Kornimate/medical-research-clean huggingface dataset:
atri transition rollover study

Conditions: Advanced Stage Solid Tumors

Summary: the main purpose of the study was to monitor the safety of participant receiving long-term treatment of berzosertib as monotherapy.


Eligibility criteria:
inclusion criteria: * participants ongoing treatment in vertex study vx13-970-002. * participant must be able to understand and provide written informed consent. * participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures. exclusion criteria: * participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.

Keywords: ataxia telangiectasia mutated and rad3-related protein inhibitor (atri) m6620 solid tumors
safety and efficacy of the therapeutic vaccine gi-4000 in combination with gemcitabine versus placebo for the treatment of non-metastatic, post-resection pancreas cancer

Conditions: Pancreas Cancer

Summary: the gi-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. patients will be monitored for recurrence as well as safety, and immune responses related to the injections.


Eligibility criteria:
(a few general items required) inclusion criteria: * patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation * \>18 years of age * negative skin test for hypersensitivity to saccharomyces cerevisiae exclusion criteria: * metastatic pancreas cancer patients post-resection * patients with no product-related ras mutation.

Keywords: pancreas cancer resected pancreas cancer non-metastatic pancreas cancer
morbid obesity: effects of conservative treatments and gastric bypass surgery

Conditions: Morbid Obesity

Summary: the purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).

the aim of this study is to evaluate 3 different treatments of obesity with gastric bypass. two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic. sixty patients will participate in each group. behavioural changes and weight loss over 4-5 years will be followed. we will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 40 or bmi \> 35 with complications exclusion criteria: * unstable atherosclerotic disease * psychologically unstable * unable to participate in the training program

Keywords: obesity lifestyle treatment complications endocrine changes lipids c18.654.726.500.495
predictors of postoperative left ventricular function in patients undergoing mitral valve repair for severe degenerative mitral regurgitation

Conditions: Severe Degenerative Mitral Regurgitation

Summary: the aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation. a single center, prospective cohort study


Eligibility criteria:
inclusion criteria: * age 18- 85 years * patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution exclusion criteria: * functional or ischemic mitral regurgitation * presence of relevant (symptomatic) coronary artery disease * inability of exercising on semi supine bicycle
mineralocorticoid receptor, nmda receptor and cognitive function in depression

Conditions: Major Depression

Summary: the steroid hormone cortisol is released in response to stress and acts in the central nervous system upon glucocorticoid (gr) and mineralocorticoid receptors (mr). gr are widely distributed across the brain while mr are predominantly expressed in the hippocampus and prefrontal cortex - two brain areas closely related to memory and executive function. stimulation of mr leads to an increase of glutamate that act on glutamatergic nmda receptors in the hippocampus and prefrontal cortex. in previous studies, the investigators have shown that fludrocortisone, a mineralocorticoid receptor (mr) agonist, improves memory and executive function in depressed patients and healthy controls. however, depressed patients not only exhibit cognitive deficits in traditional neuropsychological domains such as memory or executive function. in addition, there are depression-specific alterations such as cognitive bias and deficits in social cognition, two clinically highly relevant areas. therefore, the specific aims of this renewal proposal are two-fold: * to examine whether beneficial effects of fludrocortisone in depressed patients can be extended to depression-specific cognitive bias and to social cognition * to determine whether beneficial effects of fludrocortisone depend on nmda-receptor function and whether these beneficial effects can be enhanced by nmda receptor stimulation. the investigators hypothesize that fludrocortisone will improve cognitive bias and social cognition in depressed patients and that its beneficial effects depend on the nmda receptor. therefore, the investigators further hypothesize that the effects of fludrocortisone can be enhanced by co-administration of the partial nmda receptor agonist d-cycloserine. the study not only advances current knowledge by further examining the mechanism of action by which mr stimulation exerts beneficial effects on cognition but extends these effects to depression-specific cognitive bias and alterations in social cognition. furthermore, a potential interaction between mr and nmda receptors is highly clinically relevant given the promising results with nmda receptor antagonists in the treatment of major depression.


Eligibility criteria:
inclusion criteria: * age 18-65 years * depressed male and female patients according to dsm-v \& minimum of 17-items hamilton depression score of 18 * healthy controls * informed consent signed exclusion criteria: * current use of antidepressants, antipsychotics, or mood stabilizer * relevant medical or neurological disorders * pregnancy or unsure contraception * relevant psychiatric comorbidity (bipolar or psychotic disorders) * active alcohol or other substance abuse/dependance
pelvic girdle pain early postpartum: underlying condition and associated factors

Conditions: Pelvic Girdle Pain; Pubic Symphysis Diastasis; Diastasis Recti

Summary: background: pregnancy-related pelvic girdle pain (pgp) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (sij). the pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. the endurance capacity for standing, walking, and sitting is diminished. the diagnosis of pgp can be reached after exclusion of lumbar causes. the pain or functional disturbances in relation to pgp must be reproducible by specific clinical tests. lack of accurate and early diagnosis of the pgp reasons postpartum may contribute to development of chronic condition, lowering quality of life years after delivery. objectives: the aim of the project is to evaluate the underlying cause of the severe pelvic girdle pain postpartum (whether it is real pgp or diastasis pubic symphysis) and to assess the differences between females with severe postpartum pgp, mild and moderate pgp and with no pgp in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea alba dysfunction, factors associated with labour and maladaptive mental processing (catastrophizing). materials and methods: because of low incidence of researched conditions, a case control study will be the study design of choice. the subjects with pgp will be matched with those with no pgp. subjects' assessment will consist of palpation and ultrasonography evaluation of diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis (inter-pubic width) and mental processing (catastrophizing assessed with pain catastrophizing scale) analysis. factors connected with labour (time from epidural anaesthesia injection to full dilatation and delivery) will be also investigated. expected results: to the investigators' knowledge, postpartum pelvic girdle pain has not been extensively studied so far. the study will bring information about the possible underlying cause of postpartum pgp: whether it is pgp or diastasis pubic symphysis.


Eligibility criteria:
inclusion criteria: * natural labour or vacuum extractor or forceps * for the study group - pain due to pgp confirmed with dedicated functional tests * for control group with no pain - no pain due to pgp * agreement to participate exclusion criteria: * diseases that can mimic pgp f.ex. scheuermann disease, rheumatoid arthritis, ehler's-danlos syndrome, hip dysplasia * major peri-partum events like internal haemorrhage, pelvic fracture
antenatal platelet response on aspirin and correlation with hdp (hypertensive disorders of pregnancy)

Conditions: Preeclampsia

Summary: this proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (hdp) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. the results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of hdp.

this proposal has four aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hdp through a prospective, cohort study using pharmacodynamics, pharmacogenomics and bioinformatics. the results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of hdp. aim 1: establish pharmacodynamic endpoints for aspirin in prevention of hdp hypothesis: pfa-100 closure time and serum thromboxane/urinary dehydrothromboxane-b2 (dtx-b2) are pharmacodynamic markers of aspirin response and are predictive of hdp high risk pregnant patients. aim 2: explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of hdp hypothesis: platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of hdp. aim 3: assess the utility of circulating microrna as a marker of aspirin response in pregnancy and risk of hdp hypothesis: quantitative expression of selected mirnas are biomarkers for response to aspirin therapy and risk of hdp. aim 4: evaluate aspirin pharmacokinetics/pharmacodynamics hypothesis: individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin

Eligibility criteria:
inclusion criteria: * pregnant singleton, \<16 weeks' gestation * at least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome exclusion criteria: * contraindication to aspirin * current or planned use of any other anticoagulation * use of aspirin in pregnancy prior to enrollment * known platelet disorder at time of enrollment
treatment targets in rheumatoid arthritis: tetra-study

Conditions: Rheumatoid Arthritis

Summary: there is currently no cure for rheumatoid arthritis (ra), but many treatment options are available. the central aim of ra treatment is lowering disease activity. the proactive treatment strategy called treat to target (t2t) includes measuring disease activity, setting a target and adjusting treatment accordingly until the goal is reached. t2t has proven to be superior to usual care, but there is much debate regarding the most optimal treatment measure and target. the disease activity score with 28-joint counts and c-reactive protein (das28crp) low-disease activity (lda) target and the more stringent simplified disease activity index (sdai) remission target are the best validated targets. especially the das28crp is the most commonly used in research and practice, whereas the sdai remission target is most recommended. the european alliance of associations for rheumatology (eular) recommends to strive for remission, whereas the american college of rheumatology (acr) recommends to strive for lda. in patients with new and established ra, the (cost)effectiveness of aiming for remission compared to lda when starting and tapering antirheumatic drugs has not been directly compared. this study therefore aims to directly compare two t2t strategies, aiming at das28crp-lda and sdai remission, in patients with established ra.


Eligibility criteria:
inclusion criteria: * diagnosis of ra (according to the 2010 or 1987 acr/ eular classification criteria and/or clinical diagnosis) * (starting) use of a dmard * aged 16 years or older * at most low disease activity, operationalised as das28-crp \<3.5 (das28 crp 2.9 cut off for low disease activity with measurement error 0.6) or sdai \<19 (sdai 11 cut off for low disease activity with measurement error of 8). a state of low disease activity is required at inclusion, as for ra patients in moderate or high disease activity there is no equipoise on the best course of action (treatment needs to be escalated). * fluency of dutch or english, both written and verbally; able to fill in questionnaires * provided informed consent exclusion criteria: * clinical deep remission, operationalised as sdai \<3.3 or das28-crp \<2.4, and an taper attempt in the past 2 years that was discontinued due to occurrence of flare. * fewer than 3 dmard treatment options left for this patient (severe difficult-to-treat or refractory ra) * current severe comorbidity or other serious life-shortening conditions hampering trial participation * inability to comply with the study protocol or to provide informed consent with regard to intervention control and measuring outcomes
association between qeeg measure and post-operative cognitive dysfunction (pocd) and postoperative delirium (pod)

