linjc16/ctgov huggingface dataset:
The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease

Official Title
-----------------
A Clinical Study to Evaluate the Efficacy and Safety of MK0633 in Patients With Atherosclerosis

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: MK0633


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease Inflammatory marker found in your blood, known as hsCRP > 0.5 mg/L Exclusion Criteria: Age < 40 or > 85 Female Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months Liver diseased or abnormalities HIV infection Lupus, rheumatoid arthritis, cancer <5 years

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: Drug | Drug: MK0633<br>* Single dose MK0633 100mg po in the fed state administered during a 4-wk study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis |  | 4 Weeks |
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Official Title
-----------------
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: tacrolimus ointment
* Drug: pimecrolimus cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area Negative pregnancy test and agrees to practice effective birth control during the study Exclusion Criteria: Skin disorder other than Atopic Dermatitis in the areas to be treated Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters Clinically infected Atopic Dermatitis at baseline Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug Known hypersensitivity to macrolides or any excipient of either study medication Chronic condition which is either not stable or not well controlled Pregnant or breast feeding an infant

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus ointment<br>* topical<br>* Other names: FK506 ointment;|
| Active Comparator: 2<br> | Drug: pimecrolimus cream<br>* topical<br>* Other names: Elidel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eczema Area and Severity Index (EASI) |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) |  | 6 Weeks | 
| Patient's evaluation of itch |  | 6 Weeks | 
| Body surface area affected |  | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis, Protopic, Elidel
UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.

Official Title
-----------------
The Application of UGT1A1 Genotype Combined With Pharmacokinetics of SN-38 in the Detection of Irinotecan-based Neoadjuvant Chemoradiotherapy in Patients With Advanced Rectal Cancer

Conditions
-----------------
Locally Advanced Rectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Blood concentration check


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological confirmed adenocarcinoma clinical stage T3-4 and/or N+ the distance from anal verge less than 12 cm without distance metastases performance status score: 0 1 UGT1A1*28 6/6 or 6/7 without previous anti-cancer therapy sign the inform consent Exclusion Criteria: pregnancy or breast-feeding women serious medical illness baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN DPD deficiency UGT1A1*28 7/7

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT group<br>Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check | Diagnostic Test: Blood concentration check<br>* Blood concentration check：the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 | the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 | During the chemoradiation weekly，assessed up to 5 weeks | 
| pathological response rate | pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen. | Surgery scheduled 6-8 weeks after the end of chemoradiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoadjuvant chemoradiotherapy, irinotecan, SN-38
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Official Title
-----------------
Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome

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

Intervention / Treatment
-----------------
* Drug: Ecabet 2.83%
* Drug: Ecabet 3.70%
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agree to avoid systemic & topical ophthalmic meds & disallowed meds Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye Diagnosis of moderate dry eye syndrome Exclusion Criteria: Uncontrolled ocular or systemic disease that could interfere with study Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis Contraindications or hypersensitivity to use of study meds or components Wear contact lenses Secondary dry eye to surgery Eye surgery (including laser) within 6 months Use of systemic or topical ophthalmic meds within 14 days Punctal plugs in one or both eyes in place for <45 days Permanent occlusion of the lacrimal puncta

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecabet 2.83%<br>Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. | Drug: Ecabet 2.83%<br> <br> |
| Experimental: Ecabet 3.70%<br>Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. | Drug: Ecabet 3.70%<br> <br> |
| Placebo Comparator: Vehicle<br>One drop of vehicle in study eye 4 times daily for 90 days. | Drug: Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular discomfort | Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE | Day 91 | 
| Tear Film Break-up Time (TFBUT) | Group mean change in time to tear break-up from pre-CAE to post-CAE. | Day 91 | 
| Blink Rate | Group mean change in blinks/min from pre-CAE to post-CAE. | Day 91 |
Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements

Study Overview
=================
Brief Summary
-----------------
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Detailed Description
-----------------
Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Official Title
-----------------
Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.

Conditions
-----------------
Pregnancy, Women

Intervention / Treatment
-----------------
* Device: pelvic measurements using the LaborPro Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subject is eligible to participate in the study if she meets all of the following inclusion criteria: Singleton pregnancy Pregnant adult woman in labor Willing to participate in the study and understands the study procedures Exclusion Criteria: A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria scheduled for c/s active infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pelvic measurements using the LaborPro Device|pelvic measurements using the LaborPro Device,ultrasound non invasive measurements|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pelvis measurements influence on the Delivery mode | pregnant woman's during a routine visit in the ultrasound unit will be requested to sign a concent and will undergo pelvic measurement using the LaborPro system. statistic analysis will ensue in order to ascertain the relationship between pelvic measurement and the mode of delivery. | labor and delivery process | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the influence of maternal parameters on delivery mode. | Assessing the influence of relevant obstetric and maternal parameters on delivery mode in relation to the study measured parameters | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delivery mode, pelvic measurement
Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Study Overview
=================
Brief Summary
-----------------
Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the Emergency Department.

