linjc16/ctgov huggingface dataset:
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Study Overview
=================
Brief Summary
-----------------
Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Official Title
-----------------
A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Conditions
-----------------
Corneal Edema

Intervention / Treatment
-----------------
* Drug: Netarsudil Ophthalmic
* Drug: Netarsudil Ophthalmic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years or older Documented diagnosis of FCD Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s) Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s) Exclusion Criteria: FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once Daily Netarsudil Ophthalmic Solution<br>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects. | Drug: Netarsudil Ophthalmic<br>* Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution<br>* Other names: Rhopressa®;|
| Experimental: Twice Daily Netarsudil Ophthalmic Solution<br>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects. | Drug: Netarsudil Ophthalmic<br>* Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution<br>* Other names: Rhopressa®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Thickness (CCT) | Mean change from baseline in CCT by ultrasound pachymetry | Baseline & 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal Edema, Fuchs Corneal Dystrophy, Netarsudil Ophthalmic Solution
Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

Study Overview
=================
Brief Summary
-----------------
The amount of air leaking from a chest tube can be measured in two main ways: electronic monitor connected to the chest tube numerical (non-electronic) monitor connected to the chest tube For people who have had lung surgery, it is important to understand the impact of measuring air leaks accurately in both the short term and the long term. An electronic medical device called Thopaz measures air leak electronically. Another medical device called Pleur-evac measures air leak numerically. The purpose of this study is to understand the accuracy of the method used by doctors and nurses to determine if a chest tube has an air leak. It is also important to determine the size or severity of an air leak.

Detailed Description
-----------------
Patients with air leaks following lung surgery will be assessed by a target number of 6 observers each (three nurses and three MDs) who will be randomly asked to participate. Patients will first be connected to the numerical air leak detector, followed by the electronic air leak detector. Observers will record their responses for each device. They will be blinded to responses from other observers.

Official Title
-----------------
Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

Conditions
-----------------
Pulmonary Air Leak

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or over Male and Female. Air leak occuring after any pulmonary resection Air leak persisting on or after the first post-op day of pleural drainage Air leak not entirely secondary to poor air seal at the pleural drainage incision site Pulmonary resection for benign or neoplastic diagnosis Exclusion Criteria: Tension pneumothorax Traumatic or iatrogenic pneumothorax Primary or recurrent spontaneous pneumothorax awaiting surgery Pneumonectomy patient (history of or current)

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 |
| --- | --- | --- |
| Inter-rater variability of air leak measurements. | Time frame will occur once patients have experienced an air leak. 70% of patients are expected to have a PAL on postoperative day 1. There will be a 4 hour window to complete observations from the numerical device. These observations will be followed by observations on digital device. Each observer should spend 5-10 min to complete both tasks. | Post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary air leak, Thopaz, analog, digital
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

Official Title
-----------------
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Conditions
-----------------
Advanced Stage Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Pardoprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients who have completed S308.3.002 trial Exclusion Criteria Patients with medically relevant abnormal findings (ECG, physical examination, Aes) at end of the maintenance phase (visit M6, week 24) of study S308.3.002

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pardoprunox<br>* 12-42 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: laboratory data, adverse events, vital signs, ECG |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease
Group Counseling for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of group therapy for cigarette smoking cessation. The group meets for 8 sessions and includes education and group discussion about the effects of smoking and ways to cope with withdrawal symptoms and other challenges to maintaining abstinence. In one condition, the groups also learn techniques based on cognitive therapy, to help cope with negative feelings.

Detailed Description
-----------------
The comparison condition is the same length as the cognitive behavior therapy condition but omits the cognitive restructuring component. In both conditions, smokers prepare for a quit date by using scheduled reduced smoking, which involves smoking on a set schedule that gradually reduces the number of cigarettes smoked. Post-treatment assessments occur one week after the end of treatment, and at 3-month followup. Pre- and post-treatment assessments include measures of coping skills and emotional acceptance, as well as smoking rate.

Official Title
-----------------
Cognitive Behavior Therapy for Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular daily smokers interested in quitting Exclusion Criteria: Significant suicidal ideation

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: cognitive behavior therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cigarette smoking abstinence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive coping skills |  |  | 
| depressive symptoms |  |  | 
| acceptance |  |  | 
| distress tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive behavior therapy, coping, smoking cessation, acceptance, expectancies, quit smoking, quitting smoking
The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication

Study Overview
=================
Brief Summary
-----------------
The study , observe the effect of releasing the Tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure The effect was assessed by Hb drop post operative and Hematoma formation ( measured by ultrasound ) as well as the wound complication

Detailed Description
-----------------
The study is conducted in tertiary university hospital as a referral hospital for joint arthroplasty , the patients was informed about the study and consent was taken , the same operator , same theater and the same prosthesis company as well as the same radiologist during the study period. the patient randomly assigned to either group A (Tourniquet release before closure of the wound and hemostasis ensured ) , or a group B ( Tourniquet release after wound closure ) post operative Hb drop was studied between the groups , and each patient underwent ultrasound measurement of the intraarticular hematoma . The wound complication between the groups was also studied .

