linjc16/ctgov huggingface dataset:
Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.

Official Title
-----------------
A Phase III, Double-blinded, Randomized, Multicenter, Clinical Study to Assess the Safety and Immunogenicity of GSK Biologicals' Tdap 0.3 mg Candidate Vaccine When Given as a Booster Dose to Healthy School Children and Adolescents (9-13 Years of Age), Previously Vaccinated With a 5th Consecutive Dose of Acellular Pertussis-containing Vaccine, in Studies APV-118 or APV-120

Conditions
-----------------
Acellular Pertussis, Diphtheria, Tetanus

Intervention / Treatment
-----------------
* Biological: Prophylaxis: Diphtheria, tetanus and pertussis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period Administration of immunoglobulins and/or blood products within 3 months prior to vaccination

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Prophylaxis: Diphtheria, tetanus and pertussis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety after vaccination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity and safety after vaccination |  |  |
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.

Detailed Description
-----------------
It is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. However,whether patients with stage II or III thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage II or III thymoma.

Official Title
-----------------
An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Conditions
-----------------
Thymoma

Intervention / Treatment
-----------------
* Radiation: adjuvant radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent. Exclusion Criteria: Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy group<br>complete resection and adjuvant radiotherapy | Radiation: adjuvant radiotherapy<br>* 50Gy/25Fx<br>* Other names: RT;|
| No Intervention: observation group<br>complete resection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS (Disease free survival) | from registration to disease progression or death. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS(overall survival) | from registration to death | 5 years | 
| Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0 | Adverse Events Assessed by CTCAE v4.0 | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thymoma, adjuvant radiotherapy, complete resection
Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.

Official Title
-----------------
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

Conditions
-----------------
Castration-Resistant Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained prior to the initiation of study procedures. Men ≥ 18 years of age. Histologically documented prostatic adenocarcinoma. History of Castration-Resistant Prostate Cancer. Exclusion Criteria: Known M1 disease. Undergone imaging study for metastatic prostate cancer ≤ 3 months. ECOG performance status ≥ 3. Known malignant pleural effusions or ascites. Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).

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

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

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 |
| --- | --- | --- |
| Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration | The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease. | Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan. |
Application of Bronchial Blocker in Minimally Invasive Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.

Official Title
-----------------
Bronchial Blocker in Blocking the Right Middle Lower Lobe Versus Double-Lumen Endotracheal Tube for One-Lung Ventilation in Minimally Invasive Cardiac Surgery

Conditions
-----------------
Minimally Invasive Cardiac Surgery

Intervention / Treatment
-----------------
* Device: bronchial blocker for BB group
* Device: double lumen tube for DLT group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA II-III BMI 18-31 elective minimally invasive cardiac surgery by right thoracotomy Exclusion Criteria: asthma COPD previous lung surgery previous cardiac surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BB<br> | Device: bronchial blocker for BB group<br>* Using bronchial blocker to block right middle lower lobe during surgery.<br>|
| Experimental: DLT<br> | Device: double lumen tube for DLT group<br>* Using double lumen tube to achieve single lung ventilation during surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation | record SpO2 and PaO2 during selective ventilation | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of pulmonary collapse | surgeon score the degree of pulmonary collapse (1 for no pulmonary collapse and 5 for excellent pulmonary collapse) | intraoperative |
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. The hypothesis of the study is that association between non-nutritive sucking and swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking alone.

Official Title
-----------------
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Non-nutritive sucking
* Other: Swaddling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term healthy neonates Exclusion Criteria: NICU admission

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 5 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-nutritive sucking|Non-nutritive sucking is applied by using a gloved finger|
|Other: Swaddling|Swaddling is an age-old practice of wrapping infants snugly in swaddling cloths, blankets or similar cloth so that movement of the limbs is tightly restricted|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score |  | pre painfull procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, neonate, nursing care
Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan

Study Overview
=================
Brief Summary
-----------------
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea

Detailed Description
-----------------
Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.

Official Title
-----------------
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea of Adult

Intervention / Treatment
-----------------
* Device: iNAP® Lite Sleep Therapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with OSA with AHI>5 Exclusion Criteria: Patients with central sleep apnea (CSA). Patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc. Patients with loose teeth or advanced periodontal disease. Patients with pathologically low blood pressure.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: iNAP® Lite Sleep Therapy System|Class II intraoral devices for snoring and/or obstructive sleep apnea|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events in this entire study. | All safety events will be listed and tabulated for their occurrence rate | through study completion, up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iNAP® Lite-treated clinical success rate | AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. Clinical success rate is defined as the proportion of patients in the PP cohort with an AHI reduction of >50% and treated AHI <20 on the Tx PSG Study when compared with the baseline | a treated polysomnography or polygraphy assessment night |
Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept

Study Overview
=================
Brief Summary
-----------------
Assessment of surgiflo injection for treating pilonidal sinus disease

Detailed Description
-----------------
Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation includes recurrence, infection, complications and patient satisfaction over 2 years of follow up

Official Title
-----------------
Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept

Conditions
-----------------
Pilonidal Sinus Disorder

Intervention / Treatment
-----------------
* Procedure: Surgiflo injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study Exclusion Criteria: We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 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: Surgiflo injection<br>Injection of surgiflo in the pilonidal sinus cavity after curettage of its content | Procedure: Surgiflo injection<br>* Curettage of sinus cavity then injection of surgiflo material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the condition | number of patients presenting with recurrent pilonidal sinus | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of the procedure | number of patients presenting with complications after injection of surgiflo | 2 years |
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Study Overview
=================
Brief Summary
-----------------
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Official Title
-----------------
Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Conditions
-----------------
Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older Growth disturbance for chronological age and sex according to country specific references Birth weight and/or length below -2 standard deviations (SD) for gestational age Exclusion Criteria: Onset of puberty Closed epiphyses Diabetes mellitus type I or type II Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes Acute critical illness Previous treatment with any hGH preparation Treatment with antidiabetic medication (e.g. metformin, insulin) Drug abuse, substance abuse, or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- |
| Other: 1<br>single-arm non-comparative somatropin safety study (PASS) | Drug: Somatropin<br>* Infant, Small for Gestational Age, Omnitrope®/Somatropin, rhGH,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the long-term effect of growth hormone treatment on the development of diabetes during the treatment period in short children born SGA. |  | Patients discontinues treatment when final height is reached. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •to report the incidence of anti-rhGH AB´s and of E. coli host cell peptide AB´s during Omnitrope® treatment •to evaluate the efficacy of Omnitrope® treatment in SGA, IGF-I and IGFBP-3 levels during treatment and incidence and severity of adverse events |  | Patients discontinues treatment when final height is reached. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA