linjc16/ctgov huggingface dataset:
Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.

Official Title
-----------------
Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome, Menstrual Pattern, Hyperandrogenism, Metabolic Features

Intervention / Treatment
-----------------
* Drug: myo-inositol,alpha-lipoic acid and folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PCOS in accordance with Rotterdam criteria Exclusion Criteria: pregnancy past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension, significant liver or renal impairment, other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs), neoplasms, unstable mental illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Open label<br>Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months | Drug: myo-inositol,alpha-lipoic acid and folic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cycles in six months of therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hirsutism | Ferriman Gallwey score | 6 months | 
| Hyperandrogenism | Testosterone, Androstenedione, free androgen index | 6 months | 
| Insulin response to oral glucose tolerance test |  | 6 months | 
| Lipidic profile | Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride | 6 months |
OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease

Official Title
-----------------
A Prospective, Multicenter, Randomized, Parallel-Arm, Bilateral, Double-Masked, Vehicle Controlled Feasibility Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Other: Placebo Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had a known history of dry eye disease Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye Exclusion Criteria: History of intraocular inflammation in either eye Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study Uncontrolled glaucoma or is on medications to treat glaucoma History of IOP spikes in either eye Active epiphora

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-DP<br>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: PV<br>PV (placebo drug delivery vehicle) | Other: Placebo Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Corneal Fluorescein Staining | National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining) | Day 15 | 
| Total Corneal Fluorescein Staining | National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining) | Day 30 | 
| Total Conjunctival Lissamine Green Staining | National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining) | Day 15 | 
| Total Conjunctival Lissamine Green Staining | National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining) | Day 30 |
Virtual Reality as Anxiety Management Tool for Preparing Children for MR Exam

Study Overview
=================
Brief Summary
-----------------
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration. The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.

Official Title
-----------------
EvaLuation de l'Apport de l'Irm Virtuelle Sur la qualité de la Prise en Charge Des Enfants en Irm

Conditions
-----------------
Claustrophobia

Intervention / Treatment
-----------------
* Device: Virtual Reality headset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child from 6 to 12 years old, Child who will have an MRI for the first time, Outpatient child, Child dependent on a parent affiliated to or beneficiary of a social security scheme, Child who has received age-appropriate information on the organization of the research, Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent. Exclusion Criteria: Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...), Child with a contraindication to performing an MRI, Child who has benefited from another MRI simulation system before (IRM en Jeu for instance) Child's opposition to participate.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI simulation<br>MRI simulation with a Virtual Reality headset | Device: Virtual Reality headset<br>* MRI simulation with a Virtual Reality headset<br>|
| No Intervention: Standard medical care<br>Standard medical care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10 | 2 hours |
Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions

Study Overview
=================
Brief Summary
-----------------
This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others.

Detailed Description
-----------------
A large number of people diagnosed with COVID-19 suffer from long term symptoms, predominantly breathlessness and fatigue whether or not they were admitted to hospital. While there are a number of causes of long-term breathlessness following COVID-19 one of the most common, and potentially concerning with regards to long term prognosis is Interstitial Lung Disease. The fibrogenic potential of SARS-CoV-2 is currently unknown but is predicted to be substantial based on the experience of previous coronavirus outbreaks and emerging data from this pandemic. The investigators do not yet understand how scarring occurs following SARS-CoV-2, nor why there is resolution in some individuals and persistent or progressive disease in others. The investigators therefore plan to undertake bronchoscopy (camera test into the lungs) to examine for changes in the way the cells lining the lung behave, using genetics, and differences in the bacteria living in the airways in patients whom have developed scarring following COVID-19.

Official Title
-----------------
POST COvid-19 Interstitial Lung DiseasE (POSTCODE) A Study of Genetic and Environmental Interactions: an Observational Cohort Study.

