Kornimate/medical-research-clean huggingface dataset:
clinical and structural outcome after early repair of the traumatic rotator cuff tear

Conditions: Full Thickness Rotator Cuff Tear

Summary: the optimal timing for surgical repair of traumatic rotator cuff tears is controversial. today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the swedish national musculoskeletal competence centre requests more research to this subject. the investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery. the investigators hypothesise that the outcome after rotator cuff repair is good.

there exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. we have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair. we hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.

Eligibility criteria:
inclusion criteria: * trauma to the shoulder with sudden onset of symptoms * asymptomatic shoulder before trauma * mr positive for full thickness rotator cuff tear exclusion criteria: * fracture * severe comorbidity * more than 6 weeks after trauma * glenohumeral degeneration signs or osteoarthritis on x-ray

Keywords: traumatic rotator cuff tear arthroscopic rotator cuff repair age early rotator cuff repair
girh chronic obstructive pulmonary disease observational study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to establish the large copd cohort and biological database in china, aiming for precision medicine to optimize diagnosis and treatment choices.


Eligibility criteria:
inclusion criteria: -aged 40-70 years copd group: baseline post-bronchodilator fev1/fvc \< 0.7 signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years exclusion criteria: * acute exacerbation in the past 3 months having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc the usual criteria of serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months eye surgery in the last three months retinal detachment myocardial infarction in the last 3 months admission to hospital for any cardiac condition in the last month heart rate over 120 beats per minute antibacterial chemotherapy for tuberculosis pregnant or breast feeding
cell therapy in hfpef

Conditions: Heart Failure With Normal Ejection Fraction

Summary: the primary objective of the study is to investigate safety and efficacy of transendocardial cd34+ cell therapy in patients with hfpef by evaluating changes in myocardial structure and function, patient exercise capacity and clinical outcome. the safety end-points include serious adverse events (saes), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.

in all patients, peripheral blood stem cells will be mobilized by daily subcutaneous injections of g-csf (10 mcg/kg, divided b.i.d) for 5 days. peripheral blood stem cells will then be collected with miltenyi cell separator (miltenyi biotech, germany) and the magnetic cell separator isolex 300i (nexell therapeutics inc., california, usa) will be used for the immunomagnetic positive selection of the cd34+ cells.

Eligibility criteria:
inclusion criteria: * preserved left ventricular systolic function on echocardiography (lvef\>50%) * evidence of diastolic dysfunction by echocardiography (e/e'\>15) * symptoms of heart failure * nt-probnp levels \>300 pg/ml * absence of permanent atrial fibrillation exclusion criteria: * acute multi-organ failure * history of any malignant disease within 5 years * diminished functional capacity due to non-cardiac co-morbidities (copd, paod, morbid obesity) * pregnancy
virtual reality treadmill training in individuals with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: this pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with traumatic brain injury (tbi). participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group. this pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with tbi. the data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.


Eligibility criteria:
inclusion criteria: 1. 18 to 90 years old 2. diagnosed with a non-penetrating tbi 3. at least 12 months post most recent injury 4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year 5. able to understand and speak english language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in english 6. able to walk with minimal assistance or less (with bracing and assistive devices as needed) exclusion criteria: 1. history of severe cardiac disease 2. neuromuscular or neurological pathologies other than tbi that limit study participation 3. uncontrolled seizure disorder 4. weight greater than 135 kg or less than 25 kg 5. height greater than 6' 2'' 6. severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions 7. open skin lesion or bandage in the area of c-mill harness contact
chs nurses clinical competence in detecting signs of ppd in non-native speaking immigrant mothers'

Conditions: Depression, Postpartum

Summary: the aim is to develop, test and evaluate an educational intervention with the purpose to strengthen child health services (chs) nurses clinical competence in detecting signs of postpartum depression in non-native-speaking immigrant mothers. the pilot study has a pre-post experimental design. data are collected before and after the intervention. the differences in the values of the collected data are used to estimate the effect of the intervention.

