cyrilzakka/clinical-trials huggingface dataset:
Venous Thrombosis Virtual Surveillance in COVID-19

The overall goal of the VVIRTUOSO study is to determine the incidence of VTE including symptomatic DVT and PE after hospital discharge in patients with COVID-19 by implementing a pragmatic patient-centred prospective virtual VTE monitoring program in Canada and the United States.

Emerging evidence suggests that COVID-19 induces a highly prothrombotic state particularly among hospitalized patients based on abnormal coagulation parameters and high rates of venous thromboembolism (VTE). Reported rates of VTE among hospitalized ward (3%) and critically ill (17% to 69%) patients with COVID-19 suggest that the risk of VTE is substantially higher than patients with other acute medical illnesses. VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the most common preventable causes of hospital-associated morbidity and mortality, and most events occur after hospital discharge. The incidence of VTE after hospitalization for COVID-19 is not currently known. However, the combination of COVID-induced hypercoagulability, ongoing recovery, reduced mobility, advanced age, and comorbidities likely confers a high risk of VTE in this setting. The overall goal of the VVIRTUOSO study is to determine the incidence of VTE including symptomatic DVT and PE after hospital discharge in patients with COVID-19 by implementing a pragmatic patient-centred prospective virtual VTE monitoring program at 12 sites in Canada and the United States. Additional objectives are to explore risk factors for VTE post-discharge, characterize the use of pharmacological measures for VTE prevention, assess patient awareness of VTE and provide VTE education.

Eligibility Criteria:
Inclusion Criteria:

i) adults 18 years of age or older (or their delegate) ii) admitted to hospital with COVID-19 (laboratory confirmed) or diagnosed with COVID-19 (laboratory confirmed) during hospitalization iii) discharged from acute care hospital within prior 7 days.

Exclusion Criteria:

i) unconfirmed diagnosis of COVID-19, ii) no access to a telephone, computer or tablet for virtual assessment, iii) treated with therapeutic doses of anticoagulation after hospital discharge (e.g. atrial fibrillation, mechanical heart valve, previous VTE), iv) patient (or their delegate) is unable or unwilling to provide informed consent,
Targeting Emotion Dysregulation to Reduce Suicide in People with Psychosis

People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Psychosis spectrum disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorder Studies
* Heightened suicide risk as determined by a score of 8+ on the Suicide Behaviors Questionnaire-Revised (SBQ-R). This cutoff may be revised downwards (toward lower suicide risk) if recruitment appears difficult, but will not be revised upwards.
* Enrollment and engagement in outpatient mental health services with at least one mental health service in the previous month
* 6+ grade equivalent reading level as assessed by the Wide Range Achievement Test 4 (WRAT-4)

Exclusion Criteria:

* Chart diagnosis of intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases

During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula.

Epiretinal membrane (ERM), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.

Different study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.

The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.

Eligibility Criteria:
Inclusion Criteria:

* Epiretinal Membrane, lamellar hole of the macula, macular hole and vitreomacular traction syndrome

Exclusion Criteria:

* Other diseases of the eye, such as AMD, retinopathia pigmentosa
Modified Double Wire Technique to Facilitate the Successful Cannulation

Selective cannulation is considered the most challenging step for most of Endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct (PD), the following cannulation of common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-90 with native papilla;
* CBD as the targeted duct;
* Inadvertent PD cannulation more than twice;
* Selective biliary cannulation was not possible within 10 minutes or 5 attempts.

Exclusion Criteria:

* Contraindications of ERCP;
* Major or minor PD as the targeted duct;
* NK or transpancreatic precut before enrollment ;
* Surgically altered GI anatomy;
* Papillary carcinoma or stone impaction within papilla or fistula in papilla;
* Prior endoscopic sphincterotomy;
* Complete pancreas divisum;
* failure of pancreatic duct cannulation;
* Pregnant or breastfeeding women;
* Unwilling or inability to provide consent.
The Analgesic Effects of Melatonin

A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged between 20 and 40 years

Exclusion Criteria:

* Under aged/minors
* Does not speak or understand danish
* Alcohol or abuse of medicines
* Prior QST-trial within the last 2 month
* Prior medical trail within the last month
* Serious comorbidity (ASA-class 3-4)
* Chronic pain (defined by analgesic treatment) Shift-work or night work within the last 14 days Known sleep-disorder
Ambulatory Heart Failure Service Model Study

The aim of the study is to assess the efficacy of this new ambulatory service model in reducing heart failure hospitalization (HHF), improving clinical as well as functional outcomes of post-discharge patients with Heart Failure of reduced ejection fraction (HFrEF) and Heart failure with preserved Ejection Fraction (HFpEF).


Eligibility Criteria:
Inclusion Criteria:

* Dyspnoea (exertional or at rest) and 2 of the following signs:
* Congestion on chest X-ray
* Rales on chest auscultation
* Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale)
* Elevated jugular venous pressure
* NT-proBNP ≥300 pg/mL (Patients with AF: NT-proBNP ≥900 pg/mL)
* Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v loop diuretics)
* Ambulatory patients

Exclusion Criteria:

* Cardiogenic shock required inotropics
* Cardiac mechanical support implantation like LVAD
* Life expectancy less than 1 year due to underlying significant comorbidities like metastatic cancer or end-stage COPD
* Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study.
* End stage renal failure or eGFR \<15 mL/min/1.73m2 as measured during index hospitalization or requiring dialysis
This is a Study to Determine the Antidepressant Effects of AZD6765

The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features
* Females must be of non-childbearing potential.

Exclusion Criteria:

* Treatment with Clozapine or ECT within 3 months prior to study
* Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV
Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose

This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study will enrol Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05; NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).

