linjc16/ctgov huggingface dataset:
Influenza Vaccine in HIV Study

Study Overview
=================
Brief Summary
-----------------
The aims of this study are: to investigate if HIV infection alters the antibody responses to influenza and to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.

Official Title
-----------------
A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects

Conditions
-----------------
Influenza, Human

Intervention / Treatment
-----------------
* Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 positive by licensed diagnostic test (for HIV-positive group only) Planning to receive the seasonal influenza vaccine outside the study Provision of written informed consent Exclusion Criteria: Previous allergy to influenza vaccination Pregnancy or planning to become pregnant Unwilling or unable to provide blood samples

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-positive<br> | Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)<br>* Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.<br>|
| HIV-negative<br> | Biological: 2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)<br>* Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-influenza antibody responses in plasma with Fc-mediated functions |  | Four weeks after influenza vaccination |
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.

Official Title
-----------------
A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated. Able to provide archived biopsy or resected tissue. Adequate performance status and labs. Exclusion Criteria: Patients who did not receive at least radiotherapy as prior definitive treatment. Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control. Has nasopharyngeal or sinonasal carcinoma. Has confirmed metastatic disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab<br>Nivolumab starting 4-11 weeks after surgery for 6 doses. | Drug: Nivolumab<br>* Nivolumab 480 mg IV infusion<br>* Other names: Opdivo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Grade 3 and 4 adverse events of nivolumab |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients any grade adverse events of nivolumab |  | 28 weeks | 
| Disease free survival |  | 1 year | 
| Disease free survival |  | 2 year |
Surgical Outcome at HFSUH

Study Overview
=================
Brief Summary
-----------------
the study was conducted on already intervened hospital patients with surgical management and their final outcome was followed from the chart of the patients.

Detailed Description
-----------------
It was a prospective chart review of operated patient at Hiwot fana specialized hospital for different emergency as well elective surgeries. The study subjects signed informed written consent and their data collected anonymously. the follow up protocol was until discharge from hospital the longest date as 30 days.

Official Title
-----------------
Postoperative Complication and Associated Factors Among Patients Operated at Hiwot Fana Specialized University Hospital, Ethiopia

Conditions
-----------------
Surgical Outcome

Intervention / Treatment
-----------------
* Procedure: operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all operated patients at surgical ward Exclusion Criteria: patients operated at other facilities and transferred here. readmission within a month of discharge
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: operation|The intervention was not decided by the investigator but studied following emergency or elective surgeries undergoing in the system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative complications | the outcome variable is adichotomous on with no complication and has complictions | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outcome
Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis

Study Overview
=================
Brief Summary
-----------------
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis

Official Title
-----------------
Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial

Conditions
-----------------
Colorectal Cancer, Liver Metastases

Intervention / Treatment
-----------------
* Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years; Histologically proven colorectal liver metastasis； With liver-dominant disease； Primarily evaluated as potentially resectable and conversed successfully Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization) Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization); Written informed consent for participation in the trial. Exclusion Criteria: Primarily evaluated as resectable Failed to converse Patients with known hypersensitivity reactions to any of the components of the study treatments. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding Other previous malignancy within 5 years Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>DEB-TACE before liver surgery | Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads<br>* preoperative chemoembolization with Irinotecan Drug-eluting Beads<br>* Other names: Irinotecan Drug-eluting Beads;|
| No Intervention: Arm B<br>direct liver surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver relapse-free survival | from liver surgery to liver relapse | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse-free survival |  | 6 months | 
| overall survival |  | 12 months | 
| response rate |  | 2 months |
Screening Study for the Department of Rehabilitation Medicine

Study Overview
=================
Brief Summary
-----------------
The primary function of the Department of Rehabilitation Medicine (RMD) is to diagnose and treat patients at the NIH who have problems in locomotion, activities of daily living, occupational roles, communication, swallowing, or problems with chronic pain. The major goal of this department s to help patients achieve maximal function so that they can resume their daily living activities as normal as possible. In order for the department to accomplish it's goal it requires the involvement of medical staff and the use of a variety of tests and instruments. Before a new test, evaluation technique, or piece of physical equipment can be considered for use in the treatment of patients it must be carefully studied. Researchers must make sure the test, technique, or instrument is safe, sensitive, accurate, specific, and reproducible. Therefore all of these tests, techniques, and instruments must first undergo a trial period. Normal volunteers and patients from the RMD and outside of the RMD may be selected to participate in the trial period. This study provides a framework for researchers in the Department of Rehabilitation Medicine (RMD) to develop new tests, techniques, technology, and equipment.

Detailed Description
-----------------
This protocol provides a framework for clinicians in the Department of Rehabilitation Medicine (RMD) to develop and pilot new tests, techniques, technology, or equipment to remain state-of-the-art.

