Kornimate/medical-research-clean huggingface dataset:
meta-analysis of drug therapy in patients with severe alcoholic hepatitis

Conditions: Alcoholic Hepatitis; Alcoholic Liver Disease

Summary: in the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a df ≥ 32. the need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses. the present study is a meta-analysis of individual data from rcts restricted to patients with a df ≥ 32. the primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline. the secondary endpoints will be: a) assessment of response to the assigned treatment using the lille model; b) analysis of 6-month survival according to allocated therapy.


Eligibility criteria:
inclusion criteria: * patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published. exclusion criteria: -
multi-electrodes set for deep brain stimulation in parkinson disease

Conditions: Parkinson Disease

Summary: this study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.

bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.

Eligibility criteria:
inclusion criteria: * more or equal than 18 years old and less than 70 years * patient affiliated to social security or similarly regime * informed consent form signed * parkinson disease (updrs iii20 score up than 30/108 except for severe tremors) * motor and non motor dysfunctions * pre-operative cerebral mri without lesion * without chirurgical contraindications * without psychiatric disease exclusion criteria: * pregnant women and lactating mothers * ward of court or under guardianship * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalized without their consent * person under legal protection * person with carcinological antecedent during precedent 5 years * chirurgical or mri contraindications
extension study evaluating etanercept in 3 subtypes of childhood arthritis

Conditions: Juvenile Idiopahtic Arthritis

Summary: this is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of juvenile idiopathic arthritis (jia) \[extended oligoarticular jia, enthestitis related arthritis (era), or psoriatic arthritis (psa)\] who have completed approximately 96 weeks of participation in study 0881a1-3338 (b1801014). the study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).


Eligibility criteria:
inclusion criteria: receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881a1-3338 (b1801014) personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study. exclusion criteria: exclusion criteria for subject planning to continue investigational product: withdrawal from investigational product in study 0881a1-3338 for any reason (safety or non-safety). history of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.

Keywords: use of etanercept to treat pediatric subjects with extended oligoarticular jia enthestitis related arthritis (era) or psoriatic arthritis (psa).
registry study of revcovi treatment in patients with ada-scid

Conditions: Adenosine Deaminase Severe Combined Immunodeficiency

Summary: this registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ada-scid) who require enzyme replacement therapy (ert) treatment with revcovi. data on safety and on measures of efficacy are collected.

patients with ada-scid who require ert will receive revcovi on a dosage and schedule determined by the treating physician. they will be followed for safety throughout the study, and will be monitored for the efficacy markers of adenosine deaminase (ada) activity and deoxyadenosine nucleotide (daxp) concentration according to a suggested schedule. some subjects will be new to ert; some will have transitioned from adagen, which was the ert available before revcovi; and some will have previously participated in an earlier phase 3 trial of revcovi (study stp-2279-002). patients will be followed either until they are able to successfully undergo a stem cell transplant or stem cell gene therapy and thus no longer require ert treatment, or until all ongoing participants have received a minimum of 24 months of revcovi treatment. note: due to the nature of this study, all analyses are descriptive and no statistical hypotheses will be tested.

Eligibility criteria:
inclusion criteria: * male or female, aged newborn to adult * in need of ert treatment due to one of the following circumstances: * waiting to receive a stem cell transplant * previously declined, had been found to be ineligible for, or did not respond to a stem cell transplant * waiting to enrol in a clinical trial on gene therapy, or had been found to be ineligible for or had failed such a trial * one of the following histories of ert treatment: * revcovi only * previously on adagen but had transitioned to revcovi * not yet on any ert but about to start on revcovi exclusion criteria: * any condition that, in the opinion of the investigator, makes the patient unsuitable for the study.

