Kornimate/medical-research-clean huggingface dataset:
3f8/gm-csf immunotherapy plus 13-cis-retinoic acid for consolidation of second or greater remission of high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: the purpose of this study is to find out what effects, good and/or bad, the combination of 3f8 and gm-csf has on the patient and the cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of nb as defined by a) histopathology (confirmed by the mskcc department of pathology), or b) bm metastases or mibg-avid lesion(s) plus high urine catecholamine levels. * high-risk nb as defined by risk-related treatment guidelines1 and the international nb staging system,89 i.e., stage 4 with (any age) or without (\> or = to 18 months of age) mycn amplification, mycn-amplified stage 2 or stage 3 (any age), or mycn-amplified stage 4s. * the patients are in \>2nd cr/vgpr, including no measurable mibg-avid soft tissue tumor assessable for response. * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * creatinine \> 3.0 mg/dl * alt, ast and alkaline phosphatase \> 5.0 times the upper limit of normal * bilirubin \> 3.0 mg/dl * patients with grade 3 or higher toxicities (using the ctcae v34.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. patients must have normal blood pressure for age. * progressive disease * history of allergy to mouse proteins * active life-threatening infection. * human anti-mouse antibody (hama) titer \>1000 elisa units/ml. * inability to comply with protocol requirements.

Keywords: gm-csf mab 3f8 retinoic acid (cis-9 & 13) 09-160
real life evaluation of lupron in the management of prostate cancer: a canadian post marketing observational study

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the canadian real life evaluation of the effectiveness of lupron in the management of prostate cancer.

this is a canadian post marketing observational study utilizing a prospective cohort design. patients with prostate cancer who are prescribed lupron will be entered into the study cohort and will be followed for a maximum of 36 months with recommended assessments at 3, 6, 12, 18, 24, 30 and 36 months after baseline. treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph.

Eligibility criteria:
inclusion criteria: * has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel * diagnosed with prostate cancer * prescribed lupron as part of his treatment by his treating physician exclusion criteria: * currently participating in another prospective study including controlled clinical trials and observational studies. * patient cannot or will not sign informed consent * survival expectancy less than 2-3 years as per the treating physician's judgment * presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of prostate cancer * history of alcohol or drug abuse * no longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (lhrh) treatment

Keywords: prostate cancer
food assistance, diabetes, and hiv

Conditions: Diabetes; HIV/AIDS; FOOD SECURITY

Summary: diabetes prevalence is increasing among people living with hiv (plwh), yet blood glucose control is less successful in this population who are also often food insecure. food assistance programs often provide nutrient-poor foods. this proposal asses the feasibility of monitoring diabetes-related health outcomes among food insecure plwh who are receiving food boxes higher in dietary protein and fiber and lower in simple carbohydrates.

the objective of this investigation is to develop and assess a study protocol to evaluate the impact of food assistance on diabetes-related health outcomes in food insecure people living with hiv (plwh). compared to the general population, plwh have increased risk for type 2 diabetes and worse glycemic control when using similar pharmaceutical treatments. interventions to improve diet quality could thus have a clinically meaningful impact on diabetes treatment in this population. however, many plwh are food insecure and rely on food assistance to meet basic nutrition needs. this proposal will determine the feasibility of a protocol to evaluate diabetes-related health outcomes in food insecure plwh and diabetes who receive high protein, high dietary fiber food boxes from birmingham aids outreach. the study will consist of retrospective analysis of electronic medical record data and stored specimens, and prospective cross-sectional analysis of food security and diet quality in plwh who do versus those who do not receive the food boxes. specific aim 1: to determine the feasibility of recruiting, enrolling, and collecting dietary intake data from people living with hiv who are food insecure. specific aim 2: to compare changes over twelve months in glycemic control, food security, and diet quality in b-fed participants compared to non-participating 1917 clinic patients. this proposal aligns with the uab diabetes research center's goal to facilitate development of new methods to treat diabetes and its complications. the investigators will determine the effect size for scale-up of larger, longer-term assessment through an niddk-r18 grant to evaluate the real-world impact of b-fed on glycemic control and food security.

Eligibility criteria:
inclusion criteria: * cnics participants aged 18 and over * currently prescribed antiretroviral therapy * have a diagnosis of diabetes, or documented hemoglobin a1c \>7.0%, or glucose \>125gm/dl exclusion criteria: * not diagnosed with hiv * plwh who are not patients at 1917 clinic * under age 18 * pregnant women * recent cancer diagnosis current serious illness or trauma persons with an active secondary infection including tuberculosis or untreated hepatitis c.
longitudinal ldl-c studies in black and white families

Conditions: Cardiovascular Diseases; Atherosclerosis

Summary: to longitudinally investigate multigenerational familial clustering of plasma low density lipoprotein cholesterol (ldl-c), with particular emphasis on the influences of apoe genotypes and various 'behaviors'.

