linjc16/ctgov huggingface dataset:
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

Study Overview
=================
Brief Summary
-----------------
This is an extension study of A7501013 (P05771/NCT00145496) to further test the efficacy and safety of Asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.

Official Title
-----------------
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: asenapine
* Drug: olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continue to meet all demographic and procedural inclusion criteria of the A7501013 trial to enter into this extension trial. Have demonstrated an acceptable degree of compliance and completed the A7501013 trial, and would benefit from continued treatment according to the investigator. Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition. Have been judged to be medically noncompliant in the management of their 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: asenapine<br> | Drug: asenapine<br>* 5-10 mg sublingually twice daily for 26 weeks<br>|
| Active Comparator: olanzapine<br> | Drug: olanzapine<br>* 5-20 mg by mouth once daily for 26 weeks<br>* Other names: Zyprexa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms. | Baseline of A7501013 to Day 365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life. | Baseline of A7501013 to Day 365 |
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.

Official Title
-----------------
Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Other: Road-tracking test
* Other: Car-following test
* Other: Harsh-braking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥18.5 and <25.0 kg/m2 at screening inspection No visual impairment (enable to correct the vision with eyeglasses or contact lens) Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study Exclusion Criteria: History of drug and food allergy Routinely drink alcohol before bedtime Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: driving test<br> | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation of Lateral Position (SDLP) |  | 60 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Coefficient of Variation (DCV) |  | 25 min. | 
| Brake Reaction Time (BRT) |  | 15 min. |
Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

Study Overview
=================
Brief Summary
-----------------
The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.

Official Title
-----------------
A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: shock waves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction for more than 6 months Informed consent Positive effect of phosphodiesterase type 5 inhibitor (PDE5i) IIEF-15 score less than 20 No neurological disease Stable partnership for more than 3 months Age 18-75 Exclusion Criteria: Total prostatectomy Another reason for ED except for vascular disorder Clinically significant hematological disease Heart stroke, Arrythmia during the last 6 months Cancer during the last 5 years Intake of antiandrogen ED treatment with the last 7 days IIEF score higher than, equal to 20 Previous shockwave treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- | --- |
| Active Comparator: Shock wave treatment<br>Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2) | Device: shock waves<br>* extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off<br>* Other names: extracorporeal shock wave therapy;|
| Placebo Comparator: Placebo Shock wave treatment<br>Shock waves are prohibited to enter the body by placebo stand-off. | Device: shock waves<br>* extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off<br>* Other names: extracorporeal shock wave therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire) |  | up to 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of erection (Quality of Erection Questionnaire) |  | At screening, 1, 3 and 6 months post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IIEF score, ED
Evaluating a Website for Parents of Injured Children

Study Overview
=================
Brief Summary
-----------------
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills.

Detailed Description
-----------------
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. Secondary objective is to compare conditions as above with regard to child and parent PTS symptoms at 6 wks.

Official Title
-----------------
Evaluating a Website for Parents of Injured Children

Conditions
-----------------
Acute Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: After The Injury website
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 6 through 17 who sustained an injury within the past 2 months and their parents. Have access to the Internet at home (for Stage 3 only) Exclusion Criteria: Parent does not read or understand English Child's injury is due to participation in organized sports Child's injury is due to suspected abuse or family violence

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: After The Injury website<br> | Behavioral: After The Injury website<br>* Parents participate in a web-based prevention intervention, which provides education and tips specific to coping with a child's injury.<br>|
| Other: Usual care<br>Treatment as usual | Other: Control<br>* Usual hospital care provided.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on measure of parent knowledge re: traumatic stress and coping assistance. |  | 6 wks post-intervention |
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a narrow therapeutic index drug for which a large number of relevant drug-drug interactions are known. Flibanserin is now under evaluation in postmenopausal women which increases the likelihood that flibanserin and digoxin will be administered together in the clinical setting.

