linjc16/ctgov huggingface dataset:
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys

Study Overview
=================
Brief Summary
-----------------
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.

Detailed Description
-----------------
We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.

Official Title
-----------------
A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya

Conditions
-----------------
HPV Vaccine, HPV Infection, HIV-1-infection

Intervention / Treatment
-----------------
* Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: receipt of 3 doses of QHPV vaccine participated in primary immunogenicity study consent/assent with parental consent for participants age <18 years willing to continue extended follow up for 36 months Exclusion Criteria: decline consent

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine|Intramuscular injection with 3 doses of QHPV|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Papillomavirus Antibody Titers | Geometric mean titers for HPV type -6, -11, -16 and -18 | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV RNA viral load | Impact of HIV RNA viral load on HPV antibody response | 48 months | 
| CD 4 cell count | Impact of immune status on HPV antibody response | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV Vaccine, HIV infection, Adolescents, Africa
Genetic Basis of Odor Discrimination

Study Overview
=================
Brief Summary
-----------------
Prior to the main study we will perform a pilot study on 60 subjects. The purpose of the pilot study is to identify the range of odor concentrations that will be used in the main study and to optimize the tasks performed in the main study.

Official Title
-----------------
Genetic Basis of Odor Discrimination

Conditions
-----------------
Non-smokers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 Current non-smokers Exclusion Criteria: Current smokers Allergy to fragrances or smells of any kind Active head cold, upper respiratory infection, or seasonal nasal allergies History of nasal health problems, including endoscopic nasal surgery for sinus conditions or polyp removal. Pre-existing medical condition that has caused anosmia or near total loss of the sense of smell, such as: head injury, cancer therapy, radiation to head and neck, or alcoholism

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of correct responses when discriminating between (-)-carvone and (+)-carvone, isovaleric acid and isobutyric acid, androstenone and androstadienone DNA sequence of ORs sensitive to these odors |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration at which odors need to be added to allow for discrimination; thresholds to all six odors; verbal descriptors assigned to all six odors |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Odor Discrimination
Anecortave Acetate Risk-Reduction Trial (AART)

Study Overview
=================
Brief Summary
-----------------
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.

Conditions
-----------------
Dry AMD

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry AMD study eye, Wet AMD non-study eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Age Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: AL-3789<br>One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months. | Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg<br>* One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.<br>|
| Sham Comparator: Anecortave Acetate Vehicle<br>One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye. | Other: Anecortave Acetate Vehicle<br>* One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 | ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site. | Month 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, Dry AMD, Drusen, CNV
Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Clinical and Economic study of some new biomarkers in chronic heart failure.

Detailed Description
-----------------
The study aimed at evaluation of the clinical and economic value of some new biomarkers in chronic heart failure.

Official Title
-----------------
Clinical and Economical Study Evaluating the Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: New york Heart Association Class II-IV
* Diagnostic Test: New york Heart Association Class I


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NYHA-Class II-IV Exclusion Criteria: Liver or renal dysfunction. --DM

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: New york Heart Association Class II-IV<br>New york Heart Association Class II-IV heart failure | Diagnostic Test: New york Heart Association Class II-IV<br>* New york Heart Association Class II-IV  study of markers<br>* Other names: Severe heart failure;|
| Active Comparator: New york Heart Association Class I<br>New york Heart Association Class I with no heart failure | Diagnostic Test: New york Heart Association Class I<br>* New york Heart Association Class I<br>* Other names: No heart failure;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with elevated markers (IL17) | Number of participants with elevated markers (IL17) | 6 months |
Enteral Feeding and Early Gut Colonization of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.

Detailed Description
-----------------
First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit. To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured. Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.

Official Title
-----------------
Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants

Conditions
-----------------
Premature Birth of Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age of less than 32 weeks or with birth weight of less than 1,200 g Exclusion Criteria: any malformation or suffering from any genetic metabolic disorder

Ages Eligible for Study
-----------------
Minimum Age: 2 Hours
Maximum Age: 8 Hours

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infant<br>Preterm infants born from October 2009 to June 2010 at a gestational age of less than 32 weeks or with birth weight of less than 1,200 g | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants sharing bacterial strains with the milk received by each one | The meconium and fecal samples of the infants have been analysed microbiologically. In parallel, own's mother milk, donor milk and formula milk have been analyzed microbiologically after their pass through the nasogastric feeding tube. The bacterial strains isolated from fecal samples of each infant have been compared with the bacterial strains isolated from the milk that have received each of them. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bacterial strains shared by each infant and the milk received. | In each infant the number of the same bacterial strains isolated from fecal samples and milk received have been determined. | two years |
ACT for CP Individual Patient Expanded Access IND Protocol

Study Overview
=================
Brief Summary
-----------------
Individual patient expanded access protocol for a child with cerebral palsy (CP) who has autologous umbilical cord blood available and who is ineligible to participate in other stem cell studies for children with CP.

