linjc16/ctgov huggingface dataset:
Efficacy and Safety of Lumiracoxib

Study Overview
=================
Brief Summary
-----------------
This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.

Official Title
-----------------
A One-week Multicenter, Multiple-dose, Randomized, Double-blind, Double-dummy, Parallel-group Comparison of the Analgesic Efficacy and Safety of Lumiracoxib (COX189), Celecoxib, and Placebo in the Treatment of Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Osteoarthritis of the knee Pain intensity at baseline of at least 50mm on a 100mm visual analog scale Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 50 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumiracoxib, osteoarthritis
4-PBA: Will it Increase the Level of Alpha 1-Antitrypsin(AAT) in Persons With AAT Deficiency?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether 4-PBA will increase the level of AAT in persons with AAT deficiency whether or not they have liver disease.

Detailed Description
-----------------
The purpose of this study is to determine whether 4-PBA will significantly increase serum Z AAT levels in AAT-deficient individuals with and without evidence of hepatocellular injury and to assess its effects on liver injury.

Official Title
-----------------
4 Phenyl Butyrate Mediated Secretion Rescue in Alpha 1-Antitrypsin Deficient Individuals

Conditions
-----------------
Alpha 1-Antitrypsin Deficiency

Intervention / Treatment
-----------------
* Drug: 4-PBA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 Serum A1-PI levels <11uM an appropriate genetic phenotype/genotype 5 of 10 subjects must have documented laboratory evidence of liver disease Willingness to withhold Prolastin therapy for 6 weeks prior to screening and throughout the 4-PBA dosing period (up to 3 months) Exclusion Criteria: Any cause of liver disease other than Alpha-1 Antitrypsin deficiency Evidence of advanced liver disease HIV positive Use of systemic steroids, ursodeoxycholic acid (Actigall, Urso), or herbs in the prior 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: 4-PBA<br>The study will involve a 4-PBA dose escalation and pharmacokinetics component The study group will be comprised of a total of at least 10 AAT-deficient,(phenotype ZZ referred to as PiZZ) patients. These patients will be divided into two groups: with and without clinical evidence of mild to moderate hepatocellular injury. | Drug: 4-PBA<br>* During the first 3 days of this phase baseline serum AAT levels will be determined. The participants will be then given increased amounts of 4-PBA orally in 6 divided doses (day 4-6, 30 g/day and day 7-9, 40/day<br>* Other names: 4-phenyl butyric acid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if 4-PBA significantly increases secretion of AAT in AAT-deficient individuals with and without liver disease. |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics of 4-PBA |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Disease, Liver Disease
Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of bacteria will assist in decreasing the use of antibiotics and help more patients survive bacterial infections of the blood.

Detailed Description
-----------------
It is our overall goal to develop a new diagnostic technology that will facilitate antibacterial stewardship to reduce selective pressure and improve patient outcomes. The Institute of Medicine has identified antibiotic resistance as one of the key microbial threats to health in the United States and has prioritized decreasing inappropriate use of antimicrobials as the primary solution to address this threat. The emergence of carbapenem resistance among Enterobacteriaceae (CRE) in the United States represents a recent and severe byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. A major barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid diagnostic tests for identifying bacterial etiologies of infection.

Official Title
-----------------
Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood

Conditions
-----------------
Bacteremia, Enterobacteriaceae Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboratory confirmed gram negative bacilli blood culture Exclusion Criteria: Pregnancy Prisoner

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Bacteria identification | Accuracy of bacteria identification by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli. | 3 hours | 
| Accuracy of carbapenem susceptibility testing | Accuracy of carbapenem susceptibility testing by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli. | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbapenem-resistant Enterobacteriaceae, Accelerate ID/AST
Surgery for Intravenous Leiomyomatosis

Study Overview
=================
Brief Summary
-----------------
Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. However, different opinion of surgical strategies remain controversial. The purpose of this report is to describe our experience of surgical management for the IVL with intracardiac extension.

Detailed Description
-----------------
All patients underwent surgical management. Clinical data were obtained from medical reports. Following-up was made through email and telephone.