Conditions: Cognitive Dysfunction

Summary: cognitive complications after major surgery are a common phenomenon. the incidence of postoperative cognitive dysfunction (pocd), may vary from 5% to 25% in adult patients, depending on different risk factors. age has been strongly associated with cognitive complications. pocd is a prolonged decline in cognitive function that appears after surgery as compared with preoperative functions. in order to classify evaluate pocd, it requires at least 2 measurements. a baseline, completed before surgery and a second measurement, post surgery. in light of the high prevalence of pocd and the difficulties in its prediction, neuroindex has developed a quantitative eeg system and software that aim to produces risk predictor index (is) for pocd. this study aims to evaluate the relationship between the software produced predictor index and the actual pocd events. the qeeg will be monitored during the surgery in addition to the routine clinical practice in operating rooms. pocd will be evaluated using montreal cognitive assessment test (moca) prior and post surgery.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 65 or above. * subjects with american society of anesthesiologists physical status i-iii. * subjects who are intended to undergo cardiac surgery (cabg or valve replacement) under general anesthesia. * surgical procedures scheduled for over 30 minutes. * lack of significant hearing disturbances. * subjects with ability to read and understand the consent form. exclusion criteria: * significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium. * profound dementia or aphasia that interfered with the assessment of cognitive dysfunction (positive delirium in cam-icu). * patients with a history of stroke. * any documented major neurologic or psychiatric dysfunction. * pregnant women. * long term use of sedative-hypnotic drugs and antidepressant drug. * subjects with scalp or skull abnormalities (s/p brain surgery, cranial implants).
magnetic resonance-guided high-intensity focused ultrasound treatment of locally advanced pancreatic cancer

Conditions: Pancreas; Cancer; Locally Advanced Pancreatic Cancer; Non-invasive Treatment

Summary: patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. ultrasound-guided high intensity focused ultrasound (hifu) ablation has been introduced as a feasible treatment option in these patients. however, in other anatomical regions us-guided hifu has been replaced by the more accurate mr-guided focused ultrasound (mrgfus) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. the aim of this study is to explore feasibility and clinical performance of mrgfus ablation of unresectable pancreatic cancer. two are the main end-points: pain palliation and local tumor control. as compared to conventional us-guided hifu, mrgfus could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic mrgfus ablation have been reported.


Eligibility criteria:
inclusion criteria: * biopsy proven unresectable pancreatic adenocarcinoma; * unable or not willing to undergo chemo-radiation therapy * celiac plexus alcoholization failed to control pain symptoms exclusion criteria: * contraindication to mr or general anesthesia

Keywords: locally advanced pancreatic cancer noninvasive treatment high intensity focused ultrasound magnetic resonance
study to assess the safety and efficacy of lebrikizumab (ly3650150) in adolescent participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is an open-label, single arm study of 52 weeks duration. the study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (ad) who are candidates for systemic therapy.


Eligibility criteria:
inclusion criteria: 1. male or female adolescent (≥12 years to \<18 years, and weighing ≥40 kg). 2. chronic ad (according to american academy of dermatology consensus criteria) that has been present for ≥1 year before the screening visit. 3. eczema area and severity index (easi) score ≥16 at the baseline visit. 4. investigator global assessment (iga) score ≥3 (scale of 0 to 4) at the baseline visit 5. ≥10% body surface area (bsa) of ad involvement at the baseline visit. 6. history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. exclusion criteria: 1. participation in a prior lebrikizumab clinical study. 2. treatment with the following prior to the baseline visit: 1. an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer. 2. dupilumab within 8 weeks. 3. b-cell-depleting biologics, including to rituximab, within 6 months. 4. other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer. 3. treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study. 4. uncontrolled chronic disease that might require bursts of oral corticosteroids. 5. evidence of active acute or chronic hepatitis 6. history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening. 7. history of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. 8. pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Keywords: eczema dermatitis dermatitis, atopic skin diseases
tricaprilin in age-associated memory impairment

Conditions: Age-Associated Memory Impairment

Summary: the purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.

one physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. the impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. however, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. the purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders. study participants will be 120 men and women aged 50-85 who have been diagnosed as having age-associated memory impairment (aami). during the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. each participant will be seen six (6) times: at screening; baseline; treatment days days 30, 60, 90; and 14 days after the conclusion of treatment (day 104).

Eligibility criteria:
inclusion criteria: * complaints that memory has declined since young adult life * scores on standardized tests that are at least one standard deviation below the mean score of young adults exclusion criteria: * dementia, including alzheimer's disease and mild cognitive impairment (mci) * drugs that impair cognition * psychiatric conditions that may impair cognition (e.g.,depression etc.)

Keywords: mild cognitive impairment cognition disorders nutritional supplement dietary supplement