Conditions
-----------------
Pulmonary Fibrosis, COVID-19 Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of SARS-CoV-2 PCR/Seropositive Presence of interstitial lung disease on CT Participant is willing and able to give informed consent for participation in the study Aged 18 years or above Exclusion Criteria: Confirmed ILD diagnosis prior to March 2020 Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study. Use of steroids at baseline visit

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 |
| --- | --- | --- |
| Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health | The lower airway bacterial burden and microbiome will be characterised in patients with post covid fibrosis and compared to that of health. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bacterial burden over time in post covid fibrosis | Differences in the airway bacterial burden at baseline and one year following covid-19 infection | 2 years |
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Study Overview
=================
Brief Summary
-----------------
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

Official Title
-----------------
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Conditions
-----------------
Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female Subject is pregnant Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure Subject is willing to provide blood specimen Exclusion Criteria: Subject is not pregnant Subject is not willing to provide blood specimen Subject is not haveing aneuploid screening

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare investigational assay results for Down Syndrome to standard of care results. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down Syndrome
Children's Intake of Foods Reduced in Energy Density

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.

Official Title
-----------------
Children's Intake of Foods Reduced in Energy Density

Conditions
-----------------
Vegetable Intake

Intervention / Treatment
-----------------
* Other: Energy density feeding study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled in daycare centers at Penn State University Exclusion Criteria: food allergies or intolerances

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entree energy density 100%<br>100% energy density | Other: Energy density feeding study<br>* In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).<br>|
| Experimental: Entree energy density 85%<br>85% energy density | Other: Energy density feeding study<br>* In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).<br>|
| Experimental: Entree energy density 75%<br>75% energy density | Other: Energy density feeding study<br>* In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake |  | 1 month |
Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401

Study Overview
=================
Brief Summary
-----------------
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.

Detailed Description
-----------------
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.

Official Title
-----------------
An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401

Conditions
-----------------
Waldenstrom's Macroglobulinemia

Intervention / Treatment
-----------------
* Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed 24 weeks of treatment in Protocol 8400-401 Exclusion Criteria: Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401. Has evidence of disease progression under Protocol 8400-401. Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.

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: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk<br>Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401 | Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly<br>* IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia | During receipt of study treatment on the trial. |
A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this retrospective study was to investigate the influence of methylenetetrahydrofolate reductase (MTHFR) C677T/A1298C polymorphism on the survival of pediatric patients with Non-Hodgkin lymphoma (NHL) treated with modified NHL-BFM95 protocol in south China.

Official Title
-----------------
A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma

Conditions
-----------------
Pediatric Non-Hodgkin Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≤ 18 years; newly diagnosed as the four main categories of NHL(Burkitt's lymphoma, lymphoblastic lymphoma, anaplastic large cell lymphoma, and diffuse large B-cell lymphoma) between 2014 and 2020; treated according to the modified BFM95 protocol. Exclusion Criteria: aged > 18 years; not newly diagnosed as the four main categories of NHL between 2014 and 2020; treated according to chemotherapeutic regimens except for the modified BFM95 protocol.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| MTHFR polymorphism<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Overall survival time was calculated from the time of initial diagnosis to death | About six years | 
| Events including progression, relapse, and secondary cancer | Event-free survival (EFS) time was calculated from the time of initial diagnosis to first event. | About six years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MTHFR C677T polymorphism；A1298C; Pediatric Non-Hodgkin Lymphoma；Survival.
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.

Official Title
-----------------
Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-contracepting women >15 years of age who were reported to Public Health Seattle & King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification Exclusion Criteria: Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age <15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control participants were advised where they could obtain hormonal contraception on a sliding scale basis. Participants were also advised where they could obtain hormonal contraception on a sliding scale basis. | |
| Experimental: Intervention<br>Study subjects were prescribed levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and a package of 30 condoms provided via a commerical pharmacy at no cost to the study subject. The subject could refill this prescription as many times as they wanted for 12 months | Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms<br>* levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse<br>* Other names: Plan B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy |  | 1 year - measured via interview every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abortion |  | 1 year - measured via interview every 3 months | 
| Condom use |  | Measured every 3 months for one year | 
| Use of hormonal contraception |  | Measured via interview every 3 months for one year |