linjc16/ctgov huggingface dataset:
Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.

Official Title
-----------------
Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant

Conditions
-----------------
Infant, Preterm

Intervention / Treatment
-----------------
* Drug: low dose remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants mechanically ventilated requiring peripherally induced central catheterization with informed consent of their parents Exclusion Criteria: major congenital anomalies cardiopulmonary instability use of sedative, antiepileptic drugs or anesthetic drugs grade III or IV intraventricular hemorrhage

Ages Eligible for Study
-----------------
Maximum Age: 12 Weeks

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose remifentanil<br>continuous infusion of remifentanil 0.1mcg/kg/min | Drug: low dose remifentanil<br>* non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control<br>* Other names: high dose remifentanil;|
| Active Comparator: high dose remifentanil<br>continuous infusion of remifentanil 0.25mcg/kg/min | Drug: low dose remifentanil<br>* non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control<br>* Other names: high dose remifentanil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Infant Pain Profile | P0-P2 units on a scale ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2) PIPP (preterm infant pain profile) min 0   max 21 higher pain scale on higher score | first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Reaction | bradycardia, hypotension, apnea, desaturation | during and after 10min of remifentanil continous infusion |
Role of CGMS Usage in Predicting Risk for Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
This is a clinical study to examine rates hypoglycemia (self-report, EHR review, and review of values from a FDA approved continuous glucose monitoring system (CGMS)). Subjects will wear either blinded or unblinded CGMS. This is a 1:1 assignment with one group (50%) wearing 1 unblinded/1 blinded CGMS and the other group 50% wearing 2 blinded CGMS. The assignment will be computer based in a random fashion. Participants will continue with their usual diabetes management and glycemic monitoring profile as per usual. Those assigned to an unblinded CGMS can use the CGMS to manage their glucose levels at their own discretion. Individuals recruited will be those Type 2 diabetes who are deemed to be at high risk for hypoglycemia or low risk for hypoglycemia from a point score system established in an affiliated study.

Official Title
-----------------
Development of Novel Predictors of Hypoglycemia for Type 2 Diabetes: Role of CGMS Usage in Predicting Risk for Hypoglycemia

Conditions
-----------------
Type 2 Diabetes Mellitus, Hypoglycemia

Intervention / Treatment
-----------------
* Device: Continuing Glucose Monitor System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes 18 years or older Exclusion Criteria: Type 1 diabetes Current pregnancy or anticipation of pregnancy during study period At screening visit, HR> 130 or SBP>160 or DBP>100 which remains present on recheck

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blinded<br>Continuing Glucose Monitoring System will be blinded | Device: Continuing Glucose Monitor System<br>* glucose monitoring<br>|
| Unblinded<br>Continuing Glucose Monitoring System will be open. Participant can review results if they choose. | Device: Continuing Glucose Monitor System<br>* glucose monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia rate | Overall rate | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison hypoglycemia rate | Comparison between blinded and unblinded arms | Week 16 |
Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function

Official Title
-----------------
Candesartan in Heart Fail. Assess. of Reduction in Mortality & Morbidity. Candesartan in Patients With Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function

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

Intervention / Treatment
-----------------
* Drug: Candesartan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 or above Congestive Heart Failure with symptoms for more than 4 weeks before starting study Provision of informed consent Exclusion Criteria: Current low blood pressure with symptoms Liver disease considered significant by the study doctor Pregnant or lactating females

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

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

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 |
| --- | --- |
| Active Comparator: 1<br> | Drug: Candesartan<br> <br> * Other names: Atacand;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality or hospitalisation due to congestive heart failure |  | 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI |  | 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Atacand, Candesartan
Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.

Official Title
-----------------
Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication

Conditions
-----------------
Total Knee Replacement, Osteoarthritis of the Knee, Preoperative Osteopathic Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total knee arthroplasty (TKA) For osteoarthritis of the knee Without surgical history on the operated knee Exclusion Criteria: Previous surgery on the operated knee Bilateral TKA Patient refusal

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteopathy<br> | |
| No osteopathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessment of knee pain on Visual Analog Scale (VAS) |  | At one month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain self-assessment during the first postoperative month on Visual analog scale (VAS) |  | Twice daily during the first postoperative month | 
| Functional assessment of the knee with International Knee Society (IKS) score |  | At six months postoperatively | 
| Functional assessment of the knee with International Knee Society (IKS) score |  | At one year postoperatively |
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

Official Title
-----------------
A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

Conditions
-----------------
Non-Metastatic Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib, radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer PSA below 20 ng/mL Lymph node negative Non-metastatic Written informed consent Exclusion Criteria: Well differentiated stage T2 prostate cancer (Gleason score 2 to 4) Distant or nodal metastases Prostatectomy Concomitant LHRH analog treatment Previous or concomitant anti-androgens Active ILD

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib, radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Safety (incidence of DLTs) |  |  | 
| Part B: Tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis |  |  |
Renalof in the Treatment of Elderly Patients With Gallstones

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.

