linjc16/ctgov huggingface dataset:
Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.

Official Title
-----------------
Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients(AdVEnTR)

Conditions
-----------------
Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult kidney transplant recipients Greater than 3 months post-transplant Exclusion Criteria: Has already received influenza vaccination for 2012-2013 season Egg allergy Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks Unable to provide informed consent Unable to comply with study protocol

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?
-----------------
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
-----------------
kidney transplant recipients
SEP Changes During Deep Anesthesia

Study Overview
=================
Brief Summary
-----------------
The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied. 60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).

Official Title
-----------------
The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials

Conditions
-----------------
Somatosensory Evoked Potentials, and Electroencephalography

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an elective surgery under general anaesthesia Location Department of Neurosurgery, University Hospital Düsseldorf: all patients with intracranial interventions and the possibility to place a stripe electrode without complications on cortex (it is decided by the surgeon while surgery because of the situs and tumorlocation) Exclusion Criteria: periodical consumption of drugs and pharmaceuticals which influence cortical excitability intraoperative contraindication for required depth of anaesthesia neurological pre-existing illness advanced hepatic insufficiency

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain surgery<br>Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography | Drug: Propofol<br> <br> |
| Experimental: Spine surgery<br>Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography | Drug: Propofol<br> <br> |
| Active Comparator: General surgery<br>Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography | Drug: Propofol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEP ampiltude in burst-suppression-EEG |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, burst-suppression, N20, SEP, median nerve, facilitation
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)

Official Title
-----------------
Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Conditions
-----------------
Patients With T1-4 Advanced Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Goserelin (Zoladex)


Participation Criteria
=================
Eligibility Criteria
-----------------
• Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA > 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA > 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent • Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to < 10 ng/mL. If the baseline was < 20ng/mL, at least 50% decrease from the baseline measurement is required Exclusion Criteria (run-in period): Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status -

Ages Eligible for Study
-----------------
Minimum Age: 0 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Goserelin (Zoladex)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Progression (TTP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and prostate cancer-specific survival, time to treatment failure, quality of life |  |  |
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

Detailed Description
-----------------
The following parameters will be evaluated as part of this study: Aneurysm morphology Aneurysm size For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH) Size of the embolization device(s) used in the procedure Intra-procedural assessment of aneurysm occlusion and flow stasis Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate) Aneurysm occlusion durability Recanalization rate Device-related changes in Modified Rankin Scale from baseline Complications/adverse events Rebleed/new bleed

Official Title
-----------------
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Procedure: Intracranial aneurysm embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 18 years of age Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures Exclusion Criteria: Must not have clinical or angiographic evidence of vasospasm Must not have lesion with characteristics unsuitable for endovascular treatment Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule Must not be concurrently involved in another investigational or post-market study Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Index Embolization Cohort<br>WEB Aneurysm Embolization System | Procedure: Intracranial aneurysm embolization<br>* Treatment of intracranial aneurysms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of occlusion | Evaluated by the Corelab | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence/recanalization rate | Evaluated by the Corelab, based on Raymond Roy occlusion scale | 6 months | 
| Modified Raymond Scale | Evaluation of patient's functional level of activity by the physician | 6 months | 
| Percentage occlusion of target aneurysm | Evaluated by the Corelab | 6 months |
Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).

Detailed Description
-----------------
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA). Statistical analysis will be performed on this retrospective population to determine in tobacco smoking could influence the development of OSA.

Official Title
-----------------
Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Obstructive Sleep Apnea, Tobacco Use

Intervention / Treatment
-----------------
* Other: Tobacco Smoking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Entire population<br>All patients included in this retrospective study. These patients were analyzed following their tobacco smoking habits. | Other: Tobacco Smoking<br>* Influence of Tobacco Smoking on the development of OSA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive Sleep Apnea (OSA) | Diagnosis of OSA based on a polysomnography recording | 1 month |
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

Study Overview
=================
Brief Summary
-----------------
Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.

Detailed Description
-----------------
After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.

