Kornimate/medical-research-clean huggingface dataset:
study to assess bmd and bone turnover response to 5 mg daily risedronate treatment in women with pmo

Conditions: Postmenopausal Osteoporosis

Summary: a 2-year, multicenter, open-label, phase iiib extension study to assess bone mineral density and bone turnover response to 5 mg daily risedronate treatment in women with postmenopausal osteoporosis who sequentially completed clinical studies rve009093, rve1996077, rve1998080, and rve2001079 (nct01249261)

a 2-year, multicenter, open-label, phase iiib extension study to assess bone mineral density and bone turnover response to 5 mg daily risedronate treatment in women with postmenopausal osteoporosis who sequentially completed clinical studies rve009093, rve1996077, rve1998080, and rve2001079 (nct01249261)

Eligibility criteria:
inclusion criteria: * have satisfactorily completed clinical study rve2001079 (year 8 extension study) exclusion criteria: * can not use any bone modifying substances except risedronate
study of changes in hepatic fat following administration of mk-4074 and pioglitazone hydrochloride (mk-4074-008)

Conditions: Non-alcoholic Fatty Liver Disease

Summary: this study will evaluate changes in liver fat content following multiple oral doses of mk-4074 and pioglitazone hydrochloride in adult males and females with fatty liver disease. the primary hypothesis of the study is that a multiple-dose administration of mk-4074 200 mg twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction in hepatic fat with respect to placebo is expected).


Eligibility criteria:
inclusion criteria: * females must be of non-childbearing potential * body mass index (bmi) ≥32.0 kg/m\^2 * in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests * no clinically significant abnormality on electrocardiogram * has documented hepatic fat content ≥10% within 6 months of enrollment * maintained stable weight (by history) for at least 4 weeks * agrees not to initiate a weight loss program and agrees to maintain consistent dietary habits and exercise routines for the duration of the study * has a rating of 'moderate' or 'severe' steatosis on ultrasound at the prestudy (screening) visit exclusion criteria: * change in weight greater than 4% between prestudy visit and randomization into the study * history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant * liver disease other than fatty liver or non-alcoholic steatohepatitis (nash) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥3x the upper limit of normal range * serum triglyceride level \>600 mg/dl * history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal, cardiovascular (including congestive heart failure), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * had abdominal surgery, gastric bypass, bowel resection, recent liver biopsy, or any other procedure within a minimum of 4 weeks * history of neoplastic disease * claustrophobia or other contraindication to magnetic resonance imaging (mri) * have not washed off agents associated with changes in hepatic fat or used for treatment of non-alcoholic fatty liver disease (nafld) or nash for a minimum of 3 months prior * consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages * had major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks * significant multiple and/or severe allergies * intolerance or hypersensitivity to pioglitazone hydrochloride or any inactive ingredients * regular user of any illicit drugs or has a history of drug (including alcohol) abuse.
pedicle screw usage in conventional fixation pattern constructs compared to thoracic hook constructs in scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: scoliosis is a deformity in which there is an abnormal curvature of the spine. surgery is the main method of correcting this deformity. rods are attached to the spine to make it strait. there are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle screws. hooks are an older form of fixation and do not penetrate the bone, but are instead placed over a part of the vertebra called the lamina. screws are newer and do penetrate the bone. screws are placed into the part of the vertebra called the pedicle. most surgeons think screws correct scoliosis better than hooks. the current literature agrees that screws are better for deformity correction in the lumbar spine and patients with severe deformity. there is disagreement in the literature regarding which works better in the thoracic spine in less severe deformity. there are no randomized, controlled trials in the literature that examine whether constructs that use hooks in the thoracic spine and screws in the lumbar spine (called hybrid constructs) work as well as all-screw constructs. this clinical study is a randomized controlled trial being conducted to evaluate treatment outcomes in patients with scoliosis undergoing surgical correction for their curves using either all-screw or hybrid constructs as fixation devices. the study population is limited to those with less severe deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable as screws in terms of correction.


