Kornimate/medical-research-clean huggingface dataset:
diabetic cardiomyopathy and heart failure

Conditions: Diabetic Cardiomyopathies; Heart Failure

Summary: this study will demonstrate the beneficial effects of ketone bodies in type 1 diabetes (t1d) patients and will have significant translational applications to prevent serious metabolic conditions such as t1d induced diabetic cardiomyopathy (dcm).

t1d remains the primary cause of dcm. the long-term goal is to understand the mechanism of t1d leading to dcm. proprotein convertase subtilisin/kexin type 9 (pcsk9) plays an important role in degrading the low-density lipoprotein receptors (ldlrs) and that increases the circulating ldl cholesterol (ldl-c). further, pcsk9 increases duringt1d and that, in turn, decreases mitochondrial bioenergetics, transcription factor- mitochondrial (tfam), and the mitochondrial numbers thus creates an oxidative stress. these changes lead to oxidation of high-density lipoprotein paraoxonase-1 (hdl-pon1). because pon1 hydrolyzes homocysteine (hcy), the oxidized pon1 thus causes accumulation of hcy (i.e. hyperhomocysteinemia; hhcy). also, the 'metabolic memory' is associated with epigenetic modification (methylation) of genes encoding proteins such as thioredoxin interacting protein (txnip). since methylation/epigenetics inhibits genes, this phenomenon generates even more amounts of hcy. investigators have shown that hhcy decreases g-protein coupled receptor (gpcr) gαs subunit, protein kinase-b (akt), focal adhesion kinase (fak) but increases calpain-1, inflammasome and oxidative stress. the central hypothesis is that an increase in pcsk9 causes oxidative stress and decreases txnip thus causing oxidation of hdl-pon1 and subsequent accumulation of hcy. these alterations lead to decrease in gαs, akt, fak and concomitant increase in pcsk9 and calpain-1 causing metabolic, diastolic, and systolic cardiac dysfunction. treatment with ketone bodies (the food for mitochondria) will mitigate these changes.

Eligibility criteria:
inclusion criteria: -diabetic subjects with high blood glucose levels exclusion criteria: - comorbidities affecting glucose levels and cardiac function

Keywords: diabetic cardiomyopathy, metabolic dysregulation, and heart failure.
non-interventional post-authorisation study to document the immunogenicity, safety, and efficacy of nuwiq

Conditions: Hemophilia A

Summary: prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. the diagnosis of fviii inhibitor will be based on clinical observations and confirmed by fviii inhibitor testing in the laboratory.


Eligibility criteria:
inclusion criteria: * haemophilia a (fviii:c ≤ 2%) based on medical history; at least 100 patients should have severe haemophilia a (fviii:c \< 1%) * male patients of any age * previous treatment with a fviii concentrate for more than 150 eds * availability of detailed documentation (patient diary, log book, etc.) covering either the last 50 eds or the last 2 years per patient to confirm treatment modality (i.e., prophylaxis, on-demand, recent surgery, or immune tolerance induction) * inhibitor negative (\< 0.6 bu) at study entry as confirmed by a recovery test with previous fviii product and inhibitor test in a central laboratory * immunocompetence (cd4+ count \> 200/µl), hiv-negative, or having a viral load \< 200 particles/µl or \< 400,000 copies/ml * decision to prescribe human-cl rhfviii before enrolment into the study * written informed consent by the patient or the patient's parent or legal guardian exclusion criteria: * patients treated with any investigational medicinal product (imp) except fviii imp within 30 days prior to the screening visit or patients planning to undergo treatment with any imp other than human-cl rhfviii are not eligible for enrolment into the study.
early versus late use of ibuprofen for patent ductus arteriosus (pda) closure

Conditions: Patent Ductus Arteriosus; Prematurity

Summary: the primary objective is to evaluate the patent ductus arteriosus (pda) closure rate of early vs. late use of ibuprofen (ibu). the investigators believe that early use of ibu will have a higher pda closure rate than later use of ibu. early use is defined as medication given before the infant reaches 96 hrs old. late use is defined as medication given when infant is more than 96 hrs old.

infants with birth weight at \ 96 hrs old. ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. an echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Eligibility criteria:
inclusion criteria: * birth weight less than 1200gm * less than 28 weeks gestational age * confirmed patent ductus arteriosus (pda) via echocardiogram and clinical exam exclusion criteria: * active bleeding * currently being treated for persistent pulmonary hypertension (pphn) * cardiac anomalies * chromosomal abnormalities * endocrine, metabolic, renal, or hepatic disorders

Keywords: premature infants pda ibuprofen
safety, tolerability and efficacy of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (hpt).


