linjc16/ctgov huggingface dataset:
Personalized Drinking Feedback Interventions

Study Overview
=================
Brief Summary
-----------------
The objective of this research is to better understand how to reduce hazardous drinking among OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered preventative program.

Detailed Description
-----------------
Excessive drinking among OEF/OIF veterans represents an important public health problem for both the veterans themselves and those with whom they interact. The objective of this research is to better understand how to reduce hazardous drinking among this group by assessing the effectiveness of a low-cost, computer-delivered preventative program. It is hypothesized that an intervention that provides personalized feedback about drinking behaviors will be more effective than an education-only control condition at reducing alcohol use and negative alcohol-related consequences.

Official Title
-----------------
Personalized Drinking Feedback Interventions for OEF/OIF Veterans

Conditions
-----------------
Alcohol Abuse

Intervention / Treatment
-----------------
* Behavioral: Personalized Drinking Feedback
* Behavioral: Education-Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OEF/OIF Veteran Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Drinking Feedback<br>Personalized feedback on drinking behaviors | Behavioral: Personalized Drinking Feedback<br>* Personalized feedback about one's drinking habits<br>|
| Active Comparator: Education-Only<br>Educational information about alcohol | Behavioral: Education-Only<br>* Educational information about alcohol use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Drinking Questionnaire | Several quantity/frequency measures of alcohol use | Past 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Inventory of Problems | Measures alcohol-related problems | Past 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, Brief Intervention, Personalized Feedback, Veterans
Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation

Study Overview
=================
Brief Summary
-----------------
Increasing experience of Ruxolitinib pre-allo SCT and data concerning Ruxolitinib during transplantation Diagnosis MF(includ Post-ET,Post-PV,PMF,MDS/MPN with MF) With at least two month Ruxolitinib treatment prior to transplantation DAC+BF as myeloablative conditioning regimen CSA from day -3 and MMF from day +1 until day 28 ATG Neovii® at dose of 7.5mg/KG for mismatch donor received Rux at +6d in ASCT and continued to +60d

Official Title
-----------------
Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation

Conditions
-----------------
Time of Hematopoietic Reconstruction

Intervention / Treatment
-----------------
* Other: comprehensive treatment regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60 years old, gender is not limited; Diagnosis MF(includ Post-ET,Post-PV,PMF) according to 2016 WHO With at least two month Ruxolitinib treatment before transplantation Informed consent of the patient or his legal representative Exclusion Criteria: HCT-CI score≥2 Woman who is pregnant or nursing MPN Patients who have received allogeneic hematopoietic stem cell transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: treatment group<br>MF patients exposure to ruxolitinib during transplantation | Other: comprehensive treatment regimen<br>* Diagnosis MF(includ Post-ET,Post-PV,PMF，MDS/MPN with MF) With at least two month Ruxolitinib treatment prior to transplantation DAC+BF as myeloablative conditioning regimen received Rux at +5d in ASCT and continued to +60d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of neutrophils reconstruction | Neutrophils count≧0.5G/L without G-CSF | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of GVHD | The incidence rate of aGVHD and cGVHD | 1 year |
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients

Official Title
-----------------
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Darapladib (SB480848)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Japanese males, 20-64 years of age, inclusive Body weight >50Kg Body Mass Index (BMI): 18-28 Subjects must have lived outside of Japan no more than 10 years Non-smoker or smokes fewer than 10 cigarettes/day Exclusion criteria: History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses History of sensitivity to heparin or heparin-induced thrombocytopenia History of alcohol/drug abuse or dependence within 12 months of the study Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C History of cholecystectomy or biliary tract disease or history of liver disease Participation in a clinical study within 30 days prior to first dose Subject has been exposed to more than 4 chemical entities within 12 months Positive urine drug and alcohol at screening Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darapladib (SB480848)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Safety/tolerability of single oral doses of darapladib |  | 4, 24 and 96h post-dose | 
| - Primary Pharmacokinetic parameters of single oral doses of darapladib |  | pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SB480848,, Japanese healthy volunteers, darapladib,
Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients

Study Overview
=================
Brief Summary
-----------------
Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.

Conditions
-----------------
Post-Extubation Stridor

Intervention / Treatment
-----------------
* Procedure: Bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal or greater than 18 years old Intubation over 24 hrs Match weaning profile Cuff leak volume less than 24% VS and subject/family agree Exclusion Criteria: Re-Intubation History of upper air way obstruction Severe CV disease (ex. AMI) Active UGI Bleeding Blood sugar persistent more than 250 mg/dl under medication control Risk of IICP Open T.B. Bleeding tendency/ Platelet less than 40 thousands Subject or family refuse

