linjc16/ctgov huggingface dataset:
Color Doppler and Mri Diffusion in Major Salivary Gland Masses

Study Overview
=================
Brief Summary
-----------------
This study intend to evaluate the combined value of ADC and COLOR DOPPLER in differentiating benign and malignant salivary gland tumors in comparison to histopathological findings and its use in preoperative prediction of benign and malignant masses.

Detailed Description
-----------------
the study aim to achieve preoperative differentiation between benign and malignant masses of the major salivary glands using the ADC values and Color Doppler values (PSV - PI - RI)

Official Title
-----------------
Combined Role of Color Doppler and Diffusion Weighted MRI In Differentiation Between Benign and Malignant Tumors of Major Salivary Glands

Conditions
-----------------
Salivary Gland Diseases

Intervention / Treatment
-----------------
* Device: MRI
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands. Exclusion Criteria: Patients with history of metal plates or screws or artificial joints. Patients who have phobia of indoor places. Patients with contraindication to MRI like intra-cerebral aneurysmal clips, cardiac pacemaker, and metallic foreign body at region of examination.

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

| Intervention/Treatment |
| --- |
|Device: MRI|diffusion weighted MR|
|Device: Ultrasound|Color Doppler ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses | The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses will differ according to the nature of the mass determined by histopathological finding | baseline |
[18F]-F13640 as a New Brain Radiopharmaceutical

Study Overview
=================
Brief Summary
-----------------
This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.

Official Title
-----------------
First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging

Conditions
-----------------
Neurological Pathology, Healthy Subjects

Intervention / Treatment
-----------------
* Drug: [18F]F13640
* Drug: [18F]F13640


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects Weight between 50 kg and 90 kg Affiliated to a social security or similar scheme Not subject to any legal protection measures Exclusion Criteria: Subjects with neurologic or psychiatric disease including all substance addictions Daily smokers Active infectious disease MRI contraindications PET contraindications determined with FDG injection Subjects deprived of their liberty by judicial or administrative decision Subjects unable to sign written consent for participation in the study. Severe and progressive medical pathology Volunteer who has exceeded the annual amount of compensation authorized for participation in research protocols

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Input function group<br>Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling | Drug: [18F]F13640<br>* Radiotracer injection and PET scan acquisition of 90 min: *150 Mbq + 1 MBq/Kg of [18F]F13640 at t=0 min Arterial Blood Sampling during the 90min acquisition<br>|
| Experimental: Test-retest group<br>Each subject underwent 2 PET scans distant from 1 to 3 weeks | Drug: [18F]F13640<br>* 2 Radiotracer injections and PET scan acquisition of 90 min distant from 1 to 3 weeks: For each exam: 150 MBq + 1 MBq/kg of [18F]F13640 at t=0 min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binding potentials | Binding potentials are calculated using compartimental modelling techniques. | 180 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET imaging- Serotonin-Radiotracer
COPD Patient-Powered Research Network

Study Overview
=================
Brief Summary
-----------------
The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with the goal of enrolling 75,000 or more COPD patients and those at risk who are willing to share their heath information over several years and participate in research. The COPD PPRN has built an online platform to allow volunteers to enroll electronically, complete surveys, be contacted about studies they qualify for and become connected to COPD resources. The goal of the registry is to speed research to find better treatments for COPD and ultimately a cure.

Official Title
-----------------
COPD Patient-Powered Research Network

Conditions
-----------------
Chronic Obstructive Pulmonary Disorder, Chronic Obstructive Lung Disease, Emphysema, Chronic Bronchitis

Intervention / Treatment
-----------------
* Other: Patient Reported Outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older that says yes to one of the following: COPD diagnosis Current or former smoker Family history of respiratory disease Symptomatic of respiratory disease Exclusion Criteria: Non-English speaking

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patient Reported Outcomes|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measurement Information System-29 (PROMIS-29) |  | 15 years | 
| COPD Assessment Test (CAT) |  | 15 years | 
| Modified Medical Research Council (MMRC) Dyspnea Scale |  | 15 years | 
| Charlson Comorbidity Index (CCI) |  | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
copd, emphysema, bronchitis, bronchiectasis
Coronary Care Caffeine: Influence of Coffee on Heart Rate Post Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial infarction) is a common cause of death. It is well documented that sudden cardiac death after a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is a measure of beat-to-beat changes in heart rate, with a greater variation associated with a healthier heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the effect of coffee or tea on HRV after MI.

Detailed Description
-----------------
120 post MI patients on CCU will be studied during the first week of admission. Patients will be categorised using the following criteria: Infarct size and site; PMH; Co-morbidities; Drugs; Regular caffeine ingestion. Patients will be randomised to receive either caffeinated or de-caffeinated coffee or tea during admission. HRV will be assessed by non-invasive Holter-monitoring on the fifth day. Salivary caffeine concentration will be assessed concurrently to assess compliance.

