Kornimate/medical-research-clean huggingface dataset:
effect of sodium glucose cotransporter 2 inhibitiors on left ventricular remodeling among diabetic and non diabetic patients with chronic heart failure

Conditions: SGLT2 Inhibitiors Remodeling Effect; Chronic Heart Disease

Summary: to evaluate the efficacy of sglt2 inhibitors on left ventricular global longitudinal strain and diastology parameters among diabetic and non-diabetic patients with chronic heart failure

sodium-glucose cotransporter 2 inhibitors (sglt2i) have an established place in the therapy of heart failure (hf), as they have been shown to significantly reduce all-cause mortality, cardiovascular mortality, and hospitalizations in hfref patients, regardless of the presence of diabetes mellitus. the growing evidence of the effect of sglt2i on cardiac remodeling through cellular, molecular, vascular, interstitial, and electrical effects justifies its role as fundamental hf therapy. sglt2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes. adverse myocardial remodeling affecting the left ventricle is a key factor in hf progression, and current well-established hf phenotypes are based on lvef. however, other relevant players, such as the left atrium, have received less attention. indeed, the left atrium plays a critical role in cardiac function, particularly in left ventricular (lv) filling during diastole. additionally, atrial dysfunction can directly lead to pulmonary congestion. left atrial (la) remodeling occurs in hf irrespective of the degree of lv systolic dysfunction and can be observed in the presence of preserved or reduced lvef. sglt2 inhibition has been associated with reduced left ventricular (lv) and left atrial volumes in hf; however, its relationship with contemporary echocardiographic parameters of global lv systolic function, including global longitudinal strain and myocardial work, has not been thoroughly investigated. measuring the effect of sglt2i therapy on left ventricular systolic function (lv) has previously been assessed by changes in heart size volume and ejection fraction. in current clinical practice, the assessment of lv systolic function is still mainly based on the measurement of lv ejection fraction (lvef), which remains the gold standard despite some notable limitations. in the last decade, lv global longitudinal strain (gls) has emerged as a more accurate predictor of poor outcomes, revealing subtle abnormalities and preclinical lv systolic dysfunction.

Eligibility criteria:
inclusion criteria: - the study will enroll outpatients with hf on optimized medical therapy defined by the guidelines of the european society of cardiology (esc) that were used when the study was initiated. age ranges from 18 to 75 years exclusion criteria: * age \ 75 years. 2. if there is any contraindication in using sglt2 inhibitors, patients that had symptomatic hypotension (systolic blood pressure \ 5.2 mmol/l and liver dysfunction (defined as hepatic parameters such as alt, ast and/or alp elevated ≥3 times above the upper 99th reference percentile.
identification of genetic mutations involved in chiari type i malformations

Conditions: Chiari Malformation, Type 1

Summary: although most cases of chiari malformation type i (cm1) are sporadic, familial cases of cm1, with or without syringomyelia, suggest a genetic cause in the pathogenesis of these malformations. the hypothesis is that there is one or more genes, in particular among those involved in the development of the axial skeleton and the cranium, which could lead to an abnormal morphology of the posterior fossa resulting in tonsillar herniation defining cm1. the abnormal circulation of cerebrospinal fluid due to tonsillar herniation is believed to be responsible, in some patients whose predisposing factors remain to be determined, for the progressive onset of associated syringomyelia. since the determinants underlying the development of the posterior fossa of the skull are multigenic, the analysis of familial cases would make it possible to reduce genetic and phenotypic heterogeneity allowing to identify common pathogenic variants. for this study the investigators will be taking a blood sample to perform whole exome sequencing, build a biological collection and record imaging and clinical data.


Eligibility criteria:
inclusion criteria: * having a social security * participant or legal representative having given his consent * for patients: diagnosis of a chiari malformation type 1, defined morphologically as cerebellar tonsillar herniation beyond the foramen magnum greater than 5 mm, with or without associated syringomyelia, and which has at least one relating to the 1st or 2nd degree (parents, siblings; grandparents, uncles, aunts, cousins) carrying the malformation. * for relatives: at least two 1st degree relatives diagnosed with a chiari type 1 malformation exclusion criteria: * syndromic form of chiari malformation * patient with a legal protection measure * pregnant or breastfeeding woman * contraindication to mri * for patients: diagnosis of chiari malformation type 1 that could not be confirmed by mri * for relatives: age under 18 years

