Kornimate/medical-research-clean huggingface dataset:
acupuncture vs. core stability training in women with fibromyalgia

Conditions: Fibromyalgia

Summary: this study analyse the effectiveness of a core stability training physiotherapy programme versus acupuncture treatment for the management of balance and functional capacity impairments of women with fibromyalgia.

objective: this study investigated the effectiveness of a core stability training physiotherapy programme versus acupuncture for the management of balance and functional capacity impairments of women with fibromyalgia. design: a single-blind randomized clinical controlled trial. setting: university of extremadura and olivenza fibromyalgia association, spain subjects: women with fibromyalgia and balance impairment. interventions: 135 participants were randomized to a core stability training physiotherapy programme group (n=45), an acupuncture treatment group (n=45) and control group (n=45) for 13 weeks. main measures: measures were taken at baseline (week 0), post intervention (week 6) and at follow up (week 13). the primary outcome measures were static balance (posturography) and dynamic balance and functional mobility (berg balance test, time up and go test and 10-metre walk) and functional capacity (fibromyalgia health assessment questionnaire (fhaq) and the physical function item from the spanish fibromyalgia impact questionnaire (sfiq)).the secondary outcome measure were quality of life (spanish- fibromyalgia impact questionnaire), pain, joint stiffness, difficulty to work and depression (measured with the visual analogue scale).

Eligibility criteria:
inclusion criteria: * women between 18 and 71 years old, * diagnosed with fibromialgia by a specialized physician, * having subjective sensation of balance impairments. exclusion criteria: * the exclusion criteria were to present any medical contraindication for acupuncture and/or physiotherapy, phobia of needles, adverse reactions to medication that could influence in balance, associated pathologies such as alcoholism or severe visual deficit, to have receive acupuncture or core stability based physiotherapy in the two months previous to the intervention and to do physical exercises that train core stability such as pilates or yoga

Keywords: rehabilitation balance functional capacity quality of life pain acupuncture
epidemiology and immunology of hemophilia a inhibitors

Conditions: Blood Disease; Hemophilia A

Summary: to determine the risk factors associated with inhibitor formation in hemophilia a and to study the mechanism of tolerance in the murine hemophilia a model.

background: the major hypothesis of this study is that suppression of immunoregulatory cytokines will prevent factor viii inhibitor formation in the hemophilia a murine model: if successful, a treatment protocol could be developed for individuals identified to be at highest risk for inhibitor formation. through this approach to the epidemiology and immunology of inhibitor formation, the health care of individuals with hemophilia may be improved. the study is in response to a request for applications released in 1998 on the immunogenetics of inhibitor formation in hemophilia. . design narrative: a case-control study is conducted comparing prevalent hemophilia patients with inhibitors identified in the hms study with three age-matched controls without inhibitors to determine clinical and laboratory characteristics associated with inhibitor development. a histocompatibility study is conducted identifying patterns of hla class ii antigens by molecular typing in hemophilic subjects identified in hms, with and without inhibitors, which may be linked to inhibitor formation. an animal tolerance study is conducted in the hemophilia a murine model, evaluating blockade of t cell costimulatory pathways by ctla4-ig and anti-cd40l mab, to prevent inhibitor formation. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
prophylactic pregabalin treatment following spinal cord injury

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Summary: patients arriving to rehabilitation up to 3 months following sci will be given (study group) or not (control group) lyrica (75x2). they will be followed for central pain development.

patients arriving to rehabilitation up to 3 months following sci will be recruited, if they have not yet developed central pain. two thirds (the study group) will be treated with lyrica (pregabalin75x2) for 3 months. one third (the control group) will not receive preventative treatment. participants will be followed for central pain development.

Eligibility criteria:
inclusion criteria: * up to 3 months following traumatic or non-traumatic scl * ability to give informed consent and cooperate exclusion criteria: * pregnancy * neurological or other medical conditions that may interfere with sensation * neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing) * being treated with pregabalin * blood creatinine levels \>1.2 or creatinine clearance \<60 * sensitivity to lactose
phirst-1: tadalafil in the treatment of pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

this is a randomized, double-blind, placebo-controlled, multicenter study. the key measure of effectiveness of the study drug will be determined using a 6-minute walk test. eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase study (phirst-2). study procedures for both studies (phirst-1 and phirst-2) will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.

