Kornimate/medical-research-clean huggingface dataset:
lifestyle, eating, and activity patterns

Conditions: Overweight; Obesity

Summary: the purpose of this research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention.

previous observational and experimental research suggests that increased eating frequency is related to lower weight, body mass index (bmi)and body fatness. it is proposed that eating frequently during the day reduces overall energy consumed by preventing the development of excessive hunger. as elevated hunger increases the reinforcing value of food, and greater intake occurs when the reinforcing value of food increases, eating frequently during the day may be a dietary strategy that can aid with reducing energy intake and improving weight loss during a behavioral weight control program. therefore, the purpose of this proposed research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. participants will be randomized to 1 of 2 conditions: 1) a condition in which participants will be given an eating frequency prescription to eat every 2 to 3 hours (grazing); or 2) a condition in which participants will be given an eating frequency prescription of eating 3 meals per day (three meals). both conditions will receive an identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week. additionally, both conditions will receive an identical state-of-the-art, 6-month, behavioral weight loss program.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 27 and 45 kg/m2 exclusion criteria: * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness * report being unable to walk 1/4 mile without stopping * report major psychological disease or organic brain syndromes * report a diagnosis of type i or type ii diabetes * are currently participating in a weight loss program, are taking weight loss medication, have had surgery for weight loss, or have lost \> 5% of their body weight in the past 6 months * are currently participating in a program that manipulates their eating habits * intent to move outside of the east tennessee area within the time frame of the intervention * are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the intervention * are unwilling to attend group intervention meetings, assessments, or complete a food diary for the duration of the study

Keywords: intervention studies feeding behavior eating frequency weight loss dietary intake
clinical trial on the efficacy and safety of bemiparin in patients hospitalized because of covid-19

Conditions: Covid-19

Summary: the 2019 coronavirus disease (covid-19) is a new disease caused by the sars-cov2 virus of which many things are not yet known. among others, there is a need to define the best therapeutic strategy to treat covid-19, improving patients survival and reducing complications in its management, for which many different types of treatments are being tested. the drug being tested in this clinical trial is called bemiparin. bemiparin is a drug authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or more veins, generally in the legs) and venous thromboembolism (when the clot can detach and lodge in other organs such as the lungs). covid-19 patients have been shown to be at increased risk of developing clotting problems such as those described above. in this context, this clinical trial is being carried out to find out if certain doses of bemiparin can contribute to better management of the disease.


Eligibility criteria:
inclusion criteria: 1. informed consent. 2. age of 18 years or more. 3. patient with suspected covid-19 and who meets hospitalization criteria. 4. d-dimer\> 500 ng / ml. 5. clinical characteristics highly compatible with sars-cov-2 infection and confirmation by rt-qpcr at baseline or in the second sample in case of a first negative test and clinical suspicion remains. 6. patient admitted to hospital exclusion criteria: 1. icu admission criteria. 2. need for invasive or not invasive mechanical ventilation 3. pregnancy. 4. creatine clearance \<30 ml / min (cockroft-gault). 5. severe liver or pancreatic function disorder. 6. acute bacterial endocarditis and slow endocarditis. 7. patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit). 8. patient with high hemorrhagic risk due to previous medical-surgical history. 9. severe thrombocytopenia (\<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia. 10. active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies). 11. damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months. 12. simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate. 13. any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.

Keywords: covid-19 immunothrombosis d-dimer
the safety and efficacy of maintenance therapy with cp-690,550

Conditions: Crohn's Disease

Summary: this study investigates safety and efficacy of cp-690,550 in adult patients with moderate to severe crohn's disease who completed the double-blind induction treatment in study a3921083 and achieved clinical response-100 and/or clinical remission (cdai\<150) at week 8.


Eligibility criteria:
inclusion criteria: * subjects who met study entry criteria, and who completed week 8 visit of induction study a3921083. * subjects who achieve clinical response-100 (reduction in cdai by 100 points) and/or clinical remission (cdai\<150) in study a3921083. * women of childbearing potential must test negative for pregnancy prior to study enrolment. exclusion criteria: * subjects who had major protocol violation (as determined by the sponsor) in the a3921083 study. * subjects likely to require any type of surgery during the study period. * fecal culture/toxin assay indicating presence of pathogenic infection.

