Kornimate/medical-research-clean huggingface dataset:
pump study mdi lantus/lispro vs continuous insulin+lispro

Conditions: Diabetes Mellitus

Summary: whether a once-daily basal injection of insulin glargine with mealtime injections of insulin lispro achieves equivalent glycaemic control (hba1c) to administration of insulin lispro by continuous subcutaneous insulin infusion in type 1 diabetic patients.


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes mellitus for at least one year. * subjects with no previous experience with continuous subcutaneous insulin infusion (csii) or insulin glargine, * capable of managing a basal-bolus regimen and meeting glycaemic targets in accordance with the protocol. * hba1c \> than or = to 6.5 \ 126 mg/dl). exclusion criteria: * previous therapy using insulin glargine or continuous subcutaneous insulin infusion. * lipodystrophy preventing adequate use of csii. * unwilling or unlikely to be able to use minimedr insulin pump with insulin lispro for csii. * unwilling or unlikely to be able to use an mdi regimen with insulin glargine and insulin lispro in accordance with the protocol (for instance, subjects who routinely use a twice-daily mixed insulin regimen should not be included). * history of more than two severe hypoglycaemic episodes in the past 6 months. * acute infection which, in the opinion of the investigator, could lead to increased insulin resistance. * acute or chronic metabolic acidosis. * episode of dka (diabetic ketoacidosis) within the last three months. * active, uncontrolled, advanced diabetic retinopathy. * impaired hepatic function, as shown by \> 2.5 times the upper limit of normal range for ast. * impaired renal function, as shown by serum creatinine \> 1.5mg/dl. * history of gastroparesis. congestive heart failure requiring ongoing pharmacological treatment. * stroke, myocardial infarction (mi), coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) or angina pectoris within the last 12 months. * treatment with a non-selective beta blocker. * treatment with inhaled or systemic steroids. * history of hypersensitivity to insulin lispro or to any drug with a similar chemical structure to insulin glargine or insulin lispro or to any of the excipients of the insulin glargine and insulin lispro preparations used in the study. * any malignancy within the last five years, except adequately treated basal cell carcinoma. * history within the last two years or current addiction to substances of abuse including ethanol. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
semi-automatic assessment of aortic roots by three-dimensional transoesophageal echocardiography (smarter)

Conditions: Aortic Valve Disease

Summary: the progress in surgery of the aortic root and the evolution of transcatheter aortic valve replacement as an alternative to surgical treatment in selected patients have refocused the need for quantitative imaging of the aortic root during transcatheter aortic valve replacement and valve-sparing aortic root surgery. in this study, we aim to assess the ability of semi-automated quantitative modeling (esie valves, autovalve prototype version, siemens medical solutions, usa) of the aortic valve and root in patients with clinical normal aortic valve and root, who are indicated for both 3d transesophageal echocardiography (tee) and computed tomographic (ct) due to atrial fibrillation or patent foramen ovale. measures of the aortic valve and root obtained by 2d tee, 3d tee and ct are compared, and the ability of the semi-automated 3d tee modeling software is tested. given the workflow advantages of automation, this 3d tee approach may enhance the clinical adoption of routine 3-dimensional imaging beyond ct.

recent developments in aortic root interventions have focused on the need for 3-dimensional imaging of the aortic functional anatomy. the progress in surgery of the aortic root and the evolution of transcatheter aortic valve replacement as an alternative to surgical treatment in selected patients have refocused the need for quantitative imaging of the aortic root during transcatheter aortic valve replacement and valve-sparing aortic root surgery. in this study, we aim to assess the ability of semi-automated quantitative modeling (esie valves, autovalve prototype version, siemens medical solutions, usa) of the aortic valve and root in patients with clinical normal aortic valve and root, who are indicated for both 3d transesophageal echocardiography (tee) and computed tomographic (ct) due to atrial fibrillation or patent foramen ovale. measures of the aortic valve and root obtained by 2d tee, 3d tee and ct are compared, and the ability of the semi-automated 3d tee modeling software is tested. given the workflow advantages of automation, this 3d tee approach may enhance the clinical adoption of routine 3-dimensional imaging beyond ct.

