Kornimate/medical-research-clean huggingface dataset:
a study of ro6885247 in adult and pediatric patients with spinal muscular atrophy (moonfish)

Conditions: Muscular Atrophy, Spinal

Summary: this multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study will investigate the safety and tolerability of ro6885247 in adult and pediatric patients with spinal muscular atrophy (sma).


Eligibility criteria:
inclusion criteria: * males and females, aged 2 to 55 years inclusive or below 7 months inclusive * confirmed diagnosis of 5q-autosomal recessive sma (types 1 to 3), for patients aged 7 months or below clinical symptoms attributable to type 1 sma and 2 smn2 copies * able and willing to provide informed consent and to comply with the study protocol. alternatively, a legally authorized representative must be able to consent for the patient and assent must be given by the subject wherever possible. * female patients of childbearing potential and male patients with a female partner of childbearing potential must agree with the required contraceptive methods as defined per protocol. * for patients aged 7 months or below, gestational age of 37 to 42 weeks and not considered small for gestational age at birth exclusion criteria: * concomitant or previous participation in any investigational drug or device study within 90 days prior to screening * concomitant or previous participation in a smn2-targeting antisense oligonucleotide study within 12 months prior to screening * concomitant or previous participation at any time in a gene therapy study * for patients aged 2-55 years, hospitalization for pulmonary event within the last 2 months or planned at the time of screening * surgery for scoliosis in the last 6 months from screening or planned within 6 months from screening * unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease * clinically relevant ecg abnormalities at screening or baseline; personal or family history (first degree relatives) of congenital long qt syndrome * clinically significant abnormalities in laboratory test results at screening * any concomitant disease or condition that could interfere with the conduct of the study, or pose an unacceptable risk to the subject in this study * use of prohibited medications as per protocol within 90 days prior to randomization. patients who are on inhaled corticosteroids, administered either through a nebulizer or an inhaler, are allowed. * recently initiated treatment (within \<6 months prior to randomization) with oral salbutamol or another beta2-adrenergic agonist taken orally is not allowed. patients who have been on oral salbutamol (or another beta2-adrenergic agonist) for at least 6 months before randomization are allowed. use of inhaled beta2-adrenergic agonists is allowed. * for patients aged 7 months or below, patients requiring invasive ventilation or tracheostomy, presence of non-sma related morbidities
elastic nail versus screw for intramedullary fixation of displaced fractures of the fifth metacarpal neck

Conditions: Metacarpal Fracture; Boxer's Fracture

Summary: the goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture. the main questions it aims to answer are: * can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application? * can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application? patients will be followed up at the 1st week, 1st month and 3rd month postoperatively. functionality will be evaluated with quick dash score at the 3rd month. at the 1st and 3rd month controls, grip strength will be evaluated. at the same time, metacarpal shortening and angulations will be measured on x-ray. researchers will compare percutaneous screw and elastic nail group to see grip strength, healing time and radiologic parameter difference.

in this study, patients admitted to the emergency department with displaced fifth metacarpal neck fracture will be included. exclusion criteria will include patients with other concomitant trauma, open fractures, fractures with intraarticular joint extension, and previous hand surgery in which the hand anatomy was distorted. patients between the ages of 18 and 60 who have more than 30 degrees of angulation from the 30 degree hand pronation radiograph at admission and who consent to surgery will be included in the study. one of the two groups in the study will undergo closed reduction followed by percutaneous intramedullary retrograde screw fixation, while the other group will undergo intramedullary antegrade elastic nail application. patients will be followed up with ulnar gutter splint for the first week postoperatively. after the first week, the splint will be removed and range of motion, gripping and pinching exercises will be given to the patients. radiological examinations (dorsal angulation and metacarpal shortening will be measured) will be performed in the first week, first and third months postoperatively. hand grip strength will be measured with cambry dynamometer at the first and third month. at the 3rd month, upper extremity functionality will be evaluated with quick dash score and a comparison will be made between the two groups. randomisation will be performed with an internet-based application. clinical ethics committee approval was obtained before the study started.

