Kornimate/medical-research-clean huggingface dataset:
a study with clevudine monotherapy or adefovir and clevudine combination in proportion to roadmap concept in patients with hbv associated-hcc

Conditions: Hepatitis B Associated Hepatocellular Carcinoma

Summary: an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in proportion to roadmap concept in patients with chronic hepatitis b associated hepatocellular carcinoma


Eligibility criteria:
inclusion criteria 1. patient with chronic hbv dna and/or with symptoms of liver cirrhosis 2. patient with hepatocellular carcinoma evidenced by sonography, ct scan, or mri scan) 3. patient is 18 years and older. 4. patient is documented to be hbsag positive for \> 6 months. * laboratory report proving hbsag positive or hbeag positive for at least six months * igm anti-hbc negative, igg anti-hbc positive at screening 5. patient is hbv dna positive with dna levels ≥ 2,000 iu/ml within 30 days of baseline. 6. patient has alt or ast levels \>=40 iu/l 7. cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year. 8. patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 9. patient who is classified as nyha functional classification grade 1-2. (nyha;new york heart association) 10. patient who is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria 1. patient is currently receiving antiviral therapy. 2. patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months. 3. patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for hbv infection. 4. patient is coinfected with hcv, hdv or hiv. 5. patient with metastatic malignancy. 6. patient with previous liver transplantation 7. patient is pregnant or breast-feeding. 8. patient has a clinically relevant history of abuse of alcohol or drugs. 9. patient use oriental medicine within the previous 2 weeks. 10. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. 11. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]
advanced visuohaptic surgical planning for trauma surgery

Conditions: Maxillofacial Injuries

Summary: this study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.

the proposed tool will allow surgeons from different specialties to simulate, plan and iterate on complex procedures based on individual patient data in 3-d from a ct scan. the software will allow surgeons to both see and feel the results of their interventions - for example, the quality of the bite or bone alignment of a reconstructed jaw following severe trauma - before the actual surgery, leading to better planning, fewer errors, shortened surgery time and improved outcomes for the patients. the purpose of this study is the evaluation of a visuohaptic planning system for mandibular trauma surgery that is based on interactive manipulation of ct data.

Eligibility criteria:
inclusion criteria: * craniofacial deformity, including post-traumatic, congenital or acquired deformity * patients who have already have surgery because there was a clinical indication for surgical correction exclusion criteria: * no craniofacial deformity * no clinical indication for surgical correction * contraindication for surgical correction

Keywords: reconstructive surgical procedures visuohaptic
echocardiography as risk-assessment for major adverse cardiac events in major vascular surgery patients

Conditions: Left-Sided Heart Failure; Right-Sided Heart Failure; Heart Valve Diseases

Summary: patient with coronary artery disease (cad), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. the prevalence of cad in vascular surgery patients approaches 50%. proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. the investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (lv and rv function) and valvular (aortic / mitral / tricuspid) function and expanded major adverse cardiac events (x-mace).


Eligibility criteria:
inclusion criteria: * major vascular surgery operation (e.g. cea, open aortic repair, suprainguinal and infrainguinal bypasses, evar, tevar) captured in the uva vascular quality initiative database * echocardiography within two years of index operation exclusion criteria: * if patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded

Keywords: major vascular surgery major adverse cardiac events
slim: combined effects of slo-niacin and atorvastatin on lipoproteins and inflammatory markers in hyperlipidemia

Conditions: Dyslipidemia

Summary: slo-niacin and atorvastatin (lipitor) are both drugs that lower cholesterol. in this research, we will compare the effectiveness of slo-niacin and atorvastatin taken alone and together. this study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.

