Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of glpg1205 in subjects with active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: * approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking glpg1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment. * during the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of glpg1205 present in the blood (pharmacokinetics) as well as the effects of glpg1205 on disease- and mechanism of action-related parameters (pharmacodynamics) in blood, stool and colonic biopsies will be determined.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 75 years * documented history of uc * presence of active uc for a minimum period of 14 days prior to screening and spread beyond the rectum, mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2 * absence of infectious colitis * tumor necrosis factor alpha (tnfα) inhibitor-naive subjects should have failed at least 1 prior conventional therapy * continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), immunosuppressants and 5-aminosalicylates at stable dose is allowed * female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year * subjects will have to use highly effective contraceptive methods exclusion criteria: * history of sensitivity to any component of the study drug, or a history of drug or other allergy * any concurrent illness, condition, disability, or clinically significant abnormality that, in the investigator's opinion, represents a safety risk for the subject's participation, may affect the interpretation of data, or may prevent the subject from safely completing the assessments * history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gi (other than uc), pulmonary, or metabolic disease * history of active infections requiring intravenous antibiotics within the past 4 weeks prior to screening. * history of malignancy within the past 5 years; presence or history of intestinal malignancy * history of bowel surgery within 6 months prior to screening; history of colon resection with \< 30 cm of the colon remaining * suspicion of crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, diverticular disease-associated colitis, or radiation-induced colitis * subject who has received non-permitted uc therapies within specified timeframes, depending on the medication, as stated in the protocol * subject who is pregnant or lactating

Keywords: moderate to severe ulcerative colitis glpg1205
shade evaluation of monochromatic versus polychromatic layering techniques inrestoration of fractured incisal angle

Conditions: Anterior Teeth

Summary: this clincl trial will be conducted to compare theshade evaluation of monochromatic versus polychromatic layering techniques in restoration of fractured incisal angle

the use of enamel and dentin shades allow us to reproduce anatomical features such as incisal edge translucency, halo effect, other internal colors and pigments such as craze lines, white patches, white horizontal striations . anterior composites usually have small filler particles to increase smoothness, nanotechnology has enabled recent advances in dental composite restorations. as a result , a different category of composite resins has emerged, known as nanocomposites. however polychromatic layering is considered to be technique sensitive, from detection of details to proper reproduction of such fine details. the presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult. the use of monochromatic layering with only body shade can serve as a substitute for enamel and dentin, since it has an intermediate opacity between enamel and dentin , and can serve as an easier option with less technique sensitivity than polychromatic layering. filtek universal as claimed by the company manufacturer to have a "naturalmatch" which is a term that describes the combination of 3m technologies and features present within 3m™ filtek™ universal restorative. it contains nanofillers, pigments and proprietary low-stress monomers which gives filtek™ universal restorative a combination of esthetic and universal opacity which in turn allow shade blending and making the restoration more invisible with surrounding dentition.

Eligibility criteria:
inclusion criteria: 1. patients with fractured incisal angle. 2. vital teeth. 3. anterior permanent teeth. 4. good oral hygiene. 5. co-operative patients approving to participate in the study. exclusion criteria: 1. non vital teeth. 2. severe or active periodontal disease. 3. severe medical complications. 4. uncooperative patients
the effectiveness of cognitive functional therapy in adults with chronic neck pain

Conditions: Chronic Pain

Summary: the aim of this study was to compare the effectiveness of cognitive functional therapy compared with conventional therapy in treating adults with chronic neck pain

after being informed about the study and potential risks, all patients giving written informer consent will undergo 1 week screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility criteria will be randomized in a single- blind manner (assessor), in a 1:1 ration to cognitive functional therapy or conventional therapy twice a week for 8 weeks.

Eligibility criteria:
inclusion criteria: * age 18-64 * pain in neck area for more than 3 months * pain in nprs more than 40/100 * independently mobile (with or without aids), to be capable of participating in a rehabilitation program twice a week exclusion criteria: * serious psychological pathology * recently surgery on shoulder or neck area (\<6 months) * pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months * pregnancy * rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (ra), ankylosing spondylitis (as), psoriatic arthritis, lupus, scheuermann's disease) * progressive neurological disease (e.g. multiple sclerosis (ms), parkinson's disease (pd), motor neuron disease (mnd) * unstable cardiac conditions * red flag disorders like malignancy/cancer, acute traumas like fracture (\<6 months ago) or infection, spinal cord compression/cauda equina

Keywords: chronic neck pain
cholinergic status and the metabolic syndrome

Conditions: Overweight; Obese

Summary: the investigators aims in the current study are to examine whether the cholinergic status should be considered as another risk factor for the metabolic syndrome and it's co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the cholinergic status of overweight and obese adults with and without the metabolic syndrome.

intervention studies have demonstrated that the autonomic disturbances of the metabolic syndrome may be reversible. a reduction in body weight induced by a hypocaloric diet exerts a marked reduction in sympathetic activity in obese people with or without metabolic syndrome. incorporation of regular, moderate intensity aerobic exercise training during a dietary weight loss program does not confer additional benefits on resting sympathetic neural activity, compared with weight loss by diet alone. a new method has been developed to examine the sympathetic-parasympathetic status of an individual - the cholinergic status. cholinergic status represents the total soluble circulation capacity for acetylcholine hydrolysis. higher cholinergic status means the individual is more sympathetic . a cross sectional study that took place in tel aviv sorasky medical center and included 632 participants found that the cholinergic status is related to metabolic syndrome parameters in a dose response manner and that it correlates significantly with glucose,hba1c, lipid profile and hs-crp.

Eligibility criteria:
inclusion criteria: * bmi ≥ 25kg/m2 * stable weight (±1kg)in the previous six months * non smokers exclusion criteria: * type ii diabetes * hypertension pharmacologically treated * cardiovascular disease * renal disease * cirrhosis and end-stage liver failure * thyroid disease * cerebrovascular disease * cancer * autoimmune disease * chronic inflammatory disease * surgery or heart catheterization in the previous six months * use of drugs known to affect measured parameters

Keywords: high complex carbohydrates hypocaloric diet cholinergic status overweight obese
understanding blood pressure changes after birth

Conditions: Hypertension in Pregnancy

Summary: research question how does maternal blood pressure respond in the postpartum period for women who had a hypertensive disorder in pregnancy? aim to evaluate the recovery of maternal blood pressure after a pregnancy affected by new onset hypertension after twenty weeks gestation objectives * to identify rates of persistent hypertension after pregnancies affected by hdp * to assess and compare the accuracy of hbpm against the gold standard of abpm * to assess the maternal acceptance of hbpm and abpm * to explore what cvd-related care information is provided at the 6-8 week gp appointment

this research aims to investigate how women's blood pressure responds after birth and assess the time it takes to return to normal ranges. this will be calculated by participants undertaking three consecutive days of home blood pressure monitoring, every fortnight from two until twelve weeks postpartum. at twelve weeks postpartum, women will have a twenty-four ambulatory blood pressure assessment. this will highlight the prevalence of persistent high blood pressure and how often gps will need to monitor women's blood pressure in the immediate few weeks after birth. women will be asked to complete a questionnaire after their six to eight week gp appointment, assessing if women recall having their blood pressure checked and/or the risks of heart disease explained to them and if they received any lifestyle advice to reduce these risks. women will be asked to complete a second questionnaire at twelve weeks postpartum assessing their acceptance and preference of home and twenty four hour blood pressure monitoring. this research aims to identify any gaps in the current care of women in the postnatal period and use this information to provide better quality of care to women so they can lead healthier lives and reduce their risk of heart disease.

Eligibility criteria:
inclusion criteria: * pregnant women with a confirmed diagnosis of new onset of high blood pressure after twenty weeks gestation * maternal age \>16 years old * mental capacity to give informed consent * ability to be able to communicate to hcp if their bp range is above target (for example women where english is not their first language). exclusion criteria: • pre-existing hypertension
laparoscopic surgical treatment of aorto-iliac occlusive disease

Conditions: Aorto Iliac Occlusive Disease

Summary: patients with aorto-iliac occlusive disease (tasc, type d) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

patients with aorto-iliac occlusive disease (tasc, type d) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality. secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered. besides short form- 36 (sf-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively. early, midterm and long time results shall be followed.