Eligibility criteria:
inclusion criteria: * at least 12 years of age. * body weight at least 40 kg (approximately 88 pounds). * pulmonary hypertension (pah) that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting sao2 greater than or equal to 88%); with surgical repair, of at least 1 year duration, of a congenital systemic-to-pulmonary shunt. * if on bosentan, must be at the maximal dose of 125 mg twice daily for a minimum of 12 weeks prior to screening and have an ast/alt less than 3 times normal. * history of pah established by a resting mean pulmonary artery pressure greater than or equal to 25 mm hg, pulmonary artery wedge pressure less than or equal to 15 mm hg, and pulmonary vascular resistance greater than or equal to 3 wood units via right heart catheterization * have world health organization functional class i, ii, iii or iv status. * have a qualifying 6-minute walk test distance at screening * have no evidence of significant parenchymal lung disease exclusion criteria: * are nursing or pregnant. * pah due to conditions other than noted in the above inclusion criteria. * history of left-sided heart disease. * history of atrial septostomy within 3 months before study entry * history of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug. * history of symptomatic coronary disease. * have any therapy with a prostacyclin or analogue, l-arginine, phosphodiesterase (pde) inhibitor, or investigational drug within 4 weeks before administration of study drug.

Keywords: hypertension, pulmonary; pulmonary heart disease
effects of receptive language intervention vs individual therapy for preschool children with autism spectrum disorder.

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a neurodevelopmental disorder characterized by deficits in social communication and social interaction and the presence of restricted, repetitive behaviors. atypical behaviors, conditioning, and difficulties interacting with others are emblems of autism spectrum disorder (asd). autism spectrum disorder (asd) frequently affects receptive language skills essential for comprehension and communication. early intervention is crucial for optimizing language outcomes. this randomized controlled trial (rct) investigates the comparative efficacy of receptive language intervention (rli) in group versus individual therapy settings for preschool children with asd. this study aims to investigate the efficacy of receptive language intervention (rli) in group versus individual therapy settings for preschool children with autism spectrum disorder (asd) aged 3-5 years. the study aims to address the knowledge gap regarding optimal delivery methods for receptive language interventions. twenty preschool children (ages 3-5) with asd will be randomly assigned to either group (n=10) or individual (n=10) therapy conditions. outcome measures will assess by laura mize teach me to talk receptive language checklist, noted before therapy and after completing 20 sessions post-therapy (after 7 weeks). statistical analysis was done using spss 20. an independent t-test was utilized to see any difference between groups. the study's findings will inform evidence-based practice, enhancing receptive language skills in preschool children with asd. the study could give precious perceptivity to clinicians, preceptors, and policymakers, helping them make informed, substantiation-based opinions about the most effective and doable intervention strategies. the expected outcomes include comparable receptive language outcomes between group and individual therapy, identification of setting-specific benefits and challenges, and child characteristics influencing treatment response.


Eligibility criteria:
inclusion criteria: * children aged 3 to 5 years diagnosed with asd. * children who are able to attend regular therapy sessions as scheduled in the study (either group or individual therapy). * both male and female will be included. exclusion criteria: * children with co-occurring severe medical conditions. * children who have already received intensive speech and language therapy for receptive language skills within the last 6 months. * children with behavioral issues so severe (e.g., aggression, extreme hyperactivity) that they might disrupt group therapy sessions or be unable to focus in individual therapy.
electromagnetic transduction therapy on osteoarthritis in the foot and ankle

Conditions: Osteoarthritis Ankle; Osteoarthritis Foot

Summary: the purpose of this study is to determine if electromagnetic transduction therapy (emtt) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.


Eligibility criteria:
inclusion criteria: • men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs. exclusion criteria: • pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with mris, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.

