linjc16/ctgov huggingface dataset:
Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.

Official Title
-----------------
An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)

Conditions
-----------------
Chronic Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years of age. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML). Written informed consent. Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible. Exclusion Criteria: Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires. Patients who are unable to speak and read the language of the questionnaire.

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 |
| --- | --- | --- |
| The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML. |  | 18 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24). |  | 18 months from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic myeloid leukemia; quality of life
Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.

Detailed Description
-----------------
After a trabeculectomy with mitomycin C 0,02% for 3 minutes, the blebs are controlled by a glaucoma specialist on day 1, week 1,2,3,4, month 3 and 6 after surgery. The glaucoma specialist will evaluate the bleb appearance according to a standardized protocol. At the same time points the bleb will be imaged with the spectral domain optical coherence tomography, to monitor bleb changes objectively. The investigators hope to see signs of bleb incapsulation and scarring earlier and then treat the patient accordingly.

Official Title
-----------------
Imaging of Blebs After Trabeculectomy With Mitomycin C 0,02% Using the Spectral Domain Optical Coherence Tomography

Conditions
-----------------
Glaucoma, Filtering Blebs

Intervention / Treatment
-----------------
* Procedure: trabeculectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent Exclusion Criteria: patient without glaucoma, under 18 years of age, not willing to take part in the study

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 |
| --- | --- |
| Trabeculectomy<br>glaucoma patients undergoing trabeculectomy with mitomycin c 0,02% | Procedure: trabeculectomy<br>* postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grading of filtering bleb |  | December 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, trabeculectomy, filtering bleb, spectral domain optical coherence tomography
Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Evaluating the use of Liraglutide in patients with Type 1 Diabetes.

Detailed Description
-----------------
This investigation will be a retrospective chart review of in type 1 diabetics who have been treated with liraglutide. The study will be conducted at Diabetes-Endocrinology Center of WNY at Millard Fillmore Hospital, affiliated to the State University of New York at Buffalo. Study Population: 40 patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day on continuous glucose monitoring system (CGMS) will be included in the study. These patients with type 1 diabetes have been treated with liraglutide in addition to insulin. The investigators would retrospectively review their charts to evaluate decreases in fasting, postprandial and the overall mean glucose concentrations. The investigators will compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following one week and 12 weeks of treatment with liraglutide daily. In addition, the investigators will compare the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl. HbA1c levels before and after 12 weeks of treatment with liraglutide daily will be compared.

Official Title
-----------------
Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review

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

Intervention / Treatment
-----------------
* Drug: Liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes Mellitus Exclusion Criteria: Type 2 Diabetes Mellitus

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Liraglutide|Liraglutide s/c 0.6mg once daily.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide |  | 20 weeks |
Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms

Study Overview
=================
Brief Summary
-----------------
This aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative French population (from several hospital centers and liberals from several departments in the west and east of France). This population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. The control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers). This innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of difficult files.

Official Title
-----------------
Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult woman (40 to 75 years old) Treatment at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer including mammography and histological evidence available Patient who has already given her consent for the reuse of her anonymous data for research purposes Exclusion Criteria: Woman who expressed her opposition to participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| Evaluate the diagnostic performance (sensitivity, specificity) for operator tumor detection assisted by mammographic diagnostic aid software, and compare it to the diagnostic performance of an unassisted operator. | This assessment is based on contouring the tumor area on mammograms. | Files analysed retrospectively from January 01, 2010 to January 01, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Mammography, Artificial intelligence, Tumor detection on mammograms
Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Detailed Description
-----------------
Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes. Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

Official Title
-----------------
Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enlarged discrete N2/N3 lymph nodes central tumor with normal mediastinal lymph nodes enlarged N1 lymph nodes with normal mediastinal lymph nodes Exclusion Criteria: metastatic disease severe co-morbidity that disqualified surgical treatment mediastinal infiltration by tumor small peripheral lung tumor with normal-sized mediastinal lymph nodes

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 |
| --- | --- | --- |
| elastography strain ratio | Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) | up to 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endobronchial ultrasound, EBUS - TBNA, elastography, strain ratio, lung cancer staging
Wheeze Detection Using Aevice Medical Device

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine if Aevice Medical Device can detect wheeze as accurately as a physician through auscultation. The secondary objective is to investigate if Aevice Medical Device can be used for remote auscultation of the lung.

