Kornimate/medical-research-clean huggingface dataset:
tritanium® study in japan

Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis of the Femoral Head

Summary: the purpose of this study is to evaluate early fixation and stability of the tritanium cup. it is expected that the tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of japanese surgeons.


Eligibility criteria:
inclusion criteria: 1. patient is a candidate for a primary total hip arthroplasty (tha). 2. patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis. 3. patient whose age is 20 or over. 4. patient who signed an institutional review board (irb)-approved, study specific informed patient consent form. 5. patient who is willing and able to comply with postoperative scheduled evaluations. exclusion criteria: 1. patient who has a bacterial infectious disease or has a high risk of a bacterial infection. 2. patient who requires revision surgery of a previously implanted total hip arthroplasty. 3. patient who is morbidly obese, defined as having a body mass index (bmi) \> 40. 4. patient who is or may be pregnant female. 5. patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 6. patient with diagnosed systemic disease (i.e. paget's disease, renal osteodystrophy), which limits ability to evaluate the safety and efficacy of the device. 7. patient who is immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device. 8. patients who is judged ineligible with specific reason by primary doctor.
validation of patient reported outcome measures for use in vulvodynia

Conditions: Vulvodynia

Summary: the overall aim of this project is to demonstrate content validity and usability of the modified vulvar pain assessment questionnaire (mvpaq), the modified female sexual function index (mfsfi), and pain on intercourse numeric rating scale (nrs) for adult patients with vulvodynia


Eligibility criteria:
inclusion criteria: * fluent in understanding, speaking and reading us-english * have vulvodynia with pain for at least 6 months exclusion criteria: * clinically significant history of alcohol/drug abuse or dependence within the last 2 years
long-term effectiveness study on cholesterol-reducing activity

Conditions: Normal and Mild Hypercholesterolemic Subjects

Summary: the purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (ldl-cholesterol) concentration during 12 weeks of product consumption.


Eligibility criteria:
inclusion criteria: 1. subject with total cholesterol plasma level between 200 mg/dl to 240 mg/dl; and ldl-cholesterol between 120 mg/dl to 160 mg/dl. 2. subject aged from 20 to 65 years (bounds included) 3. subject with bmi between 19 - 30 kg/m² (bounds included) 4. subject with triglycerides under 400 mg/dl (4.6 mmol/l) 5. non diabetic subjects (bs≤125 mg/dl) 6. non hypertensive subjects (sbp\<140mmhg and dbp\<90 mmhg) 7. subject accepting to follow the dietary recommendations advisable for hypercholesterolemic 8. subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period 9. subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study exclusion criteria: 1. subject currently involved in a clinical trial. 2. subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 fa, fibrates) 3. subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study. 4. for female subject: pregnancy or intention to be pregnant during the study. 5. for female subject: breast feeding. 6. subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products. 7. subject having lactose intolerance. 8. subjects having sitosterolemia 9. diabetic subject (type i and type ii) 10. subject with heavy alcohol intake (\>60g/day) 11. subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 12. subject receiving a transplant or under immunosuppressor treatment 13. subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 14. subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months 15. subject deemed unsuitable by the investigator.

Keywords: plant sterol - hypercholesterolemia - diet - dairy
verbal cueing vs constraint-led approach for teaching the kettlebell swing

Conditions: Movement Disorders; Muscle Tenderness

Summary: the purpose of this study is to determine which method is most effective for teaching the kettlebell swing: verbal cueing, physical constraints, or a combination of the two.

