linjc16/ctgov huggingface dataset:
How to Differentiate and Treat Cystic Laesions in the Anterior Mediastinum (DETECTION)

Study Overview
=================
Brief Summary
-----------------
Multicenter trial about anterior mediastinal cysts

Official Title
-----------------
How to Differentiate and Treat Cystic Laesions in the Anterior Mediastinum (DETECTION)

Conditions
-----------------
Cysts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cysts in the anterior mediastinum Thymic cysts Bronchogenic cysts Pericardial cysts Cystic thymoma Cystic teratoma Exclusion Criteria: Patients <18 years old Patients without radiological imaging Patients without approval for follow-up

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 |
| --- | --- | --- |
| Percentage correctly diagnosed cystic laesions |  | 2000-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics, complications, comborbidities |  | 2000-2022 |
Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.

Official Title
-----------------
Comparison of Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia on Remifentanil Requirement in Desflurane Anesthesia

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Behavioral: Analgesia nociception index-guided anesthesia
* Behavioral: Standard anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gastric cancer Exclusion Criteria: Conversion to open laparotomy Prior opioid abuse Prior infection Cardiac arrythmia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analgesia nociception index group<br> | Behavioral: Analgesia nociception index-guided anesthesia<br>* Maintaining the blood pressure based on analgesia nociception index of >50 value<br>|
| Placebo Comparator: Standard group<br> | Behavioral: Standard anesthesia<br>* Maintaining the blood pressure based on anesthesiologist's decision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remifentanil requirement | Assessing the total dose of remifentanil administered from skin incision until skin suture | at time of the end of skin suture (up to 4 hours) |
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.

Official Title
-----------------
An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

Conditions
-----------------
Advanced Gastroenteropancreatic Neuroendocrine Tumor

Intervention / Treatment
-----------------
* Drug: 68Ga-DOTATOC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide a written informed consent; 18 75 years old,male or female； ECOG performance status 0 or 1; Confirmed or suspicion of GEP-NET. Exclusion Criteria: Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device; Individuals planning to be pregnant, and lactating women; Individuals with concurrent active infections or with unexplained fever >38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT imaging with 68Ga-DOTATOC<br> | Drug: 68Ga-DOTATOC<br>* Detection of somatostatin positive lesions in GEP-NETs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET | The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth | 12 months | 
| Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET | The number of patients who have no SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AE and SAE |  | up to 1 year follow-up |
Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.

Detailed Description
-----------------
The main objective of this study is to compare the analgesic effect of two distinct waveforms (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor cortex in patients suffering from neuropathic pain resistant to the best pharmacological treatment.

Official Title
-----------------
Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study

Conditions
-----------------
Neuropathic Pain

Intervention / Treatment
-----------------
* Other: Retrospective analysis of patients' choice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from neuropathic pain refractory to best pharmacological treatment, operated on for MCS with an internal pulse generator (IPG) capable of delivering both tonic and Burst DR(TM) stimulation waveforms. Exclusion Criteria: Patients under 18 years old ; pregnancy

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 |
| --- | --- |
| Tonic then Burst DR(TM)<br>Tonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months | Other: Retrospective analysis of patients' choice<br>* Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.<br>|
| Burst DR(TM) then tonic<br>Burst DR(TM) MCS for 3 months then tonic MCS for 3 months | Other: Retrospective analysis of patients' choice<br>* Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of pain relief | Percentage of analgesic relief compared with baseline (i.e. preoperative pain level) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antalgic drugs intake | Modification of pharmacological treatment doses (analgesics) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor cortex stimulation, neuropathic pain, Burst DR(TM) waveform
Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy, including time in both the interventional study and study LTF-001.

Official Title
-----------------
Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk for Cardiovascular Disease

Conditions
-----------------
Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria A participant has completed or discontinued from a Verve sponsored clinical study in which they received at least one dose of study drug. A participant has provided informed consent for LTF-001. Exclusion Criteria: N/A

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 |
| --- | --- | --- |
| Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and other events of interest using CTCAE 5.0 to assess the long-term safety of gene-editing therapies. | To assess the long-term safety of gene-editing therapies, the following will be assessed: Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and any CTCAE grade 3 or higher AEs. | up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent and absolute change from baseline of lipid concentrations and target biomarkers over time after administration of a gene-editing therapy. | Blood samples will be collected to assess percent change from baseline in lipid concentrations (including LDL-C) and target biomarkers. | up to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LTF-001, Cardiovascular Disease, Gene Editing, Familial Hypercholesterolemia, Base Editing
PortoSinusoidal Vascular Diseases and Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. Nodular regenerative hyperplasia (NRH) is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.

Detailed Description
-----------------
The study aims to compare the outcome of patients with MVPS associated with SSc to patients with MVPS without SSc. We will conduct a multicenter retrospective study comparing two groups of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc. Patients with MVPS associated with SSc will be recruited from French university hospital departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.

