linjc16/ctgov huggingface dataset:
Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Official Title
-----------------
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Drug: Talactoferrin alfa
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Onset of severe sepsis within the previous 24 hours Must be receiving antibiotic therapy Informed consent form signed by patient or authorized representatives according to local rules or regulations Able to take liquid medication by mouth or feeding tube Exclusion Criteria: Receipt of investigational medication within 4 weeks prior to participation in the study Pregnant or breast-feeding Severe congestive heart failure Known severe HIV infection Presence of severe burns Patients on high dose immunosuppressants Patients whose death is considered imminent Patients whose life expectancy for concurrent illness is less than 6 months Severe hypoxic encephalopathy or persistent vegetative state Severe liver disease Chronically bed bound Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit<br>|
| Experimental: Talactoferrin alfa<br> | Drug: Talactoferrin alfa<br>* 15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality |  | 3 months | 
| All Cause Mortality |  | 6 months | 
| All Cause Mortality |  | 12 months | 
| Assess Safety and Tolerability |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin
Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are benefiting from the treatment as judged by the investigator.

Official Title
-----------------
An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is currently enrolled in a Novartis-sponsored, Oncology CD&MA study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator. Exclusion Criteria: Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nilotinib<br>16 patients who are currently enrolled in a Novartis- sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study receiving nilotinib and has fulfilled all their requirements in the parent study will be enrolled. | Drug: nilotinib<br>* Nilotinib can be provided as 200 mg and 150 mg hard gelatin capsules. The starting dose of nilotinib should be the same as the last dose that was given in the parent nilotinib study. After this, the dose of nilotinib is based on the investigator's judgment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | To collect and assess long-term safety of nilotinib in patients receiving nilotinib and are benefiting from treatment with nilotinib n a Novartis-sponsored Oncology study which had reached its objectives. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal,, ggastrointestinal stromal tumors, stromal,, tumors,, GIST,, AMN107,, nilotinib
Iatrogenesis Imperfecta- Extent and Characteristic in NICU in Israel.

Study Overview
=================
Brief Summary
-----------------
Iatrogenesis is inevitable in the NICUs.

Detailed Description
-----------------
In the first 3 months of the study we will document Iatrogenic events in 3 NICUs in Israel without informing the medical and nursing staff. In the second 3 months of the study we will try to draw the attention of the medical and nursing staff that we are documenting iatogenesis, and we will assess wether this intervention will decrease the events of Iatrogenesis.

Conditions
-----------------
Iatrogenesis in NICU

Intervention / Treatment
-----------------
* Behavioral: Increasing the level of awareness to Iatrogenesis
* Behavioral: Increasing awareness .


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All infants in NICU - Exclusion Criteria:None -

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Behavioral<br>The intervention is basically by letting the care givers to be aware that there is active recording of iatrogenesis | Behavioral: Increasing the level of awareness to Iatrogenesis<br>* Increasing the level of awareness to Iatrogenesis<br>Behavioral: Increasing awareness .<br>* Increasing awareness to Iatrogenesis and active daily recordings<br>* Other names: In the first 3 months the medical teams were unaware of recordings while in next 3 months they became aware to recordings;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19

Study Overview
=================
Brief Summary
-----------------
Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.

Official Title
-----------------
STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19

Conditions
-----------------
Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over the age of 18; Diagnostic COVID-19 by RT-PCR; Hospitalisation in resuscitation for the management of complications related to COVID-19 Implanted ECMO-VV during hospitalisation; Patient agreeing to participate in the study Exclusion Criteria: Sujet under guardianship or trusteeship Sujet under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective description of COVID-19 patients receiving respiratory ECMO-VV supplementation and what happens to them |  | Files analysed retrospectily from March 1st, 2020 to April 15, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Distress Syndrome, ARDS, SARS-COV-2, Extracorporeal membrane oxygenation, ECMO, Veno-venous ECMO
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

Study Overview
=================
Brief Summary
-----------------
Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.

Detailed Description
-----------------
Patients : All children treated by ECMO in the 4 PICUs involved in the study Measurements : A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.

Official Title
-----------------
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2

Conditions
-----------------
Cardiac Arrest, Acute Respiratory Distress Syndrome (ARDS), Cardiogenic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Patients under the age of 18 years treated by ECMO Exclusion Criteria : Lack of parental consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between CA metrics and neurological outcome | Association between the percentage of time spent in critical region of CA and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the influence of PCO2 on CA | Association between PCO2 value (mmHg) and COX value | 1 year | 
| Analysis of the influence of PCO2 on CA | Influence of ECMO settings on CA | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECMO, Cerebral autoregulation
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.

