linjc16/ctgov huggingface dataset:
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

Study Overview
=================
Brief Summary
-----------------
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

Official Title
-----------------
Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: HX575 epoetin alfa (Sandoz)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Adult male and female patients w or w/o dialysis treatment Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve. Adequate iron substitution Main Exclusion Criteria: History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies Contraindications for ESA therapy Serum albumin < 3.0 g/dL Immunocompromized patients (immunosuppressive treatment, chemotherapy) Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection Systemic lupus erythematosus Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months History of malignancy of any organ system within the last 5 years History of use of any non-EU approved ESA

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: HX575 epoetin alfa (Sandoz)<br>Single arm | Drug: HX575 epoetin alfa (Sandoz)<br>* Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.<br>* Other names: Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Erythropoietin (EPO) Antibodies | The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1) | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epoetin alfa, ESA, HX575, CKD
Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.

Study Overview
=================
Brief Summary
-----------------
To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine

Detailed Description
-----------------
Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed

Official Title
-----------------
Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section

Conditions
-----------------
Post-Surgical Complication

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Ketamine
* Drug: Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman of age 18-60 Pregnant woman in outdoor patient department and emergency Exclusion Criteria: patient. with history of hypersensitivity to opioids, ketamine or bupivacaine History of cardiovascular disease, Hypertension, psychosis, antepartum hemorrhage, cord prolapse, fetal distress

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 drugs were given to patients
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes | Drug: Dexmedetomidine<br>* Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.<br>|
| Experimental: Ketamine<br>Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes | Drug: Ketamine<br>* Ketamine<br>|
| Experimental: Tramadol<br>Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes | Drug: Tramadol<br>* Tramadol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of post spinal shivering by observing grades of shivering | Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering. | 10 minutes |
Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas

Study Overview
=================
Brief Summary
-----------------
Investigating the performance of 18F-FDG PET/CT and PET/MRI in lymphomas

Detailed Description
-----------------
In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by 18F-FDG PET (PET/CT and PET/MR). Prior to treatment, all patients will undergo whole-body 18F-FDG PET/CT and PET/MR. The methods' efficiency was compared in the diagnosis of lymph node (LN) and organ involvement.

Official Title
-----------------
Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas

Conditions
-----------------
PET/MRI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically diagnosed as lymphoma; Written informed consent for receiving PET/MRI after PET/CT examinations. cancer planned chemotherapy or immunotherapy scheme. expected survival ≥ 12 weeks Exclusion Criteria: cannot lie supine for half an hour; refuse to join the clinical researcher; severe liver or kidney dysfunction pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| SUVmax | Standardized uptake value of 18F-FDG PET/CT and PET/MRI for target lesion of subject or suspected tumor in each time point window (SUV) | 150 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positron-Emission Tomography, lymphoma
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

Study Overview
=================
Brief Summary
-----------------
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

Official Title
-----------------
A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis

Conditions
-----------------
Recurrent Bacterial Vaginosis (BV)

Intervention / Treatment
-----------------
* Drug: 1% SPL7013 Gel
* Drug: 3% SPL7013 Gel
* Drug: placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode). Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria Otherwise healthy Exclusion Criteria: No active STIs and/or current UTI Previous exposure to SPL7013 Gel A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% SPL7013 Gel<br> | Drug: 1% SPL7013 Gel<br>* vaginal gel<br>|
| Experimental: 3% SPL7013 Gel<br> | Drug: 3% SPL7013 Gel<br>* vaginal gel<br>|
| Placebo Comparator: placebo gel<br> | Drug: placebo gel<br>* vaginal gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women who have experienced a recurrent episode of BV as a measure of efficacy | Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria | Day 112 +/- 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BV, Bacterial vaginosis, recurrent, SPL7013 Gel, VivaGel
Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography

Study Overview
=================
Brief Summary
-----------------
Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement. This retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.

Official Title
-----------------
Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Diagnostic Test: Contrast Boost post processing technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who underwent thoracic CT angiography for suspicion of pulmonary embolism in our institution between March and June 2018 Exclusion Criteria: None
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 |
| --- | --- |
| Pathological group<br>Patients with pulmonary embolism on thoracic CT angiography | Diagnostic Test: Contrast Boost post processing technique<br>* Contrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement.<br>|
| Healthy group<br>Patients without pulmonary embolism on thoracic CT angiography | Diagnostic Test: Contrast Boost post processing technique<br>* Contrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of thrombi within each branch of the pulmonary arteries | The pulmonary arteries were divided into 11 zones according to their anatomical characteristics then each visible thrombus was reported in a Excel table according to the zone where it was located | Between March and June 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary embolism
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

Study Overview
=================
Brief Summary
-----------------
Rupture of unstable atherosclerotic plaques is the underlying pathophysiologic mechanism of acute coronary syndromes and thus also of perioperative myocardial ischemia. Lipid lowering drugs such as statins and fibrates have been shown to improve the outcomes of patients with atherosclerosis. This is not only mediated through their therapeutic actions on lipid metabolism, but relies on a multitude of pleiotropic effects of these substances. One of the most interesting of these effects is the stabilisation of atherosclerotic plaques. To investigate these effects in a perioperative setting, patients scheduled for thromboendarterectomy of the carotid artery will be recruited. They will be randomised to receive either atorvastatin 10mg/d, gemfibrozil 1200mg/d or placebo for two weeks preoperatively. Specimens of carotid plaques will be obtained intraoperatively. After microscopic characterisation of plaques, DNA-microarray analyses will be done to gain insights into the transcriptional regulation and expression profiles of various types of atherosclerotic plaques under different pharmacological circumstances (stable or unstable with statin/fibrate/placebo).