Eligibility criteria:
inclusion criteria: * subject provides written informed consent. * intact parathyroid hormone (pth) at least 350 pg/ml. * corrected calcium at least 9.0 mg/dl. * hemoglobin at least 9.0 g/dl. * adequate hemodialysis three times per week. * excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests. exclusion criteria: * history or symptomatic ventricular dysrhythmias. * history of angina pectoris or congestive heart failure * history of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months. * history of or treatment for seizure disorder. * recent (3 months) parathyroidectomy. * serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.

Keywords: clinical trial, phase 2 renal dialysis secondary hyperparathyroidism parathyroid hormone
evaluation of interstitial lung disease severity in patients with antisynthetase syndrome according to specific autoantibodies profile

Conditions: Antisynthetase Syndrome

Summary: antisynthetase syndrome (ass) is an overlap connective tissue disease characterized by the presence of myositis-specific autoantibodies directed against trna-synthetases. clinical manifestations are myositis, interstitial lung disease (ild), raynaud's phenomenon, mechanic's hands and polyarthritis. clinical presentation varies between ass patients. ass is potentially life threatening due to lung involvement, especially in rapidly progressive forms. anti-histidyl-trna synthetase (anti-jo1) antibodies are the most frequently detected antibodies in ass (60 % of patients). anti-threonyl-trna synthetase (anti-pl7) and alanyl-trna synthetase (anti-pl12) antibodies are each detected in 10 % of patients approximatively. anti-trna-synthetases antibodies are mutually exclusive. clinical heterogeneity of ass patients appears to be associated with specific autoantibodies profile. patients with anti-jo1 antibodies have a more systemic presentation (especially with muscle involvement), whereas patients with anti-pl7 or anti-pl12 antibodies have more frequent and isolated ild. if anti-pl7 and anti-pl12 antibodies are associated with more severe ild and poorer survival is still matter of debate. aims of this study were to compare ild severity at diagnosis and clinical course in patients with ass according to antisynthetase autoantibodies types.


Eligibility criteria:
inclusion criteria: * patients with antisynthetase syndrome according to connors criteria exclusion criteria: * none

Keywords: interstitial lung disease
study of medication compliance - a comparison of patients in pain management and pre-surgical patients

Conditions: Pain

Summary: in this study medication compliance regarding current drug use is investigated using toxicological analyzes in two patient groups: patients from a pain management department and pre-surgical control patients. the aim is to explore the incidence of concealed and feigned substances and to determine the respective substance classes. expecting that noncompliance is higher in the pain patient group, the investigators want to identify clinical risk factors for noncompliant drug report.


Eligibility criteria:
inclusion criteria: * provided informed consent * current pain exclusion criteria: * no taking of blood sample possible * no consent with toxicological analyzes * insufficient comprehension of the german language

Keywords: medication compliance adherence toxicological analyzes gc-ms hplc pain patients opioid misuse patients with current pain
safety and efficacy of switching to quetiapine in outpatients with schizophrenia

Conditions: Schizophrenia

Summary: this is a single-arm, phase iv, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved spc.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia at least 1 year prior to screening * inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication * provision of informed consent prior to enrolment exclusion criteria: * known hypersensitivity to active substance of excipients * patients receiving p450 3a4 inhibitors * pregnancy or lactation * substance abuse or dependence

Keywords: switching quetiapine schizophrenia unsuccessfully treated antipsychotics
tibio-talo-calcaneal fusion by hindfoot nail versus open reduction and internal fixation in treatment of complex fractures distal tibial and fragility ankle fractures in elderly