background: elevated concentrations of plasma low density lipoprotein cholesterol (ldl-c), a major risk factor for coronary heart disease, cluster significantly in families. this clustering has been observed in cross-sectional studies in both black and white families, but longitudinal data on the familial clustering of ldl-c are virtually nonexistent. design narrative: the longitudinal study will provide new and important information about changes in the familial low density lipoprotein cholesterol (ldl-c) correlations in black and white families from the period of shared household environments to that of separate households, using families from the princeton lipid research clinics (lrc) prevalence (1973-75) and family studies (1975-76). the study will also provide important information on changes in individual ldl-c levels over the same 25 year period. the former student participants were six to 18 years of age and are now 32 to 45 years of age; their parents were (largely) 26 to 55 years of age and are now 51 to 80 years of age. plasma ldl-c concentrations in children and adults have been shown to associate with the apolipoprotein (apo) e genotype, with obesity, and with such elective behaviors as diet, cigarette smoking, and physical activity. in the lrc study, measurements were made of ldl-c, body habitus, elective behaviors, and the family history of cardiovascular disease (cvd). the study will obtain repeat measures of these factors, plus determine the apo e isoforms. changes in individual ldl-c levels and in familial associations can then be assessed in association with apo e isoforms, body composition, elective behaviors, and family history of cvd. family members share ranges of body weight, patterns of fat distribution, dietary and smoking habits, and physical activity levels. the extent to which the familial clustering of ldl-c levels is determined by apo e isoforms interacting with the similar levels of obesity, and with the similar behaviors, is not currently known.

Eligibility criteria:
no eligibility criteria
pedal@work: a worksite wellness program

Conditions: Physical Activity

Summary: the primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. a secondary aim will be to test pedal time at work as a measure of compliance with the intervention.

recent research indicates prolonged sedentary behaviors such as computer use and workplace sitting are particularly damaging resulting in increased risk for chronic diseases such as cardiovascular disease, type 2 diabetes and obesity. few interventions have been tested with the specific purpose of reducing sedentary time to improve risk factors for cardiometabolic diseases. the primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. a secondary aim will be to test pedal time at work as a measure of compliance with the intervention. participants will be followed for 12 weeks and randomized to either a treatment or wait list control group which will have the option to crossover into the intervention after 12 weeks.

Eligibility criteria:
inclusion criteria: * adults between 21 and 65 years * sedentary (engaging in moderate intensity physical activity for less than 60 minutes per week) * working full time (35+ hours/week) at a sedentary desk dependant occupation * overweight (body mass index \> 25.0 kg/m2 but less than 40.0 kg/2) * apparently healthy as assessed by a health history screening survey * devoid of overt complicated or acute cardiovascular, metabolic, respiratory, or neurological diseases * free from exercise/physical activity limitations exclusion criteria: * adults with significant health problems exacerbated by exercise, such as uncontrolled hypertension, diabetes, orthopedic limitations, etc. will be excluded from the study. note, with physician approval and adequate control of these health problems, these conditions will not necessarily preclude participation. * being unable to exercise
acute evaluation of the safety of left ventricular-left ventricular (lv-lv) delays and its effects on mechanical dyssynchrony

Conditions: Cardiac Resynchronization Therapy

Summary: the purpose of this study is to evaluate the effects of various lv-lv delays during multi-site left ventricular (mslv) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (crt) patients post-implant.


Eligibility criteria:
inclusion criteria: 1. have an approved indication for a crt implant 2. undergoing or previously received the implant of a st. jude medical promote q 3221-36 crt-d with a quartet model 1458q lv lead at participating clinical study site 3. ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations exclusion criteria: 1. have persistent or permanent atrial fibrillation 2. have an intrinsic heart rate of \<50 beats per minute 3. have cheyne-stokes breathing 4. have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures 5. have had a recent cva or tia within 3 months prior to enrollment 6. be less than 18 years of age 7. be pregnant

Keywords: crt
feasibility study of transcutaneous tibial nerve stimulation for urinary symptoms in people with multiple sclerosis

Conditions: Bladder Dysfunction; Neurogenic Bladder Dysfunction; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Nocturia; Urinary Frequency More Than Once at Night; Lower Urinary Tract Symptoms; Multiple Sclerosis; Urinary Bladder, Neurogenic

Summary: neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. transcutaneous tibial nerve stimulation (ttns) is a non-invasive treatment option to manage bladder storage symptoms, however, the potential efficacy of ttns among people with multiple sclerosis is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. the feasibility and acceptability of ttns to manage storage bladder symptoms using transcutaneous electrical nerve stimulation (tens) needs to be established before proceeding with a definitive randomised trial. this study aims to assess whether ttns is feasible and acceptable as a treatment for bladder storage symptoms in people with ms

the investigators will use a single-arm experimental study to explore the feasibility and acceptability of ttns in the treatment of bladder storage symptoms in multiple sclerosis. the consort extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. the recruitment plan is twofold: 1) open recruitment for people with ms through ms ireland's communication channels; 2) recruitment from a convenience sample of people with ms who have previously participated in a qualitative study. the investigators will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life using international classification of incontinence questionnaire - overactive bladder (iciq-oab), 3-day bladder diary, king's health questionnaire and collect self-reported data on adherence and adverse events and acceptability of using ttns.

