Kornimate/medical-research-clean huggingface dataset:
dose escalation study of eg110a, administered by intradetrusor injections to adults with neurogenic detrusor overactivity-related incontinence following spinal cord injury who regularly perform clean intermittent catheterization

Conditions: Neurogenic Detrusor Overactivity; Spinal Cord Injuries

Summary: this is a first-in-human, phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of eg110a in male and female adult participants with neurogenic detrusor overactivity (ndo)-related incontinence following spinal cord injury (sci), who have persistent incontinence after standard of care therapy and who perform clear intermittent catheterization (cic) on a regular basis.

this first-in-human clinical study, performed in sci participants with urinary incontinence (ui) due to ndo and an inadequate response to current therapy, will evaluate the safety and tolerability of eg110a, and explore the potential doses for further clinical development. the present clinical study will also investigate the efficacy of eg110a via data collected in a bladder diary and via urodynamic assessments.

Eligibility criteria:
main inclusion criteria: 1. participant has stable supra-sacral traumatic sci with american spinal injury association (asia) impairment scale grade a, b, c, d or e which occurred at least 12 months before screening. 2. participant has ui due to urodynamically-confirmed ndo for at least 3 months prior to screening. 3. participant has: 1. been treated for ndo for at least 3 months prior to screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 ui episodes in a week despite consistent use of the therapy. participant does not wish to proceed to bont/a treatment, and their next step would be surgical intervention. or 2. had an inadequate response to bont/a treatment in the opinion of the investigator and participant, i.e., at least 8 ui episodes in a week, and the last bont/a treatment for their ndo was at least 9 months prior to the anticipated date of dosing (day 1). treatment with bont/a was not started more than 7 years ago, and their next step would be surgical intervention. main exclusion criteria: 1. participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of sci. 2. participant with active oral or genital herpes lesion. if the participant has an active oral or genital herpes infection this needs to be treated and healed first. the participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed). 3. participant had cancer therapy or radiotherapy ≤ 4 weeks prior to screening and has toxicities/aes attributable to previously administered cancer therapies that have not resolved or stabilized.
multi-omics analysis of chronic kidney disease

Conditions: Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD

Summary: chronic kidney disease (ckd) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (esrd), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.


Eligibility criteria:
inclusion criteria: age-matched and gender-matched hc with normal renal and liver function and not taking any medications were enrolled exclusion criteria: 1. age\<18 years. 2. individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy. 3. individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.
efficacy of fish oil in multiple sclerosis

Conditions: Relapsing- Remitting Multiple Sclerosis

Summary: the aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in ms.

current research findings suggest that omega-3 polyunsaturated fatty acids (pufa) such as eicosahexanoic acid (epa) and docosahexaenoic acid (dha) contained in fish oil may have anti-inflammatory, antioxidant and neuroprotective effects. the aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in ms. 50 patients with relapsing-remitting ms were enrolled. the experimental group received orally 4 g/day of fish oil for 12 months. the primary outcome was serum tnfα levels; secondary outcomes were il-1β, il-6, nitric oxide catabolites, lipoperoxides, progression on the expanded disability status scale (edss) and annualized relapses rate (arr).

Eligibility criteria:
inclusion criteria: * patients had clinically definite and magnetic resonance image supported ms * had at least one relapse in the year before entry into the study * edss score of 0-5 * treated with subcutaneous 250 μg interferon beta-1b (betaseron, bayer) exclusion criteria: * they were taking another supplement * had progressive forms of ms * had history of severe depression * had history of acute liver or renal dysfunction * had history of tobacco, drug or alcohol abuse * had intolerance, contraindication or allergy to fish oil

Keywords: r-r ms
a study of olaratumab (ly3012207) plus pembrolizumab in participants with advanced or metastatic soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of advanced unresectable or metastatic sts, not amenable to curative treatment and after available standard therapies have failed to provide clinical benefit. note: participants with a diagnosis of grade 1 liposarcoma (atypical lipomatous neoplasms) are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. * presence of measurable or nonmeasurable but evaluable disease as defined by the response evaluation criteria in solid tumors (recist 1.1). * performance status 0-1 on the eastern cooperative oncology group (ecog) scale. * must be able to provide tumor tissue obtained within 6 months of study enrollment. if such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed. * have an anticipated life expectancy of ≥3 months. exclusion criteria: * have received any previous systemic therapy (including investigational agents) targeting pd-1/programmed cell death ligand 1 (pdl-1) or pd-1/pdl-2 signaling pathways (including previous participation in merck mk-3475 trials). prior treatment with olaratumab is allowed. prior therapy with other immune checkpoint inhibitors, including but not limited to, anti-cd137 antibody or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody, is not permitted. * have known active central nervous system (cns) metastasis and/or carcinomatous meningitis. participants with treated cns metastases are eligible for this study if they have not received corticosteroids and/or anticonvulsants within 7 days of study treatment, and their disease is asymptomatic and radiographically stable for at least 60 days. * have active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years. * history of interstitial lung disease or non-infectious pneumonia. * have received a live-virus vaccine within 30 days prior to planned treatment start. * have histologically or cytologically confirmed kaposi's sarcoma or gastrointestinal stromal tumor (gist). * have inflammatory bowel disease for which the participant has used immunosuppressive agents within the last 2 years.
mk-0954e study in participants with hypertension (mk-0954e-357)

Conditions: Hypertension

Summary: this study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (l50) + hydrochlorothiazide 12.5 mg (h12.5) + amlodipine besylate 5 mg (a5) (mk-0954e). the primary hypothesis is that l50/h12.5/a5 is more effective in lowering mean trough sitting diastolic blood pressure (sidbp) after 8 weeks of treatment compared to l50+a5 in japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (l50+a5).


