linjc16/ctgov huggingface dataset:
Vaginal Progesterone Supplementation in the Management of Preterm Labor

Study Overview
=================
Brief Summary
-----------------
This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.

Official Title
-----------------
Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: progesterone
* Drug: Tocolytics
* Drug: Steroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnant women with preterm labor, gestational age 24-34 weeks Exclusion Criteria: have indicated preterm birth allergy to progesterone fetal anomalies cervical dilate > 5 cm. have medical disease have obstetric complication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaginal progesterone<br>Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours | Drug: progesterone<br>* vaginal utrogestan<br>* Other names: utrogestan;Drug: Tocolytics<br>* tocolysis for 48 hours<br>Drug: Steroids<br>* antenatal corticosteroids for 48 hours<br>|
| Other: no medication<br>only tocolysis plus corticosteroid for 48 hours | Drug: Tocolytics<br>* tocolysis for 48 hours<br>Drug: Steroids<br>* antenatal corticosteroids for 48 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from preterm labor pain to delivery | time since preterm labor to delivery | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational age at delivery | gestational age at birth | 9 weeks | 
| number of pregnant women deliver before 34 weeks | preterm birth < 34 weeks | 6 weeks | 
| number of pregnant women deliver before 37 weeks | preterm birth < 37 weeks | 9 weeks | 
| Number of newborn with respiratory distress syndrome | Number of newborn with respiratory distress syndrome | 9 weeks | 
| Number of newborn with intraventricular hemorrhage | Number of newborn with intraventricular hemorrhage | 9 weeks | 
| Number of newborn with necrotizing enterocolitis | Number of newborn with necrotizing enterocolitis | 9 weeks | 
| Number of newborn with sepsis | Number of newborn with sepsis | 9 weeks |
Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy and safety UK-390,957.

Official Title
-----------------
A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation

Conditions
-----------------
Ejaculation

Intervention / Treatment
-----------------
* Drug: UK-390,957


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature ejaculation as defined by DSM-IV Exclusion Criteria: History of erectile dysfunction

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

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

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: UK-390,957|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy and safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of sexual life |  |  |
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.

Official Title
-----------------
Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: efalizumab plus placebo
* Drug: efalizumab plus acitretin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 18-70 Women in postmenopausal Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA PASI > 10 e/o BSA (Body Surface Area) > 10 Exclusion Criteria: Drug induced psoriasis Pustular or erythrodermic psoriasis Fertile women Pregnancy or lactation cholesterol > 230mg/dL e triglyceride > 200 mg/dL Known intolerance to efalizumab and acitretin Serious infection at enrollement History of previous neoplasia

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral | Drug: efalizumab plus acitretin<br>* 1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day<br>|
| Placebo Comparator: 2<br>efalizumab 1 mg/Kg/week subcutaneous plus oral placebo | Drug: efalizumab plus placebo<br>* 1 mg/kg/week subcutaneous for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI 75 and PASI 50 at week 24 Physician Global Assessment |  | week 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 |  | week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, acitretin, efalizumab
Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.

Detailed Description
-----------------
This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. Subjects will be assigned to one of three treatment arms on Day 0.

Official Title
-----------------
A Randomized, Masked (Reading Center), Prospective Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically, Versus a Bandage Contact Lens for Acceleration of Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).

Conditions
-----------------
Corneal Epithelial Wound

Intervention / Treatment
-----------------
* Device: Acuvue Oasys
* Device: Ocular Bandage Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to comply with the protocol Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>Ocular Bandage Gel | Device: Ocular Bandage Gel<br>* 0.75% crosslinked HA<br>|
| Experimental: Treatment 2<br>Ocular Bandage Gel | Device: Ocular Bandage Gel<br>* 0.75% crosslinked HA<br>|
| Active Comparator: Control Group<br>Artificial tears with Acuvue Oasys | Device: Acuvue Oasys<br>* Bandage Contact Lens<br>Device: Ocular Bandage Gel<br>* 0.75% crosslinked HA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to corneal re-epithelization post PRK | Time to corneal re-epithelization post PRK | Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photorefractive Keratectomy, Corneal Defect
Oral Health Among Children

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents. This study could justify the implementation of public health actions in terms of prevention.

