linjc16/ctgov huggingface dataset:
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
* Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension
* Drug: Timolol 5 mg/ml eye drops, solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Diagnosis of open-angle glaucoma Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Pregnant Other protocol-defined exclusion criteria may apply

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brinzolamide +Timolol<br> | Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension<br>* One drop twice daily in each study eye for six months<br>|
| Active Comparator: Brinzolamide<br> | Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension<br>* One drop twice daily in each study eye for six months<br>* Other names: AZOPT;|
| Active Comparator: Timolol<br> | Drug: Timolol 5 mg/ml eye drops, solution<br>* One drop twice daily in each study eye for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intra-ocular pressure (IOP) |  |  |
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone in the prevention of atrial fibrillation after cardiac surgery.

Official Title
-----------------
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery

Conditions
-----------------
Atrial Fibrillation, Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: metoprolol, amiodarone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective CABG and aortic valve patients in cardiac surgery, previous use of betablocker therapy Exclusion Criteria: previous atrial fibrillation or flutter, thyroid disease, uncontrolled heart failure, II or III degree atrioventricular block
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 |
| --- | --- |
| Active Comparator: metoprolol<br> | Drug: metoprolol, amiodarone<br>* to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery<br>|
| Active Comparator: amiodarone<br> | Drug: metoprolol, amiodarone<br>* to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of atrial fibrillation |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention
Three Times Daily Dosing of UT-15C

Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Official Title
-----------------
A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: UT-15C


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy male and female subjects aged 18-55 years of age; weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UT-15C<br> | Drug: UT-15C<br> <br> * Other names: UT-15C SR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing. | Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2 | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of UT-15C after a single 0.5mg dose on Day 1 | Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2 | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volunteers
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to determine whether an interactive, online educational platform could improve procedure show rates and bowel preparation scores in an outpatient population presenting for routine colonoscopy.

Detailed Description
-----------------
The investigators performed a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. Eligible patients were randomized to two groups. Both groups received verbal and written instructions per standard care, while the intervention group received access to an interactive, on-line video. Primary outcomes were bowel preparation scores graded using the Boston Bowel Prep Score (BBPS), procedure show rates, patient satisfaction, and pre-procedure anxiety. Secondary outcomes included adenoma detection rate, mean bowel prep score per colonic segment, total number of polyps detected, and complication rates.

Official Title
-----------------
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy: A Randomized Controlled Trial

Conditions
-----------------
Colon Cancer Screening

Intervention / Treatment
-----------------
* Other: educational video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Access to text messaging and the internet (mobile phone access alone was considered sufficient) Prescribed standard split-dose bowel preparation Able to provide informed consent via telephone. Exclusion Criteria: Pregnant Mentally impaired Undergoing screening or surveillance for inflammatory bowel disease .
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard education<br> | |
| Active Comparator: educational video<br> | Other: educational video<br>* an interactive educational video was viewed by participants in the intervention arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of bowel prep | adequacy of colonoscopy bowel prep was scored from 0 (worst) to 9 (best). | intra procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

Study Overview
=================
Brief Summary
-----------------
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.

Official Title
-----------------
A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Peginterferon Alfa-2B
* Drug: Peginterferon Alfa-2A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand and sign the informed consent form. Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon. Exclusion Criteria: Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| peginterferon alfa 2b<br> | Drug: Peginterferon Alfa-2B<br>* pre-received standard peginterferon alfa-2b therapy<br>* Other names: pegberon;|
| peginterferon alfa 2a<br> | Drug: Peginterferon Alfa-2A<br>* pre-received standard peginterferon alfa-2a therapy<br>* Other names: pegasys;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of HBeAg seroconversion |  | from the second year to the fifth year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decent degree of HBeAg |  | from the second year to the fifth year | 
| decent degree of HBV DNA |  | from the second year to the fifth year | 
| rate of alanine aminotransferase normalization |  | from the second year to the fifth year | 
| rate of HBeAg loss |  | from the second year to the fifth year | 
| rate of HBV DNA undetectable |  | from the second year to the fifth year | 
| rate of HBeAg seroconversion |  | from the second year to the fifth year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peginterferon alpha, HBeAg seroconversion, immune control
Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).