Eligibility criteria:
inclusion criteria: * patients aged 18-60 years with displaced fifth metacarpal fractures with angulation greater than 30 degrees exclusion criteria: * open fracture * patients with multiple injuries * history of hand surgery * intraarticular metacarpal neck fractures
study of the impact of hypersplenism and splenectomy on hepatocarcinogenesis in patients with posthepatitic cirrhosis

Conditions: Liver Cirrhosis; Carcinoma, Hepatocellular; Splenomegaly; Laparotomy

Summary: the purpose of this study is to investigate the impact of splenectomy coupled with portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic cirrhosis after hepatitis b or c virus infection by retrospective case-control study,we hope to find a new idear and method to prevent or cure hcc.

a case-control study was carried out. the factors studied include age, gender, ascites, hepatic encephalopathy, alt, ast, tbil, alp, ggt, child-pugh classification of liver function, and history of splenectomy with portal-azygous disconnection during the treatment of portal hypertension. according to the child-pugh classification, these cases were graded as a, b, and c. and according to the ranges of the normal reference values of the data, they were categorized into two groups including a normal group and an abnormal group.the data mainly comes from fmmu and xi'an jiaotong university from the year of 2002 to 2012.

Eligibility criteria:
inclusion criteria: * after surgery exclusion criteria: * without surgery

Keywords: posthepatitic cirrhosis; hepatocarcinogenesis; splenectomy;
effects of ldl apheresis system on the expression of genes involved in lipoprotein metabolism and inflammation in homozygotes for familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: familial hypercholesterolemia (fh) is an autosomal codominant single-gene disorder caused by mutations in the ldl receptor gene that disrupt the normal clearance of ldl particles from the plasma compartment. heterozygous patients present a 2- to 3-fold raise in plasma ldl-cholesterol (c) concentrations, tendinous xanthomatosis and premature atherosclerotic coronary heart disease (chd), usually occurring between the age of 35 and 55 years. since the mid-1970s, ldl-c has been removed from the blood of patients using plasmapheresis, and this technique has been shown to improve the life expectancy of fh homozygotes. ldl apheresis selectively removes ldl particles but not immunoglobulins and other beneficial proteins, thereby overcoming a potential drawback of the traditional plasmapheresis method. ldl-c is effectively reduced by more than 60% immediately after ldl apheresis, although ldl levels rebound rapidly. dextran sulfate adsorption is a commonly apheresis technique used in familial hypercholesterolemia patients. in this apheresis plasma is separated from red blood cells and passed over columns of cellulose beads containing dextran sulfate which binds apolipoprotein b (apob) by a highly selective electrostatic binding mechanism. since ldl, very-low density lipoprotein (vldl), and lipoprotein (a) all contain apob, dextran sulfate adsorption apheresis selectively reduces these lipoproteins while having little effect on the non-apob containing hdl particles. in clinical practice, ldl apheresis reduces the rate of future cardiovascular events and has been postulated to have additional effects on potentially pro-atherogenic factors. some proteins have been identified with adhesive characteristics to lipoproteins, rheological, immunological and inflammation relevant proteins16-19 that influence microcirculation as well as the inflammatory response. however, no studies have yet to investigate the impact of ldl apheresis on the expression of different genes involved in cardiovascular disease. the main objective of the present research project is to investigate the impact of the ldl apheresis dextran sulfate adsorption system on the messenger ribonucleic acid (mrna) expression of genes involved in cardiovascular disease using microarrays analysis in 9 fh homozygotes.


Eligibility criteria:
inclusion criteria: * homozygotes for familial hypercholesterolemia who receive lipid apheresis * aged between 18-60 years exclusion criteria: * smokers (\> 1 cigarette/day) * subjects with a previous history of cardiovascular disease * subjects with type 2 diabetes * subjects with a monogenic dyslipidemia that it is not homozygote for familial hypercholesterolemia * subjects with endocrine or gastrointestinal disorders * history of alcohol or drug abuse within the past 2 years * subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
gabapentin for the treatment of neuroleptic-induced tremor

Conditions: Neuroleptic-Induced Tremor

Summary: we will attempt to establish whether gabapentin as compared with placebo will reduce the severity of tremors caused by the use of antipsychotic medications. baseline severity of tremor will be measured using both clinical ratings and ratings obtained with an instrument designed to measure tremor, giving more objective evidence of tremor frequency and severity.

we propose to enroll 40 veterans with antipsychotic induced tremor in this rct of gabapentin. baseline measurements will be obtained with the tremor section of the updrs, the simpson-angus scale, the esrs, aims, and the barnes akathisia sscale. the tremorometer, an instrument designed to quantatatively measure frequency, amplitude, and tremor power will be used for baseline and subsequent assessments. demographic data will be collected. diagnoses will be established with the scid. appropriate lab studies with an ekg will be done at baseline and at study end. patients will be randomized to gabapentin or placebo and assessed on a blinded basis. effectiveness of the blind will be assessed at study end. gabapentin will be started at 300 mg/day and tapered up to a maximum of 1800 mg/day. the sf36 will be used to assess quality of life.

