linjc16/ctgov huggingface dataset:
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.

Official Title
-----------------
A Single Centre, Randomised, Double-blind, Double-dummy, 2-way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 Pmdi (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and the Free Combination of Licensed Beclomethasone Dipropionate and Formoterol Fumarate in Asthmatic Children Already Treated With Inhaled Corticosteroids

Conditions
-----------------
Childhood Asthma

Intervention / Treatment
-----------------
* Drug: CHF 1535 50/6µg
* Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment Clinical diagnosis of mild asthma during at least two months prior to screening visit Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit Exclusion Criteria: Endocrinological diseases including growth impairment or other chronic diseases Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 1535 50/6µg<br> | Drug: CHF 1535 50/6µg<br>* fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg<br>|
| Active Comparator: beclomethasone dipropionate 50µg + formoterol fumarate 6µg<br> | Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg<br>* free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower leg growth rate measured by knemometry |  | after a 2 week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary free cortisol/creatinine levels |  | after a 2 week treatment period | 
| Changes in pre-dose morning and evening PEF (L/min) |  | pre and after a 2 week treatment period |
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses

Study Overview
=================
Brief Summary
-----------------
The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%. Cerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation. Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).

Official Title
-----------------
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.

Conditions
-----------------
Withdrawal Syndrome, Cerebral Lesion

Intervention / Treatment
-----------------
* Other: Variation of Jasinski score between H0 (stop of sedatives) and H6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Patient Admitted in Neuroreanimation Cerebroséé (TC-HSA-AVC) Mono or multi failing After a neurosedation ≥ 3 days by hypnotic type benzodiazepine (Midazolam®) and morphinomimetic (Sufentanyl®) in IVSE Affiliation to Social Security Agreement of the person of confidence Exclusion Criteria: Addiction to opiates, cocaine or cannabis Neurological Pathology Before Hospitalization Patient suffering from cardiac arrest Pregnant woman Sedation window Patient under tutelage or curatorship or deprived of public law

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual weaning management<br> | Other: Variation of Jasinski score between H0 (stop of sedatives) and H6<br>* To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))<br>|
| Other: Introduction to H2 for the discontinuation of therapeutics<br> | Other: Variation of Jasinski score between H0 (stop of sedatives) and H6<br>* To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal |  | 3 months |
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.

Official Title
-----------------
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Device: Adhesive A
* Device: Adhesive B
* Device: Adhesive C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 19 years of age Must have at least 3 qualifying noncarious Class V lesions of appropriate depth Must be willing to sign consent form Must be willing and able to return to UAB clinic for 4 study appointments Must be in good medical health and able to tolerate dental procedures Exclusion Criteria: Current participation in other restorative product studies Severe salivary gland dysfunction Rampant caries (cavities) Chronic periodontitis (gum disease) Known allergies to the study materials Unacceptable level of oral hygiene Inability or unwillingness to attend study appointments

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Adhesive A<br> | Device: Adhesive A<br>* Applied per manufacturer's instructions.<br>* Other names: Adper Scotchbond SE (3M ESPE);|
| Adhesive B<br> | Device: Adhesive B<br>* Applied per manufacturer's instructions.<br>* Other names: Adper Easy Bond (3M ESPE);|
| Adhesive C<br> | Device: Adhesive C<br>* Applied per manufacturer's instructions.<br>* Other names: Single Bond Plus (3M ESPE);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of the restoration. |  | 6, 12, 24, 36 months post-placement |
Open Label, Phase I ZD6474 Head and Neck Cancer Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.

Official Title
-----------------
An Open Label Phase 1 Study to Assess the Maximum Tolerated Dose of ZACTIMA™ Given Concomitantly With Weekly Cisplatin Chemotherapy and Radiation Therapy in Patients With Previously Untreated, Unresected Stage III-IV Head and Neck Squamous Cell Carcinoma

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: ZD6474 (vandetanib)
* Drug: Cisplatin
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III-IV squamous cell carcinoma of the head and neck Exclusion Criteria: No previous treatment for head and neck cancer, adequate cardiac function

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Radiation + vandetanib | Drug: ZD6474 (vandetanib)<br>* once daily oral dose<br>* Other names: ZACTIMA™;Radiation: Radiation<br>* radiation of head and neck<br>|
| Experimental: 2<br>Radiation + cisplatin + vandetanib | Drug: ZD6474 (vandetanib)<br>* once daily oral dose<br>* Other names: ZACTIMA™;Drug: Cisplatin<br>* intravenous infusion<br>Radiation: Radiation<br>* radiation of head and neck<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous Cell Carcinoma
Using New Ultrasound Techniques to Assess Peritoneal Fibrosis in Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Explore the role of new ultrasound techniques in the assessment of peritoneal fibrosis and encapsulating peritoneal sclerosis in peritoneal dialysis patients

