Kornimate/medical-research-clean huggingface dataset:
pharmacodynamic and pharmacokinetic effects of insulin glulisine in obese subjects with type 2 diabetes after a standard meal in comparison to insulin aspart

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: * to assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes. secondary objectives: pharmacodynamic objectives: * to assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart. pharmacokinetic objective: * to assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups safety objective: * to assess the safety of insulin glulisine in comparison to insulin aspart

duration of treatment: two study days separated by a 7-day wash-out period duration of observation: * screening period of 1-2 weeks, \>2 study days (with a wash-out period of 7 days between the study days), * follow-up visit (within 2 weeks after the end of the study treatment period).

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes for at least one year * treated with oral antidiabetic agents (oads) for at least 6 months * baseline c-peptide ≥0.1 nmol/l * bmi (body mass index) between 30 and 40 kg/m2 * hba1c (glycosylated hemoglobin) \< 8.5% * signed informed consent exclusion criteria: * type i diabetes mellitus * current treatment with insulin * pregnant and breast-feeding women * any medication known to influence insulin sensitivity * current treatment with systemic corticosteroids * history of acute metabolic complications in the past 3 months * recurrent severe hypoglycaemia or hypoglycaemic unawareness * active proliferative diabetic retinopathy and known diabetic gastroparesis * impaired hepatic function, as shown but not limited to alt or ast above 2 times the upper limit of normal * clinically relevant illness such as nephropathy and impaired renal function as shown by clearance \< 30 ml/min * any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult * hypersensitivity to insulins or insulin analogs the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study evaluating effects of multiple-dose administration of itraconazole on the single dose pharmacokinetics of conjugated estrogens/bazedoxifene in non-obese and obese postmenopausal women

Conditions: Healthy

Summary: this study will assess if itraconazole will affect the blood levels of duavee when they are given together. this study will also assess if a subject's body size affects the blood levels of duavee.


Eligibility criteria:
inclusion criteria: * generally healthy postmenopausal women, aged 40-64. intact uterus exclusion criteria: * the use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.

Keywords: postmenopausal women obese non-obese drug interaction with itraconazole pharmacokinetic
mixed chimera allogeneic transplantation from matched unrelated donors for the treatment of multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.

the primary objective of the protocol is to evaluate the toxicity and tolerability of this mixed chimerism matched unrelated donor allogeneic transplant approach for patients with multiple myeloma. response, toxicity, survival and graft-versus-host disease will be evaluated.

Eligibility criteria:
inclusion criteria:a) multiple myeloma which is responsive to therapy. eligible patients may have early or relapsed disease. patients must have stage ii-iii disease or have progression after initial treatment of stage i disease. patients who have relapsed following autologous transplantation may be eligible for this protocol. b) age \<= 60 years. c) no prior therapy which would preclude the use of low-dose total body irradiation. d) patients must have their pathology reviewed and the diagnosis confirmed at stanford university medical center. patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study. e) patients must have a karnofsky performance status \> 70%. f) dlco \>= 60% predicted. g) alt and ast must be \ = 50 ml/min. i) patients must be hiv negative. j) pregnant or lactating women will not be eligible to participate. k) patients must provide signed, informed consent. exclusion criteria:a) severe psychological or medical illness b) patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study. c) patients who have an hla-identical sibling donor will be excluded
continuous versus intermittent sciatic block for total knee arthroplasty

Conditions: Total Knee Arthroplasty; Pain

Summary: the role of a sciatic block in addition to a femoral block remains controversial. the study addresses this topic by comparing a continuous block versus an injection on demand.


Eligibility criteria:
inclusion criteria: * patients scheduled for total knee arthroplasty exclusion criteria: * failure to establish femoral and sciatic block * insufficient analgesic effect of the block * patient declines to participate

Keywords: pain score
individualized adaptive de-escalated radiotherapy for hpv-related oropharynx cancer

Conditions: Oropharynx Cancer

Summary: this prospective study aims to utilize pre- and mid-treatment pet-ct to guide de-escalation of radiation therapy in hpv-related squamous cell carcinoma of the oropharynx.


