linjc16/ctgov huggingface dataset:
CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)

Study Overview
=================
Brief Summary
-----------------
This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.

Official Title
-----------------
An International, Multi-centre, Randomised, Stratified, Double-blinded, Placebo-controlled, 4-parallel Group Trial Investigating the Efficacy and Safety of Three Different Dose Levels of CRD007 (The AORTA Trial)

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Drug: CRD007
* Drug: CRD007 matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infra-renal abdominal aortic aneurysm Exclusion Criteria: Previous infra-renal aortic surgery Known diabetes

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRD007 10 mg tablet<br> | Drug: CRD007<br> <br> |
| Experimental: CRD007 25 mg tablet<br> | Drug: CRD007<br> <br> |
| Experimental: CRD007 40 mg tablet<br> | Drug: CRD007<br> <br> |
| Placebo Comparator: CRD007 matching placebo tablet<br> | Drug: CRD007 matching placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation

Study Overview
=================
Brief Summary
-----------------
Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team.

Official Title
-----------------
Randomized Study Comparing the ASV to Conventional Ventilation for Intubated Patients During Inter-hospital Transfers. Controlled Randomized Monocentric Prospective Study Comparing ASV Versus Conventional Ventilation Modes

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

Intervention / Treatment
-----------------
* Device: Hamilton T1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubation Secondary transfer (interhospital) Informed patients / close relations, signed consent Exclusion Criteria: Primary transport of a ventilated, intubated, sedated patient Patient in limitation and stop of active therapeutics, dying person Broncho pleural fistula Patient under ECMO Patient included in another research submitted to consent Supervision, loss of liberty Pregnant woman

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional ventilation<br>Conventional ventilation - manual mode | Device: Hamilton T1<br> <br> |
| Experimental: ASV<br>Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode | Device: Hamilton T1<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation parameter: VT |  | Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours | 
| Ventilation parameter: respiratory rate |  | Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours | 
| Ventilation parameters: Fi02 |  | Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours | 
| Ventilation parameter: PEEP |  | Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours | 
| Ventilation parameter: ETC02 |  | Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of manual adjustments |  | Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours |
Methadone Monitoring for Insights Into Adverse Events

Study Overview
=================
Brief Summary
-----------------
Methadone has been an effective and inexpensive therapy in the management of chronic pain and opioid dependence. However it has been associated with sudden, unexpected deaths. Two mechanisms have been suggested, increased drug concentration in the blood, and a change in the heart rhythm. This study will look at blood samples for drug levels and genetic components and EKG's (a noninvasive test which reveals heart rhythm). There will be no intervention.

Official Title
-----------------
Methadone Monitoring for Insights Into Adverse Events

Conditions
-----------------
Pain, Opiate Addiction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be 18 years of age or older; eligible for methadone treatment as judged by Discovery House criteria must sign informed consent for methadone treatment prior to being approached for this study must sign a written informed consent for this study is willing and has a means to return for all scheduled follow-up visits Exclusion Criteria: pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism use of methadone in the 30 days prior to study enrollment; concomitant use of QT prolonging drugs considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Total Methadone Peak Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| Total Methadone Trough Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (S)- Methadone Peak Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (S)- Methadone Trough Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (R)-Methadone Peak Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (R)-Methadone Trough Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| Total EDDP Trough Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (S)-EDDP Peak Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (S)-EDDP Trough Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (R)-EDDP Peak Plasma Concentration |  | Day 1, Day 7, Day 21 | 
| (R)-EDDP Trough Plasma Concentration |  | Day 1, Day 7, Day 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetic, methadone
Non-compliance on Treatment Among Diabetic Students at Sohag University

Study Overview
=================
Brief Summary
-----------------
A cross-sectional study on diabetic students in Sohag University will be conducted to collect data about factors affecting compliance and adherence to diabetes treatment and its impact on development of complications.

Detailed Description
-----------------
Personal interviews with diabetic students through a questionnaire : To determine factors affecting non compliance on treatment among diabetic students. To detect relation between non compliance on treatment and development of complications.

