linjc16/ctgov huggingface dataset:
[18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of specific bone marrow maps developed with18F-FLT PET/CT imaging on the ability to spare proliferating bone marrow using proton beam radiotherapy compared to IMRT. Participants will be 18 years of age or old with a history of gynecologic cancer. Subjects will undergo 3 FLT-PET scans (one before treatment, one during the course of RT, and one 2-5 weeks after initiation of RT). Scans will take place in the Department of Radiation Oncology.

Official Title
-----------------
[18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Radiation: [18F]Fluorothymidine (FLT) PET/CT Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be 18 years of age or older History of gynecologic cancer. Recommended to undergo IMRT or PBT of the pelvis with concurrent chemotherapy Female participants of child-bearing potential must have a negative urine or serum pregnancy test at the time of the screening visit. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific procedures. Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician. Exclusion Criteria Females who are pregnant or breast feeding at the time of screening will not be eligible for this study. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subjects safety or successful participation in the study. Unwilling or unable to provide informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Proton subjects<br> | Radiation: [18F]Fluorothymidine (FLT) PET/CT Imaging<br> <br> |
| IMRT subjects<br> | Radiation: [18F]Fluorothymidine (FLT) PET/CT Imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Changes in Bone Marrow Assessed Through Images |  | up to 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
concurrent chemotherapy
Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)

Study Overview
=================
Brief Summary
-----------------
Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia (VAP) and its correlation with response to treatment and outcome.

Detailed Description
-----------------
A prospective, interventional study conducted between August 2006 and August 2007 in MICU in Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated. sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture. The sTREM-1 levels in BAL fluid were measured and compared between patients with positive BAL culture and negative BAL culture. Serial changes in sTREM-1 levels were evaluated in relation to patient outcome.

Official Title
-----------------
Serial Changes of Soluble TREM-1 Level in Bronchoalveolar Lavage Fluid During Ventilator-associated Pneumonia

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Procedure: Bronchoscopy BAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (older than 18 years)with clinically suspected VAP Exclusion Criteria: mechanically ventilated patients post cardiopulmonary resuscitation patients with end stage diseases with life expectancy less than 3 months patients with solid or hematology transplantation patients on immunosuppressive agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 86 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 |
| --- | --- |
| Ventilator-associated pneumonia<br> | Procedure: Bronchoscopy BAL<br>* The bronchoscope was passed through endotracheal tube via a specific adaptor without topical anesthesia. The bronchoscope was introduced and wedged into the segmental bronchial orifice where pneumonia was suspected. Five aliquots of 20ml sterile saline were instilled and aspirated gently. The first aliquot was discarded and the last 4 aliquots were pooled for analysis. Part of the retrieved specimen in the first BAL fluid was sent to the laboratory immediately after collection for measurement of sTREM-1 level, the rest of sample was sent to microbiology lab for quantitative culture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STREM-1, BAL, VAP
Free Fatty Acids: Threshold Repeatability Study

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds change with repeated testing. Threshold testing for NEFA taste has been reported by a number of laboratories, including our own; however, these studies have reported data for only one testing occasion. The investigators seek to conduct repeated testing to measure the test-retest reliability of these methods. The investigators believe that with repeated exposure to NEFA, a person's sensitivity increases. The investigators are also testing the efficiency of testing by two methods (forced-choice ascending trial versus staircase). Additionally, the association between taste responses, diet and BMI will be explored.

Official Title
-----------------
Free Fatty Acids: Threshold Repeatability Study

Conditions
-----------------
Taste, Non-esterified Fatty Acids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 years old in good health available for three months Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-esterified fatty acid detection thresholds in humans |  | 6 months | 
| BMI |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Habitual fat intake | Block Rapid Dietary Fat Screener will be used as well as the ASA-24. | Baseline | 
| testing method | Comparison of time to maximum sensitivity by participants based on forced-choice versus staircase stimulus presentation techniques. | 6 months | 
| hunger | Visual analog scale | each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fat, taste, threshold, sensitivity, human
Purify Antigen-specific B Cells From Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is an autoimmune disease characterized by the presence of autoantibodies directed against citrullinated proteins, called ACPAs. These antibodies are very specific to RA, and the severity of the disease is closely correlated with the level of these ACPAs, even though they appear much earlier than the clinical signs. Current treatments by biotherapies are effective but only treat the inflammatory symptoms of the disease or, on the contrary, induce a global immunosuppression with a depletion of all B lymphocytes. Contrary to the current approaches, the CURE RA project proposes a double innovative character: The project aims at specifically destroying B lymphocytes expressing / or secreting ACPAs for a more specific approach to RA, without inducing immunosuppression. The new therapeutic molecule is entirely original and has no equivalent at present, it uses the target antigens of autoantibodies, the citrullinated peptides, as tools to destroy the pathogenic B cells that express/produce these autoantibodies.