Official Title
-----------------
Oral Health Knowledge and Practice Among 8-9 Years Old Children.

Conditions
-----------------
Schoolboy

Intervention / Treatment
-----------------
* Other: classical lecture style presentation
* Other: an intervention in the form of fun workshops
* Other: digital media intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - All children of classrooms selectionned Exclusion criteria: - Children absent on the day of the intervention

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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
Interventional Model Description: Test group Classes with a classical lecture style presentation classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) classes with digital media intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: witness<br>2 control CE2 classes without oral sensitization actions | |
| Experimental: group intervention 1<br>2 CE2 classes with a classical lecture style presentation | Other: classical lecture style presentation<br>* classical lecture style presentation<br>|
| Experimental: group intervention 2<br>2 CE2 classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) | Other: an intervention in the form of fun workshops<br>* an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)<br>|
| Experimental: group intervention 3<br>2 CE2 classes with digital media intervention | Other: digital media intervention<br>* digital media intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of children's notes before and after a prevention intervention | The main result will be calculated with the total score to the questions. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25. We will compare the evolution of the averages obtained by the control group and by all three other groups with Student test | 1 day |
Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Diabetes and high blood pressure are risk factors for developing heart disease. An increase in the number of diabetes patients is expected. This increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these diseases can be prevented and treated. Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can expand blood vessels, thus lowering blood pressure, but it is not known whether the effects is found in humans, which we will investigate. Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1 has an effect on the muscles which increases the uptake of sugar. We investigate whether GLP-1 enhances the absorption of sugar in the leg. The investigators also examines whether these effects are greater in people with diabetes then in healthy.

Conditions
-----------------
Type 2 Diabetes, Blod Pressure, Glucagon-like Peptide-1, Human Physiology, Blood Flow

Intervention / Treatment
-----------------
* Other: human glucagon-like peptide 1 (7-36)amide
* Other: human glucagon-like peptide 1 (9-36)amide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent T2DM according to WHO's criteria (only T2DM subjects) Exclusion Criteria: Anemia T1DM Severe liver or renal disease Severe heart disease Atrial fibrillation

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy subjects<br> | Other: human glucagon-like peptide 1 (7-36)amide<br> <br> Other: human glucagon-like peptide 1 (9-36)amide<br> <br> |
| Active Comparator: Patients with type 2 diabetes<br> | Other: human glucagon-like peptide 1 (7-36)amide<br> <br> Other: human glucagon-like peptide 1 (9-36)amide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral artery blood flow |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg glucose uptake |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Blod pressure, Glucagon-like peptide-1, Human physiology, Blood flow
Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. Patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode. The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Detailed Description
-----------------
The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Official Title
-----------------
Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation

Conditions
-----------------
Chronic Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: respiratory settings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic respiratory failure Clinical symptoms of chronic alveolar hypoventilation PaCO2 ≥ 45 mmHg in case of restrictive pulmonary disorder or PaCO2 ≥ 55 mmHg in case or obstructive pulmonary disorder Exclusion Criteria: Clinical exacerbation during the three previous weeks Previous treatment by domiciliary non invasive ventilation Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months Bronchiectasis Duchenne muscular dystrophy Amyotrophic lateral sclerosis

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: respiratory support<br>a mode of ventilation in comparison | Procedure: respiratory settings<br> <br> |
| Active Comparator: Assist Control<br>an other mode of ventilation in comparison | Procedure: respiratory settings<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 | Blood gases response to ventilation | months |
ACR | LAB Urine Analysis Test System Evaluation of Performance

Study Overview
=================
Brief Summary
-----------------
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm. The degree of agreement of the ACR | LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.

Official Title
-----------------
A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System

Conditions
-----------------
Diabetes, Hypertension

Intervention / Treatment
-----------------
* Device: ACR LAB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18-80 years of age; Subjects who are healthy or pregnant; or Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin: Diabetes Type I/Type II, Hypertension, Any kidney disease, Other relevant conditions. Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion); Subject is capable and willing to provide informed consent; Subject has facility with both hands Subject is capable and willing to adhere to the study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACR LAB for Professional User<br> | Device: ACR LAB<br>* The ACR | LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users. |  | 11 months |