cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
* Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or \<80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) \< 0.70 at screening.
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Symptomatic patients according to daily diary data.

Exclusion Criteria:

* Pregnant or nursing (lactating) women.
* Women of child-bearing potential unless using adequate contraception.
* Patients with Type I or uncontrolled Type II diabetes.
* Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation
* Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.
Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements

The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. The French High Authority of Health (HAS) recommends to identify and prevent risk situations of violence and to develop research at this level. Some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. To our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date The investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. The investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.

This study aims at identifying elements that can provoke frustration and lead to aberrant driving behaviors. The question is whether there are triggers that occur more frequently for the same subject. If so, these specific contextual elements could be detected in order to prevent violent acts.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Over 18
* Detention sentence in prison in Rochefort between March and August 2015
* Positive psychopathy score at PCL-R (Psychopathy Checklist-revised) test: score greater than or equal to 30

Exclusion Criteria:

* Chronic psychosis
* Bipolar disorder
* Women
* Minors,
* negative score at the PCL-R
* Subject under protection measure (curator or guardian)
* Refusal to participate
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)

The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe sepsis or septic shock (ACCP/SCCM)
* Presence of 4 SIRS criteria/indicators
* Suspected or proven infection (refer also to: 1.)
* Age 18-80
* APACHE II score \> 18
* At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)

Exclusion Criteria:

* Suspected or proven pregnancy
* Absolute contraindication for anticoagulation (active bleeding)
* Absolute IgA-deficiency
* History of anaphylactic reaction to egg-albumin
* Participants in other clinical trials (\<12 wks. prior to study inclusion)
Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients

In this research study, two different oral contrast materials that can be used for CT or MR enterography will be studied. This study is designed to compare which oral contrast material (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality exams.

VoLumen, a low Hounsfield unit 0.1% barium sulfate suspension that also contains sorbitol and a gum, is the most common oral contrast material used in children and adults undergoing CT and MR enterography (advanced imaging tests used to evaluate the bowel lumen and bowel wall in children and adults, usually with suspected or known Crohn disease). This contrast material is typically administered orally to non-sedated patients during the 45-60 minute period prior to imaging. The goal of oral contrast material administration is to completely fill the small bowel with fluid at the time of imaging. Benefits of oral contrast material at cross-sectional enterography include: improved delineation of bowel from non-bowel structures in the abdomen and pelvis, improved accuracy when assessing bowel wall thickness, and improved visualization of mucosal hyper-enhancement in the setting of active intestinal inflammation.

In some children (and adults), the standard-of-care contrast agent (VoLumen) is poorly tolerated. This is likely due to a variety of factors, including taste, texture, and the volume that is required to be consumed. Recently, a new oral contrast material called "Breeza for neutral abdominopelvic imaging" (or simply Breeza) has become available for use at CT and MR enterography. This agent contains sorbitol, mannitol, and xantham gum (a thickening agent), and it is marketed as a "flavored beverage" as it contains no active ingredient (e.g., barium sulfate). A single study performed in adult volunteers has shown that this new agent performs similar to VoLumen, has a superior taste, and is associated with greater willingness for repeat drinking.

The objective of our study is to compare our standard-of-care oral contrast material to the newly available contrast material in a prospective, randomized, blinded manner. Primary outcomes will include degree of small bowel opacification, distention of the terminal ileum, and patient acceptance/tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 8 years and \< 18 years
* Patients undergoing clinically indicated CT or MR enterography

Exclusion Criteria:

* Age \< 8 years and ≥ 18 years
* Requirement for sedation for CT or MRI enterography
* Cannot drink oral contrast (will require tube administration)
Prediction Model for Postoperative AKI in Patients Undergoing Lung Transplantation Using Machine Learning

Since 1963, lung transplantation progress has surged due to immunosuppressive agent advancements. In 2004, 1,815 global lung transplantations were reported. Elderly recipients face impaired lung function and health instability, leading to potential respiratory complications post-surgery.

Postoperative acute renal injury (AKI) can cause temporary or chronic dysfunction, increasing hospitalization, complications, and additional treatment needs. Various factors contribute to postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and medications. Retrospective analysis of adult lung transplant patients' records aims to explore characteristics, anesthesia methods, intraoperative tests, and postoperative acute renal dysfunction, analyzing incidence and risk factors to develop a machine learning predictive model.