Official Title
-----------------
Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes

Conditions
-----------------
Leiomyomatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years. Tumor markers were all within normal limits. Patients underwent surgical management. Patients were followed-up for more than 12 months. Exclusion Criteria: -Tumor markers were all within abnormal limits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Intravenous leiomyomatosis, Surgery, Smooth muscle tumor
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis

Official Title
-----------------
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial

Conditions
-----------------
Vasomotor Rhinitis

Intervention / Treatment
-----------------
* Drug: esomeprazole
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English Exclusion Criteria: pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>esomeprazole 40mg po bid | Drug: esomeprazole<br>* 40mg by mouth twice daily<br>* Other names: Nexium;|
| Placebo Comparator: 2<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Scores | (1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm | Last two weeks of each treatment arm | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-allergic rhinitis, laryngopharyngeal reflux
Changing Technique of Abdominal Wall Closure (PHACPA)

Study Overview
=================
Brief Summary
-----------------
Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

Detailed Description
-----------------
Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique. Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with short stitch technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.

Official Title
-----------------
Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital

Conditions
-----------------
Closure of Abdominal Wall

Intervention / Treatment
-----------------
* Procedure: Short stitch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated on by laparotomy Exclusion Criteria: Previous mesh Concomitant hernia repair

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short stitch<br>Patients in which abdominal wall is closed by short stitch technique | Procedure: Short stitch<br>* Surgeons will receive instructions to change the technique of abdominal wall closure<br>|
| No Intervention: Large stitch<br>Patients who didn't receive properly closure according with the protocol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia and burst abdomen rate | Analysis of the number of incisional hernia and burst abdomen after one year follow-up | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fulfillment of the protocol | Analysis of results related with the fulfillment of the protocol | One year | 
| Complication rate | Analysis of complications related with the closure technique | One month | 
| Mesh complications rate | Analysis of mesh related complications in patients with a prophylactic mesh | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal wall closure
HalfLytely Bowel Prep System for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.

Official Title
-----------------
HalfLytely Bowel Prep System for Colonoscopy

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: HalfLytely
* Drug: NuLytely


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients at least 18 years of age All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study. In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent Patient is undergoing a colonoscopy for a routinely accepted indication Exclusion Criteria: ileus possible intestinal obstruction or perforation prior alimentary tract surgery significant gastroparesis or gastric outlet obstruction impaired consciousness that predisposes a patient to pulmonary aspiration

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HalfLytely|nan|
|Drug: NuLytely|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Bowel preparation success: preparation rated as good or excellent by the blinded examiner |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Review of preparation symptoms, adverse events, and laboratory testing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy preparation, prep
Statin Choice Decision Aid Implementation First Phase

Study Overview
=================
Brief Summary
-----------------
This study is designed to answer a key question in the field of implementation science. Specifically, it seeks to determine if a proposed model for the implementation and scale-up of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the potential of this model, the investigators will conduct a multi-year study comprising 3 phases. This proposal represents the first of these phases.

Official Title
-----------------
The Statin Choice Implementation Project: Phase 1

Conditions
-----------------
Cardiovascular Factor Risk

Intervention / Treatment
-----------------
* Other: Statin Choice Implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects of the Mayo Clinic Care Network

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin Choice Implementation<br> | Other: Statin Choice Implementation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Implementation of Statin Choice Decision Aid (SCDA), as indicated by the cumulative reach (% usage in appropriate primary care consultations) across all 3 health systems (as measured by EMR-based calculations). |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statin, decision aid
Handling Medium for ICSI With Ionomycin and Latrunculin A

Study Overview
=================
Brief Summary
-----------------
Using Latrunculin A and Ionomycin would improve the outcome of ICSI if the handling medium during the ICSI procedure has them.

Official Title
-----------------
Latrunculin A and Ionomycin as a Handling Medium for ICSI

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for ICSI Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICSI medium supplemented with Ionomycin and Latrunculin A<br> | Other: Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A<br>* Ionomycin and Latrunculin A would activate oocyte during ICSI along with cytoskeleton stabilization for a favourable outcomes<br>|
| No Intervention: ICSI medium as it is<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate |  | 6 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Blastocyst formation and quality | Number of formed blastocysts and blastocysts with good-quality per fertilized oocytes | 6 days of culture | 
| embryo utilization rate |  | 6 days of culture | 
| clinical pregnancy rate |  | three months | 
| ongoing pregnancy rate |  | 12 weeks |