Keywords: genetic mutation syringomyelia
sodium-glucose cotransporter-2 inhibitors: a potential novel treatment for epilepsy

Conditions: Epilepsy

Summary: about 30% of persons with epilepsy have seizures that do not respond to drugs. the ketogenic diet is an effective treatment option for them, but this high fat diet is strict and difficult to maintain. the properties of gliflozins, which often are used to treat type 2 diabetes, make them a potential replacement for the ketogenic diet. this pilot study will determine whether gliflozins induce ketosis and could be used to treat adults with epilepsy safely.

the 30% of persons with epilepsy who are drug-resistant bear most of the financial and psychosocial costs of this common neurological disorder. an effective, clinically used treatment for these individuals is the ketogenic diet, a high fat, low carbohydrate diet. newer variants of the ketogenic diet including the modified atkins diet (mad) and low glycemic index treatment (lgit) are more palatable than the older versions but are challenging to maintain because they are strict. the mad and lgit lower blood glucose and produce mild ketosis. sodium-glucose cotransporter-2 inhibitors (sglt2i) such as empagliflozin have become important additions to the armamentarium for treating type 2 diabetes. sglt2i decrease blood sugar by causing glucosuria, and they induce mild ketosis. these actions raise the possibility that sglt2i can replace the mad and lgit as epilepsy treatments. this pilot, phase 1 study will determine the feasibility, safety, and tolerability of the sglt2i empagliflozin in adults with epilepsy.

Eligibility criteria:
inclusion criteria: * age 18-45 years * focal, generalized, combined generalized and focal, or unknown epilepsy type * drug-responsive or drug-resistant epilepsy exclusion criteria: * seizure frequency \>2 seizures per day during the 6 months prior to enrollment * status epilepticus during the 2 years prior to enrollment * taking a gliflozin * allergy to gliflozins * taking a carbonic anhydrase inhibitor such as acetazolamide * on any ketogenic diet variant * having an absolute contraindication to a ketogenic diet * type 1 or type 2 diabetes * pregnancy * moderate to severe intellectual disability, * significant cardiovascular disease * renal insufficiency * body mass index \<18.5 or ≥30 * hemoglobin a1c ≥5.7%
liverpal: a trial of inpatient palliative care for patients with advanced liver disease

Conditions: Liver Disease Chronic; End Stage Liver DIsease; Cirrhosis; Cirrhosis, Liver; Advanced Cirrhosis

Summary: the goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (advld) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

the main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (advld). the investigators aim to find out whether introducing hospitalized patients with advld to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.

Eligibility criteria:
patient inclusion criteria: 1. hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent: * ascites (requiring diuretics or serial large volume paracenteses) * spontaneous bacterial peritonitis * hepatic hydrothorax (requiring diuretics) * variceal bleed (with one or more occurrences) * overt hepatic encephalopathy (requiring medications) 2. ability to comprehend english patient exclusion criteria: 1. prior history of liver transplantation 2. have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent 3. current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer) 4. presence of hepatocellular carcinoma beyond milan criteria 5. are already receiving hospice care 6. receive a score of \<10 on the simplified animal naming test caregiver inclusion criteria 1. adult caregiver (≥ 18 years of age) 2. a relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone 3. ability to comprehend english and can complete questionnaires caregiver exclusion criteria 1. inability to comprehend english
biomarkers for bipolar disorder: chaperones and reticulum endoplasmatic stress response chap´s study

Conditions: Bipolar Disease Type I

Summary: the purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar i patients (manic phase) compared to healthy controls. hypothesis: there is no difference in chaperones proteins expression between bipolar i manic patients and healthy controls


Eligibility criteria:
inclusion criteria: * bipolar disease type i manic phase * ymrs \> 14 * hdrs \< 9 exclusion criteria: * use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days
si joint stabilization in long fusion to the pelvis

Conditions: Sacroiliac Joint Disruption; Scoliosis Lumbar Region

Summary: the purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (mlf) surgery with and without the ifuse 3-d implants in the "bedrock" trajectory.

this is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard mlf surgery with s2ai fixation in the pelvis vs the additional placement of ifuse 3-d in the bedrock configuration during mlf surgery. subjects will be monitored for sacroiliac (si) joint pain and at two years post surgery a ct scan will be taken to assess s2ai screw loosening or any other findings.

