linjc16/ctgov huggingface dataset:
Growth and Tolerance of Cow's Milk-Based Infant Formulas

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.

Official Title
-----------------
Growth and Tolerance of Cow's Milk-Based Infant Formulas

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Other: Previously marketed infant formula
* Other: Previously marketed formula using a similar protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 10-14 days of age at randomization Term infant with birth weight of a minimum of 2500 grams Solely formula fed Signed Informed Consent and Protected Health Information Exclusion Criteria: Anemia at time of birth Current use of iron or iron-containing supplements History of underlying metabolic or chronic disease or immunocompromised Feeding difficulties or formula intolerance

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 14 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Previously marketed infant formula<br>Cow's milk-based infant formula | Other: Previously marketed infant formula<br> <br> |
| Experimental: Previously marketed formula using a similar protein<br>Cow's milk-based infant formula | Other: Previously marketed formula using a similar protein<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight measured at each study visit | Measurement collected with a calibrated infant scale | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body length measured at each study visit | Measurement collected with a standardized length board | 12 months | 
| Head circumference measured at each study visit | Measurement collected with a standardized measuring tape | 12 months | 
| Parental recall of study formula intake at each study visit |  | 12 months | 
| Parental recall of stool consistency measured at each study visit |  | 12 months | 
| Blood Collection | Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein | Once at 12 months | 
| Medically-confirmed adverse events collected throughout the study period |  | 12 months |
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness

Conditions
-----------------
Excessive Somnolence

Intervention / Treatment
-----------------
* Drug: VSF-173


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects with no medical, psychiatric, or current sleep disorders Subject must sign a written consent form Exclusion Criteria: Evidence of excessive daytime sleepiness History of sleep disorders Psychiatric or neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VSF-173|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood |  |  | 
| Psychomotor performance |  |  | 
| Safety and tolerability |  |  |
Neurofilaments for NEDA Assessing in MS

Study Overview
=================
Brief Summary
-----------------
Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.

Detailed Description
-----------------
Primary To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients. Secondary To assess prognosis at the end of the study based on neurofilament status. To correlate neurofilament levels with clinical and MRI markers of disease activity. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.

Official Title
-----------------
Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Alemtuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS). Age 18-55 years. EDSS score between 0-5.5. Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D Exclusion Criteria: A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS. Those unable to comply with study requirement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alemtuzumab|Licensed dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood and CSF neurofilaments in Alemtuzumab patients over 24months | Neurofilaments | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical response based on neurofilament response | neurofilaments | 2 years | 
| Neurofilament status and association with clinical and MRI markers of disease activity. | Correlation index | 2 years | 
| Longitudinal assessment of other biomarkers of inflammation & plasticity | Correlation index | 2 years |
Mother-to-child Hepatitis D Transmission

Study Overview
=================
Brief Summary
-----------------
HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about vertical HDV transmission are old, justifying a new study.

Detailed Description
-----------------
Hepatitis B Virus (HBV) can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA viral load during the last trimester of pregnancy. Nucleosides analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir DF decrease HBV mother-to-child transmission risk, and are recommended in Guidelines (EASL 2012) for pregnant women with HBV DNA above 1,000 000 I.U/mL. HDV is a defective virus using HBs Ag for its own replication. HDV-HBV co-infection is a re-emerging infectious disease in western countries, due to immigration of people coming from endemic areas. Nucleosides analogues have only a minor impact on quantitative HBs Ag level (Boyd A et al. AIDS Research and Human Retroviruses 2013). Data about vertical HDV transmission are old (Rizzetto, et al. J Med Virol 1982), before a large use of nucleosides/nucleotides analogues in HBV infected pregnant women, justifying a new study.

Official Title
-----------------
Hepatitis D Virus (HDV) Mother-To-Child Transmission (MTCT) From Hepatitis B Virus (HBV)-Hepatitis D Virus (HDV) Co-infected Pregnant Women: a Retrospective Study.

Conditions
-----------------
Hepatitis D, Transmission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV co-infected women with a positive HDV RNA during pregnancy in the pregnant woman Exclusion Criteria: negative HDV RNA during pregnancy in the pregnant woman

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 15 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 |
| --- | --- |
| Children born to HBV-HDV women<br>Children born to HBV-HDV co-infected women will be checked for: HDV antibodies if positive, HDV RNA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis D antibodies (Ab) in children | Antibodies (Ab) against Hepatitis D Virus (HDV) | up to 10 years (expected average: 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDV RNA in children with positive HDV Ab |  | up to 10 years (expected average: 5 years) |
The Impact of Starbright World on Children Being Treated at the NIH

Study Overview
=================
Brief Summary
-----------------
This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. Our outcome evaluation of SBW will include assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and willingness to return to the NIH for treatment of children who are being treated at NIH. They will be assessed while engaging in normal recreational activities (in one of two available playrooms) and while using Starbright World. In addition, we will conduct a process evaluation of the implementation of Starbright World.

Detailed Description
-----------------
This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. Our outcome evaluation of SBW will include assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and willingness to return to the NIH for treatment of children who are being treated at the NIH. They will be assessed while engaging in normal recreational activities (in one of two available playrooms) and while using Starbright World. In addition, we will conduct a process evaluation of the implementation of Starbright World.

