linjc16/ctgov huggingface dataset:
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.

Official Title
-----------------
A Phase 3, Prospective, Double-masked, Randomized, Multi-center, Vehicle-controlled, Parallel-group, 12-week Administration and 40-week Extension Study Confirming the Efficacy and Safety of K-161 Ophthalmic Solution for the Treatment of Moderate to Severe Dry Eye Disease

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

Intervention / Treatment
-----------------
* Drug: K-161
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age at the time of Informed Consent Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom Meet all other inclusion criteria outlined in the clinical study protocol Exclusion Criteria: Have any clinically significant ocular condition Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months Meet any other exclusion criteria outlined in the clinical study protocol

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-161<br>K-161 Ophthalmic Solution | Drug: K-161<br>* K-161 Ophthalmic Solution<br>|
| Placebo Comparator: Placebo<br>Vehicle Solution | Drug: Placebo<br>* Vehicle Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eye dryness score (EDS) |  | Baseline to Day 85 | 
| Change in conjunctival sum fluorescein staining score. |  | Baseline to Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total eye sum fluorescein staining score |  | Baseline to Day 85 | 
| Change in corneal sum fluorescein staining score |  | Baseline to Day 85 | 
| Change in ocular surface disease index (OSDI) | Questionnaire | Baseline to Day 85 | 
| Change in Schirmer's test | Assessed by Schirmer Tear Test (length of moistened area (mm)) | Baseline to Day 85 | 
| Change in tear film break-up time (TFBUT) | TFBUT will be assessed using fluorescein solution and measured in seconds | Baseline to Day 85 | 
| Safety and Tolerability of K-161 in participants with DED | Safety and tolerability measured in terms of the number of treatment related adverse events (TEAEs) | Baseline to Day 85 |
Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.

Official Title
-----------------
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Drug: GAP-486 (ZP-123)
* Drug: 0.9% Sodium Chloride, USP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with or without ICDs (implantable cardioverter defibrillators) Patients undergoing an electrophysiology study for evaluation of ventricular rhythm Patients with a history of heart disease Exclusion Criteria: Patients with uncontrolled blood pressure Patients with certain cardiac risk factors Patients with significant kidney or liver problems

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: GAP-486 (ZP-123)|nan|
|Drug: 0.9% Sodium Chloride, USP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study takes place within 24 hours, and looks at whether the test article makes a difference in inducing the abnormally fast heart rhythm during a 24 hour observational period. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, antiarrhythmic, programmed electrical stimulation
Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

Study Overview
=================
Brief Summary
-----------------
Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.

Official Title
-----------------
Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

Conditions
-----------------
Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or Woman whose age ≥ 18 years Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group Francophone patient Exclusion Criteria: Patient under tutorship or curatorship Patient deprived of liberty Patient under safeguard of justice Patient opposing his participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Characterize meningitis with Klebsiella pneumoniae | This corresponds to characterize Klebsiella pneumoniae meningitis, portal entry, secondary infection, associated antibiotic and associated therapies and the clinical course of patients. | Day 1 |
Monitoring Living Donor Liver Functions by Thromboelastometry

Study Overview
=================
Brief Summary
-----------------
A prospective Observational study including 50 living donor liver transplant recipients to monitor the graft functions through thromboelastometry

Detailed Description
-----------------
This is a prospective observational study Includes 50 living donor liver transplant recipients performed in gastroenterology surgical center - Mansoura University liver transplantation program. Study period: from June 2014 to May 2015 The early post-operative graft functions will be correlated with concomitant monitored thromboelastometric (TEM) parameters derived from a ROTEM Delt device TEM Samples will be collected at the following times: Pre-transplant 10 minutes post portal declamping at ICU admission Morning of Days from 1 to 7 Laboratory data relevant to graft functional status will be collected at the same times.

Official Title
-----------------
Monitoring Post-transplant Living Donor Liver Functions by Thromboelastometry. A Prospective Observational Study.

Conditions
-----------------
THROMBELASTOGRAPHY and Liver Graft Functions

Intervention / Treatment
-----------------
* Procedure: living donor liver transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living donor liver transplant recipients successively performed in the liver transplantation program - Mansoura university Exclusion Criteria: Non

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| LDLT Recipients<br>Patients subjected to living donor liver transplantation | Procedure: living donor liver transplantation<br>* living donor liver transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| r (correlation coefficient) between clot firmness time at 20 minutes, clotting time and INR | Both blood sample for INR and other lab test and the sample for TEG will be simultaneously drawn from the arterial line for reading of days 0,1 and 2 then from the CVP for the rest of the study readings | 20 minutes after starting the TEG test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum bilirubin |  | 20 minutes after the start of the TEG test | 
| r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum SGPT |  | 20 minutes after the start of the TEG test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
living donor liver transplantation, graft function, thromboelastometry
Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent

Study Overview
=================
Brief Summary
-----------------
This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.

