linjc16/ctgov huggingface dataset:
To Investigate the Clinical Efficacy of an Experimental Toothpaste

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.

Official Title
-----------------
Clinical Efficacy of an Experimental Toothpaste

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Drug: isopropylmethylphenol and Fluoride
* Drug: Fluoride and Silica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects aged 18 years and older A minimum of 20 permanent gradable teeth For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental toothpaste<br>0.1% isopropylmethylphenol and 1150ppm fluoride | Drug: isopropylmethylphenol and Fluoride<br>* 0.1% isopropylmethylphenol and 1150ppm fluoride<br>|
| Other: Marketed toothpaste<br>NaF/Silica toothpaste containing 1150ppm fluoride | Drug: Fluoride and Silica<br>* NaF/Silica toothpaste containing 1150ppm fluoride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Modified Gingival Index at 24 weeks |  | baseline to 24 weeks | 
| Change from baseline Bleeding Index at 24 weeks |  | baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Modified Gingival Index at weeks 6 & 12 |  | baseline to week 12 | 
| Change from baseline Bleeding Index at weeks 6 & 12 |  | baseline to week 12 | 
| Change from baseline Plaque Index at weeks 6, 12 & 24 |  | baseline to week 24 | 
| Change from baseline plaque bacteria at weeks 12 & 24 |  | baseline to week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plaque, Toothpaste, Gingivitis
A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

Study Overview
=================
Brief Summary
-----------------
This is an observational study designed to follow patients with RA who have had an inadequate response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000 patients in the United States with RA who have had an inadequate response to anti-TNF therapies and who will receive Rituxan therapy will be recruited. There is no protocol mandated treatment assignment in this study. Patients will be evaluated and treated according to their physician's standard practice and discretion.

Official Title
-----------------
A Long-Term Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No prior use of Rituxan (except if received within 8 weeks of screening) Signed Informed Consent Form Age ≥ 18 years Diagnosis of RA Inadequate response to one or more anti-TNF therapies Exclusion Criteria: Have known hypersensitivity to any component of a humanized or murine monoclonal antibody

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA, Rituximab, Sunstone, anti-TNF, Rituxan
Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

Study Overview
=================
Brief Summary
-----------------
Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.

Official Title
-----------------
Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

Conditions
-----------------
Severe Trauma

Intervention / Treatment
-----------------
* Device: Coagucheck, Roche, France


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 15 y-o Admission for severe trauma Exclusion Criteria: Patients under oral anticoagulant

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coagucheck, Roche, France|Capillary puncture for POC INR measurement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5 |  | Admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of RBC transfusion |  | 24 hours post admission | 
| Prediction of FFP transfusion |  | 24 hours post admission | 
| In-hospital mortality assessed using patients' files |  | up to Day 28 | 
| Injury severity (ISS) |  | Day 1 | 
| Organ failure measured with the SOFA score at Day 1 |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Point of Care Device; post traumatic coagulopathy
Bottle PEP in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis

Official Title
-----------------
Safety and Sustainability in Bottle PEP in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Bottle-PEP
* Other: Routine physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cystic fibrosis Acute exacerbation Exclusion Criteria: Any contraindication using the Bottle - PEP such as the presence of pneumothorax

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bottle-PEP<br>Bottle-PEP | Other: Bottle-PEP<br>* A device that gives positive pressure from a bottle with the help of a non deflating tube<br>|
| Active Comparator: Routine physiotherapy<br>v | Other: Routine physiotherapy<br>* Routine pulmonary physiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test | distance of meters walked in 6 minutes | every 3 months |
A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.

Official Title
-----------------
A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
* Device: ROX Anastomotic Coupler System (ACS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination Exclusion Criteria: Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications | Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)<br>* The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).<br>Device: ROX Anastomotic Coupler System (ACS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean office SBP | Change in mean office SBP at six months as compared to Baseline | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean office DBP | Change in mean office DBP at six months as compared to Baseline | Change in mean office DBP six months as compared to Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Blood Pressure, Hypertension, Resistant Hypertension
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.

Official Title
-----------------
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Conditions
-----------------
Laryngeal Mask Airway, Tonsillectomy

Intervention / Treatment
-----------------
* Device: Endotracheal Tube
* Device: Laryngeal mask airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study. Exclusion Criteria: Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endotracheal Tube<br>Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. | Device: Endotracheal Tube<br>* Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.<br>* Other names: Endotracheal intubation;|
| Experimental: Laryngeal Mask Airway<br>Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. | Device: Laryngeal mask airway<br>* Randomized to either Laryngeal mask airway or endotracheal tube<br>* Other names: LMA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Laryngospasm |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postanesthesia Recovery Times |  | After surgery |
Population-Based Modeling of Cholesterol Lowering in the United States

Study Overview
=================
Brief Summary
-----------------
To evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition computer simulation model used to obtain forecasts of the public health impact and economic cost of CHD in the United States population.