Official Title
-----------------
Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Dietary Supplement: Renalof
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms. Signed informed consent Exclusion Criteria: Previous surgical intervention for the treatment of cholelithiasis Cholelithiasis with acute symptoms requiring emergency surgery Cholelithiasis associated with neoplastic condition of any localization or origin Usage of other antioxidants within the duration of the clinical trial Handicap and/or psychiatric condition preventing treatment accomplishment

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renalof<br> | Dietary Supplement: Renalof<br>* One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* One Placebo tablet (Orally administered) every 8 hours, for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment) |  | 6 month | 
| Number of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment) |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of digestive symptoms associated with cholelithiasis |  | 6 month | 
| Occurrence of adverse effects during treatment |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary supplement, Renalof, gallstones, elderly
Study Evaluating the Effect of Food on the Bioavailability of PN400 Components

Study Overview
=================
Brief Summary
-----------------
We will evaluate the effect of food on the bioavailability of the components of PN400

Official Title
-----------------
An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Drug: PN400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female subjects between 18-55 years old as well as other standard inclusion criteria for a study of this nature. Exclusion Criteria: Standard exclusion criteria for a study of this nature.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>PN400 administered after meal | Drug: PN400<br>* naproxen/esomeprazole<br>|
| Other: 2<br>PN400 administered prior to meal | Drug: PN400<br>* naproxen/esomeprazole<br>|
| Other: 3<br>PN400 administered prior to meal | Drug: PN400<br>* naproxen/esomeprazole<br>|
| Other: 4<br>PN400 followed by fast | Drug: PN400<br>* naproxen/esomeprazole<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects. |  | 72-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of PN 400 under fasting and fed conditions. |  | entire study duration |
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
To determine prevalence of local allergic rhinitis (LAR) To evaluate clinical characteristic and severity of local allergic rhinitis To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp) after nasal allergen provocation test (NAPT)

Detailed Description
-----------------
Children 8-18 years with NAR were recruited. A NAPT with Der p 1 solutions (NAPT-DP) at 200 AU/mL, 600 AU/mL and 2000 AU/mL at 15-minute interval was performed, respectively. The immediate responses to NAPT-DP were assessed using symptoms score, peak nasal inspiratory flow (PNIF) and acoustic rhinometry (ARM). The nasal tryptase and sIgE-DP were measured at baseline, 15 min and 1 h after positive NAPT-DP. Allergic rhinitis (AR) patients were used as positive control.

Official Title
-----------------
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis

Conditions
-----------------
Other Allergic Rhinitis

Intervention / Treatment
-----------------
* Procedure: nasal allergen provocation test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 8-15 years who were diagnosed with nonallergic rhinitis (NAR) at least 1 year No respiratory infections in the previous 4 weeks No following treatment of systemic corticosteroid 4 weeks intranasal corticosteroid 2 weeks oral antihistamine 1 week leukotriene antagonist 1 week Exclusion Criteria: Patients with underlying disease: chronic rhinosinusitis and nasal polyp immunological disease chronic renal disease hepatobiliary disease cardiovascular disease cancer Parental withdraw consent Patient with uncontrolled asthma, peak expiratory flow rate (PEFR) < 80% of predicted

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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 |
| --- | --- |
| Other: nonallergic rhinitis<br>nonallergic rhinitis nasal allergen provocation test | Procedure: nasal allergen provocation test<br>* nasal allergen provocation test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of local allergic rhinitis (LAR) | positive nasal allergen provocation test with Der p1 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1 prevalence, 2 children, 3 local allergic rhinitis
The Use of Nasal Phenylephrine in Infants With Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Drops of either saline or phenylephrine are placed in the nose of infants less than 12 months of age to determine if it helps them to breathe easier.

Official Title
-----------------
A Randomized, Double-Blinded Placebo Control Trial of Nasal Phenylephrine in Infants With Bronchiolitis

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Phenylephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 4 weeks to 12 months; admitting diagnosis of bronchiolitis; admitted to hospital's bronchiolitis pathway, admitted during weekdays, need for nasal suctioning. Exclusion Criteria: Congenital heart disease, history of hypertension, previous wheezing, prior use of inhaled corticosteroids, gestational age at birth of <34 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 12 Months

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

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: Phenylephrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes. |  |  |