Kornimate/medical-research-clean huggingface dataset:
a study to investigate weight management with bimagrumab (ly3985863) and tirzepatide (ly3298176), alone or in combination, in adults with obesity or overweight

Conditions: Obesity; Overweight

Summary: the main purpose of this study is to evaluate the efficacy and safety of bimagrumab and tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without type 2 diabetes. the study will last about 70 weeks.


Eligibility criteria:
inclusion criteria: * have a bmi of * ≥30 kilograms per square meter (kg/m2) or * ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities: * hypertension * dyslipidemia * cardiovascular disease * obstructive sleep apnea * have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss) exclusion criteria: * have a prior or planned surgical treatment for obesity * have at least one laboratory value suggestive of diabetes during screening * use of metformin, or any other glucose-lowering medications * have type 1 diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma * have poorly controlled hypertension * have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes * have ongoing or a history of bradyarrhythmias other than sinus bradycardia * have a history of new york heart association (nyha) functional classification iii or iv congestive heart failure * have a history of symptomatic gallbladder disease within the past 2 years * have signs and symptoms of any liver disease * have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality * have a history of acute or chronic pancreatitis * have renal impairment, measured as estimated glomerular filtration rate \<30 ml/minute/1.73 m2 * currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening

Keywords: muscle lean fat
nicotinamide riboside in hospitalized patients

Conditions: Inflammation; Acute Illness

Summary: patients will receive oral nicotinamide riboside or placebo and clinical and paraclinical outcome will be determined

patients experiencing acute illness will often have a prolonged recovery time. the cause of this is unknown, but certain factors, like age, duration, and graveness of the illness, is associated with prolonged recovery. in this study, we will investigate whether nicotinamide riboside can shorten the recovery phase and improve outcome after acute illness.

Eligibility criteria:
inclusion criteria: 1. adults \> 18 years old, admitted to hospital with tissue damage, can be included when they are considered medically stable though still expected to remain hospitalized for at least 7 more days (from inclusion). 2. preferably: previously included in the janus cohort or any other cohort or study with stored biological samples. exclusion criteria: 1. allergy to nr or ingredients in capsules or placebo. 2. patients expected to pass away within 90 days. 3. patients unable to give their consent 4. unstable patients: i. uncontrolled infection (clinical septicaemia, inadequate response to treatment, inadequate control of source of infection or at treating physician's discretion). ii. mean arterial pressure \ 3 times upper limit v. moderate to severe peripheral oedema and/or pulmonary oedema, any unstable cardiac rhythm, myocardial infarction with peak tnt \>300 past week. signs of elevated intracranial pressure (headache, vomiting and depressed global consciousness in conjunction with focal neurological signs, papilledema, spontaneous periorbital bruising and a triad of bradycardia, respiratory depression and hypertension). vi. arterial ph \ 7.50 vii. serum potassium under 3,2 or over 5 mmol/l. 5. pregnancy or breastfeeding \* 6. any cancer not in full remission for \>10 years 7. use of st john's wort based supplements during the past 30 days 8. patient has undergone solid organ transplantation 9. participation in any clinical trial with unknown medications 10. major gastrointestinal or other internal bleeding past week 11. logistical challenges after discharge. patient must be able to attend follow up. 12. the treating physician considers the patient unfit or unable to participate. \*all fertile women must have a human chorionic gonadotropin test.

Keywords: nicotinamide riboside nad+ epigenetics aging parp
chronic kidney disease knowledge and awareness among american indians

Conditions: Chronic Kidney Disease

Summary: few educational intervention clinical trials have been conducted among those at risk for or with early chronic kidney disease. to the investigators' knowledge none have used digital storytelling as a means to deliver the educational message and have been conducted among american indians, a group with high prevalence of chronic kidney disease and end stage kidney disease. the aims of the research project are to: 1. quantify levels of chronic kidney disease knowledge and awareness among american indians. 2. determine the effectiveness of a culturally tailored health presentation with computerized digital stories made by american indians for improving chronic kidney disease knowledge and factors thought to be preventative of chronic kidney disease or its progression at baseline and follow-up in a pilot educational clinical intervention trial.


