Kornimate/medical-research-clean huggingface dataset:
effect of aerobic exercise versus resistance exercise on bone density in postmenopausal diabetic women

Conditions: Osteoporosis

Summary: osteoporosis is a significant public health issue, especially among postmenopausal women with diabetes, and its prevalence is increasing. this trial aims to determine the influence of moderate intensity aerobic exercise vs resistance exercise on bone mineral density among postmenopausal diabetic women.

has diabetes. postmenopausal osteoporosis (pmo) is an increasingly serious metabolic bone disease in the world, which generally develops in middle-aged and elderly women and postmenopausal women, and it is characterized by low bone mass and microstructure degradation of bone tissues. there are complex pathophysiological effects between them: t2d directly affects bone metabolism and strength. some antidiabetic drugs affect bone metabolism, and diabetes complications are related to the risk of falls and subsequent fractures. patients with t2d have higher trabecular and lower cortical bone density, leading to lower bone intensity. exercise is considered a highly relevant component in the prevention and treatment of osteoporosis and fracture reduction. exercise greatly affects bone geometry as it increases periosteal apposition through increasing osteoblast formation. in addition to influencing bone mineral density, exercise can improve muscle function to potentially decrease fall risk through improved balance and strength. the purpose of this study was to investigate the effect of moderate-intensity aerobic exercise versus resistance exercise on bone mineral density in postmenopausal diabetic women.

Eligibility criteria:
inclusion criteria: * fifty women postmenopausal obese women * (bmi) 30 -35 kg/m2 * their age ranges from 50 to 60 years old and * complain of diabetic type 2 for 10 years ago. exclusion criteria: * women with renal or liver disease, * cardiac or chest disease psychological problems, * cognitive problems are excluded from the study. * any women who have therapeutic problems that will interfere with performing exercise or affection bmd will be excluded from this study.
effect of high protein diet in stroke patients with low muscle mass

Conditions: Ischemic Stroke; Diet, Healthy; Muscle Loss

Summary: our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and blood urea nitrogen/cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. however, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient. our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (cer), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. an animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. a study also showed that high protein intake was associated with a better outcome in previous cardiovascular events. we will calculate cer based on published equation. based on our prior study, acute stroke patients with their cer\<1500 mg/day will be enrolled. a randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. we plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. we will consult dietitians for arrangement of their diet. we assume that patients receiving high protein diet will have higher opportunity to walk independently (modified rankin scale 0-1) at 3 month after stroke.


Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke during hospitalization 2. egfr \>30 3. urine albumin creatinine ratio \< 30 mg/g 4. urinary creatinine excretion rate (cer) \< 1500g/day exclusion criteria: 1. chronic kidney disease stage 4 or 5 (i.e. egfr \< 30) 2. proteinuria (protein 1+ or more in urine routine) 3. known impairment of functional status (mrs ≥ 2) prior to the index stroke 4. refuse to participate in this study.
a trial to evaluate the effect of c21 on endothelial dysfunction in subjects with type 2 diabetes

Conditions: Type2diabetes; Endothelial Dysfunction

Summary: this trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of c21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * male or female patient aged ≥ 40 years at the time of the screening visit (visit 1). * documented diagnosed with t2dm prior to the screening visit (visit 1). * an rhi score ≤ 2 as assessed by endopat at the time of the screening visit (visit 1). exclusion criteria: * known, active hepatitis b, c, or human immunodeficiency virus (hiv) infection (i.e., hiv with a cd4 (cluster of differentiation 4) count \<500 cells/mm³). * impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial. * severe renal impairment (i.e., estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73 m2). * prolonged qtcf (qt interval with fridericia's correction) (\>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ecg (electrocardiogram) at screening (visit 1), as judged by the investigator. * unstable or deteriorating cardiac condition. * malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade i.
a study of enzastaurin in participants with follicular lymphoma

Conditions: Lymphoma, Follicular

Summary: to evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in participants with follicular lymphoma (fl).


