linjc16/ctgov huggingface dataset:
MP-3 Biofeedback Training and Central Vision Loss

Study Overview
=================
Brief Summary
-----------------
The objectives of this investigation are: evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing; compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.

Official Title
-----------------
The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: MP-3 microperimeter
* Device: MP-3 microperimeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age related macular degeneration Exclusion Criteria: Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Training will be performed for two days a week | Device: MP-3 microperimeter<br>* Biofeedback stimulation two days a week<br>Device: MP-3 microperimeter<br>* Biofeedback stimulation three days a week<br>|
| Experimental: Group B<br>Training will be performed three days a week | Device: MP-3 microperimeter<br>* Biofeedback stimulation two days a week<br>Device: MP-3 microperimeter<br>* Biofeedback stimulation three days a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fixation stability | Achievement of a stable fixation, defined according to Fuji classification (Stable: if more than 75% of the fixation points are inside a 2° diameter circle that has as a center the centroid of all fixation points) and the Bivariate Contour Ellipse Area, were selected as primary outcomes. | 6 months | 
| Reading speed | Achievement of good reading speed: higher than 87 words per minutes was defined as our secondary outcome. Parameters for words per minutes are referred to visually impaired functional reading reported in literature | 6 months |
High-Intensity Laser Therapy for Eosinophilic Fasciitis

Study Overview
=================
Brief Summary
-----------------
Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. This case report will describe use of high-intensity laser therapy (HILT) using the Mectronic Exand MY high-intensity laser system in a patient with EF, highlighting its potential as an alternative or adjunct treatment option.

Official Title
-----------------
Efficacy of High-Intensity Laser Therapy for the Management of Eosinophilic Fasciitis: A Case Report

Conditions
-----------------
Eosinophilic Fasciitis

Intervention / Treatment
-----------------
* Device: High-Intensity Laser Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Eosinophilic fasciitis. Exclusion Criteria: a diagnosis unrelated to Eosinophilic fasciitis
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single participant case study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Intensity Laser Therapy (HILT)<br> | Device: High-Intensity Laser Therapy<br>* The patient will receive HILT using the Mectronic Exand MY high-intensity laser system with the following parameters: Wavelength: 1064 nm (near-infrared) Power: 12 W Energy density: 8 J/cm² Pulse duration: 200 µs Treatment duration: 10 minutes Frequency: 3 sessions per week for 4 weeks Total energy delivered: 96 J per treatment session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity via Numeric pain rating scale |  | Changes in pain intensity at baseline and 4 weeks | 
| Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) |  | Changes in DASH at baseline and 4 weeks | 
| Quality of life via Short Form-36 Health Survey |  | Changes in Short Form-36 Health Survey at baseline and 4 weeks | 
| Adverse event | adverse events are recorded by the patient and therapist | 4 Weeks |
Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection

Study Overview
=================
Brief Summary
-----------------
Recently, Park et al. introduced a new technique for performing S1 TFESI using ultrasound. S1 TFESI using ultrasound can be considered to overcome the disadvantages of exposure to radiation. We hypothesized that the frequency of intravascular injection differs depending on the type of needle during S1 TFESI under ultrasound guidance.

Official Title
-----------------
Comparison of the Incidence of Intravascular Injection Using the Tuohy and Quincke Needles During Ultrasound-guided S1 Transforaminal Epidural Injection: a Prospective Randomized Controlled Study

Conditions
-----------------
S1 Transforaminal Epidural Block

Intervention / Treatment
-----------------
* Device: Tuohy needle group
* Device: Quincke needle group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient diagnosed with S1 radiculopathy because S1 root compression was confirmed on MRI and related symptoms 2. NRS of back and/or radiating pain score of 4 or more 3. Patients aged 19 years or older Exclusion Criteria: 1. Cases in which lumbar count is expected to be difficult due to lumbarization, sacralization, or lumbosacral transition 2. When the S1 posterior foramen is not clearly identified on ultrasound 3. Malignancy 4. Systemic infections 5. Bleeding tendency 6. Contrast allergy 7. Pregnant Women 8. If you cannot read or agree to the consent form 9. If you are unable to sign the consent form yourself