Eligibility criteria:
inclusion criteria: * both transesophageal echocardiography (tee) and computed tomographic (ct) are referred by cardiologists * apparent normal aortic valve and root structure * written consent exclusion criteria: * post-operation of aortic valve * severe cardiomyopathy * cardiac functional insufficiency (nyha iii or iv) * contraindications for either tee or cardiac ct angiography

Keywords: automatic data processing three-dimensional echocardiography aortic valve
a phase i clinical study to evaluate the effect of gzr18 injection on the pharmacokinetics of oral metformin hydrochloride tablets in overweight/obese subjects

Conditions: Type 2 Diabetes

Summary: this is a single-center, open-label, fixed-sequence phase i clinical study to evaluate the effect of multiple subcutaneous injections of gzr18 injection on the pharmacokinetics of multiple oral doses of metformin hydrochloride tablets.


Eligibility criteria:
inclusion criteria: * overweight/obese chinese subjects, who voluntarily sign the informed consent form (icf), can receive subcutaneous injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol. * male or female, 18 to 50 years of age at signing the icf (both inclusive). * weight ≥ 50 kg and body mass index (bmi) within 24-33 kg/m2 (both ends inclusive) at screening. * subjects of childbearing potential with no birth plan from the signing of icf to 3 months after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and visit 2 (prior to enrollment). exclusion criteria: * subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disease, malignant tumor and other diseases that are judged by the investigator to have an impact on pharmacokinetics and safety evaluation. * history or existing diseases that increase the risk of subjects, such as hypoglycaemia, acute or chronic pancreatitis, pancreatic injury, history of symptomatic gallbladder disease; cholelithiasis with high risk of acute biliary pancreatitis at screening (e.g., silt-like lithiasis, gallbladder ≤ 5 mm in diameter and bile duct stone, etc.). * subjects with previous or existing diseases that significantly affect drug absorption, metabolism or excretion, such as history of active peptic ulcer or haemorrhage, inflammatory bowel disease, abnormal gastric emptying (such as gastric paresis or pyloric stenosis, gastric outlet obstruction), long-term use (continuous for ≥ 1 week) of drugs that affect gastrointestinal motility (including but not limited to domperidone, mosapride, macrolides). * subjects with severe infection or unexplained infection within 4 weeks before screening. * major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study. * history of drug abuse prior to screening; or positive results for drug abuse at screening. * subjects who used nicotine-containing products within 3 months prior to screening or are screened positive for nicotine in urine. * other factors that make subjects unqualified to participate in this trial as judged by the investigator.
gh in adults with pws, effect on hypotonia evaluated by functional mri, relationship with strength and body composition

Conditions: Prader-Willi Syndrome

Summary: prader-willi syndrome (pws) is a genetic disorder associated with growth hormone (gh) deficiency, central hypotonia and hyperphagia that leads to life-threatening obesity. treatment with gh in adult patients is not well stablished in guidelines of health national system (hns). the investigators has experience in the study of brain connectivity in these patients in relation to satiety. to date, there is no evidence about the effect of gh on central hypotonia (brain areas related with muscle tone maintenance). so, the main objective is to examine these anatomical areas before and one year after gh treatment. methodology: structural and functional magnetic resonance imaging to 30 pws patients before and after gh treatment and we will compare them to a control group. expected results: pws group will show abnormal functional and structural connectivity in circuitry of muscle tone maintenance that will improve after gh treatment. these favorable changes and the absence of secondary effects will help to justify the use of this treatment and its inclusion in practical clinical guidelines of hns for the management of this syndrome in the adulthood.


Eligibility criteria:
inclusion criteria: * pws \>=18 years with growth hormone deficit * signed informed consent by the patients or their legal guardian exclusion criteria: * severe obesity * no controled diabetes mellitus * no treated obstructive sleep apnea or severe obstructive sleep apnea * active cancer * active psychosis

Keywords: growth hormone functional magnetic resonance strength body composition
choroidal and retinal changes after rlrl therapy in diabetes and diabetic retinopathy

Conditions: Diabetes Mellitus, Type 2; Diabetic Retinopathy

Summary: the choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. repeated low-level red-light (rlrl) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. notably, rlrl was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. this study aims to answer whether rlrl therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.

the goal of this study is to investigate the effect of repeated low-level red-light (rlrl) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. this study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. the control group will use the sham device but with only 5% of the original device's power. comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up

Eligibility criteria:
inclusion criteria: 1. aged 35-55 years 2. diagnosis of type 2 diabetes mellitus 3. no dr or only mild non-proliferative dr (npdr) assessed by baseline clinical ocular signs and 7-field fundus color photography exclusion criteria: 1. spherical equivalent (se) ≤ -6.0 diopter or axial length ≥26 mm 2. patients with complications such as dme and retinal detachment 3. history of ocular surgical operations 4. severe systemic diseases 5. those who could not cooperate with the examination for any reason 6. cognitive impairment or mental illness 7. patients with other ocular diseases

Keywords: repeated low-level red-light (rlrl) therapy choroidal thickness
effects of virtual reality meditation in older adults

Conditions: Older Adults; Stress; Mental Disorder

Summary: virtual reality (vr) allows users to interact within a simulated environment using electronic devices such as a vr headset or goggles. multiple studies with younger adults have demonstrated that vr meditation can be an important tool in reducing stress, however, this has not been studied in older adults. in this study, the investigators aim to assess the effects of a 4-week program of 15-minutes sessions, twice per week of meditation delivered through vr with the aim of evaluating its impact on stress in older adults.