Official Title
-----------------
An Exploratory Study Using New Ultrasound Techniques to Assess Peritoneal Fibrosis and Encapsulating Peritoneal Sclerosis in Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patients on PD PD duration ≤12 months or ≥10 years Age between 18-75years Exclusion Criteria: Refusing to sign up informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| short-term peritoneal dialysis<br>the time of treatment of peritoneal dialysis less 12 months | |
| long-term peritoneal dialysis<br>the time of treatment of peritoneal dialysis more than 10 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parietal peritoneal fibrosis | Ultrasonography evaluates parietal peritoneal fibrosis, including parameters such as thickness, stiffness, elasticity, and blood supply. | the 1 day when being recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| encapsulting peritoneal sclerosis | Ultrasonography assesses for encapsulting peritoneal sclerosis. | the 1 day when being recruited |
Validation of Prediction Model of Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. The investigators' previous multi-center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. The investigators used the data of that observational study to train a predictive model for predicting vitamin D deficiency. In addition, the association between vitamin D and the immune regulation of critically ill patients in Taiwan has not been investigated. This study aims primarily to validate the performance of the prediction model of vitamin D deficiency. Moreover, this study will investigate the association between vitamin D level and inflammatory cytokine levels. This multi-center prospective observational study will enroll critically ill patients admitted to intensive care units (ICUs) less than 28 days. After inform consent, blood will be drawn for examination of vitamin D, interleukin 6, and interleukin 10 levels. The main diagnosis of ICU admission, past medical history, vital signs within 24 hours of admission, disease severity, and laboratory data will be recorded. The predictive model will use the required parameters to predict the patient's risk of vitamin D deficiency and vitamin D severe deficiency.

Official Title
-----------------
Validation of Prediction Model of Vitamin D Deficiency in Critically Ill Patients

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: Admitted to intensive care units


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to intensive care units Exclusion Criteria: aged < 20 years admitted to intensive care unit longer than 28 days body max index < 18 kg/m2 receive vitamin D supplement > 3000 IU/day previously admitted to intensive care unit within 3 months have parathyroid disease, rickets, or severe liver cirrhosis [Child C]

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Critically ill patients<br>Patients admitted to intensive care units | Other: Admitted to intensive care units<br>* Admitted to intensive care units<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic | Area under the receiver operating characteristic of the prediction model of vitamin D deficiency | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical care, vitamin D
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?

Study Overview
=================
Brief Summary
-----------------
The study is aimed to evaluate if the education of the caregiver is able to reduce hospital admissions of patients with heart failure assisted at home.

Detailed Description
-----------------
The primary objective of the study is to assess whether an educational intervention aimed at increasing the caregiver's skills is able to reduce hospital admissions for any cause in patients with heart failure assisted at home. The General Practitioners who agree to participate are randomized in two groups: a) intervention group, whose patients are assisted in accordance with the procedures established by the project; b) control group, whose patients continue to be assisted in the usual modality. The intervention consists of an educational session for each caregiver aimed at improving his ability to recognize early symptoms and signs of heart failure.

Official Title
-----------------
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults of any age and gender in NYHA (New York Heart Association) classes II, III, IV, assisted exclusively at home; willingness and ability to sign a written informed consent; presence of a person who cared for the patient in a prevalent and regular way; willingness of the caregiver to attend a training meeting.
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- |
| Active Comparator: Intervention<br>Education of the caregiver | Other: Education<br>* Education of the caregiver about early symptoms and signs of heart failure<br>|
| No Intervention: No intervention<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admissions for any cause | Hospital admissions for any cause | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admissions for cardiovascular causes | Hospital admissions for cardiovascular causes | Twelve months | 
| Mortality for general or cardiovascular causes | Mortality for general or cardiovascular causes | Twelve months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
home care services, comorbidity, heart failure, caregivers, health education, patient admission
Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.

Official Title
-----------------
Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material

Conditions
-----------------
Sinus Elevation, Dental Implant, Bone Formation

Intervention / Treatment
-----------------
* Procedure: perforation of the sinus floor
* Procedure: no perforation of the sinus floor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in need of bilateral sinus floor elevation residual alveolar ridge height 2-6mm residual alveolar ridge width > 4mm Exclusion Criteria: uncontrolled periodontal disease acute or chronic sinusitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>standard sinus floor elevation | Procedure: no perforation of the sinus floor<br>* standard procedure for sinus floor elevation<br>|
| Experimental: Test<br>standard sinus floor elevation with additional perforation of the sinus floor | Procedure: perforation of the sinus floor<br>* perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New bone formation | histological assessment of new bone formation after sinus floor elevation (%) | 4-6 months after sinus floor elevation |
Prevenar (13v) Infant Drug Use Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.

Detailed Description
-----------------
The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.

Official Title
-----------------
Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Conditions
-----------------
Infants

Intervention / Treatment
-----------------
* Drug: Prevenar (13v)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation: Infants aged 2 months, inclusive, to 7 months, exclusive Infants with no history of administration of pneumococcal vaccines including Prevenar 13 Infants expected to receive 4 vaccinations Exclusion Criteria: Vaccines must not be performed if the vaccinee corresponds to any of the following: Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident Persons with evident pyrexia Persons who evidently have serious acute diseases Besides the persons listed above, persons who are in a status inappropriate for immunization

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prevenar (13v)<br> | Drug: Prevenar (13v)<br>* Prevenar (13v)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Reactions | An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13. | The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination. |