Kornimate/medical-research-clean huggingface dataset:
interoceptive nutritional processing in healthy participants and patients with binge-eating-disorder

Conditions: Food Habits; Binge-Eating Disorder

Summary: binge-eating-disorder (bed) is a common eating disorder characterized by recurring episodes of uncontrollable eating. the underlying neural mechanisms are largely unknown. however, dysfunctional hormonal satiety signaling as well as dysfunctional neural processing of food cues are discussed as possible casual factors in the development and maintenance of this disorder. additional research is needed to specify the exact contribution of these observations and how they interact with each other. accordingly, the current study plans to investigate metabolic gut-brain signaling to better understand the underlying causes of abnormal eating behavior. to this end, 25 healthy normal weight control participants as well as 25 patients with bed will be recruited. the responsivity of the hypothalamus (i.e., the core region of homeostatic control) and its interaction with the mesocorticolimbic reward system will be assessed by applying a single-blind, randomized, crossover design of intravenous infusion of glucose or nacl. this approach allows the study of gut-brain signaling to the hypothalamus and the reward system by controlling for sensory aspects of food intake (sight, smell, and taste). the interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. fmri with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be employed. a better understanding of the underlying psychobiological mechanisms of bed is a fundamental requirement for the development of improved prevention and treatment strategies


Eligibility criteria:
inclusion criteria: 1. patients that meet the diagnostic criteria for bed 2. over age of 18 years. 3. right-handedness. 4. normal or corrected-to-normal vision. 5. no other lifetime or current medical illness that could potentially affect appetite or body weight exclusion criteria (for all participants): 1. history of head injury or surgery 2. history of neurological disorder 3. severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse) 4. smoking 5. borderline personality disorder 6. current psychotropic medication 7. inability to undergo fmri scan (e.g. metallic implants, claustrophobia, pacemakers) 8. pregnancy

Keywords: fmri interoceptive food processing
observational study on quality of life of patients receiving nab-paclitaxel/gemcitabine first line therapy, including a translational program

Conditions: Metastatic Pancreatic Cancer

Summary: current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine vs. gemcitabine mono therapy, but no data are available yet on the quality of life (qol) under this combination therapy. in the framework of a german multicenter prospective, observational study ('qolixane'), detailed qol-data are now collected. qol development under treatment will be analyzed and data will be compared to existing data of the gemcitabine mono therapy. qol and course of therapy are collected using the eortc c30 questionnaires once a month over a 6-month period. additionally patients are requested to answer a supplementary questionnaire addressing e.g. fears related to qol deterioration and side effects of chemotherapy. primary endpoint is the proportion of patients with maintained global health status/qol at 3 months (10 points threshold). 600 patients shall be enrolled at about 90 study sites in germany.


Eligibility criteria:
inclusion criteria: * metastatic pancreatic carcinoma * no previous therapy in the metastatic stage * planned firstline therapy with nab-paclitaxel and gemcitabine exclusion criteria: * previous therapy in the metastatic stage * patient unable to understand the study and to give informed consent * patient unable to answer quality of life questionnaires

Keywords: pancreatic cancer metastatic
new combination inhaler (flutiform hfa mdi 100/10 µg and 250/10 µg) versus fluticasone and formoterol administered alone, and placebo in patients with moderate to severe asthma

Conditions: Asthma

Summary: the purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug flutiform with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.


Eligibility criteria:
ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring inclusion criteria: * history of asthma for at least 12 months. * documented use of inhaled corticosteroid for at least 4 weeks prior to screening visit demonstrate fev-1 of 40-80% of predicted normal values at screening and baseline visit. * documented reversibility of 15% within 12 months of screening visit or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation or nebulized albuterol administration). * symptoms of asthma during run-in. * females of childbearing potential must have a negative urine pregnancy test at screening and baseline visits. females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception * must otherwise be healthy. * provide written informed consent. wishes of minors must be respected. exclusion criteria: * life-threatening asthma within past year or during run-in period. * history of systemic corticosteroid medication within 3 months before screening visit. * history of omalizumab use within past 6 months. * history of leukotriene receptor antagonist use, e.g. montelukast, within past week. * current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. * upper or lower respiratory infection within 4 weeks prior to screening visit or during run-in period * significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[copd\], cystic fibrosis, bronchiectasis). * known human immunodeficiency virus (hiv)-positive status. * smoking history equivalent to "10 pack years". * current smoking history within 12 months prior to screening visit. * current evidence or history of alcohol and/or substance abuse within 12 months prior to screening visit. * patients who are confined in institution.