Since the first report of lung transplantation in humans in 1963, there has been rapid progress in both the quantity and quality of lung transplantation, driven by the significant advancements in immunosuppressive agents since the mid-1990s. In 2004, a total of 1,815 lung transplantations were reported worldwide. Patients undergoing lung transplantation are often elderly and face not only impaired lung function but also overall health instability, leading to the potential occurrence of respiratory complications post-surgery, even with successful lung transplantation outcomes.

Postoperative acute renal injury (AKI) can result in temporary or even chronic renal dysfunction. AKI following surgery can lead to an increase in hospitalization duration, complications, and the need for additional treatment. Various factors are associated with postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, hypoperfusion related to intraoperative and postoperative bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and more. Medications related to renal dysfunction include those associated with thrombosis or embolism, such as aminoglycosides, amphotericin B, non-steroidal anti-inflammatory drugs (NSAIDs), proton-pump inhibitors, contrast agents, and others. Additionally, graft-versus-host disease is known to be related to renal dysfunction.

The retrospective analysis of medical records from adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of postoperative acute renal dysfunction. The goal is to analyze the incidence and risk factors of postoperative renal dysfunction and develop a predictive model through machine learning.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease

Exclusion Criteria:

* None.
An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria

OC5-OL-02 (ePHex-OLE) is a 2 year, open-label, extension study to evaluate the long-term efficacy and safety of Oxabact OC5 for patients with primary hyperoxaluria who completed treatment in the parent double-blind, placebo-controlled study OC5-DB-02 (ePHex).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent (as applicable for the age of the subject).
2. Participation in and completion of study OC5-DB-02.
3. Subjects who had received vitamin B6 during OC5-DB-02 study should maintain a stable dose. Subjects not receiving vitamin B6 during OC5-DB-02 must be willing to refrain from initiating pyridoxine during study participation.

Exclusion Criteria:

1. Inability to swallow size 4 capsules.
2. Use of antibiotics to which O. formigenes is sensitive.
3. Current treatment with a separate ascorbic acid preparation.
4. Pregnant or lactating women (or women who are planning to become pregnant).
5. Women of childbearing potential who are not using adequate contraceptive precautions.
6. Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures or any condition that is likely to interfere with the study drug mechanism of action (such as abnormal GI function).
7. Participation in any interventional study of another investigational product, biologic, device, or other agent or not willing to forego other forms of investigational treatment during this study.
Chronobiological and ACT-based Training to Handle Stress at Work

The aim of the present project is to combine "Acceptance and Commitment Therapy" and "sleep hygiene + light-therapy (so-called chronotherapy)" serially in a sample of employees to reduce levels of subjective exhaustion.


Eligibility Criteria:
Inclusion Criteria:

* working in an office mainly (i.e., \> 60% of work time)
* Age: ≥18 years old
* Sex: male and female individuals
* Ownership of cell phone with internet connection
* informed consent as documented by signature

Exclusion Criteria:

* diseases of the retina or related diseases such as diabetes mellitus
* taking drugs which heighten photosensitivity
* inability to understand and follow procedures in German
Wound Drain After Lumbar Fusion Surgery

Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.

The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
* Surgery indicated for lumbar degenerative disease

Exclusion Criteria:

* Undergoing revision surgery
* Surgery indicated for infection
* Intraoperative dural tear
* Surgery requiring intraoperative transfusion
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).

This study will screen and consent approximately 150 patients undergoing non-emergent cardiac surgery. Approximately 60 of these patients are likely to develop stable postoperative atrial fibrillation (POAF) in the postoperative period. Amiodarone is commonly given as an initial intravenous (IV) bolus (150 mg IV) followed by a combined IV and oral load to a total dose of 8 gm. Because of amiodarone's beta-blocker activity, the IV bolus in patients with POAF is associated with a reduced heart rate that may lead to restoration of NSR. For this reason, some clinicians will provide up to 5 additional IV amiodarone boluses during the drug's loading period to treat RVR.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years old or older
* Subject must be willing to give written informed consent
* Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures

Exclusion Criteria:

* Documented allergy to amiodarone or iodine
* History of atrial fibrillation or other heart conduction system abnormality
* History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
* Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
* Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
* History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
* History of cirrhosis or other chronic liver diseases
* Pregnancy or breastfeeding mothers
* Prisoner status
SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes

Primary Goal:

To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS (Primary Outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as DNA methylation (DNAm) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (UC).