Eligibility criteria:
inclusion criteria: * veterans 18 and older with an observable tremor judged to be caused by exposure to antipsychotics exclusion criteria: * concomitant use of other anticonvulsants, l-dopa, cocaine, amphetamines, or other tremorogenic agents excepting ssris, tcas. * current suicidality, severe psychosis, inability to sign informed consent or to cooperate with study procedures. * current use of gabapentin or exposure to gabapentin in the past 2 years. * women who are pregnant, or not using adequate birth control.

Keywords: antipsychotics, tremor
digital tracking with auto data reporting

Conditions: Type 1 Diabetes Mellitus (T1DM)

Summary: type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families. the objective of the treatment of dm1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease. however, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals. in this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.

patients are enrolled to a prospective, observational post-market clinical follow-up study. this is a pilot study. the protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the declaration of helsinki

Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes mellitus * patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems * patients using a glucose monitoring system * patients who are able to complete the study questionnaires * patients who are able to handle the application on a smart mobile phone. * informed consent is obtained from the patient. exclusion criteria: * patients who, in the opinion of the investigator will not be able to commit to carrying out the follow-ups or do not have adequate technological skills

Keywords: t1dm digital platforms remote patient monitoring glycemic control caaring
study to evaluate the pharmacokinetics of vitamin d (cholecalciferol) in patients undergoing obesity surgery in a deficit situation and after standardization

Conditions: Obesity; Gastric Bypass; Gastrectomy

Summary: set the pattern of vitamin d supplementation in obese patients undergoing bariatric surgery in deficit of vitamin d. patients receive a single oral dose of vitamin d, during the 28 days will be done a kinetic curve. then and over the next 3 months, levels are normalized. once normalized, will be administered another single oral dose to a second pharmacokinetic evaluation.

the study is conducted in obese patients undergoing bariatric surgery (for bypass or sleeve gastrectomy) in deficit of vitamin d. will include a total of 44 patients, 22 from each type of surgery. patients receive a single oral dose of vitamin d of 50,000 iu. during the 28 days after administration of vitamin d will be done a kinetic curve determining plasma levels of vitamin d on 15 occasions. then and over the next 3 months, levels are normalized by providing a daily oral dose for each patient. once levels are normalized, will be administered another single oral dose of 50,000 iu vitamin d and proceed to a second pharmacokinetic evaluation determining plasma levels 15 times. patient follow up is approximately 36 weeks. patients go to the screening visit, baseline visit and visits on days 1, 2, 3, 14 and 28 days after each pharmacokinetic evaluation.

Eligibility criteria:
inclusion criteria: * 18 or more years old * with bariatric surgery in the last 18 months (+/- 6 months) * bmi: 25-33 kg/m2 * vitamin d3 (ok)\<20ng/ml. * clinically stable, in the opinion of the investigator, at the time of inclusion * signed consent form exclusion criteria: * pregnancy, lactation or intention during the study period. * menopause * gop, gpt\>2 unl * glomerular filtration rate \<60ml/min * previous renal lithiasis * any digestive disease to suggest malabsorption, granulomatous diseases, diabetic gastroenteropathy and taking medication likely to interfere with the absorption of vitamin d and bone metabolism such as corticosteroids and anticonvulsants * taking medication that interferes with calcium metabolism. * cholecalciferol hypersensitivity. * other bariatric surgery (different of by-pass or tubular gastrectomy)

Keywords: cholecalciferol
a study investigating the efficacy and safety of abt-494 given with methotrexate in subjects with rheumatoid arthritis who failed anti-tumor necrosis factor (tnf) biologic therapy

Conditions: Rheumatoid Arthritis

Summary: the primary objective is to compare the safety and efficacy of multiple doses of abt-494 versus placebo in moderately to severely active ra subjects on stable background mtx therapy with inadequate response or intolerance to anti-tnf biologic therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis (ra) based on either the 1987-revised american college of rheumatology (acr) classification criteria or the 2010 american college of rheumatology/european league against rheumatism (acr/eular) criteria for ≥ 3 months. * subjects must have been receiving oral or parenteral methotrexate (mtx) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. subjects should continue with their stable doses of mtx and folic acid throughout the study * subjects have been treated with 1 or more anti-tumor necrosis factor (tnf) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active ra, or had to discontinue due to intolerability or toxicity. in addition, subjects with prior exposure to non-anti-tnf biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed. * have active ra as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at screening and baseline, ≥ 6 tender joints (based on 68 joint counts) at screening and baseline, high sensitivity c reactive protein (hs-crp) \> upper limit of normal (uln) or positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-ccp) antibody. exclusion criteria: * prior exposure to janus activated kinase (jak) inhibitor (e.g. tofacitinib, baricitinib) * pregnant or breastfeeding female * ongoing or active infection.

