Kornimate/medical-research-clean huggingface dataset:
vitamin d supplementation and glycemic outcomes

Conditions: Insulin Resistance

Summary: the investigators examined the effect of vitamin d supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in beirut, lebanon.

a low serum 25-hydroxyvitamin d (25(oh)d) concentration has been shown to correlate with higher fasting blood glucose (fbg) and insulin levels and other metabolic abnormalities like dyslipidemia. previous studies suggest that vitamin d supplementation is able to improve insulin sensitivity and metabolic markers. the aim of the study was to investigate the effect of vitamin d supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in beirut, lebanon. participants (n= 180; 93 men and 87 women) deficient in vitamin d were recruited from saint charles hospital, beirut, lebanon. four groups were recruited: normal-weight adults (n=30, age ≤ 65 years and bmi \< 25 kg/m²), overweight adults (n=30, age ≤ 65 years and bmi ≥ 25 kg/m²), normal-weight elderly (n=60, age ≥ 65 years and bmi \< 25 kg/m²) and overweight elderly (n=60, age ≥ 65 years and bmi ≥ 25 kg/m²). participants received a supplement of 10,000 iu cholecalciferol to be taken three times per week for a period of 6 months. glucose homeostasis and metabolic markers were measured at start of treatment, at 3 months and at 6 months.

Eligibility criteria:
inclusion criteria: * participants with no medical history of congestive heart failure, acute heart insufficiency and renal failure were included exclusion criteria: * participants with medical history of congestive heart failure, acute heart insufficiency and renal failure were excluded

Keywords: vitamin d glucose hba1c insulin resistance blood lipids
decision making deficit and dna methylation in opioid receptor genes among community heroin addicts

Conditions: Heroin Addiction

Summary: heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and the society. since the introduction of opioids substitutive treatment in 2006, more than 30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment currently. however, an unknown proportion of patients hidden in community remained un-treatment. to motivate the community heroin addicts is thus a challenging task. it is suggested that decision making deficit is core feature which determine outcomes and treatment motivations in patients with addiction disorders. recently, the state-of-the-art development of epigenetics uncover that environmental modification, via altering level of dna methylation and gene expression will influence on neurocognitive functioning. via respondent-driven sampling, this study aims to recruit a representative sample targeting at the hard-to-reach community heroin addicts. the goal of this study is to identify the clinical feature as well as decision making-related neurocognitive deficit in these patients. moreover, the investigators will explore the interplay of clinical features, dna methylation and gene expressions on opioids receptor genes. the findings will help to clarify the clinical characteristics of community heroin addicts, to uncover the links between dna methylation and clinical features of heroin addiction and to develop modifiable treatment targets in the future.


Eligibility criteria:
inclusion criteria: * 1) 20 to 65 of age; 2) meeting dsm-iv criteria of opioids dependence exclusion criteria: -
phase 3 trial in squamous non small cell lung cancer subjects comparing ipilimumab plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin

Conditions: Lung Cancer (NSCLC)

Summary: the purpose of the study is to determine whether ipilimumab plus paclitaxel and carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus paclitaxel and carboplatin.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects with nsclc of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone * stage iv or recurrent nsclc (per the 7th international association for the study of lung cancer (iaslc) classification) * at least 1 measurable tumor lesion, as defined by mwho criteria, that is not located in a previously irradiated area * eastern cooperative oncology group (ecog) performance status ≤1 exclusion criteria: * brain metastases * malignant pleural effusion that is recurrent * documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
a novel way to estimate epidural depth in morbidly obese parturient

Conditions: Obesity

Summary: the purpose of this study is to determine the correlation between actual epidural needle depth (nd) and the use of ultrasound with an epidural depth equation (eq-us) to estimate epidural depth (est-d) in morbidly obese parturients. it is well documented that in women with a bmi greater than 40 kg/m2 successful epidural placement is more difficult. to the best of our knowledge the use of an epidural depth equation, which was developed in an earlier study using height and weight, with ultrasound visualization will improve identification of the epidural space.