Eligibility criteria:
inclusion criteria: * patients must have fdg-avid and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) that is p16 positive by immunohistochemistry or hpv positive by in situ hybridization. * ajcc eighth edition staging stage 1 and stage 2 * appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: * history/physical examination, including documentation of weight within 4 weeks prior to registration; * fdg-pet/ct scan for staging and rt plan within 4 weeks prior to registration; * zubrod performance status (a quantification of the functional status of cancer patients that runs from 0 to 5, with 0 denoting perfect health and 5 death) 0-1 within 4 weeks prior to registration; * age ≥ 18; * able to tolerate pet/ct imaging required to be performed * cbc/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function; * serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml/min within 4 weeks prior to registration; * women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study. * the patient must provide study-specific informed consent prior to study entry. exclusion criteria: * ct4, cn3 or cm1 disease * "matted nodes" as determined by review with neuroradiology * gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. in other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. * carcinoma of the neck of unknown primary site origin (even if p16 positive); * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study; * prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; * severe, active co-morbidity; * pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; * poorly controlled diabetes
outcomes of sleeve gastrectomy in obese patients, retrospective study.

Conditions: Morbid Obesity

Summary: this study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at sohag university hospital in the period from january 2017 to may 2018.assessment of outcomes as effects on weight, effects on co-morbidities and post operative complications.


Eligibility criteria:
inclusion criteria: * age from 18 to 65 years old * body mass index ≥ 35 kg/m2 with comorbidities disease or body mass index ≥ 40 kg/m2, with failure of non operative attempts to lose weight * a minimum 2-year follow-up at our outpatient clinic. exclusion criteria: * secondary causes of obesity (e.g. endocrine diseases) * patients unable to participate in medical follow-up; * associated comorbidities or diseases impacting on weight loss.

Keywords: morbid obesity sleeve gastrectomy bariatric surgery weight loss
comparison of segmentectomy versus lobectomy for lung adenocarcinoma ≤ 2cm

Conditions: Lung Adenocarcinoma

Summary: this study aims to evaluate the superiority in recurrence-free survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype positive by intraoperative frozen sections.

at present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. however, there is still little evidence whether segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. this prospective and multi-center study was aimed to evaluate the superiority in recurrence free survival and overall survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma (≤ 2 cm) containing positive micropapillary components.

Eligibility criteria:
inclusion criteria: * tumor size ≤ 2 cm; * solitary tumor and located in the outer third of the lung field; * preoperative ct indicated that the nodules were single nodules or concomitant nodules was less than minimal invasive adenocarcinoma; * intraoperative frozen section confirmed invasive lung adenocarcinoma and with micropapillary and solid patterns positive (\>5%); * confirmation of r0 status by intraoperative frozen section analysis; * pulmonary function could withstand both segmentectomy and lobectomy (fev1 \> 1.5 l or fev1% ≥ 60%); * sufficient organ function; * performance status of 0,1 or 2； * written informed consent. exclusion criteria: * the tumor is close to the hilum, which cannot perform segmentectomy ; * patients suspected of lymph node positive by preoperative examination, including ct scans and mediastinal lymph node biopsy; * evidence revealed locally advanced or metastatic disease; * intraoperative exploration revealed accidental pleural dissemination. * patients with severe damage to heart, liver and kidney function (grade 3 \~ 4, alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) over 3 times the normal upper limit, cr over the normal upper limit). * patients concomitant with other malignant tumors； * patients had prior chemotherapy, radiotherapy or molecular targeted therapy for this malignancy. * history of severe heart disease, heart failure, myocardial infarction within the past 6 months. * the patients who were not suitable for inclusion by researchers' evaluation.