Official Title
-----------------
Influence of Coffee on Heart Rate Variability Post Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ST-segment elevation (trans-mural) MI; sinus rhythm. Age < 80 years. Exclusion Criteria: Cardiogenic shock Nothing by Mouth (NBM) Caffeine intolerance Atrial fibrillation, temporary or permanent pacing Complete heart block, bundle branch block, severe left ventricular impairment, non-ST segment MI/acute coronary syndrome

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Robot-assisted and Connected 6-minute Walk Test (TM6)

Study Overview
=================
Brief Summary
-----------------
Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6. Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot. The PEPPER robot will also collect the parameters of the 6MWT and produce a report. The EFRED service technician will remain present during the 6MWT and will take note of the test parameters. An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.

Official Title
-----------------
Robot-assisted and Connected 6-minute Walk Test (TM6)

Conditions
-----------------
Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years Speak fluent French. Exclusion Criteria: Patient's refusal to participate in the study Language barrier Cognitive disorders.
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 |
| --- | --- | --- |
| 6MWT parameters Robot vs Technician | Measurement of the distance traveled by the patient compared to the measurement made by the medical technician | 1 day |
Medication-overuse Headache: 4 Years Follow up

Study Overview
=================
Brief Summary
-----------------
From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.

Detailed Description
-----------------
The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.

Official Title
-----------------
Treatment of Medication-overuse Headache: 4 Years Follow up

Conditions
-----------------
Medication Overuse Headache

Intervention / Treatment
-----------------
* Other: No new specific intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized during the initial trial during 2004-2006.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 74 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 |
| --- | --- |
| Medication-overuse headache<br>Chronic daily headache combined with medication overuse | Other: No new specific intervention<br>* No new specific intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Headache Days/Month After 4 Years Compared to Baseline | Change in headache days/month after 4 years compared to baseline | Baseline and after 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Medication Days/Month Compared to Baseline |  | Baseline and after 4 years' of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Medication overuse, chronic, relapse
EnTRINSIC - EnPulse Trial on Search AV+ Influence

Study Overview
=================
Brief Summary
-----------------
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.

Official Title
-----------------
EnPulse Trial on Search AV+ Influence

Conditions
-----------------
Arrhythmia, Sinus

Intervention / Treatment
-----------------
* Device: Search AV+ algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms Patients treated with a Medtronic pacemaker with Search AV+ algorithm Exclusion Criteria: Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction New York Heart Association (NYHA) III/IV Instable angina pectoris Heart valve vitium Persistent AV-block II and III Early diastolic mitral regurgitation Implantable cardioverter defibrillator Participation in other clinical studies Pregnancy or unreliable birth control AV-block under strain

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

| Intervention/Treatment |
| --- |
|Device: Search AV+ algorithm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of right ventricular pacing |  | Baseline to 36 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intrinsic AV delay |  | Baseline to 36 months post-implant | 
| Hospitalizations because of symptomatic heart failure |  | Baseline to 36 months post-implant | 
| Hospitalizations because of symptomatic atrial fibrillation |  | Baseline to 36 months post-implant | 
| Medication |  | Baseline to 36 months post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sinus Node Disease, Pacemaker, Dual Chamber Pacemaker
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

Study Overview
=================
Brief Summary
-----------------
This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency. Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.

Detailed Description
-----------------
*10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.

Official Title
-----------------
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

Conditions
-----------------
IgG Deficiency, Infections

Intervention / Treatment
-----------------
* Drug: IV Gamunex 10%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin. Exclusion Criteria: Patients with panhypogammaglobulinemia or selective IgA deficiency.

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: IV Gamunex 10%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lab values ck'ed baseline and with each treatment, and 15 mo. visit |  |  | 
| Xray of Chest and sinus baseline and on 12th and last treatment |  |  | 
| Clinical assessment baseline, every treatment, and 15 mo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunodeficiency, Gammaglobulin, IgG subclass deficiency with recurrent infections
A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)

Study Overview
=================
Brief Summary
-----------------
This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Official Title
-----------------
Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment

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

Intervention / Treatment
-----------------
* Drug: bevacizumab [Avastin]
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Locally recurrent or metastatic Her2-negative breast cancer Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of >/=12 months is required Adequate haematological, renal and liver function Exclusion Criteria: Previous chemotherapy for locally recurrent or metastatic disease Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of </= 30% of marrow-bearing bone) CNS metastases Pre-existing peripheral neuropathy Clinically significant cardiovascular disease

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: bevacizumab [Avastin]<br>* 10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks<br>Drug: paclitaxel<br>* 90 mg/m2 iv days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 iv day 1 of each 21-day cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile: Adverse events |  | approximately 2 years |