Kornimate/medical-research-clean huggingface dataset:
hypobaric lateral spinal anesthesia versus general anesthesia for the hip fracture surgery

Conditions: Hip Fractures

Summary: hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. it is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (mins) or acute kidney injury (aki) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability. low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. it has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. however, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects. the aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.


Eligibility criteria:
inclusion criteria: - every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture. exclusion criteria: * patients younger than 70 years of age * pathological fractures or multiple trauma * contraindications to spinal anesthesia: * allergy to the local anesthetic * patients treated by clopidogrel (plavix®) * patients treated by oral anticoagulants: dabigatran (pradaxa®), rivaroxaban (xarelto®), or apixaban (eliquis®). * coagulation disorders: (prothrombin time \ 1.5, or platelets \< 80 g/l), * local infection of the puncture site * hyperthermia (\> 38.5°c) * agitated patients * patients included in another study * patients under judicial protection

Keywords: unilateral spinal anesthesia general anesthesia hemodynamic stability mins hip fracture elderly aki
efficacy and safety of dexlansoprazole mr on maintaining healing in subjects with healed erosive esophagitis

Conditions: Esophagitis, Reflux; Esophagitis, Peptic

Summary: the purpose of this study is to assess the ability of once-daily (qd) treatment with dexlansoprazole modified-release (mr) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (ee).

this is a phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. the study is designed to compare the efficacy and safety of daily dexlansoprazole mr (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis. because the development plan for dexlansoprazole mr formulation was revised, the results of 2 identical studies, t-ee04-086 (this study, nct00255164) and t-ee04-087 (nct00255151), were combined and analyzed as a single larger study referred to as study t-ee04-086. a total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into study t-ee04-086, and 214 subjects were enrolled into study t-ee04-087.

Eligibility criteria:
inclusion criteria: * subjects must have successfully completed the phase 3 study t-ee04-084 (nct00251693) or tee04-085 (nct00251719); and have healed esophageal erosions proven by endoscopy. complete healing was assessed for change in la esophagitis classification grades a, b, c, or d to healed (defined as anything less than the criterion for grade a). the subject was counted as healed if endoscopy findings did not meet the grade a criterion. exclusion criteria: * use of prescription or nonprescription proton pump inhibitors (ppis), histamine (h2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study * use of antacids (except for study supplied) throughout the study. * subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study. * need for continuous anticoagulant therapy.

Keywords: erosive esophagitis
intranasal lorazepam versus intramuscular paraldehyde in paediatric convulsions

Conditions: Status Epilepticus; Convulsions

Summary: the purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. this is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.

the ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. it should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. no combination of drug or delivery system fully satisfies these criteria. there are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.

Eligibility criteria:
inclusion criteria: * children aged between 2 months and 12 years * presenting with generalised convulsions exclusion criteria: * any child who had received an anticonvulsant agent within 1 hour of presentation * seizure stopped with rapid cooling or treatment of hypoglycaemia * features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy

Keywords: intranasal lorazepam paediatric convulsions
cameo-fontan -dapagliflozin in the failing fontan circulation

Conditions: Fontan Circulation; Single Ventricle Heart Disease; HFpEF - Heart Failure With Preserved Ejection Fraction

Summary: the purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (pcwp) at rest and during exercise in adults with failing fontan circulation.


Eligibility criteria:
inclusion criteria subjects are eligible to be randomized in the study only if all the following inclusion criteria and none of the exclusion criteria apply: 1. signed informed consent prior to any study specific procedures 2. history of fontan procedure 3. male or female subject 4. age ≥ 18 5. symptoms of dyspnea (nyha ii-iii) with no non-cardiac or ischemia explanation 6. undergoing clinically indicated cardiac catheterization 7. elevated pulmonary capillary wedge pressure (pcwp) during exercise (≥25 mmhg) ascertained at visit 1. patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized. exclusion criteria 1. type i diabetes 2. any of the following medications: insulin or pramlintide, sandostatin, akeega (abiraterone acetate), growth hormone (somatogrogon-ghla), lithium, chloroquine, hydroxychloroquine, thioctic acid (alpha lipoic acid), empagliflozin or canagliflozin 3. recent hospitalization (\<30 days) or revascularization (\<90 days) 4. significant valvular heart disease (≥moderate stenosis, \>moderate regurgitation) 5. significant fontan obstruction with resting svc-ivc gradient \>4 mmhg 6. primary cardiomyopathy (such as amyloid) 7. dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator 8. severe anemia (hemoglobin \<9 gm/dl) 9. severe kidney disease (estimated gfr\<30) or liver disease 10. women of childbearing potential not willing to use a medically accepted method of contraception or who are currently pregnant (confirmed with positive pregnancy test) or breast feeding. 11. history of serious hypersensitivity reaction to dapagliflozin 12. subjects on dialysis 13. subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding 14. single ventricle heart disease without fontan palliation 15. those with a history of fontan takedown