Official Title
-----------------
The Impact of Starbright World on Children Being Treated at the NIH

Conditions
-----------------
Child, Hospitalized

Participation Criteria
=================
Eligibility Criteria
-----------------
Children between the ages of 8 and 21. Currently on active protocol at NIH. Access to playrooms on the 9th, 11th, 13th, and 14th floors. Ability to read and understand English. No presence of mental illness. Ability to understand and/or perform tasks involved in using Starbright World.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anger, Loneliness, Mood, Psychosocial, Virtual Network
Tacrolimus Ointment in Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).

Official Title
-----------------
Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus

Conditions
-----------------
Oral Lichen Planus

Intervention / Treatment
-----------------
* Drug: 0.1 % tacrolimus ointment
* Drug: 0.1 % triamcinolone paste
* Drug: Orabase paste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features Clinical score for OLP ≥ 20 at baseline Symptomatic OLP at baseline Washout period of 2 weeks Age over 18 Exclusion Criteria: Pregnant or lactating women Allergy to tacrolimus or other macrolides Allergy to other drugs or substances used in the study Abnormal liver function Netherton's syndrome Cyclosporin medication Other regular medication that could have significant interactions with tacrolimus

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus<br>Tacrolimus ointment 0.1%, three times a day for 6-9 weeks. | Drug: 0.1 % tacrolimus ointment<br>* applied topically to oral mucosa<br>* Other names: Protopic;|
| Active Comparator: Triamcinolone<br>Triamcinolone paste 0.1%, three times a day for 3-6 weeks. | Drug: 0.1 % triamcinolone paste<br>* applied topically to oral mucosa<br>* Other names: Kenacort-T paste, Kenacort-A paste;|
| Placebo Comparator: Placebo<br>Orabase paste, three times a day for 3-6 weeks. | Drug: Orabase paste<br>* applied topically to oral mucosa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical score for OLP | The clinical score for OLP is a measure designed by the investigators for assessing the clinical extent and type of OLP, and the symptoms experienced by the patient. The value of the score is between 0-120. | 1,2,3,4,5,6,7,8 and 9 weeks, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral lichen planus, Tacrolimus ointment, Triamcinolone paste
Fluvastatin Versus Hepatitis C Virus

Study Overview
=================
Brief Summary
-----------------
This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.

Detailed Description
-----------------
Four different oral doses of fluvastatin will be used for 14 days and the viral load of hepatitis C will be measured weekly. This has been extended to different doses for 9-12 weeks.

Official Title
-----------------
A Dose Finding Study of Fluvastatin for in Vivo Demonstration of Inhibiting Hepatitis C Replication in Patients Infected With Chronic Hepatitis C With Special Attention to the African-American Population.

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV RNA positive Exclusion Criteria: Testing positive for alcohol or marijuana

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load Reduction, Liver test changes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, fluvastatin
Reproductive Outcomes Following Uterine Septum Resection

Study Overview
=================
Brief Summary
-----------------
Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data. A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points. Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births). The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.

Official Title
-----------------
Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study

Conditions
-----------------
Uterine Septum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major female (≥18 years old) To be an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019. Exclusion criteria: Particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) Minor patients, patients under guardianship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of the uterine septum resection technique by operative hysteroscopy |  | Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine septum, Hysteroscopic septum resection, Metroplasty, Subfertility, Infertility, Preterm delivery, Spontaneous abortion
Antioxidant Status During Burn Rehabilitation

Study Overview
=================
Brief Summary
-----------------
It is believed that children with a prior history of significant burn injury continue to manifest low levels of antioxidants well into their convalescence.The purpose of this study is to examine malondialdehyde (an oxidative lipid marker) and vitamins E, C and beta carotene status in reconstructive burn patients.

Official Title
-----------------
Prospective Assessment of Antioxidant Status of Pediatric Patients During Burn Rehabilitation

Conditions
-----------------
Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 3 but less than 19 years Reconstructive or followup outpatient care at least 1 year postburn Initial burn size > 40% Written informed consent and HIPAA authorization Exclusion Criteria: History of multivitamin or steroid use, liver disease, preburn malnutrition

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 19 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 |
| --- | --- | --- |
| serum antioxidant levels |  | > 2 years postburn | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, pediatrics
Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Study Overview
=================
Brief Summary
-----------------
We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.

Detailed Description
-----------------
A SpermComet assay will be used to characterize DNA fragmentation of surplus sperm samples remaining after in vitro fertilization (IVF) cycles. We will investigate potential correlation between these assay results and the outcomes of IVF cycles that used those sperm samples.

Official Title
-----------------
Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: SpermComet assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing IVF Surplus sperm available after oocyte insemination Consented Exclusion Criteria: Surgical sperm extraction Use of donated sperm or oocytes No minors may participate

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| SpermComet Assay<br>All study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay. | Other: SpermComet assay<br>* Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastulation rate | The proportion of oocytes and of fertilized oocytes that form blastocysts. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Proportion of inseminated oocytes that form exactly two pronuclei. | 1 day | 
| Embryo grade | Grade and measurements of blastocysts that form. | 6 days |