there is a method of teaching and learning movement and exercise skills known as the constraint-led approach. this method of movement learning has the learner exploring and experimenting different variations of an exercise by self-organizing around a set of given constraints of the individual, environment and task. individual constraints are qualities about the person performing the task such as their arm length and height. environmental constraints regard the environment where the task is being performed and include factors such as lighting and temperature. finally, the task constraints are qualities about the movement and exercises being performed such as asking someone to do a half squat onto a box instead of a full bodyweight squat in the air. this constraints way of teaching movement has the movement educator as a guide or architect that shapes the qualities of the task the learner must navigate. the kettlebell swing was chosen as the primary exercise for this study due to its efficacy and practicality as a functional movement pattern. current literature suggests that kettlebell swings may elicit an increase in strength measured in the form of a deadlift exercise, which may have carry over to activities of daily living, such as bending over to lift a box with proper form. in a 2016 study, edinborough et al. examined the proposed implications that repeated kettlebell swings could be used as a practical tool to increase endurance capacity of the lumbar extensor complex. the investigators of this study found that after a 60 second bout of continuous kettlebell swings, participants demonstrated a reduction in isometric strength, demonstrating fatigue of this musculature. the implications of this study suggest that kettlebell swings may increase the fatigue threshold of the lumbar extensor musculature, which may provide protective measures regarding the development of musculoskeletal conditions such as low back pain, as a decrease in activation of these associated muscles may be apparent during periods of fatigue.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 18 and 55 years. * subjective rating of 3/5 or less on confidence with kettlebell swings. exclusion criteria: * inability to read and write in english. * previous injury to the lower extremity that prevents normal squatting motion. * physical activity readiness questionnaire suggesting inability to safely participate in exercise.
how does orthognathic surgery affect jaw and neck motor function?

Conditions: Cleft Lip and Palate

Summary: in a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (emg) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. the results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. we will have blinded evaluation of outcomes.

consecutive patients referred to department of oral and maxillofacial surgery, umeå university hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. expected number of patients: 20 - 25 patients annually. blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.

Eligibility criteria:
inclusion criterias: * patients accepted for orthognathic surgery due to jaw discrepancies. * patients given their consent for participation exclusion criterias: * patients with syndromes * patients not given their consent for participation * patients unable to follow instructions due to lack of knowledge in swedish and/or english language

Keywords: orthognathic surgery cleft lip and palate
musical engagement of brain lobes in alzheimer's disease patients study

Conditions: Alzheimer Disease; Dementia; Music Therapy

Summary: this is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe alzheimer's disease when exposed to emotionally impactful music compared to control intervention.

in partnership with the study partner (a person who spends 10 hours or more a week with the subject and can reliably report on the subject's condition), three tunes will be chosen for the purposes of the study. the tunes chosen will need to be related to a past meaningful, positive experience of the subject, as determined by the subject and the subject's study partner. the pieces will be restricted in duration to between 1.5 and 2 minutes each. a piece will be chosen at random and will be saved on a portable device, and subjects will be asked to listen to the melody using high quality, over-ear headphones. the total exposure time will be 10 minutes each hour over a three-hour period. the melody will be repeated as many times as necessary to complete the 10-minute period. the control intervention will involve listening to nature sounds at the same duration and administration scheme. functional magnetic resonance imaging will be used to identify how brain networks are modulated via exposure to this music and how they associate with the clinical findings.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * person of any sex/gender aged between 55 and 90 * stated willingness to comply with all study procedures and availability for the duration of the study * in the opinion of the investigator, has an informant able and willing to provide accurate information about the participant (may be paid or unpaid caregiver) * suffer from moderate to severe alzheimer's disease as established by the study team using the national institute of neurological and communicative diseases and stroke/alzheimer's disease and related disorders association (nincds-adrda) alzheimer's criteria for possible and probable alzheimer's disease * diagnosis of alzheimer's disease or other type of dementia as defined by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) * mini mental state examination (mmse) score of 5-20 * subject is reported by the study partner to be able to listen to a minimum of 10 minutes of music and a sound in an uninterrupted manner. exclusion criteria: * suffer from severe hearing impairment as reported by the informant * presence of neuropsychiatric symptoms of dementia as determined by clinical observation by the principal investigator, including history of agitation and/or combative behavior. * individuals who score ≥ 12 seconds on the timed up and go (tug) test.