to be eligible for the study the chs nurse must perform screening of immigrant mothers for postpartum depression with help of an interpreter according to the edinburgh postnatal depression scale (epds) method more than three times a year. the epds is a likert form scale with ten statements and is used in combination with a clinical interview. approximately 40-45 chs nurses will be enrolled in the pilot study. the number of nurses are calculated in comparison to two other published studies within the same context. the instruments clinical cultural competence training questionnaire (ccctq) and general self-efficacy scale (gse) will be used as primary outcomes measures. data are collected before the first education day and after the second education day. secondary outcomes are also collected in connection to the educational intervention and consists of reported yearly statistics; how many mothers were are offered screening, participated in screening, number of screenings preformed with help og an interpreter and number of mothers offered follow-up after participating in screening.

Eligibility criteria:
inclusion criteria: * nurse specialized in primary healthcare nursing or pediatric nursing * employed in the child health services in the county scania in sweden * performing at minimum three screenings per year for postpartum depression, according to the epds-method, with help of an interpreter exclusion criteria: -

Keywords: postpartum depression immigrant women child health services nurse edinburgh postnatal depression scale
a pharmacokinetic (pk) study of natrova topical creme (1%) in pediatric subjects 6 to 24 months of age

Conditions: Pediculosis Capitis (Head Lice)

Summary: this is an open label, single center, single dose pk study of natrova creme rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.

there are millions of children and adults affected with head lice each year in the united states. it has become a major nuisance in school children resulting in many lost school days and frustrated parents. lice and nit resistance to current otc products is being widely reported. compliance with product instructions is thought to be low. therefore a safe and effective alternative to these products is desirable. spinosad (the active ingredient in natrova) and its formulations have been approved as agricultural insecticides in the us, canada and australia, and has received provisional approval in the uk, spain and several other european union countries. spinosad is being formulated into a creme rinse product (natrova) using excipients that are widely used and are "generally regarded as safe" (gras) this study is intended to measure the absorption (or lack thereof) of spinosad through the scalp of infants aged 6 to 24 months, as well as to observe any adverse events related to use of the study drug. a validated method for determining the levels of spinosad in plasma will be utilized.

Eligibility criteria:
inclusion criteria: 1. male or female, 6 to 24 months of age 2. individuals in good general health, free of any systemic or dermatologic disorders which will interfere with the study results. 3. completion of an appropriate informed consent agreement. 4. subjects must be available to stay in the clinic for blood draws. parents or guardians must be available to stay in the clinic with the minor subject, for the duration of the study. 5. subjects must have veins capable of withstanding multiple blood draws. 6. normal values (at screening) for serum chemistry and hematology for subjects. exclusion criteria: 1. history of irritation or sensitivity to pediculicide or hair care products or ingredients. 2. history of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine. 3. systemic diseases that could interfere with the results of this study. 4. any condition or illness that, in the opinion of the principal investigator or designee, may compromise the objectivity of the protocol or the safety of the subject. 5. the use of antibiotics or other systemic medications within two weeks of the screening visit, which in the opinion of the investigator, could interfere with the outcome of the study. 6. participation in a previous drug study within the past 30 days. 7. individuals with any visible skin/scalp condition at the treatment site which will interfere with the evaluations according to the opinion of the investigator. 8. parents or guardians who, in the opinion of the investigator, do not understand their child's requirements for study participation and/or may be likely to exhibit poor compliance.

Keywords: pediculosis capitis head lice crawlers ova nits
the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams

Conditions: Dyspnea; Coma; Hypotension and Shock

Summary: study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (met)

