Kornimate/medical-research-clean huggingface dataset:
correlation between clinical assessment and neurophysiological assessment in spinal cord injury

Conditions: Incomplete Spinal Cord Injury; Spastic Tetraplegia; Spastic Paraplegia; Spinal Cord Injury

Summary: this study is a cross-sectional study that aims to explore the correlation between clinical assessment and neurophysiological assessment in sci. the clinical outcome assessment are modified-modified ashworth scale (m-mas) and lower extremity motor score. the neurophysiological outcome is h-reflex outcome.

spinal cord injury (sci) cause disruption of descending control pathway in spinal cord. the disruption of descending control induce impaired motor and sensory function below the level of injury, as well as the electrical signal from supraspinal pathway. during spinal shock phase, spinal motoneuron become hypoexcitability, as resulting in muscle hypotonicity or flaccidity in clinical manifestation. the spinal motoneuron gradually increase during sub-acute to chronic phase as resulting in development of spasticity in sci. development of spasticity is realted to increase of spinal motoneuron excitability, which shown in a decrease in h-reflex latency and increase in hmax/mmax ratio. a previous study shown a medium correlation between hmax/mmax ratio and mas in sci and stroke people. moreover, the mas shown a strong correlation with fugle-meyer score in stroke people. however, it remains unclear in correlation between clinical outcome and neurophysiological outcome assessment of spasticity, and the correlation of spasticity and the motor function in sci. this study aims to explore the correlation between clinical assessment and neurophysiological assessment of spasticity in sci.the clinical outcome assessment are modified-modified ashworth scale (m-mas) and lower extremity motor score (lems). the lower extremity motor score is obtained from american spinal injury association (asia) imapirement scale. the neurophysiological outcome assessment is h-reflex methode. all particiants who will participated into this study will be assessed the m-mas, lems and h-reflex.

Eligibility criteria:
inclusion criteria: * individuals with any level of sci with age between 18-70 years. * onset of injury between 1-30 month. * presentation of h-reflex. exclusion criteria: * having history of other neurological disease e.g. stroke * absent of h-reflex.

Keywords: spinal cord injury h-reflex spasticity
paroxetine-cr to treat post-traumatic stress disorder (ptsd) symptomatic after initial exposure therapy

Conditions: Stress Disorders, Post-Traumatic

Summary: both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for ptsd. however, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. in this study, we will examine the relative efficacy of the addition of paroxetine-cr compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy (cbt).

this is a systematic controlled study examining the use of augmentation with pharmaotherapy for ptsd patients remaining symptomatic despite cbt (exposure therapy). the aims of the study include examination of: (1) the efficacy of paroxetine-cr compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive cbt; (2) the tolerability of paroxetine-cr compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive cbt; (3) the outcome of patients at 6 months follow-up to randomized treatment. patients will initially have intensive (8 sessions over 4 weeks) prolonged exposure therapy. patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-cr (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.

Eligibility criteria:
inclusion criteria: * male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of ptsd as defined by dsm-iv criteria * patients must have remained symptomatic (cgi-s \> or = 3) and a score of at least 6 on the sprint after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment. exclusion criteria: * serious medical illness or instability for which hospitalization may be likely within the next 3 months * pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception * concurrent use of other psychotropic medications * lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder * obsessive-compulsive disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 months * a current primary diagnosis of major depression, dysthymia, social anxiety disorder, and generalized anxiety disorder * a history of hypersensitivity or poor response to paroxetine or those using antidepressants, buspirone, or beta-blockers within 2 weeks of randomization * concurrent dynamic or supportive psychotherapy if started within 2 months prior to onset of study entry

Keywords: ptsd anxiety cbt exposure paroxetine paroxetine-cr
a study of the kinetics of a 13c-cholesterol infusate in healthy male subjects (0000-108)(completed)

Conditions: Dyslipidemia

Summary: this is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of \[13c3,4\]-cholesterol (part i) and to assess the test-retest reproducibility (part ii) of reverse cholesterol transport (rct) measurements. the study will determine whether atom percent enrichment (% ape) at 18 hours can be extrapolated from the steady-state value and whether the mean difference in repeat ra measurements is below is a prespecified level.


