linjc16/ctgov huggingface dataset:
Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group

Study Overview
=================
Brief Summary
-----------------
Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Detailed Description
-----------------
Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Official Title
-----------------
Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Procedure: Blood sampling for determination of serum Zn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cystic fibrosis Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling for determination of serum Zn|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
PIO Laser Sclerectomy IOP SLT Sclerectomy

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to characterize the changes in IOP over 24 hours after selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after selective laser trabeculoplasty.

Official Title
-----------------
Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.

Conditions
-----------------
Primary Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Open-Angle Glaucoma IOP more than 21 mmHg Progression under maximal medical therapy aged more than 18 years Exclusion Criteria: 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective laser trabeculoplasty (Tango Laser, Ellex)<br>Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA) | Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)<br>* One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change over 24 hours after selective trabeculoplasty SLT according to chronobiological data (decrease of IOP; type of 24h-IOP rhythm and 24h-PPm rhythm: MESOR, acrophase, bathyphase, amplitude and modeling) |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT. | To find predictive factors 1 month before efficacy of the treatment (after 6 month). Efficacy is defined by a mean IOP decrease, at least 30%, with a smoothed pressure-peaks (decrease at least 40% of pressure changes) To characterize changes of ocular blood flow parameters (optic nerve head; Volume, Velocity and Flow): 20% at least of increase. | Baseline and 6 months |
Management of Diverticulitis in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study aims to describe current treatment practices in the US for managing acute uncomplicated diverticulitis. In addition, we will identify clinical factors associated with the decision to discharge versus hospitalize patients with uncomplicated diverticulitis with the goal of informing clinical decision-making and providing a foundation for diagnostic algorithms to guide clinical practice.

Official Title
-----------------
Management of Diverticulitis in the Emergency Department

Conditions
-----------------
Diverticulitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Emergency department presumptive or confirmed final diagnosis of acute diverticulitis Verbal or written consent provided in English (or Spanish depending on study site) Exclusion Criteria: None

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 |
| --- | --- | --- |
| Rates of hospital admission | Rates of hospital admission from the emergency department among patients being treated for acute diverticulitis will be determined. In addition, factors associated with hospital admission will be examined. | Day 1 | 
| Rate of Imaging | The rate of imaging performed in the emergency department among patients treated for acute diverticulitis will be determined. Factors associated with imaging will also be examined. | Day 1 |
Alternate-Day Buprenorphine Administration. Phase VIII - 9

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate open buprenorphine dosing with dose choice.

Official Title
-----------------
Alternate-Day Buprenorphine Administration. Phase VIII

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 48 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid withdrawal |  |  | 
| Opioid agonist effects |  |  | 
| Dose choice |  |  |
Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas

Study Overview
=================
Brief Summary
-----------------
Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer

Detailed Description
-----------------
Finding patients with pancreatic cancer (in all stages), before any treatment. Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver. Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease. Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

Official Title
-----------------
Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients With Pancreatic Cancer

Conditions
-----------------
Cancer of Pancreas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with any pancreatic cancer, in any stage, before treatment. >18 y.o Exclusion Criteria: claustrophobia GFR<30 patients with non mri compatible devices (e.g. orthopaedic external fixation system) After chemotherapy treatment or surgical procedure

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 |
| --- | --- | --- |
| Percentage of fat in pancreas measured in the head, body and tail excluding the lesion area. | measuring Pancreatic Steatosis in patients with pancreatic cancer using MRI DIXON scan, at 24 hours before chemotherapy starting. | at 24 hours before chemotherapy starting | 
| Blood levels of free DNA | Correlation of free DNA level and metastatic spread. | The blood sample taken 15 minutes prior to MRI study, at time of IV access. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer of pancreas, steatosis, MRI
New Anticoagulation Strategies of VV-ECMO

Study Overview
=================
Brief Summary
-----------------
Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.

Official Title
-----------------
the Efficacy and Safety of New Anticoagulation Strategies of Maintain Normal Clot Rate to Prevent Hemorrhage While VV-ECMO

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years old, VV-ECMO is estimated more than 3 days Exclusion Criteria: hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days

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 |
| --- | --- | --- |
| Percentage of Participants with hemorrhage events | 1) fatal bleeding; 2) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; and/or 3. bleeding causing a drop in hemoglobin level by 20 g/L or more or requiring transfusion of two units of whole blood or red cells. | 4 weeks |
Trial of Smoking Cessation Programs in Black Churches

Study Overview
=================
Brief Summary
-----------------
To provide a comprehensive description of smoking beliefs and behavior among rural Blacks, and to test the effectiveness of smoking cessation strategies delivered through Black churches.

