Kornimate/medical-research-clean huggingface dataset:
bioequivalence of single dose phenylephrine extended release tablets and phenylephrine hcl immediate release tablets dosed every four hours (p08340)(completed)

Conditions: Nasal Congestion

Summary: this study will assess the food-effect bioavailability of an extended release formulation of phenylephrine hcl and its bioequivalence to the marketed immediate release phenylephrine hcl product.


Eligibility criteria:
inclusion criteria: * in good health * female participants must not be pregnant * agrees to use two acceptable methods of birth control throughout the study * agrees not to take monoamine oxidase inhibitor (maoi) for 2 weeks prior to, during, and 2 weeks after the end of the study exclusion criteria: * any significant medical condition which is a contraindication to the use of phenylephrine hcl, might interfere with the study, or requires treatment expected to affect blood pressure * any infectious disease within 4 weeks prior to initial treatment administration * history of malignancy, except basal cell carcinoma * cannot comply with requirement to abstain from the use of any drugs (except acetaminophen or herbal/vitamin supplements) within 14 days prior to study and alcohol or xanthine-containing substances (coffee, chocolate) within 72 hours prior to study * received an investigational drug within thirty days prior to study drug dosing * known or apparent current or former drug addicts or alcoholics * positive for human immunodeficiency virus (hiv) antibody, hepatitis b surface antigen, or hepatitis c antibody * cannot accept a high-fat, high-calorie breakfast * known allergy or intolerance to phenylephrine hcl * have used phenylephrine-containing product within 2 weeks prior to study start * have smoked tobacco, used tobacco products, or used a nicotine-containing smoking cessation aid within the past 6 months
influence of albumin on acute renal dysfunction associated with cardiac surgery under extracorporeal circulation

Conditions: Acute Kidney Injury

Summary: acute renal dysfunction associated with cardiac surgery (dra-acc) in our hospital population affects 39% of patients, being an important cause of morbidity and mortality, increasing the need for dialysis and assuming a prolongation of stay in the unit of intensive care, as well as an increase in the economic cost. in this sense, extracorporeal circulation (cpb) is a clear aggression for renal function due to multiple effects, not entirely known. human albumin is sometimes used as part of the priming of the cec circuit in variable concentration according to published centers and studies, demonstrating benefits on the maintenance of plasma oncotic pressure during the period of ecc, as well as other effects that can protect renal function during this period of renal injury. despite the use of albumin in the ecc priming both in spain and in other countries, there are currently no published studies demonstrating the effect of albumin on renal function administered during cpb in cardiac surgery during the postoperative period. with a high incidence of kidney injury, although there are current studies that confirm a decrease in the incidence of kidney injury in patients with hypoalbuminemia and who undergo heart surgery without extracorporeal circulation. the hypothesis of this study is based on the potential protective effect of albumin on renal function in patients undergoing heart surgery under cpb, in which there is a high incidence of postoperative hypoalbuminemia. this study aims to obtain information about the effect that albumin can have in this population of patients with a high incidence of acute renal dysfunction, and if this benefit exists, whether it is significant or not to justify its systematic use.

this study is aimed to analyze the effect of the use of human albumin during ecc on the incidence of ard-acc in patients undergoing cardiac surgery with cpb diagnosed according to the kdigo scale during the first 7 days after the intervention.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) scheduled for cardiopulmonary bypass surgery with glomerular filtration rate (gfr) greater than or equal to 60 and left ventricular ejection fraction greater than or equal to 40% exclusion criteria: * patients who do not meet the inclusion criteria and those who have a history of allergic reactions to human albumin, as well as those who have received iodinated contrast during the 7 days prior to surgery and pregnant women, will be excluded from the study.
evaluating the feasibility, health and behavioral impact of mid-ohio farmacy + ww

Conditions: Food Insecurity; Overweight and Obesity; Produce Prescription; Weight Change, Body

