Kornimate/medical-research-clean huggingface dataset:
effects of physical training on bone and muscle quality, muscle strength, and motor coordination in children with nf1

Conditions: Neurofibromatosis Type 1

Summary: a physical training program will improve quality of life, participation in physical activity, motor coordination, muscle strength, and bone and muscle strength in children with neurofibromatosis type 1.

disorders of the ras pathway have significant phenotypic overlap and include noonan syndrome, cardiofaciocutaneous syndrome (cfc syndrome), legius syndrome, costello syndrome and neurofibromatosis type 1 (nf1). nf1 is one of the most common genetic disorders presenting in childhood with an incidence of 1/3000. nf1 is associated with skeletal abnormalities such as short stature, scoliosis, and long bone fracture with non-union. we recently reported that children with nf1 have abnormalities of bone and muscle architecture as evidenced by decreased bone mineral density, decreased bone strength, and low muscle mass, all of which may predispose them to fractures and scoliosis (stevenson et al., 2005, 2007, 2009). our preliminary data show that children with nf1 have poor motor coordination and muscle strength, potentially secondary to abnormal neuromotor learning. we hypothesize that poor motor coordination and decreased muscle strength contribute to the osteopenia in nf1. our objective is to identify effective and non-invasive strategies to improve motor coordination, muscle strength, and bone and muscle architecture in children with disorders of the ras pathway, in hopes of decreasing fractures and improving physical activity levels. plyometric physical training consists of quick, high-intensity, weight-bearing movements, and is an encouraging intervention for use in these children.

Eligibility criteria:
inclusion criteria: * fulfill nih clinical diagnostic criteria exclusion criteria: * visual impairment * participation in a simultaneous medical intervention trial * orthopedic procedure within the last 6 months. * pregnancy * home location greater than 3-4 hours drive time from shriners hospital * tibial pseudarthrosis

Keywords: neurofibromatosis type 1 nf1
effects of cx516 on functioning in fragile x syndrome and autism

Conditions: Fragile X Syndrome; Autism

Summary: this study will investigate whether cx516 can improve attention, memory, language, or behavior in adults with fragile x syndrome and/or autism. cx516 is an ampakine® compound. ampakine compounds enhance synaptic strength. there is evidence to suggest that the synapses in the brain of an individual with fragile x syndrome are immature and abnormal. it is possible cx516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning. there is also reason to believe that these changes caused by cx516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder. involvement for each participant will last 28 days. participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.


Eligibility criteria:
inclusion criteria: fragile x group * dna-based diagnosis of fragile x syndrome autism group * documented diagnosis with ados; adi-r; cars and gars both groups * 18-50 years * measured iq below 85 * measured iq \>20 * mental age \>30 months * stable medication regimen for past 8 weeks * normal hearing * vision corrected to at least 20/50 * all females of childbearing age must have a negative pregnancy test at enrollment exclusion criteria: * recent history of seizure, epilepsy, or blackouts * unresolved medical issue impacting performance * behavioral dysfunction to the point that subject cannot cooperate for testing * history of drug-induced neutropenia * uncontrolled hypertension

Keywords: fragile x syndrome autism
dalbavancin outpatient pilot

Conditions: Gram-Positive Bacterial Infections; Soft Tissue Infections

Summary: the purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.

a phase 4, single-center, pilot open-label trial assessing the safety and efficacy of dalbavancin in the outpatient therapy of susceptible gram-positive infections requiring prolonged intravenous therapy.

