Kornimate/medical-research-clean huggingface dataset:
a study to evaluate tace sequential tislelizumab as adjuvant therapy in participants with hcc at high risk of recurrence after curative resection

Conditions: Hepatocellular Carcinoma; Adjuvant Therapy

Summary: this is an open label, multi-center, phaseⅱstudy to evaluate the efficacy and safety of tace sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (hcc) patients who are at high risk of recurrence after curative resection.

hepatocellular carcinoma (hcc) is a malignant tumor with high morbidity and mortality. surgical resection is the most important radical treatment. however, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. how to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring. until now there is no standard postoperative adjuvant therapy. previous studies have shown that tace combined with pd-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of tace sequential tislelizumab as adjuvant therapy in hcc patients who are at high risk of recurrence after curative resection.

Eligibility criteria:
inclusion criteria: * subjects with a histopathological or cytologically diagnosis of hcc * subjects who have undergone a curative resection * high risk for hcc recurrence as protocol defined * no previous systematic treatment and locoregional therapy for hcc * child-pugh score, class a * ecog performance status 0 or 1 * full recovery from surgical resection * adequate organ function * absence of major macrovascular invasion * no extrahepatic spread * life expectancy of at least 6 months exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc or mixed cholangiocarcinoma and hcc * evidence of residual, recurrent, or metastatic disease * known history of serious allergy to any monoclonal antibody * history of hepatic encephalopathy * tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein * portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment * any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * any active malignancy within 2 years prior to the start of treatment * active or history of autoimmune disease * other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * prior therapy with an anti-pd-1, anti-pd-l1, or anti pd-l2 agent or other immunotherapy * pregnant or lactating women

Keywords: hepatocellular carcinoma immunotherapy transarterial chemoembolization recurrence antineoplastic agents, immunological antineoplastic agents
polarization sensitive retinal tomography for glaucoma diagnosis

Conditions: Glaucoma

Summary: the proposed human clinical studies have three main objectives: 1. to determine reproducibility of peripapillary birefringence maps and identify features that measure the health of the rnfl. 2. to determine the normal variation in the birefringence maps with age. 3. to develop and test a classifier for glaucoma based on the birefringence maps using a case-control clinical trial. this study is a case-control study intended to optimize feature selection for a future multi-center blinded study. the proposed clinical study does not measure conversion from normal to glaucoma.

this study evaluates rnfl birefringence in normal and glaucoma human subjects: the primate experimental glaucoma study will characterize the spatial and temporal dynamics of rnfl birefringence during glaucoma progression and establish an initial feature set and classifier for a case-control clinical study. the case-control clinical study will refine the initial feature set and classifier and use roc analysis to test sensitivity and specificity of the feature set and classifier for discriminating between normal and glaucomatous human eyes. the feature set and classifier formulated in the case-control clinical study is a prerequisite for planning a large-scale longitudinal study. a large-scale longitudinal study to compare different approaches for detecting early glaucoma is outside the scope of the proposed research. moreover, considering the large number of subjects required for statistical significance when the conversion rate from ocular hypertensive to glaucoma is low (\<10%/year), a longitudinal study is best performed in a multi-institution clinical trial over several years.

Eligibility criteria:
inclusion criteria: patient age between 40 and 80, visual acuity score of 20/40 or better; spherical refraction within ± 5 diopters, cylinder refraction within ± 3 diopters, ability to cooperate with study procedures and personnel and to perform tests reliably. case-control assignment for the human clinical trials is based on medical and ocular history and on a comprehensive eye examination (including intraocular pressure history, standard disc photography and humphrey-zeiss 24-2 visual field test) by a glaucoma specialist. - exclusion criteria: discernable anomaly of the anterior chamber, uveitis, significant opacification of the cornea or crystalline lens, eyes with secondary glaucoma, eyes with pigmentary or pseudoexfoliation glaucoma, concurrent active eye disease in the study eye that may affect intraocular pressure or its measurement, patients on kidney dialysis, eyes with proliferative or severe nonproliferative retinopathy, retinal detachment, retinitis pigmentosa, or other significant retinopathy, eyes with field loss attributed to a non-glaucoma condition, dilated pupil diameter less than 4mm, and visual fields \< 20 degrees. -

Keywords: glaucoma neurotubules birefringence retinal nerve fiber layer (rnfl)
nursing follow up in geriatric oncology : tracking time of caregiver exhaustion risk

Conditions: Exhaustion; Geriatric Disorder

Summary: in geriatric oncology, caregivers are submitted to a risk of exhaustion. to investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. the recruitment will take place during the oncogeriatric assessment consultation.

the primary purpose aim to describe the caregiver of patient with 70 years old or more, suffered from cancer and for which a treatment is planned, along with their long term evolution. the secondary purposes are to : * assess the exhaustion level felt by this caregiver * assess the medium delay of caregiver exhaustion apparition * relate factors associated to the medium delay of caregiver exhaustion apparition during patient chemotherapy and/or radiotherapy treatment