Keywords: electromagnetic transduction therapy
influence of cognitive function software therapy on the improvement of manual skills in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic demyelinating disease of the central nervous system leading to the impairment of motor, visual and cognitive functions. a standardized rehabilitation of cognitive functions can be provided by a systematized treatment program devised to improve neurological patients' quality of life. the degree of difficulty of the computerized tasks was adapted to a patient's predispositions and modified once a desirable improvement in the practiced skill has reached. the aim of the study was to assess the influence of cognitive therapy by means of the cognitive software on manual dexterity in patients with multiple sclerosis. we also attempted to establish whether factors like age, sex and expanded disability status scale (edss) scores contribute to the outcomes of that therapy. all patients enrolled will have a documented history of ms disease prior to study enrollment. the edss scores varied between 1.5-4 (mean score 2.1). the nine hole peg test (nhpt), administered to all of the patients, was used to evaluate the subjects' manual dexterity. having been administered the nhpt test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. three times a week the study group received the upper limb treatment by means of the cognitive function platform. they were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. after completing each task the patient would move on to a higher level of difficulty. failure meant having to redo that particular task. one training session lasted 20 min., after which the patient could take a break. having completed the training each patient was administered the nhpt test again in view of assessing the efficiency of their upper limb. due to progressive deterioration of health and other factors only 10 patients managed to complete the training.


Eligibility criteria:
inclusion criteria: ms clinically diagnosed based on mcdonald's criteria of 2011 the edss between 1.5-4; relapsing-remitting form ms; exclusio criteria mental disorders, alcoholism, severe vision disorders including diplopia coinciding upper limb therapy -

Keywords: manual therapy; multiple sclerosis; rehabilitation; motor cortex; neuroplasticity
effects of automated oxygen titration alone or with high flow nasal therapy on dyspnea and exercise tolerance

Conditions: Dyspnea; Lung Diseases; Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease; Cystic Fibrosis; Interstitial Lung Disease

Summary: the main purpose of this study is to evaluate the effects of automated oxygen administration (freeo2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.


Eligibility criteria:
inclusion criteria: one of them * moderate to severe copd (forced expiratory volume in 1 second (fev1) \< 80% predicted and fev1/forced vital capacity (fvc) ratio \< 0.7) * chronic interstitial lung disease such as usual interstitial pneumonitis (uip), non-specific interstitial pneumonitis (nsip) or hypersensitivity pneumonitis on high-resolution computed tomography * pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure \> 25 mm hg at right heart catheterization * cystic fibrosis, as diagnosed by a positive sweat test (\>60 mmol/l) or having 2 genetic mutations known to cause cystic fibrosis. and having a 6-minute walking test with significant desaturation defined as a decrease in o2 saturation greater or equal to 5% with o2 saturation at the end of the walking test \< 88% exclusion criteria: * exacerbation of the primary lung disease in the past 8 weeks * exercise limiting diseases other than the primary lung disease. * not reaching the target dyspnea score during the walking tests. * stage 1 pulmonary sarcoidosis * history of syncope on exertion * spo2 with effort less than 90% despite the use of 6 l of o2 per minute * cardiac condition deemed unstable or severe (e.g. severe aortic stenosis) * disabling or severe rheumatological or neurological condition * participation in a pulmonary rehabilitation program within the last year * patients with multi-resistant bacteria
drug outcome survey for biological treatments in rheumatoid arthritis: an observational study (dose)

Conditions: Rheumatoid Arthritis

Summary: the primary purpose of this observational study is to describe and define the current daily practice of management of anti-tnf-agents in rheumatoid arthritis (ra) patients. data will be collected only from subjects providing informed consent.


Eligibility criteria:
inclusion criteria: 1. eighteen years of age or older 2. diagnosis of ra in accordance with ara 1987 classification has satisfied at least 4 of the following 7 criteria: 1. morning stiffness in and around the joints lasting at least 1 hour; 2. arthritis of 3 or more joint areas; 3. arthritis of hand joints; 4. symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body; 5. rheumatoid nodules; 6. serum rheumatoid factor (rf) 7. radiographic changes. criteria 1 through 4 must have been present for at least 6 weeks. 3. patients refractory or without complete response to dmards according to the italian guidelines for the clinical practice established by italian society of rheumatology 4. patients naive to anti-tnf drugs 5. outpatients exclusion criteria: patients involved in controlled or interventional trials in the 12 previous months
teen-longitudinal assessment of bariatric surgery (teen-labs) adolescent bariatrics: assessing health benefits and risk

Conditions: Obesity

Summary: the five teen-labs clinical centers use standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.

the goal of teen-labs is to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers. teen-labs will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. also, the use of standardized definitions, shared clinical protocols and data collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care. in addition to investigating surgical outcomes, another broader goal of teen-labs is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time. in the 3rd five year cycle of funding for this project, several additional long-term research aims have been added, all in general alignment with the original aims of the project to assess efficacy and safety of bariatric surgery performed in adolescent years.

