linjc16/ctgov huggingface dataset:
A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine

Study Overview
=================
Brief Summary
-----------------
Investigators in the Division of Infectious Diseases and the Division of Hospital Medicine of The George Washington University Medical Center are carrying out a study to determine if hospitalized patients receiving the polyvalent pneumococcal vaccine during an acute illness develop an adequate antibody response. The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol, which assigns appropriate patients for vaccination based on the current guidelines from the Advisory Committee on Immunization Practices (ACIP).

Official Title
-----------------
A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Other: Pre and post vaccination titers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or female patients ages 18 or older Diagnosis of pneumonia requiring hospitalization Admission to the Medicine Ward under the Pneumonia Core Measure protocol Eligible to receive standard of care pneumococcal vaccine by the treating physician Able to receive an injection Able to provide informed consent Exclusion Criteria: Preexisting history of immunosuppression, to include any of the following: HIV/AIDS, Chronic corticosteroid use, Malignancy requiring myeloablative chemotherapy, Hematologic malignancy, History of solid organ or stem cell transplant Pregnancy Receipt of pneumococcal vaccine within the last 5 years Prior history of hypersensitivity reaction to the vaccine Unable to return for follow-up testing

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Pneumonia patients<br>The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol. | Other: Pre and post vaccination titers<br>* Titers will be obtained pre vaccination and 4 weeks post vaccination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in the pre- and post-vaccination pneumococcal serotype-specific IgG concentration from baseline will be considered protective based on the laboratory reference range. |  | 5 weeks |
Exploring the Visual Sensitivity for Topological Properties in Newborn Infants

Study Overview
=================
Brief Summary
-----------------
The topological perception theory proposed a precise description for how one organizes the visual world that eliminates the vagueness of subjective phenomenology. In addition, the topological theory challenges the dominant computational view on the part-to-whole hierarchy of visual information processing. Lines of evidence from adult psychophysics, brain imaging data, and even honeybee's behavior have supported the notion that the global topological properties are the very primitives of visual representation. However, the question of how the sensitivity to topological properties originates during development has not been explored much. In a previous study, the investigators found that 2- to 6 month old infants could reliably discriminate stimuli based on topological differences, but failed to do so based on geometric differences. Using familiarization/novelty preference procedure, the present study intends to explore the visual sensitivity for topological properties in newborn infants. Experiment 1 focuses on whether neonates can discriminate a disk (no hole) and a ring (with a hole) that are topologically different, and/or a disk (no hole) and a triangle (no hole) that are geometrically different. Experiment 2 focuses on whether neonates can detect a change in the number of holes and/or the size of the hole. If newborn infants are only sensitive to topological properties and not to geometric properties, this will be a strong proof for the claim that topological property is the very primitive visual representation at empirical as well as theoretical level.

Official Title
-----------------
Exploring the Visual Sensitivity for Topological Properties in Newborn Infants

Conditions
-----------------
Visual Sensitivity in Newborns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full-term and healthy newborns Exclusion Criteria: Eye illnesses or other physical problems

Ages Eligible for Study
-----------------
Minimum Age: 3 Hours
Maximum Age: 14 Days

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
perceptual development, topological perception theory, familiarization/novelty preference method, Discriminate a disk and a ring (topologically different),, Discriminate a disk and a triangle (geometrically different), Detect a change in the number of holes, Detect the size of the hole
Speckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge

Study Overview
=================
Brief Summary
-----------------
Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper time for surgery

Official Title
-----------------
Assessment of Rheumatic Heart Disease Patients With Chronic Severe Mitral Regurge by Speckle Tracking Echocardiography for Proper Timing of Surgical Operation.

Conditions
-----------------
Rheumatic Heart Disease

Intervention / Treatment
-----------------
* Procedure: Replacment of mitral valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rhuematic heart disease with severe mitral regurge Exclusion Criteria: non rheumatic mitral regurge

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Group a<br> | Procedure: Replacment of mitral valve<br>* Mitral valve replacment by prothsis<br>|
| Active Comparator: Group b<br> | Procedure: Replacment of mitral valve<br>* Mitral valve replacment by prothsis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of surgical operation in patients with chronic severe mitral regurge |  | One year |
Clinical Effects of Soluble Dietary Fiber Supplementation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.

Detailed Description
-----------------
Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.