Eligibility criteria:
inclusion criteria: * caregiver of : * patient with 70 years old or more, suffered from cancer and receiving specific cancer treatment (chemotherapy or radiotherapy ) * patient evaluated in a specific comprehensive oncogeriatric assessment * informed patient given a non-opposition form * patient affiliated to a social protection scheme * informed consent given by the caregiver exclusion criteria: * patient and caregiver under judicial protection * caregiver with understanding difficulties with french language * psychological, familial, social or geographic conditions that avoid a good clinical trial continuity * patient with ≤ 18 years old * caregiver and patient with significant cognitive troubles * caregiver and patient located in institution during inclusion period

Keywords: cancer patient oncology caregiver
safety, tolerability and efficacy of isis-gccrrx in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of isis-gccrrx in combination with metformin versus placebo + metformin


Eligibility criteria:
inclusion criteria: * male or female, age 18 to 75 * bmi greater than or equal to 25 * hba1c greater than or equal to 7.5% and less than or equal to 10.5% * type 2 diabetes mellitus and on stable dose of oral metformin * agree to conduct home-based (fasted) blood glucose testing as directed exclusion criteria: * clinically significant abnormalities in medical history or physical exam * show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results * history of renal transplantation or renal dialysis * history of liver disease * history of greater than 3 episodes of severe hypoglycemia within 6 months of screening * use of oral anti-diabetic medication other than metformin within 3 months of screening * use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or acth therapy within 3 months of screening * history of diabetic ketoacidosis * current or previous diagnosis of gilbert's disease * any other significant illness or condition that may interfere with the patient participating or completing the study * inability or unwillingness to comply with protocol or study procedures

Keywords: type 2 diabetes mellitus t2dm
glad: dose-finding, efficacy, and safety of az 242 (tesaglitazar) in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. the study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are 30 to 80 years of age * female patients: postmenopausal or surgically sterile * diagnosed with type 2 diabetes with c-peptide levels \> 0.8 ng/ml * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), or to other ppar g or ppar a and g agonists. * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above 1.2 mg/dl * received any investigational product in other clinical studies within 30 days * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Keywords: tesaglitazar type 2 diabetes
autologous stem cell therapy for fracture non-union healing

Conditions: Non-union of Fractures

Summary: do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous bmscs or carrier alone (control). secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.

Eligibility criteria:
inclusion criteria: * an established non-union according to the us food \& drug administration criteria14. * non-union following fracture of tibia or femur suitable for synthetic bone grafting. exclusion criteria: 1. skeletal immaturity. 2. pregnant or breast-feeding. 3. non-union following pathological fractures. 4. positive to hepatitis b, hepatitis-c or hiv. 5. infection during bmsc culture.

Keywords: non-union fracture bone marrow stem cells
time restricted eating for weight loss maintenance

Conditions: Obesity

Summary: the aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (tre) interventions on weight loss maintenance (wlm). this study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the nyu langone health weight management program and ny-move! weight management clinic at the manhattan va. measurements will occur at baseline, 4 and 12 weeks. participants will be randomized with equal allocation to 2 groups: (1) tre6 or (2) tre10. the tre6 will restrict their eating window to 6 hours per day and the tre10 to 10 hours per day.


Eligibility criteria:
inclusion criteria: * ≥5% non-surgical weight loss from nyulh-wmp and ny-move! endocrinology weight management clinic in the last 3 months * bmi between 20.5 - 45 m/kg2 * between the ages 25 to 65 years old * own a smartphone or willing to use a smartphone if provided for self-monitoring * eating window \>12 h per day * \<150 mins/wk of physical activity * log at least 2 meals into the smartphone app on ≥5 days exclusion criteria: * \ 65 years of age * body weight in excess of 400lbs (181.4kg) * pregnant, trying to get pregnant or breastfeeding * previous or planned bariatric surgery * previous or current history of eating disorder * ongoing participation in another weight-management research study * continued participation in a weight loss program other than the proposed study * currently on appetite suppressants * currently following intermittent fasting or skipping meals * eating window \<11h 59min/day * perform overnight shift work more than once a week * work that includes travel across one or more time zones * currently on anti-obesity medications (aoms) such as, glp-1 analogues (exenatide, tirzepatide, semaglutide, liraglutide) and pancreatic lipase inhibitors (orlistat/xenical and alli) * prescribed medications expected to result in weight loss such as orlistat, naltrexone, bupropion, lorcaserin, phentermine, topiramate, or liraglutide, and who are unwilling to delay treatment with these medications for the next 3 months * unable or unwilling to provide informed consent * unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment) * unwilling to accept randomization assignment * unable to log at least 2 meals into the smartphone app on ≥5 d during the screening period * have type 1 or other conditions that would preclude restricted eating windows * have type 2 diabetes with a hba1c \>7.0% on medications except for metformin alone * narcolepsy * active cancer * organ dysfunction * current steroid use * daytime sleepiness with the epworth sleepiness scale \>10 * severe insomnia with a score ≥15 on the insomnia severity index * \>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)

Keywords: weight loss maintenance intermittent fasting time-restricted eating weight-reduced state
pilot study: mindfulness-based cognitive therapy as a tool for prophylactic mood stabilizing therapy in bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to evaluate the feasibility and short-term efficacy of mbct as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder.


