Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of daxibotulinumtoxina for injection for the treatment of adult upper limb spasticity

Conditions: Upper Limb Spasticity

Summary: this is a randomized, double-blind, placebo-controlled, parallel group, dose-ranging, trial to evaluate the efficacy and safety of daxibotulinumtoxina for injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury. the study will be conducted in the u.s.a., approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. the study consists of a 21-day screening period, a treatment visit and follow-up visits. the protocol was amended and the study was completed with fewer subjects than described in the initial protocol due to impact of covid-19 on enrollment.

subjects will be randomly assigned to daxi for injection 250 u, daxi for injection 375 u, daxi for injection 500 u, or placebo group, respectively. eligible subjects will have uls characterized by a primary aggregate posture

Eligibility criteria:
inclusion criteria: * 18 to 75 years of age * written informed consent including authorization to release health information * focal upper limb spasticity (uls) after a stroke (as defined by who criteria) or traumatic brain injury (tbi), last stroke or tbi \> 24 weeks prior to screening * uls with the primary aggregate posture * moderate to severe uls with a mas score ≥ 2 at the elbow, wrist, and finger flexors * moderate to severe functional disability (disability assessment score \[das\] score ≥2) on the principal target of treatment * has sufficient cognitive and communication ability to be able to give informed consent exclusion criteria: * upper limb spasticity attributable to an etiology other than stroke or tbi. * bilateral upper limb paresis or quadriplegia. * initiated in physiotherapy of the upper extremities ≤ 30 days prior to screening or planned to start physiotherapy of the upper extremities during the course of the study. * previous or planned treatment of the spastic upper limb with phenol, alcohol injection, or surgery * profound muscular atrophy or fixed contracture leading to marked limitation on range of motion * prior treatment with intrathecal baclofen * any neuromuscular neurologic conditions (amyotrophic lateral sclerosis, lambert- eaton, myasthenia gravis)

Keywords: uls juniper daxi for injection botulinum toxin
a phase iii study of pa21 in hemodialysis patients with hyperphosphatemia

Conditions: Hemodialysis; Hyperphosphatemia

Summary: the purpose of this study is to evaluate the efficacy and safety of pa21 in hemodialysis patients with hyperphosphatemia


Eligibility criteria:
inclusion criteria: * patients age 20 or older, regardless of gender. * receiving stable maintenance hemodialysis 3 times a week. * patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start. exclusion criteria: * patients having history of a pronounced brain / cardiovascular disorder. * patients having severe gastrointestinal disorders. * patients having severe hepatic disorders.

Keywords: hemodialysis hyperphosphatemia
does an additional antirotation u-blade (rc) lagscrew improve treatment of ao/ota (orthopaedic trauma association) 31 a1-3 fractures with gamma 3 nail?

Conditions: Hip Fractures

Summary: the purpose was to evaluate whether the additional use of the gamma3 ® rc lag screw is associated with a reduced cutout rate in patients with ota/ao 31a1-3 inter-trochanteric fractures.


Eligibility criteria:
inclusion criteria: * ota/ao 31a1-3 fractures treated with gamma 3® nail (stryker trauma germany) and either with standard lagscrews or with the gamma3 ® rc lag screw (stryker trauma germany) exclusion criteria: * patients with pathological fractures * patients treated with a long gamma nail were excluded
effect of photobiomodulation by 808nm diode laser on the stability of orthodontic mini-implants.

Conditions: Malocclusion, Angle Class II

Summary: the study aimed to evaluate the influence of a 635nm diode laser on the stability of orthodontic mini-implants in vitro, as well as mini-implants failure rate (mini-implant loss) and patients pain level after the treatment. a randomized clinical split-mouth trial was concluded with 22 subjects (14 women, 8 men), 44 orthodontic mini-implants with a diameter 1.4mm and length of 10mm. mini-implants were placed between teeth 3 and 4; and 13 and 14 (universal numbering system), in the area of the attached gingiva, 2 mm below mucogingival junction.


