linjc16/ctgov huggingface dataset:
Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)

Study Overview
=================
Brief Summary
-----------------
Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and long-term outcomes. Study type: Observational (Patient Registry) Study design: Observational Model: Cohort Time Perspective: Prospective and retrospective

Official Title
-----------------
Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)

Conditions
-----------------
Advanced Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort I: diagnosis of advanced non-small cell lung cancer from 2012-2016; Cohort II: documented positive driver gene mutations; and diagnosis of advanced non-small cell lung cancer; Cohort III: diagnosis of advanced non-small cell lung cancer and in immune-therapy; Cohort IV: diagnosis of advanced non-small cell lung cancer, and with wild-type driver gene or unknown driver gene status; Cohort V: treated with anti-VEGF drug in first line, diagnosis of advanced non-squamous and non-small cell lung cancer in 6 months before recruit; Age>18 years; Provision of written informed consent. Exclusion Criteria: not applicable

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 |
| --- | --- |
| I Retrospective cohort<br>Diagnosis of advanced non-small cell lung cancer from 2012-2016 | |
| II Prospective cohort<br>Advanced non-small cell lung cancer with driver gene mutations | |
| III Prospective cohort<br>Non-small cell lung cancer in immuno-therapy; | |
| IV Prospective cohort<br>Non-small cell lung cancer with wild-type driver gene or unknown driver gene status; | |
| V Prospective cohort<br>Advanced non-small lung cancer with wild-type gene treated with anti-Vascular Endothelial Growth Factor (VEGF) drug. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS was calculated from the diagnosis of advanced non-small cell lung cancer to death from any reasons | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced non-small cell lung cancer
Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut

Study Overview
=================
Brief Summary
-----------------
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.

Official Title
-----------------
Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)

Conditions
-----------------
Recurrent GBM

Intervention / Treatment
-----------------
* Biological: rindopepimut


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has histologically confirmed relapsed or recurrent GBM. EGFRvIII expression in tumor tissue, as assessed by a central laboratory using the Celldex assay. Prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate. Systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day. The patient does not have a known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins. The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive rindopepimut vaccine therapy. The patient is surgically sterile or post-menopausal, or, if of child-bearing potential, had a negative serum pregnancy test within the week prior to initiation of rindopepimut and is not nursing. Males and females of childbearing potential must agree to practice an effective form of contraception during the time from signing of informed consent through 28 days after the last dose of rindopepimut. The patient is able to read and understand, and has signed a patient informed consent form, which outlines the anticipated benefits and risks of treatment with rindopepimut. Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rindopepimut|Rindopepimut is an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have glioblastoma multiforme (GBM) that expresses an EGFR mutation, called EGFRvIII. Data from, a randomized, controlled phase 2 study in patients with EGFRvIII positive progressive glioblastoma (the ReACT trial) suggested that vaccination with rindopepimut could improve survival. A randomized, controlled phase III study in patients with newly diagnosed EGFRvIII expressing GBM did not show a survival advantage from rindopepimut vaccination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Validation of a NICS Method Using the Culture Medium

Study Overview
=================
Brief Summary
-----------------
This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium. The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy [PGT-A]) will be compared.

Official Title
-----------------
Validation of a Noninvasive Chromosome Screening (NICS) Method Using the Culture Medium

Conditions
-----------------
Chromosome Abnormality, Abnormality

Intervention / Treatment
-----------------
* Diagnostic Test: Noninvasive chromosome screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A). Embryonic cryopreservation. Informed consent signature Exclusion Criteria: Embryo transfer without embryo freezing Embryonic block. Bad embryo quality.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 49 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>No intervention. Couples who come to the study center to carry out a PGT-A cycle will be selected. Only couples that will use their own gametes will be selected and the indication of PGT-A will be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations. The results of chromosomal status of the embryo will be compared using the NICS and the conventional invasive method (PGT-A). | Diagnostic Test: Noninvasive chromosome screening<br>* Screening based on MALBAC-NGS technology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Mosaicism | Presence of mosaicism | At Day 5-6 after FIV | 
| Quality value of NICS DLRS | Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS) | At Day 5-6 after FIV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Reproduction, Chromosomal Endowment
Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.