Official Title
-----------------
An Open Two-way Cross-over Study to Evaluate the Effect of Multiple Doses of Flibanserin 100 mg Film-coated Tablets Given Once Daily on the Single Dose Pharmacokinetics of Digoxin 0.5 mg in Healthy Male and Female Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Flibanserin plus Digoxin
* Drug: Digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: healthy male and female subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digoxin plus Flibanserin<br>Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose | Drug: Flibanserin plus Digoxin<br>* Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose<br>|
| Experimental: Digoxin<br>Digoxin 0.5 mg as single dose | Drug: Digoxin<br>* Digoxin 0.5 mg as single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration of digoxin in plasma after single dose (Cmax) |  | 72 hours | 
| Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24) |  | 72 hours |
Surgical Treatment of Adult Trigger Finger

Study Overview
=================
Brief Summary
-----------------
Trigger finger is a condition commonly treated with surgical intervention, yet no specific incision type has been associated with improved or worsened scar quality or outcome. Therefore, the investigators objective is to determine if the incision type may affect the results of operative treatment of trigger finger. Therefore, the goals of this study are as follows: Primary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release with scar quality and patient satisfaction via a validated scar evaluation scale. Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release to patient outcome via a validated upper extremity outcome score.

Official Title
-----------------
A Prospective, Randomized Trial Evaluating the Type of Incision on Outcomes and Patient Satisfaction in the Surgical Treatment of Trigger Finger

Conditions
-----------------
Trigger Finger

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over the age of 18 presenting to the four attending surgeons (Don Coleman, Douglas Hutchinson, Andrew Tyser, Angela Wang) through either the University of Utah Orthopaedic Center or the Veteran Affairs Hospital will be evaluated for possible inclusion into the study Patients who fail conservative treatment and elect to proceed with open surgical release of the A1 pulley will be offered the option of being included in the study. Exclusion Criteria: Patients aged less than 18, previous failed surgical A1 pulley release, and patients receiving their care outside of the University of Utah Hospital system or the Veteran Affairs Hospital In addition, this study will evaluate trigger finger release; patients receiving treatment for trigger thumb will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale |  | 1 Year Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score |  | 1 Year Follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigger Finger, Prospective Clinical Research, Randomized, Questionnaires, Transverse, Longitudinal
Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

Study Overview
=================
Brief Summary
-----------------
This randomized trial is determining the role of antibiotic prophylaxis in the prevention of the infectious complications in patients carrying out totally implantable venous access device.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: cefazolin Sodium
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years of age Have solid tumor White cells >4000 Platelets >100.000 Prothrombin time in normal range Exclusion Criteria: Drug allergy Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Placebo Comparator: placebo<br>no antibiotic is used | Drug: placebo<br>* placebo<br>|
| Active Comparator: drug<br>cefazolin Sodium 1g i.v. before the operation | Drug: cefazolin Sodium<br>* cefazolin Sodium 1g i.v. before operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infectious complication |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implantable catheters, Indwelling Catheters, infection, cefazolin sodium, prophylactic, antibiotic, totally implantable venous access device, cancer patients
Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.

Official Title
-----------------
Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ms diagnosis verified age > 18 years central pain symptoms for more than 3 months central pain diagnosis confirmed by neurological examination adequate anticonceptive treatment for women with child bearing potential informed consent baseline pain of more than 4 on numeric rating scale Exclusion Criteria: other cause of pain previous allergic reaction towards levetiracetam known adverse drug reaction on levetiracetam pregnancy severe disease inability to follow study protocol treatment with antidepressants, other anticonvulsants or opioids

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levetiracetam|Levetiracetam tablets 500 mg, total daily dose 3000 mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period) |  | Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rated on a 0 to 10 point numeric rating scale |  | Daily | 
| Pain subtypes rated on the same scale. |  | Daily | 
| Brush-evoked pain |  | Baseline and end of each treatment period | 
| Pin-prick-evoked pain |  | Daily | 
| Cold-evoked pain |  | Daily | 
| Health related quality of life (SF36) |  | Baseline and end of each treatment period | 
| Pain related sleep disturbance |  | Daily | 
| Use of escape medication |  | Daily | 
| Muscle spasms as measured on 2 different scales |  | Baseline and end of each treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, central pain, levetiracetam