linjc16/ctgov huggingface dataset:
Real World Clinical Outcomes in Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP: An Observational, Multisite Prospective 2 Year Study in the Southern U.S.

Study Overview
=================
Brief Summary
-----------------
Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.

Official Title
-----------------
Real World Clinical Outcomes in Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP: An Observational, Multisite Prospective 2 Year Study in the Southern U.S.

Conditions
-----------------
Hiv

Intervention / Treatment
-----------------
* Drug: Cabotegravir Injection [Apretude]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cisgender females, ages 18 years and older Negative HIV test at baseline Negative Pregnancy test at baseline Weigh at least 35 kilograms Already Prescribed CAB-LA (Apretude) Exclusion Criteria: Transgender females or males Cisgender males Cisgender female who is actively breastfeeding Severe hepatotoxicity Evidence of Hepatitis B Infection History or presence of allergies to cabotegravir or its components

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cisgender Females<br> | Drug: Cabotegravir Injection [Apretude]<br>* Apretude for PrEP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the percent of cisgender females persistent on CAB-LA over 44 weeks. |  | 44 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe incidence of bacterial STIs through weeks 20, 44 and 92 |  | Weeks 20, 44 and 92 | 
| Describe satisfaction of cisgender female patients while being on CAB-LA through weeks 20, 44 and 92 with the use of satisfaction surveys |  | Weeks 20, 44 and 92 | 
| Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females |  | Weeks 20, 44 and 92 | 
| Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females with substance use and/or unstable housing. |  | Weeks 20, 44 and 92 | 
| Describe percentage of cisgender female patients with HIV prevention failure while on CAB-LA, with detection of HIV, at weeks 20, 44 and 92. |  | Weeks 20, 44 and 92 | 
| Describe percentage of cisgender female patients with weight gain > 10% from baseline on CAB-LA at weeks 20, 44 and 92 |  | Weeks 20, 44 and 92 |
Safety and Efficacy of Evolocumab in Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).

Official Title
-----------------
Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke

Conditions
-----------------
Ischemic Stroke, Acute

Intervention / Treatment
-----------------
* Drug: Evolocumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age between 18-80 years Time of onset: within 1 week NIHSS score ≤12 Acute ischemic stroke confirmed by head CT or MRI Premorbid mRS ≤1 Signed informed consent Exclusion Criteria: Intracranial hemorrhage found by head CT Severe hepatic or renal dysfunction Pregnant females Abnormal elevation of creatine phosphokinase Blood sugar is out of control Receiving statins within 1 month before onset Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures Unsuitable for this clinical studies assessed by researcher

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the evolocumab plus statin therapy<br>Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period | Drug: Evolocumab<br>* Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.<br>|
| No Intervention: the statin alone therapy<br>Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C |  | baseline, 4 weeks, 8 weeks, 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular events | incidence of Transient ischemic attack, stroke or other vascular events | 3 months, 6months | 
| mRS (0-2) | proportion of mRS (0-2) | 3 months, 6months | 
| death of any causes | proportion of death | 12 months |
Left Cardiac Chambers Size in Obese Individuals and Its Relation to BMI and Waist Circumference

Study Overview
=================
Brief Summary
-----------------
Aim of study: To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals. Primary outcomes: -To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals. Secondary outcomes: To determine the effect of obesity on heart health in obese individuals.

Detailed Description
-----------------
Body mass index and waist circumference are important measurements of our bodies as they can affect our health.The person is obese if he has BMI equal 30 or higher.Increased risk of obesity related disease occurs in men with waist circumference equal 102 cm or more and woman with waist circumference equals 88 cm or more. increasing BMI and waist circumference can increase risk of type 2 diabetes mellitus ,hypertension ,cardiovascular disease and cerebrovascular accidents.There are many diseases that can affect left cardiac chambers size like aortic, mitral valvediseases,hypertension and atherosclerosis.Screening of patients heart by echocardiography allow us to detect changes in the muscle of heart and this allow doctors to put treatment plan to patient to prevent heart health from deterioration. In this study the investigators want to know if there an association between left cardiac chambers size ,BMI and waist circumference in obese individuals.

Official Title
-----------------
Left Cardiac Chambers Size in Obese Individuals and Its Relation to BMI and Waist

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

Intervention / Treatment
-----------------
* Device: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Patient age 18 years old or above. 2-Patient BMI 30kg/m2 or higher . 3-Patient waist circumference in men 102cm or more and in women 88cm or more. 4-Obese patient with comorbidities (e.g DM,HTN). Exclusion Criteria: 1-Patient age 18 years old. 2-Patient BMI less than 30 kg/m2. 3-Patient waist circumference in men less than 102cm and in women less than 88cm.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Echocardiography|Do echocardiography to obese patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is correlation between left cardiac chambers size in mm ,BMI in kg/m^2 and waist circumference in cm in obese individuals | effect of obesity on left cardiac chambers size | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of obesity on heart health in obese individuals. | effect of obesity on left cardiac chambers size | Baseline |
Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

Study Overview
=================
Brief Summary
-----------------
This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.