Eligibility criteria:
inclusion criteria: * subject is male 18 to 45 years of age at screening * subject has a stable weight (± 2 kg) for more then 6 weeks prior to screening exclusion criteria: * subject has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption * subject has an active or recent (\<2 weeks) gastrointestinal condition (gastroenteritis, diarrhea, chronic constipation, irritable bowl syndrome, etc.) affecting bowel movements * subject has a known allergy to beans, peas, eggs or egg-derived products and/or soy or soy-derived products * subject has a history of plant sterol storage disease (sitosterolemia, cerebrotendinotic xanthomatosis) or a history of intolerance to plant sterols and/or plant sterol containing products * subject has a history of hepatic or gall bladder disease (including gallstones, cholecystectomy, etc.) * subject is currently taking psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (otc) therapies that are known to affect serum lipids * subject has taken lipid-lowering agents within 6 weeks prior to screening * subject has previously been administered an intravenous infusion of \[13c3,4\]-cholesterol
efficacy & tolerance of cosmetic product rv5098a on face pigmentation maintenance in adult vitiligo patients.

Conditions: Vitiligo

Summary: vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient. despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. different treatment strategies could lead to cosmetically acceptable repigmentation (\>75%), particularly on face and neck. however, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment. to date, long-term management remains a challenge. with their topical product rv5098a adapted for patients with vitiligo, pierre fabre laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.


Eligibility criteria:
inclusion criteria: criteria related to the population: - subject aged between 18 and 75 years included. criteria related to the disease: * subject with facial vitiligo, regardless of its duration. * having a sufficient repigmentation rate of the vitiligo after repigmenting treatment criteria related to treatments and/or products: - subject responder to a repigmenting treatment non-inclusion criteria: criteria related to the diseases / skin condition: * subject with active vitiligo. * subject with spontaneous repigmentation without treatment. * subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the investigator hazardous for the subject or incompatible with the study requirements. criteria related to treatments and/or products: * systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study. * any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study. * any other topical or systemic treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy according to the investigator's assessment. * any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.

Keywords: vitiligo adults face repigmented maintenance of repigmentation
biopsychosocial factors' influence on shoulder pain

Conditions: Pain

Summary: the purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability.

the purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability. previous studies have suggested that specific genes influence pain perception. other studies have suggested that specific psychological factors influence pain perception. we plan to investigate both of these factors to see if they contribute to the development of chronic shoulder pain and disability.

Eligibility criteria:
inclusion criteria: * chronic shoulder pain and disability exclusion criteria: * none
full vs partial weightbearing during the first six weeks of rehab. after fibular collateral ligament reconstruction

Conditions: Knee Injuries

Summary: this is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (fcl) reconstruction alone or combined fcl and anterior cruciate ligament (acl) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.

patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: 1. partial weightbearing 2. full controlled weightbearing an immobilizer brace in extension will be used from post-operative day 0 through 13 and a cti ligament knee brace (össur americas, foothill ranch, california) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing. specific aims 1. primary aim: to determine if there is a difference in millimeters of varus gapping on anteroposterior (ap) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. this distance will be compared to varus gapping measured on the contralateral uninjured control knee. 2. secondary aim: to determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups. the investigators hypothesize that there will be no clinically significant difference (\< 2 mm change) in varus gapping between the control and treatment groups. results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis. the current standard of care for fcl reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.

Eligibility criteria:
inclusion criteria: * ≥ 14 years old, \<60 * reconstruction of fcl alone * combined fcl + acl reconstructions * males or females * is willing and able to comply with the clinical trial plan and able to understand and sign the patient informed consent form. exclusion criteria: * \ 60 * pregnant * revision fcl reconstructions * concurrent biceps femoris or lateral capsular repairs * concurrent pcl or mcl reconstructions * concomitant meniscus root or radial repair surgery with transtibial technique

Keywords: fibular collateral ligament (fcl) anterior cruciate ligament (acl)
effects of strict volume control in hypertensive hemodialysis patients on cardiac structure and chronic inflammation

Conditions: End-stage Renal Disease

Summary: this study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume control (by strict dietary salt restriction and persistent ultrafiltration) without using antihypertensive drugs on cardiac structure and inflammation.

this randomised, controlled and prospective study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus persistent strict volume control without using antihypertensive drugs on cardiac structure (mainly left ventricular hypertrophy)and inflammation. we hypothesize that better blood pressure control and regression of left ventricular mass may be reached by a policy of strict volume control consisting of strict dietary salt restriction and persistent ultrafiltration. 258 hypertensive hemodialysis patients (bp\>130/80 mmhg and/or being on antihypertensive medication) will be randomized to two arms: group 1: antihypertensive medicine will be stopped and strict volume control policy will be applied. group 2: antihypertensive medicine will be continued. target bp will be 130/80 mmhg in both groups. the patients will be evaluated at 12 months for primary outcomes. primary end-points are significant changes in left ventricular hypertrophy and left ventricular mass and significant change in left ventricular end-diastolic volume. secondary end-points are changes in post-dialysis weight, changes in hematocrit, albumin, bnp and hscrp levels.

