linjc16/ctgov huggingface dataset:
Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.

Official Title
-----------------
Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Conditions
-----------------
Arthritis, Rheumatoid, Spondylitis, Ankylosing

Intervention / Treatment
-----------------
* Drug: TNF blockers (infliximab, adalimumab, etanercept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers Exclusion Criteria: Clinical heart failure Chagas'disease Stable or unstable angina Past history of myocardial infarct Systemic árterial hypertension (grade 3) Valvulopathy Chronic kidney disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TNF blockers<br> | Drug: TNF blockers (infliximab, adalimumab, etanercept)<br>* Subjects enrolled, who were eligible to anti-TNF therapy, were evaluated by echocardiography (conventional and tissue doppler imaging)and biomarkers (NT-proBNP and troponin T)at baseline. Then, they were treated with adalimumab 40mg subcutaneously every 2 weeks or infliximab 3 or 5mg/Kg (0, 2 and 6 weeks and thereafter every 8 weeks)or etanercept 50mg subcutaneously every week. And they were re-evaluated with 6, 12, 18 and 24 months from first dose of the TNF blocker .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development, deterioration ou improvement of subclinical heart dysfunction |  | 0, 6 ,12, 18 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infliximab, Adalimumab, Etanercept, Heart failure, Diastolic disfunction, TNF blocker, Anti-TNF, Echocardiography, Tissue doppler imaging, Brain Natriuretic Peptide, NT-proBNP
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

Detailed Description
-----------------
The duration of treatment is 8 weeks.

Official Title
-----------------
A Double-Blind, Multicenter, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder With Melancholic Features

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: MK0869, aprepitant
* Drug: Comparator: paroxetine HCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Depressive Disorder

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: MK0869, aprepitant|nan|
|Drug: Comparator: paroxetine HCL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual CGI-I score at week 8, improving social disability by change from baseline in Sheehan Disability Score at Week 8, change from baseline in the HAMA score at week 8, change from baseline in depressed mood of the HAMD-17 at week 8 |  |  |
Impact of COVID-19 on Personal Protection Among Dentist in Egypt

Study Overview
=================
Brief Summary
-----------------
Dentist exposed to coronavirus (COVID-19) may not have adequate access to personal protective equipment (PPE), safety procedures, and diagnostic protocols. Our objective will be to evaluate the reality and perceptions about personal safety among dentist in Egypt

Detailed Description
-----------------
This is a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire will be developed and distributed using Google Forms. Participants were recruited through social networking websites and applications (Twitter, Instagram, Facebook, LinkedIn, and WhatsApp). The questionnaire will be conducted from 24 May 2020 and until 30 june 2020. The survey will be delivered in Enlish. Participants will be able to complete the survey only once and will be allowed to terminate the survey at any time they desired. The survey will be anonymous and confidential. An introductory paragraph outlining the purpose of the study will be posted along with the survey.

Official Title
-----------------
Impact of COVID-19 on Personal Protection Among Dentist in Egypt: A Quick Online Survey

Conditions
-----------------
COVID 19

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All dentist actively working in Egypt Exclusion Criteria: non dentist resident outside egypt

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire developed and distributed using Google Forms.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal protection measures | measure the personal protection measures used among dentist during Covid-19 pandemic through online Survey | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of Covid-19 pandemic on type of face masks used in dental clinic | measure the personal protection measures used among dentist during Covid-19 pandemic through online Survey | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Personal Protection, Dentist, Egypt
Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant

Study Overview
=================
Brief Summary
-----------------
The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level

Official Title
-----------------
Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant

Conditions
-----------------
Malocclusion; Displaced or Missing Teeth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with single missing maxillary or mandibular premolar or molar The edentulous sites should be healed sites The opposing tooth will be a natural dentition Exclusion Criteria: general contraindications to dental implant surgery Patient with irradiation in the head and neck region Immuno-suppressed or immuno-compromised patients Patients who took or are taking amino-bisphosphonates Patients with poor oral hygiene and motivation Patients with untreated periodontitis Uncontrolled diabetes Pregnancy or lactation Addiction to alcohol or other drugs patients with psychiatric problems Lack of occluding dentition/prosthesis Restricted mouth opening (less than 3.5cm inter-arch anteriorly) Patients with an acute or chronic infection/inflammation in the area intended for implant placement Patients unable to commit 5 years follow up Patients referred for implant placement only

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?
-----------------
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
-----------------
AstraTech Osseospeed Profile Implant, Marginal bone level, soft tissue, soft tissue responds
A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.

Official Title
-----------------
Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF

Conditions
-----------------
B-Cell Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Biological: MyVax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have signed a written informed consent B-CLL diagnosis Rai Stage 0, I, or II Previously untreated Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured Exclusion Criteria: Anti-leukemia treatment prior to beginning immunization Anti-leukemia treatment other than Id-KLH during immunizations Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ) Pregnant or lactating Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia) Participation in any other clinical trial in which an investigational agent is administered

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MyVax|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with positive humoral immune responses |  |  | 
| Safety and toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B-Cll
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer. A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment. Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.