Eligibility criteria:
inclusion criteria: * primary diagnosis of adolescent idiopathic scoliosis or neuromuscular scoliosis * fusion to include six of more levels in thoracic, thoracolumbar, or lumbar region * less than 21 years of age * able to undergo surgery based on physical exam, medical history, and surgeon judgement * willing to comply with the follow-up clinical and radiographic evaluation schedules * informed consent signed by patient and parent or legal guardian exclusion criteria: * scoliosis with curvature greater than 100 degrees or less than 40 * smaller juvenile subjects weighing less than 30 kg * rigid curves * infection in the disc or spine, past or present * subject is pregnant * evidence of abuse of alcohol and/or illicit drugs * subject is prisoner * subject has evidence of tumor(s), malignant disease or other significant illness with decreased life expectancy * subject is immunocompromised or being treated with immunosuppressive agents

Keywords: randomized controlled hooks screws
fes vs constrained induced mt recovery and spasticity in upper limb hemiparetic ischemic patients

Conditions: Stroke

Summary: to determines the effects of functional electrical stimulation versus constrained induced movement therapy for motor recovery and spasticity in upper limb hemiparetic chronic ischemic stroke patients


Eligibility criteria:
inclusion criteria: clinically diagnosed chronic ischemic stroke patients. patients from both genders age 45 year and older. patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale. patients having active cognitive scoring on mini mental state examination. exclusion criteria: having pacemaker and other stimulation devices. prosthesis of bones, joints in targeted region of treatment. patients presenting the history of recurrent stroke. patients having history of bilateral hemiparesis. co-morbid history of tumor, heart disease, hypertensive. patients presenting with skin lesions, wounds, discoloration will be excluded from this research.
learning curve of vl for intubation during cpr

Conditions: Cardiopulmonary Arrest

Summary: this is a clinical study based on analysis of video-clip data of endotracheal intubation (eti) using videolaryngoscope (vl) and clinical data for cardiopulmonary resuscitation patients between 2012.03.01.-2015.02.28. the purpose of this study is to evaluate the appropriate numbers of vl usages for successful eti at first attempt during cardiopulmonary resuscitation.

direct layngoscope (dl) is a basic tool for endotracheal intubation(eti) during cardiopulmonary resuscitation(cpr). eti during cpr has higher risks of failure or delayed success with frequent attempts, misplacement of the tube, and prolonged interruptions of chest compressions. the main problems associated with eti relate to the inherently technical difficulty in using dl. vl have various advantages of fast learning curve and overall success comparing with the dl in non-arrest patients, but there was no known data of learnig curve of successful eti during cpr. this study tried to estimate the the appropriate numbers of vl usage for successful eti at first attempt during cpr. so the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of eti using vl which in real clinical setting. in addition, this study analyze the residency training term, total number of of vl usage using vl at that time.

Eligibility criteria:
inclusion criteria: * patients who suffer sudden cardiac arrest and physician tried ti intubate using viseolaryngoscope. exclusion criteria: * case of requesting the do-not-attempt resuscitation befor eti * intubated cases before arrival to emergency department * physician tried ti intubate using direct-laryngoscope

Keywords: intubation cardiopulmonary resuscitation learning curve videolaryngoscope
genetics of hyperuricemia therapy in hmong

Conditions: Hyperuricemia, Gout

Summary: to pursue this objective, we will be measuring uric acid at baseline and post 14 days of twice daily allopurinol therapy in 30 hmong participants with documented gout or hyperuricemia and known genotype for key renal transporters of uric acid.

minnesota hmong are a unique population of individuals of south east asian descent who have been noted to have a higher prevalence of gout and gout related comorbidities compared to non-hmong. elevated levels of uric acid are thought to be at the root cause of gout. elevated levels of serum uric acid can result from either overproduction and or under-excretion. xanthine oxidase plays a key role in the breakdown of purines to form uric acid. transporters in the kidney also play a key role in excretion and/or re-absorption of uric acid. the objective of this study is to explore whether genetic variations in renal transporters may influence the disposition of serum uric acid in response to a drug (allopurinol) as well as the disposition of its active metabolite (oxipurinol) which may also be a substrate for these same transporters responsible for uric acid disposition. genetic variations unique to the hmong population may explain their increased prevalence in gout and or perceived lack of responsiveness to the drug (allopurinol) used to treat the condition.