Keywords: ada-scid revcovi ert
compare patients' perception of surgical experience based on garment

Conditions: Anxiety; Orthopedic Disorder

Summary: this study seeks to compare how patients rank perception of anxiety, modesty, dignity and overall satisfaction when patients are provided with either a standard patient gown or a standard patient gown plus a pair of specialized surgical undergarments (covr medical) for orthopedic surgical procedures.

given the movement in patient modesty, and the limited number of studies focused specifically on how preserving patient modesty/privacy impacts the patient's perception of the hospital experience, targeted studies with larger sample sizes are clearly needed to better understand these complex interactions. this study seeks to compare how patients rank perception of anxiety, modesty, dignity and overall satisfaction when patients are provided with either a standard patient gown or a standard patient gown plus specialized surgical undergarments (covr medical) for orthopedic surgical procedures. the investigators hypothesize that the group with the standard patient gown plus a specialized surgical undergarment will have lower anxiety and increased perception of modesty, dignity, and satisfaction. a secondary objective is to determine whether there is a difference in treatment surgical subgroups regarding anxiety, modesty, dignity, and overall satisfaction.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo surgery by a musculoskeletal surgeon at the core institute orthopedic specialty hospital (cish). * adults 18 years or older. * will receive orthopedic surgery of the lower extremity, upper extremity or spine. * speaks, reads, and understands english * enrolled pre-operatively within 3 weeks of surgery date. exclusion criteria: * unwilling to provide informed consent. * unwilling to participate in surveys. * body habitus outside of the covr medical size range. (see appendix 1) * procedure that does not meet the medical billing and coding definition of surgery. * incarcerated.

Keywords: anxiety modesty dignity satisfaction
natural history study for patients with angelman syndrome

Conditions: Angelman Syndrome

Summary: this study is a 9-year natural history study for patients with angelman syndrome in belgium (a genetic neurodevelopmental disorder, affecting 500,000 individuals in the world). it includes a 3-year recruitment phase, a 5 year follow-up and a year to analyze the collected data. the investigators plan to include 30 patients with a semi-annual follow-up for 4 years. the investigators will collect relevant retrospective and prospective data using age-standardized scales and questionnaires for functional motor assessments and global developmental assessment.

patients are seen every six months for five years. in these visits, patient have medical review (general medical examination, neurological examination), vital signs (height, weight, respiratory rate, heart rate, blood pressure), cognitive assessment (bayley-iv), language assessment and questionaire (bayley-iv, orca), motor assessments (bayley-iv, fms, developmental milestones and hine), quality of life questionnaire (pedsql, cgi-cass) and general development questionnaire (vineland-ii).

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of as * 0-99 years * male or female * participant's carer is willing to give ic/sign a "record of consultation" for participation in the study exclusion criteria: * comorbidity that could potentially affect the results of the study coexists. this

Keywords: actimyo° accelerometry daily living
ondansetron vs doxylamine and pyridoxine in treating nausea of pregnancy

Conditions: Vomiting of Pregnancy

Summary: our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first line therapy for nausea and vomiting in pregnancy by the american congress of obstetricians and gynecologists (acog). since both treatments are safe in pregnancy, many physicians are using ondansetron as first line in practice. despite this practice and the recommendations from acog, there is not data to suggest that ether practice is superior. this will be the first prospective, randomized, double blind, controlled trial comparing the two treatments. we hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes of emesis. by alleviating nausea and vomiting associated with pregnancy, patients will likely benefit from less emergency department visits, urgent clinic visits, and admissions for progression to hyperemesis gravidarum.


Eligibility criteria:
inclusion criteria: * women who are less than 16 weeks pregnant by last menstrual period or ultrasound * greater than 18 years of age * english speaking * no significant visual or hearing impairment * requesting treatment for nausea associated with pregnancy exclusion criteria: * if nausea or vomiting preexisted the pregnancy * requires hospitalization at the time of initial enrollment * already taking anti-emetics to include metoclopramide, ondansetron, doxylamine, pyridoxine, or promethazine * the patient has an allergy to either study regimen * if they are unable to return for a follow up visit in 1 week

Keywords: nausea vomiting pregnancy ondansetron doxylamine vitamin b6 pyridoxine
evaluation of nutritional status and fatigue in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic progressive neurological disease, the leading cause of disability after injury accidents in young adults. among the many symptoms, fatigue is very common with a significant impact on quality of life. also, the disability caused by multiple sclerosis can alter food intake and can cause nutritional deficiencies. nutrients such as proteins, minerals (iron, calcium, magnesium), some vitamins (b12, 25 ohd) are often deficient in this population with consequences in physical performance such as endurance and muscle strength. we propose to study the link between fatigue and shortcomings encountered in a defined population of ms patients.