Eligibility criteria:
inclusion * \>=18 years of age * provide informed consent * agreement to attend required follow-up visits with reasonable transportation plan * afebrile for at least 24 hours prior to enrollment * expected survival ≥3 months * if female, non-pregnant and non-lactating; all females of child-bearing potential must have a negative pregnancy test prior to study entry and must agree to use a highly effective method of birth control during the study and for one month thereafter. * anticipated hospital discharge within 8 days * joint and bone infection: * sterile site culture positive for susceptible organism * participants with bacteremia and right-sided infective endocarditis (ie): * 2 or more blood cultures positive for s. aureus (mssa or mrsa or streptococci) * blood cultures negative for 72 hours within 7 days on standard of care antibiotic therapy * definite diagnosis of right sided infective endocarditis by duke criteria * echocardiographic assessment (tte or tee) * for patients with opioid use disorder and history of injection opioid use, * injection of opioid substances (ios) in the last 6 months * fulfill criteria for opioid use disorder exclusion * polymicrobial infection * baseline qtc \>500 msec * creatinine clearance \<30 ml per min * immunocompromised from neutropenia, aids, malignancy, chemotherapy, or receiving immunosuppressant medication including systemic corticosteroids (intranasal or inhaled corticosteroids acceptable) * patients with documented allergies to lipoglycopeptides, vancomycin, or teicoplanin * concurrent diseases that, in the investigator's medical judgment, would interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being * for participants with right-sided ie: * no mitral or aortic valve involvement on echocardiogram * large, mobile vegetations (\>10mm) * perivalvular abscess * presence of an intracardiac device (defibrillator or pacer) or prosthetic valve

Keywords: dalbavacin
insulin resistance and end stage renal disease: the role of retinol binding protein 4

Conditions: Insulin Resistance; Diabetes; End Stage Renal Disease

Summary: the purpose of this study is to determine whether retinol binding protein 4 has a role in insulin resistance development in patients suffering from end stage renal disease on hemodialysis.


Eligibility criteria:
inclusion criteria: * hemodialysis for "end stage renal disease group" * normal renal function for "control group" exclusion criteria: * diabetes * malnutrition * malignancy * acute infection * chronic active infection

Keywords: retinol binding protein 4 insulin resistance diabetes end stage renal disease dialysis nutrition
neovascular age related macular degeneration (amd), periocular corticosteroids, and photodynamic therapy (pdt)

Conditions: Choroidal Neovascularization; Age-Related Macular Degeneration

Summary: randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (pdt) for patients with neovascular age-related macular degeneration (amd). patients undergoing pdt are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to pdt. patients are followed for 6 months. primary outcome is leakage from choroidal neovascularization (cnv) at 3 months on fluorescein angiography.


Eligibility criteria:
inclusion criteria: * active choroidal neovascularization * age related macular degeneration * visual acuity 20/20 to 20/400 exclusion criteria: * neovascular lesion \>6500 microns is greatest linear diameter * more than one prior photodynamic therapy treatment * receiving systemic corticosteroids * intraocular pressure \> 21 mm hg or glaucoma medication use * history of glaucoma or history of ocular hypertension

Keywords: corticosteroids triamcinolone photodynamic therapy choroidal neovascularization age-related macular degeneration
multidisciplinary approach and counseling of the obese patient before and after bariatric surgery

Conditions: Obesity

Summary: the project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different flemish hospitals. these interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. this will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

the project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different flemish hospitals. these interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. we will do a benchmarking and also qualitative analyses of the interviews using nvivo 10. this will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

Eligibility criteria:
inclusion criteria: * all the members of the obesity team should be prepared to participate in the study
vinorelbine plus fluorouracil in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.

objectives: * determine the least toxic time of vinorelbine administration when combined with chronomodulated fluorouracil in women with previously treated metastatic breast cancer. * determine the toxic effects and dose intensities of each drug in these women. outline: this is a randomized, multicenter study. patients are stratified according to prior chemotherapy (second line vs third line) and participating center. patients are randomized to 1 of 8 vinorelbine dosing times (0000, 0300, 0600, 0900, 1200, 1500, 1800, or 2100). patients receive vinorelbine iv over 20 minutes on days 1 and 6 and fluorouracil iv over 12 hours according to a chronomodulated delivery rate (2200 to 1000 with a maximum dose at 0400) on days 1-4. treatment repeats every 3 weeks for at least 3 courses in the absence of unacceptable toxicity. patients are followed for 30 days. projected accrual: a minimum of 80 patients (10 per dosing time) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic breast cancer * at least 1 line of prior chemotherapy for metastatic disease (adjuvant or neoadjuvant chemotherapy is considered first line if completed less than one year prior to palliative chemotherapy) * no cerebral metastases * hormonal receptor status: * not specified patient characteristics: age: * not specified sex: * female menopausal status: * not specified performance status: * who 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm \^3 hepatic: * bilirubin no greater than 2.5 times upper limit of normal (uln) * ast/alt no greater than 2.5 times uln renal: * creatinine no greater than 1.58 mg/dl cardiovascular: * no clinically significant cardiac insufficiency or ischemic disease pulmonary: * no bronchoconstriction other than pulmonary lymphangitis other: * no serious chronic disease * no bowel obstruction * not pregnant or nursing prior concurrent therapy: biologic therapy: * no concurrent immunotherapy * no concurrent prophylactic growth factor chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy * no prior high-dose chemotherapy * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy * no concurrent steroid therapy except in an emergency radiotherapy: * at least 4 weeks since prior radiotherapy (for primary tumor or axillary or mammary chain treatment only) * no concurrent radiotherapy surgery: * not specified other: * no other concurrent antitumor therapy

