linjc16/ctgov huggingface dataset:
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after prolonged surgery. The investigators identify all patients undergoing prolonged surgery which the operation time >3 h, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.

Official Title
-----------------
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery

Conditions
-----------------
Postoperative Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Undergoing Prolonged Surgery Exclusion Criteria: Patients with incomplete electronic medical record information
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Death |  | The mortality within 5 years after the prolonged surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative death, Prolonged surgery, Prediction model
Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.

Official Title
-----------------
Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: OC000459
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria At Screening: Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception Non smokers Mild to moderate asthmatics according to GINA guidelines for at least 12 months. History of asthma symptoms increasing in response to external allergens. Testing positive on skin prick test to an allergen associated with the subject's asthma Exclusion Criteria: Use of inhaled or local corticosteroids in the period from 28 days prior to screening. Receipt of prescribed or over the counter medication within 14 days of the first study day.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: OC000459<br> | Drug: OC000459<br>* OC000459 capsules 2x100mg BID for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsules to match OC000459 100mg capsules, 2 tablets BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S)) |  | 28 days | 
| Sputum eosinophilia (subset of patients) and serum IgE |  | 28 days | 
| Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters |  | 28 days |
Soy Formula Feedings in Healthy, Term Infants

Study Overview
=================
Brief Summary
-----------------
This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

Official Title
-----------------
Efficacy of Soy Formula Feedings in Healthy, Term Infants

Conditions
-----------------
Gastrointestinal Tolerance

Intervention / Treatment
-----------------
* Other: Experimental Infant Formula 1
* Other: Experimental Infant Formula 2
* Other: Experimental Infant Formula 3
* Other: Active Comparator: Control Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects). Health infants reported to be tolerating a milk-based formula (Cohorts). Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 9 Weeks

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

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

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 |
| --- | --- |
| Active Comparator: Control Infant Formula<br>Ready-to-Feed (RTF) Soy Infant Formula | Other: Active Comparator: Control Infant Formula<br>* Ready-to-Feed (RTF) Soy Infant Formula<br>|
| Experimental: Experimental Infant Formula 1<br>Experimental Ready-to-Feed Soy Formula | Other: Experimental Infant Formula 1<br>* method A phytate reduction and 5% protein hydrolysis<br>|
| Experimental: Experimental Infant Formula 2<br>Experimental Ready-to-Feed Soy Formula | Other: Experimental Infant Formula 2<br>* method A phytate reduction and 10% protein hydrolysis<br>|
| Experimental: Experimental Infant Formula 3<br>Experimental Ready-to-Feed Soy Formula | Other: Experimental Infant Formula 3<br>* method B phytate reduction and 5% protein hydrolysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics Questionnaire | stool number, consistency, and color | Change from Baseline (Study Day 1) to Study Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula Intake | volume consumed | Change from Baseline (Study Day 1) to Study Day 15 | 
| Gastrointestinal Tolerance Questionnaire | Incidence of spit up and vomiting | Change from Baseline (Study Day 1) to Study Day 15 | 
| Weight | weight and weight gain | Change from Baseline (Study Day 1) to Study Day 15 |
Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in subjects with painful gonarthrosis

Official Title
-----------------
A Randomized, Double-Blind, Comparative Parallel Group Study of Analgesic Effectiveness and Safety of Three Different Doses of Lamaline® New Formulation vs Dafalgan® Codeine, After 10 Days Administration in Subjects With Painful Gonarthrosis.

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Lamaline® , 3 different doses, Dafalgan codeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of knee (unilateral or bilateral) osteoarthritis for at least 6 months Pain intensity assessed by Visual Analogue Scale ≥ 40 mm Partial functional disability assessed by Lequesne index ≥4 and < than 12 Exclusion Criteria: Patient unable to interrupt his/her NSAIDs to participate in the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Drug: Lamaline® , 3 different doses, Dafalgan codeine|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
-----------------
osteoarthritis, pain
Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.