Official Title
-----------------
Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Small-Cell Lung Carcinoma, Carcinoma, Bronchogenic

Intervention / Treatment
-----------------
* Drug: Motexafin Gadolinium Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old ECOG score of 0, 1, or 2 Histologically confirmed diagnosis of non-small cell lung cancer Exclusion Criteria: Laboratory values demonstrating inadequate function of the following: Bone marrow Kidneys Liver and Peripheral neuropathy Grade 2 or higher Greater than 2 prior chemotherapy 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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin Gadolinium Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin |  |  | 
| Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Small Cell Lung Cancer, Lung Cancer, Metastatic lung cancer, Inoperable lung cancer, Advanced lung cancer, Large-cell lung cancer, Adenocarcinoma, lung, Squamous cell carcinoma, lung, Squamous cell lung cancer, Large cell carcinoma, lung, Bronchogenic
Antibodies in Repeated Influenza Vaccination (ARIVA) Study

Study Overview
=================
Brief Summary
-----------------
Viruses with high mutation rates, such influenza or HIV, pose a major challenge for vaccine design. The current influenza vaccination strategy of yearly vaccination with adapted strains aims to maximally diversify the antibody immune response to prevent viral escape. There is, however, growing evidence, that repeated vaccination with very similar viral proteins might limit, instead of broaden, diversification and thereby reduce vaccine efficacy. The ARIVA Study prospectively studies the immunological impact of repeated influenza vaccination on viral variant recognition and antibody responses in healthy subjects cross-sectionally and over three consecutive vaccination seasons.

Official Title
-----------------
Antibodies in Repeated Influenza Vaccination (ARIVA) Study

Conditions
-----------------
Vaccine Response Impaired

Intervention / Treatment
-----------------
* Biological: Influenza Vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: influenza vaccination (QIIV) independent of the study age >18 yo Exclusion Criteria: no vaccination current acute illness

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza Vaccination|Only subjects vaccinated against influenza will be enrolled. The study itself is observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza specific Antibody Responses | Hemagglutination titers against different H3N2 Influenza strains will be measured and compared between study subjects stratified by number of previous vaccinations | Change between baseline and 28 days post-vaccination will be compared | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmablast generation | Frequency of plasmablasts in the peripheral blood will be assessed and compared between study subjects stratified by number of previous vaccinations | Day 7 post-vaccination | 
| BCR Repertoire composition | Sorted B cell subsets will be sequenced to define the BCR repertoire. Subjects will be compared stratified by vaccination status | Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28 |
Efficacy of Peppermint and Green Tea in Malodor

Study Overview
=================
Brief Summary
-----------------
Background: Herbal remedies can have the role of prevention and control of bad breath Since in the previous studies, therapeutic and antibacterial effect of green tea and peppermint had been proven .we studied and compared the effects of green tea and peppermint mouthwashes on halitosis. Materials and Methods: This single-blind clinical trial study with cross over design total of 88 volunteer dental students who complained bad breath and had organoleptic score (>= 2) and higher average test scores were enrolled. The students were divided randomly into two groups Green Tea - Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney u, GEE (Generalized Estimating Equation -ordinal logistic regression).

Official Title
-----------------
Comparative Study of the Effects of Green Tea and Peppermint Herbal Mouthwash on Halitosis.

Conditions
-----------------
Bad Breath

Intervention / Treatment
-----------------
* Other: mouthwash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: organoleptic number equal to or higher 2 no foods (garlic and onion) 48 hours before organoleptic test Exclusion Criteria: systemic disease use of antibiotics during study use of other mouthwash during study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: green tea and peppermint<br> | Other: mouthwash<br>* mouthwash containing herbal peppermint or green tea<br>|
| Active Comparator: peppermint and green tea<br> | Other: mouthwash<br>* mouthwash containing herbal peppermint or green tea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of changes in organoleptic score | 0-5 organoleptic scale | baseline,7 days,14 days,21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction of patients | questionnaire | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mouth wash , green tea , peppermint , bad breath
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.

Official Title
-----------------
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B

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

Intervention / Treatment
-----------------
* Drug: LDT600 (Telbivudine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents patients HBsAg seropositive Exclusion criteria: Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C) Prior anti-HBV therapy within 30 days of study drug dosing. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stratum 1<br> | Drug: LDT600 (Telbivudine)<br>* LDT600 (Telbivudine)<br>|
| Experimental: Stratum 2<br> | Drug: LDT600 (Telbivudine)<br>* LDT600 (Telbivudine)<br>|
| Experimental: Stratum 3<br> | Drug: LDT600 (Telbivudine)<br>* LDT600 (Telbivudine)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) | To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events. | To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis B,, telbivudine,, pharmacokinetics,, safety,, tolerability,, pediatric