combined niacin and a statin treatment has greater potential value than either agent alone for the dyslipidemia of insulin resistance, obesity and the metabolic syndrome. the efficacy of slo-niacin and atorvastatin has not been formally examined in this setting. methods: forty-four dyslipidemic men and women (ldl-c \>130mg/dl and below average hdl-c (\<55 in women and \<45 in men) were randomized to a 3 month course of atorvastatin 10 mg or slo-niacin increased monthly at doses of 500, 1000 and 1500 mg/day. the alternate drug was added in the second 3-month segment. lipid profiles and transaminase measurements were obtained monthly and full lipoprotein quantifications, apoproteins, remnant like lipoproteins (rlp), ldl buoyancy, glucose, insulin, and c-reactive protein were measured at the end of each 3-month sequence. results: mean entry lipids were (mg/dl) tg 187, ldl-c 171, hdl-c 39. mean bmi was 32.6 kg/m2. when slo-niacin and atorvastatin were given alone, respective decreases in triglyceride (tg) were 18% and 10%, ldl-c 12% and 36% and non-hdl-c 15% and 36%. hdl-c increased 8% and 6%, respectively. combined therapy decreased median tg 33% and mean ldl-c 43% and increased mean hdl-c 10%. mean hs crp decreased 23% and rlp 44.5% in the combined groups. conclusions: slo-niacin with atorvastatin improves all lipoprotein fractions, rlp and hscrp in combined hyperlipidemia. the reduction of ldl with the drug combination is equivalent to that obtained with 20-80 mg of atorvastatin alone.

Eligibility criteria:
inclusion criteria: * ldl-c \> 130 mg/dl * hdl-c \<= 45 mg/dl in men and \<= 55 mg/dl in women exclusion criteria: * history of hypersensitivity to any statin, niacin or aspirin * diagnosis of diabetes or a fasting glucose \> 125 mg/dl * hyper or hypothyroidism (unless treatment stable) * meet other health, medication, and logistical criteria

Keywords: cholesterol dyslipidemia hypercholesterolemia c-reactive protein
the variation of movement related cortical potential, cortico-cortical inhibition, and motor evoked potential in intracerebral implantation of antologous peripheral blood stem cells(cd34)in old ischemic stroke

Conditions: Stroke

Summary: stem cell theray in old stroke patients is a study to treat stroke patients approved before in our hospital. we recruit these patients who received stem cell therapy and completed the study. we adopted movement-related cortical potential,and cortico-cortical inhibition to assess the stroke patients with or without stem cell therapy. further analyzing the correlation of the motor related cortical potential and cortico-cortical inhibition among them. we wanted to find out if there are changes in cortical excitability in subjects with chronic stroke after stem cell therapy.


Eligibility criteria:
inclusion criteria: * 1.old cerebral infarction (middle cerebral artery territory as documented on the t2 weight image \[t2wi\] of mri) 2.between 6 months and 5 years of onset 3.national institute of health stroke scale (nihss) of between 9 and 20. exclusion criteria: * 1.seizure history 2. pacemaker insertion

Keywords: changes in cortical excitability in subjects with chronic stroke after stem cell therapy
interventional cooperative agreement program - vocational intervention demonstration

Conditions: Spinal Cord Injuries; Brain Injuries; Employment; Spinal Cord Diseases

Summary: for many people with spinal cord injury or brain injury, seeking employment after injury is an important goal. there are services available to help people with disabilities. however, the best ways to coordinate and deliver these services are not yet known. this project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury or brain injury obtain employment.

employment is important for financial security, social connection, and life satisfaction. unfortunately, rates of unemployment remain high among people with spinal cord injury (sci) and brain injury (bi). to help address this challenge, the investigators are conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with sci or bi. in one program, services are coordinated by a counselor employed by the new jersey state division of vocational rehabilitation services, a state-based agency that assists people with disabilities who are interested in pursuing employment. in the other program, services are coordinated by a facilitator who is employed by the rehabilitation hospital at which the participant receives inpatient care. services provided in both programs will be customized to the participant's needs and goals. services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions. the project will enroll 500 participants who are interested in becoming employed or returning to work. information about employment status, earnings, benefits use, community participation, and health will be collected through a combination of surveys, medical record review, and information available in state and federal administrative databases. analyses will examine the rate of participants employed at 1 year after enrollment in each group, time to employment, earnings, benefits usage, community participation, and well-being. findings from this study will be used to determine which ways of delivering services are most effective in enabling employment, and to provide information to help other rehabilitation centers adopt effective programs.

