linjc16/ctgov huggingface dataset:
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

Official Title
-----------------
Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Conditions
-----------------
Vomiting, Diarrhea, Fever

Intervention / Treatment
-----------------
* Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 4 weeks through 12 weeks at Dose 1 Parent able to understand study procedures and give consent Exclusion Criteria: Clinical evidence of active gastrointestinal disease Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 12 Weeks

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq™ | Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 2.0 mL oral dose of RotaTeq™. 14 week treatment period<br>* Other names: V260;|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: Placebo<br>* Arm 2: Placebo. 14 week treatment period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose |  | At least 14 days following the third vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer) | 14 days following the 3rd vaccination | 
| Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer) | 14 days following the 3rd vaccination |
Bucillamine Study of Holding Remission After Infliximab Dose-off

Study Overview
=================
Brief Summary
-----------------
Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.

Official Title
-----------------
The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: bucillamine
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA according to American College of Radiology (ACR) classification criteria Age of 20 or greater DAS28-ESR < 3.2 or DAS28-CRP < 2.6 for more than 6 months Exclusion Criteria: Previously teated with bucillamine Pregnancy or lactation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bucillamine<br>* bucillamine 100 mg, twice a day<br>Drug: methotrexate<br>* methotrexate 6 mg or more per week<br>|
| Active Comparator: 2<br> | Drug: methotrexate<br>* methotrexate 6 mg or more per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of disease flare |  | 2 years |
Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look for evidence of bacteria in the urine or bladder of people with overactive bladder. Because you do not have overactive bladder, your participation in this study will be used as a comparison to those who have overactive bladder.

Official Title
-----------------
Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urge urinary incontinence based on clinical history and bladder diary; subjects must have 3 or more urge incontinence episodes/day and 10 or more voids/day. 21 years or older Healthy volunteers for control subjects Exclusion Criteria: Active cystitis performed on a catheterized urine specimen Known or suspected correctable etiology for her urge incontinence History of urinary tract stones, foreign bodies or malignancy History of recurrent Urinary Tract Infections Pregnant women, children Evidence of urge urinary incontinence or more than 1 episode of stress incontinence/day by control subject

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Subjects with urge incontinence due to overactive bladder | |
| 2<br>women with no urge symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation | Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques. | within one week of enrollment |
Reversal of Ventricular Remodeling With Toprol-XL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Seloken ZOK/Toprol-XL
* Drug: Seloken ZOK/Toprol-XL
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stable asymptomatic heart failure. Documented ejection fraction less than 0.40. Must be able to comply with all study procedures. Exclusion Criteria: Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization. Have heart problems that would not allow B-blocker therapy. Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma). Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty. Have certain heart diseases. Pregnant or breast feeding. Unlikely to survive.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seloken ZOK/Toprol-XL|50 mg|
|Drug: Seloken ZOK/Toprol-XL|200 mg|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554

Study Overview
=================
Brief Summary
-----------------
The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.

Official Title
-----------------
An Open Label Study, To Evaluate The Pharmacokinetics, Safety And Toleration Of A Single Oral Dose Of Pf-00868554 In Subjects With Hepatic Impairment To Subjects With Normal Hepatic Function

Conditions
-----------------
HEPATITIS C (HCV)

Intervention / Treatment
-----------------
* Drug: PF-868554
* Drug: PF-868554
* Drug: PF-868554


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive; Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh >50 kg (110 lbs); Exclusion Criteria: Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10); Severe ascites and/or pleural effusion; Had a transplanted kidney, heart or liver;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 62 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: PF-868554<br>* 200 mg, Child-Pugh Class A<br>|
| Experimental: B<br> | Drug: PF-868554<br>* 200 mg, Child-Pugh Class B<br>|
| Experimental: C<br>200 mg | Drug: PF-868554<br>* 200 mg, healthy volunteers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters |  | 8 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  | 8days |
Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI

Study Overview
=================
Brief Summary
-----------------
This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.

Detailed Description
-----------------
This study was designed as a retrospective case-control study. All 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times.

Official Title
-----------------
Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI, and Comparison of MR Imaging Evaluation Between NCT and NCRT

Conditions
-----------------
Rectal Cancer, MRI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological diagnosis of rectal cancer; received neoadjuvant chemoradiotherapy before surgery; before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum. before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or MRI showed that the lower margin of the tumor was within 12cm from the anal margin; pre-neoadjuvant clinical stage II/III (AJCC 7th edition); Exclusion Criteria: simultaneous distant metastatic tumor should be considered at the first diagnosis; patients with distant metastasis were not considered at the initial diagnosis; with other malignant tumors; before neoadjuvant therapy, patients had received other relevant treatments; to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;
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 |
| --- | --- | --- |
| pTRG | pathological tumour regression grading | within 2 week after surgery |
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.

Official Title
-----------------
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline (CP-526,555)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: Subjects who have used bupropion (Zyban, or Wellbutrin) previously.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline (CP-526,555)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence Weeks 9-52 |  |  | 
| Long-term Quit Rate Week 52 |  |  | 
| Continuous abstinence Weeks 9 -24 |  |  | 
| 7-day Point Prevalence Abstinence Weeks 12, 24, and 52 |  |  | 
| 4-week Point Prevalence Abstinence at Week 52 |  |  | 
| Minnesota Nicotine Withdrawal Scale |  |  | 
| Brief Questionnaire of Smoking Urges |  |  | 
| Smoking Effects Inventory |  |  | 
| Change from baseline in bodyweight |  |  |
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.

Official Title
-----------------
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Procedure: Femtosecond Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye. Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation. The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity. Exclusion Criteria: Concurrent participation or participation in the last thirty days in any other clinical trial. Known steroid IOP responder Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.) Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.) Uncontrolled systemic or ocular disease Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies) Pseudoexfoliation Ocular hypertension IOP >25 mmHg by tonometry or glaucomatous changes in the optic nerve

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femtosecond Laser<br> | Procedure: Femtosecond Laser<br>* Using the Femtosecond Laser to make a clear corneal incision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Measure the fluid pressure inside the eye | 3 months | 
| Uncorrected and Best corrected Visual Acuity | Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected). | one month |
Macrolane for Enhancement of the Shape and Fullness of the Female Breast

Study Overview
=================
Brief Summary
-----------------
The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.

Detailed Description
-----------------
This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.

Official Title
-----------------
An Open, Multi-center Study Evaluating Treatment Procedure, Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

Conditions
-----------------
Breast Enhancement

Intervention / Treatment
-----------------
* Device: Macrolane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast Exclusion Criteria: Unreasonable expectations Any medical condition that may interfere with the treatment

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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 |
| --- | --- |
| Other: Macrolane<br>Open label | Device: Macrolane<br>* Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment | Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Breasts With Improvement as Assessed by the Investigator | Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS). The scale has five grades ranging from worse to very much improved. Subjects defined as at least improved are assessed as improved, much improved or very much improved. | 6 weeks |