Detailed Description
-----------------
Breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's Sepsis Patient Management Protocol for blood lactate point of care testing. The breath samples will be collected from the patient by the Respiratory Therapist (RT) at the time of blood sample collection for the blood lactate test. The breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (VOCs). Multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique VOC pattern with septic/severe septic/septic shock patients.

Official Title
-----------------
Study to Assess Feasibility of Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Device: Breath sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted to Emergency Department suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed age 18 or older Exclusion Criteria: member of Vulnerable Patient Population unable to complete Patient Informed Consent process/document

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath sample collection<br> | Device: Breath sample collection<br>* Subject exhales into breath collection container.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volatile Organic Compound (VOC) Pattern | Detection of a unique pattern of Volatile Organic Compounds (VOCs) in the breath samples of patients confirmed as having sepsis/severe sepsis/septic shock differentiated from subjects confirmed as not septic. | five minutes |
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition

Study Overview
=================
Brief Summary
-----------------
Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness. However, its usefulness in open-chest conditions has been equivocal. The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy.

Official Title
-----------------
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition in the Patients Undergoing Off-pump Coronary Arterial Bypass Grafting

Conditions
-----------------
Cardiac Surgical Procedures, Thoracic Surgical Procedures, Sternotomy

Intervention / Treatment
-----------------
* Procedure: Valsalva maneuver
* Other: Fluid loading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult patients undergoing elective off-pump coronary arterial bypass grafting Exclusion Criteria: Preoperative LV EF <= 35% Moderate or severe valvular heart disease Cardiac arrhythmia Intracardiac shunt Severe renal or liver disease Moderate to severe pulmonary hypertension (mean PAP > 35 mmHg) Patients with bullous lung disease or combined pneumothorax

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Valsalva maneuver<br>This is an observational study and as a diagnostic intervention, subjects in the study would receive valsalva maneuver. Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration. The investigators perform this procedure to every patients and do not assign this intervention to the subjects of the study. | Procedure: Valsalva maneuver<br>* Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.<br>* Other names: Lung recruitment maneuver;Other: Fluid loading<br>* We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid<br>* Other names: Balanced crystalloid infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse pressure variation during Valsalva maneuver |  | during Valsalva maneuver | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse pressure variation after sternotomy |  | 5 min after sternotomy |
Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

Study Overview
=================
Brief Summary
-----------------
This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.

Detailed Description
-----------------
Benign prostatic hyperplasia (BPH) is a very common disease affecting men. Patients with BPH may present with voiding symptoms including hesitancy, intermittence, slow stream and sensation of incomplete emptying, and storage symptoms including urinary frequency, urgency and nocturia. Patients may also suffer from complications including urinary retention, recurrent urinary tract infection, bladder stone formation and obstructive uropathy. For patients who have lower urinary tract symptoms refractory to medications, or those who suffer from complications of BPH, transurethral prostatectomy should be considered. Surgical intervention options have evolved from electrosurgical resection to the use of lasers for enucleation and ablation [1]. Aquablation and Rezum system are new minimally invasive surgical technology for BPH management. [2,3,4]. Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. However, large-scale studies investigating the different modalities of surgical treatment of BPH are lacking. Therefore, a prospective data registry is created to assess the perioperative surgical outcomes for different surgical treatment of BPH.

Official Title
-----------------
A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

Conditions
-----------------
Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at the age of 18 or above Exclusion Criteria: Patient is unable to give consent

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

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

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 |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) questionnaire total Score | Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires | Baseline, 3 months after surgical treatment for BPH | 
| Voiding function in uroflowmetry | Change in urodynamic function assessed by Uroflowmetry | Baseline, 3 months after after surgical treatment for BPH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication after surgical treatment | The 30-day complications will be graded according to the Clavien-Dindo classification | Post operation 30 days after surgical treatment for BPH |
Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)

Study Overview
=================
Brief Summary
-----------------
To determine the accuracy and generalizability of VA-LRTI algorithm to detect and predict three high-incidence and high-impact VAEs from electronic health records data: 1) ventilator-associated event, 2) ventilator-associated pneumonia, and 3) ventilator-associated tracheobronchitis.

Official Title
-----------------
Predictive Analytics in Ventilator-Associated Events

Conditions
-----------------
Ventilator-Associated Event

Intervention / Treatment
-----------------
* Other: Diagnostic and prognostic models for VA-LRTIs


Participation Criteria
=================
Eligibility Criteria
-----------------
All invasively ventilated ICU patient (aged 18 or over)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dataset for development and testing<br> | Other: Diagnostic and prognostic models for VA-LRTIs<br>* Diagnostic and prognostic models for VA-LRTIs<br>|
| Dataset for external validation<br> | Other: Diagnostic and prognostic models for VA-LRTIs<br>* Diagnostic and prognostic models for VA-LRTIs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with VA-LRTI as assessed by risk-calculator | Prediction model to be used at the moment of diagnosis and algorithms to be used prior IMV to predict the risk of VA-LRTI. | 1.6.-31.12.2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of in-hospital mortality | Prediction model to be used at the moment of diagnosis to predict the risk of mortality in VA-LRTIs. | 1.6.-31.12.2021 |