Kornimate/medical-research-clean huggingface dataset:
vitamin d for the prevention of diabetes type 2

Conditions: Impaired Glucose Tolerance

Summary: the prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. intervention at this stage with change in lifestyle or with medication may prevent such progression. there are indications that vitamin d is of importance in glucose metabolism, and that supplementation with vitamin d may increase both insulin secretion and insulin sensitivity. accordingly, supplementation with vitamin d may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. however, this has so far not been demonstrated in a prospective, randomised clinical study. in the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the tromso study 2007/2008 and randomize to supplementation with vitamin d 20.000iu per week or placebo for 5 years. a glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.


Eligibility criteria:
inclusion criteria: * impaired glucose tolerance exclusion criteria: * serious heart disease * renal stone disease * hypercalcemia * sarcoidosis

Keywords: diabetes vitamin d cholecalciferol glucose tolerance
travoprost/brinzolamide fixed combination versus travatan and versus azopt

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of the study is to compare the iop lowering efficacy of travoprost/brinzolamide dosed daily in the morning or evening, vs travatan dosed once daily in the evening, and vs. azopt dosed bid in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 yoa or older * either gender or any race * oag or oht * currently on stable (at least 4 weeks) iop lowering medication * iop at screening visit â‰¥ 18mmhg in at least one eye * mean iop in same eye (at both eligibility 1\&2 visits * 24 and 36 mmhg at 9am * 21 and 36 mmhg at 11am and 4pm * able to discontinue use of iop lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1 exclusion criteria: related to disease condition being investigated (oag or oht) in either eye * severe central visual field loss * angle shaffer grade \< 2 * c/d ratio \>0.8(horizontal or vertical measurement) related to ocular patient history or current ocular condition in either eye * bscva worse than 55 etdrs letters read (equivalent to approximately 20/80 snellen or 0.25 decimal) * ocular infection or inflammation or laser surgery within the last 3 months * intraocular surgery or trauma with the last 6 months * any abnormality preventing reliable applanation tonometry * history or chronic, recurrently or current severe inflammatory disease * history of or current clinically significant or progressive retinal disease * history of or current ocular pathology(including severe dry eye) that would affect the conduct of the study related to systemic or ocular medication in either eye * allergy/hypersensitivity to study medications * unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period * use of oral cais during the study * recent use (\ 1 gram) * less than 30 days stable dosing regimen of medications used on a chronic basis that may affect iop * therapy with another investigational agent within 30 days prior to the screening visit

Keywords: oag oh open-angle glaucoma or ocular hypertension
affective touching on poststroke depression

Conditions: Post-stroke Depression

Summary: this mixed-method study includes a randomised controlled trial and an exploratory qualitative study, and aims to examine the effects of caregiver-delivered affective touch on depressive symptoms, state of attachment security, self-esteem, and perceived family harmony among stroke survivors, and to explore the mediating effect of attachment security and how an intervention may affect depressive symptoms from stroke survivor's perspective. a total of 184 survivor-caregiver dyads will be recruited from various non-governmental organisations. the dyads will be randomly allocated to intervention (ig) and control (cg) groups, stratified by the survivor's attachment style. ig caregivers will be taught to deliver a 15-minute affective touch intervention to stroke survivors. to address the attention effect, cg caregivers will be asked to sit with the survivors during a 15-minute fine motor coordination exercise. both activities, affective touching and fine motor exercise, will be performed for 12 weeks (3 times/week), and the outcomes mentioned earlier will be measured at baseline, 12 and 36 weeks after study entry.


Eligibility criteria:
inclusion criteria: 1. stroke survivor-caregiver dyads * hong kong residents, aged 18 years or above, * able to understand and give informed consent \[abbreviated mental test (hong kong version) score ≥6\]. 2. stroke survivors * within the first three months of being diagnosed with first-onset acute ischemic/haemorrhagic stroke, * able to comprehend verbal instructions, * with premorbid depressive symptoms \[20-item centre of epidemiology studies depression scale score ≥8\]. 3. family caregivers * family members who assume the primary responsibility for caring for a stroke survivor and who are identified by the survivors as their primary caregivers, * live with the survivors and provide care ≥4 hours/day, * have no history of self-reported or medical diagnosis of psychiatric illness, * are able to learn and willing to provide the intervention. exclusion criteria: * stroke survivor-caregiver dyads who are not chinese

Keywords: family caregiver attachment security affective touch self-esteem family harmony
validity of manipulation taxonomy of spastic hemiplegic cerebral palsy (cp) forms

Conditions: Hemiplegia; Cerebral Palsy

Summary: in recent years ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use. the investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks. the aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the assisting hand assessment and the scores of the melbourne assessment of unilateral upper limb function.