Summary: the aim of this research is to undertake a feasibility study to assess uptake and impact of providing access to a widely available weight management and wellness program (ww; formerly known as weight watchers) among individuals experiencing food insecurity and overweight/obesity, who are eligible to receive weekly produce at the mid-ohio food collective (mofc) through their pre-existing enrollment in the mid-ohio farmacy program. participants (n=90) adults over the age of 18 with a bmi between 27-50 kg/m2 will be recruited for a 6 month single-arm clinical trial, where participants will be provided with ww unlimited workshop + digital. the primary objective is to test the feasibility and acceptability of a commercial weight loss and wellness program with an established produce prescription program among individuals experiencing food insecurity and overweight/obesity. secondary outcomes will include assessments related to weight, height, blood pressure, dietary intake, physical activity, food access, depression, wellbeing and economic factors. this feasibility study will help inform future interventions among this population. more specifically, this study will help answer questions about the feasibility and acceptability of such an intervention, adherence to the ww program as described to the participant, and the impact that access to a free weight management and wellness program can have on health-related outcomes among individuals experiencing food insecurity and overweight/obesity.


Eligibility criteria:
inclusion criteria: * 18 year or older * bmi 27-50 kg/m2 * positive screen for food insecurity at healthcare provider * enrolled in mid-ohio farmacy (produce prescription program) * speak english * live in greater columbus,ohio area for duration of study * reliable internet access * ability to download and install ww app on phone exclusion criteria: * participation in a structured weight loss program in the last 12 months * ww membership in the last 12 months * pregnant, nursing or planning to become pregnant * weight loss of 5kg or more in the past 6 months * taking prescription medications for weight loss
smile trial - imaging sub-study

Conditions: Major Depressive Disorder

Summary: this is a pilot sub-study of an ongoing trial comparing n2o to midazolam in mdd and will examine neuroimaging correlates of treatment response.

magnetic resonance imaging (mri) scans of mdd-affected brains have revealed changes in structural and functional connectivity compared to healthy subjects. this pilot sub-study examines structural and functional connectivity associated with mdd-affected patient participants' responsiveness to n2o compared to the midazolam placebo, which induces similar sedative effects. the investigators intend to address the changes in brain functional activity and connectivity between baseline and after a four-week intervention course involving weekly nitrous oxide inhalations measured by mri.

Eligibility criteria:
inclusion criteria: * eligible for main nitrous oxide (smile) study exclusion criteria: * contraindication for undergoing mri scans (e.g., hip circumference \< 180 cm or metal in the body)
effect of cholecalciferol, soy isoflavones in patients with irritable bowel syndrome

Conditions: Irritable Bowel Disease

Summary: fasting blood specimens will be taken from the patients with ibs that have inclusion criteria. first, the objectives and method of study will be explained to the patients and informed consent form will be taken from them. they will be divided into 4 groups by an adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress questionnaires will be completed before and after intervention. during 6 weeks, they will receive 2 capsules of soy isoflavones per day, 50000iu vitamin d biweekly in addition to the other placebo form, both of them and placebo of both. at the end, body mass index ( bmi), serum tnf-alpha, tac, gene expression of gata3, ror gamma, foxp3 in lymphocytes and gut permeability will be measured. the quantity of polymorphisms of vitamin d and estrogen receptors will be determined.


Eligibility criteria:
inclusion criteria: 1. age 18-75 yrs 2. patients with irritable bowel syndrome (ibs) according to rome iii criteria 3. bmi 18-25 4. a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery 5. no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs 6. no pregnancy and lactation 7. not athlete or bed rest 8. no history of breast cancer in herself or her family 9. no severe psychosis exclusion criteria: 1. a- use of soy isoflavones or vitamin d one year before the study b- use of soy milk or soy nuts during study 2. diet changes during study 3. use of artificial sweetener 2 days before study 4. no desire to complete the study 5. adverse effect of supplement 6. pregnancy during study
video-based task oriented activity training in patients with juvenile idiopathic arthritis

Conditions: Video-based Task Oriented Activity Training

Summary: juvenile idiopathic arthritis (jia) is most common chronic rheumatic disease in childhood. the upper extremity involvement in jia causes muscle imbalance, joint destruction, pain, stiffness and limitations on daily living activities (dla) in varying degrees. however, the information about prevalence of symptoms, disorders, dla limitations, participation restriction and options of treatments for upper extremity involvement in jia are limited. it has been reported that improvements of upper extremity functions were achieved by video-based games (vbg) in various disease groups. however, in the literature, no study has been found about effectiveness of wbg in children with arthritis. the aim of the study was to investigate effects of task-oriented activity training (toat) with vbg versus activity training in real life on activity performance and participation in children with arthritis. participants with upper limb involvement in jia were randomly assigned to the activity training in real life group (group i) and toat with vbg in real life group (group ii). the actual materials and rehabilitation kits will be used for activity training in group 1, the dla that expected to gain independence will be trained with vbg in group 2. upper extremity muscle strength and grip, range of motion, upper limb functions, activity, participation and quality of life will be evaluated. the hypothesis of this study is that toat with vbg improves the activity performance and physical functions and increases the participation, via being stimulative and interactive in order to provide feedback and to increase interest and motivation.