Conditions: Fragility Ankle Fractures and Complex Distal Tibial Fractures

Summary: tibiotalar calcaneal fusion by hindfoot nail vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly


Eligibility criteria:
inclusion criteria: * pilon fractures complex distal tibial fractures ankle comminuted fractures age more than 65yrs osteoprotic fractures surgically fit patients exclusion criteria: ankle fractures unimalleolar undisplaced pathological fractures young adults dvt peripheral vascular diseases age less than 65 unfit patient for surgery -
advanced reperfusion strategies for refractory cardiac arrest

Conditions: Cardiac Arrest; Extracorporeal Membrane Oxygenation Complication; Ventricular Fibrillation; Pulseless Ventricular Tachycardia; Out-Of-Hospital Cardiac Arrest

Summary: this is a phase ii, single center (under the center for resuscitation medicine at the university of minnesota medical school), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (vf/vt) out-of hospital cardiac arrest (ohca) who are transferred by emergency medical services (ems) with ongoing mechanical cardiopulmonary resuscitation (cpr) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) early extracorporeal membrane oxygenation (ecmo) facilitated resuscitation or 2) standard advanced cardiac life support (acls) resuscitation


Eligibility criteria:
inclusion criteria: * adults (presumed or known to be aged 18-75 years, inclusive), * an initial documented ohca rhythm of vf/vt, * no rosc following 3 defibrillation shocks, * body morphology able to accommodate a lund university cardiac arrest system (lucas™) automated cpr device, and * estimated transfer time from the scene to the ed or ccl of \< 30 minutes. exclusion criteria: * age \ 75 years old; * non-shockable initial ohca rhythm (pulseless electrical activity \[pea\] or asystole); * valid do-not-attempt-resuscitation orders (dnar); * blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose; * known prisoners; * known pregnancy; * nursing home residents; * unavailability of the cardiac catheterization laboratory. * severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure; * absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding

Keywords: advanced reperfusion mechanical cardiopulmonary resuscitation
efficacy of novel edible gel-based artificial saliva in cancer patients

Conditions: Cancer of Head and Neck; Cancer; Radiation-induced Xerostomia; Dry Mouth

Summary: the purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.


Eligibility criteria:
inclusion criteria: * cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems exclusion criteria: * mucositis more than grade 1 * cannot perform oral intake of gel-based artificial saliva eg. aspirate
real life study evaluating the clinical and organisational impact of moovcare® lung connected medical device in lung cancer patients : real-moov-lung

Conditions: Lung Cancer

Summary: evaluation of patient's proportion, whose management care has been modified at least once and specially by moovcare® lung application at 12 and 24 months.

primary objective of the study: the primary objective is a clinical one and is to evaluate the proportion of patients, whose management care has been modified at least once and specially by moovcare® lung application at 12 and 24 months.

Eligibility criteria:
inclusion criteria: 1. patient with lung cancer at any diagnostic stage and histology. 2. patient willing to use the follow-up setting with moovcare® lung apps. 3. age ≥ 18 years. 4. patient received anti-cancer treatment (surgery, chemotherapy, radiation (stereotaxy or not) or radio-chemotherapy association ended less than 12 weeks (cohort 1 post-treatment); or during maintenance treatment or consolidation by chemotherapy or targeted therapy, or by immunotherapy initiated less than 12 weeks (cohort 2 during treatment). 5. imaging tumor evaluation less than 12 weeks showing disease control (response or stability according to recist 1.1 criteria). 6. patient with symptomatic score on moovcare® lung apps less than 7. 7. patient (or relatives) with internet access, a personnal e-mail box and a smartphone. 8. patient with social security affiliation. 9. signed informed consent form. exclusion criteria: 1. patient with progression after the first evaluation of initial treatment. 2. pregnancy and breast-feeding. 3. patient under tutorship or guardianship. 4. dementia, mental alteration or psychiatric pathology influencing patient consent procedure and/or protocol observance and study follow-up. 5. patient enable to protocol follow-up for psychological, social, familial or geographical reasons.
localized therapeutics for the treatment of gastrointestinal disorders

Conditions: Healthy Adults

Summary: the purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. the thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as gras (generally recognized as safe) by fda. it could subsequently be used as a medium for drug delivery. the poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.