Keywords: frozen sections lobectomy segmentectomy micropapillary
retrospective evaluation of safety and efficacy of daptomycin used in patients with serious gram-positive infections

Conditions: Serious Gram-positive Infections

Summary: daptomycin was approved since 2005 in taiwan and have been studied and published in west countries. after review the published papers, the few data were described in the asian countries or taiwan. the objectives of this study are to evaluate the efficacy and safety of daptomycin for the treatment of gram-positive infections under actual conditions of use, and to understand other information concerned with daptomycin prescription. this study represents an opportunity for acquiring real world data on daptomycin usage, and may provide physicians in taiwan with the information of characteristic of the patients receiving daptomycin and to evaluate outcomes. it also provides a means to identify safety signals that emerge with clinical usage.

this is a retrospective, non-comparative study, which will be performed after obtaining permission from the institutional review board. patients with serious gram-positive infections who had received daptomycin from january 2009 and completed daptomycin therapy by the end of december 2010 will be screened, and patients who received ≥ 3 days of daptomycin will be identified eligible to be included. eligible patients' medical records will be reviewed. as this is a retrospective chart review, it is expected that informed consent will not be necessary. for patients' confidentiality concern, patients' name or chart number will not to be record in any part of data collection form (appendix 1). a patient identification number will be assigned to each patient included in this surveillance. a study coordinator at site will be identified, and hospital specific process will be utilized to identify patients. information to be collected was shown on data collection form (appendix 1). after completing patient data collection, the efficacy and safety will be evaluated for the included cases.

Eligibility criteria:
inclusion criteria: * patients started daptomycin therapy since january 2009. * patients completed daptomycin therapy by the end of december 2010. * patients had gram positive infections. * patients received daptomycin therapy for at least 3 days. exclusion criteria: * daptomycin therapy will be chosen by the treating physician based on clinical indication and it is expected that risks of therapy will have already been considered. * subjects are only to be excluded if he/she was enrolled in any antibiotics clinical trial during daptomycin treatment.

Keywords: daptomycin serious gram-positive infections
oral miltefosine for the treatment of pediatric cutaneous leishmaniasis in colombia

Conditions: Cutaneous Leishmaniasis

Summary: the purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric cutaneous caused by l. viannia species in colombia.


Eligibility criteria:
inclusion criteria: * 2 to 12 years of age (inclusive) * parasitologically confirmed cl * availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed") * availability to return for follow-up visits for at least 6 months after treatment is initiated exclusion criteria: * weight under 10kg * previous use of sbv, miltefosine or other antileishmanial therapy * simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis * if a girl, ability to reproduce (history of menarche) * relative or absolute contraindications for the use of sbv drugs or miltefosine, including history of cardiac, renal or hepatic disease * patients with pretreatment haemoglobin \<10g/dl or blood urea nitrogen (bun), serum creatinine, alt, ast or amylase values that exceed the upper limit of normal * if living in malaria endemic areas (eg. tumaco) only: a positive malaria thick smear

Keywords: cutaneous leishmaniasis leishmania viannia pediatric miltefosine randomized colombia
accumulation of dietary bioactives and prostate cancer

Conditions: Prostate Cancer

Summary: current research suggests that diets rich in multiple food types (such as broccoli, onions and garlic) are beneficial to our health and may reduce the risk of some cancers, including prostate cancer. the purpose of this study is to investigate the relationship between ingestion of the bioactive compounds from broccoli and garlic, and prostate metabolism.


Eligibility criteria:
inclusion criteria: * scheduled for template biopsy of the prostate as part of routine investigation or staging for prostate cancer at the norfolk and norwich university hospital * bmi between 19.5 and 35 kg/m2 * smokers and non-smokers exclusion criteria: * those regularly taking 5α-reductase inhibitors or testosterone replacement medicines * those on warfarin treatment * those diagnosed with diabetes * those diagnosed with or suspected to be high-risk for human immunodeficiency virus (hiv) and/or viral hepatitis * those allergic to any of the ingredients included in the supplements (including those with lactose intolerance) * those taking additional dietary supplements or herbal remedies that could affect the study outcome. * those that are unable to understand english or give informed consent * parallel participation in another research project that involves dietary intervention * any person related to or living with any member of the study team.
silicone hydrogel contact lenses on low astigmatism in japan

Conditions: Refractive Error; Myopia; Astigmatism

Summary: this study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.