Keywords: asthma fluticasone propionate formoterol fumarate pressurized metered dose inhaler hydrofluoroalkane moderate-severe asthma
effects of remote ischemic preconditioning during free flap reconstruction

Conditions: Remote Ischemic Preconditioning

Summary: remote ischemic preconditioning (ripc) has been revealed organ-protective effect in many previous clinical settings including coronary intervention or cardiovascular surgery. however its protective role during free flap reconstructive surgery in head and neck cancer patients has not yet been elucidated. the purpose of the current study is to evaluate the effect of ripc on tissue oxygen saturation and skin temperature of the flap, as well as its organ-protective effect using langendorff isolated heart ischemia-reperfusion model.

patients undergoing free flap reconstructive surgery for head and neck cancer will be randomized to either remote ischemic preconditioning (ripc) group or control group. on the day of surgery, after induction of anesthesia, ripc, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmhg) followed by 5-min reperfusion at upper arm, or sham-ripc (pressure \< 10 mmhg) will be induced in the ripc or control group, respectively. before completion of surgery, ripc or sham-ripc will be repeated. tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1. as a sub-study, blood samples will be obtained before and after ripc/sham-ripc. from them, plasma dialysate will be prepared to use for langendorff isolated heart model. myocardial infarct size of langendorff rat heart will be compared between the groups to evaluate organ protective effect of ripc during free flap reconstuctive surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing free flap reconstructive surgery exclusion criteria: * bmi \ 35 kg/m\^2 * av fistula at arm, any reason to protect arm * vascular abnormality or discomfort at arm * peripheral vascular disease, peripheral neuropathy, or coagulopathy * uncontrolled diabetes mellitus * preoperative use of beta-blocker * history of radiation therapy * refuse to enrol

Keywords: remote ischemic preconditioning free flap reconstruction tissue oxygen saturation
evaluation of the standard catheter-directed thrombolysis effectiveness in intermediate-high-risk pulmonary embolism patients

Conditions: Pulmonary Embolism Acute

Summary: a single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (pe). patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (sсdt) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group


Eligibility criteria:
inclusion criteria: * age \> 18 years * computed tomography angiography (cta) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) pe and symptom onset \< 14 days prior * intermediate-high risk pe with a rv dysfunction (rv/lv diameter ratio \>1 on tte or cta) and an elevated biomarker (hs-troponin or nt-probnp) level * signed informed consent exclusion criteria: * high-risk pulmonary embolism * thrombus in the heart chambers on tte * absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding currently or within the previous 6 months, hemorrhagic diathesis; diseases of the central nervous system (including neoplasms, aneurysm, surgery on the brain or spinal cord); intracranial (including subarachnoid) hemorrhage currently or in history, suspicion of hemorrhagic stroke; severe uncontrolled arterial hypertension; major surgery or major trauma within the previous 3 months, recent traumatic brain injury; labor during the previous 10 days; severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; confirmed peptic ulcer of the stomach or duodenum within the last 3 months; arterial aneurysms, congenital anomalies of arteries/veins; * haemoglobin level \< 70 g/l, platelet count ≤ 100 x 109 * allergic to alteplase or ufh or contrast allergy * pregnant or breastfeeding * clinically significant malignancies

Keywords: acute pulmonary embolism catheter-directed thrombolysis anticoagulant therapy
use of a lifeline graft in the a-v shunt model

Conditions: ESRD; Hemodialysis

Summary: this study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (tebv) called lifeline™ used as an arteriovenous fistula for dialysis access.