Eligibility criteria:
inclusion criteria: * diagnosed as jia according to ilar classification * aged between 6-18 * at least one affected joint in upper extremity (shoulder, elbow, wrist, and hand joints) * adequate cognitive function in the compliance of exercise program exclusion criteria: • surgery or arthroscopic operation in the last year

Keywords: activity performance juvenile idiopathic arthritis virtual reality
parkinson's disease and experiences throughout the covid-19 pandemic

Conditions: Parkinson Disease; Covid19; Satisfaction, Patient; Quality of Life

Summary: the purpose of this research study is to examine the relationship between personal characteristics and satisfaction with care in those diagnosed with parkinson's disease during the covid-19 pandemic. participants will take 4 different surveys regarding their satisfaction with care throughout the duration of the covid-19 pandemic. the surveys in total should not take more than 30 minutes to complete


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosed with parkinson's disease * must be able to complete the surveys without any help exclusion criteria: * under the age of 18 * not diagnosed with parkinson's disease * unable to complete the surveys without help
daratumumab combined with venetoclax and dexamethasone for newly diagnosed light-chain amyloidosis with translocation (11;14)

Conditions: Light Chain (AL) Amyloidosis

Summary: venetoclax is considered as a promising agent for light-chain (al) amyloidosis due to the high percentage of t(11;14). several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in al patients with favorable safety profile. as an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated al amyloidosis patients.


Eligibility criteria:
inclusion criteria: * biopsy proved treatment-naïve al amyloidosis * fluorescence in situ hybridization (fish) t(11;14) ≥ 10% * dflc \> 50mg/l exclusion criteria: * co-morbidity of uncontrolled infection * co-morbidity of other active malignancy * co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia * co-morbidity of grade 2 mobitz ii or grade 3 atrioventricular block (expect for those with implanted pacemaker) * co-morbidity of sustained or recurrent nonsustained ventricular tachycardia * seropositive for human immunodeficiency virus * hepatitis b virus (hbv)-dna \> 1000 copies/ml * seropositive for hepatitis c (except in the setting of a sustained virologic response) * systemic treatment with moderate or strong cytochrome p450 3a （cyp3a） inducers, moderate or strong cyp3a inhibitors within 7 days prior to the first dose of study drug * neutrophil \<1×10e9/l，hemoglobin \< 8g/dl，or platelet \< 100×10e9/l * severely compromised hepatic or renal function: alanine transaminase (alt) or aspertate aminotransferase (ast) \> 2.5 × upper limit of normal (uln), total bilirubin \> 3 × uln，egfr \< 15 ml/min, or receiving renal replacement therapy

Keywords: light chain (al) amyloidosis ccnd1 translocation venetoclax daratumumab
a pilot study of the effectiveness of intra-operative ozurdex® in vitrectomy surgery for epiretinal membranes

Conditions: Epiretinal Membrane; Macular Edema

Summary: to determine if an intravitreal sustained release dexamethasone implant (ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.

we believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. the unique pharmacokinetics of the sustained released dexamethasone implant (ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina. this is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.

Eligibility criteria:
inclusion criteria: * patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane. * central retinal thickness ≥ 250 μm. * age more than 18 years old. * decision makers able to give informed consent. * females of child bearing potential must agree to use acceptable means of birth control for the duration of the study. exclusion criteria: * secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.). * any other macular pathology that could affect anatomic or functional results. * history of uveitis requiring intravitreal triamcinolone injection. * history of steroid-responsive glaucoma. * history of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7). * iop \> 23 mm hg if untreated, or \> 21 mm hg if treated with medication. * pregnant or breast-feeding woman. * unable to attend the scheduled follow-up appointments. * patients with known hypersensitivity to any components of ozurdex® or to other corticosteroids. * patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Keywords: ozurdex dexamethasone epiretinal membrane macular edema
gas exchange for predicting hospital heart failure readmissions

Conditions: Acute Decompensated Heart Failure

Summary: to determine whether, and if so, which gas exchange parameters measured on the shape-hf cardiopulmonary exercise testing system predict 30 and 180 day re-hospitalization in subjects discharged from hospitalization for an episode of acute decompensated heart failure.

this is a prospective, single-specialty clinical study. this study is intended to evaluate the select gas exchange parameters during a short, sub-max bout of exercise using a simple stationary step on day of discharge to predict the subjects' readmission for acute decompensated heart failure.