Keywords: stage iv breast cancer recurrent breast cancer
gait analysis in children with clubfoot treated with tibialis anterior tendon transfer

Conditions: Clubfoot

Summary: patients with clubfoot treated with the ponseti method and undergoing tibialis anterior tendon transfer from a prospective database are evaluated using gait analysis including the oxford foot model and compared to a group of healthy children.

children with dynamic clubfoot recurrence after initial ponseti treatment who underwent tatt between 2014 and 2017 are considered for this study. exclusion criteria are neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad. gait analysis, including the oxford foot model, will be conducted, and the kinematic and kinetic data of the lower extremity will be compared with a group of age-matched healthy children. to comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study. patients will undergo gait analysis, including video recordings with a vicon motion capture system (vicon, oxford, uk) with kinetic data collected from three amti force plates (advanced mechanical technology, inc., watertown, ma). placement of markers will be a combination of cleveland (lower extremity), plugingait (upper body), and oxford foot (movement within the foot) models.

Eligibility criteria:
inclusion criteria: * children with unilateral or bilateral idiopathic clubfoot treated with the ponseti method * full tatt exclusion criteria: * clubfoot associated with syndromes or neurological diseases * initial treatment elsewhere with more than 3 casts * prior joint invasive or bony surgery * split transfer of the tibialis anterior tendon

Keywords: tibialis anterior tendon transfer oxford foot model gait analysis
ketamine combination with spinal morphine for post thoracic surgery pain : a randomized control study

Conditions: Pain; Postoperative Period

Summary: thoracotomy is one of the most painful operation. continuous thoracic epidural or paravertebral analgesia are gold standard for postoperative pain. but both techniques require skills. spinal morphine is alternative simple method with less efficacy. adding low dose ketamine during intraoperative may be helpful in postoperative pain relief.


Eligibility criteria:
inclusion criteria: * asa physical status 1-3 * elective thoracotomy * can operate patient-controlled analgesia (pca) machine exclusion criteria: patient with history of * allergy to morphine or ketamine * contraindicate to ketamine * remain intubated in the postoperative period

Keywords: thoracotomy postoperative pain ketamine
bioavailability study of (buspar) buspirone hcl tablets under fasting and fed conditions

Conditions: To Determine Bioequivalence Under Fed Conditions

Summary: to compare the single-dose bioavailability of par and bristol-myers squibb buspirone hcl tablets

to compare the single-dose bioavailability of par and bristol-myers squibb (buspar) 15 mg buspirone hcl tablets, following administration of a 30 mg dose, under fed conditions. in addition, the bioavailability of the par product was compared under fed and fasting conditions.

Eligibility criteria:
inclusion criteria: * healthy male volunteers, 18-45 years of age * weighing at least 60 kg, who are within 10% of their ideal weights (table of "desirable weights of adults", metropolitan life insurance company, 1983) * physical examination and laboratory tests of hematologic, hepatic and renal functions. * medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. * in addition, the presence of alcoholism or drug abuse within the past year: hypersensitivity or idiosyncratic reaction to buspirone hcl. * subjects who have been receiving monoamine oxidase inhibitors. * subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study. * subjects who, through completion of the study, would have donated in excess of 500 ml blood in 14 days, or 500-750 ml blood in 14 days (unless approved by the principal investigator, 1000 ml blood in 90 days, 1250 ml blood in 120 days, 1500 ml blood in 180 days, 2000 ml blood in 270 days, 2500 ml blood in 1 year. * subjects who have participated in another clinical trial with 28 days of study start.

