linjc16/ctgov huggingface dataset:
An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial

Study Overview
=================
Brief Summary
-----------------
This is an extended follow-up study to follow-up study participants who received 1 booster dose of Gardasil 9 in the HPV vaccine delayed booster trial. This was a prospective, single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (Gardasil 9) over 24 months, with a delayed booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provided blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) were measured at each time point. One hundred and thirty-three (133) participants received one booster dose at month 24 and elected not to receive the second booster at month 30. For this follow-up study, we anticipate that we will be able to accrue 120 participants from the original study who received just one booster dose. Participants who received one booster dose of Gardasil 9 will be contacted to return to the clinic to provide blood specimens at 48 (±3), 60 (±3), and 72 (±3) months after the priming dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point.

Official Title
-----------------
An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial

Conditions
-----------------
HPV-associated Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participants who received one booster dose of Gardasil 9 at month 24 and elected not to receive the second booster at month 30 in the original HPV vaccine delayed booster trial Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant. Ability to understand and the willingness to sign a written assent document by the participant. Exclusion Criteria: - Has received any HPV vaccine dose from an external source at any point during or after participation in the HPV vaccine delayed booster trial.
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 |
| --- | --- | --- |
| The differences in geometric mean titer (GMT) of HPV 16 and HPV18 between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the priming dose of Gardasil |  | 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences in geometric mean titer of other HPV types (HPV6/11/31/33/45/52/58) between 30 vs. 48, 48 vs. 60, and 60 vs. 72 months after the priming dose of Gardasil 9 |  | 72 months |
Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether co-administration of rifampin with neratinib has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of neratinib.

Official Title
-----------------
A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Neratinib When Administered Concomitantly to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy men or women (of non childbearing potential) Ages 18 to 50 years old.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Neratinib alone | Drug: Neratinib<br>* HKI-272<br>|
| Experimental: 2<br>Neratinib plus rifampin | Drug: Neratinib<br>* HKI-272<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (plasma blood concentrations) |  | 4 weeks |
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.

Official Title
-----------------
The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Device: Thoraco-lumbo-sacral Orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Diagnosis of AIS Age ≥10, ≤15 years old Risser 0, 1 or 2 Primary Cobb angle between 20 and 40 degrees (inclusive) Apex (of at least one of the primary curves) caudal to T7 Pre-menarchal OR post-menarchal by ≤1 year Physical and mental ability to adhere to bracing protocol Exclusion Criteria: Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature A history of previous surgical or orthotic treatment Inability to read and understand Chinese

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 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: Treatment Group<br>Treatment with bracing | Device: Thoraco-lumbo-sacral Orthosis<br>* Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis<br>* Other names: The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China);|
| No Intervention: Control Group<br>Watchful waiting without bracing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curve progression | Curve progression to Cobb angle of 50 degrees or more | Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent Idiopathic Scoliosis, Scoliosis, AIS, Brace, TLSO
Evaluation of Triclosan Coated Suture in Obstetrical Surgery

Study Overview
=================
Brief Summary
-----------------
A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021. The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.

Official Title
-----------------
Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study

Conditions
-----------------
Cesarean Section; Infection

Intervention / Treatment
-----------------
* Drug: Coated Vicryl+
* Drug: Vicryl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with indicated cesarean delivery and who have signed a written consent. Exclusion Criteria: Cases with incomplete follow up Breach of operative protocol

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triclosan coated suture<br> | Drug: Coated Vicryl+<br>* We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.<br>|
| Active Comparator: Non coated suture<br> | Drug: Vicryl<br>* We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infection |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care costs attributable to surgical site infection | Evaluation of health care costs from Hospital perspective (USD) | 30 days | 
| Wound healing time | Evaluation of healing time (days) | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Site Infections, caesarean section, healthcare costs
Calf Muscle Tightness in Flat Foot Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.

Detailed Description
-----------------
Pes planus (Flat foot) deformity is a common chronic foot and ankle condition characterized by flattening of the medial longitudinal arch (MLA), rearfoot valgus and abduction of the midfoot on the hind foot. A flexible pes planus is caused by tibialis posterior dysfunction, ligament loosening, Achilles tendon shortening, and weakness of the intrinsic foot muscles. These deformations cause plantar flexion and adduction of the talus bone and valgus of the calcaneus bone. Up to our knowledge: No previous studies investigated whether all flat foot is usually associated with gastrocnemius and soleus muscle tightness or it is a random association. And whether tightness of gastrocnemius and soleus is highly found in all cases of flat foot. Consequently this study is conducted.

