Kornimate/medical-research-clean huggingface dataset:
fmri and appetite-related hormones pre and post obesity surgery

Conditions: Obesity

Summary: the investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery. obese persons between the ages of 18 \& 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.

currently, the only effective long term treatment for severe obesity is bariatric surgery.2 nearly 200,000 procedures are performed each year, with this number increasing rapidly.3 however, the mechanisms of reduced food intake and weight loss after obesity surgery, particularly rouen-y gastric bypass (rygb), are not well understood. this study utilizes functional magnetic resonance imaging (fmri) and measures of appetite-related gut peptide levels pre and post bariatric surgery to investigate the neurological and hormonal mechanisms involved in initiation and termination of meals. the general objective is to better understand the physiological changes resulting in weight loss from obesity surgery, particularly roux-en-y gastric bypass (rygb). the main hypothesis is that the differential mechanisms of action in rygb will alter the signals involved in the initiation and termination of meals, reflected by changes in both peptide hormone levels and regional brain activity in response to foods. the investigators anticipate that the trigger for meal initiation by potent food stimuli will be diminished following rygb, as indicated by reduced brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (ofc). rygb will be compared to: a. gastric banding (gb), representing the restrictive component of surgery, which itself enhances fullness, but in the absence of any rerouting of the gut, should result in fewer changes in gut peptide levels and brain activation; b. weight loss (wl) on a formula diet over 3 mo, which represents the weight loss component of surgery; and c. no treatment (nt), a general control, with no gastric restriction or weight loss. these group comparisons will help parse the contributions of rygb surgery to weight loss. the plan is to study clinically severe obese subjects (s's) pre surgery, and at 3 and 18 mo post surgery. the investigators will examine: 1) fmri brain activation in response to food stimuli and 2) appetite-related gut peptide levels before and following a fixed meal prior to the fmri. the findings should reveal potential mechanisms associated with the changes in appetite, eating behaviors, and body weight, both during the rapid weight loss phase at 3 mo post surgery as well as when weight typically stabilizes at a nadir at 18 mo post surgery. the investigators plan to enroll 160 patients: 40 with rygb, 40 gb, 40 wl, and 40 nt (4-arm study). s's will be within the bmi range of 40-50 and matched across groups for bmi, gender (3:1, f:m), and bed status.

Eligibility criteria:
inclusion criteria: * bmi range 35-50 kg/m\^2 exclusion criteria: * diabetes, * smoking, * pregnancy

Keywords: obesity bariatric surgery weight loss fmri gut peptides
clinical evaluation of the powerglide™ pro midline catheter

Conditions: Pain; Catheter Infection

Summary: clinical evaluation of the powerglide™ pro midline catheter in patients with vascular diseases

clinical evaluation of the powerglide™ pro midline catheter in patients with vascular diseases. the selected patients are in need of a long-term i.v. therapy for reasons as antibiotic therapy or alprostadil therapy. the midline catheter is a device, which is placed via seldinger's technique to a vein usual on the upper extremity under ultrasound-control.

Eligibility criteria:
inclusion criteria: * need for i.v. therapy longer than 7 days * poor peripheral vein status * administration of alprostadil exclusion criteria: * pending dialysis * allergy to catheter material * minor age * life threatening conditions * requirement for central venous catheter
standard temodal (temozolomide) regimen versus standard regimen plus early postsurgery temodal for newly diagnosed glioblastoma multiforme (study p05572)

Conditions: Glioblastoma

Summary: the primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.