Eligibility criteria:
inclusion criteria * participant has a diagnosis of essential hypertension. * participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication. * participant has a mean trough sidbp of ≥ 90 mmhg and \< 110 mmhg. * participant has a mean trough sisbp of ≥ 140 mmhg and \< 200 mmhg. * participant has no clinically significant abnormality at screening visit. exclusion criteria * participant is currently taking \> 2 antihypertensive medications. * participant has a history of significant multiple and/or severe allergies to ingredients of nu-lotan or preminent, amlodipine or dihydropyridine drug, and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines). * participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence. * participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit (visit 1). * participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Keywords: essential hypertension uncontrolled hypertension antihypertensive agents blood pressure
impact of stent length and diameter on patients undergoing primary pci

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Summary: the goal of the study is to evaluate the impact of coronary stent length and/or diameter in patients with st segment myocardial infarction undergoing primary pci, on short term clinical outcomes.

* st segment elevation myocardial infarction is serious condition to the blood supply to the heart muscle. rapid reperfusion of the ischemic myocardium using percutaneous coronary intervention (pci) is the standard treatment for acute myocardial infarction (mi) to rescue the ischemic myocardium and reduce infarction size. * there are two types of stents: 1. drug-eluting stent which achieving local drug delivery to the injured blood vessel at the time of intervention, a drug is released from a polymer coating or loaded directly onto the stent (2). this is the best one. 2. bare metal stent is the old one and not effective as des in reducing vascular restenosis by suppressing smooth muscle cell (smc) proliferation. * the management of long coronary lesions by percutaneous coronary intervention (pci) has become increasingly important because of the rising incidence of long or complex lesions in aging populations (3) stent length has been considered as an important predictor of adverse events after pci. the exact impact of lesion length on the short- and long-term clinical outcomes of des implantations is not clear yet. * myocardial necrosis complicates one-third of percutaneous coronary intervention (pci) and may adversely affect the outcome(4)

Eligibility criteria:
inclusion criteria: * patients with st segment myocardial infarction who are eligible for pci. * all categories (all age groups and both sex groups) exclusion criteria: * patients with previous pci. * patients of ectatic lesions. * patients with with multi vessel disease and suitable for cabg. * patients with complex lesions including bifurcational lesions and lm stenting.
phase i pharmacokinetics and safety study of naloxegol in paediatric oic patients

Conditions: Constipation, Signs and Symptoms, Digestive

Summary: to characterize the pharmacokinetics (pk) of naloxegol after single oral dose and through population pk in paediatric patients with opioid induced constipation (oic) or at risk of oic.


Eligibility criteria:
main inclusion criteria, patient with: * malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids * newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment * ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling. main exclusion criteria: * current acute or chronic use of methadone * history of an neoplasm or an ongoing gastrointestinal-related issue * signs or symptoms of gastrointestinal obstruction * history of prolonged neutropenia or thrombocytopenia with clinical sequelae. * patients currently receiving the first cycle of chemotherapy

Keywords: constipation colonic inertia dyschezia pharmacokinetics naloxegol paediatric opioids opioid induced constipation oic phase 1
applicability of 3t shoulder mri in detection of labral pathology

Conditions: Labral Tear, Glenoid

Summary: the purpose of this observational study is to compare image quality between 3 tesla magnet (3t) non-contrast mri to the current standard of mr arthrogram (1.5t magnet) in detecting shoulder labral and cartilage pathology. an orthopedic surgeon on the research team will screen for patients with high probability of labral and/or cartilaginous pathology and the need for advanced imaging. the orthopedic surgeon's inclusion of patients will be based on a thorough clinical exam and obtained history. patients included in the study will be imaged using both protocols - the current standard of mr arthrogram with a 1.5t magnet and non-contrast imaging with a 3t magnet. both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.

the specific aim of this investigation is to determine the accuracy and reliability of 3t mri in the detection of shoulder labral and cartilage pathology as compared to the current standard of mr arthrography with a 1.5t magnet scanner. patients who present to a henry ford orthopedic clinic associated with a surgeon participating in this study and are indicated for labral surgery will be assessed for eligibility. patients will be interviewed, and their medical chart reviewed to determine whether they meet inclusion and exclusion criteria. sections of the medical chart that will be reviewed include history of present illness, medical and surgical history, and the physical exam. patients who meet criteria for this study will be consented by the surgeon or other key study personnel. a password-protected spreadsheet stored on henry ford onedrive will be used to track patients enrolled in the study and make record of patients who do not meet inclusion criteria. patients between 14-65 years of age being seen in orthopedic clinic with shoulder pathology likely requiring surgical intervention will be screened into the study. patients will be imaged with standard of care mri shoulder arthrogram on a 1.5 t magnet and additionally with non-contrast mri of the shoulder on a 3 t magnet. all patients will be dually imaged. initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast mri as part of the study protocol. both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.