Official Title
-----------------
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques: a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Gemfibrozil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: atherosclerosis stenosis of carotid artery Exclusion Criteria: therapy with statine or fibrate pregnancy

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: Atorvastatin|nan|
|Drug: Gemfibrozil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression profile in atherosclerotic plaque |  |  |
Evaluating Color Perception Under LED Red/Green and Green Dominant Light

Study Overview
=================
Brief Summary
-----------------
The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA called the Tomahawk MC Tactical Light to determine the range of colors people are able to see with these flashlights at night. The flashlight has been designed to reduce visibility of the user and uses a combination of green and red LED lamps to achieve this. In this study investigators wish to determine how well a subject can differentiate colors at night in a quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which requires the user to put shades of red, green, blue and yellow into progressive color order which is scored according to the manufactures specifications.

Official Title
-----------------
Evaluating Color Perception Under LED Red/Green and Green Dominant Light

Conditions
-----------------
Color Blindness, Acquired

Intervention / Treatment
-----------------
* Device: White LED Flashlight
* Device: Red/Green Green Dominant LED Flashlight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal vision 18-65 years Exclusion Criteria: blindness colorblind pregnant women prisoners decisionally challenged

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 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 |
| --- | --- |
| Night Vision<br>White LED Flashlight, Red/Green Green Dominant LED Flashlight | Device: White LED Flashlight<br>* white light setting<br>* Other names: Tomahawk serial number TMC12420;Device: Red/Green Green Dominant LED Flashlight<br>* Green LED light dominant setting<br>* Other names: Tomahawk serial number TMC12420, green dominant setting;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Normal Color vision | The Farnsworth Munsell 100 Hue Test is used to determine normal color vision and vision using the red green Tomahawk LED flashlight. | 1 hr |
Living Alone in Old Age With Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand the experience of living alone in older age with cognitive impairment. We recruit adults 55+ living alone with cognitive impairment such as Alzheimer's disease or mild cognitive impairment. This study investigates the priorities and concerns of older adults living alone with cognitive impairment. Participants are interviewed 5 times for one hour in their homes within 3 months at a time that works for them.

Detailed Description
-----------------
The purpose of this study is to better understand the experience of living alone in older age with cognitive impairment. This knowledge is important to design programs that are appropriate. Dr. Elena Portacolone, an Assistant Professor from the Institute of Health and Aging is the study researcher. Study participants are interviewed by Elena at a time and place convenient to them, usually their home. Interviews are audio recorded and last around one hour. Study participants are interviewed five times within 3 months. After the interview, a transcriptionist will type into a computer the recording and will remove personal names. The sound recording will then be destroyed. Participants can stop being in the study at any time.

Official Title
-----------------
Living Alone in Old Age With Cognitive Impairment

Conditions
-----------------
Living Alone, Alzheimer Disease, Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living alone Medical diagnosis of Alzheimer's disease or mild cognitive impairment Exclusion Criteria: Living in nursing homes, assistive living facilities. Alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
| Ethnographic interviews | Questions that follow the train of thought of study participants | One hour |
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).

Detailed Description
-----------------
The study will have four groups: Group HRV + OPV, Group HRV alone, Group Placebo + OPV and Group Placebo alone. Two-dose immunisation will be administered in healthy infants at approximately 12 and 16 weeks of age. Immunogenicity, reactogenicity and safety relative to the placebo will also be evaluated. Treatment allocation: randomized (2:2:1:1). Routine EPI vaccines should be administered during the study following the EPI recommendation in Bangladesh.

Official Title
-----------------
Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine (RIX4414 at 106.5 CCID50) When Given Concomitantly With OPV Versus Given Alone (HRV Vaccine Dose Given 15 Days After the OPV Dose) in Healthy Infants in Bangladesh

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: Rotavirus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy infants aged 6 weeks±1 at first study vaccination. Exclusion criteria: Malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic gastrointestinal disease, not received protocol-prohibited treatment.

Ages Eligible for Study
-----------------
Minimum Age: 5 Weeks
Maximum Age: 7 Weeks

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion, vaccine take, and rotavirus shedding at Visit 6 in each group; Immunogenicity of OPV at Visit 6 in each group; Reactogenicity and safety in each group. |  |  |