Kornimate/medical-research-clean huggingface dataset:
glucose homeostasis, metabolomics and pregnancy outcomes after bariatric surgery

Conditions: Bariatric Surgery Status Complicating Pregnancy

Summary: the aim of the gloria study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. in addition, the investigators also aim to evaluate whether continuous glucose monitoring (cgm) can be used to diagnose gestational diabetes (gdm).

the gloria study is a belgian multicenter prospective cohort study. the investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and bmi-matched cohort of 95 pregnant women without bariatric surgery. participants will be recruited before 12 weeks of pregnancy. to evaluate glucose homeostasis, a masked cgm will be used for 10 days during each trimester in pregnancy and at the time of screening for gdm (at 24-28 weeks). the primary outcome is the mean glycaemia levels and glycaemic variability (sd) measured by cgm in pregnancy. at the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. in addition, in collaboration with the lab of cristina legido quigle from the steno diabetes center in copenhagen, metabolomics will be analyzed. women with a history of bariatric surgery will receive screening for gdm between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (smbg) with a glucometer during one week. in addition to smbg, women will receive a masked cgm during one week.

Eligibility criteria:
inclusion criteria: * age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days * for the group with bariatric surgery: history of gastric bypass (rybg) or sleeve gastrectomy (sg) * participants need to speak and understand flemish, french or english and have e-mail access. exclusion criteria: * multiple pregnancy * pregnancy ≥12 weeks * other types of bariatric surgery than rybg or sg * known pregestational diabetes * a physical or psychological disease likely to interfere with the conduct of the study * medications known to interfere with glucose metabolism.
emotion-diet interactions in pregnancy

Conditions: Pregnancy Related; Stress, Psychological; Glucose Intolerance During Pregnancy; Emotional Stress; Postprandial Hyperglycemia; Insulin Sensitivity/Resistance

Summary: this study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low gi) compared to a less healthy meal (high gi).

maternal glucose-insulin homeostasis in pregnancy represents one of the most important physiological processes for maternal and child health outcomes. although maternal diet is a key regulator of this process, its effects vary widely across individuals. maternal stress could represent a moderator of considerable importance in this regard, yet little is known about the effects of stress on glycemic control in pregnancy and whether the effects of stress may vary as a function of diet quality. this project will investigate the effects of acute psychosocial stress exposure on the postprandial metabolic response to a meal of varying glycemic index (gi) among women with overweight/obesity in mid-pregnancy.

Eligibility criteria:
inclusion criteria: * english and/or spanish speaking * 18-22 week's gestation * pre-pregnancy bmi 25.0-39.9 kg/m2 * singleton, intrauterine pregnancy * non-smoker * non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (\<200 mg/dl) exclusion criteria: * non-fluency in english or spanish * bmi \<25.0 or ≥40.0 kg/m2 * \>22 week's gestation * multiple pregnancy * current smoker * present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities) * presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders * current psychiatric disorders or undergoing treatment/taking psychiatric medications * use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications * gestational diabetes mellitus or raised glucose result detected on the screening visit * unwilling to eat the standard breakfast meal at each laboratory visit
a head-to-head comparison of mri, ct, 18f-fdgal and 18f-choline in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is the most common primary liver tumour and is the fourth leading cause of cancer-related death worldwide. in denmark, the incidence of hcc is 5.2 per 100.000 population per year with a dismal prognosis as the median survival time is just 7.7 month. extrahepatic spread of hcc is common at advanced stages. the majority of patients who develop hcc has cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on ct and/or mri. although contrast-enhanced ct and mri are considered equal in current guidelines, mri may have a better sensitivity especially for small lesions. positron emission tomography (pet) is a molecular imaging technique based on the injection of a very small dose of a tracer substance labelled with a positron emitting radioisotope. pet with the glucose tracer 18f-fdg is an important tool in the staging of many cancer forms, but it is not included in the international guidelines for management of hcc because of suboptimal sensitivity of only up to 50-60 % for hcc situated in the liver. other pet tracers such as 11c- or 18f-choline have also been investigated in patients with hcc with detection rates of 84% in meta-analysis. in aarhus, the liver specific tracer 18f-fdgal has been developed. it is a fluorine-18 labelled galactose analogue which in the human body is trapped in hepatocytes by phosphorylation by galactokinase. the first study of the diagnostic use of 18f-fdgal pet/ct in patients suspected for having hcc was published in 2011. the study showed good clinical potential for 18f-fdgal as a tracer for detection of intra- as well as extrahepatic hcc. both 18f-choline and 18f-fdgal show potential to improve the detection of extrahepatic disease. some centres use 18f-choline pet/ct in evaluation of patients with hcc, but the reported results for choline pet/ct do not appear superior to 18f-fdgal pet/ct. furthermore, 18f-fdgal pet/ct also enables evaluation of regional metabolic liver. a head-to-head study of the two tracers is very much warranted. the aim of the present project is to establish the clinical impact and utilization of 18f-fdgal pet in concert with state-of-the art radiological methods (ct and mri) in patients with hcc. hypotheses: i) 18f-fdgal pet performs better than 18f-choline for diagnosis and staging of patients with hcc. ii) mri is expected to perform better than contrast-enhanced ct.


Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma * age above 18 years exclusion criteria: * the patient does not want to take part in the study * the responsible investigator determines that the patient is not qualified for a pet scan * a history of moderate or intense hypersensitivity to a gadolinium-based contrast agent * renal insufficiency (estimated glomerular filtration rate \[egfr\] \<30 ml/min/1.73 m2 body surface area * contraindications for mri including claustrophobia * pregnant or nursing patients.
a study of the pre- and post-operative semen analyses and reproductive hormone levels of men undergoing weight-reduction surgery

Conditions: Male Infertility

Summary: a correlation between obesity and male fertility has been observed in a few clinical studies. normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. however, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. the aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery. this will direct future research and treatment.

we will recruit 60 subjects for this study. volunteers will provide pre-operative semen and blood samples prior to undergoing weight-reduction surgery. those with normal pre-operative sperm samples will be invited to continue participating in the study by providing subsequent post-operative semen samples and hormonal testing over a two year time period. it is estimated to take approximately one year to enroll the desired 60 subjects. the study will conclude two years from the last enrollment. the main analysis will be a comparison of sperm concentrations over time.

Eligibility criteria:
inclusion criteria: * adult male subjects between the ages of 18-65 undergoing bariatric surgery exclusion criteria: * subjects with abnormal sperm analysis

Keywords: bariatric surgery, weight loss surgery, male infertility, roux-en-y, gastric banding
persea americana for total health (path ) study

Conditions: Obesity, Abdominal; Insulin Resistance; Insulin Sensitivity

Summary: the proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.

the proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. further, changes in gi microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. this research study has two aims: 1) to determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of gi microbiota composition and cognitive function.

Eligibility criteria:
inclusion criteria: * males and females * between the ages of 25-45 years at the time of consent * body mass index ≥27.5kg/m2 * normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision). * ability to drop-off fecal sample within 15 minutes of defecation exclusion criteria: * current pregnancy or lactation * tobacco use * avocado allergy or intolerance * food allergies, lactose intolerance * latex allergy * prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, hiv, cancer, etc.) * prior diagnosis of cognitive or physical disability, including adhd, severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking * use of any anti-psychotic, anti-depressant, anti-anxiety, or add/adhd medications * use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants). * high bmi that is not representative of being overweight or obese (e.g. resistance trained individuals, football players) * prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years
otivacto regional center vienna (rcv) non-interventional study (nis)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: real-world data on the effects of a fixed-dose combination long-acting beta agonists + long-acting antimuscarinic agent (laba+lama) therapy with tiotropium and olodaterol administered in a single device, in copd patients who need treatment with two long-acting bronchodilators, is not available. this is a self-controlled study design enrolling consented copd patients who will be treated with spiolto respimat according to the approved summary of product characteristics (smpc).