Study participants previously immunized with CD-JEV (Clinical Trials identifier: NCT01567865, JEV05) will have serum collected three and four years after initial vaccination to assess long-term immunogenicity. Four years after receiving the initial dose of CD-JEV, eligible participants will be vaccinated with a second subcutaneous dose of CD-JEV to assess the antibody response.

Participants will be monitored for safety for 28 days following receipt of the booster dose.

Eligibility Criteria:
Inclusion Criteria:

* Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV.
* Resides in the Matlab or Mirpur study area.
* At least one parent or guardian willing to provide written informed consent.

Exclusion Criteria:

* Received a second dose of Japanese encephalitis vaccine within the past three years.
* Received immunoglobulins and/or any blood products within 90 days prior to enrollment.
* Been diagnosed with a primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection within the past three years.
Ketamine Associated With Morphine PCA After Total Hip Arthroplasty

Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.

We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.

Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion

Eligibility Criteria:
Inclusion Criteria:

* total hip arthroplasty

Exclusion Criteria:

* pre operative opioid administration
Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.

Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.

Eligibility Criteria:
Inclusion criteria (additional criteria apply):

1. Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash.
2. Subject is in general good health.
3. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.

Exclusion Criteria (additional criteria apply):

1. Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
2. Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological \[e.g., diabetic neuropathy\], respiratory, or hepato-biliary systems \[e.g., Gilbert Syndrome\]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol.
3. Subject is being treated for a medical condition that affects cardiac conduction.
4. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
5. Subject has a history of asthma requiring management for reactive airway disease in the last year.
6. Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia.
7. Subject currently requires anticonvulsant medications to control seizures.
MAP-guided Preemptive Therapy of aGvHD

Acute graft versus host disease (aGvHD) is a severe and potentially fatal complication of allogeneic hematopoietic stem cell transplantation (HCT). The Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm probability (MAP) identifies patients who are at high risk for severe aGvHD as early as 7 days after HCT based on 2 serum biomarkers, suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3α (Reg3α). Patients who consent to this study will have their blood tested weekly up to four times within the first month post HCT to determine if they are at high risk for severe GVHD based on MAP. Patients who are at high risk at any of these four tests will be treated with methylprednisolone to see if it prevents the development of severe aGvHD. Methylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually tapered within the following 16 days. Patients will be followed for the development of severe aGvHD for up to 3 months from the HCT and will continue to be followed at routine clinic visits for up to one year after HCT.


Eligibility Criteria:
Inclusion Criteria:

* Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).
* Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
* GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.
* The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
* Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
* ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days prior to enrollment.
* Signed and dated written informed consent obtained from patient or legal representative.

Exclusion Criteria:

* Patients who develop acute GVHD prior to start of study drug
* Patients at very high risk for relapse post HCT as defined by very high disease risk index
* Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
* Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
* Patients who are pregnant
* Patients on dialysis within 7 days of enrollment
* Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.
* Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of methylprednisolone.
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation:

* Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)?
* Is taking one type of antibiotic just as good as taking two types?

Cystic Fibrosis Foundation (CFF) treatment guidelines for the management of pulmonary exacerbations (PEx) identified evidence gaps in current clinical best practices. The STOP program offers a platform for the conduct of controlled trials to develop the evidence base in order to define clinical best practices. The interventional Aminoglycoside Study (AG Study) will be a prospective, multi-center, parallel group, randomized (1:1 ratio), open-label, superiority study of intravenous aminoglycoside and β-lactams versus intravenous β-lactams only. Randomization will occur at Visit 1. The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF PEx during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms.

Eligibility Criteria:
Inclusion Criteria:

* All genders ≥ 6 years of age at Visit 1
* Documentation of a CF diagnosis
* Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
* At least one documented Pa positive culture within two years prior to Visit 1

Exclusion Criteria:

* Participant is not pregnant
* No known renal impairment or history of solid organ transplantation
* No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
* No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
* No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
* No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1
A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations

1. To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients with nasopharyngeal carcinoma (NPC).
2. To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas.
3. To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for both endemic and non-endemic patient populations.


Eligibility Criteria:
Inclusion Criteria:

* Having a new diagnosis of Nasopharyngeal carcinoma.
* Being treated with either radiotherapy or chemoradiotherapy for this condition.

Exclusion Criteria:

* Age \<18 since NPC is a very rare condition in this age group and may have a different biological behavior
* Patients who are unable to provide informed consents for themselves.
Decision-Making and Quality of Life Surrounding Hematologic Disease and Gene Therapy

Determine knowledge, attitudes, and beliefs among adult patients, and parents of pediatric patients, with transfusion dependent beta-thalassemia and sickle cell disease toward gene therapy to treat their or their child's illness, and to assess the likely impact of gene therapy on patients' quality of life.

The overarching aim of this research is to determine knowledge, attitudes, and beliefs among adult patients, and parents of pediatric patients, with transfusion dependent beta-thalassemia toward gene therapy to treat their or their child's disease, and to assess the likely impact of gene therapy on patients' quality of life. We will compare and contrast these findings to those obtained from a sample of adult patients and parents of pediatric patients with sickle cell disease. We will also assess perceptions of the pros/cons of gene therapy, including its financial and time costs.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (ages 18+) or parents of pediatric patients (\<age 18) eligible to receive treatment for their disease with gene therapy

Exclusion Criteria:

* Non-English-speaking
Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer.

Eligibility Criteria:
Inclusion Criteria:

Differentiated thyroid cancer Tumor \>4 cm, or Gross extra-thyroid extension, or 1 lymph node \>1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression

Exclusion criteria:

Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2