linjc16/ctgov huggingface dataset:
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

Study Overview
=================
Brief Summary
-----------------
Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.

Official Title
-----------------
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

Conditions
-----------------
Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing unilateral femoral endarteriectomy Exclusion Criteria: emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter |  | Change - One month, six months and one year after the surgery |
Novel PET/CT Agents and MRS/MRI in Prostate CA and High Risk Prostate Cancer: An Inter-SPORE Collaboration

Study Overview
=================
Brief Summary
-----------------
Prostate cancer imaging using traditional anatomic modalities including CT, MR, and ultrasound is limited. Improvement in current imaging modalities or development of new ones should be a priority in prostate cancer research. Optimal treatment varies considerably for patients with different staging characterizations and new imaging methods that more accurately stage patients could lead to more appropriate treatment. The objective of this study is to obtain preliminary, comparative data on new, promising imaging methods for prostate cancer. PET/CT imaging using 11C-choline,11C-acetate, and Y86 or 18F-Adenosylcobalamin and MRI spectroscopy (MRS) of prostate cancer will be compared. Direct comparison of these imaging methods has never been done and Mayo Clinic and Johns Hopkins are uniquely able to conduct such a trial as an inter-SPORE collaboration.

Official Title
-----------------
Comparison of Novel PET/CT Imaging Agents and MRS/MRI in Metastatic and High Risk Prostate Cancer: An Inter-SPORE Collaboration

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 18 years of age or older Patients who have completed staging CT and/or bone scan as part of their routine workup Patients with bulky metastatic prostate cancer who have 5 or more lesions suspicious for distant metastases as determined by routine CT and/or bone scans that are untreated by radiation Exclusion Criteria: Patients who are less than 6 weeks post operative for Greenfield filter placement Patients with metallic surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at Mayo and only those inserted after October of 1994 and /or metal fragments in the body including metal fragments in the eyes

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Prostate cancer patients | Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy<br>* C11 Choline, C11 Acetate PET and MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test accuracy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test comparative accuracy of PET and MRI |  | 2years |
Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment

Study Overview
=================
Brief Summary
-----------------
Objective To evaluate the accuracy of data acquisition by Health e pod device in measurement of body temperature, to compare it to a standard body temperature measure equipment About 400 consecutive patients admitted to PEU in Assaf Harofeh Medical Center will compile the Study Population. Basic vital signs will be recorded on admission and during hospitalization as per the PEU policy and not in particular for this study. As a part of routine check-up all admitted patients undergo body temperature measure (oral or rectal - as per the PEU policy and with PEU devices). Following an explanation and patient agreement, eligible patients (and their legal guardian) will sign informed consent and enter the study. The health e pod device will be applied to measure body temperature, immediately after the standard temperature measure has been performed by the PEU professional.

Official Title
-----------------
Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment

Conditions
-----------------
All Children Admitted to the ED, Children With Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed an Informed Consent by the patients' legal custodian / guardian (and assent by the patient when applicable). Age 0 to 18 years Clinically stable patients hospitalized in PEU. Exclusion Criteria: Implanted pacemaker or defibrillator. Patients participating in other clinical trail.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children in the ED<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreament between measurments by Health e pod device and the gold standard reference device. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fever, Children
Endomicroscopy and Crohn´s Disease

Study Overview
=================
Brief Summary
-----------------
Purpose: The main objective of this study is to determine endomicroscopic features of Crohn´s disease. Background: Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy of the gastrointestinal mucosa during the endoscopic procedure. Scope: In patients with Crohn´s disease.

Detailed Description
-----------------
Methods: Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed. Procedure: The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.

Official Title
-----------------
Confocal Laser Endomicroscopy in Patients With Crohn´s Disease

Conditions
-----------------
Crohn´s Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age 18-85 years Ability of subjects to understand character and individual consequences of clinical trial Subjects undergoing colonoscopy Exclusion Criteria: Inability to provide written informed consent Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s) Impaired renal function (Creatinine > 1.2 mg/dl) Pregnancy or breast feeding Active gastrointestinal bleeding Known allergy to fluorescein, acriflavin or cresyl violet Residing in institutions (e.g. prison)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 determine endomicroscopic features of Crohn´s disease. |  | October 2009 until May 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of CLE findings with conventional histology. |  | October 2009 until May 2010 |
COVID Breath Test - Ancon

Study Overview
=================
Brief Summary
-----------------
This study is designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.

Official Title
-----------------
Breath Test Feasibility Trial for COVID-19 Infection Diagnosis

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Breath test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older Patients that present for COVID-19 testing, have tested Covid negative, or Covid Positive patients. Exclusion Criteria: Unable to consent Patients on a ventilator Pregnant Women

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 |
| --- | --- |
| Test group<br>Participants who have a positive Covid-19 Test or negative Covid-19 test who provide a breath sample. | Diagnostic Test: Breath test<br>* Participants provide a breath sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide an adequate sample and compare the signals given from the two groups. | The samples from the participants will be analyzed to identify the different signals given from Covid-19 positive patients and Covid-19 negative patients | 10 minutes |
Clinical Trial for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Phase III trial using an injectable for treatment of prostate cancer.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Leuprolide Acetate for Injectable Suspension 22.5 mg


Participation Criteria
=================

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Leuprolide Acetate for Injectable Suspension 22.5 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Cancer, PSA, Leuprolide
Qualitative Assessment of Patients Suffering From Difficult Asthma

Study Overview
=================
Brief Summary
-----------------
Asthma is a chronic inflammatory disease, resulting from environmental, genetic and immunological factors. This is a triad specific to the diseases of the 21st century, linked to our environment, which the investigators thought were perfectly characterized and stable and which presents us with new challenges in their management. Our environment has not stopped changing over the past 30 years, so has our way of life and our way of working. The early detection of asthma and the initiation of an adequate therapy are most often carried out by primary care physicians, such as the general practitioner and the general pediatrician. These practitioners find themselves confronted with the medical complexity of asthma which essentially resides in the management of severe forms of asthma, defined by the high therapeutic charge needed to obtain a good control of the disease and, sometimes, in the management of difficult asthma which is an uncontrolled asthma independently of the patients' compliance and of the prescribed therapies. While general practitioners refer many cases of asthma to hospital experts, the investigators wanted to address the issue of difficult asthma, the management of which is less codified. The main objective of this work is to identify, by a qualitative analysis of medical records, the profiles of patients referred for difficult asthma in a tertiary hospital in order, secondly, to target individual characteristics or subgroups on which therapeutic actions could be implemented, and to provide educational support for doctors.

Official Title
-----------------
Qualitative Analysis of Patients' Medical Records, to Understand the Reasons of the Difficulty in Controlling Asthma, in Difficult Forms

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients assessed for difficult asthma, from December 2015 to November 2020, at the University Hospital of Montpellier Patients aged from 5 to 99 years Exclusion criteria: Patients not affiliated to French Social Security Patients not capable of understanding French Patients who don't have a diagnosis of difficult asthma

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Qualitative analysis of the medical records | Qualitative analysis of the medical records from patients addressed to a tertiary hospital for difficult asthma | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment, Allergy, Compliance, Severe, difficult-to-treat asthma, Difficult Asthma, Diagnosis, Comorbidities
Alucent Vessel Restoration System for AVF

Study Overview
=================
Brief Summary
-----------------
Feasibility of the Vessel Restoration System for AVF

Detailed Description
-----------------
A study of the safety and feasibility of the Vessel Restoration System for AVF to promote the physiologic and functional maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients with Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF

Official Title
-----------------
A Study of the Safety and Feasibility of the Vessel Restoration System for AVF to Promote the Physiologic and Functional Maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients With Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF

Conditions
-----------------
AV Fistula

Intervention / Treatment
-----------------
* Combination Product: Alucent Vessel Restoration System for AVF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and can provide informed consent Use birth control Chronic Kidney Disease Exclusion Criteria: Receiving hemodialysis Pregnant, breastfeeding, planning to become pregnant Receiving immunosuppressants Has Long COVID

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: Sequential Assignment
Interventional Model Description: A prospective, single-arm, multicenter, open-label study of the VRS-AVF for use as adjunctive therapy in the surgical creation of an end-to-side brachiocephalic (BC) AVF.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alucent VRS for Treatment of Atherosclerotic Lesions<br>Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components: VRS 10-8-10 Dimer Coated Balloon Catheter for AVF VRS Light Fiber VRS Light Source | Combination Product: Alucent Vessel Restoration System for AVF<br>* Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components: VRS 10-8-10 Dimer Coated Balloon Catheter for AVF VRS Light Fiber VRS Light Source<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF Maturation | Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points | 2 weeks to 3 months |
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

Study Overview
=================
Brief Summary
-----------------
Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy. In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil. In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples. The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.

Official Title
-----------------
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

Conditions
-----------------
Metastatic Anal Canal Cancer, Human Papillomavirus

Intervention / Treatment
-----------------
* Drug: DCF regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG performance status ≤ 1 patient with metastatic anal cancer HPV+ presence of a measurable target lesion according to radiological criteria (Recist V1.1) patient with more than 12 months of complete remission of metastatic anal cancer according to radiological criteria (Recist V1.1)after treatment by DCF regimen (Docetaxel, Cisplatin and 5-Fluorouracil) Exclusion Criteria: pregnancy or lactation patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients in complete response<br> | Drug: DCF regimen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence and characterization of anti-HPV immune responses in patients in complete remission |  | 3 months after sample | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global survival |  | from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months | 
| progression free survival |  | from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months |
Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count

Study Overview
=================
Brief Summary
-----------------
The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women. The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count. The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.

Detailed Description
-----------------
The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to 20 antral follicles) determined by ultrasound scans.

Official Title
-----------------
Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count

Conditions
-----------------
Antral Follicle Deficit, Fertility

Intervention / Treatment
-----------------
* Procedure: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 35 years old 1 to 9 or 13 to 20 antral follicles Caucasian, occidental Europe Presence of both ovaries Informed consent Exclusion Criteria: Ovarian anomalies Menopause Pregnancy Other diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood samples|Blood samples|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polymorphism P1, Polymorphism P2, FSH Receptor, Antral follicle count, FSH receptor polymorphism