linjc16/ctgov huggingface dataset:
Efficacy of Mydriatic Drops in Premature Infants

Study Overview
=================
Brief Summary
-----------------
Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.

Detailed Description
-----------------
Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants. Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.

Official Title
-----------------
Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Drug: Drug used in the examination of premature infants.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who were first ROP examinations infants born before 32 weeks. Exclusion Criteria: Developmental ocular and/or systemic anomalies. Drug use that can affect vital values Unstable general condition Food intolerance Recurrent vomiting.

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks
Maximum Age: 34 Weeks

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Drug used in the examination of premature infants.|to investigate side effects of eye drops used|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean pupillary diameter | will be measured with a ruler after 60 minutes instillation of mydriatic | an average of 1 year |
Sun Protection Factor (SPF) - Static and Water Resistant Assay

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Official Title
-----------------
Sun Protection Factor (SPF) - Static and Water Resistant Assay

Conditions
-----------------
Sunscreen Agents

Intervention / Treatment
-----------------
* Drug: BAY 987519
* Drug: SPF 15 Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of an age of 18 to 70 years inclusive; Fitzpatrick Skin Type I, II and/or III for SPF testing; Good health as determined from the CRO Subject History Form (SHF); Signed and dated Informed Consent Form; Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; An unambiguous minimal erythema dose (MED).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Subjects with Good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing. | Drug: BAY 987519<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>Drug: SPF 15 Control<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of water resistant SPF in accordance to ISO 24444 |  | 16-24 hrs post exposure |
Irradiation Modulates the Pharmacokinetics of Anticancer Drugs

Study Overview
=================
Brief Summary
-----------------
Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell proliferation, induce cell death and suppress tumor growth. To improve the treatment outcome, in terms of both locoregional control and survival, the concurrent use of chemotherapy during radiation therapy (CCRT) is now the standard treatment for various malignancies, especially locally advanced cancers. Among the drugs used to enhance RT effect, 5-fluorouracil (5-FU) is one of the most commonly used chemotherapeutic agents of CCRT. In the past, RT was solely used as a local treatment and its effect was estimated by local effect model. However, growing evidence shows that irradiation has direct DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, we reported that abdominal irradiation could significantly modulate the systemic pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the daily treatment dose for target treatment in an experimental rat model. Additionally, the results from a clinical investigation showed that colorectal cancer patients with lower AUC of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these lines of evidence support the importance and necessity to search for the mediators responsible for the unexpected effect of local RT on systemic pharmacokinetics of chemotherapeutic agents, such as 5-FU. In the present study, the investigators investigated whether the phenomena and mechanism of RT-PK is a fact for different anticancer drugs in human.

Conditions
-----------------
Rectal Cancer, Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: World Health Organization (WHO) performance status of 0 or 1 Age 18-80 years Locally advanced rectal cancer Locally advanced cervical cancer Exclusion Criteria: Cancer history Abnormal liver and renal disease Immune disease Hematological disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C/T-RT group<br>Chemotherapy (C/T) is applied in the morning. After 2-4 hrs, radiotherapy (RT) is delivered (according to the clinical practice) | |
| RT-C/T group<br>Radiotherapy (RT) is delivered in the morning. After 2-4 hrs, chemotherapy (C/T) is applied (according to the clinical practice). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation therapy, 5-fluorouracil, Cisplatin, Pharmacokinetics, Matrix Metalloproteinase
Rheumatoid Arthritis Patients in Training

Study Overview
=================
Brief Summary
-----------------
Aim of the study was to investigate the effectiveness (functional ability and physical capacity) and safety (disease activity and damage of the joints) of long-term high-intensity weight-bearing exercises in patients with rheumatoid arthritis (RA).The training proved to be safe and effective.

Detailed Description
-----------------
The 300 patients with RA were randomized into two groups; exercise group and usual care group. The patients who participated in the 2 years intensive exercise training (2 times a week, training duration 65 minutes) improved their functional capacity and functional ability without detrimental effects on the large joints damage or on disease activity. Only patients with excessive large joint damage at baseline were at risk to develop additional damage when participating in intensive weight-bearing exercises. Patients who exercised were able to delay the decrease of bone mineral density of the hips.