Eligibility criteria:
inclusion criteria: * patients with class ii malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant; * the patients were treated first time using fixed orthodontic appliance; * no systemic diseases; * were not using anti-inflammatory drugs; exclusion criteria: * had used antibiotics in the previous 24 months; * smokers; * had history of radiotherapy, * taking bisphosphonate medication
the effectiveness of commercial weight loss programmes

Conditions: Obesity

Summary: the objective is to compare the effectiveness of 4 different commercial weight-loss diets available to adults in the uk. this is achieved with a 6 month multi-centre randomised unblinded controlled trial of * dr atkins' new diet revolution, * the slimfast plan, * the weight watchers pure points programme, * rosemary conley's "eat yourself slim" diet \& fitness plan. * no diet (control) subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and obese adults. main outcome measures are weight and body fat change over 6 months.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 27 and \< 40 kg/m2. exclusion criteria: * history of coronary heart disease * type 1 or type 2 diabetes * renal, liver or respiratory failure * gout * taking lipid lowering or anti-hypertensive drugs * history of obesity with known cause (i.e. cushings disease, hypothyroidism) * previous gastric or weight loss surgery * taking any weight loss drug (including orlistat or sibutramine) * clinical depression * eating disorders * drug or alcohol abuse * any malabsorptive state (including lactose intolerance) * being treated for a malignancy * being pregnant * breastfeeding
community antibiotic use, susceptibility and resistance among patients with urinary tract infections (cast-uti)

Conditions: Urinary Tract Infections (UTIs)

Summary: 1. general objective this pilot study aims to compare the prevalence of resistance in bacteria causing utis among patients seeking care outside the hospital settings (cdros) to the who-glass data. 2. specific objectives 2-1 primary objectives: * determine the resistance profiles of uropathogens and carriage strains from patients with uncomplicated utis attending community drug retail outlets (cdro's) and in hospitals\*. * compare the resistance profiles of the uropathogens from patients with uncomplicated utis attending cdros and hospitals to those in the who-glass database. * explore the patient pathway and its impact on antibiotic use among patients presenting to cdros and hospitals with uncomplicated utis. * determine the appropriateness of antimicrobial use in the treatment of uncomplicated utis among patients presenting to cdros and hospitals 2-2 secondary objectives: * compare resistance profiles among the uropathogens from patients from two neighbourhoods in kampala. * examine environmental samples between the study sites to determine the presence of antibiotic residues and amr two neighbourhoods in kampala.


Eligibility criteria:
inclusion criteria: * must have one or more of the following clinical presentations regardless of age: acute (\< 2 weeks) dysuria. increased urinary urgency and frequency, irritation, discharge. increased lower abdominal pain or discomfort and sometimes gross haematuria. * in elderly patients with pre-existing urinary symptoms: increased acute urinary changes. exclusion criteria: * people without symptoms of uti.

Keywords: low- and middle-income countries uganda antibiotic resistance urinary tract infection multidrug resistant organisms
ultrasound-guided femoral vein accessibility, safety and time for atrial fibrillation treatment

Conditions: Atrial Fibrillation; Peripheral Vascular Disease; Vascular Access Complications

Summary: this study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .

the number of pulmonary vein isolation (pvi) therapy for atrial fibrillation (af) is increasing. multiple femoral vein cannulation is mandatory for this procedure. there are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. as high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication. real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. in the field of af treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. in this setting, the use of ultrasound use is not well studied. the current study is to confirm whether real time ultrasound-guided femoral vein cannulation for pvi can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. two seethes for each femoral vein is going to be cannulated. the study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. also time for cannulation, number of puncture attempts, need of x-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.

Eligibility criteria:
inclusion criteria: * patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment. exclusion criteria: * patients with prior known vascular access problems or priory included to the current study.

Keywords: femoral vein puncture
population pharmacokinetic analysis of daptomycin in patients with osteoarticular infections

Conditions: Bone Infection; Joint Infection

Summary: daptomycin is validated as a treatment of bone and joint infections by the infectious disease society of america. however, most of studies did not investigate daptomycin pharmacokinetics in this indication while it is known that efficacy and toxicity concentration studies show a close therapeutic margin. evaluation of p-glycoprotein (p-gp), a transmembrane transport protein, has demonstrated its influence on the concentration and intracellular activity of daptomycin. recent work has linked the genetic polymorphism of p-gp to the pharmacokinetics of daptomycin, which may explain inter-individual variability but requires further explorations. previous studies demonstrated existence of interindividual variabilities as sex, renal function and p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet. a population approach will be used to determinate the pharmacokinetics factors, their intra and interindividual variabilities, the parameters associated to those variabilities (as the p glycoprotein). the investigator's goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection.