Keywords: tofacitinib xeljanz cp-690,550 maintenance therapy
serotonin selective reuptake inhibitor (ssri) effects on cerebral connectivity in acute ischemic stroke

Conditions: Stroke

Summary: fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

in this placebo-controlled study, using functional resting state mri, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.

Eligibility criteria:
inclusion criteria: * first-ever ischemic stroke * cortical or subcortical stroke * national institute of health stroke scale nihss\>12 or motor nihss\>6 at inclusion * mri-proved ischemic stroke exclusion criteria: * pregnant or breast-feeding women * alcoholism * ongoing selective serotonin reuptake inhibitor treatment or interruption \< 1 month * allergic reaction after ssri administration * mri contraindication * nihss\>22 * severe aphasia * coma

Keywords: acute ischemic stroke
study of the steroid hormone milieu in obese patients

Conditions: Obesity, Morbid

Summary: the aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity. it will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients. eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism. questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, bmi, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.


Eligibility criteria:
inclusion criteria: * morbid obesity exclusion criteria: * patients suffering from severe systemic pathologies, fever, chronic inflammatory states known to cause pcr \>10 mg/dl * use of corticosteroids at the time of enrollment * the patient's poor understanding of spoken and written italian * patients suffering from primary pathologies of the testicle, known at enrollment * patients suffering from hypothalamic-pituitary or adrenal pathologies already known at the time of enrollment

Keywords: hypercortisolism hypogonadism
using cultural ceremonies to reduce intimate partner violence and hiv transmission

Conditions: HIV

Summary: violence against women (vaw), the most extreme manifestation of the unequal power balance between women and men, is a major global public health concern. one of the most common forms of vaw is that perpetrated by a husband or other intimate partner. in ethiopia, 70.9% of women reported having experienced physical and/or sexual intimate partner violence (ipv) in their lifetime, demonstrating the pervasiveness of the problem. a growing body of evidence has also linked ipv and hiv risk. this study is a cluster randomized controlled trial assessing the impact of a community-based intervention focused on intimate partner violence and hiv delivered in the context of the ethiopian coffee ceremony, a culturally established forum for community discussion and conflict resolution. villages will be randomly assigned to one of 4 study arms (3 intervention and one control arm): 1) women only participate in the intervention, 2) men only participate, 3) both men and women (couples) participate, 4) women and men receive the control intervention comprising a short informational session on violence reduction.


Eligibility criteria:
inclusion criteria: * currently married or cohabitating with partner * residing in selected village for at least 6 months exclusion criteria: * eligible women who do not consent

Keywords: gender physical violence sexual violence hiv aids prevention community intervention ethiopia intimate partner violence
sevoflurane versus intravenous anaesthetic agents in morbid obese patients

Conditions: Morbid Obesity

Summary: the objective of this prospective randomized clinical study was to compare anesthesia, in morbidly obese patents (bmi \>50) who underwent bpd-rygbp with either sevoflurane or propofol with remifentanyl.

this is a prospective double blind randomized controlled trial. the patients will be assigned to one of 4 groups (gr): (1) sevo group, guided by a target end tidal concentration 1 - 2 mac and modified according to the haemodynamics (bp, hr) of the patients using a bolus inhalation (4 mac), (2) sevo-bis group, using sevo to a target bis of 40 - 50, (3) propo-remi and (4) propo-remi-bis groups accordingly. in groups 1 and 2, anaesthesia will be induced with iv propo (2 mg/kg tw \[tw = ideal body weight, ibw + 0.4 \* difference to the excess weight\]), remi (1 μg/kg ibw) and succinylcholine (1mg/kg ibw). in groups 3, 4 anaesthesia will be induced with a continuous iv propo infusion (21mg/kg tw/h for 5 min, 12 mg/kg tw/h for 10 min and then 6 mg/kg tw/h), followed by an iv bolus of remi and succinylcholine as above. every rise of bp or hr \> 15% of baseline will be followed by a bolus sevo inhalation in grs 1 and 2 or remi bolus iv (1 μg/kg ibw) and increase in the continuous infusion rate of remi from 0.1 to 1.0 μg/kg/min in groups 3 and 4. an epidural catheter will be placed prior to induction for postoperative analgesia only. intraoperative bp and hr, anaesthetic consumption, recovery scores (aldrete, chung, white) and anaesthesia cost will be evaluated.