Eligibility criteria:
inclusion criteria: only the patients who meet all these criteria can be enrolled in the study: * patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere. * gross total resection or partial resection (imaging) \>70%. * at least be capable to obtain a tissue sample for mgmt analysis during surgery. * chemo-radiotherapy to be expected from week 5 (day 29) after surgery. * age \>=18 and \<=70 years. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * life expectancy \>=9 months. * laboratory test values must satisfy the following criteria: * absolute neutrophil count \>=1.5 x 10\^9/l; * platelet count \>=100 x 10\^9/l; * hemoglobin \>=80 g/l; * blood urea nitrogen and creatinine \< 1.5 x upper limit of normal value (uln); * total bilirubin and direct bilirubin \< 1.5 x uln; * alanine aminotransferase and aspartate aminotransferase \< 3 x uln; * alkaline phosphatase \< 2 x uln. * patients must be willing to provide written informed consent. * patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception. exclusion criteria: patients will not be enrolled if any of the following criteria apply: * patient with previous or current malignancies (except melanoma) at other sites, unless disease free for at least 3 years. * patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery. * patient with recurrent or multiple malignant glioma (including gliomatosis cerebri). * patient with metastatic lesions at the subtentorial or outside of calvaria. * patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor. * patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping. * patient with acute infections requiring intravenous antibiotics. * frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction). * known human immunodeficiency virus (hiv)-positive or acquired immune deficiency syndrome (aids)-related illness. * woman who is pregnant or breastfeeding. * patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents. * patient with any other conditions under which investigators think the subject is not suitable for enrolment, such like having known that the subject may not have good compliance.
sthlm3-mr: comparing standard with targeted prostate biopsies

Conditions: Prostate Cancer

Summary: prostate cancer is a leading cause of cancer death among men in the western world. early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. the sthlm3 trial has paved the way for improved specificity in early detection of prostate cancer using the blood-based sthlm3 test for identifying men at increased risk of harbouring significant prostate cancer. targeted prostate biopsies based on mri images have been shown to increase sensitivity of high-grade cancers compared to the currently used systematic biopsies, but existing evidence are contradictory and not free from methodological flaws. the primary aim of sthlm3-mr/fusion is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers by introducing targeted prostate biopsies and comparing to traditional prostate biopsies. the primary endpoints are the number of performed biopsies and the number of detected high-grade prostate cancers defined as gleason 7 or higher. secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. additional aims include to assess the health economic consequences of implementing mri based prostate cancer diagnostics and to improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in stockholm. the sthlm3-mr/fusion project will be performed in two separate phases, analyzed separately. based on power calculations, approximately 500 planned for prostate biopsies will be included in the first phase. men who have previously been diagnosed with prostate cancer may not take part in the study. the study period of phase 1 is march 2016 to january 2017. the second phase will start in autumn 2016 and end by december 2017.


Eligibility criteria:
inclusion criteria: * men age 45-75 years referred to any of the participating urological centers for prostate biopsies exclusion criteria: * a prior diagnosis of prostate cancer (icd-9 c61) * severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia * contraindications for magnetic resonance imaging (mri) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
intervention evaluation weh (women who have experienced homelessness)

Conditions: Posttraumatic Stress Disorder

Summary: homelessness and associated traumas disproportionately impact women relative to men. women who have experienced homelessness (weh) universally face traumatic stress, often before becoming homeless and while experiencing homelessness. for weh who are incarcerated, additional trauma may occur while in correctional settings. black weh are disproportionately impacted by trauma, homelessness, and incarceration, as is related to structural and individual racism and discrimination (racial trauma).

homelessness and associated traumas disproportionately impact women relative to men. women who have experienced homelessness (weh) universally face traumatic stress, often before becoming homeless and while experiencing homelessness. for weh who are incarcerated, additional trauma may occur while in correctional settings. black weh are disproportionately impacted by trauma, homelessness, and incarceration, as is related to structural and individual racism and discrimination (racial trauma). in our stepwise, multi-year research process, across hundreds of interviews, weh identified trauma as their priority health issue. in response to a dearth of culturally acceptable trauma care models, our team pilot tested narrative exposure therapy (net)-a brief, human rights-informed treatment for complex ptsd in resource-limited settings. in this randomized controlled trial (rct), we seek to understand whether supplementing nurse-delivered net with peer/program support will strengthen its effects on ptsd, co-occurring symptoms, and social determinants of health outcomes compared to an attentional control, while optimizing implementation outcomes.

Eligibility criteria:
inclusion criteria: * self-identifies as a woman * ≥18 years of age * history of homelessness or currently experiencing homelessness (hrsa criteria) * affected by trauma-related distress (≥1 on life events checklist + ptsd checklist for dsm-5 ≥28) * at least 75% of the sample must self-identify as black/african american exclusion criteria: • impaired decisional capacity (uc-san diego brief assessment ≤14.5)
outcome of bariatric surgery in patients with bmi greater than 60 .