Eligibility criteria:
inclusion criteria: * aged between 18-70 years old * on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week * willingness to participate in the study with a written informed consent. exclusion criteria: * to be scheduled for living donor renal transplantation * to have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating

Keywords: end-stage renal disease hemodialysis volume control ultrafiltration inflammation cardiovascular disease left ventricular hypertrophy dietary salt restriction
a study to characterize the pharmacokinetics of oxycodone in healthy volunteers

Conditions: Pain

Summary: this is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). this study will consist of three parts that will take place over approximately 90 days. part 1 of the study has 4 dosing periods, while parts 2 and 3 have one dosing period each.

this study will estimate the pk and relative ba of oxycodone following single oral 40-mg doses of 3 modified pf-00345439 formulations e, f, and g compared with the reference pf-00345439 formulation a under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between 18 and 55 years of age (inclusive). exclusion criteria: * evidence or history of clinically significant disease. * history of obstructive sleep apnea. * positive urine drug test.

Keywords: pharmacokinetics bioavailability oxycodone.
pivotal response treatment (prt) telemedicine

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to evaluate the application of a modified version of prt designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. the project will feature an 18-week trial of parent training prt via telemedicine in 12 cognitively able 3- to 6-year-old children with asd. intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

the purpose of this study is to evaluate the application of a modified version of prt designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. the project will feature an 18-week trial of parent training prt via telemedicine in 12 cognitively able 3- to 6-year-old children with asd. intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Eligibility criteria:
inclusion criteria: * fits age requirement: age 3-6 years * have been diagnosed previously with asd and meet criteria for asd when characterized by research team. * be in good medical health * be cooperative with testing * english is a language spoken in the family * full scale iq \> 70 exclusion criteria: * significant hearing loss or other severe sensory impairment * a fragile health status * a history of significant head trauma or serious brain or psychiatric illness

Keywords: asd
a study of monthly subcutaneous or intravenous mircera in dialysis patients with chronic renal anaemia

Conditions: Anemia

Summary: this open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[mircera\] in dialysis patients with chronic renal anaemia. patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous mircera for 6 months. target sample size is \<200 patients.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * chronic renal anaemia * haemoglobin 10.0-12.0g/dl at screening * adequate iron status * continuous stable esa (erythropoietic stimulating agent) therapy for \>/= 2 months * regular haemodialysis or regular peritoneal dialysis for \>/= 3 months exclusion criteria: * uncontrolled hypertension * haemoglobinopathy * anaemia due to haemolysis * pure red cell aplasia (prca)
clinical study to assess the performance of the dialyzer with endexo™

Conditions: Kidney Failure, Chronic

Summary: endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. the intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with endexo."

this is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (hd). after a screening period, there will be 12 hemodialysis treatments on the optiflux dialyzer (optiflux period), followed by 38 hd treatments on the dialyzer with endexo (endexo period), and then a follow-up visit. the study population will consist of end-stage renal disease esrd subjects who are a minimum of 22 years of age. the primary objective of the study is to collect data on the performance of the dialyzer with endexo when used to perform hemodialysis (hd) in end-stage renal disease (esrd) subjects.

Eligibility criteria:
inclusion criteria: 1. must be an adult, older than 22 years of age. 2. has been prescribed in-center thrice-weekly hd continuously for at least 180 days prior to the date of signed informed consent 3. has been prescribed the optiflux f160nr dialyzer continuously for at least 30 days prior to the date of signed informed consent 4. has a prescribed hd treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours) 5. has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent 6. has a most recent single pool kt/v (spkt/v) ≥1.2 within 45 days prior to the date of a signed informed consent 7. has a most recent hemoglobin ≥9 g/dl within 45 days prior to the date of a signed informed consent 8. has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent 9. a female of childbearing potential must have a negative serum pregnancy test at the time of screening and agree to use an acceptable method of contraception during the study exclusion criteria: 1. use of citric acid concentrate (such as citrasate®) at the time of signed informed consent 2. known allergic reactions to endexo 3. hospitalization within 30 days prior to the date of signed informed consent 4. presence of active malignancy, congestive heart failure new york heart association (nyha) class iii or iv, or liver cirrhosis 5. are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent 6. are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent 7. are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent 8. has a life expectancy of less than 1 year