Eligibility criteria:
inclusion criteria: * both parents are hmong (self report) * self report history of gout, or * history (within one year) of active use of xanthine oxidase inhibitors, or * evidence of serum uric acid ≥ 6mg/dl , or * serum uric acid \< 6mg/dl with history of ≥ 2 gout episodes within the last 6 months * ability to provide informed consent for participation in the study * demonstrate understanding of the study procedures and ability to comply with the study drug for the entire length of the study * ability to obtain permission from treating clinician to allow stopping the drug for 10 days exclusion criteria: * pregnant women or women of childbearing age sexually active and not using any contraception * estimated creatinine clearance (ecrcl) \<30ml/min * elevated liver enzymes (3 x upper normal limit of liver function tests (ast and alt)) * contraindication to receiving allopurinol * active participation in other clinical trial (or within 30 days)
preemptive resuscitation for eradication of septic shock

Conditions: Sepsis; Severe Sepsis

Summary: the purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.

sepsis is a challenging and elusive entity with a high mortality rate. as a syndrome, clinicians are challenged to distinguish individuals with systemic infection warranting further interventions from lower severity patients. sepsis is now recognized as a time-sensitive emergency, as patients stand the best chance for survival when effective therapeutic interventions are delivered as early as possible. recent data has shown that in-hospital disease progression from sepsis to septic shock is associated with a higher risk of morbidity and mortality than those with shock on initial presentation. yet, even when identified and treated with early aggressive interventions, the development of septic shock is still associated with a mortality rate of 25-40%. although the presence of sustained arterial hypotension or serum lactate elevation (\>4.0 mmol/l) are the currently recommended threshold to define the presence of overt shock and the need for aggressive resuscitation, the investigators have shown that, in patients with systemic infection, a moderate lactate elevation (2.0-3.9 mmol/l) is a common occurrence and an important warning sign for the increased risk of disease progression and death. sepsis with an elevated lactate between 2.0-3.9, referred to as the "pre-shock" state, identifies this population of patients at-risk for poor outcome. current guidelines for sepsis management do not recommend any specific resuscitation measures or therapies for this at-risk population. this study marks the first in a series of investigations addressing the pre-shock population to further define the adverse events within this cohort and to investigate novel interventions to improve outcomes. the investigators hypothesize that an early quantitative resuscitation strategy using a protocol-directed iv fluid resuscitation will result in a significant reduction in the development of worsening organ failure (including shock) and mortality compared to standard care.

Eligibility criteria:
inclusion criteria: * emergency department patient with suspected or confirmed infection as primary reason for admission * serum venous lactate 2.0 - 3.9 mmol/l * hospital admission planned exclusion criteria: * age \< 18 years * pregnancy * serum lactate ≥ 4.0 mmol/l * any vasopressor or inotrope requirement * mechanical ventilation or non-invasive positive pressure ventilation * chronic end-stage renal disease requiring hemodialysis * pulmonary edema as diagnosed by the primary care team * requirement for surgery within the treatment protocol timeframe * inability to obtain informed consent from subject or surrogate * patient to receive comfort measures only

Keywords: sepsis multiple organ failure resuscitation
caudal combination of dexamethasone and/or dexmedetomidine to bupivacaine in pediatric hypospadias surgery

Conditions: Caudal Block

Summary: one of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. its main disadvantage remains the short duration of action. hence, different additives have been used. dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. the investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

sixty three children scheduled for hypospadias randomized into 3 groups. group i (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group ii(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupiii(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. in pacu, mops scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. also the time of first analgesic request was recorded.

