Kornimate/medical-research-clean huggingface dataset:
skin transcriptional profiles in psoriatic patients under adalimumab biotherapy

Conditions: Chronic Plaque Psoriasis

Summary: the expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.the investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful adalimumab biotherapy. skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. the investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. the modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response psoriasis area and severity index.


Eligibility criteria:
inclusion criteria: * patients with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy. * adalimumab prescribed in usual practice exclusion criteria: * patients presenting a contraindication to the use of adalimumab: hypersensibility in adalimumab or in one of the excipients. * patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections * presenting patients one cardiac insufficiencies moderated in severe * patients under anakinra or abatacept * current participation in another study of clinical research
robot assisted laparoscopic hysterectomy vs. abdominal hysterectomy in endometrial cancer

Conditions: Endometrial Cancer

Summary: the purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.

if detailed description is requested, please contact sponsor.

Eligibility criteria:
inclusion criteria: * over 18 years of age. * scheduled to total hysterectomy + bilateral salpingooophorectomy (bsae) and peritoneal lavage because of endometrial carcinoma, international federation of gynecology and obstetrics (figo) stage 1, grade 1 and 2, with diploid dna profile (i.e. low risk profile). * who (world health organisation) performance status ≤ 2. * proficiency in swedish * accept to participate in the study and has signed written informed consent document. * the operation should be considered possible to be perform laparoscopically and by laparotomy through a low transverse abdominal wall incision. exclusion criteria: * the operation is anticipated to comprise more than the hysterectomy + bsae. * a midline incision is planned for the laparotomy. * contraindications towards spinal anesthesia with intrathecally applied morphine. * physically disabled women who cannot be expected to be mobilized in accordance to the fast track program in a way similar to what is expected from not-physically disabled women. * mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial. * severe psychiatric disease or on medication for psychiatric disease so that the physician consider participation in the trial inappropriate.

Keywords: endometrial cancer robot assisted laparoscopy abdominal hysterectomy fast track program
dose optimization for safe and efficient fluorescein angiography (dose study)

Conditions: Retinal Disease

Summary: this study aims to compare the efficacy and safety of fluorescein angiography using 1ml versus 3ml of 10% fluorescein dye.

the investigators will recruit patients who need fluorescein angiography for their retinal diseases. the investigators will collect data on image quality and complications.

Eligibility criteria:
inclusion criteria: * patients who required an fluorescein angiography for their retinal diseases (eg. diabetic retinopathy, retinal vein occlusion, etc.) exclusion criteria: * media opacity (corneal opacity, vitreous hemorrhage grade 2 or more, cataract locs iii grade 3 or more) * known history of adverse reactions to fluorescein * dilated pupil diameter less than 5 mm
circadian timing, information processing and energy balance study

Conditions: Overweight and Obesity

Summary: this study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.

the goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. the investigators propose that circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. there is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. insulin resistance and increased caloric intake over time lead to increased bmi and body fat. in this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. this study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.

Eligibility criteria:
inclusion criteria: * demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy; * able to read and write in english; * bmi 25-39.9 (overweight, class one obesity, or class two obesity) exclusion criteria: * high risk or presence of sleep disorders (obstructive sleep apnea (osa), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight osa screening; * diagnosed with diabetes or hba1c\>7 at screening or taking medications known to affect glucose; * history of cognitive or neurological disorders; * presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report; * unstable or serious medical illness; * overnight shift work or travel over 2 time zones in the past 2 months; * use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily nsaids; * current smoking; * daily caffeine intake \>300 mg; * pregnant or lactating; * currently on a restrictive of special diet.
safety and efficacy of shed for decompensated liver cirrhosis

Conditions: Liver Cirrhosis

Summary: this study is an prospective, randomized control study. patients with decompensated cirrhosis will be randomly assigned to receive 4 times of shed treatment plus standard medical care(treatment）or standard medical care (control). the primary outcome is meld-na score. secondary outcomes are child-pugh, liver function, life quality and survival.

at present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.stem cells from human exfoliated deciduous teeth (shed) has been shown to be safe and effective for liver diseases. randomization controlled studies are needed to confirm the long term effect of shed treatment for liver cirrhosis. the present study aimed to investigate the safety and efficacy of shed in hepatitis b related liver cirrhosis patients. this study is an prospective, randomized control study. patients with decompensated cirrhosis will be randomly assigned to receive 4 times of shed treatment plus standard medical care(treatment）or standard medical care (control). shed infusion (1x10e6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.the primary outcome is meld-na score. secondary outcomes are child-pugh, liver function, life quality and survival.

Eligibility criteria:
inclusion criteria: 1. aged 18-70 years 2. hbv-related liver cirrhosis with presentations of decompensation 3. antiviral treatment with nucleotide drugs for more than half a year and hbv dna is less than the minimum detection limit; 4. child-pugh score b and meld-na score≤25 5. written consent exclusion criteria: 1. hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis 2. child-pugh score a or c 3. hepatocellular carcinoma or other malignancies 4. cirrhosis or liver failure caused by non-hepatitis b 5. pregnancy or breastfeeding 6. severe bacteria infection,coinfection with hiv or other viral hepatitis. 7. history of severe allergy to biological products or history of immunization within half a year 8. patients or family members refused to participate in the study 9. drug abuse or alcohol abuse 10. other candidates who are judged to be not applicable to this study by doctors.