Eligibility criteria:
inclusion criteria: * living in the greater montreal area and able to speak english or french * perceived stress score (pss)equal or greater than 10 * over \>=60 years of age exclusion criteria: * diagnosis of epilepsy, schizophrenia, brain tumor * history of recurrent migraines or seizures or tbi in the past year * substance use disorders in the last year * psychiatric hospitalizations in the last year. * acute psychotic symptoms * acute suicidal ideation or intent * glaucoma * ptsd * changes to psychoactive medications in the past 4 weeks * alcohol, caffeine or cannabis consumption within 24 hr before the session, or nicotine consumption within 15 min of the session * important hearing impairment * recovery phase of any eye surgery

Keywords: virtual reality meditation mindfulness stress older adults
a study evaluating the efficacy and safety of the lentiglobin® bb305 drug product in participants with transfusion-dependent β-thalassemia

Conditions: Beta-Thalassemia

Summary: this is a single-arm, multi-site, single-dose, phase 3 study in approximately 18 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (tdt), who have a β0/β0, β0/ivs-i-110, or ivs-i-110/ivs-i-110 genotype. the study will evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (hsct) using lentiglobin bb305 drug product.


Eligibility criteria:
inclusion criteria: • participants less than or equal to (\<=) 50 years of age at the time of consent or assent (as applicable), and able to provide written consent (adults, or legal guardians, as applicable) or assent (adolescents or children). provided that the data monitoring committee (dmc) has approved enrolling participants younger than 5 years of age, participants younger than 5 years of age may be enrolled if they weigh a minimum of 6 kilograms (kg) and are reasonably anticipated to be able to provide at least the minimum number of cells required to initiate the manufacturing process. * diagnosis of tdt with a history of at least 100 milliliter per kilogram per year (ml/kg/year) of prbcs in the 2 years preceding enrollment (all participants), or be managed under standard thalassemia guidelines with \>= 8 transfusions of prbcs per year in the 2 years preceding enrollment (participants \>=12 years). * clinically stable and eligible to undergo hsct. * treated and followed for at least the past 2 years in a specialized center that maintained detailed medical records, including transfusion history. exclusion criteria: * presence of a mutation characterized as other then β0 (e.g., β+, βe, βc) on at least one β-globin gene (hbb) allele. * positive for presence of human immunodeficiency virus type 1 or 2 (hiv-1 and hiv-2), hepatitis b virus (hbv), or hepatitis c (hcv). * a white blood cell (wbc) count less than (\<) 3×10\^9/liter (l), and/or platelet count \<100×10\^9/l not related to hypersplenism. * uncorrected bleeding disorder. * any prior or current malignancy. * prior hsct. * advanced liver disease. * a cardiac t2\* \<10 ms by mri. * any other evidence of severe iron overload that, in the investigator's opinion, warrants exclusion. * participation in another clinical study with an investigational drug within 30 days of screening. * any other condition that would render the participant ineligible for hsct, as determined by the attending transplant physician or investigator. * prior receipt of gene therapy. * pregnancy or breastfeeding in a postpartum female or absence of adequate contraception for fertile participant. * a known and available human leukocyte antigen (hla) matched family donor. * any contraindications to the use of granulocyte colony stimulating factor (g-csf) and plerixafor during the mobilization of hematopoietic stem cells and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients.
the united states healthy living study

Conditions: Colo-rectal Cancer

Summary: the purpose of this study is to pilot test the efficacy of a patient-centered, tailored message intervention delivered via virtual human technology for increasing colorectal cancer (crc) screening within guidelines. although participation is not limited to these groups, the study team is particularly interested in the feasibility of the intervention for reaching racial/ethnic minority and rural patients.

the primary goal of the study is to reduce colorectal cancer (crc) morbidity and mortality by increasing crc screening rates among the at-risk patient community and to reduce racial and geographic (rural vs. urban) disparities in crc screening and mortality rates. to accomplish this long-term goal, this study aims to develop and test precision messaging tailored to target audiences through development and evaluation of culturally sensitive, interactive messages about crc screening delivered using vht. the study will investigate whether interactive, tailored messages contribute to an overall enhancement of knowledge of crc and screening options by eliciting positive attitudes and behaviors toward fit screening. to date, there is no other study that has looked to partner specific message strategies and colorectal cancer screening with an emphasis on racial concordance and modality. as such, the researchers hope to shed new light on how, as health communicators, to more successfully engage target audiences to change attitudes and/or behaviors towards getting screened for colorectal cancer.