Eligibility criteria:
inclusion criteria: * age 18-50 yrs * bmi\>50 kg/m2 * written consent for the participation in the study exclusion criteria: * history of significant cardiac disease, (aortic stenosis, angina, chf or previous cardiac or intrathoracic operations) * significant renal dysfunction (serum creatinine\>1.8 mg/dl) * significant liver dysfunction (evidenced by abnormal lfts) * history of hyper or hypothyroidism * history of psychiatric or neurologic disorders * recall during general anesthesia * substance abuse (alcohol or other drugs) * counter-indications of placement of thoracic epidural catheter( previous spine surgery or coagulation abnormalities ) * refusal to participate in the study

Keywords: morbid obesity sevoflurane propofol remifentanyl bis cardiovascular stability recovery scores drug consumption
the maternal well-being study

Conditions: Postpartum Depression; Postpartum Anxiety; Weight Retention, Postpartum; Nutritional and Metabolic Diseases

Summary: this project aims to understand the local feasibility and acceptability of mamameals (a home-delivered nutritious, postpartum meal delivery program) and mamamatters (a moderated social media-based peer support group) among peripartum women who are eligible for federal supplemental nutrition assistance programs such as the special supplemental nutrition program for women, infants and children (wic) or supplemental nutrition assistance program (snap). the investigators will conduct a prospective randomized controlled trial (rct) of these two interventions among postpartum individuals. analyses will be performed to determine the relative risk of postpartum depressive or anxiety symptoms (primary outcome) and overall well-being and maternal/infant health (secondary/exploratory outcomes) between groups. findings from this pilot intervention study will inform a future, large rct exploring the effectiveness of mamameals and/or mamamatters on reducing postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.

1. to assess the local feasibility and acceptability of mamameals (home-delivered, nutritious meals) during the 4th trimester for mothers with peripartum food insecurity. 2. to explore perceptions about receiving a medically-tailored meal delivery intervention during the 4th trimester (mamameals) among a diverse sample of peripartum individuals with food insecurity (fi). 3. to assess through a randomized trial the potential efficacy of the mamameals (nutritious, home-delivered meals) and mamamatters (ehealth postpartum support) interventions on peripartum mood disorders (primary outcome), postpartum cardiometabolic risk\* (exploratory outcome), maternal wellbeing (exploratory outcome), and infant health (exploratory outcome) during the first 12 months following delivery. hypothesis: individuals who receive the mamameals + mamamatters interventions will have lower edinburgh postpartum depression scale (epds) scores throughout the first 12 weeks postpartum compared to groups receiving only one intervention or the control group.

Eligibility criteria:
inclusion criteria: * screen positive for food insecurity or qualify for any of the following governmental assistance programs medicaid, wic, snap, tanf, * speak english, * are between 20-40 completed weeks of pregnancy, * are ages 18 years or older. exclusion criteria: * type 1 diabetes * dietary contraindications (e.g., severe food allergy, or inflammatory bowel disease, celiac disease, chronic renal disease, bariatric surgery, short bowel syndrome) * an active eating disorder (self-reported) * hospitalization in the past 12 months for a mental health concern * a history of postpartum psychosis * individuals with a history of being banned from any social media site will also be excluded.

Keywords: nutrition postpartum perinatal mood disorders medically-tailored meals
a open-label study of cp-690,550 as long-term therapy (48 weeks) in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the study hypothesis is to establish the safety and tolerability of long-term open-label (ol) cp-690,550 therapy in subjects with crohn's disease.