Eligibility criteria:
inclusion criteria: patients * having had a bone or joint infection, with or without implant, * having an antibiotherapy with daptomycin between december 2012 and december 2016 at the croix-rousse hospital * are at least 18 years old exclusion criteria: * none

Keywords: bone and joint infection daptomycin population pharmacokinetics glycoprotein-p (pgp)
epidemiology of sleep disordered breathing - scor in cardiopulmonary disorders of sleep

Conditions: Lung Diseases; Sleep Apnea Syndromes

Summary: to address the public health importance of sleep disordered breathing and ultimately reduce morbidity through information gained from longitudinal, population-based, epidemiologic studies.

background: the investigators have shown that undiagnosed sleep disordered breathing is prevalent for both men and women throughout the range of middle age; multidisciplinary research findings suggest that untreated sleep disordered breathing may lead to significant behavioral and cardiovascular morbidity. the relative risks are of direct application to public health estimates of: how much behavioral and cardiovascular morbidity would be eliminated if prevalence of untreated sleep disordered breathing were significantly reduced? how much reduction in sleep disordered breathing prevalence could be achieved by eliminating the modifiable etiologic factors? should high risk groups be targeted for early detection of risk factor reduction programs? design narrative: the study quantified the etiologic role of hypothesized risk factors for sleep disordered breathing, described progression of the pathophysiologic process, and tested causal hypotheses of adverse health outcomes. the study was conducted on a unique, established cohort of over 800 subjects, representative of middle-aged employed adults. extensive baseline polysomnographic and other data were available on the established cohort of 800 subjects; additional cohorts of 50 perimenopausal women and 200 older adults were added for maximum study power. the research resulted in longitudinal data, over a 5-9 year period, on multiple parameters of sleep, breathing, risk factors and outcomes. the independent relative risks were calculated with multivariate techniques to express the temporal relationships for sleep disordered breathing etiologic factors and for consequences of sleep disordered breathing. the study was renewed in 1993 and used longitudinal studies to focus on specific questions of greatest relevance to public health, namely: the roles of aging and menopause in the development of sleep-disordered breathing and the effect of sleep disordered breathing on hypersomnolence and systemic hypertension. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
no eligibility criteria
diagnostic evaluation of obscure gastrointestinal bleeding

Conditions: Obscure Gastrointestinal Bleeding

Summary: up to 5% of patients with recurrent gastrointestinal (gi) bleeding remain undiagnosed by egd and colonoscopy, the presumed source of bleeding in these patients being the small intestine. these patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up. for these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, ct scan, angiography, and radionuclide scan. recently, many centers (included the brigham and women's hospital) have begun using capsule endoscopy and ct enterography (cte) for evaluation of suspected small bowel pathology. this is an observational study enrolling patients referred to the brigham and women's hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and ct enterography in the evaluation of obscure gastrointestinal bleeding.


Eligibility criteria:
inclusion criteria: * anemia, hematochezia, melena, hematemesis, heme positive stool with negative egd+/-colonoscopy exclusion criteria: * under the age of 18 * unable to give consent * iv contrast allergy (excluded from ct) * renal insufficiency (excluded from ct) * unable to swallow (excluded from capsule) * small bowel obstruction or stricturing disease (excluded from capsule)

Keywords: obscure gastrointestinal bleeding occult gastrointestinal bleeding overt gastrointestinal bleeding capsule endoscopy ct enterography
study comparing two methods of transversusabdominis plane

Conditions: Pain, Postoperative

Summary: interventional, randomised, prospective, multicentric study

interventional, randomised, prospective, multicentric and single blind study primary objective : demonstrate the equivalence of c-tap block to us-tap block in postoperative analgesia secondary objective : * assess the effectiveness of c-tap block on us-tap block in the obese and/or malnourished patient subgroup * compare the running time of the c-tap block to the us-tap block * assess the safety of the c-tap block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups: * arm a : c-tap block performed by the surgeon * arm b : us-tap block performed by the anesthesist under ultrasound control schedule : * inclusions start at: 16/09/2019 * end date of inclusions: 31/03/2022 * end date of follow-up: 01/04/2022 * study report: 30/09/2022

Eligibility criteria:
inclusion criteria: patient over 18 years old * patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital. * patient mastering the french language * patient who received informed information about the study and signed a consent * patient affiliated to a social security scheme. exclusion criteria: * patients with chronic pain * patients with opioid dependence * patients allergic to local anesthetic * patient who has not signed the consent of the study.
plasma aldosterone levels and atrial fibrillation reduction (aldo-af study)

