linjc16/ctgov huggingface dataset:
Study of Epratuzumab in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE.

Official Title
-----------------
A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: epratuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has SLE by ACR revised criteria (meets <4 criteria); Has SLE with at least one elevated lupus antibody; Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic Exclusion Criteria: Active severe CNS or Renal disease defined by BILAG as Level A Allergy to murine or human antibodies Antiphospholid antibodies AND a history of thrombocytopenic events

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: epratuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with complete response or partial response; |  |  | 
| Individual BILAG assessments; |  |  | 
| Physician and patient assessment scores; |  |  | 
| Time-to treatment failure; |  |  | 
| Successful steroid reduction by weeks 20 and 24; |  |  | 
| Maintenance of steroid reduction at 24 and 48 weeks; |  |  | 
| Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; |  |  | 
| Assess epratuzumab on Health-related quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, Antibody, B-cell immunotherapy
Pediatric Vaccinations

Study Overview
=================
Brief Summary
-----------------
As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.

Official Title
-----------------
Pediatric Vaccinations

Conditions
-----------------
Pediatric ALL, Vaccination, Immunization

Intervention / Treatment
-----------------
* Behavioral: Text messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network. Exclusion Criteria: Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 2 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 |
| --- | --- |
| Text message 1<br>Text messaging frame = safety and cleanness of clinic site. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network. | Behavioral: Text messaging<br>* Text parents of children (age 0-2yrs) who are due and due soon for a vaccine across the entire NYU-Brooklyn FHC network to increase vaccination rates.<br>|
| Text message 2<br>Text messaging frame = importance of vaccines. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network. | Behavioral: Text messaging<br>* Text parents of children (age 0-2yrs) who are due and due soon for a vaccine across the entire NYU-Brooklyn FHC network to increase vaccination rates.<br>|
| No text message<br>No text sent. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person) |  | Baseline - 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of scheduled appointments |  | 1 year |
Nurses Ability to Assess Visual Acuity in Geriatric Consultation

Study Overview
=================
Brief Summary
-----------------
Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation. The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, sensory disorders screening is a non-vulnerable examination, and can be performed by nurses. Therefore, they can use these scales, after training. We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist. This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.

Official Title
-----------------
Nurses Ability to Assess Visual Acuity in Geriatric Consultation

Conditions
-----------------
Visual Acuity, Accidental Fall, Aging, Nurse's Role

Intervention / Treatment
-----------------
* Diagnostic Test: ophthalmologist examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 2 falls in the last 12 months, applied in geriatric evaluation talking French affiliated to the social security system Exclusion Criteria: not communicating illiterate Total blindness

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ophthalmologist examination|ophthalmologist examination after geriatric consultation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity values concordance between nurses and ophthalmologist | On 2 (near and far) binocular values per patient with their usual glasses. Concordance is assessed on the assignment of patients to one of the 3 groups: ≤ 5 / 10e, 6-7 / 10 e, ≥ 8/10 e | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new diagnosis or ophthalmologic pathology aggravation | Percentage of patients in whom new diagnosis or ophthalmologic pathology aggravation was identified | day 1 | 
| cognitive influence | Compare the binocular visual acuity values agreement in each subgroup: with MMSE <18/30 and with MMSE ≥18/30 | day 1 |
DuoTrav® Eye Drops As Replacement Therapy Program

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DuoTrav


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction Exclusion Criteria: None

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: 1<br>DuoTrav | Drug: DuoTrav<br>* DuoTrav Eye Drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular Pressure |  | visit 1, Visits 2-3, Visits 6-8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, IOP, DuoTrav
Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood

Study Overview
=================
Brief Summary
-----------------
This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. This study is part of a secondary data analysis of the INMA (INfancia y Medio Ambiente-(Environment and Childhood)) Project.