Eligibility criteria:
inclusion criteria: * subjects who complete 26-week maintenance treatment of the a3921084 study or subjects who withdraw early due to a3921084 study treatment failure (see appendix 5). * women of childbearing potential must test negative for pregnancy prior to study enrolment. * sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. no specific contraceptive measures are required in male subjects during study participation. exclusion criteria: * subjects who have been discontinued due to protocol violation(s) (as determined by the sponsor) in the a3921084 study. * subjects who were discontinued from the a3921084 study due to an adverse event. * subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
dark chocolate and glucose levels in diabetes

Conditions: Type 2 Diabetes; Type 1 Diabetes

Summary: diabetes is a growing concern in the world with an estimated 9.3% of adults, ages 20-79, with it in 2019, type 2 diabetes accounting for 90% of this total. a common recommendation for individuals with diabetes is to limit sugars and sweets as it may cause a high blood glucose response. as a result, chocolate is often avoided due to the sugar content; though, high-polyphenol chocolate may have a beneficial effect on hyperglycaemia and vascular function. the sugar-free chocolate from ross chocolates is formulated with a blend of inulin, erythritol, and stevia. these alternatives to sugar are not expected to cause a significant change in blood glucose levels following consumption. the main objective of this study is to verify glucose levels before and after consumption of ross chocolates' blend of sweeteners dark chocolate and conventional chocolate in people with diabetes.

individuals with type 1 or type 2 diabetes (10 participants each) will consume a ross chocolate or conventional sugar-sweetened dark chocolate bar on two occasions in a randomized crossover trial. blood glucose levels will be measured by finger prick for 120 minutes after consumption to determine postprandial glucose excursions after consumption of each type of chocolate bar. due to the covid-19 pandemic, the trial was converted to be completed remotely/virtually with participants completing the testing at their home under the supervision of a research team member who will describe the study procedures and monitor testing via video conferencing.

Eligibility criteria:
inclusion criteria: * physician-diagnosed t1d or t2d of ≥1 year; * current hba1c of 6.5-8.5%; * bmi: 25-40 kg/m2; * blood pressure of \<160/99 mm hg assessed according to guidelines; * non-smoking; * not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications; * 18-75 years old. exclusion criteria: * are taking more than 2 glucose lowering medications; * are ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders; * have allergy, intolerance or aversion to cocoa, stevia, erythritol, inulin, or any other dietary restrictions (e.g., vegan) that will prevent them from following the standardized study diets; * are unable to follow remote guidance by internet or smartphone; * are unable to follow the controlled diet instructions; * are unable to read or communicate in english.
comparison of the effects of 2 drugs on lumbar spine volumetric bmd in men with glucocorticoid-induced osteoporosis

Conditions: Osteoporosis

Summary: the objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (bmd) in males with glucocorticoid-induced osteoporosis.

this study is a multinational, european, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will be enrolled into the study. approximately one-half of the participants (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (ug/day given as a subcutaneous (sc) injection), and the other half randomized to risedronate 35 milligrams (mg) once weekly (qw) oral (po) tablet. all participants will receive approximately 1000 mg/day elemental calcium and 800 to 1200 international units per day (iu/day) of vitamin d.

Eligibility criteria:
inclusion criteria: * ambulatory men 25 years of age and older presenting to visit 1 with a bone mineral density (bmd) of at least 1.5 standard deviation (sd) below the corresponding normal young adult men average bmd (t score of -1.5 or lower), as determined from the manufacturer's database at any of the following regions of interest: total hip, femoral neck, or lumbar spine * have received glucocorticoid therapy at an average dose of at least 5.0 milligrams (mg) per day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding screening (visit 1), as determined by medical history. * a minimum of 2 lumbar vertebrae (l) in the l-1 through l-3 region must be evaluable by quantitative computerized tomography. * normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, parathyroid hormone (pth) (1 84), and 25 hydroxyvitamin d concentrations, and alkaline phosphatase activity. exclusion criteria: * presence of a mild, moderate, or severe spinal fracture in both the twelfth thoracic vertebra (t-12) and first lumbar vertebra (l-1), as determined by the central reading facility using the semiquantitative technique. * abnormal albumin-corrected serum calcium levels * history of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis * history of malignant neoplasms in the 5 years prior to visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. increased baseline risk of osteosarcoma; this includes patients with paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. * abnormal thyroid function not corrected by therapy * past and/or current treatment with certain medications.

Keywords: glucocorticoid induced