the investigators plan to enroll women who are morbidly obese (bmi \> 40 kg/m2) and request epidural analgesia for labor. after written informed consent, 160 patients will have the use of the epidural depth equation with ultrasound (eq-us) to estimate epidural depth (est-d). us visualization of the epidural space will be completed by the principle investigator who has had extensive training in epidural us visualization. the eq-us depth will be recorded. after us use, another provider who is listed as an investigator will place the epidural catheter without prior knowledge of the estimated epidural depth with the use of the equation and us. the actual needle depth to the epidural space (nd) will be recorded. data collected from the patient's medical record will include demographic data (age, height, weight) gravidity, parity, and cervical dilation. measured variables will include the estimated epidural depth (est-d) as measured by the epidural depth equation with the use of ultrasound (eq-us), and actual epidural needle depth (nd). the investigators believe that the use of ultrasound with the epidural depth equation (eq-us) to estimate epidural depth (est-d) in morbidly obese parturients will have a high correlation with actual epidural needle depth (nd).

Eligibility criteria:
inclusion criteria: all women of childbearing age (including children aged 14 years and above) with a bmi \> 40kg/m2 who request epidural analgesia at magee-womens hospital will be eligible to participate in the study. men will not be included since they can not become pregnant. all patients will be recruited at magee-womens hospital. exclusion criteria: patients with severe preeclampsia will be excluded from the study, as these patients may have significant edema which could alter ultrasound and/or epidural needle depth measurement. patients with a history of back surgery, significant scoliosis, and/or lumbar pathology (i.e. ankylosing spondylitis) will be excluded from the study because these conditions could complicate ultrasound visualization and/or epidural needle placement.

Keywords: obesity ultrasound
outcomes of 3 incision-size-dependent phacoemulsification systems

Conditions: Cataract

Summary: the purpose of this study is to compare the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).

it is generally the case that smaller corneal cataract surgical incisions are associated with more rapid wound healing, more stable corneal biomechanical properties and less surgically induced astigmatism (sia). with the development of phacoemulsification and foldable intraocular lenses (iol) during recent decades, the size of clear corneal incisions has been reduced from 3.2-mm (coaxial small incision) to 1.4-mm (bimanual micro incision). micro incision cataract surgery (mics), including bimanual and micro coaxial phacoemulsification, has attracted much interest recently, due to its safety and ease of learning. however, the superiority of coaxial micro incision cataract surgery as compared conventional coaxial cataract surgery is still not certain, because micro incision phacoemulsification may result in longer ultrasound time (ust), the use of more ultrasonic power and consequently higher endothelial cell loss (ecl). in our previous studies of the ozil torsional phacoemulsification system (infinity, alcon), we reported that the safety and effectiveness of cataract surgery are influenced by many factors, including the blade used to create the incision, the phacoemulsification apparatus, and the iol and mode of iol delivery, which together constitute a surgical system, whose outcomes are restricted by the best performance of each component. today, micro coaxial phacoemulsification is in wide use for cataract surgery, but the lower limits of incision size should be understood in the context of the various components of the surgical system. in this study, we compared the safety and efficacy of three different incision-size-dependent phacoemulsification systems, 1.8, 2.2 and 3.0 mm, and evaluated the relationship between incision size and sia.

Eligibility criteria:
inclusion criteria: * age between 55 and 85 years * the presence of nuclear or cortex-nuclear cataract, grades 2.0 to 4.0 (lens opacities classification system iii) * a transparent central cornea * pupil dilating to \>= 7 mm at the time of preoperative examination * a preoperative central endothelial cell count of \>= 1500 cells per square millimeter exclusion criteria: * previous intraocular surgery * glaucoma * pseudoexfoliation * uveitis * high myopia * diabetes mellitus

Keywords: cataract
a drug-drug interaction (ddi) study of ly3437943 in obese participants