Detailed Description
-----------------
This is an open label study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

Official Title
-----------------
An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

Conditions
-----------------
Alzheimer's Disease, Stroke, Parkinson's Disease, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: AVP-923


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 75 years of age, inclusive Clinical diagnosis of PBA (pseudobulbar affect) If female, must not be pregnant or breast feeding Exclusion Criteria: Sensitivity to quinidine or any opiate drugs Current or prior history of major psychiatric disturbance Currently participated in a trial within the past 30 days

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AVP-923|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional control |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS, MS, CNS, AD, TBI, Dextromethorphan, IEED, Emotional
Bimatoprost as a Treatment for Graves' Orbitopathy

Study Overview
=================
Brief Summary
-----------------
Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease

Official Title
-----------------
The Role of Bimatoprost in Graves' Periorbitopathy

Conditions
-----------------
Graves Ophthalmopathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis - Exclusion Criteria: Active Graves Disease, Currently pregnant, Taking Steroids -

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost in more proptotic eye<br>Patients instill Bimatoprost in their more proptotic eye one nightly | Drug: Bimatoprost Ophthalmic<br>* Bimatoprost, aka Lumigan, one drop in one eye nightly<br>|
| No Intervention: Control<br>Bimatoprost is not instilled in the patient's fellow eye | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in periorbital fat causing improvement in proptosis |  | 1 year |
Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Study Overview
=================
Brief Summary
-----------------
Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia. Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected. Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested. Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability. Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.

Official Title
-----------------
Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

Conditions
-----------------
Mastectomy

Intervention / Treatment
-----------------
* Drug: lidocaine aguettant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic Age: upper to 18 years Weight: upper to 50 kg Exclusion Criteria: Cutaneous infection in the point of draining Clinical Disorder(Confusion) of the coagulation Retreat(Withdrawal) of the consent in the course of protocol Unwanted Effect engraves(burns) requiring the stop(ruling) of the treatment(processing)

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

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

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: lidocaine<br>lidocaine traitment | Drug: lidocaine aguettant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of 'drug lidocaine' | during tumescent infiltrative anaesthesia for mastectomy. | 36 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic postoperative efficacy |  | 36 MONTHS |
Diabetic Patients With End-Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
In diabetic patients with end-stage renal disease to investigate the prevalence of diabetic complications and quality of life and to compare with non-diabetic patients with ESRD and diabetic patients with normal kidney function.

Conditions
-----------------
Diabetes, End-Stage Renal Disease, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of diabetes and treatment with either dialysis or renal transplantation Exclusion Criteria: Age < 18 Pregnancy

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life

Study Overview
=================
Brief Summary
-----------------
Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS

Detailed Description
-----------------
Quality of life and risk factors for developing major LARS are explored using the EORTC QLQ C30. Therapeutic options were explored in the cohort experiencing major LARS

Official Title
-----------------
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life

Conditions
-----------------
Rectal Cancer, Low Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Behavioral: LARS score/ EORTC QLQ C30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low anterior resection for rectal cancer between 2006-2016 Adults Exclusion Criteria: abdomino perineal resection patients who do not understand Dutch

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: cross sectional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: QOL, risk factor and therapeutic options<br>questionnaires | Behavioral: LARS score/ EORTC QLQ C30<br>* administering questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment QoL | Assessments using questionnaire European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ C30) | up to 10 years after rectal resection | 
| frequencies of therapeutic options to manage LARS | Self developed questionaire to determine what therapeutic options were used to manage LARS | up to 10 years after rectal resection | 
| Frequency of LARS | Assessment of LARS using validated LARS Score | up to 10 years after rectal resection |