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tuohy needle group<br>Ultrasound-guided S1 transforaminal epidural block with Touhy needle | Device: Tuohy needle group<br>* Ultrasound-guided S1 transforaminal epidural block with Touhy needle<br>|
| Active Comparator: Quincke needle group<br>Ultrasound-guided S1 transforaminal epidural block with Quincke needle | Device: Quincke needle group<br>* Ultrasound-guided S1 transforaminal epidural block with Quincke needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of intravascular injection | incidence of intravascular injection during S1 transforaminal epidural block | 1 minute after finishing the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time required to complete S1 transforaminal epidural block | time required to complete S1 transforaminal epidural block | Baseline, 1 second after the completion of the procedure |
Gene Therapy for ACM Due to a PKP2 Pathogenic Variant

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM

Official Title
-----------------
A Phase 1/2 Study of the Safety and Efficacy of LX2020 Gene Therapy in Patients With Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant

Conditions
-----------------
PKP2-ACM, PKP2-ARVC, Arrhythmogenic Cardiomyopathy

Intervention / Treatment
-----------------
* Genetic: LX2020


Participation Criteria
=================
Eligibility Criteria
-----------------
Selected Inclusion Criteria: Adults with a clinical diagnosis of ACM meeting the 2010 revised Task Force Criteria (TFC) Genetic testing documenting a pathogenic or likely pathogenic variant in PKP2 Frequent premature ventricular complexes (PVCs) Implantable cardioverter-defibrillator (ICD) implantation ≥ 12 weeks prior to consent Left ventricular ejection fraction ≥ 50%

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LX2020<br>Single ascending dose of LX2020, with a starting dose of 2.0 x10^13 gc/kg, in multiple cohorts | Genetic: LX2020<br>* LX2020 is an adeno-associated viral vector encoding the human Plakophilin-2 (PKP2) gene (AAVrh.10hPKP2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and/or 1 treatment emergent serious adverse event (TESAE). | Evaluation of Safety and Tolerability of LX2020 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACM, Sudden Cardiac Death, Cardiac Arrest, Arrhythmogenic Cardiomyopathy, Cardiomyopathy, ARVC, Arrhythmogenic Right Ventricular, Arrhythmogenic Right Ventricular Dysplasia, Genetic cardiomyopathy, Gene Therapy, PKP2 Gene, Plakophilin-2, LX2020, HEROIC-PKP2, Ventricular Arrhythmia, PVCs
Study of 18F-FAPI Applied to Gastrointestinal Cancer

Study Overview
=================
Brief Summary
-----------------
Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT imaging.

Official Title
-----------------
Comparative Study of 18F-FAPI and 18F-FDG PET/CT for Gastrointestinal Cancer

Conditions
-----------------
Gastrointestinal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG Exclusion Criteria: The diagnosis can be clarified by 18F-FDG PET/CT examination The presence of recurrence or metastasis can be clarified by 18F-FDG PET/CT examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 18F-FDG<br> | Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT<br>* 18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer<br>|
| 18F-FAPI<br> | Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT<br>* 18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax | Measurement of the maximum standardized uptake value of the lesion | 1 day (During the inspection) |
Intestinal Metaplasia Cohort for Gastric Cancer Prediction

Study Overview
=================
Brief Summary
-----------------
In this study, we aim to establish a prospective cohort of patients with endoscopically and histologically confirmed intestinal metaplasia, collect gastric mucosal tissue samples from this cohort, and follow the development of gastric cancer over time.

Detailed Description
-----------------
Patients visiting Seoul National University Hospital, who have previously received an incidental diagnosis of intestinal metaplasia during a prior gastroscopy examination, will be considered as potential candidates for this study. Upon obtaining their informed consent to participate, the initial endoscopy procedure will involve the collection of biopsies to ensure an accurate histological diagnosis of intestinal metaplasia. These biopsies will be taken from the antrum and body of the stomach, according to the protocol of the updated Sydney system, to pathologically diagnose the extent and severity of intestinal metaplasia. One to two pieces of tissue remaining from this diagnostic process will be retained for future analysis. Subsequently, patients will be followed up on an outpatient basis to track the development of gastric cancer through routine screening endoscopies. In cases where patients develop gastric cancer, a comparative analysis will be conducted with those who do not develop gastric cancer, to determine the differences in expression of markers in the gastric mucosal tissue that was collected during the initial endoscopy. Our ultimate aim is to identify potential biomarkers that may serve as predictive indicators for the development of gastric cancer in patients with a preexisting diagnosis of intestinal metaplasia.