Eligibility criteria:
inclusion criteria: * clinical and instrumental (tc or rmn) diagnosis of child hemiplegia * age \> 5 years exclusion criteria: * acquired hemiplegia at the age \> 3 years * anti-spastic drug inoculations or functional surgery on the plegic ue 6 months prior to the video recordings * severe mental retardation attested by the diagnostic and statistical manual of mental disorders iv * pharmaco-resistant epilepsy * behavioural disorders

Keywords: cerebral palsy hemiplegia upper limb assessment classification system
heart transplant and primary transplant dysfunction: a retrospective analysis of the strasbourg experience

Conditions: Primary Graft Dysfunction

Summary: among the complications of heart transplant, primary dysfunction of the graft (pdg) is the most feared with a net impact on early morbidity and mortality. the all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. mortality at 30 days is secondary in 66% of cases with dpg or multi-organ failure. the treatment of choice for the more severe pdg remains ecmo-type circulatory mechanical assistance or ventricular assistance. according to several studies, this could reduce early mortality. early placement and short-term (\<30 days) of support appear to improve survival in the first year after transplantation. the haemodynamic parameters revealing this dpg are not clearly described in the literature. hypothesis of this research is that: * dpg risk factors in strasbourg's hospital center are comparable to other european and international centers. * simple hemodynamic parameters can be used to detect pdg earlier in order to set up assistance more quickly.


Eligibility criteria:
inclusion criteria: * all patients who had an isolated heart transplant in the cardiac surgery department of hus (hôpitaux univertsitaires de strasbourg) between june 2008 and december 2015. exclusion criteria: * multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.

Keywords: graft dysfunction primary graft dysfunction heart transplant heart failure hemodynamic parameters incidence of pdg
prico: opti target range

Conditions: Neonatal Respiratory Distress; Very Low Birth Weight Infant

Summary: the aim of the study is to determine if a narrower spo2 target range setting automated control of fio2 (a-fio2) is more effective than a wider spo2 target range

a-fio2 systems have consistently proven to be more effective than manual control. because it is more precise than manual control, studies of some a-fio2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. similar studies of the a-fio2 system (prico) used in the investigator's nicu have not been conducted. the standard of practice in the investigator's nicu is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. based on the studies of other a-fio2 systems the investigators believe a slightly narrower width target range would be more effective. therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.

Eligibility criteria:
inclusion criteria: * all vlbw on respiratory support and oxygen requirements after 2 weeks of age in the nicu are eligible after informed consent is obtained. exclusion criteria: * informed consent is not obtained * recording device for automated control of fio2 is not available

Keywords: spo2 target range pulse oximetry automatic oxygen control
clinical and radiological outcomes of subchondroplasty in the treatment of bone marrow edema of the knee

Conditions: Bone Marrow Edema

Summary: bone marrow lesions (bmls) of the knee are common subchondral defects, often associated with pain and functional limitation. subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside bml areas, ensuring stability and promoting the deposition of new bone. primary outcome of this study was to obtain a reduction of the numeric rating scale score of 4 points or more at 6 months follow-up in more than 75% of patients. the secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.