Conditions: Bariatric Surgery Candidate

Summary: patients that underwent any type of bariatric surgery with bmi more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction.

patients that underwent bariatric surgery for bmi =60 or greater were considered for the study. the type of surgery were be analyze related to weight loss. complication and operation difficulty will be assessed. co morbidities and treatment results post surgery will be considered as also, need for revisional surgery/

Eligibility criteria:
inclusion criteria: bmi above 60 any bariatric surgery performed including revision exclusion crite ria: tourist patients patients under 18 years old -
map-guided preemptive therapy of agvhd by ruxolitinib

Conditions: GVHD; Acute Stem Cell Transplant Complications

Summary: the goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-hsct). the main question it aims to answer is: • effect of magic algorithm probability guided preemption of agvhd with ruxolitinib on prevention of severe agvhd. participants will take ruxolitinib with the dose of 5mg bid for 28 days. if no signs of agvhd, the dose of ruxolitinib is gradually tapered within the following 16 days. researchers will compare patients who don't receive preemption of agvhd with ruxolitinib to see if there is an improvement in severe agvhd.


Eligibility criteria:
inclusion criteria: * any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood). * any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable. * gvhd prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide. * the use of serotherapy to prevent gvhd (e.g., antithymocyte globulin) prior to day 3 post-hct is permitted * direct bilirubin must be \<2 mg/dl unless the elevation is known to be due to gilbert syndrome within 3 days prior to enrollment. * alt/sgpt and ast/sgot must be \<5 x the upper limit of the normal range within 3 days prior to enrollment. * signed and dated written informed consent obtained from patient or legal representative. exclusion criteria: * patients who develop acute gvhd prior to start of study drug * patients at very high risk for relapse post hct as defined by very high disease risk index * patients participating in a clinical trial where prevention of gvhd is the primary endpoint * uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis) * patients who are pregnant * patients on dialysis within 7 days of enrollment * patients requiring ventilator support or oxygen supplementation exceeding 40% fio2 within 14 days of enrollment. * patients receiving investigational agent within 30 days of enrollment. however, the principal investigator (pi) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of ruxolitinib
assessment of liver and spleen fibrosis in patients with gaucher disease using fibroscan

Conditions: Fibrosis

Summary: the investigated cohort will examine liver and spleen fibrosis in patients with gaucher disease divided into two groups, naive gd patients and gd patients treated with ert. as liver biopsy in these patients not recommended because the risk of bleeding using fibroscan is a safe with diagnostic accuracy regarding the liver (\& spleen) fibrosis. estimating spleen fibrosis is an innovative approach in liver disease and gaucher. the evaluation of fibrosis with this new and safe method could avoid complications antiinvasive procedure in gd patients. the addition of fibrosis biomarkers will help for patients score evaluation. the finding of liver and spleen stiffness will be evaluated in native and ert treated gaucher patients in order to assess ert effect on fibrosis. the aims are: 1) to assess liver and spleen stiffness measurement using fibroscan and evaluate liver and spleen fibrosis in patients with gd. 2) to compare the elastography in two cohorts of gd patients: ert treated and naïve gd patients and two control groups of patients: healthy and non alcoholic steatohepatitis (nash) patients. 3) to correlate the elastography findings with clinical and laboratory data in the four patient groups focusing on gaucher disease manifestations and gd severity. to compare the elastography in gd naïve and ert treated patients.

the investigated cohort will include 4 groups of patients 20 probands in each group including: 1) naïve gd patients 2) gd treated with ert 3) healthy control 4) patients with nonalcoholic steatohepatitis( nash) which are followed at hepatology unit of the ziv hospital and healthy controls. serum fibrosis markers will be tested including: bilirubin ,ggt, haptoglobin,ast,alt .the findings of spleen and liver fibrosis will be correlated with disease severity usingzimran's severity score index (ssi) liver function tests , serology for viral hepatitis, gdbiomarkers, hemoglobin, platelet levels, and a gd severity score. protein c will be measured in all groups of patients protein c activity as it may be used as a sensitive marker of hepatocellular damage even in those patients with mild liver affection .also patients with cirrhosis possess an imbalance in pro-coagulant versus anticoagulantactivity due to increased factor viii and decreased protein c.