Eligibility criteria:
inclusion criteria: * reside within the united states but outside of florida * speak english * are of either black or white racial background. * are out-of-guidelines for colorectal cancer screening (\>10 years for colonoscopy, \>3 years for cologuard, \> 1 year for fecal immunochemical test) exclusion criteria: * does not meet the above criteria
lipoprotein metabolism in hypertensive african-americans

Conditions: Cardiovascular Diseases; Heart Diseases; Hyperinsulinism; Hypertension; Insulin Resistance

Summary: to study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in african american males and females. the study was part of a collaborative project on minority health which investigated the mechanisms by which insulin contributes to cardiovascular disease.

background: the study was part of the initiative "collaborative projects (r01s) on minority health". the concept for the initiative was developed by the nhlbi staff after the 1993 report of the committee on appropriations, house of representatives, encouraged the nhlbi to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. the initiative was approved at the september 1992 national heart, lung, and blood advisory council and released in october 1992. julian marsh was one of three investigators in a collaborative program with bonita falkner as program coordinator. design narrative: in a sub-set of subjects with either high or low plasma insulin levels after a glucose challenge (insulin sensitive or insulin resistant), the investigators determined the fractional and absolute synthesis and catabolic rates of apolipoproteins b and a-i, the dominant lipoproteins of low density lipoprotein (ldl) and high density lipoprotein (hdl). they used stable isotopes and multicompartmental kinetic analysis following an oral bolus dose of deuteroleucine. they hypothesized that in hypertensive african americans with hyperinsulinemia, more of the smaller very low density (vldl) particles are secreted and converted to ldl. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
transforming the cascade of hepatitis c care

Conditions: Hepatitis C, Chronic

Summary: several factors are barriers to effective hepatitis c care: 1) the majority of hepatitis c virus (hcv)-positive patients (45-85 percent) are unaware that they are infected; 2) only a small minority of those in need of treatment receive it; 3) members of minorities and older patients are even less likely to receive needed care; and 4) until recently, even those who were treated had a low chance of clearing the virus or achieving cure; 5) it is possible that older attitudes and expectation of futility might continue to persist among patients and provider in primary care settings. community health centers are often the most culturally appropriate and accessible choices, particularly for underserved populations, with the benefit of ongoing trust and relationships with patients. therefore, these can be ideal places to deliver complex hcv care if they possess the needed expertise. however, most community-based primary care and community health centers lack access to hepatitis c evaluation and treatment services, leading to a major public health problem. thus, investigators propose to implement and evaluate a pragmatic trial to implement and evaluate a multi-disciplinary model for hcv treatment at currently, the treatment initiation rates at each of these sites is estimated as less than 10%. the investigators hypothesize that our project will increase the rate of participation in all the steps of the hcv care cascade and ultimately lead to more than doubled rates of treatment uptake

primary objective: determine uptake, effectiveness and safety of ifn-free, daas among "real world" patients, including those with multiple comorbidities, in the primary care setting. secondary objective(s): 1. demonstrate the transformation of the cascade of hepatitis c care at 3 primary care clinics in terms of changes from baseline in rates for rates of access to hcv care including hcv screening, evaluation, treatment consideration, treatment uptake, completion, loss to follow-up, and treatment success rate. 2. advance understanding of hepatitis c related decision-making in the era of interferon (ifn)-free direct acting agents (daas) by examining the context, needs, motivators, barriers, and preferences among patients and providers to the delivery of hepatitis c treatment at primary care clinics

Eligibility criteria:
inclusion criteria: * all patients with detectable hcv rna level, currently receiving care at any of these three community health centers exclusion criteria: * criteria for automatic specialty referral (exclusion from treatment at community health centers) child turcotte pugh class b or c any history of decompensated liver disease or hepatocellular carcinoma evidence of renal disease (gfr \<50) or coexisting autoimmune condition hiv of hepatitis b co-infection

Keywords: cascade of care