Detailed Description
-----------------
This protocol is part of an FDA Individual Patient Expanded Access IND submitted at the request of the parents of a child with cerebral palsy (CP) who is ineligible to participate in other stem cell studies. For this child, there are no other treatment options.

Official Title
-----------------
Autologous Cell Therapies for Cerebral Palsy-Chronic (ACT for CP) Individual Patient Expanded Access IND Protocol

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Biological: Autologous Cord Blood Stem Cells


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous Cord Blood Stem Cells|This is an individual patient expanded access protocol.|

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
-----------------
Autologous Cord Blood Stem Cells
Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia

Study Overview
=================
Brief Summary
-----------------
The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care

Official Title
-----------------
Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient (≥18 years of age) Admitted in March 2020 for confirmed Covid-19 lung disease (nasopharyngeal smear or sputum with SARS-CoV-2 positive PCR). Exclusion Criteria: Patient who has expressed opposition to participation in the study. Mild forms of infection that do not require hospitalization, Subject under safeguard of justice Subject under guardianship or trusteeship

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 |
| --- | --- | --- |
| Identification of risk factors for severity (death or transfer to resuscitation) of Covid-19 infection |  | Files analysed retrospectively from March 1st, 2020 to April 15, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Covid_19, SARS-CoV-2, risk factors, infection
Somatic Diseases in Autistic Children

Study Overview
=================
Brief Summary
-----------------
For many reasons, medical monitoring in autistic patients is very difficult. This study is designed to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases…) in patients suffering from ASD to prevent them or diagnose them earlier.

Detailed Description
-----------------
Mean goal : to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases…) in patients suffering from ASD to prevent them or diagnose them earlier. Secondary goals : to obtain an objective assessment of the general monitoring in these patients (vaccinations, growth…) to assess their habits (food, sleep, screen exposition) to determine, in this monitoring and the habits, vigilance points which will need a specific pediatric consultation.

Official Title
-----------------
Medical Monitoring and Somatic Diseases in Children Who Suffer From Autism Spectrum Disorder (ASD)

Conditions
-----------------
Autistic Spectrum Disorder, Somatic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - consultation after psychiatric evaluation Exclusion criteria: age > 18 years Impossibility to obtain the consent of parents / legal representatives.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Determine the prevalence of comorbid diseases | Determine the prevalence of comorbid diseases | 1 day |
Refractive Error in Chinese Students

Study Overview
=================
Brief Summary
-----------------
This cohort study aimed to assess the change of refractive status in Chinese school children.

Detailed Description
-----------------
A cohort study was conducted in 96 primary and secondary schools in 16 districts of Tianjin from 2018 to 2020, including about 36452 people totally. The changes in myopia rate in 3 years were compared by a generalized estimation equation. The distribution of average equivalent spherical mirror and different regions and grades was evaluated by linear regression analysis, and the correlation between the equivalent spherical mirror and different gender, nationality, and age was evaluated.

Official Title
-----------------
Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Other: outdoor time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no concurrent eye disease age from 6 to 18 years old Exclusion Criteria: significant systemic illnesses ocular conditions congenital corneal diseases pterygium, keratoconus corneal degeneration or dystrophy media opacity, uveitis, glaucoma history of ocular surgery neurologic diseases retinal disease.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Grade<br>The changes in myopia rate in 3 years were compared by generalized estimation equation in different grades | Other: outdoor time<br>* This cohort study aimed to assess the change of refractive status in Chinese school children under different outdoor time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| refractive error | The changes in refractive error were compared by generalized estimation equation. | change from baseline at 36 months | 
| sex disparity | The changes in refractive error were compared between different sex | change from baseline at 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Refractive error, China, Myopia
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps

Study Overview
=================
Brief Summary
-----------------
Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.

Detailed Description
-----------------
Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base of the stalk, followed by conventional snare polypectomy. In conventional group, conventional snare polypectomy was done without any preventive management. Immediate and delayed bleeding complications were assessed.

Official Title
-----------------
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Large Pedunculated Colonic Polyps: a Randomized, Controlled Trial

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Procedure: Prophylactic clip
* Procedure: No prophylactic management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included. Exclusion Criteria: bleeding tendency, poor preparation, sessile polyp

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic clip<br>Before conventional snare polypectomy, hemoclips will be applied on the base of stalk. | Procedure: Prophylactic clip<br>* Prophylactic clipping<br>|
| Active Comparator: No prophylactic management<br>Conventional snare polypectomy will be performed without any preventive management. | Procedure: No prophylactic management<br>* No prophylaxis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpolypectomy bleeding | Immediate and delayed postpolypectomy bleeding | 1 month |