purpose: study design:

Eligibility criteria:
inclusion criteria: 1. written informed consent prior to participation 2. female and male patients with more or equal to 40 years of age 3. patients diagnosed with copd and requiring long-acting dual bronchodilation (lama + laba) treatment according to approved spiolto respimat summary of product characteristics (smpc) and chronic obstructive pulmonary disease (copd) global initiative for chronic obstructive lung disease (gold) guideline recommendation exclusion criteria: 1. patients with contraindications according to spiolto respimat smpc 2. patients who have been treated with a laba/lama combination (free and fixed dose) in the previous 6 months 3. patients continuing laba- inhalative corticosteroids (ics) treatment should not be additionally treated with spiolto respimat in order to avoid a double dosing of long-acting beta-agonists 4. patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. pregnancy and lactation 6. patients currently listed for lung transplantation 7. current participation in any clinical trial or any other non-interventional study of a drug or device
improving activity in adults with chronic pain with online resources

Conditions: Chronic Pain

Summary: a randomized controlled study will test whether adults with chronic pain have improved outcomes when receiving a user guide and weekly prompts for a newly designed online pain-management resource when compared to an active-control group that receives access to the online pain-management resource, but no user guide or prompts. outcomes of interest include measures of activity, sleep, pain and level of use of the online pain-management resource.

participants with chronic pain will be randomized in this pilot study to an intervention group that receives a user guide and weekly prompts to use an online pain-management resource or an active-control group that receives access to the online pain-management resource, but no user guide or prompts. outcomes of interest include: i. changes in activity and sleep over time when online resources are paired with using a wearable activity tracker (fitbit inspire 3®); ii. self-reported pain and pain-related measures; and iii. level of use of the online pain-management resource. all participants will also be asked to provide feedback on the online pain-management resource. the information collected throughout the study will inform the development team on the website's usefulness and whether guided use is superior to unguided self-directed use of the online pain resource.

Eligibility criteria:
inclusion criteria: * 18 years old or older * chronic pain at least 3 months * interested in increasing activity level * able to read and speak english * reside within us * willing to have activity tracker shipped to address * able to download fitbit app onto phone or computer * willing to use fitbit device for most days and nights during 8 weeks study exclusion criteria: * medical or psychological conditions that would prevent study participation * planned surgery or procedure that would prevent study participation

Keywords: chronic pain activity online resources
neural control and cardiac-vascular function in women with ptsd (va psychological assessment)

Conditions: Post Traumatic Stress Disorder

Summary: the purpose of this research is 1) to investigate the role of the sympathetic nervous system and cardiac-vascular function in women with ptsd; and 2) to determine whether lifestyle modifications (exercise training and healthy eating) would be effective in reducing sympathetic activity, improving cardiovascular function, and improving psychiatric and quality of life outcomes in women with ptsd. it is hypothesized that (1) women with ptsd will have over-activation of the sympathetic nervous system and impaired cardiac-vascular function compared with women who are trauma free, and (2) lifestyle modifications can reduce sympathetic activity, improve cardiac-vascular function, and improve psychiatric symptoms and quality of life in women with ptsd.

this is a collaborative study between the institute for exercise and environmental medicine (ieem; texas health resources/university of texas southwestern medical center) and va north texas healthcare system (vanthcs). the overall study was conceptualized and initiated by dr. qi fu and her research team at the ieem. ieem researchers will be responsible for recruitment of non-veteran women without a diagnosis of ptsd, physiological assessments, and the lifestyle modification intervention. vanthcs researchers will be responsible for recruitment of women veterans with ptsd and psychological assessments. the procedures taking place at vanthcs (recruitment of women veterans with ptsd and psychological assessments) will fall under a separate study (overseen by vantchs irb and rdc) and will not include the procedures and intervention that will take place at the ieem (which will be overseen by a separate irb). data will be shared between the sites per data sharing agreement. this clinical trials entry reflects the vanthcs study. outcome measures gathered by the ieem research team are included in this entry due to the data sharing agreement.