Official Title
-----------------
Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation

Conditions
-----------------
Hypomotility, Constipation

Intervention / Treatment
-----------------
* Drug: Pectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients(age≧18y) Admitted for slow-transit constipation were considered eligible Exclusion Criteria: Mental disorders Cancer Inflammatory bowel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soluble dietary fiber<br>pectin, a kind of soluble dietary fiber | Drug: Pectin<br>* pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks<br>* Other names: soluble dietary fiber;|
| No Intervention: Placebo<br>Placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy: intestinal transit time | colonic transit time | four weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy: clinical symptoms | Wexner constipation score | four weeks after inclusion | 
| efficacy: gut microbiota | real-time PCR | four weeks after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, colon transit time, gut microbiota, soluble dietary fiber, disturbance of gut microbiota in constipation
Rifaximin Versus Lactulose in Renal Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.

Official Title
-----------------
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure

Conditions
-----------------
Liver Cirrhosis, Renal Failure

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Drug: Lactulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cirrhosis of liver of any etiology progressive renal failure stage 0-2 hepatic encephalopathy Exclusion Criteria: pregnant women

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>35 patients receiving rifaximin | Drug: Rifaximin<br>* 400 mg orally<br>* Other names: Xifaxin, Salix Pharmaceuticals;|
| Experimental: B<br>35 patients receiving lactulose | Drug: Lactulose<br>* 20 grams titrate to 2-3 bowel movements in one day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| slower progression to severe hepatic encephalopathy, stage 3 or 4 |  | during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhosis of liver and progressive renal failure
Vitamin D Treatment in Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response.

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Adding vitamin D
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Hepatitis C Genotype 1 Exclusion Criteria: Vitamin D intoxication Renal Failure Liver Failure Malignancy

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Experimental: Vitamin D<br>An addition of Vitamin D to the standard treatment | Drug: Adding vitamin D<br>* Adding 1000IU/Vitamin D daily<br>Drug: Vitamin D<br>* Addition of 1000IU/day Vitamin D<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase the sustained virological response |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with Chronic Hepatitis C
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: VB-111
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma; Measurable disease by RANO criteria; Disease progression or recurrence following standard of care treatment with temozolomide and radiation; An interval of at least 4 weeks between prior surgical resection and study enrollment; An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol; Recovered to Grade 1 or less from the toxic effects of any earlier intervention; Karnofsky performance status > 60% Exclusion Criteria: Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc); Prior stereotactic radiotherapy; Active infection; Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI; Subjects who suffered from an acute cardiac event within the last 12 months; Subjects with active vascular disease, either myocardial or peripheral; Subjects with proliferative and/or vascular retinopathy; Subjects with known active second malignancy;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VB-111<br>Antiangiogenic and vascular disruptive agent | Drug: VB-111<br> <br> Drug: Bevacizumab<br>* Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | From date of study entry until the date of death from any cause (up to 10 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed Glioblastoma Multiforme, GBM
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study

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

Intervention / Treatment
-----------------
* Drug: AK106-001616
* Drug: Placebo
* Drug: Active comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of RA (class I to III) Stable dose of methotrexate (at least 12 weeks) Exclusion Criteria: Pregnant or breastfeeding Abnormal screening laboratory test values considered to be clinically significant

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK106-001616<br> | Drug: AK106-001616<br>* Part1: Dose escalation Part2: Dose expansion<br>|
| Placebo Comparator: Placebo<br>Part1: AK106-001616 and Placebo | Drug: Placebo<br> <br> |
| Active Comparator: Active comparator<br>Part2: AK106-001616 and Active comparator | Drug: Active comparator<br> <br> |

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
-----------------
AK106-001616
Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes

Study Overview
=================
Brief Summary
-----------------
Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has been used to evacuate the premacular hemorrhage

Official Title
-----------------
Evaluation of Nd:YAG Laser Hyaloidotomy for Management of Premacular Subhyaloid Hemorrhage in Eyes With Proliferative Diabetic Retinopathy

Conditions
-----------------
Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: Nd:YAG laser Hyaloidotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea. Eyes with proliferative diabetic retinopathy Exclusion Criteria: Dense media opacity (corneal/cataract) Patients with bleeding tendency or on anti-coagulant drugs

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Procedure: Nd:YAG laser Hyaloidotomy|Using the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity improvement | Testing VA after YAG laser | 1 week |
The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements

Study Overview
=================
Brief Summary
-----------------
Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Dopamine
* Drug: Norepinephrine
* Other: no medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap Exclusion Criteria: Patients having contraindications for the operation. Patient refusal to participate in the study
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 |
| --- | --- |
| Active Comparator: dopamine group<br>vasopressor dosage individually titred according to the mean arterial pressure | Drug: Dopamine<br> <br> |
| Active Comparator: norepinephrine group<br>vasopressor dosage individually titred according to the mean arterial pressure | Drug: Norepinephrine<br> <br> |
| Active Comparator: control group<br>no medication | Other: no medication<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites |  | 72 hours |