Conditions: Obesity

Summary: the main purpose of this study is to determine the effect of ly3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. this study will last up to approximately 25 weeks for each participant.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²) * male and female participants of childbearing potential who agree to use contraceptive methods exclusion criteria: * have a history of diabetes or current diagnosis of diabetes * history or presence of a of significant bleeding disorder * participants with significant comorbidity * participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome p450 (cyp) -1a2, cyp2c9, or cyp3a4 enzymes, or drugs are cyp substrates and have a narrow therapeutic index

Keywords: overweight obesity drug interaction cocktail pharmacokinetic
a phase i clinical trial to evaluate the safety and immunogenicity of 100 mcg of env 2-3 in mf59

Conditions: HIV Infections; HIV Seronegativity

Summary: to evaluate the safety and immune response of 100 mcg env 2-3 antigen administered on days 0, 30, 180, and 365. preliminary immunologic data from protocol veu 005b show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

preliminary immunologic data from protocol veu 005b show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest. twelve healthy volunteers receive injections of 100 mcg env 2-3 in mf59 emulsion and two volunteers receive mf59 only on days 0, 30, 180, and 365. follow-up continues for 6 months after the last injection.

Eligibility criteria:
inclusion criteria subjects are: * normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study. exclusion criteria co-existing condition: subjects with the following conditions or symptoms are excluded: * positive syphilis serology (such as vdrl) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment. * circulating hepatitis b antigenemia. subjects with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, or autoimmune disease. * evidence of depression or under treatment for psychiatric problems during the past year. prior medication: excluded: * immunosuppressive medications. prior treatment: excluded: * blood transfusions or cryoprecipitates within the past 6 months. identifiable high-risk behavior for hiv infection, including: * history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.

Keywords: vaccines, synthetic drug evaluation adjuvants, immunologic aids vaccines hiv preventive vaccine
alto-100 in mdd and/or ptsd

Conditions: Major Depressive Disorder; Post Traumatic Stress Disorder

Summary: the goal of this study is to collect biologically based data for defining predictors and correlates of the effects of alto-100.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate to severe major depressive disorder (mdd) and/or post-traumatic stress disorder (ptsd) * at baseline, either not taking an antidepressant medication, or currently taking a ssri, snri, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks * willing to comply with all study assessments and procedures * must not be pregnant or breastfeeding at time of enrollment or throughout study exclusion criteria: * evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease * active suicidal ideation * diagnosed bipolar disorder, psychotic disorder, or dementia * current moderate or severe substance use disorder * has a history of hypersensitivity or allergic reaction to alto-100 or any of its components/excipients * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
tissue engineering conjunctiva for the treatment of pterygium and atretoblepharia

Conditions: Pterygium

Summary: the purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

the most important area for research on the pterygium are the recurrence occurred after operation. now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. for the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. in this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. this will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.

Eligibility criteria:
inclusion criteria: 1. primary and recurrent pterygium patients,atretoblepharia patients 2. voluntarily signed informed consent 3. no surgery and anesthesia contraindications. exclusion criteria: 1. the patients combined systemic diseases 2. reject study and follow visit 3. patients don't accept the tissue engineering conjunctiva 4. cannot tolerate surgery or anesthesia

Keywords: pterygium tissue engineering atretoblepharia
study in patients with insulin resistance

Conditions: Insulin Resistance

Summary: fluid management study in patients with insulin resistance.