Eligibility criteria:
inclusion criteria: * strong heart study or strong heart family study participant exclusion criteria: * end stage renal disease
sound processing innovations in adult and paediatric cochlear implant recipients.

Conditions: Hearing Loss

Summary: this is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a ce approved nucleus cochlear implant. subjects older than 5 years will be included. subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation. subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation. a clinical setting can consist of therapeutic elements and evaluations. subjects will be assessed with the commercially available nucleus sound processor or via the xpc, nic, etc. if required. acute testing will be done where possible. take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. the subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. the time for a clinical visit will be limited to a maximum of 4 hours. the time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks. the goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. the outcomes of the study will guide cochlear to select features for inclusion in future nucleus cochlear implant systems and/or future models of care.


Eligibility criteria:
inclusion criteria: * users of a ce approved nucleus cochlear implant, resulting in open set speech understanding. * paediatrics: older than 5 years and \<18 years when entering the study. (belgium only) or * adults: ≥18 years when entering the study (belgium and australia). * subject/legally designated representative is fluent speaker in the language used for assessments. * willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative). exclusion criteria: * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations. * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. * currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
tailored regimens of pegasys® and ribavirin for genotype 1 chronic hepatitis c patients trial (target-1)

Conditions: Hepatitis C

Summary: the purposes of this study are: 1. to test if 36 weeks of standard dose of ribavirin with pegasys® is non-inferior to standard dose of 48 weeks of ribavirin with pegasys® in svr for patients with rvr and hvl 2. to test if the 72 weeks of treatment with pegasys® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with hcv rna seropositivity at week 12

the aims of the present study are: 1. to evaluate the efficacy and safety of 36-week versus 48-week regimen of pegasys® (peginterferon alfa-2a, pegifn) plus standard-dose of ribavirin (rbv) in hepatitis c virus (hcv) genotype 1 infected, treatment-naïve chc patients who have high viral loads (hvl, defined as baseline hcv rna ≧ 400,000 iu/ml) and achieve a rapid virologic response (rvr) (defined as seronegativity of hcv rna at week 4 of treatment) 2. to evaluate the efficacy and safety of 48-week versus 72-week regimen of pegifn plus standard-dose of rbv in hcv virus genotype 1 infected, treatment-naïve chc patients with pcr-seropositive of hcv rna at week 12

Eligibility criteria:
inclusion criteria: * male and female patients \*18 years of age * patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin * serologic evidence of chronic hepatitis c infection by an anti-hcv antibody test * detectable serum hcv-rna and hcv viral genotype 1 * liver biopsy findings consistent with the diagnosis of chronic hepatitis c infection with or without compensated cirrhosis (exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.) * compensated liver disease (child-pugh grade a clinical classification) * negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug * all fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end exclusion criteria: * women with ongoing pregnancy or breast feeding * therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \*6 months prior to the first dose of study drug * any investigational drug \*6 weeks prior to the first dose of study drug * co-infection with active hepatitis a, hepatitis b and/or human immunodeficiency virus (hiv) * history or other evidence of a medical condition associated with chronic liver disease other than hcv (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) * signs or symptoms of hepatocellular carcinoma * history or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease * neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening

Keywords: hepatitis c genotype 1 peg interferon alfa 1a ribavirin
study on the establishment of a system for early warning and prognostic evaluation of patients with sepsis

Conditions: Sepsis; Prognosis; Liver Injury; Kidney Injury; Early Waking

Summary: sepsis is a clinical syndrome with high morbidity and high fatality rate in emergency department. patients with acute liver or kidney injury are more likely to develop multiple organ dysfunction syndrome(mods) secondary to the non-hepatic injury group, and the prognosis deteriorates significantly. at present, there is no unified diagnostic criteria for acute liver injury associated with sepsis, and the commonly used prognostic evaluation system is rarely included in liver injury indicators, which is not good for practicality.