Detailed Description
-----------------
DESIGN NARRATIVE: Two demographically similar rural counties in central Virginia were compared, one intervention and one control site. In each country, two cohorts were assembled, a random sample of all Black smokers (the community cohort), and all members of randomly sampled Black churches (the church cohort). The descriptive component of the study elicited the knowledge, beliefs, attitudes, and behavior concerning smoking from these cohorts. Cardiovascular risk factors, including blood pressure and cholesterol levels, were also determined in the community cohort. For the experimental component, a variety of interventions which have proven to be efficacious in other settings were implemented through Black churches. These included fostering a supportive environment, distributing self-help materials, and providing individual support and counselling through the use of peer facilitators. The results of the baseline psychosocial survey were used to modify these methods for local use. They were then implemented in a culturally appropriate fashion at the intervention sites. Baseline smoking rates were determined using the initial surveys in both counties. Smokers were surveyed again at the end of the interventions and one year later to establish one-year abstinence rates. These were used as the primary outcome variables for the analysis of effect. The principal effect of the interventions were measured by comparing smoking abstinence rates between the church cohorts in the intervention and control counties. Due to the extended nature of the social networks associated with the churches, the interventions may also have had an effect on individuals not directly exposed, and this was determined by comparing the outcomes in the community cohorts. Finally, the associations between the baseline psychosocial and physiologic variables, exposure to the interventions, and smoking cessation behavior were also analyzed, to characterize on a population basis those who were and were not influenced by these church-based programs.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)

Study Overview
=================
Brief Summary
-----------------
Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as compared to non-biologic DMARD-treated controls.

Official Title
-----------------
National Data Bank for Rheumatic Disease (NDB) Registry Study of Safety in Rheumatoid Arthritis (RA) Patients Treated With Certolizumab Pegol (CZP; Cimzia®) and Non-biologic Disease-modifying Antirheumatic Drug (DMARD) Therapies

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 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 |
| --- | --- |
| Certolizumab pegol (CZP)<br>Patients with RA receiving treatment with certolizumab pegol (CZP; Cimzia®) | |
| Non-biologic DMARD<br>Subjects with RA receiving treatment with non-biologic DMARD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with lymphoma | Number of participants with lymphoma during the observational period (up to 6 years) | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with serious infections | Number of participants with serious infections during the observational period (up to 6 years) | 6 years | 
| Number of participants with non-lymphoma malignancies | Number of participants with non-lymphoma malignancies during the observational period (up to 6 years) | 6 years | 
| Number of participants with cardiovascular events | Number of participants with cardiovascular events during the observational period (up to 6 years) | 6 years | 
| Number of participants with thromboembolic events | Number of participants with thromboembolic events during the observational period (up to 6 years) | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Certolizumab Pegol, CZP, Cimzia®, NDB, registry
A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

Study Overview
=================
Brief Summary
-----------------
It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).

Conditions
-----------------
Chronic Kidney Disease, Poorly-Controlled Hypertension

Intervention / Treatment
-----------------
* Drug: Chlorthalidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years. Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2. Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring. Treated hypertension: use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required. Exclusion Criteria: Use of thiazide or thiazide-like drugs in the previous 3 months. Use of furosemide in a dose >200 mg/d. Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring. Expected to receive renal replacement therapy within the next 3 months. Vascular event such as myocardial infarction, heart failure hospitalization, or stroke within 3 months prior to randomization. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable). Known hypersensitivity to thiazide or sulfa drugs. Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.

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

| Intervention/Treatment |
| --- |
|Drug: Chlorthalidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks |  | Baseline and 12 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, kidney disease
Safety and Performance of POLYTHESE® Vascular Prosthesis

Study Overview
=================
Brief Summary
-----------------
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device. PMCF Study.

Official Title
-----------------
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses

Conditions
-----------------
Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome, Arterial Dissections, Ehlers-Danlos Syndrome

Intervention / Treatment
-----------------
* Procedure: Implantation with POLYTHESE®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study: - Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death Exclusion Criteria: - none
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Implantation with POLYTHESE®|thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance: Primary patency rate | Patency rate | 1 year | 
| Safety : Mortality rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate | Ability to use with no need for replacement by another device and, Effective vascular flow restoration after procedure and, In case of aneurysm, exclusion of aneurysmal portion after procedure. | 5 years | 
| Primary patency rate | rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion) | 5 years | 
| Primary assisted patency rate | defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself (except for occlusion) after device implantation | 5 years | 
| Secondary patency | defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself for occlusion after device implantation | 5 years | 
| Device Failure | Uncontrolled blood leakage from device Loss of structural integrity, e.g. rupture and/or exaggerated dilation (> 50 %) Occlusion of the device Total or partial replacement of the device required | 5 years | 
| Mortality rate | freedom % from death | 5 years | 
| Limb salvage rate | defined as freedom % from target limb amputation | 5 years | 
| Adverse events | any documented adverse events, including anticipated and non-anticipated adverse events | 5 years |