linjc16/ctgov huggingface dataset:
Effects of C-section Delivery on Infant Brain Development

Study Overview
=================
Brief Summary
-----------------
The study will help investigators learn more about whether different delivery modes influence infant's brain development

Detailed Description
-----------------
For this study, the investigators are enrolling women who are pregnant with their second child who are planning to have a planned C-section or a spontaneous vaginal birth after C-section. The investigators will see the pregnant mom at 36 weeks pregnant and then have the mom and the baby return for a visit at 2 weeks postnatal.

Official Title
-----------------
Effects of C-section Delivery on Infant Brain Development

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conceived without fertility treatments Singleton pregnancy recruited at or before 36 weeks of gestation Second parity with planned repeated C-section delivery or with planned spontaneous vaginal delivery after C-section. Exclusion Criteria: Preexisting medical conditions Sexually transmitted diseases Medical complications developed during pregnancy Medical complications developed during labor and delivery Emergency c-section delivery Infants born preterm or post-term Infants needing mechanical ventilation, have congenital abnormalities, birth defects, intrauterine growth restriction, low Apgar score (<7), or other medical issues developed at birth or before 2 weeks of age affecting the outcome of interest as determined by the PI.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C-Section<br>Infants delivered by C-section | |
| Vaginal Delivery<br>Infants delivered by spontaneous vaginal delivery after C-section. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiome and how it effects Brain Structure | Evaluate the relationship between gut microbiome and brain structural in infants based on mode of delivery as determined by an MRI | up to 2 weeks | 
| Gut Microbiome and how it effects brain function | Evaluate the relationship between gut microbiome and brain function in infants based on mode of delivery as determined by an MRI | up to 2 weeks |
Mastoid Bone Autograft for Dorsal Nasal Augmentation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.

Detailed Description
-----------------
INTRODUCTION: Several grafts and/or implants have been used for dorsal augmentation. In some cases, especially the traumatic, non-caucasian, and multi-operated ones, the amount of augmentation is higher than the usually available from septal and auricular conchal autografts. OBJECTIVE: To evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty. DESIGN: A prospective study of 15 consecutive patients submitted to dorsal nasal augmentation with mastoid bone, during a 2-year period. SETTING: One major academic medical center.

Official Title
-----------------
Mastoid Bone Autograft for Dorsal Nasal Augmentation

Conditions
-----------------
Nose Deformities, Acquired

Intervention / Treatment
-----------------
* Procedure: Rhinoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nasal acquired or congenital deformity of the dorsum that requires augmentation of more than 5 mm Exclusion Criteria: Previous otologic surgery/disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rhinoplasty | Procedure: Rhinoplasty<br>* Mastoid bone autograft for dorsal nasal augmentation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer's satisfaction |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal acquired diseases, Nasal congenital diseases, Rhinoplasty, Grafts
Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection

Study Overview
=================
Brief Summary
-----------------
In the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement. Most periprosthetic joint infections are from hematogenous origin. Hence, it is considered clean wound unless there is a discharging sinus.

Official Title
-----------------
Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection

Conditions
-----------------
Wound Heal, Periprosthetic Joint Infection

Intervention / Treatment
-----------------
* Device: PREVENA incision management system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with periprosthetic joint infection indicated for debridement surgery high risk for wound complication, including one of the followings: diabetes mellitus, use anticoagulants other than aspirin, current smoker, on immunomodulators or steroids, malnutrition, liver disease, renal failure, BMI > 35 kg/m2 Exclusion Criteria: previous flap surgery on the indexed joint younger than 18 years of age silver allergy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena<br> | Device: PREVENA incision management system<br>* We will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound complication | Wound complication, including: Persistent wound drainage, blisters, hematoma, wound dehiscence, skin necrosis, suture abscess, cellulitis. | 12 weeks |
Covid-19 Epidemic Lockdown Impact on Psychomotor Performance

Study Overview
=================
Brief Summary
-----------------
PURPOSE: To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children. BACKGROUND: The corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. Psychomotor disorders are expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool. HYPOTHESES: Covid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children. RESEARCH QUESTION: Does Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?

Official Title
-----------------
Covid-19 Epidemic Lockdown Impact on Psychomotor Performance in Egyptian Children

Conditions
-----------------
Covid19 Epidemic Lockdown Impact

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between 6-9 years. 10-13 years. 14-18 years All subjects should be clinically and medically stable Exclusion Criteria: Subjects with psychological or Motor impairment will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre lockdown assessment for physical activity | Google form questionnaires include the physical activity questionnaire. | up to 24 weeks | 
| post lockdown assessment for physical activity | Google form questionnaires include the physical activity questionnaire. | up to 24 weeks |
Evaluating a Chronic Pain Treatment Program

Study Overview
=================
Brief Summary
-----------------
This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.