rationale: study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams objective: concordance between met diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. also other secondary endpoints will be evaluated. study design prospective, interventional study study population: patients on the general wards in need treatment by the met team intervention (if applicable): when the met team arrives first assessment will be done according to the abcde algorithm. if immediate interventions are needed (intubation, cpr etc) this will be done first (and noted). after the abcde assessment an initial diagnosis is noted. in the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. after the use of ultrasound various variables are noted. main study parameters/endpoints: concordance between met diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. also other secondary endpoints will be evaluated. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the use of ultrasound is without direct side effects in terms of radiation or other potential (non)physical disturbances. there are no data on the effects of the use of ultrasound during met calls. the met team will first deliver acute care if necessary, the ultrasound protocol can be done within 10-15 minutes which is acceptable in terms of met call care. the met team physician can at any point decide to use the ultrasound if he/she thinks it is necessary. in other circumstances (e.g. emergency department or intensive care units) point-of-care ultrasound is considered to be part of standard care. the investigators will study the potential influence of ultrasound during met calls in terms of accuracy of the initial diagnosis and whether ultrasound influences initial treatment, patients' disposition and so on, ultrasound is no treatment nor will be the use of ultrasound be decisive in the treatment of met call patients in this study.

Eligibility criteria:
inclusion criteria: * adult patients on the general wards in need of treatment by the met team. exclusion criteria: * age (\<18 years), * pregnancy:

Keywords: ultrasound met team concordance
indirect calorimetry: sensormedics vmax vs ge carescape - a method comparison study

Conditions: Nutrition Assessment; Critical Illness; Children

Summary: dosing of nutrition in picus is mainly based on patient weight and assumptions on clinical status. there is however poor correlation between these calculations and actual energy consumption measured with indirect calorimetry (ic). available equipment for ic has however been too cumbersome to use in daily clinical practice. of relative new date is ic integrated in modern ventilators. this functionality is easy to use, but we do not know if the results are reliable for children. this study is a method comparison study comparing measurements done with sensormedics vmax ("gold standard") vs ge carescape (modern ventilator with integrated ic) in children undergoing intensive care treatment.


Eligibility criteria:
inclusion criteria: * \< 18 years of age, * endotracheally intubated. * fio2 \ 50 ml. exclusion criteria: * ventilatory and hemodynamically unstable during 2 hours prior to inclusion.

Keywords: indirect calorimetry method comparison
functional magnetic resonance imaging (fmri) vascular reactivity in cerebral cavernous malformations (ccm)

Conditions: Cerebral Cavernous Malformation

Summary: the goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with ccm during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fmri to develop prognostic biomarkers for ccm formation


Eligibility criteria:
inclusion criteria: 1. all familial ccm subjects presenting at unmh who can consent to our study. 2. adult male/female patients ages \>18 years old exclusion criteria: 1. individuals ages \<18 year 2. subjects with a known fear of dyspnea or enclosed spaces will be excluded from this study as well as those with metal implants, copd, heart conditions, and hypercapnia. 3. subjects who have contraindications to mri such as harboring incompatible ferromagnetic objects implanted in the body. 4. pregnant women (screening for pregnancy will be performed by oral questionnaire. mri is safe in pregnancy but the study will exclude pregnant subjects, as the effects of respiratory challenge cannot be predicted in such subjects. since these effects are proportional to the stage of gestation, oral history will be sufficient to assure safety.) 5. prisoners. 6. people unable to consent. 7. people unable to participate due to prior neurological deficits. 8. subjects with underlying pre-existing pulmonary illness; such as asthma, copd, pulmonary hypertension, will be excluded. 9. cognitively impaired and/or participants not able to speak english language will not be included in the study (this pilot study involves performing motor and verbal tasks while in the mri, in addition to undergoing a respiratory challenge, that requires understanding instructions clearly. we do not have current capabilities to include a translator who would be available at all stages of the study to include subjects who do not speak english.)
chronic inflammation and exercise responsiveness

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to determine how chronic inflammation influences skeletal muscle protein metabolism and metabolic function in humans. the investigators will evaluate acute responsiveness to a single bout of exercise in men and women who are either lean or overweight/obese. the investigators will explore the relationship between circulating inflammatory markers and anabolic, proteomic, and transcriptional responses to acute exercise. the investigators will measure skeletal muscle protein synthesis in the postabsorptive state and in response to a single bout of exercise.


Eligibility criteria:
inclusion criteria: * age 30-55 years * bmi 19-45 kg/m2 exclusion criteria: * anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl) * active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment) * renal insufficiency/failure (serum creatinine \> 1.5mg/dl) * oral warfarin group medications or history of blood clotting disorders. * pregnancy or breastfeeding * alcohol consumption greater than 2 glasses/day or other substance abuse * untreated or uncontrolled thyroid disorders * debilitating chronic disease (at the discretion of the investigators)
study evaluating the safety and efficacy of etanercept in patients with psoriatic arthritis treated by dermatologists

Conditions: Arthritis, Psoriatic; Psoriasis; Skin Diseases, Papulosquamous

Summary: the purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with psa treated by dermatologists.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * clinical diagnosis of psoriatic arthritis exclusion criteria: * sepsis or risk for sepsis, * acute infection, * hypersensitive against etanercept

Keywords: arthritis
efficacy of botulinum toxin a in the treatment of bruxism-related symptomatology

Conditions: Bruxism

Summary: bruxism is defined as a parafunction that consists of a clenching of the jaw and/or grinding of the teeth. it can occur when an individual is sleeping or awake or it can be mixed. most often, it is primary or idiopathic bruxism, however when it is related to a cause it is qualified as secondary. primary bruxism is a condition that is not well known to the general public, but i is very widespread (12% of the adult population). in addition, it can alter quality of life, as a result of associated sleep disorders, concentration disorders, daytime fatigue, chronic pain, etc. the current treatment for this condition is only symptomatic. currently, one of the most effective treatments is the intramuscular injection of botulinum toxin a in the muscles of mastication. the progressive anticholinergic action results in a reduction of functional signs (dental pain, periodontal pain, temporomandibular joint pain, tension headaches, neck pain) and physical signs (reduction of the mass of the injected muscles, alba linea, tongue scalloping, limitation or stability of dental damage). however, these clinical data are practically not objectified in daily practice. objective criteria would make it possible to measure the effectiveness of the treatment, to follow the patient, and to identify the early symptoms in order to prevent a recurrence. the aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection.


Eligibility criteria:
inclusion criteria: * patient who has given written consent. * patient between 18 and 64 years of age. * patient who has never received botulinum toxins * symptomatic patient in the context of bruxism in failure to the usual treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer) * woman of childbearing age using an effective method of contraception * symptomatic patients in the context of bruxism, without a maxillary disocclusion retainer. exclusion criteria: * protected adult * patient not affiliated to the national health insurance system * pregnant or breastfeeding woman * refusal to take part in the study * neuromuscular diseases, including myasthenia gravis, myopathies, amyotrophic lateral sclerosis. lambert-eaton syndrome, patients with peripheral motor neuropathies, patients with underlying neurological disorders. * patients with a history of cardiovascular disease * patients with epilepsy or a previous seizure episode * neurogenic impairment of the face (including facial paralysis, polyradiculoneuritis) * history of dysphagia or pulmonary aspiration * injection site infection (masseter and temporal) * hypersensitivity or allergy to botulinum toxin or any of its excipients. * treatment with aminoglycosides or anticholinesterase agents.
pre-exposure prophylaxis study of lenacapavir and emtricitabine/tenofovir alafenamide in adolescent girls and young women at risk of hiv infection

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Summary: the goal of this study is to evaluate the efficacy in preventing hiv infection of the study drugs, lenacapavir (len) and emtricitabine/tenofovir alafenamide (f/taf), in adolescent girls and young women.


Eligibility criteria:
key inclusion criteria: * incidence phase * hiv-1 status unknown at initial screening and no prior human immunodeficiency virus (hiv)-1 testing within the last 3 months. * sexually active (has had \> 1 vaginal intercourse within the last 3 months) with cisgender male individuals (cgm). * randomized phase * negative fourth generation hiv-1 antibody (ab)/antigen (ag) test confirmed with central hiv-1 testing. * estimated glomerular filtration rate (gfr) ≥ 60 ml/min at screening. * body weight ≥ 35 kg. key exclusion criteria: * prior receipt of an hiv vaccine. * prior use of long-acting systemic hiv pre-exposure prophylaxis (prep) or or hiv pep (postexposure prophylaxis). note: other protocol defined inclusion/exclusion criteria may apply.