Keywords: bioequivalence buspirone hcl fed
safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), food-effect of trk-750

Conditions: Healthy, Peripheral Neuropathic Pain

Summary: this is an exploratory, randomised, double-blind, placebo-controlled, phase i study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effect of single and multiple, ascending oral doses of trk-750 in healthy adults and patients with peripheral neuropathic pain.


Eligibility criteria:
inclusion criteria: * male or female volunteers * female subjects who are either: 1. non-childbearing potential, or permanently sterile or 2. childbearing potential and agree to use at least one form of highly effective contraception * male subjects, with a female sexual partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least three months after the end of the systemic exposure of the study drug. * satisfactory medical assessment with no clinically significant or relevant abnormalities. * ability to provide written, personally signed, and dated informed consent. exclusion criteria: * current or recurrent disease * current or relevant history of physical or psychiatric illness * positive test for hepatitis b, hepatitis c or human immunodeficiency virus antibody (hiv) at screening.

Keywords: chronic pain neuropathic pain
pathological type，gene mutation and clinical characteristics of unilateral primary aldosteronism

Conditions: Primary Aldosteronism

Summary: 1. aim to investigate the pathological feature of upa in asians 2. to clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of upa in asians. 3. to explore a new pathological type of unilateral primary aldosterone

the multi-center expert team led by tracy ann williams formulated the international consensus on the pathological diagnosis of unilateral aldehyde disease, which standardized the pathological classification of unilateral pa. the previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. there was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. however, the study was retrospective and there may be inclusion bias. the pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.therefore，this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.

Eligibility criteria:
inclusion criteria: 1. no gender limitation; 2. age 18-80 years old; 3. the patient was diagnosed with upa and underwent total adrenal resection. exclusion criteria: 1. bilateral disease 2. partial of no biochemical response in follow-up 3. partial adrenalectomy

Keywords: pathological type gene mutation
safety and efficacy of heparin dosing score protocol for polymyxin-b hemoperfusion

Conditions: Septic Shock; Polymyxin B Hemoperfusion

Summary: polymyxin b hemoperfusion (pmx-hp) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. we developed a heparin dosing score protocol for heparin dosage adjustment. the purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.


Eligibility criteria:
inclusion criteria: * intra-abdominal septic shock patients or documented gram-negative bacterial septic shock patients who received polymyxin-b hemoperfusion in national taiwan university hospital during october 2013-december 2016 exclusion criteria: * pregnant woman * patients with do-not-resuscitate declaration * uncontrolled bleeding within 24hr
vegf in systemic circulation of rop-infants

Conditions: Retinopathy of Prematurity (ROP)

Summary: the purpose of this study is to measure systemic levels of vascular endothelial growth factor (vegf) and other proteins (e.g. igf-1) in the systemic circulation of infants with retinopathy of prematurity (rop) following ocular treatment with either intravitreal injections of anti-vegf agents or retinal laser photocoagulation. the primary aim is to determine if serum vegf levels change after treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of retinopathy of prematurity requiring treatment exclusion criteria: * anemia
a survey to evaluate diabetes management, control, chronic complications, psychosocial aspects of diabetic subjects in singapore

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate current status of diabetes management, control and complications in diabetic subjects in asia.


Eligibility criteria:
inclusion criteria: * diabetic patients registered in the particular centre for more than 12 months * patients should have visited the centre at least once in the last 3-6 months apart from the initial visit * patients willing to sign informed consent form exclusion criteria: * repetition of any patient as patients should not be included twice for any reason * unwilling to participate or unable to comply with protocol requirements
effect of depression, anxiety and stress scores on embryo transfer success

Conditions: Stress; Pregnancy

Summary: psychological status of couples attending to ivf programmes is important due to possible effect on final result. observers aim to investigate the depression, anxiety and stress scores of couples before and after the procedure.

studying effect of psychology on ivf is not a new idea. "before and after" scores of women attending to ivf programmes had been studied numerous times. however, there is not sufficient data about the contbibution of male compartment upon the process. investigators aimed to study both male and female participants. final scores will not be evaluated unless at least good quality blastocsyt is transferred.

Eligibility criteria:
inclusion criteria: * 20 to 40 year old women attending to ivf programme exclusion criteria: * azospermia and severe male factor for whom sperm freezing will be required * history of rif * known genetik abnormality of couples

Keywords: depression anxiety stress pregnancy ivf