Official Title
-----------------
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection：a Randomized-control Trial

Conditions
-----------------
Acute Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Drug: Amoxicillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute upper respiratory tract infection Fever Vomiting Increased white blood cell Exclusion Criteria: 0ther symptoms of digestive system Headache

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 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 |
| --- | --- |
| Active Comparator: Amoxicillin<br>Amoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting. | Drug: Amoxicillin<br>* β-lactam antibiotics<br>|
| No Intervention: control<br>Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fever | Fever stopped or mitigated in 90% participants. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vomiting | Vomiting stopped or mitigated in 90% participants. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-antibiotic prescribing, acute upper respiratory tract infection, white cell count, vomiting
Bacteriological Study of Acute Follicular Tonsillitis

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to answer the following questions :- Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes, What is (are) the possible reason(s) to explain it in our locality ?

Detailed Description
-----------------
Tonsillitis is one of the most common diseases in the throat that occurs in the younger age group . The predominant bacteria causing tonsillitis are group A b-haemolytic streptococci (GABHS), which are highly susceptible to the penicillin group of antibiotics. It has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s. Authors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria . Although there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.

Official Title
-----------------
Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital

Conditions
-----------------
Acute Follicular Tonsillitis

Intervention / Treatment
-----------------
* Drug: Amoxicillin Clavulanate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old. Exclusion Criteria: Other causes of tonsillitis that do not cause suppuration . Age below five , and above 60 years . Patients who received antibiotic one week before presentation . Immune compromised patients . Patients with quinsy.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amoxicillin Clavulanate|Intravenous drug intake of our drug.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of the isolated organism to amoxicillin clavulanate according to culture and sensitivity test | throat swabs that will be taken from the tonsillar exudate, placed in sterile bottles and brought to the laboratory for Bacteriological culture of the organism and Antibiotic sensitivity tests will be done for the isolated organism(s). | Baseline |
Fluciclovine PET/CT in Multiple Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
Comparison between image findings at aminoacid PET/CT and FDG PET/CT for myeloma patients

Official Title
-----------------
PET i Diagnostikk og Behandlingsrespons av Pasienter Med Myelomatose

Conditions
-----------------
Myeloma, Multiple, PET-CT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple myeloma patients suitable for ASCT treatment Exclusion Criteria: Patients with contraindications to ASCT treatment

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 |
| --- | --- | --- |
| Comparing of image findings at PET |  | 1 year |
Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

Detailed Description
-----------------
The purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using SDAI, CDAI, DAS28-CRP, MMP-3, MHAQ in patients with rheumatoid arthritis who have not achieved SDAI remission despite of using biological agents for over 8 weeks.

Official Title
-----------------
Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings

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

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: biological agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI < 3.3)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tacrolimus + biological agents<br> | Drug: tacrolimus<br> <br> * Other names: prograf;Drug: biological agents<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simplified disease activity index (SDAI) |  | Baseline and week-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical disease activity index (CDAI) |  | Baseline, week-12 and week-24 | 
| Disease Activity Score 28 (DAS28) |  | Baseline, week-12 and week-24 |
Zenith® TX2® Low Profile TAA Endovascular Graft

Study Overview
=================
Brief Summary
-----------------
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.

Official Title
-----------------
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Conditions
-----------------
Aortic Aneurysm, Penetrating Ulcer, Vascular Disease

Intervention / Treatment
-----------------
* Device: Zenith TX2 Low Profile TAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets one of the following Descending thoracic aneurysm with diameter ≥ 5.0 cm Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter Exclusion Criteria: Life expectancy less than 2 years Pregnant of breastfeeding or planning on becoming pregnant within 60 months Unwilling to comply with the follow-up schedule Less than 30 days beyond primary endpoint for other investigative drug or device study Receiving home oxygen Myocardial infarction within the last 3 months Stroke within the last 3 months Diagnosed or suspected congenital degenerative collagen disease Systemic infection Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion Allergy to polyester, polypropylene, nitinol, or gold Previous placement of a thoracic endovascular graft Prior open repair involving the descending thoracic aorta

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Zenith TX2 Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.|

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
-----------------
Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation