linjc16/ctgov huggingface dataset:
Measuring Temperatures of Tissues During Endoscopy

Study Overview
=================
Brief Summary
-----------------
Previous studies have indicated that tumors are warmer than the surrounding tissues. We want to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures. This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.

Official Title
-----------------
Measuring Temperatures of Tumors and Normal Tissues in the GI Tract, Using a Thermocouple Sheathed in a Catheter, in the Work Canal of an Endoscope

Conditions
-----------------
Carcinoma, Undifferentiated

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consenting adults 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 |
| --- | --- |
| examined by endoscopy<br>Patients, examined by endoscopy, being screened for GI tract tumors | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of temperature between tumors and adjacent tissues |  | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GI tract, Tumors, Temperatures
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are lacking data in respect to whether differences in composition of various marine oils may influence the inflammatory status differently. The hypothesis of the current study is that extract from the antarctic krill (Euphausia superba) is better than traditional fish oils when compared head-to-head with balanced composition of omega 3 content on inflammatory status.

Official Title
-----------------
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease

Conditions
-----------------
Stable Atherosclerotic Coronary Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Krill
* Dietary Supplement: Fish oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-80 years Sex: Male and female Stable atherosclerotic coronary heart disease (heart attack >3 months ago or objectified angina pectoris). No hospitalization for heart disease last 3 months. Exclusion Criteria: Unstable heart disease. Heart failure NYHA class III and IV. Previous valve and/or aortic surgery Significant concomitant disease (i.e. diseases with known inflammatory activation - e.g. various autoimmune diseases, chronic infections, significant acute infections three weeks before or during the study, connective tissue disease, arthritis, chronic pulmonary disease or serious liver- or kidney-disease). Simultaneous involvement in other clinical studies involving intervention. Planned operation or other invasive procedures (e.g. PCI etc.) during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Krill<br> | Dietary Supplement: Krill<br>* Encapsulated oil from the antarctic crustacean Krill<br>|
| Active Comparator: Fish oil<br> | Dietary Supplement: Fish oil<br>* Encapsulated, raffined cod-oil<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory blood status |  | 8 weeks intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fish oil, Krill, CAD
Enbrel® in Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
This study is testing the effect of etanercept in treating both the skin and joint symptoms of psoriatic arthritis patients. Enbrel®, also known as etanercept, has already been approved by the Federal Food Drug Administration for the treatment of psoriatic arthritis. It is taken as an injection under the skin. Participants in the trial will be offered etanercept free of charge to be self-injected once weekly for 24 weeks. During that period they will have 5 appointments at the study center and will also be asked to complete assessments of their health.

Official Title
-----------------
Enbrel® in Psoriatic Arthritis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Enbrel®


Participation Criteria
=================
Eligibility Criteria
-----------------
Individuals may be eligible to enroll in this study if they suffer from psoriasis (covering at least 10% of the body), and: - have had two or more swollen, tender or painful joints for at least 3 months or: - have lower back pain which your physician has diagnosed as sacroiliitis or spondylitis in one or more joints or: - have been diagnosed with active psoriatic arthritis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enbrel®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of mild or better at week 24. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and disability as measured by the DLQI and HAQ |  |  | 
| Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire |  |  | 
| Serious Adverse Events |  |  | 
| Patient Global Assessment of Psoriasis |  |  | 
| Patient Global Assessment of Joint Disease |  |  | 
| Patient Global Assessment of Joint Pain |  |  | 
| Patient Assessment of Morning Stiffness Duration |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, arthritis, Enbrel®, etanercept
Mixed Chimeric Transplantation for Primary Amyloidosis

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.

Official Title
-----------------
Mixed Chimeric Transplantation for Primary Amyloidosis

Conditions
-----------------
Amyloidosis

Intervention / Treatment
-----------------
* Procedure: autologous followed by nonmyeloablative allogeneic transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary amyloidosis adequate organ function matched sibling donor Exclusion Criteria: evidence of multiple myeloma HIV positive

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: autologous followed by nonmyeloablative allogeneic transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of patients with nonmyeloablative allogeneic transplant for amyloidosis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of therapy |  |  | 
| Changes in marrow and serum abnormalities |  |  | 
| Improvement in end-organ function. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyloidosis, nonmyeloablative, hematopoietic, cell transplantation
Pilot Study of Connected Diabetes Technology

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that remote sharing of health data - including measured blood glucose values as well as patient-reported carbohydrate counts and insulin doses - with the UC Davis Pediatric Diabetes team via connected health applications is feasible for pediatric patients with newly diagnosed type 1 diabetes.

Official Title
-----------------
Pilot Study of Connected Diabetes Technology

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Behavioral: Application Use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with T1D in the past 6 weeks Daily access to the internet via a wireless connection Exclusion Criteria: Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care Primary caregiver does not speak English

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Use of applications to share data
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application Use<br>Participants will be asked to use applications to track food intake, carbohydrate counts, insulin delivered, and blood sugar values and share the data with the study team. | Behavioral: Application Use<br>* Use applications after initial diagnosis to share information with study team.<br>|
| No Intervention: Standard of Care<br>The control group will receive usual care during their hospitalizations at the time of diabetes diagnosis, and during the time between hospital discharge and first visit to the UCD Pediatric Diabetes clinic. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Connected Health Survey | Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications. | 1 month after diabetes diagnosis | 
| Connected Health Survey | Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications. | 6 months after diabetes diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of blood glucose monitoring | How often patients are monitoring their blood sugar (documented in electronic medical record) | At each clinic visit until 6 months since diagnosis | 
| Hemoglobin A1c values | Hemoglobin A1c values collected at each clinic visit (documented in electronic medical record) | At each clinic visit until 6 months since diagnosis |
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.

