linjc16/ctgov huggingface dataset:
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Study Overview
=================
Brief Summary
-----------------
MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

Detailed Description
-----------------
This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Official Title
-----------------
An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: AXS-07


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has participated in a prior study with AXS-07 for the treatment of migraine Exclusion Criteria: Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07 Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: AXS-07<br> | Drug: AXS-07<br>* AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Safety of Chronic Intermittent Use of AXS-07 | Long-term safety as measured by: Subjects with any TEAEs Subjects with suspected to be drug-related TEAEs Subjects with serious TEAEs Subjects with TEAEs that led to drug withdrawal Subjects with TEAEs that led to withdrawal from study Subjects with TEAEs that resulted in death | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axsome, AXS-07, MoSEIC™ meloxicam, rizatriptan
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through intravenous infusion，in order to improved the quality of block in regional anesthesia. In this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed with ropivacaine in coracoid approach brachial plexus block.

Official Title
-----------------
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block

Conditions
-----------------
Injury of Upper Limb

Intervention / Treatment
-----------------
* Drug: ropivacaine
* Drug: ropivacaine mixed with dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II; Aged 18-60 years; The elbow, forearm, wrist or hand surgery Exclusion Criteria: History of allergy to local anesthetics; Coagulation dysfunction, neuromuscular disease or local infection; The operation time is longer than the local anesthetics effective time.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Group Control<br>40 ml 0.375% ropivacaine was injected after Locating brachial plexus. | Drug: ropivacaine<br>* 40 ml 0.375% ropivacaine was injected after Locating brachial plexus.<br>|
| Experimental: Group Dexmedetomidine<br>40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus. | Drug: ropivacaine mixed with dexmedetomidine<br>* 40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration time | effective analgesia time | once per hour after surgery until 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset time |  | 5,10,15,20,25,30 min after injection | 
| Visual analogue scale |  | 2,6,12,24hour after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, brachial plexus block, coracoid
Regulation of Inflammatory Genes in Psoriasis

Study Overview
=================
Brief Summary
-----------------
Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory changes in the skin. An extensive cytokine network including generated by activated dendritic cells and T cells mediates the formation of psoriatic lesions. These immune-response parameters can be used as markers in the severity and management of the disease after further in-depth studies.

Official Title
-----------------
Regulation of Inflammatory Genes in Psoriasis

Conditions
-----------------
Psoriasis, Inflammation

Intervention / Treatment
-----------------
* Diagnostic Test: Inflammatory markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of psoriasis Must be age 19 or older. Must be Fitzpatrick skin type I, II, III, IV, V, VI. Exclusion Criteria: Subjects who do not have photosensitive disease and are not on photosensitizing medications. Subjects with a history of keloids (who are more likely to develop hypertrophic scars following skin biopsy). Subjects who have an allergy to local anesthetics, antibiotics and/or anticoagulants. Subjects who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Inflammatory markers|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory genes | TNF-alpha , IFN-alpha , IL-6, IL-8, IL-12 , IL-23, IL-4, IL-5 and IL-10 | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokines
Microbial Etiology of Ventilator-associated Pneumonia in COVID-19 Infected Patients

Study Overview
=================
Brief Summary
-----------------
National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics.

Official Title
-----------------
Microbial Etiology of Ventilator-associated Pneumonia (VAP) in COVID-19 Infected Patients

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Other: Bacterial species isolated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France. Exclusion Criteria: All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| COVID19-positive patients<br> | Other: Bacterial species isolated<br>* in the respiratory specimen<br>|
| COVID19-negative patients<br> | Other: Bacterial species isolated<br>* in the respiratory specimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2 |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of multi-drug resistant bacteria responsible for VAP among patients infected or not by the SARS-CoV-2 |  | 1 month |
Evaluating Effectiveness of Educational Intervention to Help Physicians Address Inappropriate Patient Requests for Direct-to-Consumer Advertised Prescription Medications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.

Detailed Description
-----------------
Since changes in FDA regulation direct-to-consumer advertising (DTCA), pharmaceutical companies have expended increasing resources to market their products to the public. This has led to increased awareness of diseases and potential treatments, but it has also created more public demand for medications that may not be appropriate for a patient's clinical presentation. This study aims to provide physicians with the knowledge and skills required to help them address inappropriate DTCA medication requests from patients.

