linjc16/ctgov huggingface dataset:
Nutritious Eating With Soul at Rare Variety Cafe

Study Overview
=================
Brief Summary
-----------------
To date, few dissemination and implementation (D&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims: Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant. Aim 2: Assess resource use and cost associated with a train-the-trainer D&I approach in a restaurant setting. Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months). Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.

Official Title
-----------------
Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Vegan diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-identify as African American between 18-65 years old be free on meeting night (Tuesday at 6PM) be free of eating disorder be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy willing to travel weekly to Rare Variety Café Exclusion Criteria: currently following a plant-based/vegan diet have a body mass index of under 25 or over 49.9 kg/m2 currently on medication for diabetes women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months) currently participating in a weight loss program or taking weight loss medications recent weight loss (>10lbs in the last 6 months) living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina currently in the NEW Soul study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study participants<br>This is a single-arm study so all participants receive the same intervention. | Behavioral: Vegan diet<br>* Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | Assess changes in body weight | 0, 3, and 12 months |
The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.

Conditions
-----------------
Intubation, Posture

Intervention / Treatment
-----------------
* Procedure: Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class 1 or 2 scheduled for general anesthesia with endotracheal intubation decided to join this clinical study voluntarily Exclusion Criteria: history of difficult intubation anticipated the difficult intubation: Total airway score > 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neck flexion first<br>With specific head posture, intubation is done under flexible fiberoscopy guide. In this arm, at the position with neck flexion, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck extension, And the laryngeal view is gotten in the same way. | Procedure: Intubation<br> <br> |
| Experimental: neck extension first<br>In this arm, at the position with neck extension, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck flexion, And the laryngeal view is gotten in the same way. | Procedure: Intubation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POGO score | The percentage of glottic opening | a week (after get the picture) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fiberoptic, intubation, posture
Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia

Study Overview
=================
Brief Summary
-----------------
The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.

Official Title
-----------------
Prospective Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia: Multicentre Study

Conditions
-----------------
Aortic Valve, Bicuspid

Intervention / Treatment
-----------------
* Other: Study the natural history of bicuspid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients examined in the echocardiography laboratory whose objective examination was a bicuspid valve of the aortic valve Bicuspidia may be formerly known Exclusion Criteria: Refusal to participate Patients who had already undergone bicuspid surgery or ascending aorta before being examined at the echocardiography laboratory

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

| Intervention/Treatment |
| --- |
|Other: Study the natural history of bicuspid|Study the natural history of bicuspid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid | Analyzing the natural history of Bicuspidia | 10 years |
An Extension Study of LON002 in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.

Detailed Description
-----------------
This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit. Long term safety and efficacy will be evaluated.

Official Title
-----------------
An Extension Study of LON002 in Patients With Cancer

Conditions
-----------------
Solid Tumours

Intervention / Treatment
-----------------
* Drug: LON002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent; Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator; Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol; Able to comply with the protocol LON002-003; Women of child bearing potential must have a negative pregnancy test before the start of treatment; Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter; Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter Exclusion Criteria: Has not completed a LondonPharma sponsored parent trial of LON002; Unequivocal evidence of disease progression; Unacceptable toxicity experienced in the parent trial;

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LON002|Extension study to provide continuing access to LON002 medication.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability. |  | Participants will be followed for the duration of their study treatment, an expected average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Malignant Neoplasm, Anti-cancer drug
EXPLORE: A Natural History Study of Acute Hepatic Porphyria (AHP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.

Official Title
-----------------
A Natural History Study of Acute Hepatic Porphyria (AHP) Patients With Recurrent Attacks

Conditions
-----------------
Acute Hepatic Porphyria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged >/= 12 years Diagnosis of AHP [acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP) and aminolevulinic acid dehydratase (ALAD) deficient porphyria (ADP)] Porphyria attacks in the past 12 months or receiving treatment to prevent attacks Willing to provide written informed consent, medical records, and to comply with study requirements Exclusion Criteria: • Current participation in a clinical trial of an investigational product