Official Title
-----------------
Comparison Between Invasive Hemodynamic Monitoring, Using the PiCCO Monitor, to a Non-invasive Photoplethysmography Based Device in Hemodynamic Unstable Critically Ill Patients, With Vasopressor Support

Conditions
-----------------
Critically Ill, Hemodynamic Instability

Intervention / Treatment
-----------------
* Device: non-invasive monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU adult patients in the need of vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours Patients in which PiCCO monitoring is needed Exclusion Criteria: Refusal of the subject Technical difficulties in insertion of the PiCCO catheters Significant cardiac arrhythmias Significant valvular disease Pregnancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: non-invasive monitoring|Comparing the PiCCO monitor to the non-invasive BB-613PW device in hemodynamically unstable critically ill patients in the ICU|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of accordance between the BB-613PW to the PiCCO | We will compare the level of accordance of blood pressure, heart rate, stroke volume, cardiac output, heart rate variability, and systemic vascular resistance. | 72 hours per individual | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critically Ill patients, blood pressure, vital signs, non-invasive monitoring, Vasopressor support
The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector

Study Overview
=================
Brief Summary
-----------------
The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

Detailed Description
-----------------
The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

Official Title
-----------------
Validation of the ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare

Conditions
-----------------
Burnout

Intervention / Treatment
-----------------
* Behavioral: ReTA-model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently on sick leave for burnout employed in the Swedish healthcare services as a nurse or as a physician Exclusion Criteria: -
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 |
| --- | --- |
| Experimental: Intervention group<br>Will receive a rehabilitation intervention | Behavioral: ReTA-model<br>* Validating the rehabilitation model ReTA<br>|
| Active Comparator: Controll<br>Will receive conventional rehabilitation | Behavioral: ReTA-model<br>* Validating the rehabilitation model ReTA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | At work part or full-time compare to no return to work | 12 months | 
| Karolinska Exhaustion Disorder Scale KEDS | Decreased points in the KEDS scale 1-19, qith higher scores reflecting greater exhaustion severity. | 12 months | 
| Symptom Checklist - 6 | Decreased points on the SCL-6 scale, with a higher number reflecting depression. | 12 months | 
| Montgomery Åsberg Depression Rating Scale | Decreased points in the MADRAS scale with score ranging from 0 to 60, with higher scores reflecting greater depression severity. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthcare, Burnout, Stress, Return to work, Intervention
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.

Official Title
-----------------
The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees

Conditions
-----------------
Prosthesis-Related Infections

Intervention / Treatment
-----------------
* Other: Oral Antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study. Exclusion criteria: Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Antibiotics<br>Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist. | Other: Oral Antibiotics<br>* Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.<br>|
| No Intervention: No oral antibiotics<br>No oral antibiotics. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rate |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip, Revision, Knee, Arthroplasty, Oral, Antibiotics, Infection
Optimizing Fidelity of Interpersonal Psychotherapy

Study Overview
=================
Brief Summary
-----------------
The study is designed to develop and validate an instrument to measure quality and adherence to IPT for research and training purposes. The measure is now being used to evaluate training in IPT.

Detailed Description
-----------------
The study is a randomized trial comparing 4 different methods of follow-up training in IPT. Following initial 2-day training, participant therapists will be randomized to either individual supervision, group supervision, an internet-based training program, or autodidactic training. Participants will be followed for a year to determine their use of IPT, outcomes with patients, and adherence and quality of IPT in 4 case portfolios. The adherence measure for IPT developed in Phase I of the project is being used as the gold standard measure of IPT fidelity.

Official Title
-----------------
Optimizing Fidelity of Interpersonal Psychotherapy for Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: training in IPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active and licensed therapist conducting psychotherapy treatment; naïve to training in IPT Exclusion Criteria: Inactive or not treating patients

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual Supervision in IPT<br>Bi-weekly individual case supervision in IPT | Other: training in IPT<br>* Follow-up training in IPT to determine which best enhances fidelity<br>|
| Experimental: Group Supervision in IPT<br>Bi-weekly group supervision in IPT in groups of 4-6 therapists | Other: training in IPT<br>* Follow-up training in IPT to determine which best enhances fidelity<br>|
| Experimental: Internet-Based Training in IPT<br>Access to internet-based training in IPT to review information learned in initial 2-day training | Other: training in IPT<br>* Follow-up training in IPT to determine which best enhances fidelity<br>|
| No Intervention: Autodidactic Training in IPT<br>Clinicians allowed access to training materials and can engage in self-study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expert evaluation of conduct of IPT using IPT Quality and Adherence Measure | The IPT Quality and Adherence Measure is the title of a single outcome measure used to assess clinicians performance of IPT | one year |
Continuous Glucose Monitor Use in School

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes.

Detailed Description
-----------------
The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. Recent technological advancements in diabetes management have resulted in increased use of devices during class/school. Although many studies have examined the quality of life and the impact on the family and subject of these devices, to our knowledge this is the first study that will examine the impact of the continuous glucose monitor during class/school. To our knowledge, this is first study to involve the teachers. The results of this study is particularly important since the future of diabetes therapy will be to use continuous glucose monitors and insulin pumps to develop a closed loop system of insulin therapy or artificial pancreas.

Official Title
-----------------
The Impact of Continuous Glucose Monitor Use in the Classroom/School Environment

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes use continuous glucose monitor in school Exclusion Criteria not using a continuous glucose monitor

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 25 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 |
| --- | --- | --- |
| CGM usefulness score |  | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Comfort score |  | 1 yr |