Official Title
-----------------
A Prospective Cohort Study for Gastric Cancer Prediction in Patients With Intestinal Metaplasia

Conditions
-----------------
Intestinal Metaplasia of Gastric Mucosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who visit Seoul National University Hospital Patients who have been visually diagnosed with intestinal metaplasia at a prior exam Exclusion Criteria: Patients who have been previously diagnosed with gastric cancer or adenoma Patients who have previously received gastrectomy

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 |
| --- | --- | --- |
| Gastric Cancer Development | Number of Participants Who Develop Gastric Cancer | 10 years |
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

Study Overview
=================
Brief Summary
-----------------
Adipearl is an injectable filler intended to be injected subcutaneously in the face.

Official Title
-----------------
A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects

Conditions
-----------------
Mid-face Volume Deficiency

Intervention / Treatment
-----------------
* Device: Adipearl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject having given freely and expressly informed consent; Subject deemed by the Investigator to be medically fit for injection of the product; Female or male subjects aged 22 to 65 years (inclusive); Exclusion Criteria: Pregnant or nursing woman or planning a pregnancy during the study. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. Subject participating to another research study. Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face correction with Investigational device<br>Subjects will be injected with the investigational device in the face. | Device: Adipearl<br>* Injection of the investigational device in the face.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Investigational Medical Device | Collection of Injection Site Reactions and Adverse Events during the study. | Up to 6 months |
The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay May Improve ICSI Outcome.

Study Overview
=================
Brief Summary
-----------------
In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes. The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS). The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.

Official Title
-----------------
The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study

Conditions
-----------------
Fertility Issues

Intervention / Treatment
-----------------
* Procedure: Sperm selection by IMSI
* Procedure: Sperm selection by IMSI and spermslow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples Exclusion Criteria: frozen embryos surgically extracted sperm preparations embryo-biopsy cycles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The IMSI-only group<br>The IMSI-only group | Procedure: Sperm selection by IMSI<br>* Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI)<br>|
| Active Comparator: IMSI with SpermSlow group<br>IMSI with SpermSlow group | Procedure: Sperm selection by IMSI and spermslow<br>* Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow<br>|
| No Intervention: Mixed embryo group<br>Mixed embryo group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy and delivery rates | Pregnancy and delivery rates | Within up to 10 month from treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IMSI, SpermSlow, Sperm selection, ICSI outcome, Sibling-oocytes study
Adjunctive Vaginal Progesterone in Management of Preterm Labor

Study Overview
=================
Brief Summary
-----------------
This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.

Official Title
-----------------
Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: Micronized progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy with gestational age 24-33 weeks 6 days preterm labor received treatment with tocolysis and corticosteroids Exclusion Criteria: conditions that need immediate delivery such as fetal distress, chorioamnionitis have medical complications such as heart disease, seizure fetal anomalies cervical dilatation more than 5 cm allergy to progesterone contraindication to progesterone contraindication to tocolytic use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micronized progesterone<br> | Drug: Micronized progesterone<br>* Vaginal micronized progesterone effervescent once daily until delivery<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| latency period | time from preterm labor to delivery | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational age at delivery | mean gestational age at delivery | 13 weeks | 
| preterm delivery less than 34 weeks | percentage of preterm delivery less than 34 weeks | 10 weeks | 
| preterm delivery less than 37 weeks | percentage of preterm delivery less than 37 weeks | 13 weeks | 
| neonatal complications | percentage of newborn with RDS, IVH, NEC, death | 13 weeks | 
| side effects | percentage of side effects such as headache, nausea/vomiting | 13 weeks | 
| compliance | percentage of complete drug use | 13 weeks | 
| good satisfaction | percentage of good satisfaction | 13 weeks | 
| good quality of life | percentage of good quality of life | 13 weeks | 
| Time to the recurrence of uterine contractions | mean time to the recurrence of uterine contractions | 13 weeks |