Eligibility criteria:
inclusion criteria: 1. age 21-75 at time of screening 2. patient scheduled for multilevel (\>3 levels) spinal fusion surgery with planned fixation to the pelvis using s2ai screws 3. patient has signed study-specific informed consent form 4. patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements exclusion criteria: 1. indication for multilevel spine fusion surgery is any of the following: 1. congenital neuromuscular disease 2. prior pelvic fixation (i.e., patient already has s2ai or iliac bolts in place, current surgery indicated to revise this hardware) 3. grade iv spondylolisthesis 2. prior sacroiliac joint fusion/fixation on either side 3. presence of spinal cord stimulator 4. presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery 5. surgeon plans to use iliac screw for pelvic fixation 6. any known sacral or iliac pathology 7. any condition or anatomy that makes treatment with the ifuse implant system infeasible 8. known metabolic bone disease 9. severe osteoporosis 10. known allergy to titanium or titanium alloys 11. use of medications known to have detrimental effects on bone quality and soft-tissue healing 12. neurologic condition that would interfere with postoperative physical therapy 13. current local or systemic infection that raises the risk of surgery 14. patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the si joint or low back pain. 15. currently pregnant or planning pregnancy in the next 2 years 16. prisoner or a ward of the state. 17. known or suspected drug or alcohol abuse 18. uncontrolled psychiatric disease that could interfere with study participation 19. fibromyalgia

Keywords: adult scoliotic spinal deformity sacroiliac joint pain multilevel lumbar surgery si joint pain
a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of krp-104 in patients with type 2 diabetes inadequately controlled on metformin alone

Conditions: Type 2 Diabetes

Summary: to assess the safety and efficacy of chronic therapy with krp-104, a novel dpp-iv inhibitor, in patients with type 2 diabetes on stable metformin therapy. in addition, an estimate of how much of the hba1c response is attributable to nocturnal coverage will be explored.


Eligibility criteria:
inclusion criteria: 1. age 18 to 70 years, inclusive; 2. males and females of non-childbearing potential; 3. diagnosis of type 2 diabetes mellitus according; and 4. on a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry exclusion criteria: 1. history of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia; 2. history or presence of alcoholism or drug abuse 3. typical consumption of ≥10 drinks of alcohol weekly; 4. presence of any of the following conditions: * significant renal impairment (glomerular filtration rate \<60 ml/min \[to be calculated by the central laboratory\]); * diabetic retinopathy; * diabetic gastroparesis; * active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease; 5. uncontrolled high blood pressure; 6. history or evidence of cardiovascular or pulmonary disease 7. must meet other laboratory and medical history clinical criteria. please contact recruitment center for referrals
phase iii trial evaluating the effectiveness of a dose adjustment of imatinib mesylate on the molecular response

Conditions: Leukemia, Myeloid, Chronic-Phase

Summary: the imatinib mesylate at a dose of 400 mg / day is the standard treatment for patients with cml-cp. recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma imatinib.

the imatinib mesylate at a dose of 400 mg / day is the standard treatment for patients with cml-cp. recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma imatinib. this study aims to evaluate the effectiveness of a strategy for dose adjustment of imatinib mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years imatinib 400 mg / d in complete cytogenetic response for at least 1 year.

Eligibility criteria:
inclusion criteria: 1. patients with cml-cp treated for at least two years by imatinib mesylate 400 mg / d, 2. patients in complete cytogenetic response for at least 1 year 3. patients with residual disease detectable by quantitative rt-pcr (rq-pcr) 4. ecog ≤ 2, 5. age ≥ 18 years 6. signed informed consent, 7. membership of a social security system exclusion criteria: 1. patients with cml-cp philadelphia chromosome negative diagnosis. 2. patients previously treated with imatinib mesylate at doses above 400 mg / day 3. patient with non-hematologic toxicity of grade iii or iv in imatinib mesylate 400mg / d 4. patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment 5. pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective 6. known hiv positive 7. patients previously treated with another tyrosine kinase inhibitor 8. patient participating in another interventional clinical trial 9. history of non-compliance to imatinib mesylate

Keywords: chronic myeloid leukemia in chronic phase residual plasma im concentration adapted strategy
comparison of dynamic and static medial patellofemoral ligament operation technique for recurrent patellar dislocation

Conditions: Patellar Instability

Summary: this study is to evaluate whether the dynamic medial patellofemoral ligament (mpfl) reconstruction as described by becher is a successful operation technique to prevent patella instability and restore quality of life. it is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction

the recurrent dislocation rate of conservatively treated chronic patellar instability is high, therefore, it is recommended to manage it surgically. a frequently used surgical technique is static medial patellofemoral ligament (mpfl) reconstruction (e.g. schöttle-technique). a novel dynamic surgical technique according to becher was developed, addressing the most common complications occurring in static reconstruction, which are malpositioning and overtensioning of the graft. this study is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction.