Eligibility criteria:
all patients with a tasc d lesion in the aorto-iliac segment not amenable to or previously unsuccessfully treated by endovascular approach. exclusion criteria: * unsuitable for surgery due to general health status

Keywords: laparoscopic aortic surgery aorto-iliac occlusive disease
using advanced driver assistance systems (adas) as an intervention strategy for drivers with parkinson's disease

Conditions: Parkinson Disease; Driving Impaired

Summary: parkinson's disease (pd) impacts an individual's fitness to drive in a number of ways that increase the crash risk in this population. current vehicle automation technologies are available, that although designed for the general public, may help drivers with pd stay on the roads longer and safer than currently possible. using a driving simulator (a safe and cost-effective alternative with no impact on licensing for participants), this study will investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology (i.e., a simulated lane change assistance system) to address critical driving errors in individuals with mild to moderate parkinson's disease.


Eligibility criteria:
inclusion criteria: * participants must be 21 years of age or older (as a feasibility study, this study will provide the opportunity to participate to those diagnosed with early onset pd) * have been diagnosed with parkinson's disease by a neurologist or movement disorder specialist * currently hold a valid g driver's license * meet provincial visual acuity (20/50 binocular) and visual field (120 continuous along the horizontal meridian with both eyes examined together) requirements for driving * be proficient in english reading and speaking (self-reported). exclusion criteria: * have any other neurological or psychiatric conditions that would interfere with full participation in the study * be taking psychotropic medication(s) that affect their mental and/or physical functioning

Keywords: in-vehicle technologies parkinson's disease driving performance
study for subjects with chronic kidney disease(ckd) not receiving dialysis

Conditions: Chronic Kidney Disease; Kidney Disease

Summary: the proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in ckd patients not on dialysis. anemic patients who are not currently receiving esa therapy will be dosed with darbepoetin alfa q2w for 18 weeks.


Eligibility criteria:
inclusion criteria: - diagnosis of ckd and not expected to initiate dialysis for the duration of the study - estimated glomerular filtration rate (egfr): greater than or equal to 15 ml/min and less than or equal to 60 ml/min measured by the following modified mdrd (modification of diet in renal disease) equation: egfr = 186 x \[serum creatinine\]-1.154 x \[age\]-0.203 x \[0.742 if subject is female\] x \[1.212 if subject is black\] - clinically stable, in the judgment of the investigator - mean hb greater than or equal to 11.0 g/dl to less than or equal to 13.0 g/dl (mean of 2 values drawn at least 3 days apart during the screening period) - transferrin saturation (tsat) greater than or equal to 15.0% - serum vitamin b12 and folate levels above the lower limit of the normal range - receiving stable q2w subcutaneous (sc) doses of aranesp® (darbepoetin alfa). a stable dose is defined as less than or equal to a 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period exclusion criteria: - prior recipient or scheduled to receive a kidney transplant - diastolic blood pressure (bp) greater than 110 mm hg or systolic bp greater than 180 mm hg during screening - acute myocardial ischemia - hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment - parathyroid hormone level greater than 1500 pg/ml - major surgery within 12 weeks before enrollment (excluding vascular access surgery) - currently receiving antibiotic therapy for systemic infection - known positive hiv antibody or positive hepatitis b surface antigen - clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - red blood cell (rbc) transfusions within 8 weeks before enrollment - androgen therapy within 8 weeks before enrollment - systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) - any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - pregnant or breast-feeding women - all subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial - treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study

Keywords: anemia
visualization of the effect of acupuncture on brain serotonin in breast cancer survivors

Conditions: Breast Cancer

Summary: rationale: new imaging procedures, such as single photon emission computed tomography, may help in learning how acupuncture affects serotonin levels in the brain of breast cancer survivors. purpose: this phase i trial is studying the best way to visualize the effect of acupuncture on brain serotonin in breast cancer survivors.

detailed description objectives: i. to determine the feasibility of using \[123-i\] adam serotonin transporter (sert) binding as a putative biomarker to visualize the mechanism of effects of acupuncture for hot flashes involving serotonin. outline: patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. patients undergo single photon emission computed tomography imaging with iodine 123-i adam before and after completion of acupuncture. after completion of study treatment, patients are followed for 4 weeks.