Keywords: dementia alzheimer disease brain stimulation music
bronchopulmonary pk of at-527 (r07496998)

Conditions: Healthy Volunteer Study

Summary: this study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (pk) of at-527 (r07496998)


Eligibility criteria:
inclusion criteria: * subjects must agree to use birth control, as required by the protocol. * females must have a negative pregnancy test at screening and prior to dosing * minimum body weight of 50 kg and body mass index (bmi) of 18-29 kg/m2 * willing to comply with the study requirements and to provide written informed consent exclusion criteria: * infected with hepatitis b virus, hepatitis c virus, hiv or sars-cov-2 * abuse of alcohol or drugs * use of other investigational drugs within 28 days of dosing * concomitant use of prescription medications, or systemic over-the-counter medications * other clinically significant medical conditions or laboratory abnormalities
observational study: hetrombopag for platelet recovery in haploidentical hsct

Conditions: Thalassemia in Children

Summary: the objective of this observational study is to investigate the long-term effects of hetrombopag in promoting platelet engraftment during haploidentical hematopoietic stem cell transplantation (hsct) in children with thalassemia, with a specific focus on a 28-day time window post-transplantation. the core question to be addressed is: is hetrombopag safe and effective for platelet engraftment in children with thalassemia undergoing haploidentical hsct within a 28-day post-transplant period? subjects who received hetrombopag as part of routine care for haploidentical hsct in children with thalassemia will be required to complete a 28-day online survey on platelet engraftment outcomes.

allogeneic hematopoietic stem cell transplantation (allo-hsct) remains a critical and often the sole curative modality for diverse hematological malignancies and disorders. post-transplant thrombocytopenia (platelet count \<20×10⁹/l) significantly compromises long-term patient survival, with an incidence of 5-20% in allo-hsct recipients, thereby escalating treatment morbidity and costs. current research on platelet engraftment promotion in pediatric thalassemia patients undergoing allo-hsct is limited. repeated platelet transfusions are associated with substantial complications, including transfusion reactions, platelet alloimmunization, and transfusion-transmitted viral infections. eltrombopag, a thrombopoietin receptor agonist (tpo-ra), carries a black-box warning for hepatotoxicity, with a real-world incidence of 11.8%. transplant recipients frequently experience diarrhea, which impairs the absorption of oral thrombopoietic agents, while daily subcutaneous injections exacerbate pediatric patient discomfort and reduce treatment adherence. in contrast, long-acting tpo-ras administered once post-transplant have demonstrated favorable tolerability and promising efficacy in thalassemia transplant pediatric populations. to date, clinical data on hetrombopag use for platelet recovery in haploidentical hsct for pediatric thalassemia are lacking. therefore, this observational study aims to evaluate the efficacy and safety of hetrombopag in facilitating platelet engraftment during haploidentical hsct in children with thalassemia.

Eligibility criteria:
inclusion criteria: * diagnosed with severe thalassemia via thalassemia gene testing, transfusion history, and complete blood count (cbc). * pediatric patients aged 2-17 years. * consented to haploidentical transplantation and evaluated by the transplant team as having no transplant contraindications. exclusion criteria: * presence of a fully matched donor with refusal of haploidentical transplantation. * donor or recipient with transaminase levels \>2× the upper limit of normal (uln). * positive hepatitis b dna test result. * active infection at the time of enrollment. * donor-specific antibodies (dsa) \>5,000 and unable to decrease below 3,000 after antibody therapy. * presence of transplant contraindications as assessed by the transplant team.

Keywords: thalassemia hsct hetrombopag
efficacy of pulse radiofrequency durations in lumbosacral pain

Conditions: RADICULAR PAIN

Summary: brief summary: this study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (prf) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. the prf procedure will be applied to the dorsal root ganglion (drg) under fluoroscopic guidance.

in this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. after identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. the tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. once the rf cannula is properly positioned, an rf electrode will be inserted through the cannula and connected to the rf generator. the final position of the rf cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 v and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold. in the short-duration prf group, a prf cycle will be applied at 42°c for 240 seconds, while in the long-duration group, it will be applied at 42°c for 480 seconds. following the prf application, epidural spread will be confirmed using contrast dye, after which 4 ml of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.

