linjc16/ctgov huggingface dataset:
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD

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

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a documented clinical diagnosis of Major Depressive Disorder. Be able to understand and comply with the requirements of the study. Able to understand and provide written informed consent Exclusion Criteria: Patients (female) must not be pregnant or lactating Current or past diagnosis of stroke or transient ischemic attack (TIA).

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|
|Drug: Duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization to each assessment in the MADRS total score |  |  | 
| MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Quetiapine fumarate, sustained release, Depression
Demographic Characteristics of Children Suffering From Mental Retardation or Cerebral Palsy in the Israeli Arab Community

Study Overview
=================
Brief Summary
-----------------
To evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics.

Conditions
-----------------
Mental Retardation, Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral palsy mental retardation Israeli Arab Israeli Jewish Exclusion Criteria: all others

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Mentally retarded Israeli Arab children<br> | Other: Questionnaire<br>* Questionnaire developed for this purpose by the investigators<br>|
| Israeli Arab children with cerebral palsy<br> | Other: Questionnaire<br>* Questionnaire developed for this purpose by the investigators<br>|
| Israeli Jewish children with cerebral palsy<br> | Other: Questionnaire<br>* Questionnaire developed for this purpose by the investigators<br>|
| Mentally retarded Israeli Jewish children<br> | Other: Questionnaire<br>* Questionnaire developed for this purpose by the investigators<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Characteristics | Demographic characteristics will be identified through a questionnaire and will be compared with control groups. | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Israeli Arab population, Israeli/ethnology
Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for preoperative evaluation of cervical node metastasis in papillary thyroid cancer.

Official Title
-----------------
99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study

Conditions
-----------------
Papillary Thyroid Cancer

Intervention / Treatment
-----------------
* Radiation: 99mTc-MIBI SPECT-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: papillary thyroid cancer Exclusion Criteria: pregnancy Bleeding abnormality Prior history of head and neck cancer can not perform 99mTechnetium-MIBI SPECT-CT can not perform 131I remnant Ablation Prior any head and neck surgery within 3 months Prior deep neck infection within 3 months

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc positive<br>99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report | Radiation: 99mTc-MIBI SPECT-CT<br>* 99mTc-MIBI SPECT-CT for abnormal cervical lymph node<br>|
| Experimental: 99mTc Negative_Neck dissection<br>99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report | Radiation: 99mTc-MIBI SPECT-CT<br>* 99mTc-MIBI SPECT-CT for abnormal cervical lymph node<br>|
| Experimental: 99mTc Negative_No neck dissection<br>99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan | Radiation: 99mTc-MIBI SPECT-CT<br>* 99mTc-MIBI SPECT-CT for abnormal cervical lymph node<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy ) |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Papillary thyroid cancer, 99mTechnetium MIBI SPECT CT, preoperative, cervical lymphadenopathy, cervical metastasis
Grid Laser for Diffuse Diabetic Maculopathy

Study Overview
=================
Brief Summary
-----------------
Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.

Official Title
-----------------
Subthreshold Double Frequency Nd. YAG Grid Laser for Diffuse Diabetic Maculopathy

Conditions
-----------------
Diabetic Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with macular edema. both sexes conset to participate. Exclusion Criteria: focal edema. patients requiring only the focal laser. patients with proferative diabetic retinopathy. Patients with ischaemic maculopathy on fundus fluorescein angiography.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Improvement of visual acuity after grid laser | Visual acuity will be mesured pre laser and 06 weeks post laser | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Patiens willbe asked and examined for any potentiail anticipated complication. | during first six weeks after laser | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular grid, Subthreshold, diabetic macular edema, decrease in visual acuity
Prophylactic Laser Treatment of Drusen Maculopathy

Study Overview
=================
Brief Summary
-----------------
To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane.

Official Title
-----------------
Prophylactic Laser Treatment of Drusen Maculopathy in Age-related Macular Degeneration.