Eligibility criteria:
inclusion criteria: * adults aged 18-62 * new jersey resident * admitted to kessler institute for rehabilitation (kir) due to a spinal cord injury (sci) or brain injury (bi) * receiving inpatient rehabilitation at kir * community living in the state of new jersey after discharge from kir

Keywords: employment vocational rehabilitation
a single-dose study of mk-8351 in a lung allergen challenge (mk-8351-003)

Conditions: Asthma

Summary: the primary hypothesis of the study is single doses of mk-8351 will reduce the baseline early asthmatic response (ear) as assessed by area under the curve from 0-3 hours (auc0-3hr) of forced expiratory volume (fev1) when compared to placebo.

this is a randomized, placebo-controlled, 4-period study. eligible patients will undergo a single-blind phase in period 1, followed by 3 periods during which they will receive low-dose mk-8351, high-dose mk-8351, or matching placebo as a single dose in a random sequence crossover study design.

Eligibility criteria:
inclusion criteria: * females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation); * males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication; * body mass index (bmi) \>=17 kg/m\^2 and \<=33 kg/m\^2 * non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment; * history of allergen-induced asthma for at least 6 months prior to enrollment; * able to perform reproducible pulmonary function testing; * positive methacholine challenge test prior to receiving study medication; * allergic response to house dust mite allergen or standardized cat pelt or hair allergen extract; * ability to tolerate sputum induction and to produce adequate sputum. exclusion criteria: * history of clinically significant disease or disorder; * history of malignancy; * history of significant multiple and/or severe allergies; * history of milk or lactose allergies or intolerance; * history of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; * positive for human immunodeficiency virus (hiv), hepatitis b surface antigen, or hepatitis c antibodies; * history of major surgery within 3 months prior to enrollment; * participation in another investigational trial within 4 weeks of screening; * lactating females; * inability to refrain from, or anticipates the use of, any medication including herbal remedies during the trial period; * history of receiving anti-immunoglobulin e (ige) or immunotherapy; * history of serious allergies to drug or a history of hypersensitivity to inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication; * history of hospitalization for asthma-related illness within 3 months of screening; * history of emergent care more than twice in the last 12 months for asthma-related illness; * history of life-threatening asthma; * consumes \>4 glasses of alcoholic beverage per day; * consumes \>6 servings of coffee, tea, cola, energy drinks or other caffeinated beverages per day; * history or or current use of illicit drugs within past 24 months.
toric eye strain and stability study

Conditions: Astigmatism

Summary: the purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.