Official Title
-----------------
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation

Conditions
-----------------
Subject Presenting Wheeze, COPD, Asthma

Intervention / Treatment
-----------------
* Device: AeviceMD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is willing and parents/guardians are able to give informed consent for participation in the study. Male or Female, aged 3 -18 years. Presenting with wheeze. Able (in the Investigators opinion) and willing to comply with all study requirements Exclusion Criteria: Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AeviceMD|The AeviceMD will be placed on the patient to detect wheeze and perform auscultation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheeze is detected by physician and AeviceMD | Primary end point of wheeze will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation. AeviceMD will perform wheeze analysis on each 5 sec of recording | 60 Seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician | Secondary end point of normal, adventitious and lack of breath sounds will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation - i.e. bronchovesicular, crackles. Normal, adventitious and lack of breath sounds will be annotated in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the independent physician during remote auscultation - i.e. bronchovesicular, crackles | 150 Seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wheeze, Auscultation
Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.

Detailed Description
-----------------
The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.

Official Title
-----------------
Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Nasal Endotracheal Tube and a Cylindrical-shaped Cuffed Nasal Endotracheal Tube After Changing in Position of Head

Conditions
-----------------
Endotracheal Tube, Cuff Pressure

Intervention / Treatment
-----------------
* Device: TaperGuard endotracheal tube
* Device: cylindrical endotracheal tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who were underwent nasal intubation Exclusion Criteria: history of difficult intubation, limited neck movement, respiratory diseases and body mass index more than 35 kg/m2
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cylindrical tube group<br>The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube. | Device: cylindrical endotracheal tube<br>* endotracheal tube is intubated<br>|
| Experimental: tapergaurd tube group<br>The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube. | Device: TaperGuard endotracheal tube<br>* TaperGuard endotracheal tube is intubated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuff pressure | Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany). | 5 minutes after change of head position |
Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

Study Overview
=================
Brief Summary
-----------------
The need for oral antibiotics as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not been studied in a prospective trial. This study will compare the recovery rates of children with SAM treated at home with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their outpatient case management. The investigators hypothesize that there will be no significant difference in rates of recovery between children who receive and children who do not receive antibiotics.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effectiveness of Oral Antibiotics in the Community-based Treatment of Severe Acute Malnutrition in Malawian Children

Conditions
-----------------
Kwashiorkor, Marasmus

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Amoxicillin
* Drug: Cefdinir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months - 5 years old Kwashiorkor or Marasmus Qualifies for home-based therapeutic feeding with RUTF Exclusion Criteria: Obvious congenital or other malformation that makes child a poor candidate for home-based feeding with RUTF Unable to consume test-dose of RUTF in clinic Parent refusal to participate and return for follow-up

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* liquid placebo medication given twice per day for 7 days<br>|
| Experimental: Amoxicillin<br> | Drug: Amoxicillin<br>* liquid amoxicillin given twice per day for 7 days<br>|
| Experimental: cefdinir<br>cefdinir | Drug: Cefdinir<br>* liquid cefdinir given twice per day for 7 days<br>* Other names: Omnicef;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional recovery |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | 12 weeks |
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

Official Title
-----------------
Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors

Conditions
-----------------
Hepatitis C, Kidney Transplant; Complications, Heart Transplant Infection

Intervention / Treatment
-----------------
* Drug: Mavyret


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection Willing to accept and consent for accepting hepatitis C positive graft Exclusion criteria: Existing chronic liver disease (liver cirrhosis) Concomitant infection with HIV or Chronic hepatitis B Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection Pregnancy (Pregnant patients do not undergo solid organ transplants)

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: Arm 1: Pre-emptive Treatment Arm<br>Single arm study were all recipients of HCV viremic organs will receive combination therapy. | Drug: Mavyret<br>* Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients<br>* Other names: Zetia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of prevention of HCV viremia in recipients of HCV viremic solid organs | The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol. | 3 months | 
| Graft and patient survival | Study will assess the overall 1 year patient and graft survival. | 1 year |