Keywords: liver cirrhosis stem cell therapy
efficacy of the buzzy® device on the prevention of health care induced pediatric pain in a vaccination center

Conditions: Intravenous Injections; Vaccination

Summary: in vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. the topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers. a distraction and local anesthesia (cold and vibration) based medical device (buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services. research on this device has been scarce to date. three of them have shown an efficacy of buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. an ongoing study will assess the buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. to date, no study has compared buzzy® to topical anesthetic cream on healthy children in a vaccination center. the research team has formulated the following hypothesis: the buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. the aim of this study is to evaluate the efficacy of the device buzzy® on vaccination and venipuncture induced pain in a vaccination center.


Eligibility criteria:
inclusion criteria: any child who: * requires a venipuncture or a vaccination in a vaccination center * is 4 to 15 years old * is affiliated to the public social security * speaks french or is assisted by an translator in the language of the child * has given his oral consent and whose parents have given it exclusion criteria: any child who: * suffers from sickle cell anemia * has a contraindication to use lidocaine patch * requires a bacille de calmette et guérin (bcg) vaccine or tuberculin test * takes part in another research * has already participated to this study for another nursing care. * refused to participate or whose parents refused * has neurological or psychiatric disorders * has a nerve damage or an abrasion of the skin in terms of puncture or injection area. * under trusteeship or guardianship (unaccompanied foreign minors).

Keywords: buzzy anesthetic cream pediatric pain venipuncture vaccination vibration cold distraction vaccination center
the effect of high frequency oscillation on biological markers of lung injury

Conditions: Acute Respiratory Distress Syndrome

Summary: mechanical ventilation, although life-saving, damages the lungs through what is known as ventilator-induced lung injury. high frequency oscillation ventilation has been proposed as a ventilation method that may be less injurious to the lungs than conventional mechanical ventilation and may lead to better patient outcomes. to evaluate this hypothesis, the oscillate trial is comparing outcomes in patients with the acute respiratory distress syndrome randomized to high frequency oscillation ventilation vs conventional lung protective ventilation. the present study is a substudy of the oscillate trial looking at biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled in oscillate. the objective is to look for biochemical evidence of decreased ventilator-induced lung injury in patients treated with high frequency oscillation ventilation relative to conventional ventilation.


Eligibility criteria:
inclusion criteria: * enrollment in oscillate (nct01506401) exclusion criteria: * inability to provide blood samples

Keywords: acute respiratory distress syndrome high frequency oscillation ventilation ventilator-induced lung injury biomarkers
study of pcur-101 in combination with adt in patients with mcrpc

Conditions: Prostate Cancer

Summary: this is an open label, non-randomized, phase i, dose escalation/dose expansion study in cohorts of patients with metastatic crpc at screening. dose escalation uses a 3+3 design to determine the maximum tolerated dose (mtd). once the mtd is defined, the dose expansion phase is used to define the recommended phase 2 dose.

dose escalation phase: eligible patients will enter the study and start receiving daily doses of pcur-101 during cycle 1. subsequent dose cohorts will receive the next higher dose of pcur-101 according to a 3 + 3 design until the mtd is determined. patients may remain on these treatment cycles if they do not progress or experience any dose limiting toxicities (dlts). dose expansion phase: once the mtd has been determined, approximately 18 patients in 3 cohorts will be enrolled for further evaluations of safety, pk, and preliminary clinical activity during successive 28-day cycles in the dose expansion phase: expansion cohort 1 will receive pcur-101 at the mtd, expansion cohort 2 will receive pcur-101 at one dose level lower than the mtd and dutasteride once daily, and expansion cohort 3 (6 patients) will receive pcur-101 at one dose level lower than the mtd in patients about to start abiraterone (1000 mg qd) and prednisone (5 mg twice daily \[bid\]) as their standard of care.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prostate cancer * demonstrates metastatic crpc * castrate level of serum testosterone at screening * adequate hematologic, renal, and hepatic function * ecog status ≤1 * life expectancy of at least 3 months * no more than one prior course of cytotoxic chemotherapy exclusion criteria: * pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology * visceral metastasis excluding lymph nodes * use of opiate analgesics for prostate cancer pain or non-cancer pain * other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks * history of bleeding disorder * history of seizure disorder * concomitant use of warfarin * prior exposure to pcur-101 * history of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia * received wide-field external beam radiation therapy within 4 weeks * moderate to severe neuropathy
surgical techniques in diabetes mellitus-ii and obesity. metabolic surgery study (mss)

Conditions: Diabetes Mellitus; Obesity

Summary: the aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type ii diabetes mellitus and obesity (bmi\> 30).