Eligibility criteria:
inclusion criteria: * subject is 18 years and older * subject is hospitalized for acute decompensated heart failure (adhf) 1. systolic or 2. diastolic * subject is stage c:class ii/iii/iv heart failure * subject is willing and to provide appropriate informed consent * subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule * subject is willing to use the shape-hf cardiopulmonary exercise testing system exclusion criteria: * the subject is pregnant (verified in a manner consistent with institution's standard of care) * subject is currently participating in another investigational device or drug trial * subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition * subject is unwilling or unable to return for the required follow-up after test * subject has left ventricular assist device (lvad) * subject is listed for transplant * subject has a clinical diagnosis of acute myocardial infarction (ami) on admission (note: if troponin measurements have been collected and are elevated but not due to an mi subject is still eligible for study) * subject has a pulmonary embolism (pe) on admission * subject is dialysis dependent * subject has a cardiac resynchronization device (crt) which has been re-programmed at any time during the study * subject has chronic obstructive pulmonary disease (copd) who is oxygen or steroid dependent * subject has severe hypertension \> 180 millimeter of mercury (mmhg) resting systolic at time of test * subject has severe heart failure with renal insufficiency (with creatinine clearance rate (crcl) of 30 or less) and/or on iv inotropic therapy and/or enrolling in hospice

Keywords: acute decompensated heart failure gas exchange cardiopulmonary dyspnea cardiopulmonary analyzer heart disease cardiovascular disease cardiopulmonary exercise
long-term effects of sucontral(tm) on mild and moderate cases of diabetes mellitus (type 2)

Conditions: Diabetes Mellitus, Type 2

Summary: in patients with diabetes mellitus type 2 stably adjusted to diet long-term intake of aqueous-ethanolic extract from hintonia latiflora over more than 12 months leads to a statstically significant amelioration of parameters of glycaemic control (hba1c, postprandial and fasting glucose) not acchievable with diet alone. as safety parameters, liver function tests and cardiovascular parameters are to be monitored. adverse events are to be monitored.

objective: to evaluate the long term effects of an aqueous-ethanolic extract from the bark of hintonia latiflora (1:4.5, extraction medium 32% ethanol) in mild to moderate cases of type ii diabetes, especially on parameters of glycaemic control and safety. research design and methods: the trial was carried out as a controlled single-centre open study. 30 patients stably adjusted to diet were treated with the study medication (3 x 2 ml/day before meals) for up to 36 months. efficacy parameters were hba1c and fasting and postprandial serum glucose. as parameters for safety, liver function tests, cardiac functions and adverse events were assessed. results: all three efficacy parameters improved significantly, and the parameters of glycaemic control remained stable for the study duration of 36 months. as compared to baseline, after 6 months and 18 months of therapy mean fasting glucose was reduced by 23.9 and 21.9 % (1.8 mmol and 2.0 mmol in absolute values). mean postprandial glucose was reduced by 24.4 and 16.5 % (2.4 and 2.0 mmol in absolute values), and the mean hba1c was decreased by 10.4 and 12.4 % (0.76 and 1.04% in absolute figures). improvement was maintained after 18 months. tolerability was excellent. no hypoglycaemic reactions occurred. no adverse effects or change in cardiac and liver function tests were observed. there was a tendency towards decreasing triglyceride and total cholesterol levels.

Eligibility criteria:
inclusion criteria: * mild to moderate diabetes mellitus type 2 stable adjusted to diet * minimum duration of diabetic complaints 1 year * fasting serum glucose 7-14 mmol/l * hba1c max. 12% * written consent exclusion criteria: * hepatic impairment * renal impairment * pregnancy

Keywords: hintonia latiflora extract diabetes mellitus type 2 hba1c safety liver function tests