Official Title
-----------------
Rehabilitation Medicine Screening Protocol

Conditions
-----------------
Healthy, Convalescence

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: In- and outpatients referred to the Rehabilitation Medicine Department. Normal volunteers of either sex.
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
-----------------
Rehabilitation, Functional Level, Activity of Daily Living, Mobility, Normal Volunteer
CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room

Study Overview
=================
Brief Summary
-----------------
A CVA occurs when there is a sudden interruption of blood supply to the brain. Fast identification of CVA is crucial in order to refer the patient to an appropriate medical center as well as to direct him/her to a suitable treatment upon arrival to the Medical Center, in order to minimize the permanent damage to the brain. In this study, we are evaluating a tool for detecting CVA based on EEG (electroencephalograph) data analysis using innovative algorithm. The system is comprised of four electrodes, reference electrode and earphones for auditory stimulation. In the study, 120 patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness will be monitored for five-minute each, with EEG accompanied with auditory stimulation. The EEG analysis will be performed based on the synchronization of the front and back hemispheres. During CVA, specific hemisphere is damaged, therefore desynchronization is expected. The purpose of this study is to develop a tool for identifying CVA in patients who have no clear CVA related signs.

Official Title
-----------------
Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room

Conditions
-----------------
CVA

Intervention / Treatment
-----------------
* Diagnostic Test: EEG monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness Exclusion Criteria: Pregnant women

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 |
| --- | --- |
| EEG monitoring<br>Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness | Diagnostic Test: EEG monitoring<br>* Five-minute of EEG monitoring accompanied with auditory stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desynchronization Index | Desynchronization Index calculated from EEG data correlation with CVA events | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG variablity | EEG variability will be evaluated in correlation to various medical measures (ECG, hypoglycemic state, hypothermia) | 1 day |
Role of Left Ventricular Pacing Site

Study Overview
=================
Brief Summary
-----------------
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

Detailed Description
-----------------
Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order. Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed. Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure Outcomes. Hemodynamic measures using pressure-volume catheters.

Official Title
-----------------
Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure

Conditions
-----------------
Heart Failure, Cardiomyopathy, Dilated, Coronary Disease

Intervention / Treatment
-----------------
* Device: left ventricular pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure referred for cardiac resynchronization therapy NYHA Class III or IV Informed consent form signed Exclusion Criteria: Hypertension not controlled by treatment Coronary ischemia not controlled by 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: left ventricular pacing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in left ventricular dp/dt max |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pressures and volumes of the left ventricle |  |  | 
| stroke work |  |  | 
| surface ECG repolarisation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, Hemodynamics, Randomized Controlled Trials, Single-Blind Study
Malignancies in Transplanted Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.

Official Title
-----------------
Follow-up of Malignancies in Transplanted Patients

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Other: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection
* Drug: Switch from calcineurin inhibitor to an mTOR inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients willing and capable of giving written informed consent of participation in the project Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma) Exclusion Criteria: Patients with a primary liver cancer as cause of the transplantation

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 |
| --- | --- |
| Malignancy post transplantation<br> | Other: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection<br> <br> Drug: Switch from calcineurin inhibitor to an mTOR inhibitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | After inclusion | 12 months, 2 years, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival | After inclusion | 12 months, 2 years, 3 years | 
| ImmuKnow Assay value |  | 12 months | 
| Tumour progression/regression/reoccurrence |  | 12 months, 2 years, 3 years | 
| Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor |  | 3 years | 
| Kidney function | Creatinine measure | 12 months, 2 years, 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunosuppression
Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia

Study Overview
=================
Brief Summary
-----------------
Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).

Detailed Description
-----------------
The study will include patients with CLL treated with splenic irradiation in Maastro Clinic, Maastricht, The Netherlands, Maxima Medisch Centrum Veldhoven/Catharina hospital, Eindhoven, The Netherlands and Modena hospital, Modena, Italy. Data will be collected from patient records in an uniform database. Data will include demographic data, CLL stadium (RAI and Binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death

Official Title
-----------------
Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)

Conditions
-----------------
Leukemia, Chronic Lymphatic

Intervention / Treatment
-----------------
* Radiation: splenic irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic lymphatic leukaemia. 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 |
| --- | --- |
| Patients with Chronic Lymphatic Leukemia<br>Patients with Chronic Lymphatic Leukemia treated with splenic irradiation | Radiation: splenic irradiation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and haematological response | Clinical and haematological response measured by number of leucocytes and thrombocytes during and after irradiation. Hemoglobin and size of spleen during and after irradiation in the time period 2000 tot 2013 | 13 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of chronic Lymphatic leukaemia | Progression of chronic Lymphatic leukaemia after irradiation in the time period 2000 tot 2013 | 13 years | 
| Death | Patients will be followed from the time of splenic irradiation to death in the time period of 2000 tot 2013 | 13 years | 
| Toxicity of splenic irradiation | Toxicity of splenic irradiation during and after irradiation measured by evaluating clinical toxicity based on the CTCAE version 3.0 during and after irradiation (2000 to 2013) | 13 years |