Eligibility criteria:
inclusion criteria: age ≥ 18 years * pain severity nrs ≥ 4 * pain duration \> 12 weeks refractory to conservative treatments (physical therapy, medical treatments) exclusion criteria malignancy-related pain diagnosis of diabetes mellitus or polyneuropathy back pain more severe than leg pain conditions that impair follow-up (e.g., psychiatric disorders, dementia) patients refusing the procedure

Keywords: radicular pain dorsal root ganglia pulsed radiofrequency
admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients

Conditions: Blood Glucose, High

Summary: in polytrraumatized patients, does hyperglycaemia on admission increase the risk of morbidity and mortality compared to polytraumatised patients with normal blood glucose level ?

trauma is still the leading cause of death in young adults and a major cause of morbidity and mortality at all ages.(1,2). polytrauma is defined as injury to several physical regions or organ systems, where at least one injury or the combination of several injuries are life threatening with the severity of injury being equal or \>16 on the scale of the injury severity score (iss). prediction of mortality in trauma patients is an important part of trauma care (3). the trauma and injury severity score (triss) and acute physiology and chronic health evaluation iv (apache iv) are used commonly to predict injury severity and risk of mortality. although it is regarded as the international standard in trauma scoring, it has complex calculating and incorporates the glasgow coma scale (gcs) for neurological evaluation (4). regardless of the accuracy of trauma scores, is based on an anatomical description of every injury and cannot be assigned to the patients until a full diagnostic procedure has been performed(5) . many studies have revealed alteration in glucose metabolism in trauma and proportional relation of its high level to the degree of injury (6). hyperglycaemia is associated with similar complications as uncontrolled diabetes, including an increased mortality, an increased number of infectious complications, and poor wound healing. the presence of elevated blood glucose also impedes normal host defences against infection and impairs the normal inflammatory response (7.8). * therefore, this study will be conducted to compare between alterations in easy and rapid predictors as glucose level, base deficit and lactate and difficult and slow predictors as triss and apache iv. so, it could be considered an early and easy rapid predictor of outcome .

Eligibility criteria:
inclusion criteria: * • age \>= 18 years * polytrauma iss \>= 18 * recent polytrauma patients who are directly transferred by the ambulance from the scene of accident to assiut university hospital and did not receive resuscitative measurements in another hospital exclusion criteria: * known co-morbidities affecting blood glucose level like : * pregnant women * diabetic patients

Keywords: shock , poly trauma , serum lactate
biventricular versus right ventricular pacing

Conditions: Heart Failure

Summary: the study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (crt) pacing modalities in patients with left ventricular assist devices (lvad). only patients are blinded. this is a small-scale study from which future larger scale randomized controls can be performed. the primary endpoint will be the effect of biv and rv pacing setting on the 6-minute walk test.

heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. cardiac resynchronization therapy (crt) and left ventricular assist devices (lvad) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. however, minimal research documents the utility of these two modalities in unison. there have been recent investigations comparing biventricular (biv) versus right ventricular (rv) pacing suggesting better exercise performance and decreased left ventricular (lv) volumes with rv pacing. this discovery contrasts with prior meta-analysis that reports no difference between lvad patients with and without crt including mortality and hospitalizations. investigators aim to compare biv pacing and rv pacing in lvad patients with crt on patient's exercise tolerance and frequency of tachyarrhythmias. additionally, research is required to form a conclusion on the role of crt in lvad patients.

Eligibility criteria:
inclusion criteria: * patients with both an lvad and crt device with functional leads * age 18 years and older * ability to walk * ability to sign consent exclusion criteria: * patients with permanent atrial fibrillation * patients who are pacemaker dependent * patients with sustained ventricular tachycardia

Keywords: left ventricular assist device (lvad) cardiac resynchronization therapy (crt)