Conditions
-----------------
Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: laser treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 55 years of age, Soft drusen maculopathy, VA 0.8-1.0 Exclusion Criteria: VA <0.8, Pigment clumps, PED, CNV, Atrophy, Haemorrhage, Diabetes retinopathy, Sign cataract, Glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laser treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of exudative complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macula degeneration, prophylactic laser treatment, exudative complication
Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital

Study Overview
=================
Brief Summary
-----------------
Aim of the study was to assess the quality of sleep among adult patients, to explore the perceived sleep distractors among adult patients, to determine the relationship between quality of sleep and perceived sleep distractors score among adult patients. and to determine the association of quality of sleep and perceived sleep distractors score among adult patients with selected variables.

Detailed Description
-----------------
A total of 150 adult patients were selected from surgical, orthopedic and medical wards to participate in the study 50 patients from each ward. All the adult patients were selected using convenience sampling technique. Self-introduction and establishing rapport with the subjects was done. Purpose of the study was explained to the subjects, the confidentially of their responses was assured, and informed consent was taken prior to the study. The data was collected by Modified Pittsburgh Sleep Quality Index and Structured Perceived Sleep Distractors Performa.

Official Title
-----------------
Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital

Conditions
-----------------
Quality of Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study includes adult patients who were: between age group of 18-65 years hospitalized minimum for 7 days. willing to participate in the study. present at the time of data collection. Exclusion Criteria:Adult patients who were not: alert and oriented.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sleep | It comprised of total 7 components. Each item is rated as 0, 1, 2, 3. The maximum possible score was 21 and minimum possible score was zero on the Modified Pittsburgh sleep Questionnaire | 20-25 min. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of sleep, Perceived sleep distractors, Adult patients
Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure

Study Overview
=================
Brief Summary
-----------------
The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

Detailed Description
-----------------
Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

Official Title
-----------------
Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.

Conditions
-----------------
Venous Puncture

Intervention / Treatment
-----------------
* Other: Figure-of-eight suture
* Other: Perclose Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who successfully undergo venous large bore access sheath placement for structural heart procedures. Exclusion Criteria: Patients who do not consent Minors or those unable to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Figure-of-eight<br>Using the figure-of-eight closure technique when closing access for structural heart therapies. | Other: Figure-of-eight suture<br>* Using the figure-of-eight closure technique when closing access for structural heart therapies.<br>|
| Active Comparator: Perclose Device<br>Using the Perclose device when closing access for structural heart therapies. | Other: Perclose Device<br>* Using the Perclose device when closing access for structural heart therapies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis Time | To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access | Immediate | 
| Procedure Time |  | Immediate | 
| Access Site Complication |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perclose Device, Figure-of-eight suture
Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

Study Overview
=================
Brief Summary
-----------------
Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure. The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.

Official Title
-----------------
Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven lymphoma (Hodgkin's or non-Hodgkin's) Age > 18 y/o and < 70 y/o WHO score < or = 2 Life expectancy > 6 mo Left ventricular ejection fraction > 50% Informed consent Exclusion Criteria: Previous chemotherapy using anthracyclines History of radiation therapy History of congestive heart failure History of chronic renal insufficiency Contra indication to MR examination Atrial fibrillation and significant arrhythmia Pregnancy

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?
-----------------
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
-----------------
Lymphoma, Anthracyclines, Heart Failure, Radionuclide, Magnetic Resonance Imaging, Troponin, Natriuretic Peptide, Brain
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Study Overview
=================
Brief Summary
-----------------
Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Official Title
-----------------
A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 64 years Heterosexual males Erectile dysfunction for more than 6 months Exclusion Criteria: Penile anatomical abnormalities Spinal cord injury History of surgical prostatectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse<br>|
| Active Comparator: Arm 2<br> | Drug: Tadalafil<br>* Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Question 3 (SEP-3) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Question 2 (SEP-2) |  | 4 weeks | 
| International Index of Erectile Function |  | 4 weeks | 
| Global Confidence Question (GCQ) |  | 4 weeks | 
| Erection Quality Scale (EQS) |  | 4 weeks | 
| General Safety |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

Official Title
-----------------
A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.

Conditions
-----------------
Encephalitis, Tick-Borne

Intervention / Treatment
-----------------
* Biological: Tick-Borne Encephalitis vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female children, 1 to 10 years of age. Exclusion Criteria: Subjects with documented evidence of TBE Subjects, who have been previously vaccinated against TBE

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tick-Borne Encephalitis vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TBE, children, vaccine