linjc16/ctgov huggingface dataset:
Associations of Pre- and Intraoperative Endoscopic Findings of Middle Ear Status in Cholesteatoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the accuracy of preoperative HRCT of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Detailed Description
-----------------
The information of the preoperative HRCT scanning of the middle ear cavity in cholesteatoma combined with the preoperative audiologic assessment could be informed the intraoperative middle ear finding in the patients who were diagnosed with chronic otitis media with cholesteatoma, which influence the plan of surgical management. Whether these preoperative assessments can predict the intraoperative finding is unclear. The aim of this study is to assess the accuracy of preoperative HRCT of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Official Title
-----------------
Middle Ear Status in Cholesteatoma: the Associations of Preoperative Computed Tomography Scans, Audiologic Assessment, and Intraoperative Endoscopic Findings

Conditions
-----------------
Middle Ear Cholesteatoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients included in this study had otorrhea, hearing loss, or aural fullness that last more than 3 months. Otological examination revealed tympanic membrane perforation or retraction, along with cholesteatoma. Exclusion Criteria: Patients who had a previous temporal bone fracture, concomitant with congenital craniofacial anomalies, or underwent previous otologic surgery were excluded.
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 |
| --- | --- | --- |
| predictive factor of intraoperative endoscopic finding from preoperative ct finding and preoperative audiological assessment | the association of preoperative ct finding and preoperative audiological assessment compared with intraoperative endoscopic middle ear finding in middle cholestaetoma | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy between preoperative ct finding and intraoperative endoscopic finding | accuracy between preoperative ct finding and intraoperative endoscopic finding of middle ear cholesteatoma | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic,cholesteatoma,audiogram, air-bone gap
A Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

Official Title
-----------------
A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects

Conditions
-----------------
Hepatitis B, Infectious Disease, Liver Diseases

Intervention / Treatment
-----------------
* Drug: CRV431
* Drug: Placebo
* Drug: TDF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable of giving written informed consent Willing and able to complete all study requirements Healthy male or female between 18 and 55 years of age (inclusive); Body mass index 16 to 32 kg/m2 (inclusive); Exclusion Criteria: Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg Current or history of abuse of alcohol or illicit drugs Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug. Additional Exclusion Criteria for HBV Pilot Subjects Only: Evidence of significant liver fibrosis or cirrhosis History of NAFLD or NASH Positive test for HDV

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRV431<br>Either single or multiple doses of varying dose levels | Drug: CRV431<br>* Single or multiple dose(s) of CRV431<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single Placebo dose<br>|
| Experimental: TDF<br>300 mg TDF | Drug: TDF<br>* Single or multiple dose(s) of TDF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRV431, Hepatitis B Virus, Hepatitis Virus
Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

Official Title
-----------------
A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)

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

Intervention / Treatment
-----------------
* Drug: Telbivudine
* Drug: Adefovir
* Drug: Tenofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening. Other inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C, hepatitis D or HIV Patient previously received nucleoside(tide) therapy other than adefovir Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months Other exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: 1<br>Study cancelled: Withdrawn before enrollment of any participants | Drug: Telbivudine<br>* Study cancelled: Withdrawn before enrollment of any participants<br>|
| Experimental: 2<br>Study cancelled: Withdrawn before enrollment of any participants | Drug: Adefovir<br> <br> |
| Experimental: 3<br>Study cancelled: Withdrawn before enrollment of any participants | Drug: Tenofovir<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet

Study Overview
=================
Brief Summary
-----------------
The celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food. In the oral environment the investigators see enamel defects and recurrent ulcers. Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss). It has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population. In celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. These defects are classified by the grading of the CD related DED's (dental enamel defects) according to Aine. These defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. The cause is thought to be hypocalcaemia or genetic. These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population. Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population. After changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.

Official Title
-----------------
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet

Conditions
-----------------
Celiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: celiac disease Exclusion Criteria: no other systemic condition age 3-18 children on medication

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral health in children with celiac disease
Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Study Overview
=================
Brief Summary
-----------------
Pulmonary valve replacement in the adult population is an uncommon operation. The majority of native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or pulmonary stenosis created by previous childhood operations. Without the valve size constraints present at prior operations, these patients can be well-served by the placement of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac literature of the actual technique of pulmonary valve replacement. We present our current technique and the pitfalls encountered when performing pulmonary valve replacement in adults.

Detailed Description
-----------------
This will be primarily a technique paper. The only clinical data points I am interested in are the presence of pulmonary stenosis, pulmonary insufficiency or perivalvular leak on the initial post-operative echocardiogram. I estimate reviewing 50 patients' charts dated March 22.2003 through and including March 22.2006 at Emory Hospital . Primary Aim: Present an effective technique for pulmonary valve replacement Secondary Aim: Present our excellent technical results of PVR in our adult congenital patients

Official Title
-----------------
Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults undergoing pulmonary valve replacement at Emory Hospital between 3.22.03 amd 3.22.06 Exclusion Criteria: those charts that do not fall under inclusion criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PVR, cardiac, adult
An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

Official Title
-----------------
A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label Exclusion Criteria: Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin Subjects with a hypersensitivity to insulin detemir or to any of the excipients Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. Women of childbearing potential who are not using adequate contraceptive methods
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of hypoglycaemic events from baseline |  | at 12 and 24 weeks | 
| HbA1c |  | at 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects to reach HbA1c between 6.5 and 7.0% |  | at 12 and 24 weeks | 
| Glucose variability as measured by FPG |  | at 12 and 24 weeks | 
| Postprandial glycaemic control as measured by PPG |  | at 12 and 24 weeks | 
| Insulin dose and number of injections |  | at 12 and 24 weeks | 
| Body weight |  | at 12 and 24 weeks | 
| Number of adverse drug reactions (ADR) |  | at 12 and 24 weeks |
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

Official Title
-----------------
An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

Conditions
-----------------
Leukemia, Myeloid

Intervention / Treatment
-----------------
* Drug: AS1411


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary refractory or relapsed AML confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002) aged at least 18 years Exclusion Criteria: initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976) patient in blast crisis stage of chronic myeloid leukemia received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months interval of <6 months between first onset of last complete remission and current relapse those with primary refractory leukemia who have received more than three previous induction cycles relapsed patients who have received more than three previous treatment regimens

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AS1411|AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Myeloid + Acute Disease
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.

Official Title
-----------------
A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Conditions
-----------------
Ocular Inflammation

Intervention / Treatment
-----------------
* Drug: ISV-303
* Other: DuraSite Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months Signature of the subject on the Informed Consent Form Willing to avoid disallowed medications for the duration of the study Willing and able to follow all instructions and attend all study visits Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs ) Additional inclusion criteria also apply Exclusion Criteria: Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test Currently suffer from alcohol and/or drug abuse Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation Additional inclusion criteria also 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISV-303<br> | Drug: ISV-303<br>* 0.075% bromfenac in DuraSite dosed BID<br>|
| Placebo Comparator: Durasite Vehicle<br> | Other: DuraSite Vehicle<br>* DuraSite vehicle dosed BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Inflammation | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications. | 15 days |
Survivor Health and Resilience Education

Study Overview
=================
Brief Summary
-----------------
An intervention to assist pediatric cancer survivors to behaviorally manage late effects.

Official Title
-----------------
Survivor Health and Resilience Education

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Behavioral: Health education counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric cancer survivor Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 25 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Health education counseling<br>* Health education counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco use |  | 1 Month |