Official Title
-----------------
Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: NCX 470
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Either gender Subjects without glaucoma Qualifying IOP at Screening Visit Exclusion Criteria: Narrow anterior chamber angles or disqualifying central corneal thickness in either eye Clinically significant ocular disease in either eye Uncontrolled systemic disease Serious hypersensitivity to topical anesthetic eye drops Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NCX 470 0.1%<br>NCX 470 0.1% - one drop in the randomized eye once a day for 8 days | Drug: NCX 470<br>* NCX 470 0.1% vs Placebo<br>* Other names: nitric oxide (NO)-donating bimatoprost prostaglandin analog;|
| Placebo Comparator: Placebo<br>Artificial tears - one drop in the randomized eye once a day for 8 days | Drug: Placebo<br>* NCX 0.1% vs Placebo<br>* Other names: Artificial tears;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHD | The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following: Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer. The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo. | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, NCX 470, nitric oxide, prostaglandin analogue
The Role of Computed Tomography in the Phenotyping of COPD Patients

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. the CT was used for classification of COPD patients into different phenotypes: phenotype A that has minimal emphysema with or without airway disease, phenotype E that has emphysema without airway disease, and finally phenotype M as a mixed form. The investigators aimed to to identify the phenotypes of COPD using radiologic data obtained by computed tomography. Moreover, this study will be designed to answer the questions about possible correlation between pulmonary function parameters and CT.

Official Title
-----------------
The Role of Computed Tomography in the Phenotyping of COPD Patients

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Radiation: CT chest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022). Age above 18 years. Exclusion Criteria: COPD patients associated with other chest diseases as collapse COPD patients associated with consolidation COPD patients unable to perform spirometry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: CT chest|All patients will undergo MSCT chest at both inspiratory and expiratory phases in supine position without any contrast media.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying the different phenotypes of COPD using HRCT | Identifying the different phenotypes of COPD using HRCT. moreover, to identify whether there is a possible correlation between CT phenotypes and FEV1, FVC or FEV1/FVC. | one month |
Validation of the Mutuality Scale in Patients With OSA and Their Partners

Study Overview
=================
Brief Summary
-----------------
Main objective of this study is to assess the psychometric characteristics of the Mutuality Scale both in patients with Obstructive Sleep Apnea Syndrome (OSAS) and in their partners-The association between the mutuality score in OSAS patients and their adherence to the use of Continuous Positive Airway Pressure (CPAP) therapy will also be investigated. The results of the study may allow a validation of the Mutuality Score as an instrument for measuring mutuality between OSAS patients and their partners.

Official Title
-----------------
Psychometric Validation of the Mutuality Scale in Patients With Obstructive Sleep Apnea and Their Partners

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
OSA patients: Inclusion Criteria: Age 18 years and older Exclusion Criteria: -

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 |
| --- | --- |
| OSAS patients<br>Patients with Obstructive Sleep Apnea Syndrome | Other: Questionnaires<br>* Administration of the following questionnaires: Mutuality scale Pittsburgh Sleep Quality Index (PSQI) Epworth Sleep Scale (ESS) Sleep Condition Indicator (SCI) International Physical Activity Questionaire (IPAQ) Mediterranean diet score (MDS) Quality of Life SF 12 Hospital Anxiety and Depression Scale (HADS)<br>|
| Partners<br>Partners of OSAS patients | Other: Questionnaires<br>* Administration of the following questionnaires: Mutuality scale Pittsburgh Sleep Quality Index (PSQI) Epworth Sleep Scale (ESS) Sleep Condition Indicator (SCI) International Physical Activity Questionaire (IPAQ) Mediterranean diet score (MDS) Quality of Life SF 12 Hospital Anxiety and Depression Scale (HADS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Mutuality Scale in OSAS patients | 15-item scale; points for every item 0-4; minimum score 0; maximum score 60 | At baseline | 
| Score on Mutuality Scale in partners | 15-item scale; points for every item 0-4; minimum score 0; maximum score 60 | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea
Pulmonary Infection After Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
To assess the frequency of signs of pulmonary infection on a chest CT and development of clinical diagnose of poststroke pneumonia，and its effect on functional outcome in patients with acute ischemic stroke.

Official Title
-----------------
Pulmonary Infection and Clinical Pneumonia After Ischemic Stroke

Conditions
-----------------
Had a Computed Tomography Scan of the Chest Within 24 Hours After Stroke Onset

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a computed tomography scan of the chest within 24 hours after stroke onset Exclusion Criteria: -

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 |
| --- | --- |
| had a computed tomography scan of the chest within 24 hours after stroke onset<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| With radiological signs of pulmonary infection |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of clinical poststroke pneumonia |  | 2 weeks or at discharge | 
| modified Rankin Scale |  | 90 days |
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.

Official Title
-----------------
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial

Conditions
-----------------
Lung Adenocarcinoma, Frozen Section, Sublobar Resection

Intervention / Treatment
-----------------
* Procedure: Sublobar Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who sign the informed consent form and are willing to complete the study according to the plan; Aged from 18 to 80 years old; ECOG equals 0 or 1; Not receiving lung cancer surgery before; Resectable peripheral cT1N0M0 tumors; Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules; Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: Not cT1N0M0; Cannot be completely resected by sublobar resection; Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically; Receiving lung cancer surgery before; Receiving radiotherapy or chemotherapy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublobar resection<br>Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section | Procedure: Sublobar Resection<br>* Sublobar Resection includes segmentectomy and wedge resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year recurrence-free survival | The event is defined as the tumor recurrence. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival | The event is defined as the death due to any causes. | 5 years |
Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are: Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.

Official Title
-----------------
Effect of Personalized Comprehensive Diabetes Support Among Families of Children With Newly Diagnosed Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: personalized comprehensive diabetes support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families of children 16 years of age or younger with a new diagnosis Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration. Exclusion Criteria: Families of children older than 16 years Children from non-English speaking families

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis | Other: personalized comprehensive diabetes support<br>* personalized comprehensive diabetes support<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Distress Scale | The Distress Scale (DDS) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 72. A higher score indicates higher distress. | 24 months | 
| Problem Areas in Diabetes (PAID) | The Problem Areas in Diabetes (PAID) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 100. A higher score indicates higher distress. | 24 months |