Study Overview
=================
Brief Summary
-----------------
Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications [PHT related bleed, AKI, infections, HE] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.

Official Title
-----------------
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.

Conditions
-----------------
Acute on Chronic Liver Failure

Intervention / Treatment
-----------------
* Drug: Carvedilol 12.5 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, Age 18-70 yrs Baseline HVPG ≥ 12 mmHg. Exclusion Criteria: Contraindications to NSBB (heart rate < 65 /min, BP < 110/65 mm Hg, asthma, heart failure), Portal Vein Thrombosis, Hepatocellular carcinoma, HVOTO, HE grades 2-4, NSBB therapy within 5 days, Pregnancy, Lactation, Planned for LT in the next 12 weeks No consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute on Chronic Liver failure<br> | Drug: Carvedilol 12.5 MG<br>* Carvedilol 12.5 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver transplant free survival |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications [PHT related bleed, AKI, infections, HE] within 90 days |  | 90 days | 
| Liver transplant-free survival rate |  | 90 days | 
| Correlation with evolution of AARC score |  | 2 weeks |
Entacapone Augmentation for Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.

Official Title
-----------------
Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Entacapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: predominantly negative symptoms stable on ongoing antipsychotic treatment Exclusion Criteria: acute psychotic exacerbation suicidal ideation uncontrolled systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Entacapone|Entacapone 600mg BID|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in specific rating scales during the study and after completion, compared to baseline. |  | Baseline and once a month untill end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS score. |  | Before and after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, negative symptoms, entacapone
Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease the rate of Muscle Pain in patients with previous statin related Muscle Pain.

Official Title
-----------------
Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors

Conditions
-----------------
Statin Induced Myalgia

Intervention / Treatment
-----------------
* Drug: Coenzyme Q 10
* Drug: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms Exclusion Criteria: Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>PO Placebo QD | Drug: Placebo control<br>* po Placebo QD<br>|
| Experimental: 1<br>PO Coenzyme Q 10 QD | Drug: Coenzyme Q 10<br>* PO Coenzyme Q 10 120 mg QD<br>* Other names: ubiquinone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The number of patients who tolerate statin at the initial dose. 2. The number of patients remaining on statin therapy. 3. Change in myalgia score. |  | 4, 8, and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coenzyme Q 10, Statin, Myalgia
Effectiveness of Self-Help for Dually-Diagnosed Persons - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.

Official Title
-----------------
Effectiveness of Self-Help for Dually-Diagnosed Persons

Conditions
-----------------
Dual Diagnosis, Substance-Related Disorders, Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Double Trouble in Recovery
* Behavioral: Standard psychiatric day treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to psychiatric day treatment program 18-64 years old Exclusion Criteria: Did not understand or speak English, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment | Behavioral: Double Trouble in Recovery<br>* Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment<br>|
| Active Comparator: 2<br>Standard psychiatric day treatment | Behavioral: Standard psychiatric day treatment<br>* Individual counseling, groups, medication<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug/alcohol use |  | past 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychiatric medication adherence |  | recent | 
| traditional 12 step meeting attendance |  | past 90 days | 
| psychiatric symptoms |  | recent | 
| program retention |  | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self help, 12 step groups, psychiatric day treatment, co-occurring disorders, dual diagnosis
Role of Stress Cardiac MRI in Predicting Adverse Clinical Events in Patients With Known or Suspected Ischemic Heart Disease

Study Overview
=================
Brief Summary
-----------------
The investigators plan to use retrospective data to assess heart function and structure abnormalities through the use of an approved vasodilating agent for stress cardiac MRI tests. The investigators are interested in how these MRI findings relate to long-term prognosis in people who are at risk for cardiac disease.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 21 years old No contraindications for cardiac MRI (by renal function or metallic hazards)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality, MI, heart failure hospitalization or documentation of an LV ejection fraction < 0.40 after index CMR at a follow-up. | Myocardial infarction will be defined as hospital admission for acute coronary syndrome (defined by positive serum troponin level with documented electrocardiographic changes, clinical syndrome, or need for percutaneous or surgical revascularization). Heart failure hospitalization will be defined as any hospitalization for signs and symptoms of volume overload or dyspnea requiring diuretic therapy regardless of LV ejection fraction. | 5 years |