Eligibility criteria:
inclusion criteria: * patients between 18 and 65 years old * expended disability status scale (edss) between 0 and 7 * diagnosis of ms according to the revised criteria of mcdonald * clinically stable patients in the past 3 months * coverage of the social insurance * informed consent to participate exclusion criteria: * cognitive disorders that can hinder answering questionnaires * presence of uncontrolled metabolic disease(s) * malabsorption * patients with a gastrostomy * active cancer under treatment * anorexia * pregnancy or breast feeding * severe psychiatric disorder(s) * no informed consent to participate * no coverage by the social insurance

Keywords: multiple sclerosis, fatigue, nutritional status, disability.
efficacy and tolerance of a follow-on formula fed to children from 12-48 months of age in salvador, bahia, brazil

Conditions: Acute Respiratory Infection; Diarrheal Disease

Summary: the purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Eligibility criteria:
inclusion criteria: * child 12-48 months of age * has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization * signed informed consent exclusion criteria: * child who is receiving predominantly breast-milk * child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization * child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child * child with diarrhea or acute respiratory infection during the 48 hours prior to randomization * child's z-score of weight for length/height \< -3 according to world health organization criteria
efficacy and safety on heart rate control with ivabradine on cardiogenic shock

Conditions: Cardiogenic Shock

Summary: this is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years, with acute heart failure due to left ventricular systolic dysfunction (lvef ≤ 40%) in sinus rhythm, baseline hr ≥ 90 bpm, with signs of low peripheral perfusion with indication for intravenous inotropic treatment (catecholamines: dobutamine , adrenaline, dopamine or noradrenaline) and admitted to the cardiological intensive care unit. * pharmacological treatment and stable hemodynamic situation in the 4 hours before inclusion. * pulmonary wedge pressure ≥ 18 mm hg and systolic blood pressure \> 90 mm hg. * patient's signature on the consent form. exclusion criteria: * previous treatment with ivabradine (\< 48 hours). * known hypersensitivity to ivabradine. * cardiac rhythm different from sinus rhythm. * unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular premature beats, ventricular tachycardia, 2nd or 3rd degree atrioventricular (av) block. * severe chronic renal failure (estimated glomerular filtration rate ≤15 ml / min) or on chronic treatment with dialysis. * qt interval higher than 450 ms. * sepsis as a probable mechanism of tachycardia and hypotension. * need for urgent cardiac surgery, planned within 72 hours of possible inclusion. * severe aortic stenosis or severe valvular disease that requires surgical correction. * patient must not have received an iv bolus of furosemide immediately before the baseline hemodynamic assessment. * severe hepatic insufficiency. * patient must not be participating in another clinical trial. * concomitant use of potent cyp3a4 inhibitors. * acute anemia or hypovolemia uncorrected. * pregnancy.

Keywords: ivabradine, heart rate, acute heart failure
photobiomodulation and tooth analgesia

Conditions: Dental Anaesthesia; Dental Pain; Dental Analgesia

Summary: the purpose of this study is to test photobiomodulation (pbm) with a non-invasive light device for reducing discomfort during dental treatments in children. we plan to conduct a series of three clinical studies in 200 school-aged children requiring routine dental treatment. the first study aims to test if pbm works for tooth and soft tissue by assessing response to cold testing and probing of gums. the second study aims to test if use of pbm on soft tissues before injection reduces discomfort. the third study aims to test if pbm can be used to do simple dental fillings in baby teeth without numbing injection.