the project intends to collect the peripheral blood of the normal population, 24 hours after the onset of sepsis and patients in the recovery period. we will separate and extract plasma, peripheral blood mononuclear cell(pbmc), and plasma exosomal mirna, and sequence to find indicators related to disease deterioration and prognosis. and then, we will construct and verify the early warning and prognosis evaluation system. on this basis, the researcher explore cellular and molecular mediated pathological mechanisms of sepsis, and then clarify the treatment target of sepsis.

Eligibility criteria:
inclusion criteria: 1. the patient who voluntarily signs an informed consent form; 2. adult patients who meet the criteria for sepsis, who is registration to the hospital within 24 hours of onset; 3. sepsis is defined as the sequential organ failure assessment (sofa) score ≥ 2 within 24 hours after admission, accompanied by at least one site of infection; 4. patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure(map) 65 mm hg and having a serum lactate level \>2 mmol/l (18 mg/dl) despite adequate volume resuscitation. exclusion criteria: 1. age \ 90 years old; 2. patients with advanced tumors, pregnancy or lactation; 3. patients who missed out during treatment and whose data are incomplete.
lama2-related muscular dystrophy brain study

Conditions: LAMA2-MD (Merosin Deficient Congenital Muscular Dystrophy, MDC1A)

Summary: laminin alpha-2 (lama2)-related muscular dystrophy (lama2-md, merosin deficient cmd) is a form of congenital muscular dystrophy (cmd). a person with lama2-md will have changes on brain imaging (mri), a decrease or absence of the protein merosin (laminin 211) on muscle or skin biopsy and changes in the lama2 gene that are inherited from both parents. several studies have described the changes on brain mri. brain changes on mri do not correlate with the partial reduction or absence of merosin on muscle or skin biopsy. 8-30% of people with lama2-md develop seizures. the types of seizures, electroencephalogram changes and common treatment regimens have not been characterized. this study will review the magnetic resonance imaging (mri) changes, determine whether certain brain mri changes are linked to seizures and define the common seizure treatment regimens.

lama2-md is a congenital muscular dystrophy (cmd) subtype caused by mutations in the laminin alpha 2 gene. lama2-md may present clinically as an early onset, severe phenotype or a late onset limb girdle phenotype. the early onset form is most commonly associated with a complete absence of merosin on muscle biopsy with profound neonatal hypotonia, possible respiratory distress and feeding difficulties while the late onset form presents with proximal muscle weakness, contractures and is able to achieve walking. in both early and late onset forms, brain white matter abnormalities have been described on brain mri and approximately 8-30% develop a seizure disorder. on magnetic resonance (mr) spectroscopy, white matter changes are shown to be due to increased water content rather than areas of demyelination. both, non-ambulant and ambulant patients may develop respiratory insufficiency requiring non-invasive ventilation and scoliosis. although several studies have evaluated the correlation between brain mri white matter changes and cognition, no studies to date have provided a systematic evaluation of brain imaging, electrophysiologic testing and seizures in patients identified by molecular or immunohistochemical testing to have lama2-md.

Eligibility criteria:
inclusion criteria: * genetic confirmation of 2 variants in lama2 gene or muscle biopsy with complete absence of merosin * complete authorization to obtain medical records for congenital muscle disease international registry * complete authorization to obtain medical records for national institutes of health (nih) * reside in united states or canada * complete registration and intake survey in the congenital muscle disease international registry exclusion criteria: - individuals with lama2-md who have not had a brain mri

Keywords: mdc1a congenital muscular dystrophy merosin deficient lama2 brain white matter abnormalities seizure
absorption and digestion kinetics of human metabolites