Eligibility criteria:
inclusion criteria: * indicated for likely labral surgery * chronic, degenerative labral and/or cartilage pathology * ability to read and understand english * age ≥ 18 years * age ≤ 65 years exclusion criteria: * patient does not complete both the mr arthrogram and 3t non-contrast mri * unexpected trauma in between the mr arthrogram and 3t non-contrast mri * age \< 18 years * age \> 65 years
study evaluating how quickly and to what extent the 14-carbon-sam-531 is absorbed/converted/eliminated in male subjects

Conditions: Alzheimer Disease

Summary: the objective of this study is to investigate how quickly and to what extent the 14-carbon labeled sam-531 is absorbed into the bloodstream, converted and eliminated from the body after oral administration in healthy male subjects. as 14-carbon labeled sam-531 is radioactive, this enables the compound to be traced in blood, urine and feces.


Eligibility criteria:
inclusion criteria: * men aged 18 to 50 years inclusive at screening * healthy as determined by the investigator on the basis of screening evaluations exclusion criteria: * presence or history of any disorder that may prevent the successful completion of the study. * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
low carbohydrate diet vs. high carbohydrate diet in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes ≥3 years * insulin pump use ≥1 year * hba1c ≥53 mmol/mol (7.0%) * bmi 20-27 kg/m2 * willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods * willingness to use continuous glucose monitoring consistently during the intervention periods exclusion criteria: * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods * use of sglt-2-inhibitors * use of corticosteroids during or within 30 days prior to the intervention periods * celiac disease * inflammatory bowel disease * macroalbuminuria * active proliferative retinopathy combined with an hba1c ≥ 75 mmol/mol (9.0%) * known or suspected alcohol or drug abuse * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
sensitivity of echography in arthritis

Conditions: Rheumatoid Arthritis

Summary: it has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (wakefield et al. ann rheum dis). an omeract and eular working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (wakefield r, d'agostino ma). it has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-tnf treatment (ref. taylor et al). if this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments. in everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients. objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).

this is a multicenter, (10 french centers and 1 belgian center), prospective (4-month patients' follow-up) interventional study in 120 patients with rheumatoid arthritis justifying anti-tnf treatment. the overall duration of the study will be 8 months composed of a 4-month inclusion period and a 4-month follow-up period for each patient. moreover, x-ray evaluations of hands and feet will be performed 2 years from the beginning of the study in order to assess the changes in structural damage. during the patients' participation, 6 visits are planned: an inclusion visit then, a follow-up visit at 1, 2 and 3 months from the inclusion visit, and a final evaluation visit at 4 months from the inclusion visit. at each visit, synovitis will be evaluated using both methods: clinical examination and ultrasonography. for a same patient, clinical evaluation of synovitis will have to be performed - during the entire study - by the same rheumatologist and the ultrasonographic evaluation will have to be performed by the same ultrasonographist (different from the rheumatologist) and always using the same ultrasonograph. finally, patients will be performed anterior x-rays of hands and feet two years from the beginning of the study whatever the ongoing ra treatment.

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis meeting acr criteria. * justifying anti-tnf alpha treatment (switch or first administration). * to have at least 6 synovitis at the clinical examination necessary for the das evaluation * to accept to participate in this study (informed consent signed). exclusion criteria: * minor patients. * pregnancy. * breastfeeding.

Keywords: synovitis score sensitivity to change clinical examination ultra-sonography
a study comparing coq10 levels while taking 3 different statins

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to determine if pitavastatin lowers coq10 less than atorvastatin or rosuvastatin.

statins are known effectively treat high cholesterol and heart disease. however, statins may lower endogenous levels of coenzyme10 (coq10). this decrease in coq10 levels may be responsible for side effects such as myalgia. previous studies have shown that pitavastatin may not affect coq10 levels as other statins do, while still lowering cholesterol. in this study, investigators intend to compare the plasma levels of coq10 in patients taking 3 different fda-approved statins, in equipotent doses.

Eligibility criteria:
inclusion criteria: * ldl-c levels of 100-200mg/dl; triglycerides \</=200mg/dl at screening visit * willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study exclusion criteria: * ldl-c \ 200mg/dl, triglycerides \>200mg/dl * history of diabetes mellitus or documented fasting blood glucose \>125mg/dl or hba1c \>6.4% * history of coronary artery disease * history of chronic renal or hepatic disease * known sensitivity of intolerance to a statin * persistent elevated liver enzymes or cpk (\>3 x upper normal limit) * currently taking coq10 supplements and unable discontinue for duration of study

Keywords: ldl, hdl