Eligibility criteria:
inclusion criteria: 1. the subject must have read, understand, and sign the statement of informed consent and receive a fully executed copy of the informed consent form. 2. the subject must appear able and willing to adhere to the instructions set forth in this protocol. 3. the subject must be between 18 years and 45 years of age (inclusive). 4. the subject must have best-corrected snellen visual acuity of 20/30 or better in each eye. 5. if the subject has ever worn contact lenses, the subject must be a current wearer of soft spherical contact lenses for at least 5 days/week and at least 8 hours/day during the month prior to enrollment. 6. subjective refraction must result in a vertex-corrected astigmatic contact lens prescription requiring at least -0.75 dc but not more than -1.75 dc cylindrical contact lens correction in each eye. 7. subjective refraction must result in a vertex-corrected spherical contact lens prescription between +0.25d to +4.00d or between-0.50d to -9.00d in each eye. 8. the subject must not have the need for presbyopic correction (i.e., they must not be using as add in spectacles or wearing multifocal or monofocal contact lenses). 9. the subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear. 10. the subject must have access to the internet throughout the day (either desktop and/or smartphone) and be willing to answer a web-based survey within 1 hour of receiving a text message based notification throughout the day for up to 8 days, throughout the study duration. exclusion criteria: 1. self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued) 2. any previous ocular or intra-ocular surgery (e.g. radial keratotomy, prk, lasik, etc.) 3. any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. greater than or equal to grade 3 finding of edema, corneal neovascularization, corneal staining, conjunctival injection, blepharitis/meibomian gland dysfunction) on the fda classification scale or any other ocular abnormality that in the opinion of the investigator may contraindicate contact lens wear. 4. any ocular infection 5. current use of topical ophthalmic medications other than artificial tears/rewetting drops. 6. history of binocular vision abnormality or strabismus. 7. any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. hiv) by self-report. 8. other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear. 9. employee of the investigational clinic (e.g. investigator, coordinator, technician) 10. subject does not have a wearable pair of spectacles.
treatment and outcome of early onset bipolar disorder

Conditions: Bipolar Disorder

Summary: this study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.

in children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. it is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted. participants in this study are treated with lithium, divalproex (depakote), and one of the following atypical antipsychotic medications: olanzapine (zyprexa), risperidone (risperdal) or quetiapine (seroquel) for at least 24 weeks. participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. after participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. the first group will continue to receive active mood stabilizer and atypical antipsychotic medication. the second group will receive active mood stabilizer and placebo. participants are assessed weekly and followed for up to 18 months.

Eligibility criteria:
inclusion criteria: * have a diagnosis of bipolar i disorder; * have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode; * is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or depakote) and an atypical antipsychotic medication (abilify, geodon, risperdal, seroquel, or zyprexa); * live in the ny metropolitan area; * able to attend weekly to biweekly office visits exclusion criteria: * medical contraindication to treatment with lithium and divalproex * seizure disorder * pregnancy * unwillingness to use acceptable methods of birth control if sexually active * iq less than 70 * substance-induced mood disorder or mood disorder due to a general medical condition * prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study * potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode * high risk for running away or truancy

Keywords: adolescence
effects of inspiratory muscle training on functional capacity in patients with heart failure.

Conditions: Heart Failure

Summary: heart failure is a complex clinical syndrome manifesting as inability to supply adequate blood flow throughout the body due to any structural or functional cardiac abnormality. the most common complaints are exercise intolerance, balance, dyspnea, and fatigue in patients with heart failure. it is clearly stated that pulmonary muscle weakness is prevalent and contributes to exercise intolerance in patients with heart failure. purpose of the study was to evaluate the efficacy of inspiratory muscle traning on pulmonary muscle strength, pulmonary function test, functional capacity and quality of life. the tools used were 6-minute walk test, spirometry, imt threshold device for imt strength, and quality of life. study was conducted in 20 patients in single group and pre and post values were evaluated. the significance this study bears was that it helped defining for us that to how much extent we can improve the physical and pulmonary functional capacity using inspiratory muscle training. data were analysed using spss 22.0.mean and standard deviation were calculated. appropirate the stasitical test were used after checking normailty of data. parametric test were used for data analysis using spss 22


Eligibility criteria:
inclusion criteria: 1. adults 40-60 years old who are sedentary. 2. left ventricular ejection fraction of less than 45% evaluated by echocardiogram 3. functional class ii and iii (new york heart association) 4. fev1 less than 80%, predicted and/or fev1/ forced vital capacity (fvc) ratio of more than 70% predicted, and clinical stability. 5. ex-smokers of more than 5 years. exclusion criteria: 1. myocardial infarction 2. complex arrhythmias 3. uncontrolled hypertension 4. angina pectoris. 5. cognitive disorders 6. recent any trauma. 7. chronic respiratory disease. 8. unstable angina 9. recent viral infections (6 months before the study