linjc16/ctgov huggingface dataset:
A French Multi-centric Atrial Fibrillation Catheter Ablation Survey

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients. We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.

Official Title
-----------------
A French Multi-centric Atrial Fibrillation Catheter Ablation Survey

Conditions
-----------------
Observation of Outcome After Catheter Ablation of Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: catheter ablation of atrial fibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter Exclusion Criteria: patients undergoing catheter ablation of other types of arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Pasteur<br> | Procedure: catheter ablation of atrial fibrillation<br>* electric pulmonary vein disconnection<br>|
| Grenoble<br> | Procedure: catheter ablation of atrial fibrillation<br>* electric pulmonary vein disconnection<br>|
| Nantes<br> | Procedure: catheter ablation of atrial fibrillation<br>* electric pulmonary vein disconnection<br>|
| Parly<br> | Procedure: catheter ablation of atrial fibrillation<br>* electric pulmonary vein disconnection<br>|
| Rennes<br> | Procedure: catheter ablation of atrial fibrillation<br>* electric pulmonary vein disconnection<br>|
| Rouen<br> | Procedure: catheter ablation of atrial fibrillation<br>* electric pulmonary vein disconnection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation relapse | Documentation of atrial fibrillation relapse (symptomatic or asymptomatic) after the first 3 months after the index procedure | starting 3 months after the procedure till an average of 18months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early atrial fibrillation relapse | Documented atrial fibrillation relapse (symptomatic or asymptomatic) in the first 3 months after the index procedure | first 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation; catheter ablation; relapse; stroke; death
Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance. This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.

Official Title
-----------------
A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Chylomicronemia

Conditions
-----------------
Lipoprotein Lipase Deficiency, Familial, Hyperlipoproteinemia Type I, Chylomicronemia, Familial, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: CAT-2003
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Familial Chylomicronemia (Fasting triglycerides ≥ 880 mg/dL at Screening and documented history of plasma post-heparin LDL activity < 20% of normal or genetic confirmation of homozygosity or compound heterozygosity for loss-of-function mutations in familial chylomicronemia-causing genes) OR Non-familial Chylomicronemia (Fasting triglycerides ≥ 440 mg/dL at Screening and documented history of fasting triglycerides ≥ 880 mg/dL) Key Exclusion Criteria: History of any major cardiovascular event within 6 months of Screening Type I diabetes mellitus or use of insulin History of pancreatitis within 3 month of Screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAT-2003 or Placebo<br>All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period. | Drug: CAT-2003<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in fasting triglycerides in patients with chylomicronemia |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels |  | 12 Weeks | 
| Absolute and percent change from baseline on chylomicron triglyceride clearance |  | 12 Weeks | 
| Absolute and percent change from baseline in plasma non-HDL-C |  | 12 Weeks | 
| Frequency of adverse events |  | 13 weeks |
Effects of Regional Anesthesia Following Mastectomy

Study Overview
=================
Brief Summary
-----------------
Patients of breast surgery dated between April 2016 and March 2021 will be scanned in three groups; solely induced general anesthesia, general anesthesia induced with Erector Spinae Plane Block, and general anesthesia induced with Rhomboid Block. The investigators aimed to retrospectively compare the effectiveness of regional anesthesia techniques used in the clinic for postoperative recovery and opioid consumption in patients who underwent breast surgery.

Official Title
-----------------
Effects of Regional Anesthesia on Postoperative Recovery and Opioid Consumption Following Mastectomy: A Retrospective Study

Conditions
-----------------
Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent breast surgery under general anesthesia with or without one of the blocks; Erector Spinae Plane Block and Rhomboid Block. Exclusion Criteria: Incomplete patient forms.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Anesthesia<br> | |
| Erector Spinae Plane Block<br> | |
| Rhomboid Block<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption retrieved from the patient records |  | up to 24 hours | 
| Length of hospital stay |  | up to 1 week |
Study of Combination Therapy With SYR-322

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Official Title
-----------------
A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Alogliptin
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is an outpatient. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYR-322 (Alogliptin) QD<br>SYR-322 25 mg, orally. | Drug: Alogliptin<br>* Alogliptin tablets<br>* Other names: SYR-322;|
| Placebo Comparator: Insulin<br>injection | Drug: Insulin<br>* Insulin injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) |  | Baseline and Week 12 |
Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc

Detailed Description
-----------------
Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone. In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area. Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.