Eligibility criteria:
inclusion criteria: * have signed an informed consent * patients ≥ 21 years old * patients not candidates for a brescia-cimino a-v fistula (own vessels) * have an av shunt or fistula that will likely fail within 12 months because of: * signs of clinical dysfunction: increment of venous pressure, limited site of puncture, stenosis, aneurysm dilatations that cannot be surgically repaired or by other media, or * previous angioplasty, or * previous thrombolysis * fall into category of asa grade 2 or below (or uk equivalent) * are willing and able to comply with 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and 52 week follow up and able to comply with biannual follow up thereafter. exclusion criteria: * a need for urgent surgery * penicillin allergy * patients with uncontrolled hypertension * morbid obesity (\> 300 lbs) * active systemic infection * contraindication for anticoagulation * coagulopathy * acute renal failure * connective tissue diseases (i.e. marfan's syndrome) * pregnant or nursing * life expectancy \< 1 year * participation in another study involving an investigational device or new drug * other medical, social or psychological issues that, in the opinion of the principal investigator, preclude them from receiving the treatment and the procedures/evaluations of the post-operative follow up * inability or unwillingness to comply with the scheduled follow-up visit

Keywords: lifeline tissue engineered blood vessel a-v shunt
safety and tolerability evaluation of low-dose radiation in combination with cs1001 in relapsed sclc patients

Conditions: Relapsed Small Cell Lung Cancer

Summary: a phase ia/ib safety and tolerability evaluation of low-dose radiation in combination with cs1001 in relapsed sclc patients

this is a dose-escalation study of low-dose radiation in combination with cs1001 in relapsed sclc patients. patients are assigned to 3 treatment groups received from 3 gy to 15gy, to determine the safety, tolerability and the maximal tolerant dose. biomarkers and immunological markers are collected and analyzed as well.

Eligibility criteria:
inclusion criteria: 1. patients with histologically or cytologically confirmed ls-sclc or es-sclc and experienced progression since first-line standard platinum containing dual-drug chemotherapy. 2. patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons 3. at least one extracranial measurable lesion (recist v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed. 4. patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months. 5. no radiotherapy contraindications were judged by the radiologist 6. ecog performance status of 0 or 1. 7. patients with life expectancy ≥ 3 months. 8. patients must have adequate organ function. 9. fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 6 months after last study drug administration. exclusion criteria: 1. subjects known to have primary cns tumors or meningeal metastases or unstable cns metastases. 2. patients with active autoimmune diseases or history of autoimmune diseases should be excluded. 3. patients who have received immune checkpoint proteins/antibody/medicine (including pd-1, pd-l1, etc) for treatment. 4. known history of hiv infection. 5. subjects with active chronic hepatitis b or active hepatitis c . 6. patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. 7. known history of alcoholism or drugs abuse. 8. subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.
the effects of different anesthesia methods on perioperative neurocognitive disorders in the elderly

Conditions: PND

Summary: perioperative neurocognitive disorders(pnd) is a common perioperative complication among the elderly, especially in the plastic surgery. different anesthesia methods have different incidences of pnd, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. we will apply a psychometric battery test which contain different cognitive domains to estimate the incidence of pnd at a week a month and a year after surgery with different anesthesia methods. study has showed that functional magnetic resonance imaging (fmri) could detect a cognitive decline through spontaneous neuronal activity in the cortex and hippocampus. in our study, multi-mode imaging technology is used to conduct in-depth research on mri and make correlation analysis with cognitive function.


Eligibility criteria:
inclusion criteria: * aged 60-85years * asa i-iii * received elective surgery of unilateral lower extremity orthopedics * the anesthesia lasted more than 2 hours exclusion criteria: -

Keywords: pnd,anesthesia method, elderly
open-label, follow-up of doravirine/islatravir (dor/isl 100 mg/0.75mg) for participants with human immunodeficiency virus-1 (hiv-1) infection (mk-8591a-033)

Conditions: HIV-1 Infection

Summary: the safety and tolerability of mk-8591a, a 2-drug fixed dose combination (fdc) of doravirine (dor 100mg) and islatravir (isl 0.75mg) will be evaluated in participants with human immunodeficiency virus -1 (hiv-1) who were treated with dor and isl in earlier clinical studies.


