical exercise application supportive care
training and energy management education to improve quality of life in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: persons with multiple sclerosis (pwms) often suffer from impaired mobility and reduced aerobic capacity. moreover, 65% of pwms recognize fatigue as their most disabling symptom that quickly impacts patients' health-related quality of life (qol). systematic reviews that evaluate therapeutic options for ms-neurorehabilitation show good evidence for exercise and energy management/conservation programs to improve fatigue or its impact on daily life. guidelines recommend a multidisciplinary approach but to date only unimodal interventions are investigated. this study aims to investigate the influence of the combination of two different therapeutic concepts: inpatient energy management education (ieme) + high-intensity interval training (hiit). this intervention is compared with a control group that undergoes progressive muscle relaxation (pmr) + low-intensity training (st). ieme or pmr is performed on two days (tue-thur) and hiit or st on three days (mo-wed-fr) / week. the primary outcome is the effect on the quality of life after three weeks rehabilitation and after returning home (at 4 and 6 months follow-up) in pwms.


Eligibility criteria:
inclusion criteria: * definite ms diagnosis (revised mcdonald criteria, 2018). * age \>18y * expanded disability status scale (edss) score ≤ 6.5 * fatigue scale of motor and cognitive function (fsmc) total score \> 43 * literacy and understanding german * informed consent exclusion criteria: * women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * enrolment of the investigator, his/her family members, employees and other dependent persons * cognitive impairment mini-mental state examination (mmse) \< 21 * major depression or hospital anxiety and depression scale (hads) \>11 at baseline * stem cell treatment in the last 6 months * participation in a previous high-intensity interval training (hiit) or inpatient energy management education (ieme) study
linear growth of children with congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia

Summary: the congenital adrenal hyperplasias (cahs) comprise a family of autosomal recessive disorders that disrupt adrenal steroidogenesis. three specific enzyme deficiencies are associated with virilization of affected women. the most common form is 21-hydroxylase deficiency (21-ohd) due to mutations in the 21-hydroxylase (cyp21a2) gene. other virilizing forms include 3b-hydroxysteroid dehydrogenase type 2 (hsd3b2) and 11b-hydroxylase deficiencies associated with mutations in the hsd3b2 and 11b-hydroxylase (cyp11b1) genes, respectively.

it has been reported that approximately one child in every 18000 born in great britain has cah. in north america, the incidence varies from 1:15000 to 1:16000. the reported rates of cah have been as high as 1:280 among the yupik people of alaska and 1:2100 on the french island of réunion in indian ocean; both of these populations are geographically isolated. the reported incidence of cah in the two brazilian states that have routinely included cah in their public newborn screening programs is 1:11655 in the south (santa catarina) and 1:10325 in midwest (goiás). salt-losing cah accounts for about three quartes of cases reported and non-salt losing cah for one quarter. non-classic is more common ;estimated as 1 in 1000-2000 in white populations. it is more frequent in certain ethnic groups, such as the ashkenazi jewish population. the mild non-classic form is a common cause of hyperandrogenism. treatment of classic 21-ohd consists of replacement doses of gluco- (gc) and mineralocorticoids aiming to reduce excess androgen, and to allow adequate linear growth. however, several series report that growth in these children is below expectation, as compared with both the reference population and the target height (th). the reasons for the inadequate growth and impairment of the final height (fh) are not completely understood. a major cause is the difficulty in accomplishing a fine balance between inhibition of excess androgen production which accelerates bone maturation and adequate gc replacement itself which even at slightly supraphysiologic doses can be deleterious to growth.

Eligibility criteria:
inclusion criteria: * age: 1-18 y. * both sexes. * all patients who were diagnosed as having cah of at least 1 y duration. * on glucocorticoid replacement therapy . exclusion criteria: * patients diagnosed as cah for less than 1 year duration. * patients with deficient data at the time of diagnosis. * patients missed for follow up. * syndromatic patients.