Keywords: fontan hfpef sglt2 inhibitors
cancer-related venous thromboembolic disease - cohort study

Conditions: Thrombosis Embolism; Thromboses, Venous; Cancer

Summary: venous thromboembolic disease (vte) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (pe)). in cancer patients, the risk of developing vte is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also increased. the study of vte in the context of cancer is a major challenge, given the frequency of the association, the heterogeneity of the situations, the risk factors involved and the therapeutic issues in both curative and primary prevention; in this field, many uncertainties remain, justifying a study focused on the association of vte and cancer.

cancer is associated with a higher risk of vte and mortality. this association is characterized by various uncertainties at pathophysiological, diagnostic, therapeutic and prognostic levels. cape study is a prospective, single-center interventional cohort follow-up study designed to investigate the risk of recurrence of vte and its mechanisms in cancer patients. the study involves the collection of biological samples from cancer patients with venous thromboembolic disease. at inclusion and in case of recurrence of thrombosis or hemorrhage: * blood samples will be taken for analysis and to constitute a biobank for future assays. * urine samples will be collected once a year for 5 years (and adapted to the clinical context): visit as part of routine care, or mailing of a questionnaire, or telephone contact.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and more. * patients with active cancer or requiring cancer treatment at the time of their vte episode * patients with documented vte less than 2 years old * patients affiliated to the social security system * patient who has signed a written informed consent exclusion criteria: * patient under 18 * refusal to participate * incapacity to consent to the study * patient under guardianship * incapacity to communicate (comprehension disorder) * life expectancy of less than 6 months
safety and feasibility of atrial deganglionation as adjunctive therapy for af

Conditions: Atrial Fibrillation

Summary: a prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.

to assess the safety and feasibility of electroporation/pulsed electric field (pef) as a technology to achieve selective gp ablation. this treatment will be performed on 30 patients undergoing cardiothoracic surgery. primary feasibility endpoint will be demonstration of ability to access and deliver pulsed electric field energy to all of the targeted ablation sites.

Eligibility criteria:
inclusion criteria: * age is between 18 and 70 years. * scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting. * legally competent and willing to sign the informed consent. * life expectancy of at least 2 years. exclusion criteria: * • previous cardiac surgery. * prior pericardial interventions. * prior pulmonary vein isolation (pvi). * previous or existing pericarditis. * persistent or long-standing persistent atrial fibrillation. * indication for surgical ablation or pvi for atrial fibrillation. * indication for concomitant surgical valve repair or replacement. * indication for concomitant left atrial appendage (laa) ligation or excision. * history of previous radiation therapy on the thorax. * history of previous thoracotomy. * prior electrical or mechanical isolation of the left atrial appendage (laa). * the presence of laa occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (icds). * myocardial infarction within the previous 2 months. * nyha (new york heart association) class iv heart failure symptoms. * left ventricular ejection fraction (lvef) \< 40%, measured by transthoracic echocardiography (tte). * left atrial (la) diameter \> 5.0 cm, measured by transthoracic echocardiography (tte). * the presence of left atrial thrombus when examined by transoesophageal echocardiography (tee). * the presence of af attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes. * active infection or sepsis as evidenced by increased white blood cell count, elevated crp (c-reactive protein) or temperature \> 38.5°c. * known or documented carotid stenosis \> 80% * stroke or transient ischemic attack within the previous 6 months. * known or documented epilepsy. * pregnancy or child-bearing potential without adequate contraception. * circumstances that prevent follow-ups. * drug abuse. * patients cannot be enrolled in another clinical study
evaluation of prevent in underserved populations

Conditions: Prediabetes; Overweight; Obesity

Summary: the goal of this study is to evaluate an online diabetes prevention program adapted for patients with prediabetes in safety net health care settings.

the diabetes prevention program (dpp) demonstrated that intensive behavioral counseling is a successful approach to reduce the risk of developing diabetes in patients with prediabetes. while the dpp lifestyle intervention was successful and group based adaptations of the dpp have positive results, scalable alternatives that allow for even broader reach are necessary. omada health has developed an online, group-based, recognized dpp program (prevent). the goal of this study is to evaluate a literacy-adapted version of prevent for patients with prediabetes in safety net health care settings.