Eligibility criteria:
inclusion criteria: * bmi 27-36 kg/m2 inclusive and at least two additional features of the metabolic syndrome or a first degree relative with a history of type 2 diabetes mellitus. bmi = weight/height², (where weight is in kg, height in m). * male or female aged 30 to 65 years, inclusive, at screening. * female subjects must be post-menopausal (i.e. \>6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, norplant depo-provera) or intra-uterine devices (iud) (a diaphragm with spermicide or a condom with spermicide). women of childbearing potential must use effective contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study treatment. * willing and able to provide a signed and dated written informed consent. exclusion criteria: * subjects with type 2 diabetes mellitus defined as an hba1c level \>6.5% or a fasting plasma glucose of \> 7.0 mmol/l. if fasting plasma glucose is between 6.1 and 7.0 mmol/l then a 75 g oral glucose test will be performed to exclude diabetes mellitus. * subjects who have initiated lipid lowering therapy within the last 6 months and subjects who have increased the dose of these therapies within the last 3 months prior to study start. * subjects who are taking non steroidal anti-inflammatory drugs, fibrates, anticoagulants or cardiovascular medications (β-blockers, nitrates, calcium antagonists, ace inhibitors, angiotensin ii antagonists, alpha blockers, diuretics, centrally acting anti-hypertensives, directly acting antihypertensives e.g., diazoxide, digoxin, anti-arrhythmics) and are unable to stop these medications for the duration of the study. * exposure to a thiazolidinedione (tzd) or other ppar-γ agonist (e.g. rosiglitazone, troglitazone, pioglitazone, g1262570) within the last 4 months or participation in a clinical study involving a tzd or ppar-γ agonist. * subjects who have required the use of any anti-diabetic medication at any time. * use of any investigational drug within 30 days preceding the first dose of medication at the start of the study. * subjects with a documented history of significant hypersensitivity (e.g. difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones or ppar-γ agonists. * systolic blood pressure \>160 mmhg or diastolic blood pressure \>100 mmhg or receiving antihypertensive therapy. * subjects with unstable or severe angina (requiring continual therapy) or congestive heart failure. * presence of clinically significant hepatic disease. * clinically significant anaemia. * subjects with creatinine clearance \<40 ml/min. * women who are lactating, pregnant or planning to become pregnant during the course of the study. * alcohol or drug abuse within the last 6 months.

Keywords: insulin resistance vasodilatory response
effect of inhalatory sedation in subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage

Summary: the aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with sah. it will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates. perfusional ct will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).


Eligibility criteria:
inclusion criteria: * age \> 18 years old * diagnosis of non-traumatic sah * neurological and/or systemic presentation that requires support of vital functions and sedation. this occurs for a wfns score (world federation of neurosurgical societies) ≥ 3. * possibility of icp monitoring through evd which is necessary in case of acute hydrocephalous. in case of the neurosurgeon do not indicate the positioning of the evd, an intraparenchymal catheter will be positioned for the icp monitoring. * patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first ct scan). this exam will be performed at 2° - 3° day post event. * acceptance of informed consent. exclusion criteria: * documented outcomes of cerebrovascular disease * patients with acute heart failure related to esa * state of pregnancy * patients with clcr \< 30 ml/min

Keywords: perfusion isofluorane inhalatory sedation
evaluation of the efficacy and safety of herbal medicine for treating work-related chronic low back pain

Conditions: Low Back Pain; Workplace

Summary: the purpose of this trial is to investigate the efficacy and safety of sogyeonghwalhyeol-tang(sghh) on korean patients with work related chronic low back pain

investigating the efficacy and safety of sogyeonghwalhyeol-tang(sghh) on korean patients with work-related chronic low back pain

Eligibility criteria:
inclusion criteria: * inpatients with chief complaint of low back pain in oriental rehabilitation medical center * age 19 - 65 * workplace vulnerable populations(hospital workers, office worker, blue collar workers, transit workers) * patients must include all of the following symptoms: * those who have 4 \~7 cm of vas pain score; * those who has classified as 'at risk non-complier' or 'pain complaints' by kosha questionnaire * ability to have normal communication * ability to give informed consent exclusion criteria: 1. patients with pain duration of 3 months or less 2. patients with progressive neurologic deficit or severe neurologic symptoms by slr test 3. patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc) 4. patients with spondylolisthesis or spondylolysis(diagnosed with grade ii or higher level) 5. patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results 6. patients with history of spinal surgery 7. patients with more severe pain than pain caused by low back pain 8. those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc. 9. patients with history of medical malpractice case 10. patients with treatment history of low back pain within 1 month either km or wm 11. patients participating in other clinical studies within 3 months 12. pregnant patients or patients with plans of pregnancy or lactating patients 13. patients disagree to sign the informed consent form 14. patients deemed unsuitable for participating the trial by the researchers

Keywords: work related chronic low back pain korean medicine sogyeonghwalhyeol-tang