Eligibility criteria:
inclusion criteria: * males or females (\>18 years old) * bipolar disorder (as per the structured clinical interview for dsm disorders (scid)(22)), euthymic state: complete remission for at least four weeks ((montgomery and asberg rating scale (madrs) ≤ 6 and item-1 (depressed mood) = 0 and no suicidal ideations (madrs(item-10) \< 4) * must have had at least 3 depressive phases in the last 5 years * cooperative and willing to complete all the aspects of the study and especially the 45 minutes of exercise per day * must have completed a secondary v (11th grade) education exclusion criteria: * other active psychiatric disorders (as per the scid) * rapid cycling * bipolar disorder secondary to a medical condition or substance-induced mood disorder * suicidal ideations (madrs(item 10)\>3) * active i.e. unstable and/or untreated medical condition * substance abuse (defined as per dsm-iv) in the last four weeks * cbt (no more than four sessions (ever)) * previous participation in a psychoeducation group within the last 6 months * current other psychotherapy (more than once a month) * practice of meditation (more than once a month) during the last two years * practice of yoga (more than once a week) during the last year * previous participation in a mbsr group * electroconvulsive therapy (ect) within the last three months

Keywords: bipolar disorder bipolar depression mindfulness-based cognitive therapy mbct maintenance euthymic efficacy feasibility
relative contributions of red cell catabolism and dietary absorption to fetal iron accretion during pregnancy

Conditions: Iron Deficiency

Summary: the two specific aims of this study are 1) to assess the relative contributions of two major maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental transfer of these two iron sources in pregnant women and adolescents during the last trimester of pregnancy.

pregnant women and adolescents (n=24) will be recruited when entering prenatal care. they will be invited to participate in a longitudinal study comparing the relative contribution of the two major maternal iron sources, i.e. maternal dietary iron intake and maternal red blood cell iron recycling, to fetal iron accretion during pregnancy. at about 15 weeks of gestation, participants will consume an oral dose of a stable iron isotope (57fe as ferrous sulfate) to enrich their red blood cells (rbcs) with 57fe. maternal blood samples will be collected at 4 times during pregnancy to monitor changes in blood 57fe concentrations. in the third trimester of pregnancy, women will consume a dose of a different iron isotope (58fe as ferrous sulfate) as dietary nonheme iron. cord blood samples and placental tissue will be obtained at delivery to determine how much of the dietary iron (58fe) and rbc iron (57fe) was transferred to the fetus and how much of each isotope was retained in the placenta. placenta tissue samples will also be used to assess placental expression of iron transporters in relation to the amount of each iron isotopes transferred to the fetus. circulating iron status indicators and regulators will be measured in all maternal and cord blood samples to examine the effect of iron status on placental transfer of iron derived from the diet vs. rbc during pregnancy.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * non-smoker * no pre-existing medical complications (such as hiv-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) exclusion criteria: * complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia) * individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study

Keywords: pregnancy stable isotopes red blood cell catabolism
using neuroimaging to understand children's mental health and treatment outcomes

Conditions: Anxiety; Depression; Trauma; Behavior Problems

Summary: the study will compare the impact of child steps versus usual school-based therapy on neural and companion behavioral measures of self-regulation.

this project will implement and evaluate the child steps treatment approach as compared to "treatment as usual" (known as usual care or uc) through a randomized controlled trial (rct) at eight k-8 public schools. the steps model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists to guide their selection and sequencing of the steps modules. the project will examine: (a) whether self-regulation skills at baseline are associated with baseline patterns of mental health and school problems; (b) whether self-regulation skills at baseline predict degree of improvement during treatment; (c) whether self-regulation skills improve from pre-to post treatment, and whether extent of this improvement differs by treatment condition; and (d) whether self-regulation improvement (from pre-to-post treatment) mediates the long-term benefit of treatment.

Eligibility criteria:
inclusion criteria: 1. enrolled in grades 3-7 2. have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress 3. clinically elevated problem levels on the internalizing, externalizing, anxious-depressed, withdrawn-depressed, aggressive behavior, or rule-breaking behavior scales of the child behavior checklist or youth self-report or on the ucla post-traumatic stress disorder reaction index. exclusion criteria: 1. mental retardation 2. pervasive developmental disorder 3. eating disorder 4. children for whom attention problems or hyperactivity are the primary referral concern 5. active psychosis and/or a suicide attempt in the previous year to participate in the two neuroimaging tasks (emotion regulation task; emotional go/no go task), participants must be healthy (no major medical illness), right-handed, fluent in english, have no history of neurological impairment (including but not limited to history of loss of consciousness for great than 20 minutes, seizures, stroke, etc.), have normal or corrected to normal vision, and have no contra-indications or risk factors for mri research (such as braces or metal implants).

Keywords: anxiety depression trauma behavior problems evidence-based treatments manualized treatments cognitive-behavioral therapy youth mental health self-regulation neuroimaging