Eligibility criteria:
inclusion criteria: * diagnosis of gaucher in treatment and without treatment. * healthy control. * patients with non alcoholic steatohepatitis( nash) which are followed at hepatology unit. exclusion criteria: • active liver disease ,cirrhosis patients.

Keywords: fibrosis gaucher disease
a study of olaratumab and doxorubicin in participants with advanced soft tissue sarcoma

Conditions: Sarcoma, Soft Tissue

Summary: the purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin. the safety and tolerability of these drugs will be studied. each participant will complete two 21-day cycles in a fixed order. participants who complete cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met. screening is required within 21 days prior to first dose. part b was added in october, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin. participants may only enroll in one part.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of a diagnosis of soft tissue sarcoma (sts) that is advanced and/or metastatic * have the presence of measurable and/or nonmeasurable disease * have given written informed consent prior to any study-specific procedures * have a performance status of less than or equal to 2 on the eastern cooperative oncology group (ecog) scale * have discontinued previous treatments for cancer and recovered from the acute effects of therapy * are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures exclusion criteria: * have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for noncancer indications * have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones * have active central nervous system (cns) metastasis. participants with treated cns metastases are eligible for this study if they are not currently receiving corticosteroids * have unstable hepatic disease with a grade equal to or greater than child-pugh b * have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (hiv) or viral (a, b, or c) hepatitis * have a history of another primary cancer, with the exception of a) curatively resected nonmelanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry * have a history of chronic heart failure or left ventricular dysfunction * have a resting heart rate of less than (\ )100 bpm * have a history of radiation therapy involving the mediastinal/pericardial area. previous radiation therapy is allowed but must not have included whole pelvis radiation
role of left stellate ganglion block in offering myocardial protection in on-pump mitral valve replacement? a histopathological and clinical assessment

Conditions: Open Mitral Cardiac Surgery

Summary: can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? a histopathological and clinical assessment.


Eligibility criteria:
inclusion criteria: * adult population of both sex, between 25-50 years, will undergo elective on pump mitral valve replacement exclusion criteria: * -combined valve replacement ( mitral and aortic or mitral and tricuspid valves replacement). * emergency valve replacement ( stuck valve, infective endocarditis). * pre-operative cardiomyopathy (ejection fraction less than 45%). * recent myocardial infarction ( within 6 months) * redo mitral valve replacement. * pre-operative pacing, or cardioverter, any form arrhythmia ( tachy or brady). * previous history of carotid endarterectomy or presence of carotid stent. * on thrombolytic therapy. * severe chronic obstructive airway disease, * patient refusal
evaluation of vildagliptin (galvus®) as add-on to insulin in new-onset type 1 diabetes mellitus

Conditions: Type 1 Diabetes; Insulin Dependent Diabetes; Juvenile Onset Diabetes Mellitus; Autoimmune Diabetes

Summary: the primary objective of this study is to evaluate the action of dpp-iv inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months). the secondary objectives are: 1. to define the immune and inflammatory profile 2. to define the secretion of glucagon and glp-1 3. to assess the glycemic variability

clinical and autopsy studies show that up to 30% of patients with type 1 diabetes mellitus show a detectable β-cell function at clinical diabetes. the preservation of this endogenous insulin production, even if it is small, can have a great impact on the evolution of long-term disease through improving glycemic control, reducing chronic diabetes complications and hypoglycemia. strategies for preventing the loss of beta cell are based on stopping the autoimmune process and also in the preservation and regeneration of beta cells. currently have been questioned the potential use of glp-1 for new-onset type 1 diabetes. the justification for this issue is based on the fact that this class of drugs, besides acting on insulin secretion and glucose regulation, may be effective to preserve and expand beta cell mass, which has been shown in animals. ideal candidates for this treatment are newly diagnosed patients who still have significant viable beta cell mass.

Eligibility criteria:
inclusion criteria: * aged 18 to 35 years * up to 6 months of clinical diagnosis * fasting c-peptide ≥ 0.25 ng / ml * hba1c \<9.0% * positive autoantibodies (anti-gad, anti-insulin and anti-ia2) * without chronic complications exclusion criteria: * hepatic, cardiac, pulmonary and hematologic disease

Keywords: type 1 diabetes vildagliptin galvus