Eligibility criteria:
inclusion criteria: all participants must: 1. have had a histologically confirmed diagnosis of grade 1 or 2 fl, according to world health organization classification (harris et al. 1999), at the original time of diagnosis. pathology must be confirmed locally prior to enrollment at the investigational site. 2. have ann arbor stage iii or iv disease. 3. must be chemo-naive or have relapsed disease after receiving only one prior chemotherapy regimen. the chemotherapy must have been completed at least 6 months prior to first dose of study treatment. relapse after one prior course of single-agent rituximab treatment (in the chemo-naive setting) is also allowed if completed at least 6 months prior to first dose of study treatment. 4. participants must not require cytoreductive therapy for at least 3 months from first dose of study treatment, in the opinion of the investigator. 5. previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). prior radiotherapy must be completed 30 days before study entry. lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. exclusion criteria: participants will be excluded from the study if they meet any of the following criteria: 1. are unable to swallow tablets. 2. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin. 3. are receiving concurrent administration of any other antitumor therapy. 4. are pregnant or breastfeeding. 5. have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
augmenting antidepressant treatment with interpersonal psychotherapy for treating late-life depression

Conditions: Depression

Summary: this study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.

the purpose of this research study is to learn if adding psychotherapy (interpersonal psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. participation in the study will last up to 22 weeks. because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. we will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus interpersonal psychotherapy (ipt, 16 sessions). changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. this study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery. for information on related studies, please follow these links: http://clinicaltrials.gov/show/nct00178035 http://clinicaltrials.gov/show/nct00178074

Eligibility criteria:
inclusion criteria: * diagnosis of unipolar major depression * hamilton rating scale for depression (hrsd) (17 item) score of 15 or higher * speaks english * willing to discontinue other psychotropic medications * availability of family member or other caregiver * hearing capacity adequate to respond to a raised conversational voice exclusion criteria: * lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any psychotic disorder * folstein mini-mental status exam (mmse) of 17 or lower * suicidal * history of treatment non-adherence in other center protocols * history of documented non-response to citalopram in other center protocols * history of non-tolerance to escitalopram therapy

Keywords: elderly remission escitalopram interpersonal psychotherapy psychotherapy caregiving late-life
a smart design to improve sleep disturbance in adolescents with neurodevelopmental disorders

Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Sleep Disturbance

Summary: the objective of this k01 study was to pilot a sequential, multiple assignment, randomized trial (smart) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (ndds).

the investigators conducted a sequential, multiple assignment, randomized trial (smart) pilot feasibility study to inform implementation of a future full-scale smart design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (the bedtime bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (ndds). participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or the bedtime bank. response (\>/= 18 minute average nightly increase in total sleep time \[tst\]) was measured at week 4 and week 8. participants who responded (\>/= 18 minute average nightly increase in tst) at week 4 remained on the assigned intervention. participants who were non-responsive at week 4 were re-randomized to a different sleep intervention or combined interventions.

Eligibility criteria:
inclusion criteria: * age 10-18 years and consistently living with parental (or legal guardian) supervision. * diagnostic report of confirmed ndd diagnosis (asd or adhd). * documentation of adolescent being classified as non-intellectually impaired (e.g. iq\>70). * parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the children's sleep habits questionnaire. * medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation. exclusion criteria: * unwillingness to stop melatonin 2 months prior to enrollment in the study. * parent report of adolescent with a known sleep disorder (e.g. sleep apnea). * adolescents who are not able to take oral medication. * adolescents who are visually impaired with known inability to detect light. * adolescents with an ndd with known genetic etiology (e.g. angelman syndrome). * unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.

Keywords: autism spectrum disorder attention deficit hyperactivity disorder sleep disturbance melatonin asd adhd
a study to examine the safety, tolerability and pharmacokinetics of pf-04958242 in psychiatrically stable subjects with schizophrenia

Conditions: Schizophrenia

Summary: to evaluate the safety and tolerability of multiple, ascending doses of pf-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * psychiatrically stable subjects with schizophrenia * evidence of stable schizophrenia symptomatology ≥ 3 months * score on mccb letter-number span + spatial span subtest \< 40. exclusion criteria: * history of seizures or of a condition with risk of seizures * history of abnormal eeg. * pregnant or nursing females, and women of child bearing potential

Keywords: pf-04958242 multiple dose safety schizophrenia
effects of robot-assisted gait training in patients burn injury on lower extremity

Conditions: Burns; Gait Disorder, Sensorimotor

Summary: gait enables individuals to move forward and is considered a natural skill. however, gait disturbances are very common in patients with burn injury. major causes of functional impairment are pain and joint contractures. recent studies focused on the application of robot-assisted gait training (ragt). this study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after ragt on patients with lower extremity burn.

this study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after ragt on patients with lower extremity burn. 20 patients with burn were randomly divided into 2 groups. ragt group received ragt 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. subar® (cretem, korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. the conventional group underwent conventional physical therapy twice a day, 5 times a week in 12 weeks. main outcomes were functional ambulatory category(fac), 6 minutes walking test(6mwt), visual analogue scale(vas), isometric forces of bilateral knee and ankle muscles, and foot pressure analysis before and after 12 weeks training.