Official Title
-----------------
Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)

Conditions
-----------------
Spinal Tuberculosis, Mesenchymal Stem Cell

Intervention / Treatment
-----------------
* Combination Product: Mesenchymal Stem cell + Nacl 0.9%
* Combination Product: NaCl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinicoradiologically diagnoses Spinal Tuberculosis receives Anti TB drugs minimun destruction 1/3 vertebral body Exclusion Criteria: patient under 15 years old reject to be included in the study

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC Group<br>Mesenchymal Stem Cell + NaCl 0,9% 2ml | Combination Product: Mesenchymal Stem cell + Nacl 0.9%<br>* Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit<br>Combination Product: NaCl 0.9%<br>* Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertebral bony fusion | trabecular bone on xray and CT scan | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mycobacterium tuberculosis
Ultrasonic Measurements of the Clitoris in Fetuses

Study Overview
=================
Brief Summary
-----------------
Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. The purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.

Official Title
-----------------
Measurements of the Fetal Clitoris by 2D Ultrasound

Conditions
-----------------
Ambiguous Genitalia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: well dated pregnancy singleton pregnancy female fetus appropriate for gestational age Exclusion Criteria: small for gestational age other fetal anomalies maternal conditions that can cause exposure of the fetus to high androgen environment

Ages Eligible for Study
-----------------
Minimum Age: 14 Weeks
Maximum Age: 37 Weeks

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clitoris
A Long Term Follow up Study in Late-onset Pompe Disease

Study Overview
=================
Brief Summary
-----------------
This study is to observe the progression of disease in late-onset Pompe disease

Official Title
-----------------
A Long Term Follow up Study in Late-onset Pompe Disease

Conditions
-----------------
Pompe Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals with acid alpha glucosidase deficiency without obvious symptoms parents signed inform consent Exclusion Criteria: individuals with acid alpha glucosidase deficiency presenting symptoms
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 muscle function |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pompe disease, late onset
Periodontal Disease and Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.

Official Title
-----------------
Periodontal Disease and Cardiovascular Disease

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Drug: Triclosan
* Drug: Fluoride
* Drug: Fluoride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A minimum of 12 uncrowned teeth other than 3rd molars Age 18 to 75 years Informed consent Exclusion Criteria: Prosthetic heart valves Prosthetic joint replacement Previous infective endocarditis Requirement for antibiotic cover for dental treatment Current treatment with warfarin

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

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

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

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 |
| --- | --- |
| Active Comparator: A<br> | Drug: Triclosan<br>* Brush twice daily<br>Drug: Fluoride<br>* Brush twice daily<br>|
| Placebo Comparator: B<br> | Drug: Fluoride<br>* Brush twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal disease |  | 3-5 Years |
Associations Between Diabetes, Arterial Stiffness and Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?

Study Overview
=================
Brief Summary
-----------------
Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and these patients, as a consequence herby, has a lesser prognosis. DM is often related to increased arterial stiffness and hypertension. The investigators thesis is that DM and pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is under-diagnosed. At the same time the investigators imagine that DM is closely related to the degree of arterial stiffness, and that these parameters are closely related to a new biochemical marker, fibulin-1. The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if there is a connection between the degree of the dysmetabolism and arterial disease, by studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the investigators newly have identified. The results of this project will give us a measure for the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell us more in terms of the connections between a newly identified plasma arterial marker, arterial stiffness and diabetes.

Official Title
-----------------
Is There an Association Between the Presence of Diabetes, the Degree of Arterial Stiffness and a New Plasma Marker for Vascular Elasticity, Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?

Conditions
-----------------
Coronary Artery Disease, Arteriosclerosis, Carotid Stenosis, Thrombosis, Aortic Aneurysm, Abdominal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age undergoing heart- or vascular surgery Exclusion Criteria: Physical or mental disability not enabling participation in the study

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Arteriosclerosis, Intima media thickness, arterial stiffness, pulsewave velocity, fibulin-1
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).

Official Title
-----------------
An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients

Conditions
-----------------
Parkinson's Disease Psychosis

Intervention / Treatment
-----------------
* Drug: pimavanserin tartrate (ACP-103)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria- Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin Patient is willing and able to provide consent Exclusion Criteria- Female patient of childbearing potential Patient has a clinically significant concurrent medical illness Patient is judged by the treating physician to be inappropriate for the study.
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: pimavanserin tartrate (ACP-103)<br>Tablets taken once daily by mouth at 20, 40, or 60 mg doses | Drug: pimavanserin tartrate (ACP-103)<br>* Tablets taken once daily by mouth at 20, 40, or 60 mg doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | Number (%) of patients with drug-related treatment-emergent AEs | From first to last study drug dose plus 30 days |
Methadone/Buprenorphine Cross-Over Study - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore ways to cross patients over from methadone to buprenorphine.

Official Title
-----------------
Methadone/Buprenorphine Cross-Over Study

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Withdrawal symptoms |  |  | 
| Opiate craving |  |  |