Official Title
-----------------
Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood

Conditions
-----------------
Cardiometabolic Risk, Growth, Childhood Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be resident in one of the study areas to be at least 16 years old to have a singleton pregnancy to wish to deliver in the reference hospital Exclusion Criteria: to not be fluent in Spanish or other regional languages. to have followed a programme of assisted reproduction
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 |
| --- | --- |
| Pregnant women<br>Pregnant women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Offspring's body mass index z-score trajectories |  | From birth to 4 years of age | 
| Child cardiometabolic risk score |  | At 4 years |
Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index

Study Overview
=================
Brief Summary
-----------------
Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection. Even though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients

Official Title
-----------------
Association of Seminal Plasma SARS-Cov19 IgG Level With Semen Parameters and Embryological Characteristics in Vaccinated Normozoospermic Men

Conditions
-----------------
Covid-19, IgG Antibody, Semen Index

Intervention / Treatment
-----------------
* Biological: vaccinated and unvaccinated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The man's semen quality is normal, The couple meets the indications for IVF, injected with the covid-19 vaccine Exclusion Criteria: In vitro fertilization due to male factors Azoospermia The quality of the man's semen is abnormal unvacced

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vaccinated and unvaccinated<br> | Biological: vaccinated and unvaccinated<br>* the vaccinated :Male patients who received more than 2 injections of the covid-19 vaccine;the unvaccinated :Male patients who did not receive the covid-19 vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| semen index | the semen index of the participants | 2022.01-2022.03 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | The percentage of eggs fertilized | 2022.01-2022.04 | 
| embryo quality | Grading of formed embryos | 2022.02-2022.05 | 
| clinical pregnant rate | after the embryo transplantation, calculate the pregnancy rate | 2022.03-2022.05 |
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

Detailed Description
-----------------
We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.

Official Title
-----------------
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn

Conditions
-----------------
Transient Tachypnea of Newborn

Intervention / Treatment
-----------------
* Device: Nasal SIMV
* Device: nasal CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >35 gestational week wetlung Exclusion Criteria: major congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 2 Hours
Maximum Age: 3 Days

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 |
| --- | --- |
| Active Comparator: nasal SIMV<br>rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40% | Device: Nasal SIMV<br>* rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%<br>* Other names: nasal SIMV, SLE 5000;|
| Active Comparator: nasal CPAP<br>PEEP: 4-6 mmHg, Fio2: 40% | Device: nasal CPAP<br>* PEEP: 4-6 mmHg, FİO2: 40%<br>* Other names: NASAL CPAP, SLE 5000;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of respiratory support, respiratory insufficiency | pneumothorax | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy, safety, nasal SIMV, nasal CPAP, infants who are >35 gestational week with wet lung
Women's Knowledges About Gynaecological Aftercare

Study Overview
=================
Brief Summary
-----------------
The hypothesis of the investigators is that women don't have all the needfull knowledge to understand the importance of a regular gynaecological aftercare. The main objective is to assess women's knowledge's about gynaecological aftercare. The second objective is to identify barriers that prevent women of a regular gynaecological aftercare

Official Title
-----------------
Women's Knowledges About Gynaecological Aftercare, Hospitalized in Maternity Service, or Consulting in Policlinic, in University Hospitals of Strasbourg

Conditions
-----------------
Gynecology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged over eighteen years old women who are able to read and write French Exclusion Criteria: women aged under eighteen years old women who aren't able to read or write French

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

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

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 |
| --- | --- | --- |
| questionnaire | Assessment of women's knowledge of gynecological follow-up via a questionnaire. The score is calculated from the questionnaire 24 hours before the discharge of patients from the gynecology department | 24 hours before the discharge of patients from the gynecology department | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gynaecological aftercare, contraception, breast cancer, cervix cancer, cervical screening, breast self examination, mammography, midwife, body knowledge, prevention, self care
MYeloma Resistance And Clonal Evolution

Study Overview
=================
Brief Summary
-----------------
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

Detailed Description
-----------------
The MYRACLE cohort study aims at including all patients (>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.

Official Title
-----------------
MYeloma Resistance And Clonal Evolution

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: No interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with diagnosis of multiple myeloma according to standard criteria Age >18 Exclusion Criteria: Minor patient Patient under guardianship Protected patient

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No interventional study|No interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the mechanisms of resistance of myeloma cells. | Number of resistance. | Ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, Cohort, Resistance, Quality of life