Eligibility criteria:
inclusion criteria: * is receiving care at one of the three participating locations * prediabetes diagnosis confirmed by lab tests * age 18-75 at screening * not insured, medicaid insured, or safety net health plan insured * comfortable speaking/reading english or spanish at 5th grade level * body mass index greater or equal to 24 * able to access the internet weekly by computer or smartphone * able to engage in physical activity of at least moderate intensity * able and willing to give informed consent to participate exclusion criteria: * diagnosed with type 1 or 2 diabetes mellitus * taking insulin, metformin or other hypoglycemic agent * pregnant or planning to become pregnant during trial period * unstable life conditions that would preclude full program participation * acute, unstable medical or mental health conditions that would preclude program participation * inability to engage in physical activity of at least moderate intensity

Keywords: prediabetes, weight loss, behavior modification
efficacy and safety of azimilide in the prophylactic treatment of patients with atrial fibrillation.

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. the primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms). this double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. once this phase of the study is completed, a second phase with a different study design will be conducted. the second phase is an open-label, follow-up phase. the follow-up phase of the study is designed to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.


Eligibility criteria:
inclusion criteria: * history of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities * history of congestive heart failure and/or ischemic heart disease * sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study * at least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm. * sinus rhythm immediately prior to dosing exclusion criteria: * previously unsuccessful cardioversions within 60 days of screening period * failed to respond to any class iii antiarrhythmic drugs * qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization * previously in an azimilide study
romiplostim treatment for thrombocytopenia in patients with wiskott-aldrich syndrome.

Conditions: Wiskott-Aldrich Syndrome

Summary: the rationale for this retrospective study is to evaluate the efficacy and safety of thrombopoietin-receptor agonist (tpo-ra) romiplostim for reducing thrombocytopenia and bleeding tendency in pediatric participants with genetically confirmed wiskott-aldrich syndrome (was).

thrombocytopenia is a life-threatening symptom in was patients. subjects with was are at increased risk of debilitating and\\ or life-threatening bleedings due to low platelet numbers. hematopoietic stem cell transplantation is an effective treatment of was and all its symptoms yet requires time for donor search and is not widely utilized in cases with mild was with isolated thrombocytopenia. tpo-ras have been used in individual was patients, wherein publications describing large was cohorts treated with tpo-ras are lacking. based on the previous reports, was patients in our center have been receiving treatment with tpo-ra romiplostim since 2012. the aim of the study is to retrospective analyze patients' data in order to asses treatment efficacy and safety of romiplostim in was thrombocytopenia. the study will collect and analyze information that is already in the patients' medical records. information about clinical data (assessment of bleeding tendency with a modified world health organization (who) bleeding scale), laboratory values (such as clinical and biochemical analysis of blood) will be included. evaluation of the efficacy therapy was based on the results of physical examination, including bleeding events at the time of diagnosis and after 6-month tpo-ra was initiated and platelet response. a complete response was defined as a platelet count \>100 x 109/l in the absence of bleeding symptoms, partial - 30 x 109/l higher than the patient's pretreatment baseline count to 100 x 109/l. non-response was defined as not achieving a platelet count of \> 30 x 109/l from the baseline count.

Eligibility criteria:
inclusion criteria: * age under \< 18 years * subject/legal representative has signed written informed consent. ? * subjects diagnosed with was based on genetic findings. * subjects with thrombocytopenia (platelet count of less than 70 x 109/l). * subjects with a history of bleeding. * subjects received treatment with romiplostim 8-9 µg /kg for at least 30 days * available records of the points of analysis exclusion criteria: • patients, who do not meet the inclusion criteria.
a study of rivaroxaban (jnj-39039039) on the venous thromboembolic risk in post-hospital discharge patients

Conditions: Heart Failure; Respiratory Insufficiency; Stroke Acute; Infectious Diseases; Rheumatic Diseases

Summary: the purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (vte) events and vte-related death post-hospital discharge in high-risk, medically ill patients.

this is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (vte). the study is designed to evaluate rivaroxaban in the prevention of symptomatic vte events and vte-related deaths for a period of 45 days post-hospital discharge. the study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. study drug will start at randomization (day 1), and will continue until day 45 (inclusive). a total of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. the total duration for a patient who completes the study after randomization is expected to be 75 days.

Eligibility criteria:
key inclusion criteria: * the duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days * must meet venous thromboembolism (vte) risk criteria with a total modified improve vte risk score of: greater than or equal 4, or 3 with d-dimer \> 2\* upper limit of normal (uln), or 2 with d-dimer \> 2\*uln key exclusion criteria: * any serious bleeding within 3 months prior to randomization or occurring during index hospitalization * serious trauma (including head trauma) within 4 weeks before randomization * history of hemorrhagic stroke at any time in the past * any medical condition that requires chronic use of any parenteral or oral anticoagulation

Keywords: heart failure respiratory insufficiency stroke acute infectious diseases rheumatic diseases medically ill patient rivaroxaban thromboembolism prophylactic anti-coagulation