Eligibility criteria:
inclusion criteria: 1 - asa i-ii 2- males only 3- children aged from 1-6 years 4- children scheduled for hypospadias surgery exclusion criteria: 1. contraindication to caudal anesthesia. 2. cardiovascular diseases. 3. drug allergy. 4. type i diabetes. 5. clotting disorders. 6. mentally retarded children or those whose families did not approve inclusion in the study
changes in the tear film with scleral contact lens wear for keratoconic eyes

Conditions: Keratoconus

Summary: the purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.

scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. the use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. these findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.

Eligibility criteria:
inclusion criteria: * had been diagnosed with keratoconus in at least one eye. * is at least 18 years of age and has full legal capacity to volunteer. * has read and understood the information consent letter. * is willing and able to follow instructions and maintain the appointment schedule. exclusion criteria: * is using any topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities and active neovascularization. * is aphakic. * has undergone any corneal surgery. * is participating in any other type of eye related clinical or research study. * has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.

Keywords: scleral contact lens tear proteases tear cytokines
post-operative radiotherapy with cisplatin alone or in combination with iressa in upper aerodigestive tract carcinomas

Conditions: Head and Neck Cancer

Summary: this trial will be an open multicentric randomized phase ii study comparing post-operative radiotherapy + cisplatin associated or not with iressa in upper aerodigestive tract carcinomas.


Eligibility criteria:
inclusion criteria: * patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin. * patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included) * patients receiving post-operative radiation (\>=60 gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest. exclusion criteria: * previous history of cancer (except skin basal cell carcinoma)
improving access to a primary care based positive parenting program

Conditions: Program Implementation; Child Behavior Problem; Positive Parenting

Summary: this is a randomized clinical trial of the impact of incorporating a peer mentor into a primary care based group parenting program on increasing program participation by parents and improving program outcomes.

the investigators will perform a randomized controlled trial of the impact of child adult relationship enhancement (care) plus peer mentor on increasing program adoption, acceptability, and appropriateness among 2-6 year old children and their parents at unc children's primary care clinic. the investigators will also examine the effectiveness of care plus peer mentor on dysfunctional parenting and child behavior problems. participants will be randomized to care plus peer mentor or standard care. program attendance, acceptability, and appropriateness will be measured upon completion of the 6-week program. dysfunctional parenting and child behavior will be measured at baseline and 6 weeks. the investigators will conduct semi-structured interviews among a sample of parents (\~20-30) in order to understand the impact of the peer mentors on program implementation, as well as barriers and facilitators to program initiation and long-term participation.

Eligibility criteria:
inclusion criteria: * 2-6 year old child at unc children's primary care clinic and their parent * english speaking exclusion criteria: * child is developmentally younger than 2 years old * child is already received mental health services for behavioral problems
daily-life brain control of a hand exoskeleton after cervical spinal cord injury

Conditions: Spinal Cord Injury

Summary: in this study, 6 volunteer participants with chronic spinal cord injury will be invited to use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction (bnci) system fusing electroencephalography (eeg) and electrooculography (eog) to detect the intention of the user to grasp objects of daily life. the bnci system consists of a lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a computerized control system integrated into a wheelchair. before, during and after use of the bnci system the volunteers will perform standardized assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. functional outcomes primarily focus on motor function in performing daily life actions while psychological outcomes primarily focus on safety, reliability as well as predisposition and perceptions of disability.


Eligibility criteria:
inclusion criteria: * american spinal injury association (asia) impairment scale (ais) grade a, b \& c (lower extremity motor score \<20) * motor level of injury from cervical level 4 to cervical level 7, according to asia guidelines * male and non-pregnant, non-lactating female * age 15-65 years old * at least 12 months after injury exclusion criteria: * history of severe neurological injuries other than spinal cord injury (e.g. multiple sclerosis, cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury, stroke) * concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study * unstable spine or unhealed limbs or pelvic fractures * severe spasticity (ashworth grade 4; ie. affected part(s) rigid in flexion or extension) or uncontrolled clonus * diagnosis of severe osteoporosis/penia as proven with pqct or dxa. * psychiatric or cognitive conditions that may interfere with the trial * patients incapable of providing informed consent