Conditions: Atrial Fibrillation; Aldosterone

Summary: atrial fibrillation (af) is the most common cardiac arrhythmias with a constantly growing prevalence. two main techniques are used today to restore sinus rhythm: electrical cardioversion and radiofrequency ablation. radiofrequency ablation has become a recognized and effective treatment of af. despite a relatively high success rate (about 80%), a substantial number of patients require a second procedure to obtain sinus rhythm. many publications have led to the study of predictors of failure of this ablation factors (bmi, uncontrolled hypertension, size of the og...) but to date no parameter is reliable and usable in daily practice. it is the same for electrical cardioversion. despite a relatively high immediate success rate of approximately 80%, a significant number of patient relapse arrhythmia in short and long term. many publications have led to the study of predictive factors of failure (seniority and type of af, uncontrolled hypertension, size of the og, mitral valve disease...) but so far the results are disappointing. in af patients with heart disease underlying, it has been well demonstrated that the renin-angiotensin system (raas) was strongly activated. in addition, it is now well established that elevated plasma aldosterone as in primary hyperaldosteronism is associated with a significantly increased risk of occurrence of cardiovascular events. the high plasma concentrations were also highlighted in the acute phase of myocardial infarction, or heart failure and are associated with an increase in major cardiovascular event rate, especially arrhythmias. in some experimental models of heart failure, it has been demonstrated a suppression of the occurrence of spontaneous fa by an anti-aldosterone treatment. the arrhythmogenic effect of aldosterone has also been shown in animal models. all these results indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and the fa. the hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias (flutter or atrial tachycardia) after fa reduction, either in using a radiofrequency ablation or via electrical cardioversion.


Eligibility criteria:
inclusion criteria: * patients referred for atrial fibrillation cardioversion by radiofrequency ablation or electrical cardioversion * scheduled hospitalisation or hospitalisation unrelated to cardiovascular events * age at least 18 years * clinically stable (see criteria for non-inclusion) exclusion criteria: * patient unstable defined as any cardiovascular event that occurred in the previous 30 days these events are: * hospitalisation for cardiovascular causes * appearance or worsening of symptoms consistent with cardiac failure * appearance or worsening symptoms of coronary * patient refusing participation in the study * patient unable to provide follow-up visits

Keywords: catheter ablation galectin 3 ngal aldosterone atrial fibrillation
smoking cessation peds asthma

Conditions: Smoking Cessation; Asthma

Summary: the overall goal of this study is to adapt and preliminarily validate an intervention based on evidence based approaches to assist smoking parents and other family members of inner-city children ages 4 to 12 with asthma to stop smoking.this study aims (1) to adapt existing guideline-based materials used in adult medicine to create a system- and provider-level intervention for pediatrics and (2) to evaluate feasibility and acceptability of (a) procedures to recruit inner-city, ethnic minority parents and (b) intervention procedures, and to estimate intervention effects.

investigators will adapt guideline-based interventions used in adult medicine. the intervention consists of two system-level interventions (chart reminders to prompt providers to ask about in-home smoking and a state quit-line referral system), and a provider-level intervention (training in the phs guidelines, in motivational interviewing, and on how to use the system-level intervention). investigators will implement the study in the bellevue pediatric asthma clinic and the pediatric clinic at lincoln hospital using a two group (pre intervention control group / post-intervention treatment group) pilot study to test the feasibility and preliminary effects of a multi-level (i.e., system and provider) intervention. the primary outcome is provider adherence to tobacco use treatment guidelines, which will be assessed by conducting parent exit interviews with 200 smoking parents (100 pre-intervention \[control group\] and 100 post-intervention \[treatment group\]). preliminary intervention outcomes will be collected through the parent exit interviews (i.e., baseline) and 2-month post-baseline interviews with the control and treatment parents. providers will also be interviewed regarding their satisfaction with the intervention.

Eligibility criteria:
inclusion criteria: * parents of a child between the ages of 4 and 12 with uncontrolled asthma, brought to one of the clinics for an asthma-related visit * uncontrolled asthma as meeting the criteria for "not well-controlled" or "very poorly controlled" asthma: (a) score of 19 or lower on the validated asthma control test (act)45 or (b) any of the following in the prior 12 months: (1) 2+ courses of oral steroids; (ii) 2+ emergency department (ed) visits for asthma; and (iii) 1+ hospitalization for asthma. * the parents must speak english or spanish, and have the capacity to provide consent. exclusion criteria: * beyond these eligibility criteria, no exclusions will be made based on sex, ethnicity, or race of the child or parent.