Eligibility criteria:
inclusion criteria: 1. be either a female veteran with a current diagnosis of ptsd (for the ptsd group) or a female non-veteran without a current diagnosis of ptsd (for the non-ptsd control group). 2. be between the ages of 18-65. 3. sedentary (exercises less than three times a week for thirty minutes or less). exclusion criteria: 1. any evidence of cardiopulmonary and neurological diseases by history or by physical examination. 2. chronic kidney disease (serum creatinine \> 1.5 mg/dl). 3. peripheral vascular disease. 4. peripheral neuropathy. 5. current substance use disorder other than tobacco related. 6. endurance-trained athletes due to the effects of exercise training on sympathetic neural control and cardiac-vascular function. 7. current pregnancy.
a study of two approved drugs in the treatment of postoperative dental pain (0966-190)(completed)

Conditions: Postoperative Pain

Summary: the purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

the duration of treatment is 1 day.

Eligibility criteria:
inclusion criteria: * impaction of a molar tooth requiring removal exclusion criteria: * any known allergy to the study drugs

Keywords: dental surgery molar removal
safety and efficacy study of autologus bone marrow mesenchymal stem cells in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: 1. expanding and priming bone marrow (bm)- mesenchymal stem cells (mscs) to a clinical scale according to good laboratory practice using xenogenic free media instead of the previously used fcs. 2. assessing the safety of injecting autologous bm-mscs to multiple sclerosis (ms)patients who fail to respond to conventional treatment. 3. assessing the therapeutic benefits on the participants in the trial as per established methods.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of definite ms according to the revised mcdonald criteria. * expanded disability status scale (edss) ≤ 6 * failure of standard medical therapy * disease duration of at least three years prior to enrollment. exclusion criteria: * pregnant and lactating women * previous treatment with immunosuppressive agents in the last 12 months prior to enrollment * recent ms relapse in the month prior to enrollment * treatment with oral or parenteral steroids for any cause in the month prior to enrollment * significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders * previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment * any contra-indication for magnetic resonance imaging (mri) or gadolinium contrast. * positive serology for hiv, hepatitis b or hepatitis c * any history of malignancy or exposure to radiation at any time prior to enrollment * any contra-indication to lumbar puncture * severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.

Keywords: bone marrow derived mesenchymal stem cells multiple sclerosis oligodendrocytes neuroimmunology autoimmune disease
perfusion and diffusion magnetic resonance imaging, and phosphorylation of circulation endothelial cells to determine anti-anogenic effect of chemotherapeutic regimens in colorectal liver metastasis patients

Conditions: Colorectal Cancer

Summary: the purpose of our study is to establish the accuracy of the perfusion mri parameters and the availability of the vegfr2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.

the purpose of our study is to establish the accuracy of the perfusion mri parameters and the availability of the vegfr2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent. irb approval will be obtained to enroll 60 naïve patients (30 patients who will get antiangiogenic agent (avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent) with liver metastasis from colorectal cancer. mri and blood test (vegfr2 signaling assay) will be undergoing at three time points in the patients with avastin chemotherapy; at baseline (pretreatment), 3 days after avastin alone treatment, 3 days after avastin combined chemotherapy (about 10 days after initial avastin alone treatment). mri and blood test (vegfr2 signaling assay) will be undergoing at two time points in the patients who will get chemotherapy without antiangiogenic agent; at baseline (pretreatment), 3 days after chemotherapy.

Eligibility criteria:
inclusion criteria: * patients who have single or multiple liver metastasis from colorectal cancer * patients willing to undergo the study procedure * patients who are fully informed about the study and have signed the informed consent form * 60 patients (30 patients who will get antiangiogenic agent(avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent) exclusion criteria: * patients (men or women) under 20 years of age * patients who have previously entered this study * patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation * women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit * patients not eligible to contrast media injection according to product labeling * patients with a contraindication for mri or ct * patients with impaired renal function (e.g. acute renal failure) or patients on dialysis