linjc16/ctgov huggingface dataset:
Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.

Detailed Description
-----------------
This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

Official Title
-----------------
A Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension.

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

Intervention / Treatment
-----------------
* Drug: Nebivolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Black adults with an average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline. Exclusion Criteria: Recent myocardial infarction or stroke Contraindication to beta-blocker therapy

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Change in sitting systolic blood pressure (SBP) |  |  | 
| -Change in supine and standing DBP and SBP |  |  | 
| -Response rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Beta-Blocker
Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.

Detailed Description
-----------------
The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.

Official Title
-----------------
A Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Ultra
* Other: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corrected VA of 0.6 LogMar or better OU Exclusion: Topical ocular medication use Presence of Ocular conditions (blepharitis, conjunctival infections, etc)

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Systane Ultra<br>Systane Ultra Lubricant Eye Drops | Other: Systane Ultra<br>* Lubricant Eye Drops<br>* Other names: Systane Ultra Lubricant Eye Drops;|
| Active Comparator: Optive<br>Optive Lubricant eye drops | Other: Optive<br>* Lubricant eye drops<br>* Other names: Optive Lubricant eye drops;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBUT | Tear Film break-up time | 14 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye or lubricant eye drops
Pediatric Liver Database

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin.

Detailed Description
-----------------
In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment.

Official Title
-----------------
Pediatric Liver Disease and Liver Transplant Database

Conditions
-----------------
Liver Disease, Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under 18 years of age newly diagnosed with a liver disease, currently listed for liver transplant, or who are being considered for liver transplantation and evaluated receive a liver transplant prior to their eighteenth birthday Exclusion Criteria: Patients decline participation. Patients have no liver diseases.

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- |
| Liver Disease (LD)<br>These child subjects have some form of liver disease (including those who need a liver transplant) or have already had a liver transplant. | |

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
-----------------
Liver, Transplant
Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men

Study Overview
=================
Brief Summary
-----------------
To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.

Detailed Description
-----------------
Although psychological disorders such as anxiety and depression are known to be associated with sexual dysfunction, and their interactions have been reported by many studies, particularly the prevalence of these two aspects and the relationship between them in infertile men in China have not been well investigated. The investigators' aim is to evaluate the prevalence of psychological symptoms and sexual dysfunction and interactions between them systematically by using validated questionnaires and scales.

Official Title
-----------------
Study of Possible Interactions Between Psychiatric Disorders and Sexual Dysfunction in Infertile Men

Conditions
-----------------
Anxiety, Depression, Sexual Dysfunction, Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men who seek treatment for infertility (infertility is defined as the inability to conceive after 1 year of unprotected intercourse) age ≥ 18 years in a heterosexual, stable relationship for at least 1 year able to read and speak Chinese Exclusion Criteria: inability to read and understand the questionnaire because of language difficulties already evaluated during an earlier survey men on medication that could have affected their ejaculatory and erectile function and/or psychological status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with depression or anxiety<br>Hospital Anxiety and Depression Scale score over 9 points | |
| without depression or anxiety<br>Hospital Anxiety and Depression Scale score less than 8 points | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, depression, sexual dysfunction, infertility
OSA in Children Referred for Adenotonsillectomy

Study Overview
=================
Brief Summary
-----------------
In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure. There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG). The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy. The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life. The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.

Official Title
-----------------
Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 2-5 year referred for adenoidectomy and/or tonsillectomy Exclusion Criteria: craniofacial anomalies neurological diseases neuropsychiatric diseases

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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 |
| --- | --- | --- |
| Prevalence of OSA | Apne hypopne index (AHI)/ respiratory disturbance index (RDI) | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative PSG results | Apne hypopne index (AHI)/ respiratory disturbance index (RDI) | Up to 2 years |
A Pre-endoscopic Prediction Model for Inadequate Bowel Preparation in Patients Receiving Split Dose Polyethylene Glycol Preparation

Study Overview
=================
Brief Summary
-----------------
After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications. Based on answer, the investigators will develop a prediction model for inadequate bowel preparation and prove validation. This model can take the additional measures to subjects predicting improper cleansing. It can contribute to improve the accuracy of the test and reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a improvement of the quality of management

Conditions
-----------------
Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 20 years old Exclusion Criteria: Less than 20 years old Cardiac, renal, and metabolic dysfunction in patients with serious adverse Mental or central nervous system disorders Individuals with bwel obstruction Individuals who can not read and understand the consent form (literacy, foreign, etc.) However, although individuals with vision / hearing disturbance and deterioration of cognitive abilities, they may participate in the research if can be able to complete the survey with one guardian or the help of researchers.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| colonoscopy group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel cleansing state | Based on quality of bowel preparation(bowel cleansing state), we will develop a prediction model for inadequate bowel preparation. And then, assess to efficiency and reducing subjects' satisfaction. | average 24hours before colonoscopy after taking coolprep | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel preparation, coolprep, colonoscopy, prediction model
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.

Official Title
-----------------
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

Conditions
-----------------
Ebola Virus

Intervention / Treatment
-----------------
* Drug: CMX001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive for Ebola virus RNA in plasma Subject must be able to ingest, absorb, and tolerate oral medication Subject must be willing to use adequate contraception during their participation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 75 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: CMX001<br>CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses. | Drug: CMX001<br>* CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.<br>* Other names: Brincidofovir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability. |  | 4 weeks |
Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF

Official Title
-----------------
A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase II Study to Assess the Efficacy of AZD7009 (AR H065522XX) Given Intravenously (Infusion for 15 or 30 Minutes) to Patients for Conversion of Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: AZD7009, no generic name available


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical indication for cardioversion of Atrial Fibrillation. Effective oral anticoagulation according to local routines or a TEE without any finding of intracardial thrombus or signs of thrombogenecity Exclusion Criteria: Clinically significant sinus and/or AV node dysfunction. Serum or plasma potassium <3.8 mmol/L or >5.0 mmol/L. QTc(Bazett) >450 ms. Any QRS duration >150 ms

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD7009, no generic name available|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients that have converted from AF within 90 minutes from start of infusion. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to conversion of AF from start of the infusion. |  |  |
Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Study Overview
=================
Brief Summary
-----------------
Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

Official Title
-----------------
A Nonrandomized, Open-label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Drug: Cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with end-stage renal disease scheduled to receive a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age. Exclusion Criteria: Subjects with active major infection, including active hepatitis B or C infection, HIV, decreased platelets, elevated lipids, or multiple organ transplants.

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 |
| --- |
|Drug: Cyclosporine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 12 months post-transplantation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Kidney Transplant
Post-Marketing Surveillance of Lenvima in Korean Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.

Official Title
-----------------
Post-Marketing Surveillance of Lenvima in Korean Patients

Conditions
-----------------
Differentiated Thyroid Carcinoma (DTC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participants who meet the following criteria will be eligible for inclusion in the study: Participants with approved indication for lenvatinib in Korea Participants who have written consent for use of personal and medical information for the study purpose Exclusion Criteria: Investigators will refer to approved indications and contraindications regarding exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lenvatinib 4 milligram (mg) and 10 mg capsule<br>Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions |  | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E7080, Post-Marketing Surveillance, Lenvima, Lenvatinib, Differentiated thyroid carcinoma, Refractory to radioactive iodine, Progressive, locally recurrent, metastatic