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bronchoscopy|The patients in our ICU intubated for > 24h and met weaning criteria, will be examined by bronchoscopy. Five ㏄ blood will be collected for checking CRP and cytokines before performing bronchoscopy. The proposed grading of post-extubation vocal cord finding were shown (Figure 1). The patients will be classified to two groups (Figure 2). The first group is these patients without swelling or swelling area ≦50% who will be extubated after bronchoscopic examination. These patients will be followed for 48 hours to monitor the incidence of PES. The second group is those patients who develop laryngeal edema with swelling area ≧50% or swelling in the whole vocal cord. Bosmin 2 ml local injection and Solu-medrol 40 mg I.V. Q6h for 1 4 days will be given. Bronchoscopy will be done if CLV ≧24% or after treatments for 3 4 days even with CLV <24%. The above treatments will be applied again if stridor develops. Extubation will be performed if no presence of laryngeal edema.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of bronchoscopy to predict post-extubation stridor. |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal intubation, cuff-leak test, post-extubation stridor, bronchoscopy, corticosteroids, Cuff-leak volume less than 24%
Impact of Antimicrobial Stewardship in Hospital: Eight Years Review (BONANTIBIO)

Study Overview
=================
Brief Summary
-----------------
The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville (CHRMT) between 2007 and 2014. To analyze the strategies and decisions related to the appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are realized on the study period with all concerned actors of the Good Use of antibiotics. An interviewing plan and tree interview guidelines were created. All SDI are processed by the same person.

Detailed Description
-----------------
The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville (CHRMT) between 2007 and 2014. CHRMT is a 2000-bed hospital in which 160 000 short hospitalizations are performed. To analyze the strategies and decisions related to the appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are realized on the study period with all concerned actors of the Good Use of antibiotics. An interviewing plan and tree interview guidelines were created. All SDI are processed by the same person.

Official Title
-----------------
Impact of Antimicrobial Stewardship in Hospital: Eight Years Review

Conditions
-----------------
Good Use of Antibiotics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication of antibiotics Exclusion Criteria: Non Applicable
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 |
| --- | --- | --- |
| Evolution of the antibiotics use in the hospital compared with the efficacy indicators |  | 2007 to 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotics consumption |  | 2007 to 2014 | 
| Bacterial resistance |  | 2007 to 2014 | 
| Composite index of the appropriate use of the antibiotics |  | 2007 to 2014 |
Clinical Reminder to Improve Appropriateness of Echocardiography

Study Overview
=================
Brief Summary
-----------------
This study will test a clinical reminder to show recent echocardiograms when a new echocardiogram is ordered. The goal is to avoid unnecessary comprehensive echocardiography.

Official Title
-----------------
Clinical Reminder to Improve Appropriateness of Echocardiography

Conditions
-----------------
Echocardiography

Intervention / Treatment
-----------------
* Other: Clinical Reminder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Echo ordered Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Reminder<br> | Other: Clinical Reminder<br>* Clinical reminder in the electronic medical record<br>|
| No Intervention: No Reminder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive echo ordered | Number of comprehensive echos completed | 24 hours from when when the initial order was placed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Echocardiography | Cost of echocardiography during the hospital stay. | 30 days |
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Official Title
-----------------
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: ONO-8025 (KRP-197)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 20 years old or over with overactive bladder Total number of urinary incontinence episodes per week is 5 or over Mean number of micturition per day is 8 or over Mean number of urinary urgency episodes per day is 1 or over Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients with genuine stress incontinence Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study Patients suffering from complications for which anticholinergics are contraindicated Other exclusion criteria as specified in the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 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: ONO-8025 (KRP-197)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of urinary incontinence episodes per week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-8025, KRP-197, overactive bladder, antimuscarinic
Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program. This study has two objectives: Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients. Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients.

Official Title
-----------------
Real-World Medication Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Nintedanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newly initiated nintedanib during 10/01/2014 to 12/31/2018 Were at least 66 years old as of the date of their first nintedanib prescription claim (index date) Qualified for Medicare based on age Had at least 12 months (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period) Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) during the baseline period Exclusion criteria: Had any history of pirfenidone or nintedanib use during the baseline period Had any history of lung transplant during the baseline, index date or follow-up periods Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period Had evidence during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e. rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period Had dual eligibility of Medicare and Medicaid Had history of using pirfenidone at the same time with nintedanib during follow-up

Ages Eligible for Study
-----------------
Minimum Age: 66 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 |
| --- | --- |
| Idiopathic Pulmonary Fibrosis Patients<br>Medicare beneficiaries with IPF who newly initiated treatment with nintedanib | Drug: Nintedanib<br>* Nintedanib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence trajectories based on monthly proportion of days covered (PDC) |  | up to 12 months |
Video Analysis of Vaginal Deliveries

Study Overview
=================
Brief Summary
-----------------
Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum

Detailed Description
-----------------
Documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.

Official Title
-----------------
Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum

Conditions
-----------------
Birth Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women, at least 18 years of age (yoa), term deliveries (at least 37+0 weeks of gestation), vaginal delivery, fetal vertex presentation, single pregnancy Exclusion Criteria: younger than 18 yoa, preterm deliveries, cesarean sections, fetal malformations, maternal disease in form of collagenosis, multiples pregnancy, vaginal/vulvar/perineal pre-operations (excluding birth trauma), perineal birth trauma grade III+IV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| adequate support of perineum | documentation of support of perineum via video camera during delivery, documentation of birth trauma after delivery, documentation of fetal and maternal parameters as weight, hight, fetal presentation, etc. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perineum, videoanalysis