dental anxiety and fear of pain during procedures are major barriers to oral health care, especially among children. traditional local anesthesia injections can be distressing for pediatric patients. the fear of needle and dental pain are perhaps among the top reasons for avoidance of dental care. photomodulation (pbm) is a promising non-tissue penetrating (i.e. minimally invasive) approach for achieving tooth and soft tissue anesthesia/analgesia in dental patients.investigators plan to use an intra-oral pbm device with a tip comprising of a series of photonic emitters with specific wavelengths that can go through the tooth structure and bone, blocking the nerve conduction like local anesthetics. research has shown that one burst of light application (for about 20 second) can provide up to 15-20 minutes of pain relief. this could significantly reduce dental anxiety and facilitate access to care and the implications of such an alternative to needles will be a gamechanger especially in pediatric dentistry. the proposed randomzied clinical trials will evaluate if photobiomodulation (pbm) with the near-infrared device produces dental analgesia comparable to local anesthetic injection in pediatric patients. this will be a series of three prospective, clinical studies in 200 school-aged children aged 6-12 years requiring routine dental procedures. the first trial will test the effectiveness of pbm in tooth and soft tissue analgesia by assessing response to diagnostic approaches such as cold pulp testing and gingival probing. the second trial will assess the pre-emptive analgesic effect of pbm on soft tissues at the site of injection prior to local anesthesia infiltration to reduce the discomfort of injection, and the third trial will assess effectiveness of pbm in providing tooth analgesia (compared to routinely used topical anesthesia/local infiltration) for simple restorative procedures in primary teeth.

Eligibility criteria:
inclusion criteria: * healthy children, aged 6-12 years, requiring routine dental treatment exclusion criteria: * children with uncooperative behavior or signficant medical history

Keywords: photobiomodulation dental analgesia dental anesthesia
safety and efficacy of oral febuxostat in subjects with gout

Conditions: Gout

Summary: the purpose of this study is to compare febuxostat allopurinol in subjects with gout.

a randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. subjects will receive treatment for 24 weeks.

Eligibility criteria:
inclusion criteria: * hyperuricemia (serum urate ≥8.0 mg/dl) and gout by chinese rheumatism association criteria; * renal function defined as a serum creatinine level of \ 20 milliliters per minute (ml/min) by cockcroft and gault formula; * no gout flare 2 weeks beforehand during 2-week screening period. exclusion criteria: * pregnancy or lactation; * concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\>325 mg) or other salicylates; * body mass index (bmi) \>50 kilogram per meter²(kg/m²); * a history of active liver disease, or hepatic dysfunction; * a history of bronchial asthma; * a history of renal calculi or thyroid disease; * secondary gout joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor; * intolerance to allopurinol and ibuprofen; * alcohol intake of ≥ 14 drinks/week; * clinically significant medical condition.

Keywords: gout uric acid xanthine oxidase febuxostat
quantitative endoscopy of h&n

Conditions: Head and Neck Cancer

Summary: the last decade has seen progressive advances in rt delivery, such as intensity modulated radiation therapy (imrt)and image-guided radiation therapy (igrt), which now allow highly precise radiation dose delivery. together, imrt and igrt offer the potential of more selective treatment of the primary tumour and surrounding neck nodes by reducing the dose inflicted on critical organs at risk without compromising tumour dose and. imrt has been shown to significantly decrease radiation-induced toxicity, and is now considered standard treatment for h\&n tumors. with these advances in delivery technology, the accurate definition of the target is emerging as the weakest link in the radiotherapeutic treatment chain. accurate target definition is the primary link on which all subsequent treatment planning and delivery depend and is therefore critical for successful rt. incorrect target definition can result in poorer outcomes through either less tumour control, more normal tissue toxicity, or both. computed x-ray tomography (ct) is the standard volumetric imaging modality for rt because of its high resolution, accurate definition of anatomy and its intrinsic measure of electron density necessary for accurate dose calculation. however, its ability to distinguish between tumour and normal tissue is limited due to a lack of contrast for structures of similar electron density and image artifacts for objects of high density. this additional noise can result in large inter-observation variability. disease visible on endoscopy can be contoured and registered to the planning ct, allowing inclusion of superficial disease invisible on the volumetric ct image dataset into the treatment plan.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologic diagnosis of squamous cell carcinoma * primary cancer of the h\&n * intention to treat using external beam radiation therapy as part of standard radiotherapy. * ability to provide written informed consent to participate in the study exclusion criteria: * prior complete or partial radiation therapy to h\&n * prior complete or partial surgery of the tumour * contraindications to full dose radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness * concurrent illness or condition that precludes subject from undergoing endoscopy or ct scanning * psychiatric or addictive disorders that preclude informed consent or adherence to protocol

Keywords: head and neck cancer h&n cancer