Official Title
-----------------
Sound Prescribing Study - Assessing the Impact of Pharmaceutical Marketing and Promotional Practices on Physician Prescribing

Conditions
-----------------
Lumbosacral Muscle Strain

Intervention / Treatment
-----------------
* Other: Web-based educational modules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident physicians in internal medicine or family medicine specialties at participating study sites Exclusion Criteria: Completed less than 10 months of residency
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual education<br>Participants randomized into the no intervention arm were not exposed to the web-based educational modules | |
| Experimental: Web-based educational modules<br>Participants randomized into the intervention arm were exposed to the web-based educational modules | Other: Web-based educational modules<br>* Interactive case-based modules that includes video vignettes of clinical interactions between hypothetical patients interacting with physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision to prescribe celecoxib |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical education, clinical decisionmaking, pharmaceutical marketing
A Survey on Attitudes on Financial Incentives

Study Overview
=================
Brief Summary
-----------------
The study concerns a survey of attitudes of the public on issues around personal responsibility for health and the use of financial incentives to promote health in the U.S. and Germany. All data are gathered anonymously through online platforms. Two separate professional panel providers are used for access to members of the public. All participants are people who have voluntarily joined a survey panel in the past through an informed consent process and currently serve as panel members.

Official Title
-----------------
A Survey on Attitudes on Personal Responsibility and the Use of Financial Incentives for Health Promotion

Conditions
-----------------
Obesity, Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none other than age Exclusion Criteria: none other than age

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Members of the US public, non-probability sample<br> | |
| Members of the German public, non-probability sample<br> | |
| Members of the US public, probability sample<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey respondents are presented with scenarios that seek to elicit views and attitudes on the concepts of personal responsibility, and the acceptability of financial incentives. The analysis will present these views and attitudes in aggregate form. | Attitudes are measured using 5 point Likert scales, indicating the extent of agreement or disagreement with particular scenarios or questions. Other forms of multiple choice options are also used, in which respondents express their preferences by selecting one option over others. At the end of the surveys, an open text box is provided for general comments. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, personal responsibility, obesity
Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients

Study Overview
=================
Brief Summary
-----------------
Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis. Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation Secondary objectives : Assess the state of health Assess the knowledge Assess gestural know-how Assess the cognitive know-how Assess the behaviour adopted in reality by the patient Assess motivation psychosocial factors of : self-efficacy and inefficiency representation of obstacles, disadvantages of treatment sense of control over their health feeling of being supported by health professionals, by his close representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment

Official Title
-----------------
Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis Exclusion Criteria: Patient with a psychiatric disorder Patient in intensive care Palliative patient Patient aged under 18 years old Patient refusal

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
-----------------
Lung and heart transplantations, Mucoviscidosis, Educational needs
Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients

Official Title
-----------------
Deep TMS With the H Coils as a Novel Strategy for the Treatment of Negative Symptoms of Schizophrenia

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

Intervention / Treatment
-----------------
* Device: deep TMS H-coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM IV Diagnosis of Schizophrenia PANNS Negative > 21 Exclusion Criteria: risk factors for convulsions PANNS positive > 24

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: deep TMS H-coil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement

Study Overview
=================
Brief Summary
-----------------
This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.

Official Title
-----------------
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium

Conditions
-----------------
Atrial Fibrillation, Cryoablation

Intervention / Treatment
-----------------
* Procedure: Pulse Sequence
* Procedure: CMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or non-pregnant women A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation. Exclusion Criteria: Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits Allergy to gadolinium-based contrast agent Previous atrial fibrillation ablation Renal dysfunction (estimated GFR <60 mL/min/1.73m2) within 6 months Unwilling to provide informed consent for this protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMRI Pulse Sequence<br>Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison. | Procedure: Pulse Sequence<br>* Cylindrical Navigator Preparatory Pulse Sequence<br>Procedure: CMRI<br>* Cardiac Magnetic Resonance Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pool Corrected Signal Intensity |  | Through study completion, an average of 1 year | 
| Imaging Failure Rate |  | Through study completion, an average of 1 year | 
| Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme |  | Through study completion, an average of 1 year |
ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients

Study Overview
=================
Brief Summary
-----------------
The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000). Over the last ten years, substantial improvements have been made both in terms of diagnostic (immunohistochemistry and molecular biology) and therapeutic. New treatments have been marketed and are now available in clinic. New therapeutical strategies have been launched and have proved their efficacy in clinical studies or meta-analyses, generally increasing the survival rate of patients by a few months. However, little information still exists on the use and effectiveness of these molecules in clinical practice. The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years of treatment. This study should improve knowledge of the PLC treatment management in General Hospital Centres.

Official Title
-----------------
ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Primary Lung Cancer histologically (or cytologically or presence of a mutation on liquid biopsy with compatible imaging) proven between January 1st and December 31st, 2020* Follow-up by a lung specialist at a General Hospital Oral informed consent * date of collected sample Exclusion Criteria: Age < 18 years Secondary lung cancer Recurrence of same histological type PLC- left to the investigator discretion according to the clinic and the imagery Previous enrolment in the study Freedom deprived patient following a legal or administrative decision Patient unable to give his(her) consent

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 |
| --- | --- | --- |
| Describe therapeutical strategies implemented by pulmonologists in Respiratory Medicine or Oncology department of a General Hospital Centres during the first three years following PLC diagnosed in KBP-2020-CPHG cohort patients. | Data collected for the ESCAP-2020-CPHG study: - All treatments administered | 3 years |