Eligibility criteria:
inclusion criteria: * adolescents up to age 19 * approved for bariatric surgery * agreement to participate in teen-labs study/ understand and sign informed consent/assent exclusion criteria: * age 19 or greater * unable to sign informed consent/assent

Keywords: adolescents obesity bariatrics surgery for weight loss teen-labs
prep and moud rapid access for persons who inject drugs: the chorus+ study

Conditions: Opioid Use Disorder

Summary: the us opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (hiv) among persons who inject drugs. hiv pre-exposure prophylaxis (prep) is an fda approved medication taken daily orally by individuals who are hiv negative, but who are at increased risk for hiv. in order to obtain prep, a prescription is needed. before being prescribed hiv prep, it is recommended by the centers for disease control and prevention (cdc) to obtain an hiv test first. although home hiv self-test kits are recommended by the cdc and are locally available, uptake remains low. chorus+ (comprehensive hiv, hepatitis c, and opioid use disorder response to the unaddressed syndemic +) is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to hiv prep (primary outcome), and continuation of moud (secondary outcome) among persons who inject opioids. at recruitment, the intervention will include hiv self-testing, rapid initiation of prep and moud, and 6-month peer recovery coaching (prc) to support adherence to these medications. this research study seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent hiv and treat opioid use disorder. the efficacy of this multi-site, two-arm randomized control trial of chorus+ and usual care \[passive referral\]. this study is not testing the efficacy of prep or hiv home testing which is already known. in addition the investigators will determine the influence of hiv self-testing on prep uptake and adherence. in the chorus+/ intervention arm, there will be a baseline in-person session with the participant to encourage uptake of prep and moud using motivational interviewing (mi).


Eligibility criteria:
inclusion criteria: * injected opioids within the past 6 months (by self-report) * willingness to provide contact information for two family members or friends * willingness to sign medical records release forms * ability to speak english * plans to reside in boston area for the next 6 months exclusion criteria: * individuals with hiv (self report) * express desire to harm themselves or others * individuals who are pregnant at baseline * individuals who are already enrolled in an interventional study

Keywords: medication for opioid use disorder human immunodeficiency (hiv) pre-exposure prophylaxis (prep) peer recovery coaching (prc) motivational interviewing (mi) hiv self testing people who inject opioids (pwio)
aerobic exercise training in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to compare the safety and the effects of moderate-intensity aerobic endurance training to those of an usual physical therapy intervention on exercise capacity and quality of life in patients with amyotrophic lateral sclerosis (als).

scarce evidence is available regarding aerobic exercise training of patients with als. some studies using transgenic mouse models of familial als have shown markedly slowed disease progression, improved functional capacity, and extension of survival in animals undergoing aerobic exercise training. in humans, only one non-randomized study has shown that moderate-intensity aerobic exercise training was of little beneficial effect in a small group of patients with kennedy disease, a rare x-linked progressive neuromuscular disease involving lower motorneurons, presenting a pathophysiological picture quite different from that of als. to the best of our knowledge, the safety and the effects of aerobic exercise training on functional capacity and quality of life of patients with als have not been systematically evaluated as yet in a randomized, controlled trial with an adequate sample size.

Eligibility criteria:
inclusion criteria: * diagnosis of definite als, probable als, or probable-laboratory supported als according to the el escorial criteria or diagnosis of progressive muscular atrophy. * ability to perform a baseline symptom-limited cardiopulmonary exercise test with attainment of peak power and respiratory exchange ratio of \>= 50 w and \>= 1.00, respectively. * time since symptoms onset \<= 18 months. * forced vital capacity \>= 70% of predicted. * informed written consent. exclusion criteria: * coexisting neurological disease. * coexisting extra-neurological disease significantly affecting exercise capacity. * coexisting malignancy. * ongoing/planned pregnancy. * involvement in formal endurance and/or strength training program. * enrolment in any other clinical trial. * cognitive impairment.

Keywords: amyotrophic lateral sclerosis aerobic training peak oxygen consumption quality of life