Eligibility criteria:
inclusion criteria: * bmi 30-40 * diabetes mellitus type ii less than 10 years of evolution. * anti-gad, anti-pancreatic islets negative antibodies. * c peptide normally between 0.9 and 4. * glycosylated hemoglobin greater than 6.5%. * less than 5 years of use insulin. exclusion criteria: * cirrosis hepática. * coagulopathies. * type 1 diabetes. * hiv positive. * stomach or small intestine previous surgeries . * diseases of the exocrine pancreas: pancreatitis, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis. * endocrinopathies: acromegaly, glucagonoma, cushing's syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldosteronoma. * genetic syndromes with diabetes.

Keywords: metabolic surgery
more frequent in-center hemodialysis in pediatric end stage renal disease

Conditions: Pediatric End Stage Renal Disease; Hemodialysis

Summary: a health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. survival for these children has not improved over the last 20 years. these data indicate that the current dialysis treatment strategy is unacceptable. this research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.


Eligibility criteria:
inclusion criteria: * current outpatient esrd pediatric patients, 3-21 years old, receiving in-center chronic hd. * patients have to be on chronic hd for at least 2 months before eligibility exclusion criteria: * patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months * patients scheduled to be switched to peritoneal dialysis in the next 6 months * patients currently receiving \>3 days per week of hemodialysis * patients currently receiving \>12 hours per week of hemodialysis * anyone \<3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg * patients \>21 years of age at enrollment * patients receiving concomitant peritoneal dialysis * patients with \<2 months on chronic hd * patients with a temporary or femoral dialysis catheter * patients who are not hypertensive (both not on blood pressure medication and with a sbp \<95th percentile for age, sex, and height) * patients enrolled in an investigational drug trial involving blood pressure medication or any other clinical trial potentially affecting the primary outcome of the study patients listed for a deceased donor transplant will not be excluded.

Keywords: hemodialysis pediatric outcomes comparative effectiveness end stage renal disease
cholecystectomy could be performed in older adults with acute cholecystitis

Conditions: Acute Cholecystitis

Summary: the goal of this retrospective cohort observational study is to learn about the long-term and short-term effects of cholecystectomy in people aged 80 or over the age of 80, who have mild to moderate acute cholecystitis. the main question it aims to answer is: does cholecystectomy bring harm or benefit to people aged 80, or over the age of 80, who have mild to moderate acute cholecystitis? people who received cholecystectomy are compared to those who did not, for short- and long-term outcomes, with a follow up period for 18 months.

all data were collected from shuang-ho hospital electronic medical record.

Eligibility criteria:
inclusion criteria: * acute cholecystitis patients aged 80 years or older exclusion criteria: * grade iii acute cholecystitis * concurrent cholangitis, common bile duct stones, pancreatitis, gallbladder cancer, hepatocellular carcinoma, periampullary cancer * received other operations at the same admission other than cholecystectomy * discharged against advice of physician * received further management at another hospital for acute cholecystitis

Keywords: acute cholecystitis aged cholecystectomy
the contribution of incretin hormones to the amelioration of glucose metabolism after roux-en-y gastric bypass

Conditions: Type 2 Diabetes Mellitus

Summary: the study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. the hypothesis of this study is that increased glucagon-like peptide-1 (glp-1) secretion explains the amelioration in insulin secretion after roux-en-y gastric bypass (rygb) surgery.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of \> 110 mg/dl * subjects registered to receive a roux-en-y gastric bypass (rygb). exclusion criteria: * subjects taking thiazolidinediones * subjects with active systemic illness * subjects with active microvascular or macrovascular complications of their diabetes * for female subject: positive pregnancy test at the time of enrollment in study

Keywords: gastric bypass bariatric surgery glucose metabolism
a single-center, double-blind (db) study of mem 3454 on p50 sensory gating and mismatch negativity in schizophrenia patients

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effects of nicotinic alpha-7 mem 3454 on p50 sensory gating in patients with schizophrenia. the hypothesis is that mem 3454 will normalize the p50 ratio. data produced in this study will provide useful information regarding the value of p50 as an efficacy biomarker, and provide evidence for the optimal dosing of mem 3454 for additional p50 studies.


Eligibility criteria:
inclusion criteria: * 1. male or female subjects between 18and 55 years of age. * 2. fluent in english, even if english is not the primary language. * 3. able to provide informed consent. * 4. dsm iv-r primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (scid ct). * 5. few or no extra-pyramidal symptoms(eps)at screening,defined as sas \< 6. * 6. negative urine drug screen (uds). * 7. negative cotinine test. * 8. clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. at least one month on the same dose of antipsychotic medication. exclusion criteria: * current risk of suicide, or history of suicidal behavior within the last 6 months. * hospitalized for psychiatric symptoms in the past 3 months. * other psychiatric diagnoses. * substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the scid-ct. * currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including varenicline (chantix). * any medical condition, as judged by the investigator, which may interfere with the subjects' participation in this study.

Keywords: schizophrenia p50 sensory gating mismatched negativity