Eligibility criteria:
inclusion criteria: * generally healthy * age 18 to 70 years old * non-pregnant exclusion criteria: * gi complaints * pregnancy * patients with previous colonic surgery or current bowel injury or obstruction * allergies to contrast

Keywords: enema
trial of msc1936369b in subjects with solid tumors

Conditions: Solid Tumors; Cancer

Summary: this is a first in man trial with a primary objective being the determination of the maximum tolerated dose (mtd) and the dose-limiting toxicity (dlt) in several regimens of mek inhibitor msc1936369b administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with msc1936369b.


Eligibility criteria:
inclusion criteria: * pathologically-confirmed solid tumor which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available. in the regimen 3, regimen 2 food-effect, and bid cohorts, the tumor type will be restricted to melanoma. * age greater than or equal to (\>=) 18 years * has read and understands the informed consent form and is willing and able to give informed consent. fully understands requirements of the trial and willing to comply with all trial visits and assessments exclusion criteria: * bone marrow impairment as evidenced by haemoglobin less than (\<) 9.0 gram per deciliter (g/dl), neutrophil count \< 1.0\*10\^9/liter, platelets \< 100\*10\^9/liter * renal impairment as evidenced by serum creatinine \> 1.5\*upper limit normal (uln), and/or calculated creatinine clearance \< 60 milliliter per minute (ml/min) * liver function abnormality as defined by total bilirubin \> 1.5\*uln, or aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> 2.5\*uln, for subjects with liver involvement ast/alt \> 5\*uln * inr \> 1.5\*uln * serum calcium \> 1\*uln * history of central nervous system (cns) metastases, unless subject has been previously treated for cns metastases, is stable by computer tomography (ct) scan without evidence of cerebral oedema, and has no requirements for corticosteroids or anticonvulsants * history of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product * eastern cooperative oncology group performance status (ecog ps) greater than (\>) 1 * known human immunodeficiency virus (hiv) positivity, active hepatitis c, or active hepatitis b

Keywords: mek inhibitor cancer solid tumors
comparison of his bundle pacing and bi-ventricular pacing in heart failure with atrial fibrillation

Conditions: Heart Failure; Atrial Fibrillation

Summary: this study is a multicenter, prospective, randomized cross-over study to compare his bundle pacing (hbp) with bi-ventricular pacing (bivp) in hf patients with af who need atrial-ventricular node ablation.

patients who meet the inclusion and exclusion criteria will be enrolled into the study. in the study, both atrial-ventricular node(avn) ablation and cardiac resynchronization therapy (crt) implantation are performed with hbp lead implanted and connected with the a port of crt device. followed with successful avn ablation, hbp lead and crt implantation, patients are 1:1 randomized into bivp and hbp group for 9 months and then crossover for another 9 months. the primary end points of the study is the change of left ventricular ejection fraction (lvef) in both hbp and biv pacing group.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * subject or authorized legal guardian or representative has signed and dated the informed * subject is expected to remain available for follow-up visits at the study center * subjects with heart failure nyha class ii-iv * subjects with lvef no greater than 40% * subjects with persistent atrial fibrillation or atrial flutter with uncontrolled ventricular rate exclusion criteria: * subjects with the width of ecg q, r, s wave (qrs) complex \>120ms * subjects with life expectancy less than 3 years * subjects with mechanical right heart valve * subjects with primary valvular disease * subjects with heart transplant, or is currently on a heart transplant list * subjects who are pregnant, or of childbearing potential and not on a reliable form of birth control * subjects with significant renal dysfunction, as manifested by serum creatinine level \>2.5 mg/dl or ≥275 μmol/l or estimated glomerular filtration rate (gfr) ≤30 ml/min/1.72 m2, which is documented within the 30 days prior to enrollment or at baseline. * subjects with significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) \> 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline. * subjects with chronic or treatment-resistant severe anemia (hemoglobin \<10.0 g/dl), which is documented within the 30 days prior to enrollment or at baseline

Keywords: heart failure atrial fibrillation crt bivp hbp