Official Title
-----------------
The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication

Conditions
-----------------
Hematoma, Arthroplasty Complications

Intervention / Treatment
-----------------
* Device: tourniquet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary knee osteoarthrosis Exclusion Criteria: Rheumatoid arthritis post traumatic arthritis revision knee replacement patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- |
| Group A<br>Group A ( Tourniquet release before wound closure and hemostasis ensured ) | Device: tourniquet<br>* Tourniquet release before/after wound closure<br>|
| Group B<br>Group B ( Tourniquet release after wound closure ) | Device: tourniquet<br>* Tourniquet release before/after wound closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin(HG) drop | The difference in HG drop | ( pre-operative and post-operative day 2) | 
| Intra articular Hematoma formation | the difference in Intra articular ( knee ) Hematoma collection between the groups on day 3 post operative | day three post operative hematoma formation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourniquet, Intra articular Hematoma, Total Knee Replacement
CT Coronary Angiography and Computational Fluid Dynamics

Study Overview
=================
Brief Summary
-----------------
Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.

Official Title
-----------------
Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: CT coronary angiography and computational fluid dynamics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant stenosis at CT angiography Normal ejection fraction on echocardiography Informed consented patient Exclusion Criteria: total occlusion and collateral flow to target vessel AV conduction abnormality Left ventricular hypertrophy significant valvular heart or primary myocardial disease

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CT and FFR<br> | Device: CT coronary angiography and computational fluid dynamics<br>* Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fractional flow reserve | fractional flow reserve of stenotic coronary artery | 1day | 
| target vessel failure | composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization | 10 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, CT, Computational flow dynamics
Deprescribing for Older Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Aim 1 of the study is to identify the elements of a deprescribing intervention that address contextual factors specific to dialysis. Aim 2 of the study, described in this record, is to determine the feasibility of a deprescribing intervention tailored for older dialysis patients. Older adults receiving dialysis are often prescribed multiple medications. Some of these medications are used to treat symptoms, but they also can increase the chance of significant health problems. The purpose of this study is to identify if it is feasible to reduce the use of medications that have been identified as causing an increased risk for health problems.

Official Title
-----------------
Deprescribing for Older Dialysis Patients

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Behavioral: Deprescribing Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an adult receiving dialysis for at least 6 months at least one active prescription for a potentially inappropriate medication (e.g., opioid) Exclusion Criteria: advanced dementia hospice care non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Deprescribing Intervention<br> | Behavioral: Deprescribing Intervention<br>* Participants who are taking specific potentially inappropriate medications and their nephrologist will be engaged in the deprescribing process. The process involves deprescribing decision-making, implementation of deprescribing, and monitoring for adverse drug withdrawal events. The specific details of the deprescribing process are TBD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of deprescribing events |  | 6 months | 
| number of potentially eligible subjects |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction as measured by interview | To understand how acceptable the intervention is to patients, the investigators will do interviews in a subset (12-15) of subjects | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney failure, chronic, renal dialysis, aged, inappropriate prescribing, preliminary data
The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants

Study Overview
=================
Brief Summary
-----------------
The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.

Official Title
-----------------
The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants

Conditions
-----------------
Breastfeeding

Intervention / Treatment
-----------------
* Other: Telephone-based breastfeeding peer counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Oregon WIC participants in Jackson, Washington and Hood River counties or Umatilla Morrow Head Start. Exclusion Criteria: WIC participant outside of the 4 study agencies.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants receive standard WIC breastfeeding support but do not have contact with a breastfeeding peer counselor | |
| Other: Low Intensity<br>Participants will receive four scheduled phone calls from a peer counselor. Two prenatal calls and 2 postpartum. | Other: Telephone-based breastfeeding peer counseling<br> <br> |
| Active Comparator: High Intensity<br>Participants will receive eight scheduled phone contacts from a peer counselor. Two are prenatal and 6 are postpartum. | Other: Telephone-based breastfeeding peer counseling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding |  | 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding |  | 3 months postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
WIC, Oregon, Breastfeeding, Peer Counseling, Exclusive Breastfeeding
Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on episodic memory performance in patients with MCI

Official Title
-----------------
Efficacy of 15 mg and 50 mg of S18986 on Cognitive Symptoms in Mild Cognitive Impairment Patients Treated Over a 12-month Oral Administration Period

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Drug: S18986


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Memory complaint Acetylcholinesterase inhibitors stopped at least 3 months before selection Exclusion Criteria: Dementia Parkinson's disease Vascular disorder Depression Epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: S18986|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodic memory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other cognitive domains, activities of daily living, global impression of change, MRI, safety. |  |  |