Adverse Social Determinants of Health (SDOH) have been shown increase stroke risk in a dose dependent manner. The SDOH-Homecare Intervention Focus Team (SHIFT) trial is a Phase 3, randomized, blinded outcome trial that tests the hypothesis that a homecare intervention shortly after discharge from an acute stroke unit by a team comprising a community health worker (CHW), a community social worker (CSW) and a community nurse (CN) can improve health outcomes among stroke patients with three or more SDOH compared with UC.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)
2. Age 18-75 years old.
3. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care).
4. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after.
5. Pre-stroke Modified Rankin Scale score of ≤3
6. Residence in New York City..
7. English or Spanish speaking.
8. Can provide informed consent and engage in the initial assessment prior to stroke discharge.
9. Lives in a household with a telephone, and has a caregiver (family member or Home Health Aide) if not fully independent on discharge. If the patient requires a family member to assist with activities of daily living or decision-making, the family member must state a willingness to be present at home visits where their assistance is needed.

Exclusion Criteria:

1. Discharge disposition to a long term care facility.
2. Diagnosis of dementia or other neurological neurological diagnosis that affects cognition.
3. Diagnosis of active major depression.
4. Aphasia severe enough to preclude initial examination.
5. Impaired level of consciousness at initial cognitive assessment.
6. Subarachnoid hemorrhage.
7. Diagnosis of probable cerebral amyloid angiopathy by Boston criteria.
8. Life expectancy less than 1 year.
Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?

The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.

Migraine sufferers undergo vestibular tests and were excluded if there were clinically significant abnormalities. Following screening, there were 2 experimental visits in which migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the drug, subjects were idle for 2 hours. Baseline motion sickness and subjective units of distress levels were assessed prior to undergoing sinusoidal-earth-vertical earth axis rotation in darkness at 0.05 Hz. Scores were taken immediately after stopping. Subjects were given a 2 minutes rest and then underwent a motion sickness provoking rotation. Subjective scores were assessed immediately following. Another two minute rest was given and if the subject was able, underwent a second motion sickness provoking stimulus followed by an assessment.

Eligibility Criteria:
Inclusion Criteria:

* History of motion sickness
* Currently suffering from migraines with at least 2 episodes during the previous 12 months
* Previous use and tolerance to triptans

Exclusion Criteria:

* Current tobacco user
* History of or current hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
* Family history of early myocardial infarction (first-degree relative \< 45 years old at time of event)
* Constant dizziness or constant vestibular symptoms
* History of ear, nose and throat (ENT) disease, e.g. Meniere's disease
* Current treatment with propranolol or medications that would preclude use of a triptan(e.g. ergotamine)
* Major vestibular abnormality found on screening
* Testing positive on over-the-counter pregnancy test
* Taken an Monamine Oxidase (MAO) inhibitor within two weeks of testing
* Allergy or intolerance to gelatin
* Corrected visual acuity of \> 20/40 O.U.
* Women who are pregnant or breastfeeding
Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial

Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer.

Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation

Patients admitted to hospital with confirmed COVID-19, and who meet the eligibility criteria will be invited to participate in the proposed study. Following the application of the informed consent form, they will collect the D-dimer (if they have not yet collected it routinely from the hospital) and confirm the value over the normal limit in patients with confirmed COVID-19, will be randomized to 2 groups in the 1:1 ratio. Group 1 will follow the strategy of routine use of full anticoagulation therapy (oral or parenteral when indicated); and group 2 will follow the usual standard care with in-hospital prophylactic anticoagulation (without routine full anticoagulation).

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of COVID-19 admitted to hospital;
* Duration of symptoms related to hospitalization ≤ 14 days;
* Patients ≥ 18 year old;
* D-dimer above the upper limit of normal (collected until 72 hours before the randomization);
* Agreement to participate by providing the informed consent form (ICF).

Exclusion Criteria:

* Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis);
* Platelets \< 50,000 /mm3
* Need for ASA therapy \> 100 mg;
* Need for P2Y12 inhibitor therapy (clopidogrel, ticagrelor or prasugrel);
* Chronic use of non-hormonal anti-inflammatory drugs;
* Sustained uncontrolled systolic blood pressure (BP) of ≥180 mmHg or diastolic BP of ≥100 mmHg;
* INR \> 1,5;
* Patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator);
* Criteria for disseminated intravascular coagulation (DIC);
* A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm;
* Active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy;
* Hypersensitivity to rivaroxaban;
* Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort);
* Known HIV infection;
* Creatinine clearance \< 30 ml/min according to the Cockcroft-Gault Formula;
* Pregnancy or breastfeeding.