Eligibility criteria:
inclusion criteria: * patients with full or virtually full thickness involvement of \>50% on the body surface area of the lower extremity * age \> 18 years * with ≤1 functional ambulation category (fac) score ≤ 3 exclusion criteria: * patients with cognitive disorders before burn * serious cardiac dysfunction * problems with weight bearing due to unstable fractures * body weight ≥100 kg * severe fixed contracture * skin disorders that could be worsened by ragt and conventional rehabilitation * patients with severe pain who were unable to undergo conventional rehabilitation programs.

Keywords: burns rehabilitation robot assisted gait training
outcomes of different thyroid resections for multinodular non-toxic goiter

Conditions: Goiter

Summary: the aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.

the extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. on the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, graves disease and multinodular goiter. recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. this common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.

Eligibility criteria:
inclusion criterion * a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes. exclusion criteria: * multinodular goiter involving posterior aspect/s of thyroid lobe/s, * suspicion of thyroid cancer, * previous thyroid surgery, * thyroiditis, * subclinical or clinically overt hypothyroidism or hyperthyroidism, * pregnancy or lactation, * age \ 65 years, * asa 4 grade (american society of anesthesiology), * inability to comply with the follow-up protocol.

Keywords: total thyroidectomy subtotal thyroidectomy dunhill operation recurrent nodular goiter completion thyroidectomy recurrent laryngeal nerve palsy hypoparathyroidism following thyroidectomy recurrent goiter
the earlens contact hearing device (chd) spectrum study

Conditions: Hearing Loss, Sensorineural

Summary: the earlens system is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. the purpose of the proposed study (extended investigation under the continued access policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the fda.

the study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. a subset of relevant safety and efficacy measures from the definitive study (den150002) will be collected and adverse events will be tracked and reported per applicable regulations.

Eligibility criteria:
inclusion criteria: 1. age 18 to 85 years. 2. mild to severe hearing impairment between 125 to 8000 hz. 3. asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by mri. 4. no significant conductive hearing impairment; * no more than a 10 db air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 hz) * normal type a tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones) 5. greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification; 6. able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions 7. experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids; 8. fluent speaker of american english due to use of american english study materials exclusion criteria: 1. the subject must not have known or active medical issues that would preclude having a hearing device, including: * an abnormal tm (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal); * an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes; * an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane. * an anatomical configuration of the external auditory canal that prevents satisfactory placement of the tmt * a history of chronic and recurrent ear infections in the past 24 months; * a rapidly progressive or fluctuating hearing impairment; * diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years. 2. must not fit the definition of a vulnerable subject, as per fda regulations 21 cfr parts 50 and 56
a clinical investigation of the oxford® meniscal unicompartmental knee system

Conditions: Osteoarthritis; Avascular Necrosis

Summary: the purpose of this study is to collect information on complications and survivorship of patients implanted with the oxford™ meniscal unicompartmental knee system at multiple sites in the united states.

study objective to provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the oxford™ meniscal unicompartmental knee system at multiple sites in the united states. study design the study is designed as a prospective, multi-center, non-randomized post approval study. there are two phases to this study: 1. a complications study where patients will be followed for at least 2 years to record all complications that may occur, and 2. a survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason. phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. information gathered in phase 1 includes all adverse events and survival data. phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.

Eligibility criteria:
inclusion criteria: * patients with one of the following diagnoses in the medial compartment of the knee: osteoarthritis, avascular necrosis exclusion criteria: * patients with rheumatoid arthritis or other forms of inflammatory joint disease * patients with infection, sepsis, and osteomyelitis * patients with osteoporosis, paget's disease, charcot's disease, osteomalacia, and severe osteoporosis

Keywords: unicompartmental knee partial knee knee arthroplasty