Official Title
-----------------
PortoSinusoidal Vascular Diseases and Systemic Sclerosis

Conditions
-----------------
PSVD With or Without SSc

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PSVD (Valdig criteria) SSC (ACR/EULAR 2013 criteria) Exclusion Criteria: Liver cirrhosis Limited scleroderma Autoimmune hepatitis Primary biliary cholangitis

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 |
| --- | --- |
| First group : SSC with PSVD<br>medical file analysis of patients affected by SSC and PSVD | |
| Second group : PVSD without SSC<br>medical file analysis of patients affected by PSVD only | |
| Third group : SSC without PVSD<br>medical file analysis of patients affected by SSC only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis | To compare prognosis of PSVD patients with or without SSc | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Porto-Sinusoidal Vascular Disorders, Nodular regenerative hyperplasia, Systemic sclerosis
Face Perception and Impact of Surgical Masks in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The preferences to masked and unmasked faces is relevant for premature newborns, since Covid-19, most of the faces that surround them during their hospitalization are masked. The Premask project is a continuation of the InfantMask and BabyMask studies (concerning infant and newborn), by studying the visual preferences to masked and unmasked faces of premature newborns.

Official Title
-----------------
Face Perception and Impact of Surgical Masks in Preterm Infants

Conditions
-----------------
Visual Preference With and Without Mask in Term Infant, Visual Preference With and Without Mask in Preterm Infant

Intervention / Treatment
-----------------
* Other: Presentation of differents face pictures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All preterm infants born before 32SA arriving at term (at≥37SA) hospitalized in the neonatology department of the pediatric hospital of Grenoble and approaching discharge will be included. Of the potential participants meeting the inclusion criteria, those with at least 1 of the following exclusion criteria will not be eligible for inclusion in the study. Exclusion Criteria: Parents not fluent in French Parents with no social security rights Patient with a syndromic disorder Abnormal neurological examination Invasive or non-invasive ventilation at the time of testing of babies requiring, at the time of testing at ≥37SA, non-invasive or invasive ventilatory support as well as labeled syndromic or ophthalmologic disease of prematurity (retinopathies). Infection requiring isolation Ophthalmologic impairment of prematurity (retinopathy)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: visual test<br>Presentation of differents face pictures | Other: Presentation of differents face pictures<br>* Test 1: Unmasked face vs. masked face Test 2: Unmasked face up vs. unmasked face down Test 3: Face masked right side vs. face masked reverse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of visual fixation time to photos of masked/non-masked faces. | time of picture visual fixation (seconds) | once, at term (at 37 weeks corrected age) |
Asia Pacific Menopause Federation Menopause Consensus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to achieve expert consensus on the management of menopause in the Asia-Pacific

Detailed Description
-----------------
The aim of this study is to achieve expert consensus on the management of menopause in the Asia-Pacific. The experience of the menopause is deeply rooted in sociocultural perceptions unique to each population. Thus, the management of menopausal symptoms and other conditions related to the menopause also vary from region to region. The investigators will use a modified Delphi method involving the participation of experts from various countries in the Asia-Pacific. The objective of this study is to achieve consensus on various aspects of the management of the menopause in the Asia-Pacific. This study will involve several rounds of Delphi surveys, administered via Google Forms, Microsoft Word or PDF. Each survey questionnaire contains Questions on basic demographic information Statements on areas of concern in the management of the menopause; each participants vote on to what extent they agree or disagree with the statement on a Likert scale. Questions on the participants' usual clinical practice in treating menopause Multiple survey rounds will be held until agreement on the statements and stability is achieved.

Official Title
-----------------
An Expert Panel Consensus Statement on the Management of Menopause in the Asia-Pacific Using Modified Delphi Methodology

Conditions
-----------------
Menopause, Menopause Related Conditions

Intervention / Treatment
-----------------
* Other: No intervention to be performed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experience in treating menopause

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Expert group<br> | Other: No intervention to be performed<br>* No intervention to be performed. Anonymous survey only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who vote for the same option on a series of survey questions |  | 2023-2024 |
Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The primary endpoint of the study is to identify a neurophysiological biomarker (absence of synaptic depotentiation at primary motor cortex , measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of neurophysiological cTBS depotentiation protocol) as predictor of the development of Levodopa-induced dyskinesia in patients with Parkinson's disease.

Official Title
-----------------
Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Continuous theta burst stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria; age between 30 and 80 years; ongoing therapy with levodopa; fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire. Exclusion Criteria: patients unable to give informed consent; cognitive impairment (MMSE ≤ 24); history of epilepsy; pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with parkinson's disease<br> | Device: Continuous theta burst stimulation<br>* Two sessions of continuous theta burst stimulation over primary motor cortex to explore synaptic plasticity in Patients with Parkinson's disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations of synaptic depotentiation in primary motor cortex | Alterations of synaptic depotentiation in primary motor cortex will be measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of depotentiation protocol of continuous theta burst stimulation. Alterations of synaptic depotentiation at the baseline evaluation will be compared between patients who will develop and patients who will not develop dyskinesias (assessed by Unified Dyskinesia Rating Scale part III, range 0-112) during the follow-up. | 3 years |