Eligibility criteria:
inclusion criteria: * self-reported diagnosis of any type of multiple sclerosis * male or female * aged ≥18 years old * ambulatory * at least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence). exclusion criteria: * people with an indwelling urethral catheter or indwelling suprapubic catheter * urologic disease including bladder malignancy * diabetic mellitus * pregnant women or planning to be pregnant during the study time * recent pelvic related surgery \<1 year * pacemaker or other metallic internal devices * urinary tract infections (utis) during recruitment phase.

Keywords: multiple sclerosis neurogenic bladder feasibility study tibial nerve stimulation
topical vitamin e ovules for the treatment of hemorrhoids

Conditions: Bleeding Anal; Pain; Stings

Summary: patients with hemorrohoids grade ii and iii were included. patients were randomized into 2 groups: * experimental group: patients will receive a treatment with vitamin e ovules, which must be placed inside the annus * control group: patients will receive a treatment with corticoid ointment, with endoanal application bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.

patients with hemorrohoids grade ii and iii were included. patients were randomized into 2 groups: * experimental group: patients will receive a treatment with vitamin e ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days. * control group: patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days. bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).

Eligibility criteria:
inclusion criteria: * grade ii and iii hemorrhoids exclusion criteria: * grade i or iv hemorrhoids * patients with previous anal surgeries * patients having received previous pharmacological treatments for hemorrhoids
the use of domperidone for gastroparesis

Conditions: Gastroparesis

Summary: the purpose of this study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis.

individuals who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. patients on the medication will be expected to to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 18 or older 3. symptoms or manifestations secondary to gerd (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy. 4. subjects must have a comprehensive evaluation to eliminate other causes of their symptoms. 5. subject has signed informed consent for the administration of domperidone. the informed consent informs the subject of potential adverse events including: * increased prolactin levels, * extrapyramidal side effects, * breast changes, * cardiac arrhythmias including qt prolongation, and exclusion criteria: 1. history of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure. 2. history of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and torsade des pointes. subjects with minor forms of ectopy (pacs) are not necessarily excluded. 3. clinically significant bradycardia, sinus node dysfunction, or heart block. prolonged qt syndrome (qtc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged qt syndrome. 4. presence of a prolactinoma (prolactin-releasing pituitary tumor). 5. conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (note that the presence of vomiting, that may accompany gastroparesis or pseudo-obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.) 6. pregnant or breast feeding female. 7. known allergy to domperidone or any components of the domperidone formulation. 8. significantly significant electrolyte disorders. 9. gastrointestinal hemorrhage or obstruction.

Keywords: gastroparesis domperidone motilium
alliance to control diabetes

Conditions: Diabetes Mellitus

Summary: alliance to control diabetes was a 2.5-year study funded by the american academy of family physicians foundation. the study was designed to help patients better manage their diabetes, and was a partnership between the institute for behavioral and community health and clínicas de salud del pueblo, inc (cdsdp), a private, non-profit corporation providing comprehensive primary care services to residents throughout imperial and riverside counties, california. the investigators identified 336 patients with uncontrolled diabetes from three cdsdp clinics. patients were randomly assigned to intervention or control conditions. the 12-month intervention consisted of individual diabetes management support delivered by a trained volunteer peer supporter. the primary aim was determine if peer support can help patients better manage their diabetes and improve the quality of their lives. intervention effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and 12 months. this study was part of the global peers for progress network which has been testing peer support programs in 13 countries.


Eligibility criteria:
inclusion criteria: * must be at least 18 years old * must be diagnosed with diabetes mellitus type i, diabetes mellitus type ii or gestational diabetes * must be a resident of imperial county * must be a current patient of clínicas de salud del pueblo, inc., at one of the three participating clinics * must speak spanish and/or english * must plan on remaining in imperial county for at least 12 months after enrollment into the study exclusion criteria: * must not be involved in any other diabetes-related study

Keywords: diabetes peer support hispanic latino
impact of covid-19 lockdown on obesity and eating behaviors

Conditions: Feeding and Eating Disorders

Summary: covid-19 lockdown presents particular challenges for people living with obesity. indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... all of these modifications may have led to stress and anxiety. it has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . in this context caution would be exercised in obese patients especially those with binge eating disorders. indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. and one key trigger of binge eating disorder is stress and anxiety. thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management. the main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. the second objective is to compare the weight evolution between the two groups before and after the lockdown. to reach these objectives, the scientific team of the cio project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the endocrinology department of the lyon hospital. the patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders... during the lockdown. the results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown. the hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.


Eligibility criteria:
inclusion criteria: * severely obese patients exclusion criteria: * patients do not experiment the full lockdown period