Official Title
-----------------
Prevalence of Calf Muscle Tightness in Asymptomatic Flat Foot Subjects

Conditions
-----------------
Flat Feet

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects should have flexible flat foot. Age between 20 and 40 years. Navicular drop of more than 10 mm. Body Mass Index from 18.5 kg/m2 to 29.9 kg/m2. Subjects will sign the written consent form after the aim and methods of the study are explained clearly. Exclusion Criteria: Subjects with history of foot and ankle surgery, trauma, fracture or dislocation. Subjects with congenital deformities in the ankle and foot. Subjects with systemic or neurologic diseases that could affect lower extremity biomechanics.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tightness of the calf muscle | measuring of ankle dorsi flexion range of motion with knee extension and with knee flexion in flat foot subjects with navicular drop more than 1 cm | 3 months |
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia

Study Overview
=================
Brief Summary
-----------------
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Detailed Description
-----------------
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Official Title
-----------------
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Drug: BRIMOCHOL™ PF
* Drug: Carbachol PF
* Drug: Brimonidine tartrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female in good general health Must have presbyopia Exclusion Criteria: History of allergic reaction to the study drug or any of its components Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRIMOCHOL™ PF<br>A single drop in each eye at a visit. | Drug: BRIMOCHOL™ PF<br>* A single drop in each eye at a visit.<br>* Other names: carbachol/brimonidine tartrate;|
| Active Comparator: Carbachol PF<br>A single drop in each eye at a visit. | Drug: Carbachol PF<br>* A single drop in each eye at a visit.<br>* Other names: carbachol monotherapy;|
| Active Comparator: Brimonidine tartrate<br>A single drop in each eye at a visit. | Drug: Brimonidine tartrate<br>* A single drop in each eye at a visit.<br>* Other names: brimonidine tartrate monotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in near VA | Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA | Baseline Visit 1 |
Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients

Study Overview
=================
Brief Summary
-----------------
The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A hand-out was made to instruct and motivate patients to adequately clean the bowel before colonoscopy. The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients receiving the hand-out or not on the day before colonoscopy.

Official Title
-----------------
Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Procedure: Self-administered leaflet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total colonoscopy scheduled during hospital stay in the Hôpital Universitaire de Genève (excluding dependencies); Informed consent for inclusion in the study signed by the patient; Ability to read and write at least one of the following languages : French, English, Spanish, Portuguese. Exclusion Criteria: Colonoscopy scheduled under general anesthesia; Occupation inside the healthcare professions; Previous colonoscopy, colostomy or colectomy; Megacolon or idiopathic pseudo-obstruction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Self-administered leaflet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of overall colon cleansing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of cleansing in the ascending colon, |  |  | 
| Frequency of inadequate preparation and of failed procedure, |  |  | 
| Time to intubate the caecum, |  |  | 
| Cost-effectiveness of the self-administered leaflet, |  |  | 
| Patient compliance with the self-administered leaflet, |  |  | 
| Patient comfort with the colonoscopy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality, Colon cleansing, Cost-effectiveness
Prevalence and Risk Factors of Reventilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason

Study Overview
=================
Brief Summary
-----------------
Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients in the last two categories for whom it significantly prolongs life expectancy. Overall, the treatment is well tolerated, its principal adverse effects being discomfort related to the mask. In certain patients, morning dyspnoea when the mask is removed has been described. This is disabling as it limits everyday activities for at least 30 minutes, and defines deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work after a night of rest. The aim of this study is to investigate the prevalence of and factors associated with reventilation syndrome (DS) in a population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU, so as to better understand the mechanisms. Patients with DS will subsequently be invited to participate in a therapeutic trial.

Official Title
-----------------
Prevalence and Risk Factors of Dreentilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason

Conditions
-----------------
Prevalence of and Factors Associated With Reventilation Syndrome (DS)

Intervention / Treatment
-----------------
* Other: measure dyspnoea> Borg 7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years old ventilation for whatever reason in the ST mode not in life support at more than 1 month after the last episode of respiratory decompensation Exclusion Criteria: guardianship inability to understand instructions and provide consent uncontrolled psychiatric disease

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 |
| --- | --- |
| DS<br> | Other: measure dyspnoea> Borg 7<br> <br> |
| no DS<br> | Other: measure dyspnoea> Borg 7<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of diagnostic criteria for reventilation Syndrome (dyspnoea > Borg 7) |  | at withdrawal of the machine, disabling for everyday activities for at least 30 minutes after stopping the ventilation |
Parent Mentors Using Positive Deviance in Childhood Obesity

Study Overview
=================
Brief Summary
-----------------
A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.

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

Intervention / Treatment
-----------------
* Behavioral: Promotion of positive deviance behaviors
* Behavioral: Promotion of healthy behaviors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI z-score >2 Exclusion Criteria: Medical conditions or receiving medications affecting weight

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Mentor<br>Parent mentors using positive deviance findings to promote healthy behaviors | Behavioral: Promotion of positive deviance behaviors<br>* Using locally derived positive deviance findings to inform a behavioral intervention<br>|
| Active Comparator: Education<br>Community health workers providing health education to promote healthy behaviors | Behavioral: Promotion of healthy behaviors<br>* Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index z-score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peer mentors, Positive deviance