Eligibility criteria:
inclusion criteria: * atraumatic knee pain for at least 3 months; * failure of conservative treatment (including nsaids, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates); * mild to moderate osteoarthritis (kellgren-lawrence18 grade ≤ 3) * bml on a loading area at mri imaging (femoral condyles and/or tibial plateau) exclusion criteria: * knee pain and functional limitation related to other causes like osteonecrosis * fractures or inflammatory arthritis * ligamentous instabilities * malalignment on the coronal axis greater than 10 degrees in varus/valgus * severe tri-compartmental arthritis (kellgren-lawrence grade 4)
unravelling the interplay of weight stigma and pregnancy outcomes: a prospective cohort study

Conditions: Weight Stigma; Pregnancy Outcomes; Overweight and Obesity

Summary: the goal of this prospective cohort study is to investigate the contribution of stigma and discrimination due to body size to adverse pregnancy outcomes. we also aim to explore the role of psychological and social factors in this relationship. the specific objectives of this study are: objective 1: explore weight stigma as a mediator of the association between bmi ≥30 kg/m2 and adverse pregnancy outcomes. objective 2: explore confounding factors not previously considered such as weight cycling, trauma, eating disorders, and internalised weight bias as mediators in the relationship between obesity and adverse pregnancy outcomes.

the specific research questions for each objective are: objective 1 rq1.1: does weight stigma experienced during pregnancy in a healthcare setting reported up to 34 weeks gestation mediate the association between pre-pregnancy obesity (bmi ≥30) and gestational diabetes mellitis (gdm) (primary outcome)? rq1.2: does weight stigma experienced during pregnancy in a healthcare setting reported up to 34 weeks gestation mediate the association between pre-pregnancy obesity (bmi ≥30) and (i) induction of labour; (iv) mode of birth; (ii) gestational hypertension (any); (iii) infant birth weight; and (iv) establishment of breastfeeding by 6 weeks postpartum (secondary outcomes)? objective 2: rq2.1: do weight cycling, history of trauma, history of eating disorders, and internalised weight bias explain any of the variance in the mediation relationships described above?

Eligibility criteria:
inclusion criteria: * pregnant between 10-22 weeks' gestation * greater or equal than 18 years of age * booked to give birth at adelaide women's and children's hospital or royal women's and children's brisbane * access to the internet to complete the survey * consents to the extraction of hospital electronic medical record data about the woman and relevant to the study. * ability to read and understand english exclusion criteria: * pregnant with multiple gestation * insufficient english language skills to consent and complete the questionnaires.

Keywords: prenatal care healthcare
cormatrix ecm for carotid repair following endarterectomy registry

Conditions: Carotid Stenosis

Summary: assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the cormatrix ecm for carotid repair.

the objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the cormatrix ecm for carotid repair per its fda cleared indications for use. this registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the cormatrix ecm for carotid repair.

Eligibility criteria:
inclusion criteria: * subjects must be undergoing carotid endarterectomy with patch angioplasty closure. * subject's operative surgeon intends to use cormatrix ecm as the patch material for closure of the carotid artery per its fda cleared indications for use. * the subject must possess the ability to provide written informed consent. * the subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol. exclusion criteria: * subjects with a known sensitivity to porcine material.
evaluation of response to two schedules of capecitabine in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer. mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug and previous studies done al memorial sloan kettering cancer center support the tolerability of this scheme. this definitive, randomized trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer is necessary and we hypothesize it will be superior in terms of efficacy. dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. this trial is a proof of principle trial of the highest priority.


Eligibility criteria:
inclusion criteria: * 1 subject inclusion criteria * informed consent has been obtained. * metastatic breast cancer. * measurable or non-measurable disease per recist criteria. * pathologic confirmation of breast cancer. * no limit to the number of prior chemotherapy regimens permitted for metastatic disease. * at least 3 weeks since prior chemotherapy. patients should have recovered from all acute toxicity from such therapy (excluding alopecia). * age ≥18. * ecog 0-2 * absolute neutrophil count (anc )≥1.0; hemoglobin ≥9, platelets ≥75.000 * ast, alt and alkaline phosphatase \<2.5x upper limit of normal (or \<5x upper limit of normal in the case of liver metastases). total bilirubin \<1.5x upper limit of normal. * estimated creatinine clearance \>50ml/min. * if female of childbearing potential, pregnancy test is negative and the patient agrees to use an effective method to avoid pregnancy during the study. exclusion criteria: * her2 over-expression and/or amplification as determined by immunohistochemistry (3+) or fish (\>2.0). * no prior fluoropyrimidine in the metastatic setting. adjuvant fluoropyrimidine is permitted if \>12 months have elapsed since treatment. * no restriction for prior hormonal therapy. * gi malabsorption syndrome which could impair oral drug absorption. * concurrent use of warfarin is discouraged as drug interactions may make management of inr more difficult. * central nervous system metastases are permitted if previously treated or clinically stable for at least 3 months. * pregnant or nursing patients. * life expectancy \<3 months.
the monocyte subsets in obese patients with and without metabolic syndrome

