linjc16/ctgov huggingface dataset:
Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Diagnostic procedures, such as infrared thermography, may help find Kaposi's sarcoma and learn the extent of disease. PURPOSE: This clinical trial is studying how well infrared thermography finds skin lesions in patients with Kaposi's sarcoma.

Detailed Description
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OBJECTIVES: Primary Compare ultra-sensitive infrared thermographic images with visible light digital photographic images and clinical dermatologic examination as methods of measuring cutaneous lesions in patients with Kaposi's sarcoma (KS). Secondary Compare differences in modulation of temperature detected in KS skin lesions with non-involved skin of the same patient and with normal skin of healthy volunteers by sequential imaging using the infrared thermographic camera. OUTLINE: This is a controlled, pilot study. Patients undergo clinical assessment followed by simultaneous digital photographic camera imaging and high-resolution infrared thermographic camera imaging of designated normal skin areas and selected marker lesions. Before imaging, a metal bar chilled to 0º C, 10º C, and 25º C is applied to the lesions and designated normal skin areas for up to 90 seconds. Healthy volunteers (controls) undergo the same procedure as for the patient except only designated normal skin areas are used. PROJECTED ACCRUAL: A total of 20 patients and 10 healthy volunteers (controls) will be accrued for this study.

Official Title
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Ultra-Sensitive, Infra-Red Thermographic Analysis of Kaposi's Sarcoma Skin Lesions

Conditions
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Sarcoma

Intervention / Treatment
-----------------
* Procedure: diagnostic imaging


Participation Criteria
=================
Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Histologically confirmed cutaneous Kaposi's sarcoma (KS) At least one skin lesion accessible for imaging HIV positivity with proven cutaneous KS and concurrent visceral or mucous membrane involvement allowed Healthy volunteer (regardless of HIV status) (control) PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Pregnancy allowed PRIOR CONCURRENT THERAPY: Prior topical, intralesional, or systemic treatment allowed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: diagnostic imaging|nan|

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
-----------------
Kaposi sarcoma
PERG and mfPERG in Band Atrophy

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the ability of pattern electroretinogram (PERG) and multifocal pattern electroretinogram (mfPERG) to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these electrophysiological tests were able to identify this such pattern. The idea is to investigate the ability of the these electrophysiological technics in detecting the neural loss from chiasmal compression and to evaluate the ability of PERG and mfPERG parameters to differentiate between eyes with band atrophy of the optic nerve and healthy eyes.

Official Title
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Pattern Electroretinogram and Multifocal Pattern Electroretinogram For the Detection of Neural Loss in Patients With Permanent Temporal Visual Field Defect From Chiasmal Compression

Conditions
-----------------
Band Atrophy

Intervention / Treatment
-----------------
* Device: Pattern electroretinogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual acuity better than 20/30 Refractive error less 5 spherical diopter and 3 cylinder diopter Temporal field defect Exclusion Criteria: Presence of glaucoma and optic nerve anomalies Anormal nasal field

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pattern electroretinogram|Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.|

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
-----------------
Band atrophy, Pattern electroretinogram, Chiasmal compression, Neural loss, Electrophysiological tests
Non Invasive Ventilation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Patients with respiratory failure following cardiac surgery are randomized to receive standard therapy versus non invasive ventilation. The hypothesis is that patients receiving non invasive ventilation will perform better than those who received standard therapy.

Official Title
-----------------
Effectiveness of Continuous Positive Airway Pressure Outside the Intensive Care Unit After Cardiac Surgery

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: non invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypoxia Exclusion Criteria: pneumothorax cardiocirculatory instability no written consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Best available treatment<br> | |
| Experimental: non invasive ventilation<br> | Procedure: non invasive ventilation<br>* continuous positive airways pressure<br>* Other names: CPAP;|

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
-----------------
NIV, non invasive ventilation, cardiac surgery, continuous positive airway pressure
Femoral External Rotation Measured on CT and MRI

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty.