Official Title
-----------------
Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain

Conditions
-----------------
Chronic Musculoskeletal Pain

Intervention / Treatment
-----------------
* Behavioral: Mind-body emotional awareness program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program Exclusion Criteria: Autoimmune diseases Cancer pain Illiterate Cognitively impaired Too medically ill

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>This is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program | Behavioral: Mind-body emotional awareness program<br>* This intervention, developed and offered by Dr. Howard Schubiner of St. John Providence Health System, consists of a single individual session with him, followed by four, classroom group sessions. The intervention includes expressive writing, mindfulness, and other techniques designed to enhance awareness and acceptance of the emotional factors underlying the chronic pain problem.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory |  | baseline, post-treatment, 3- and 6-month follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiologic Studies--Depression Scale |  | baseline, post-treatment, 3- and 6-month follow-ups | 
| Satisfaction with Life Scale |  | baseline, post-treatment, 3- and 6-month follow-ups | 
| McGill Pain Questionnaire |  | baseline, post-treatment, 3- and 6-month follow-ups | 
| Impact of Events Scale-Revised |  | baseline, post-treatment, 3- and 6-month follow-ups | 
| Positive Affect Negative Affect Scale-Expanded Version |  | baseline, post-treatment, 3- and 6-month follow-ups |
Right Ventricular Hypertrophy After Atrial Switch and Cardiovascular Magnetic Resonance (CMR) Findings

Study Overview
=================
Brief Summary
-----------------
Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV). In this study the investigators sought to evaluate systemic RV myocardial mass and function after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (IVS) movement.

Official Title
-----------------
Right Ventricular Hypertrophy After Atrial Switch Operation and Its Role in a Systemic RV: Normal Adaptation Process or Risk Factor? A Cardiovascular Magnetic Resonance Study

Conditions
-----------------
Right Ventricular Hypertrophy, d-TGA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligibility criteria were an AS operation in childhood for correction of d-TGA and the absence of associated hemodynamically significant heart defects. Exclusion Criteria: Exclusion criteria were usual CMR contraindications such as ferromagnetic metallic implants.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
d-TGA, dextro Transposition of the great arteries, systemic right ventricle, right ventricular failure, Atrial switch procedure
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.

Official Title
-----------------
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Conditions
-----------------
Renal Insufficiency, Kidney Diseases, Urologic Diseases

Intervention / Treatment
-----------------
* Drug: Mirodenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 19 to 64 years at screening. Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9. Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. Exclusion Criteria: Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis. Subjects with hypotension or hypertension. Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br> | Drug: Mirodenafil<br>* 50mg Single Oral Dose of<br>|
| Experimental: Patients with severe renal impairment<br> | Drug: Mirodenafil<br>* 50mg Single Oral Dose of<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC and Cmax) |  | 2days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SK-3530, renal impairment, healthy volunteers
Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic in patients with persistent asthma treated with montelukast

Official Title
-----------------
Prospective, Randomized, Double-blind, Study to Evaluate the Eosinophils Activation Parameters and Phagocyte Function in Patients With Persistent Asthma Treated With Montelukast

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: Comparator: placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Between 2-18 Years With Persistent Asthma Exclusion Criteria: Patients > 18 Years Old And < 2 Years Old

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast<br>Asthmatic children and teenagers took montelukast daily. | Drug: montelukast sodium<br>* Asthmatic children and teenagers took montelukast daily for 12 weeks. Children aged 2-5 years took 4mg tablet of montelukast Children aged 6-15 years took 5mg tablet of montelukast Children >15 years took 10mg tablet of montelukast<br>* Other names: Singulair;|
| Placebo Comparator: Placebo<br>Placebo to montelukast tablet daily. | Drug: Comparator: placebo comparator<br>* Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic. |  | 12 weeks |
A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.

Official Title
-----------------
A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline (CP-526,555)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: Subjects with clinically significant, recent cardiovascular disease.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline (CP-526,555)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarization of safety data in smokers treated with either varenicline or placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information will be collected for the 7 day point prevalence of smoking cessation. |  |  |
Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management

Study Overview
=================
Brief Summary
-----------------
How are the health related quality of life among patients with chronic pain effected by interventional pain managment? Hypothesis: Health related quality of life can be improved by interventional pain management both among patients with localizable pain focuses and among patients among whom no pain focuses can be found. Method: Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the time of treatment for pain focuses an during the following 12 months.

Official Title
-----------------
Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| EQ-VAS | EQ-VAS is measured at first visit, at time for treatment and 3, 6 and 12 months after treatment. EQ-VAS gives a value of quality of life, and mainly used to verify the results achieved from EQ-5D since it is not possible to calculate QALY from EQ-VAS | 1 year | 
| EQ-5D | EQ-5D is assessed at first visit, at time for treatment and 3, 6 and 12 months after treatment. Quality of life is calculated from EQ-5D using the TTO-valuated UK value sets. This value can also be used for calculation of QALY, Quality adjusted life years. | 1 year |