Official Title
-----------------
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial

Conditions
-----------------
Ligament; Laxity, Knee, Rupture of Anterior Cruciate Ligament

Intervention / Treatment
-----------------
* Procedure: Quadriceps graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anterior cruciate ligament rupture Exclusion Criteria: current malignant disease Rheumatoid arthritis Other knee ligament instability Obesity BMI >30 Morbus Bechterew

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Quadriceps graft<br>Proximally from patella the Quadriceps graft is harvested and used as a knew anterior cruciate ligament after rupture. | Procedure: Quadriceps graft<br> <br> |
| Other: Hamstrings Graft<br>The Hamstrings graft is harvested and used as a knew anterior cruciate ligament after rupture. | Procedure: Quadriceps graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome score - IKDC | IKDC (international Knee Documentation committee) subjective score (0-100) | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee laxity | KT-1000 arthrometer | 12 month | 
| Patient reported outcome score - KOOS | Koos (Knee injury and Osteoarthritis Outcome Score) contains 5 subscores (Pain, ADL, QOL, Symptoms, Sport & recreation). Each subscore ranges from 0-100 where higher values represent a better score. | 12 month | 
| TEGNER | Patient reported outcome score (range 0-10) | 12 month | 
| Anterior knee pain scale | Patient reported outcome score (range 0-100) | 12 month | 
| Donor Site morbidity score | Patient reported outcome score (range 100-0) | 12 month |
Mechanisms of Orthopnea in Stable Obese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position. In stable obese subjects, in sitting and supine positions, the investigators measured Borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase III, and opening capacity. Orthopnea was defined as any increase in the Borg score in the supine position from its value in the sitting position

Official Title
-----------------
Mechanisms of Orthopnea in Stable Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Supine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese (BMI ≥ 30) stable condition 20 < Age < 60 years Exclusion Criteria: other respiratory disorder (COPD) left cardiac insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: sitting position<br>measurement in the sitting position | |
| Active Comparator: supine position<br>measurement in the sitting position | Other: Supine<br>* measurements after 30 minutes in complete supine position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| closing volume by nitrogen washout method |  | 30 minutes after changing position (hour 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static lung volumes by plethysmography | static lung volumes are composed of vital capacity, FEV1, inspiratory capacity, and reserve expiratory volume and are measured by plethysmography | 30 minutes after changing position (hour 2) | 
| expiratory flow limitation by NEP test | NEP test | 30 minutes after changing position (hour 2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
closing volume, expiratory flow limitation, obesity, orthopnea
Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Pediatric patients admitted to the intensive care unit and requiring conscious sedation for minor surgical procedures are at risk to hypoventilate and retain CO2. The rise in CO2 levels is not well described and unpredicted. In this study the investigators will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a device recently approved for clinical use. The hypothesis is ventilation of patients undergoing conscious sedation is compromised and CO2 levels might rise significantly to levels that potentially can effect hemodynamics. In order to avoid hemodynamic changes proper and routine monitoring is recommended.

Official Title
-----------------
Efficiency of Ventilation During Conscious Sedation of Pediatric Patients Undergoing Minor Procedures in the Pediatric Intensive Care Unit

Conditions
-----------------
Conscious Sedation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit patients requiring minor surgical procedures (e.g. bronchoscopy, central venous line placement, lumbar puncture, intracranial pressure monitoring device insertion) Exclusion Criteria: skin disease burns to thorax

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conscious sedation group<br>Pediatric patients 0 to 18 years requiring conscious sedation for procedures done in the pediatric ICU excluding burned patients or patients with severe eczema or other skin disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TcCO2 level | Transcutaneous measurement of patients undergoing conscious sedation | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TcCO2, sedation, procedure, PICU
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients. Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.

Detailed Description
-----------------
All patients receive background treatment with docetaxel.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: aflibercept (AVE0005)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Solid malignancy, documented by pathologic report, for which treatment with single-agent docetaxel (administered every 3 weeks, at dose <75 mg/m2)is planned. Written informed consent Exclusion criteria: Patient has received more than 2 prior lines of cytotoxic-containing chemotherapy Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter QTcF >480 msec on screening ECG The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4 mg/kg every 2 weeks | Drug: aflibercept (AVE0005)<br>* Intravenous route<br>|
| Placebo Comparator: 2<br>matching placebo | Drug: placebo<br>* Intravenous route<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG parameters (QTcF interval) |  | Cycle 1 and Cycle 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other ECG parameters |  | Cycle 1 and Cycle 3 | 
| Clinical safety (adverse events, serious adverse events) |  | maximum of 15 cycles | 
| Pharmacokinetic parameters |  | Cycle 1 and Cycle 3 |