Eligibility criteria:
inclusion criteria: * patients treated with isolated dynamic (operation procedure according to becher et al.using the gracilis tendon) or static mpfl plastic (operation procedure according to schöttle et al. using the gracilis tendon). mpfl reconstruction will be performed in patients with preceding patella dislocation with: 1) a patella-instability-severity (pis) score ≤ 3 with concomitant flake fracture or 2) a pis score ≥ 4 with clinical asymptomatic trochlea dysplasia (patella stability between 30°-60° knee flexion) without other clinically relevant static risk factors. * closed growth plates exclusion criteria: * combined procedures with trochleoplasty (high grade trochlea dysplasia, type dejour c,d with clinical instability between 30° and 60° of knee flexion) * combined procedures with cartilage transplantation * high grade patellofemoral arthritis (kellgren lawrence score ≥3) * combined procedures with femoral or tibial osteotomy * clinically eminent valgus axis (\>15° valgus) * femoral internal rotation \>20°, tibial external rotation \>40° * instability of the cruciate or collateral ligaments * known significant musculoskeletal disease * cognitive impairment

Keywords: chronic patellar instability static medial patellofemoral ligament (mpfl) reconstruction static reconstruction technique according to schöttle dynamic medial patellofemoral ligament (mpfl) reconstruction patellofemoral ligament reconstruction patella dislocation patella-instability-severity (pis) score dynamic reconstruction technique according to becher
assessment of neurodevelopmental needs in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: duchenne muscular dystrophy is a genetic disease that causes progressive muscle weakness. there is now substantial evidence that boys with this disease do not demonstrate age-related gains in their cognitive skills. the goals of this study are (i) to use a technology-enabled neurobehavioral assessment called national institutes of health toolbox cognition battery (nihtb-cb) to assess brain development over time; (ii) engage with key-stakeholders to understand how neurodevelopmental problems like attention-deficit hyperactivity, autism spectrum affects individuals (and/or) families, so that we can understand meaningful effects of a potential treatment at an individual level, and (iii) to investigate using brain magnetic resonance imaging (mri) changes in brain connectivity.

participants will be asked to do tasks such as solve puzzles, pay attention, and remember things through the nihtb-cb administered using an ipad as well as complete questionnaires. the nihtb-cb will be done four times (first visit, within 1 month after first visit, 12 months after first visit, and 18 months after first visit). nihtb-cb takes about 20 to 35 minutes to complete. participants will also undergo brief assessment of the upper limbs; these tests will be administered by trained physical therapists and will take about 5 minutes. focus group: a focus group consisting of families and individuals affected by dmd will be invited to share their journey of cognitive and developmental needs. the focus group will be conducted online via the study team and is planned to last between 1 to 1.5 hours. this is optional for families. a non-sedated brain mri will be performed twice; scans will be separated by a one-year interval. (a child has to be age 8 or older to participate in a brain scan.) brain imaging is optional for families.

Eligibility criteria:
inclusion criteria: * boys with confirmed genetic mutation in the dystrophin gene * boys with clinical features of dmd and in whom muscle biopsy showed absence of dystrophin * boys with clinical features of dmd and in whom there is a family history of dmd * symptomatic carrier girls with dmd * ages 3 and above at time of study screening exclusion criteria: * care-giver unable to give consent * any handicap that does not allow the ability to use an ipad * for mri, braces or any metal implants.
nepafenac 0.1% eye drops, suspension compared to ketorolac trometamol 0.5% eye drops, solution and placebo

Conditions: Cataracts

Summary: to evaluate the safety and efficacy of nepafenac 1 mg/ml eye drops, suspension, compared to placebo and ketorolac trometamol 5 mg/ml eye drops, solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with iol implantation


Eligibility criteria:
inclusion criteria: * patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens. * other protocol-defined inclusion criteria may apply. exclusion criteria: * under 18. * other protocol-defined exclusion criteria may apply.

Keywords: cataracts