Official Title
-----------------
New Therapeutic Approach to Cure Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Antibodies anti-CCP + (ACPA +) > 250 IU/mL Exclusion criteria: Current or past Rituximab (Mabthera) treatment past (< 9 months) Abatacept treatment

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of B cell line | Establishment of B cell line From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of new therapeutic molecules | Validation of new therapeutic molecules | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B cells, Rheumatoid arthritis, ACPA
Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.

Official Title
-----------------
An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Conditions
-----------------
Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind study Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study. Exclusion Criteria: Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Efficacy |  |  |
Risk Factors Related to Thirst After Surgery

Study Overview
=================
Brief Summary
-----------------
To investigate the risk factors related to xerostomia (dry mouth) after surgery

Detailed Description
-----------------
Dry mouth of postoperative makes the patient feel thirst, and the pain of the lips is cracked. It will also make the sputum thick and sticky, making it difficult for the patient to cough by himself. Especially the elderly may have sputum accumulation and pneumonia. The incidence of dry mouth was 88%, 6-8 hours after abdominal surgery. Initiating the motivation of this study, it is hoped that through research to understand the relevant factors causing dry mouth after surgery.

Official Title
-----------------
Rrisk Factors of Xerostomia (Dry Mouth) After Surgery

Conditions
-----------------
Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients Elective surgery patients >19 years old patients Exclusion Criteria: cognitive impairment patients ICU patients

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| To investigate the risk factors related to xerostomia (dry mouth) after surgery | To investigate the risk factors related to xerostomia (dry mouth) after surgery | 5 mins |
Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Study Overview
=================
Brief Summary
-----------------
Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population. The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures. Most of available studies are retrospective or include a limited number of patients. The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.

Official Title
-----------------
Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Conditions
-----------------
Congenital Heart Disease, Arrhythmia

Intervention / Treatment
-----------------
* Procedure: Catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with congenital heart disease referred for catheter ablation Exclusion Criteria: Absence of patient's consent Patient under guardianship or curatorship Pregnant woman
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Catheter ablation|Catheter ablation of arrhythmia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of targeted arrhythmia | Rate of freedom from targeted arrhythmia recurrence | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of any arrhythmia | Rate of freedom from any arrhythmia recurrence at 12 months | 12 months | 
| Long-term recurrence of targeted and any arrhythmia | Rate of freedom from targeted and any arrhythmia recurrence | 24 months | 
| Complications | Complications associated with catheter ablation | 1 month | 
| Quality of life assessed by SF36 score | Quality of life change before and after catheter ablation assessed by SF36 score | 6 months | 
| Quality of life assessed by EQ5D3L score | Quality of life change before and after catheter ablation assessed by EQ5D3L score | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catheter ablation
Telemedicine for Patients With an Hybrid Closed Loop System

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.

Official Title
-----------------
A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System

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

Intervention / Treatment
-----------------
* Device: Telemedicine Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic criteria for DM1 according to ADA They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection) Acceptance of participation in the study and signing of the informed consent Exclusion Criteria: Gestation Institutionalization, serious or terminal illness or renal replacement therapy. Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform. Refusal to participate in the study or to sign the informed 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 |
| --- | --- |
| Experimental: Telemedicine Arm<br>Use of a telemedicine platform combined with face-to-face visits according to protocol | Device: Telemedicine Arm<br>* Patients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol.<br>|
| No Intervention: Control Arm<br>conventional follow-up according to routine clinical practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on quality of life | Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are: Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control | A1c levels | 12 months |
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

Study Overview
=================
Brief Summary
-----------------
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.

Official Title
-----------------
Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: APBI (Dose Escalation)
* Device: Contura MLB Breast Brachytherapy Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Life expectancy > 10 years Lumpectomy with clear margins (negative per NSABP criteria) DCIS and/or invasive carcinoma If invasive, nodes must be negative T stage is Tis, T1 or T2<=3 cm max diameter ER(+) or ER(-)/PR(+) Exclusion Criteria: Pregnant or breast feeding Active collagen-vascular disease Paget's disease of the breast Prior history of breast cancer Prior breast or thoracic radiotherapy Multicentric carcinoma Synchronous bilateral breast cancer Surgical margins that cannot be assessed or that are positive T Stage is T2>3 cm or greater ER(-)/PR(-)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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 |
| --- | --- |
| Other: Dose Escalation<br> | Radiation: APBI (Dose Escalation)<br>* Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each.<br>Device: Contura MLB Breast Brachytherapy Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
APBI, breast cancer, brachytherapy, Contura