Eligibility criteria:
inclusion criteria: * is currently receiving dor 100 mg/isl 0.75 mg adult fdc tablet in an msd-sponsored clinical study and has completed the last treatment visit. * is considered by the investigator to have derived clinical benefit from receiving dor/isl and for whom further treatment with dor/isl is considered clinically appropriate. * female is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (wocbp); or is a non-pregnant wocbp who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines) exclusion criteria: * is taking or is anticipated to require any prohibited therapies.
screening for first trimester's hyperglycemia in high and low risk pregnancy

Conditions: Screening for Hyperglycemia in First Trimester in High and Low Risk Pregnancy

Summary: glucose intolerance is the commonest medical disorder complicating pregnancy. hyperglycemia increases the risk of delivering a large for gestational age newborn (lga) and related complications such as operative delivery, birth trauma and the poor adaptation of the newborn . maternal risks of gdm include also polyhydramnios, preeclampsia, premature delivery, prolonged labor, uterine atony, postpartum hemorrhage, infection and progression of retinopathy which are the leading global causes of maternal morbidity and mortality .detection of women at higher risk for gdm early in pregnancy is a desirable goal because interventions such as diet, medication, and exercise may be applied earlier in pregnancy and potentially can reduce later development of gdm or its associated morbidities. most gdm cases are diagnosed after mid-gestation following an abnormal glucose challenge test (gct). however, about 10% of patients with gdm can be diagnosed in the first trimester.


Eligibility criteria:
inclusion criteria: * • history of gestational diabetes in previous pregnancies * polycystic ovaries syndrome * history of macrosomic baby in previous pregnancies * past history of late third trimester fetal demise * past history of polyhydramnios * overweight /obese women women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders multi fetal pregnancies past history of shoulder dystocia past history of preeclampsia family history of diabetes in addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history. exclusion criteria: * all patient not have thev inclusion criteria
dronabinol after arthroscopic surgery

Conditions: Knee Osteoarthritis; Knee Injuries; Meniscus Tear; Synovitis of Knee; Knee Ligament Injury; Chondral Injury of Left Knee; Chondral Injury of Right Knee; Loose Body Knee

Summary: the purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. the investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. if this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.


Eligibility criteria:
inclusion criteria: * age 18 years or older * patient who will undergo arthroscopic surgery of the knee including, but not limited to, * meniscectomy * synovectomy * chondroplasty * loose body removal exclusion criteria: * patients under age 18 years * patients who cannot provide consent * patients who are pregnant, breast feeding, or are trying to become pregnant during the study period * patients with an allergy to any of the study drugs * patient who are lactose-intolerant * revision surgery * open surgery * comorbidities preventing surgery * patients with a history of mania, depression, or schizophrenia * patients taking any of the following drugs or supplements * anticholinergic agents * benzodiazepines * central nervous system depressants * droperidol * hydroxyzine * levomepromazine or methotrimeprazine * monoamine oxidase inhibitors * ritonavir * selective serotonin reuptake inhibitors * sympathomimetics * st. john's wort * current diagnosed alcohol or drug abuse * patients who cannot or will not abide by the medication restrictions listed below medication restrictions * participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (cbd) in any form during the treatment period * participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen

Keywords: knee arthroscopy
first line iressa™ versus carboplatin/paclitaxel in asia

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected nsclc patients with the objective of demonstrating non-inferiority.


Eligibility criteria:
inclusion criteria: * locally advanced stage iiib not amenable to local therapy or stage iv (metastatic) nsclc with adenocarcinoma histology. * never smokers or light ex-smokers.(ceased smoking at least 15 years before day 1 of study treatment and 10 pack-years or fewer) exclusion criteria: * had prior chemotherapy, biological (including targeted therapies such as egfr and vascular epidermal growth factor (vegf) inhibitors) or immunological therapy. * pre-existing idiopathic pulmonary fibrosis evidence by ct scan at baseline.

Keywords: nsclc gefitinib
3-point with 1-point mesh fixation in tapp for inguinal hernia

Conditions: Inguinal Hernia; Chronic Pain; Seroma; Recurrent; Infections; Hematoma

Summary: this study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in tapp surgery for patients with inguinal hernia. the main outcome include seroma, chronic pain, recurrence, et al.


Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia according to preoperative physical examination and imaging examination. the inclusion criteria were as follows: primary inguinal hernia. exclusion criteria: * age below 18 years or older than 80. recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias. patients not suitable for general anesthesia. patients requiring open surgery; patients requiring emergency surgery loss to follow-up or communication difficulties, or poor compliance.