Official Title
-----------------
Use of Antibiotic Contained Calcium Sulfate Carrier in Acute Periprosthetic Infections(APPI) of Total Knee Replacements

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Procedure: APPI of TKR-Stimulan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: APPI within 28 days of primary TKR Acute hematogenous infection within 4 weeks of symptoms Exclusion Criteria: Exposed prosthesis Infection occuring in revised joints Poly articular infections have allergies to tobramycin or Vancomycin previous chronic infections in or around any ipsilateral extremity trauma or implants

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 |
| --- | --- |
| APPI of TKR-Stimulan<br>Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin | Procedure: APPI of TKR-Stimulan<br> <br> * Other names: Vancomycin;|
| APPI of TKR-historical<br>Surgery 2.4 G Tobramycin 2.0 G Vancomycin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of components |  | 12 months | 
| Eradication of infection |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive protein (CRP) |  | 12 months | 
| Wound complications |  | 12 months | 
| Knee Society Score |  | 12 months | 
| Visual Analog Scale |  | 12 months | 
| Outcome Assessment Scores |  | 12 months | 
| Ongoing use of antibiotics |  | 6 weeks | 
| AP and lateral Radiographs of involved joint |  | 12 months | 
| Positive synovial fluid cell count |  | pre-operative | 
| Sedimentation Rate |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total, Knee, Replacment, Infection, Stimulan
Refractive Surgery and Optive Compatibility Study

Study Overview
=================
Brief Summary
-----------------
To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.

Official Title
-----------------
Refractive Surgery and Optive Compatibility Study

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 and over Patients undergoing refractive surgery Exclusion Criteria: Concurrent ocular conditions or pathology that could affect patient's ability to complete study Concurrent use of topical medications other than study medications Use of systemic medications with ocular drying sequelae: Antihistamines Decongestants Antispasmotics Antidepressants

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1.<br> | Drug: Optive<br>* Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess compatibility |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
compatibility of Optive after PRK or LASIK
Role of Ultrasound Elastography in Pleural Effusion

Study Overview
=================
Brief Summary
-----------------
Diagnostic performance of u.s elastography in pleural effusion

Detailed Description
-----------------
Pleural fluid is an extremely common problem however the diagnosis of pleural effusion remain challenging due its diverse aetiologies .transthoracic ultrasound is often the initial tool to help diagnosis of pleural effusion. Ultrasound elastography is a novel ultrasound technology that can differentiate malignant disease from benign disease by quantitatively assses tissue stifness by measuring the degree of distortion under application of an external force (shear wave ) However, very limited studies are available evaluating the efficacy of this novel technique in diagnosis of malignant pleural effusion.

Official Title
-----------------
Role of Ultrasound Elastography in Pleural Effusion

Conditions
-----------------
Pleural Effusion

Intervention / Treatment
-----------------
* Device: ultrasound Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: .patients with pleural effusion above18 year Exclusion Criteria: patients who refuse to undergone further investigations to reach final diagnosis of cause of pleural effusion .patients with intercostal tube inserted in the effusion before enrollment in the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transudate effusion<br> | Device: ultrasound Elastography<br>* application of shear wave force by ultrasound elastography<br>|
| Active Comparator: exudative effusion<br> | Device: ultrasound Elastography<br>* application of shear wave force by ultrasound elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect diagnostic performance of ultrasound elastography in pleural effusion | differentiate between elastisty index in benign and malignant pleural effuison that expressed in kpa by measuring it using ultrasound elastography | 3 months |
rTMS for Adults With Autistic Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder

Detailed Description
-----------------
First, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder. Second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.

Official Title
-----------------
Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Device: repetitive TMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with autistic spectrum disorder Exclusion Criteria: schizophrenia bipolar affective disorder major depressive disorder any systemic disease especially epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: repetitive TMS<br>repetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control | Device: repetitive TMS<br>* rTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous performance test | continuous performance test will be arranged before and after rTMS within one hour | continuous performance test will be arranged before and after rTMS within one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale | Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS. The time point of evaluation is before rTMS, one hour after rTMS, 3 days after rTMS and one week after rTMS. | Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week |
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening; stable weight +/-10% for >=3 months before screening. Exclusion Criteria: type 1 diabetes mellitus; acute gastrointestinal symptoms at screening and/or day -1; clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: taspoglutide<br>* 10mg sc once weekly for 12 weeks<br>|
| Experimental: 2<br> | Drug: taspoglutide<br>* 10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* sc once weekly for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, log (AUC), log(Cmax)of paracetamol |  | Days -1, 1, 5, 29, 33, 78 and 82 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory parameters, vital signs |  | Throughout study | 
| renal function (creatinine clearance, urine volume and electrolytes) |  | Throughout study | 
| Multiple dose pharmacokinetics of Taspoglutide |  | Throughout study |