Conditions: Postprandial Inflammation

Summary: the purpose of this pilot study is to evaluate the effects oral supplementation with four human metabolites (spermidine, nicotinamide, palmitoylethanolamide (pea), and oleoylethanolamide(oea)) at varying doses on the circulating blood levels of these metabolites as well as their immediate effects on plasma functionality and postprandial inflammation. 5 young healthy subjects will participate in a four armed study consisting of a placebo arm and a low, medium, and high dose arm. subjects will be given a standardized breakfast along with supplementation with either an escalating dose (low: 1x, medium: 2x, high: 3x) of a combination of spermidine, nicotinamide, pea and oea or a placebo control and a time course of their blood plasma will be collected after supplementation. plasma samples will be assessed for their concentration of spermidine, nicotinamide, pea, and oea as well as their experimental and clinical functionalities including their anti-inflammatory, antioxidant, and cholesterol efflux abilities on primary human macrophage.


Eligibility criteria:
inclusion criteria: * age: 20-40 years old to constitute a young study population * bmi: 19-27 kg/m2 to constitute a normal/healthy weight population * weight: 133lbs or more * subjects must be willing and able to consume a standardized breakfast bar containing cashews and dates (larabar). * subjects must be willing to consume oral dietary supplement versions of spermidine, 1-methlynicotinamide, palmitoylethanolamide, and oleoylethanolamide. * subjects must be willing and able to undergo blood draws at the uc davis ragle nutrition center at 0, 1, 2, and 4 hours after supplementation with spermidine, niacinamide, palmitoylethanolamide, and oleoylethanolamide. exclusion criteria: * smoker * anemia * documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer, autoimmune diseases, or previous cardiovascular events * any inflammatory bowel disease including ibs, crohn's disease, celiac disease * any allergy or sensitivity to wheat, gluten, or soy products * consumption of \>1 alcoholic drink/day * current consumption of any probiotic, prebiotic, or dietary supplements * extreme dietary or exercise patterns * recent weight fluctuations (greater than 10% in the last six months) * regular use of over-the-counter allergy or pain medications (\>1/week) * taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones. * use of any form of hormonal birth control including oral contraception pills, hormonal iuds or rings, or hormonal birth control patches * illness such as flu or cold of any kind within the last two weeks * allergy to components of standardized breakfast bar (cashew/dates) * changes to any of the above during the study period.
treatment of recurrent urinary tract infection (ruti) by traditional chinese medicine

Conditions: Recurrent Urinary Tract Infection

Summary: traditional chinese medicine (tcm) could be used to treat recurrent urinary tract infection (ruti).

antibiotics and tcm are used to treat ruti to evaluate treatment efficiencies.

Eligibility criteria:
inclusion criteria: * uncomplicated ruti exclusion criteria: * complicated ruti * other disease with urinary tract * infection by pathogens other than bacteria

Keywords: recurrent urinary tract infection antibiotics traditional chinese medicine
study evaluating zosyn in hospitalized patients with intra-abdominal infection

Conditions: Bacterial Infections

Summary: a phase iv, multicenter study of hospitalized patients with complicated intra-abdominal infection.


Eligibility criteria:
inclusion criteria * written informed consent will be obtained prior to enrollment into the study. if any patient is unable to give consent, it may be obtained from next of-kin or a legal representative if in accordance with local laws and regulations * hospitalized, ≥18 years of age * male or non-pregnant, non-lactating female who is post-menopausal, surgically sterilized or is using birth control pills, contraceptive implant or injection (ex: norplant®; depo-provera®), intra-uterine device, barrier methods with spermicide, or abstinence. (effective contraception should have been in place for at least two months prior to study entry and must continue for at least 30 days after treatment discontinuation) exclusion criteria * patients with underlying immunodeficiency disease or patients requiring chronic treatment with known immunosuppressant medications including \>5mg/day prednisone * active or treated leukemia, or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the past year or which is anticipated to begin prior to the test-of-cure visit; or any known or suspected malignancy to the abdomen * concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal catheters or shunts, plasmapheresis or hemoperfusion

Keywords: abdominal infections