Keywords: anti-inflammatory agents joint diseases arthritis musculoskeletal disease antirheumatic agents
temporal and kinematic analysis of timed up and go test in chronic low back pain patients

Conditions: Chronic Low-back Pain

Summary: kinematic and temporal analysis of the movement helps researchers and clinicians to better understand the way humans move and interact within the environment in which they live, better describe the alterations coming from impairments, and finally allow to better tailor interventions for patients. in this perspective, motion analysis has become, in the last 30 years, a remarkable and important field of research. even if movement assessment should be a cornerstone for definition and modulation of rehabilitation interventions, there are still few motion analysis devices that are able to influence the clinical decision process; motion analysis labs are among those, but their use is unfortunately limited due to the costs of instruments and analysis. other small unobtrusive wearable devices, easier to use and cost-effective, have been developed, like inertial measurement units (imu), composed by accelerometers and gyroscopes. they could therefore represent an incentive for a more widespread use of motion analysis within daily clinical activity in rehabilitaion. timed up and go test (tug) is a simple, widely used, functional test which involves standing up from a chair, walking three meters, turning, and going back to sit. it is used to evaluate movement, mobility, dynamic and static balance in people with musculoskeletal impairment, neurological diseases, aging related conditions, and the quality of life in people with low back pain. the only and easy outcome considered is the time to completion. nevertheless, the application of an imu to a subject performing tug can provide other objective, quantitative data, like temporal and kinematic parameters of the whole test and its sub-phases. the instrumented tug (itug) has already been applied, mainly in the neurorehabilitation field, in particular for parkinson's disease and for post-stroke impairments. clbp is one of the most burdensome health problem worldwide. clbp has been considered a bio-psycho-social disease, characterized by pain in the lumbar region, functional impairments, and condition-related disability. despite the obvious motor problems affecting people with clbp, to the best of our knowledge, chronic low back pain (clbp) has not yet been explored using itug. the aim of study is to analyse temporal and kinematic parameters of clbp subjects compared to bmi and age-matched healthy subjects, through itug and to explore the correlations of those parameters with pain and disability.


Eligibility criteria:
inclusion criteria (for chronic low back pain population): * pain from at least 3 months * numerical pain rating scale (nprs) ≥ 4 exclusion criteria (for chronic low back pain population): * history of neurological impairment or disease, * other orthopaedic impairment within the past 6 months or surgery in the previous 6 months.

Keywords: chronic low-back pain functional assessment time up and go test inertial measurement unit
sphenopalatine ganglion block to prevent shoulder pain after laparoscopic bariatric surgery

Conditions: Obesity

Summary: the purpose of this study is to determine the efficacy of sphenopalatine ganglion (spg) block to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision, band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. shoulder tip pain (stp) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia care unit and for days or possibly weeks thereafter (dixon 2005). systemic analgesics including opioids and non-steroidal anti-inflammatory drugs (nsaids) do not reliably relieve stp. this study is designed to determine if the spg block, a simple and low-risk procedure, effectively treats stp after laparoscopic bariatric surgery.

this is a randomized, placebo-controlled, parallel group prospective, double-blind study. the primary outcome variable will be change in stp from \> 4 before to after treatment in the pacu after primary laparoscopic gastric banding, band revision, band replacement, sleeve gastrectomy, or revision of sleeve gastrectomy. investigators hope to achieve a decline in stp in 2 units after treatment.

Eligibility criteria:
inclusion criteria: * elective primary laparoscopic gastric banding surgery. * laparoscopic band revision surgery * laparoscopic band replacement surgery. * sleeve gastrectomy. * revision of sleeve gastrectomy. * american society of anesthesiologists class 2 or 3. * no allergy to study drugs. * facility with english language to allow compliance with study protocol. exclusion criteria: * american society of anesthesiologists class 4 or 5. * allergy to lidocaine or to any local anesthetic * allergy to oxymetazoline (afrin) * pregnancy * bleeding diathesis * known nasal pathology including active sinusitis * previous nasal surgery * preoperative anticoagulant use other than aspirin 81 mg and/or heparin 5000 u sq bid administered for dvt prophylaxis. * acute psychiatric disease * history of chronic right or left shoulder pain * current opioid use * any patient that the study team feels will be unable to comply with all protocol related procedures * concurrent participation in another clinical trial

Keywords: obesity laparoscopic gastric banding band revision laparoscopic gastric banding sleeve gastrectomy