Official Title
-----------------
Non-compliance on Treatment Among Diabetic Students at Sohag University

Conditions
-----------------
Diabetes Mellitus, Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic students at Sohag University age from 17 to 25 Exclusion Criteria: Healthy students Students in other universities

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 25 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 |
| --- | --- | --- |
| Distribution of Participants Responses as Regards DSMQ Glucose Management Domain | through a standardized questionnaire DSMQ (Diabetes self management questionnaire) | 2 months | 
| Distribution of Participants Responses as Regards DSMQ Dietary Control Domain | non compliance on treatment among diabetic students | 2 months | 
| Distribution of Participants Responses as Regards DSMQ Physical Activity Domain | mesurment of non compliance among diabetic students at sohag university | 2 months | 
| Distribution of Participants Responses as Regards DSMQ Health Care Use Domain | measurment of non compliance among diabetic students at sohag university | 2 months |
Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge

Study Overview
=================
Brief Summary
-----------------
The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

Official Title
-----------------
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

Conditions
-----------------
ACS, Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of myocardial infarction or unstable angina Hospitalized for the first time within 24 hours of onset of symptoms Exclusion Criteria: Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances) Current participation in a clinical trial.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes |  | Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antithrombotic treatments |  | Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event) | 
| Use of health care resources |  | Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event) | 
| Quality of life |  | At index event (baseline) and then at 6 weeks and each 3 months after index event | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, heart attack, myocardial infarction, ACS long-tem follow up, antithrombotic management, quality of life, Antithrombotic
Changes of Endothelial Function Before and After DSA in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In this study, the investigators will select 200 diabetic patients who have a DSA for diabetic foot screening. Also, the investigators will select 100 healthy subjects as controls. The endothelial function will be determined by high resolution ultrasound before and after DSA. The investigators will observe the changes of endothelial function after DSA assay.

Official Title
-----------------
Changes of Endothelial Function Before and After DSA in Patients With Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: DSA assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetic foot Age 40 to 70 years old Exclusion Criteria: Heart failure Renal failure Acute infection

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DSA group<br> | Other: DSA assay<br>* All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.<br>|
| control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of endothelial function |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic foot, digital subtraction angiography, endothelial function, Patients with diabetes, Age 40 to 70 years old, Endothelial function are determined
The Chimerix CMX001 Registry

Study Overview
=================
Brief Summary
-----------------
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.

Official Title
-----------------
A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.

Conditions
-----------------
Outcomes, Survival Rates

Intervention / Treatment
-----------------
* Drug: CMX001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001. Willing and able to understand and provide written informed consent to participate in this observational study Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 10 years following the completion of study CMX001-301 or other qualifying clinical study. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CMX001<br>Subjects who have previously participated in CMX001-301 or other CMX001 study. | Drug: CMX001<br> <br> * Other names: Brincidofovir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to all-cause mortality | evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as the development of new malignancies and late cytomegalovirus (CMV)-associated events, as well as survival rates in subjects previously enrolled in selected clinical studies of CMX001 | 10 years |
Expression of EPK in Recurrent Miscarriage

Study Overview
=================
Brief Summary
-----------------
The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.

Official Title
-----------------
MAP Kinase Signaling Pathways Through ERK and p-ERK Protein in Human Placenta of Women With Recurrent Miscarriage

Conditions
-----------------
Recurrent Miscarriage

Intervention / Treatment
-----------------
* Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age less than 12 weeks. no uterine abnormalities (examined by ultrasonography or hysterosonogram) previous history of RM, defined as two or more consecutive miscarriages Exclusion Criteria: Gestational age 12 weeks or more. Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus). Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes. Uterine anatomic anomalies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recurrent miscarriage group<br>Women with previous history of RM, defined as two or more consecutive miscarriages | Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins<br> <br> |
| Control group<br>Women with no history of RM | Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The levels of ERK and AKT in placenta |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetic basis
Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the facial measurements for determining the proper sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared with the length between mouth corner and mandible angle.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Device: the length between incisor and mandible angle
* Device: the length between mouth corner-mandible angle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing surgery that requires general anesthesia Exclusion Criteria: anticipated difficult intubation patients without teeth or with loose teeth cervical spine disease upper airway disease body mass index over 35 kg/m2 pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>the length between incisor and mandible angle | Device: the length between incisor and mandible angle<br>* the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) which size is the length between incisor and mandible angle<br>|
| Active Comparator: Active comparator<br>the length between mouth corner-mandible angle | Device: the length between mouth corner-mandible angle<br>* the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) of which size is the length between mouth corner and mandible angle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proper size of oropharyngeal airway | The oropharyngeal airway will be inserted into the patient's mouth. Investigators will check the laryngeal view using fiberoptic bronchoscope and the adequacy of ventilation after the investigator ventilates the patient using the mask. If both the laryngeal view and ventilation are appropriate, the size of oropharyngeal airway will be considered as the proper size for the patient. | up to 10 minutes after the start of anesthetic induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway Management, Ventilation