linjc16/ctgov huggingface dataset:
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy. II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth hormone, and insulin. III. Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin. IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to prednisone or placebo. Therapy is administered daily for 12 weeks; prednisone is then tapered.

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Ambulatory males with Duchenne muscular dystrophy No medical/psychiatric contraindication to protocol therapy No requirement for regular use of prescription medication

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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
-----------------
Duchenne muscular dystrophy, genetic diseases and dysmorphic syndromes, muscular dystrophy, neurologic and psychiatric disorders, rare disease
Glubran Mesh Fixation in Lichtenstein Hernioplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

Detailed Description
-----------------
Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Official Title
-----------------
Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: cyanoacrylate glue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inguinal hernia adult patient Exclusion Criteria: patient not willing multiple recurrences inguinal pain without evidence of hernia femoral hernia large scrotal hernia

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>mesh fixation by absorbable sutures | |
| Experimental: 2<br>mesh fixation by cyanoacrylate glue | Procedure: cyanoacrylate glue<br>* 1 ml glue<br>* Other names: Glubran2 synthetic surgical glue;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hernia recurrence, quality of life |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia, inguinal hernioplasty, mesh fixation, Lichtenstein hernioplasty
A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.

Official Title
-----------------
An Open, Prospective, Uncontrolled, Multi-Center Study To Evaluate The Efficacy And Safety Of Voriconazole In Chinese Subjects With Proven Or Probable Serious Invasive Fungal Infections

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Drug: voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer. Exclusion Criteria: Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole. Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with a Global Efficacy assessment of either cured or improved by Week 6 visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit). |  |  | 
| Percent of subjects with a Global Efficacy assessment of either cured or improved at the time when IV administration is completed |  |  |
Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).

Official Title
-----------------
A Randomized, Open-label, Two-Treatment, Two-Period, Two-Sequence, Cross-over Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend) in Healthy Male Volunteers

Conditions
-----------------
Systemic Mycotic Infection

Intervention / Treatment
-----------------
* Drug: SYP-1018 200mg
* Drug: Voriconazole 200mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 20-45 years of age Weight of ≥ 60kg ≤ 90kg with BMI of ≥ 19 and < 27 (BMI(kg/m2)= weight(kg)/{height(m)}2 Voluntary written informed consent Exclusion Criteria: History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease Drug allergies to Voriconazole Recent history or evidence of drug abuse Recent participation(within 2 months) in other clinical studies Recent donation of blood(within 2months), plasma(within 1month) or transfusion(within 1month)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>SYP-1018 200mg → Voriconazole 200mg | Drug: SYP-1018 200mg<br>* SYP-1018 200mg, Intravenous administration<br>Drug: Voriconazole 200mg<br>* Voriconazole 200mg, Intravenous administration<br>|
| Experimental: Sequence 2<br>Voriconazole 200mg → SYP-1018 200mg | Drug: SYP-1018 200mg<br>* SYP-1018 200mg, Intravenous administration<br>Drug: Voriconazole 200mg<br>* Voriconazole 200mg, Intravenous administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters | AUClast, Cmax | pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters | AUCinf, Tmax, T1/2, CL | pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h | 
| Safety | Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs) | 16 days |
Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU

Study Overview
=================
Brief Summary
-----------------
Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU

Detailed Description
-----------------
Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine, establishing incidence of success, failure of moderate sedation or failure of dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation

Official Title
-----------------
Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU

Conditions
-----------------
Requiring Sedation in ICU, Adult Patients, Patient Covered by French Health Care System

Intervention / Treatment
-----------------
* Drug: Sedation with dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Adult patients ventilated requiring sedation in ICU with RASS objective more than -2 Exclusion Criteria: contraindication: intracranial lesion, hepatic failure pregnancy

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 |
| --- | --- |
| dexmedetomidine<br> | Drug: Sedation with dexmedetomidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with failure of sedation with dexmedetomidine | Number of patients with failure of sedation with dexmedetomidine (necessity to stop this sedation due to adverse event, RASS>+1, other) in ICU patients requiring such sedation during ICU stay. | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event of dexmedetomidine |  | at day 1 | 
| Incidence of delirium and use of other sedative drugs |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, Dexmedetomidine, ICU, Delirium
Novel Preoperative Score Predicting Outcome Following Liver Resection

Study Overview
=================
Brief Summary
-----------------
To develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.

Detailed Description
-----------------
Liver surgery is associated with a substantial rate of complications. Early identification of patients at risk of serious complications is important in order to adapt therapeutic strategies and to improve quality. The purpose of this study is to develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.

Official Title
-----------------
Novel Preoperative Score Predicting Outcome Following Liver Resection

Conditions
-----------------
Serious Complications Following Liver Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years liver resection Exclusion Criteria: Trauma cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| complication group < III<br> | |
| complication group >= III<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| develop and validate a score to predict serious complications following liver resection using pre-operative risk factors. |  | postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Development, Validation, Prediction Score, Complication, Liver resection, develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Protein Requirements for Active Adolescent Females

Study Overview
=================
Brief Summary
-----------------
Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA). Nutritional requirements for dietary amino acids in adolescents have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity. Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data. The purpose of this study is to measure the protein requirement in adolescent, females using the IAAO technique in the presence of a variable intensity exercise stimulus.

Official Title
-----------------
Evaluation of Protein Requirements in Active Adolescent Females

Conditions
-----------------
Increased Metabolic Requirement, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Amino Acid Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Adolescents): Healthy, active adolescent who regularly participates in moderate to vigorous physical activity 5 times a week for a minimum of 1 hour. Being -0.5 to +1.0 years from peak height velocity, determined by the ratio of standing to sitting height, with the maximal age for adolescents being 16 years. Obtaining a minimum level of 5.8 on the Beep Test Exclusion Criteria (All Subjects): Inability to meet health and physical activity guidelines according to the Physical Activity Readiness Questionnaire (PAR-Q+) and Physical Activity Questionnaire, An inability to adhere to any of the protocol guidelines (i.e. caffeine consumption) A biological age falling outside of the aforementioned ranges

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active, adolescent females<br>Subjects will receive different levels of amino acid intakes, varying from 0.2-2.67 g/kg/d | Dietary Supplement: Amino Acid Intake<br>* Amino acid intakes will be varied at 0.2-2.67 g/kg/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h) |  | 4 hours/ study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [13C]Phenylalanine Oxidation (µmol/kg/h) |  | 4 hours/ study day |
Pan-European Survey on the Under Treatment of Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The survey try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines, overall and by country.·

Official Title
-----------------
Pan-European Survey on the Under Treatment of Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had to be on a lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The number and percentage of patients achieving the LDL-C goals, according to the Third Joint European Task Force guidelines, overall and by country. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia, Third Joint European Task Force guidelines, Survey
The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants

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

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

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

Intervention / Treatment
-----------------
* Other: Control: Marketed routine infant formula
* Other: An investigational infant formula containing an alternate source of DHA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 10-14 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: 10 Days
Maximum Age: 14 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant formula containing an alternate source of DHA<br> | Other: An investigational infant formula containing an alternate source of DHA<br> <br> |
| Active Comparator: Marketed routine infant formula<br> | Other: Control: Marketed routine infant formula<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 | 
| Head circumference measured at each study visit |  | 3.5 months | 
| Recall of gastrointestinal tolerance measured at each study visit |  | 3.5 months | 
| Blood Collection | Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA). | Once at 120 days of age |