Detailed Description
-----------------
BACKGROUND: The study was part of an Institute-initiated Request for Applications (RFA) titled Cost-Effective Strategies of Cholesterol-Lowering released by the NHLBI in 1990. The RFA was stimulated by the controversy concerning costs and cost-effectiveness that followed the 1987 report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The RFA was intended to support a broad and thorough quantitative exploration of the potential health benefits and costs of cholesterol-lowering from multiple perspectives. DESIGN NARRATIVE: The study added to the CHD Policy Model the capability to model the consequences of reductions in LDL cholesterol and increases in HDL/LDL ratios in the United States population. The CHD Policy Model was used for several studies, including: to compare the implications of using alternative epidemiologic studies as the basis for estimating the association between cholesterol levels and CHD risk; to derive cutting points for initiating cholesterol reduction, specific to age, sex, and CHD risk factors, and based on cost-effectiveness criteria; to compare the cost-effectiveness of specific targeted and population-wide strategies for cholesterol reduction; to incorporate the effects of treatments on quality of life, including both adverse effects of cholesterol-lowering drugs and reductions in CHD morbid events; and finally, to perform a cost-effectiveness analysis of cholesterol screening, incorporating costs of screening, effects of measurement error on misclassification of patients, and variations in individual cholesterol levels over time. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Heart Disease Risk Reduction, Heart Diseases, Coronary Disease, Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

Study Overview
=================
Brief Summary
-----------------
The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC

Official Title
-----------------
Frequency and Abundance of ALK/ROS1/MET Mutations on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer Using Single Molecule Amplifcation and Re-sequencing Technology: a Perspective Observational Study

Conditions
-----------------
Non-small Cell Lung Cancer Stage III, Non-Small-Cell Lung Cancer Metastatic, Adenocarcinoma of Lung, EGFR Wildtype

Intervention / Treatment
-----------------
* Genetic: ctDNA analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed stage IIIB/IV NSCLC; Histologically confirmed adenocarcinoma; EGFR-wildtype NSCLC; Provision of blood (plasma) sample for ctDNA testing; Patient must be able to comply with the protocol; Provision of blood (plasma) sample for ctDNA testing; Exclusion Criteria: As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease); Histologically confirmed small cell lung cancer or other metastatic tumors; Patient with no histologic or cytological diagnosis;

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

| Intervention/Treatment |
| --- |
|Genetic: ctDNA analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) | The investigators will describe the proportion of ALK/ROS1/MET mutations on ctDNA detected by cSMART in patients with non-small cell lung cancer (NSCLC) | up to 2 years | 
| Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) after crizotinib resistance | The investigators will describe the proportion of ALK/ROS1/MET mutations on ctDNA detected by cSMART in patients with non-small cell lung cancer (NSCLC) after crizotinib resistance | up to 2 years |
Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether shear-induced platelet aggregation is able to discriminate first acute coronary syndrome (ACS) from recurrent ACS

Detailed Description
-----------------
Predictive factors of recurrence of ACS are not well determined. Platelet aggregation and leucocyte activation seem to be involved in the pathogenesis. The aim of our study is to compare SIPA, platelet activation and platelet-leucocytes aggregates on the onset of the ACS and 3 months later in 2 groups of patients scheduled for a first episode of ACS or recurrent ACS .

Official Title
-----------------
Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes

Conditions
-----------------
Angina, Unstable

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old. informed consent signed. acute coronary syndrome not associated with co-morbidity as bleeding diathesis or myocardial infarction during the procedure. clinical symptoms in agreement with myocardial infarction during the preceding 24 hours. CK OR troponin elevation and one or more of the following criteria: ECG modifications transient ST elevation>1 mm. new inversion of ST <1 mm on 2 contiguous derivations. Exclusion criteria: Acute coronary syndrome with persistent ST elevation. Angioplasty in emergency before blood sampling. Inflammatory disease or cancer. Coagulation abnormalities. Antiphospholipid syndrome. Treatment by vitamin K antagonist. Severe disease with life expectancy lower than 2 years. One-year follow up impossible.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SIPA, acute coronary syndrome