Conditions: Obesity; Metabolic Syndrome

Summary: obesity is associated with a chronic low-grade inflammation characterized by macrophage infiltration in adipose tissue that induces insulin resistance and the appearance of metabolic syndrome (ms). the aim of the study was the investigation of whether circulating monocyte subsets are differentially regulated in ms.


Eligibility criteria:
inclusion criteria: - exclusion criteria: age less than 18 years old, pregnancy, breast feeding, kidney disease, liver disease, gastrointestinal disease, malignancy, any endocrine disorder or metabolic disease, other than obesity or type 2 diabetes mellitus (t2dm), alteration of body weight (bw) by up of 5% of the initial bw during the last 3 months, any state of stress or systemic inflammation and taking any of the following drugs, within 3 weeks prior to the start of the study: hypolipidemic agents, antidiabetics, drugs for weight loss, nonsteroidal antiinflammatory drugs, glucocorticoids.

Keywords: monocyte subsets obesity metabolic syndrome
preoperative hexakapron reduces bleeding in bariatric surgery

Conditions: Intra-Operative Injury - Other; Post Operative Hemorrhage; Tranexamic Acid

Summary: prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. postoperative venous thromboembolic events will be recorded up to 2 months following surgery.

Eligibility criteria:
inclusion criteria: * morbid obesity * approved and scheduled for laparoscopic sleeve gastrectomy exclusion criteria: * previous bariatric surgery * platelet count under 100,000 * concurrent anticoagulation treatment * previous venous/atrerial thromboembolic event * known allergy to tranexamic acid * history of heparin induced thrombocytopenia * oral contraceptive use * female hormonal replacement therapy * active thromboembolic state * genetic hypercoagulable state

Keywords: morbid obesity sleeve gastrectomy
repeated dosing clinical trial of hl151

Conditions: Rhinitis, Allergic, Perennial

Summary: the purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of talion tab., a ir formulation of bepotastine as reference drug and hl151, a sr formulation of bepotastine as test drug in healthy male adults. additionally the safety and tolerability of two drugs will be evaluated.


Eligibility criteria:
inclusion criteria: 1. healthy male in the age of 19-45 2. body weight ≥ 50kg, bmi 18\~29 kg/m2 3. subject who sign on an informed consent form willingly exclusion criteria: 1. subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease 2. subject with acute disease within 28 days prior to study medication dosing 3. subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug 4. subject with clinically significant chronic disease 5. positive on the test of hbs ag, anti-hcv ab, anti-hiv ab, vdrl 6. use of any prescription medication within 14 days prior to study medication dosing 7. use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing 8. subject with clinically significant allergic disease 9. subject with known for hypersensitivity reaction to bepotastine 10. subject with any of the following conditions in laboratory test * ast/alt \> unl (upper normal limit) x 2 * total bilirubin \> unl x 2 * renal failure with clcr \< 50ml/min calculated on cockcroft-gault \[cockcroft-gault gfr = (140-age) \* (wt in kg) / (72 \*cr)\] * sbp\<100mmhg or ≥160mmhg, dbp\<60mmhg or ≥100mmhg * qtc\>440msec on ecg * serum potassium \ 5.5 meq/l 11. immunological incompetence, immune deficiency or taking immunosuppressants 12. subject who cannot take standard meal 13. subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing 14. subject with blood transfusion within 30days prior to study medication dosing 15. participation in any clinical investigation within 90days prior to study medication dosing 16. continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day) 17. subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator 18. subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing 19. subject who are not using adequate means of contraception 20. subject with genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 21. subject with history of drug abuse or drug addiction