Official Title
-----------------
Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Procedure: long-term intensive exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Exclusion Criteria: Prosthesis of a weight bearing joint

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: long-term intensive exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness: |  |  | 
| primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months |  |  | 
| safety: |  |  | 
| damage of the large joints (Larsen score); each year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness: |  |  | 
| muscle strength (strength of extensors of the knee); each 3 months and |  |  | 
| aerobic fitness (ergometer); each 3 months |  |  | 
| Safety: |  |  | 
| disease activity (DAS) each 3 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, exercise, damage
Differential Immune Effects of Natalizumab

Study Overview
=================
Brief Summary
-----------------
Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance.

Detailed Description
-----------------
Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+ regulatory T cells (Tregs).

Official Title
-----------------
A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Conditions
-----------------
Multiple Sclerosis, Relapsing Remitting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsing remitting MS indication for natalizumab treatment Exclusion Criteria: other disease modifying agents within 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Function of T regulatory cells |  | at month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distinct immune cell lines |  | month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natalizumab, multiple sclerosis
Local Anesthetic Properties of Neosaxitoxin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans

Detailed Description
-----------------
Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.

Official Title
-----------------
Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Neosaxitoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males with the abilities to understand and respond the tests to perform Exclusion Criteria: Use of any oral analgesics at least ten days before the study Drugs abuse history Showing at the clinical examination any signal of psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural blockade of five parameters: |  |  | 
| sensory threshold for warm |  |  | 
| sensory threshold for cold |  |  | 
| pain thresholds for heat |  |  | 
| pain thresholds for cold |  |  | 
| mechanical touch perception threshold |  |  | 
| Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on injection (VAS Score 0-10) |  |  | 
| Blood sample at 1 hour |  |  | 
| Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Local Anesthetic, Neosaxitoxin
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the levels of alpha-defensin throughout the hemodialysis course compared to the levels at the end of a course of peritoneal dialysis, as a reflection of the inflammatory burden.

Official Title
-----------------
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin

Conditions
-----------------
Kidney Failure, Inflammation

Intervention / Treatment
-----------------
* Diagnostic Test: Blood Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney failure patients undergoing hemodialysis or peritoneal dialysis Exclusion Criteria: Active inflammatory or infectious disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemodialysis group<br>Blood sample taken and sent to laboratory for analysis | Diagnostic Test: Blood Test<br>* Blood test taken and sent for laboratory analysis<br>|
| Active Comparator: Peritoneal dialysis<br>Blood sample taken and sent to laboratory for analysis | Diagnostic Test: Blood Test<br>* Blood test taken and sent for laboratory analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha-Defensin Levels | Alpha-defensin levels will be compared between the two arms | One year |
Pain and Emotional Expression in Children With Autism or Mental Retardation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture). Children will be videotaped before, during and after a venepuncture. Each recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non Communicating Children's Pain Checklist).

Detailed Description
-----------------
Children with autism will be matched with children with mental retardation and children without developmental disorder. Matching will be established according the developmental age of children with autism.

Official Title
-----------------
Pain and Emotional Expression in Children With Autism or Mental Retardation

Conditions
-----------------
Autism, Mental Retardation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group Autism: Child aged 3 to 6 years old Diagnosis of autistic disorder established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.) Admitted to children's neuropediatrics or genetics department for a venepuncture Control group mental retardation: Child aged 3 to 6 years old . Diagnosis of mental retardation established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.) Admitted to neuropediatric or genetic department for a venepuncture Control group without developmental disorder : Child aged 18 months to 5 years old. Admitted to pediatrics department for a venepuncture

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 6 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, mental retardation, pain, emotion, sensory profile, children
A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance study to evaluate the real world safety and effectiveness of Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.

Official Title
-----------------
Post-marketing Surveillance Study of Viekira/ Exviera Tablets for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

Conditions
-----------------
Hepatitis C Virus (HCV)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with type C hepatitis Participants prescribed Viekira/Exviera in accordance with approved local label Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Hepatitis C<br>Participants with Hepatitis C receiving Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) for 12 or 24 weeks. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | the lower limit of quantitation (LLOQ) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. | 12 weeks after the last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | Up to 24 weeks | 
| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment | From the end of treatment through 12 weeks after the last dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Paritaprevir, Ritonavir, Ombitasvir, Dasabuvir