linjc16/ctgov huggingface dataset:
Epidemiology of Cardiac Development in Youth

Study Overview
=================
Brief Summary
-----------------
To document normal developmental changes in cardiac structure and function during late childhood and adolescence.

Detailed Description
-----------------
DESIGN NARRATIVE: The investigators documented the nature and extent of changes in cardiac structure based on M-mode measurements and developed corresponding reference values. They documented the nature and extent of changes in cardiac function based on pulse Doppler measures and indices and developed corresponding reference values. They also investigated clinical findings based on M-mode and Doppler measurements as well as changes in body size and composition, sexual maturation, and other covariates. They used existing data from Project HeartBeat! 's 12 four-monthly examinations over the age range from 8 to 17 years. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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 |
| --- | --- | --- |
Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab (patients treated for early breast cancer) is really safe for the heart even years after treatment and if the investigators should use these two treatments concomitantly without additional harm.

Detailed Description
-----------------
The investigators know from the studies, that were already published, that for HER2 positive early breast cancer patients in adjuvant treatment concomitant radiotherapy and trastuzumab is safe during the treatment. But there is no study with long term results of cardial function, especially combination of Left ventricular ejection fraction (LVEF) and NT-proBNP.

Official Title
-----------------
Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early breast cancer patients,treated adjuvantly with radiotherapy of the operated breast or thoracic wall and treated concomitantly with trastuzumab. Reviewed many months after treatment, without recurrence of disease. Exclusion Criteria: Recurrence of disease

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

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

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 |
| --- | --- | --- |
| difference in LVEF (Left Ventricular Ejection Fraction) | we will compare LVEF (LVEF 1) measured before treatment with adjuvant Trastuzumab and concomitant Radiotherapy of breast/thoracic wall with LVEF (LVEF 2) measured at follow up (after adjuvant treatment) outpatient examination. We will then compare the difference in LVEF (LVEF 2-LVEF 1) measured in patients treated for left breast cancer with the difference in LVEF (LVEF 2-LVEF 1) measured in patients treated for right breast cancer | from one to six years from adjuvant radiotherapy for early breast cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of cardiovascular events over time in both groups (RT for left/right breast) | occurrence of cardiovascular events over time in both groups (irradiated left / right breast) will be showed by the method of Kaplan-Meier. Groups will be compared with the log rank test. | from 6 months to five years after adjuvant therapy with trastuzumab | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adjuvant treatment with Radiotherapy and trastuzumab
Preanalgesic Effect of Gabapentin in Total Knee Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.

Official Title
-----------------
Preanalgesic Effect of Gabapentin in Total Knee Repair

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

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing total knee replacement who received pain management by the following modality: Intravenous patient-controlled analgesia (IV-PCA) opioid Local femoral nerve block with 1.5% mepivacaine 20 ml and 0.5% ropivacaine 20 ml Exclusion Criteria: Age < 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Patients will receive 1200mg gabapentin 1-2 hours prior to surgery. | Drug: Gabapentin<br> <br> |
| Placebo Comparator: Arm 2<br>Patients will receive placebo 1-2 hours prior to surgery. | Drug: Placebos<br> <br> |

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
-----------------
Patients undergoing total knee replacement who received pain management by the following modality:, IV PCA opioid, Local femoral nerve block with 1.5% Mepivacaine & 0.5% Ropivacaine
Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study

Study Overview
=================
Brief Summary
-----------------
ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Device: communication system P300 Speller


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 have a diagnosis of ALS suspected, possible, probable with EMG be able to follow the study process and to comply with the schedule of visits upon entry into the study understand the purpose of the study expressing P300 wave in the conditions of the study Exclusion Criteria: have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study have a significant history of photosensitive epilepsy have a history of allergy to the gel used for the electrodes Major protected by law (guardianship, curators) have uncorrectable visual disorders not being able to maintain a sitting position and focus on a computer screen for more than 30 min.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALS patients<br> | Device: communication system P300 Speller<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the full achievement of copy spelling and free spelling tests session 1 |  | 14 days after inclusion | 
| the full achievement of copy spelling and free spelling tests session 2 |  | 28 days after inclusion |
Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring diabetes.

Official Title
-----------------
A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of diabetes mellitus for at least 2 years Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart HbA1C below 11.0% Exclusion Criteria: Impaired renal function Impaired hepatic function Serious heart diseases Known hypoglycaemia unawareness or recurrent major hypoglycaemia Proliferative retinopathy or maculopathy requiring acute treatment Uncontrolled treated/untreated hypertension Current treatment with total insulin dose of more than 100 IU/day Current treatment or expected at the screening to start treatment with systemic corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 48 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose profiles |  |  | 
| Hypoglycaemic episodes |  |  | 
| Adverse events |  |  | 
| Body weight |  |  | 
| Insulin antibodies |  |  |
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.

Official Title
-----------------
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

Conditions
-----------------
Diabetic Gastropathy

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years GI symptoms for at least 2 months before entering study Exclusion Criteria: Very high body weight Significant diarrhea Ulcers Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly global measure of dyspeptic symptom relief. |  |  | 
| Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, tegaserod, gastropathy
Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect.

Conditions
-----------------
Analgesia, Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-surgical total knee arthroplasty patients Exclusion Criteria: Skin infection near block site Allergy to local anesthetics Peripheral neuropathy Proven opioid dependency Coagulopathy Dementia

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (ISB-P)<br>Four nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml | Drug: Dexamethasone<br> <br> Drug: Bupivacaine<br> <br> |
| Active Comparator: Group II (ISB-S)<br>Four nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml | Drug: Dexamethasone<br> <br> Drug: Bupivacaine<br> <br> |
| Active Comparator: Group III (ISB-C)<br>Four nerve blocks without dexamethasone | Drug: Bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Perineural DxaM | Duration of motor and sensory block | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Systemic DxaM | Duration of motor and sensory block | One day |
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.

Official Title
-----------------
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Conditions
-----------------
Growth of Term Infants

Intervention / Treatment
-----------------
* Other: An investigational infant formula containing a probiotic source
* Other: Control: Marketed routine infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 12-16 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: History of underlying metabolic or chronic disease or immunocompromised Feeding difficulties or formula intolerance

Ages Eligible for Study
-----------------
Minimum Age: 12 Days
Maximum Age: 16 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed routine infant formula<br> | Other: Control: Marketed routine infant formula<br> <br> |
| Experimental: Infant formula containing a probiotic source<br> | Other: An investigational infant formula containing a probiotic source<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight measured at each study visit |  | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of infant formula intake at each study visit |  | 3.5 months | 
| Body length measured at each study visit |  | 3.5 months | 
| Recall of stool consistency measured at each study visit |  | 3.5 months | 
| Medically-confirmed adverse events collected throughout the study period |  | 3.5 months | 
| Parental Study Product Assessment Questionnaire completed at Study Visit 2 |  | once | 
| Head circumference measured at each study visit |  | 3.5 months | 
| Recall of gastrointestinal tolerance measured at each study visit |  | 3.5 months |
Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route

Study Overview
=================
Brief Summary
-----------------
Intraosseous vascular access can be used to effectively and safely deliver contrast dye for CT examination.

Detailed Description
-----------------
intraosseous vascular access in the proximal humerus can be used to delivery contrast dye for CT examination.

Official Title
-----------------
An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye

Conditions
-----------------
Intraosseous Vascular Access Patients Requiring CT Exam

Intervention / Treatment
-----------------
* Procedure: Intraosseous delivery of CT contrast dye


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Has received intraosseous vascular access at the proximal humerus insertion site via EZ-IO as standard of care Requires CT examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care Cognitively and physically able to give written consent to participate in the study Exclusion Criteria: Fracture in target bone, or significant trauma to the site Excessive tissue and/or absence of adequate anatomical landmarks in target bone Infection in target area IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone Allergy to contrast media Imprisoned Pregnant Requires English language translation other than Spanish Has received IO access with an IO catheter other than the EZ-IO system

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 |
| --- |
|Procedure: Intraosseous delivery of CT contrast dye|Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate CT image | ability to effectively administer the contrast medium needed for the indicated CT examination. | at time of CT examination average time is within 24 hours | 
| number of participants with adverse events within 24 hours of CT exam | incidence of complications assocated with the administration of contrast medium through the intraosseous route. | within 24 hours of CT exam | 
| number of participants with adverse events within 30 days of CT exam |  | within 30 days of CT exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraosseous vascular access, CT examination