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Acute Hepatic Porphyria<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical history of AHP patients (Part A only) |  | Baseline to 6-Month Follow-Up Visit | 
| Medication usage of AHP patients (Part A only) |  | Baseline to 6-Month Follow-Up Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma biomarkers (Part A only) |  | 0, 6 months and During Attacks | 
| Porphyria signs and symptoms (Part A only) |  | 0, 2, 4, 6 months | 
| Quality of Life (Part A only) |  | 0, 6 months | 
| Urine biomarkers (Part A only) |  | 0, 6 months and During Attacks | 
| Healthcare Utilization (Part A only) |  | 0, 6 months | 
| Change in disease activity as measured by Quality of Life (Part B only) |  | 0, 6, 12, 18, 24, 30, 36 months | 
| Change in disease activity as measured by Porphyria Screening/Follow Up Questionnaire (Part B only) |  | 0, 3, 6, 9, 12, 18, 24, 30, 36 months | 
| Change in disease activity as measured by Brief Pain Inventory form (Part B only) |  | 0, 3, 6, 9, 12, 18, 24, 30, 36 months | 
| Change in disease activity as measured by European Organization for Research and Treatment of Cancer (EORTC) Questionnaire (Part B only) |  | 0, 6, 12, 18, 24, 30, 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Porphyria, AIP, VP, HCP, Variegate, Coproporphyria
Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP

Study Overview
=================
Brief Summary
-----------------
Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.

Official Title
-----------------
Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Cross-over Study

Conditions
-----------------
Obstructive Sleep Apnea (OSA)

Intervention / Treatment
-----------------
* Device: Switch CPAP mask type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older previously diagnosed with OSA returning for PAP titrations at the Center for Sleep Medicine CPAP and titration naive Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr. Exclusion Criteria: Patients with ≥ 50% central apneas

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oronasal Mask<br>Initial administration of oronasal CPAP mask | Device: Switch CPAP mask type<br> <br> |
| Experimental: Nasal Mask<br>Initial administration of nasal CPAP mask | Device: Switch CPAP mask type<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks | Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode. | 3 weeks for each mask condition |
Natural History Study for Pediatric Patients With Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidoses, or Gaucher Disease Type 2

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to better understand the natural course of GM1 gangliosidosis, GM2 gangliosidoses and Gaucher disease Type 2 (GD2). Information is planned to be gathered on at least 180 patients with GM1 gangliosidosis, GM2 gangliosidoses, and Gaucher Disease type 2. Retrospective data collection is planned for at least 150 deceased patients (Group A). Group B is for patients alive at the time of enrollment. In Group B it is planned to prospectively collect more comprehensive data from at least 30 patients. The purpose of this study is to collect relevant information for a adequate design of a potential subsequent research program in these diseases. In this study no therapy is being offered.

Official Title
-----------------
Natural History Study for Pediatric Patients With Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidoses, or Gaucher Disease Type 2

Conditions
-----------------
GM1 Gangliosidosis, GM2 Gangliosidosis, Gaucher Disease, Type 2, Tay-Sachs Disease, AB Variant Gangliosidosis GM2, Sandhoff Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with either GM1 gangliosidosis, GM2 gangliosidoses (Tay-Sachs, Sandhoff, or AB Variant), or Gaucher Disease Type 2. Diagnosis confirmed by either biochemical (enzyme activity) or genetic testing, or both. Date of birth on or after 1 January 2000. Onset of first neurological symptom within 24 months of age. Informed consent of parent or legal guardian as required by local law.

Ages Eligible for Study
-----------------
Minimum Age: 0 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A - Retrospective data collection<br>Participants with a confirmed diagnosis, either deceased patients or patients whose survival status is not known at enrollment. | |
| Group B - Prospective data collection<br>Participants who are alive at enrollment. Data collection is retrospective for the time between birth and enrollment visit, and data collection is prospective from the enrollment visit onwards. Visits are performed as per local standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of pediatric patients with early onset of GM1 gangliosidosis, GM2 gangliosidoses, and Gaucher Disease type 2 |  | 2.5 years |
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Study Overview
=================
Brief Summary
-----------------
The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as gold standard for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.

Official Title
-----------------
Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Conditions
-----------------
Pancreatic Cyst

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age 18 years or older All patients referred for EUS-FNA of accessible PCL where surgery is contemplated Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies Exclusion Criteria: Unable to obtain informed consent Unable to tolerate the procedure Women with known pregnancy at time of procedure Patient age less than 18 years Bleeding diathesis Known allergy to fluorescein Prior pancreatic cancer Prior pancreatic surgery

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 |
| --- | --- | --- |
| Accuracy of PCL diagnosis | Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging quality | Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Confocal laser endomicroscopy