Eligibility criteria:
inclusion criteria: 1. the subject is 18 to 39 years of age. (parental consent is required for a minor child i.e. under the age of 20.) 2. the subject has signed an informed consent with his/her own judgement for participation in the study. 3. the subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases. exclusion criteria: 1. the subject has any ocular or systemic allergies that interfere with contact lens wear. 2. the subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear. 3. the subject has any systemic disease or autoimmune disease that interferes with contact lens wear. 4. the subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (grade 3 or above) that clinically apparently interfere with contact lens wear. 5. the subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear. 6. the subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject. 7. the subject has ocular infection. 8. the subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis). 9. the subject has corneal distortion resulting from previous experience of hard contact lens wear. 10. the subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (hiv positive etc.), as far as known to the subject. 11. the subject has diabetes, as far as known to the subject. 12. the subject is pregnant or in the lactation period, as far as known to the subject. 13. the subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses). 14. the subject had any ocular trauma or surgery within 8 weeks prior to participation in the study. 15. the subject is a wearer of hard contact lenses (including rigid gas permeable). 16. the subject is exposed to a dry environment on a constant basis. 17. the subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye. 18. the subject is unable to follow the principal investigator's instructions. 19. the subject is unable to follow lens hygiene procedures necessary for contact lens wear.
correlation between plasma- and endothelial dpp-4 activity

Conditions: Type 2 Diabetes Mellitus

Summary: the investigators want to estimate both the endothelial and the plasma activity of dipeptidyl peptidase 4 during different doses of sitagliptin in healthy subjects and patients with type 2 diabetes. furthermore, the investigators want to investigate whether the current clinical dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma and the endothelial activity of the enzyme dipeptidyl peptidase 4.

the two incretin hormones glucagon-like peptide-1 (glp-1) and glucose-dependent insulinotropic polypeptide (gip) are secreted from the intestinal l- and k- cells, respectively in response to ingestion of nutrients. the two hormones are able to lower blood glucose levels during high glucose levels - by the so called incretin effect. gip and glp-1 are both rapidly inactivated by the enzyme dipeptidyl peptidase 4 (dpp-4). the remaining metabolites are without insulinotropic effects. the effect of dpp-4 inhibitors used in treatment of type 2 diabetes relies on their impact on dpp-4 activity. dpp-4 exists in a soluble form in plasma ad as a membrane-bound form in blood vessels and other tissues. the impact of dpp-4 inhibitors on dpp-4 activity has only been evaluated in plasma. we aim to investigate plasma and endothelial dpp-4 activity (i.e. whole-body dpp-4 activity) in patients with type 2 diabetes during different doses of the dpp-4 inhibitor sitagliptin. both healthy control subjects and patients with type 2 diabetes are subjected to 4 experimental days (in a randomized order) with continuous infusion of glp-1 and pre-treatment with 25 mg sitagliptin, 100 mg sitagliptin, 200 mg sitagliptin and placebo, respectively. afterwards, we are going to measure the whole-body dpp-4 activity by comparing plasma levels of active (intact) glp-1 and total glp-1, and relate to plasma dpp-4 activity.

Eligibility criteria:
inclusion criteria: * caucasians with diet and/or metformin treated patients with type 2 diabetes (diagnosed according to the criterias of the world health organization) * normal hemoglobin * prior informed consent exclusion criteria: * nephropathy * liver disease * inflammatory bowel disease * pregnancy

Keywords: diabetes mellitus glucagon-like peptide 1 dipeptidyl peptidase 4 dipeptidyl peptidase 4 inhibitor sitagliptin enzyme activity
comparing human and computer-based quantification of airway stenosis from bronchoscopic images

Conditions: Airway Obstruction

Summary: this is a pilot study to assess the utility of the automatic stenosis index quantification using 3d slicer software (computer-based quantification). we will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (human-based quantification). this study relates to the latter data collection.


Eligibility criteria:
inclusion criteria: * physicians who are trained in bronchoscopy. * physicians who are willing and able to understand the scope of the study. exclusion criteria: * physicians who are not trained in bronchoscopy. * physicians who are unwilling and unable to understand the study procedure * employees under the direct supervision of the investigators conducting the research

Keywords: airway stenosis stenosis index quantification