Detailed Description
-----------------
This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.

Official Title
-----------------
Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Those HIV seropositive subjects participating in or being screened for participation in selected NIAID or NCI intramural HIV studies will be eligible for participation in this study. Eligible subjects are those willing and able to provide their own informed consent. No subjects that are unable to speak English or are unable or unwilling to communicate with investigators for any reason.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Compensation, Motivations, Volunteers
Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA

Study Overview
=================
Brief Summary
-----------------
To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children below 5 years

Official Title
-----------------
Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children Below 5 Years Old (A Before and After Study)

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Procedure: full mouth rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 2 to 5 years . Children with untreated early childhood caries . Children who will undergo dental treatment under general anesthesia. Exclusion Criteria: Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc. Children with special healthcare needs. Children whose parents had no home or mobile phone to enable postoperative contact. Parent that will not sign the consent.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: full mouth rehabilitation|full mouth rehabilitation under general anesthesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health related quality of life (OHRQOL) | Oral health related quality of life (OHRQOL) will be measured by validated questionnaire which is : Early Childhood Oral Health Impact Scale (ECOHIS) . the unit of measurement is likert scale. | change from baseline oral health related quality of life at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Children's weights will be measured in kilograms and heights in meters .Body max index (BMI) will be calculated using this formula: BMI = weight (kg) / height (m)² to report BMI in kg/m^2 | change of baseline body mass at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, full mouth rehabilitation, Quality of Life
Dietary Pork, Appetite and Weight Loss in Human

Study Overview
=================
Brief Summary
-----------------
The entire study protocol will last 13 weeks. Women will be randomly assigned to one of two experimental groups: high and low protein. All women will consume their unrestricted habitual diet during week 1 while baseline testing and measurements are taken. Starting at week 2, women in both groups will be counseled to consume a 750 kcal/day energy deficit diet containing either the RDA (LP group) or more than the recommended dietary allowance (RDA) (HP group) for protein. The energy restriction period will continue for 12 weeks (through study week 13) and is expected to result in body weight reduction of approximately 17 pounds. Testing and measurements will be repeated during week 13.

Conditions
-----------------
Appetite, Weight Loss

Intervention / Treatment
-----------------
* Other: Higher Protein (HP)
* Other: Lower Protein (LP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible women will have a body mass index (BMI: weight (kg)/height (m2)) ranging from 26-36. Must be at least 21 years old. Exclusion Criteria: Women with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded. BMI <26 or >36. Younger than 21 years old.

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher Protein (HP)<br>Subjects will be required to follow their seven day menu plan for the 12 weeks of intervention. The HP menus will contain 30% protein, 45% carbohydrate, and 25% fat. Subjects in the HP group will be provided with portioned, cooked and frozen pork products as part of their HP menu plan. | Other: Higher Protein (HP)<br> <br> |
| Experimental: Lower Protein (LP)<br>Subjects will be required to follow their seven day menu plan for the 12 weeks of intervention. The LP group menus will contain 18% protein, 57% carbohydrate, 25% fat. The LP group will follow a lacto-ovo vegetarian menu with no striated tissue foods. Subjects in the LP group will be provided with selected, portioned dairy products. | Other: Lower Protein (LP)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Study Overview
=================
Brief Summary
-----------------
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC

Detailed Description
-----------------
The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid

Official Title
-----------------
Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: endostar
* Drug: Placebos
* Radiation: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC Brain metastasis Exclusion Criteria: KPS<60

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: arm a<br>This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study | Drug: Placebos<br>* saline solution<br>* Other names: negative control;Radiation: radiotherapy<br>* radiotherapy<br>|
| Experimental: arm b<br>This group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine | Drug: endostar<br>* endostatin<br>* Other names: An antiangiogenic drug;Radiation: radiotherapy<br>* radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | the time from the start of treatment to the progression of the brain metastases, in months | From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival （OS） | the total survival time of the patient from the start of treatment | From date of randomization until the date of death, assessed up to 36 months |