Official Title
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A Prospective Cohort Study to Compare the Accuracy of Femoral External Rotation Measured on CT and MRI

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: CT and MRI


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 50-85 years old patients with osteoarthritis (Kellgren-Lawrence Grade III or IV) underwent total knee arthroplasty. Exclusion Criteria: patients cannot endure TKA due to severe heart failure, arrhythmia, myocardial infarction, infection or other reason. patients who cannot undergo MRI.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- |
| Group 1<br> | Other: CT and MRI<br>* CT and MRI were conducted to measure the femoral external rotation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral external rotation on CT | the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on CT | Preoperative | 
| Femoral external rotation on MRI | the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on MRI | Preoperative | 
| Intraoperative femoral external rotation | the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) measured intraoperatively | Intraoperative |
Investigations Regarding B-cell Subsets in Humans

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to define the human equivalent of mouse B1 cells.

Detailed Description
-----------------
The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli. The goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.

Official Title
-----------------
Investigations Regarding B-cell Subsets in Humans

Conditions
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Healthy

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is considered by the physician to be a healthy adult. Exclusion Criteria: Subject is under the age of 18 Subject has an infection or is currently ill

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Subjects<br>All subjects are considered healthy | Other: Blood draw<br>* Subject will have blood draw.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of B-1 cells in humans | an equivalent cell type was isolated in humans | determined over the years study in effect | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B-cells, CD5+, B1 Cells, Healthy Controls
MINIject Global Long-Term Follow-up Study

Study Overview
=================
Brief Summary
-----------------
The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Detailed Description
-----------------
The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Official Title
-----------------
A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Device: Minimally invasive glaucoma surgery (MIGS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who received a MINIject glaucoma implant within a prior clinical study Patient continues to have MINIject implanted at the point of enrolment Patient must provide written informed consent to participate Exclusion Criteria: Individuals under tutorship or trusteeship Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Minimally invasive glaucoma surgery (MIGS)|MINIject implant placed into supraciliary space. The implantation was done in a previous study in which patient participated and is not part of this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with serious device-related adverse event in study eye | The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation. | 5 years post-implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open Angle Glaucoma, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Ocular hypertension
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Study Overview
=================
Brief Summary
-----------------
This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.

Official Title
-----------------
A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
-----------------
* Drug: turoctocog alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, age at least 18 years at the time of signing informed consent History of more than 150 exposure days to any factor VIII products Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records Exclusion Criteria: Known history of factor VIII inhibitors Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method Known congenital or acquired coagulation disorders other than haemophilia A Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial

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

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

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: Turoctocog alfa<br> | Drug: turoctocog alfa<br>* Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma FVIII activity at 30 minutes(C30min) | Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose | At 30 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the FVIII activity-time curve |  | From 0 up to 72 hours after administration | 
| Incremental recovery FVIII at 30 minutes (IR30min) | Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose | At 30 minutes post-dose | 
| Terminal half-life (t½) of FVIII |  | From 0 up to 72 hours after administration | 
| Clearance (CL) of FVIII |  | From 0 up to 72 hours after administration | 
| Apparent volume of distribution at steady state (Vss) of FVIII |  | From 0 up to 72 hours after administration |
Living Donor Uterus Transplantation Between Identical Twins

Study Overview
=================
Brief Summary
-----------------
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

Detailed Description
-----------------
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

Official Title
-----------------
Living Donor Uterus Transplantation Between Identical Twins

Conditions
-----------------
Absolute Uterine Factor Infertility, Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: uterus transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age below 40 years absolute uterine factor infertility BMI<30- Exclusion Criteria: systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: uterus transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live births after uterus transplantation |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterus, transplantation, infertility, twin
ABLATOR Ablation Observational Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Detailed Description
-----------------
The objectives of this registry are the following: To confirm patient safety as part of the post market surveillance study. To assess performance of a combination of SJM products during procedures. To assess the learning curve with a combination of SJM products. To collect operator feedback on a combination of SJM products. All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry. In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Official Title
-----------------
ABLATOR Ablation Observational Registry

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are indicated for an atrial fibrillation ablation procedure. 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure. | 12 months post procedure | 
| Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. | Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin (Cardiovascular Serious Adverse Event) with the potential of leading to: Death A serious deterioration in the health of the subject Fetal distress, fetal death or a congenital abnormality or birth defect A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required. | 12 months post procedure |