Eligibility criteria:
inclusion criteria: * history of stage i, ii, or iii breast cancer for at least 12 months * have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history * have been receiving endocrine therapy (tamoxifen or aromatase inhibitors for at least four weeks) * experienced hot flashes with a hot flash composite score of 5 or greater per day * hot flashes have been present for at least a month before study entry exclusion criteria: * currently on chemotherapy or radiation therapy as adjuvant treatment * started with hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks * any history of use of psychotropic medication such as ssri use for the past 6 months * any past use of centrally acting medications such as clonidine for the past 6 months * any past diagnosis of a major depressive episode within the last 6 months * any allergy to iodine or shell-fish or radio-nuclear materials * current use of estrogen and/or progestin * pregnancy * breast feeding * women of child-bearing potential not willing to use a medically acceptable form of contraception * current use of any anti-convulsant such as gabapentin * history of cerebral infarction (including lacunar infarct with symptoms \>= 24 hours duration) * history of binswanger's disease (or a history of hypertensive encephalopathy) * history of intracranial hemorrhage * history of head trauma with loss of consciousness * history of encephalitis * history of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide) * uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus) * history of normal pressure hydrocephalus * history of parkinson's or other basal ganglia disease * history of substance abuse in the previous 6 months
efficacy and safety of bi 1356 bs (linagliptin) in combination with metformin in patients with type2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the study is to test the efficacy, safety and tolerability of several doses of bi 1356 bs (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their hba1c levels. in addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. the influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of bi 1356 bs will also be tested in this study.


Eligibility criteria:
inclusion criteria: inclusion_criteria: * male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug * hba1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug * hba1c 7.5 10.0% at screening for patients treated with metformin alone * hba1c 7.5 10.0% at beginning of the placebo run-in phase * age \> 21 and \< 75 years * mi \> 25 and \< 40 kg/m2 (body mass index) exclusion criteria: exclusion_criteria: * clinically relevant cardiovascular disease * impaired hepatic function * renal insufficiency or impaired renal function * treatment with rosiglitazone or pioglitazone within 6 months prior to screening * treatment with insulin within 3 months prior to screening
heart failure and risk of re-admissions determined by abnormal reveal parameters

Conditions: Heart Failure

Summary: the purpose of the heart failure and risk of re-admissions determined by abnormal reveal parameters (hf radar) study is to evaluate the ability of cardiac rhythm (cardiac compass) data to predict future cardiac events in heart failure (hf) patients recently discharged after a hospitalization for heart failure who have or plan to have a implanted loop recorder (ilr), specifically, the reveal xt device. the study will enroll 40 hf patients (with lv function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for heart failure who either have a reveal xt device in place or plan to have the ilr device inserted for clinical indication within 14 days of discharge from the hospitalization. hf patients will be followed for 6 months. device date will be captured during normal clinic visits and at 6 months.


Eligibility criteria:
inclusion criteria: 1. men and non-pregnant/non lactating women ≥ 18 years. 2. admission to hospital or observation unit for worsening heart failure. 3. has a reveal xt device or has plans for a device implant for a clinical indication within 14 days of discharge. 4. ejection fraction ≥40% by echocardiogram within 6 months of enrollment 5. able to participate in the study for at least 6 months. 6. not currently enrolled in another study. 7. able to provide informed consent and complete scheduled study visits. exclusion criteria: 1. has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator) 2. history of permanent atrial fibrillation or atrial flutter. 3. history of uncontrolled hypertension (high blood pressure) 4. has a previously implanted cardiac device (pacemaker or defibrillator) in place. 5. stage iv or v chronic renal dysfunction (estimated gfr \<25 ml/min per 1.73 m2) 6. end-stage (stage d) hf, including chronic ionotropic drugs infusions or left ventricular assist device 7. waiting on the transplant list as an unos status 1a or 1b patient

Keywords: without an indication for icd or crt left ventricular function greater than or equal to 40%