linjc16/ctgov huggingface dataset:
Kinematics of Obese Patients Perambulation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

Detailed Description
-----------------
Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese patients. Even the surgery is well described, there is no available study about its influence on the functional parameters of patients perambulation.

Official Title
-----------------
Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?

Conditions
-----------------
Morbid Obesity, Surgical Management by Laparoscopic Sleeve Gastrectomy

Intervention / Treatment
-----------------
* Procedure: 6-minute walk test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 40 and 60 kg/m2 or BMI > 35 kg/m2 with at least one comorbidity no weight loss between 18 and 65 years old history of obesity > 5 ans Exclusion Criteria: history of bariatric surgery major cardiac insufficiency pregnancy or breastfeeding no social welfare

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 6-minute walk test<br>the 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist. | Procedure: 6-minute walk test<br>* the test corresponds to that defined by Abdel Kafi et al in 2005<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test | the value of this test is obtained by the difference between the 6-minute walk test performed before the surgery and the 6-minute walk test performed 6 months after the surgery | 6 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | the quality of life is evaluated by the SF36 questionnaire which is performed before the surgery and 6 months after. | 6 months after the surgery | 
| BAROS score | the baros score is evaluated by the surgeon during the consultation 6 months after the surgery | 6 months after the surgery | 
| quality of life with the Mooreheald-Ardelt questionnaire | the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery | 6 months after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, surgery
Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

Study Overview
=================
Brief Summary
-----------------
At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described. Thus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.

Official Title
-----------------
Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Having been seen at least once in consultation in the Internal Medicine, Endocrinology and Nutrition department of Hautepierre Hospital Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021 In whom biological confirmation of recurrence has been demonstrated Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes. Exclusion criteria: Subject having expressed opposition to participating in the study Treatment pre and / or post surgery by radiotherapy No recurrence No treatment with a somatostatin analogue for recurrence Subject under guardianship, curatorship or safeguard of justice

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 |
| --- | --- | --- |
| Study of the clinical and biological evolution, after discontinuation of treatment with somatostatin analogues, of acromegalic patients with recurrence after surgery. |  | Files analysed retrospectively from January 01, 2000 to September 01, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly, Pituitary microadenoma, Pituitary macroadenoma, Somatostatin analogues, Hormonal control
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.

Official Title
-----------------
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Conditions
-----------------
Regional Saturation of Oxygen (rSO2)

Intervention / Treatment
-----------------
* Device: Masimo O3 Neonatal Sensors
* Device: 510(k) cleared sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 10 kg Subjects less than or equal to 28 days old Exclusion Criteria: Underdeveloped skin at sites of sensor placement Jaundice or bilirubin levels out of normal range Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study Subject deemed not eligible based on Principal Investigator's judgment

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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

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

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: Neonatal Test group<br>Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. | Device: Masimo O3 Neonatal Sensors<br>* Regional Oximetry sensor for Neonates<br>Device: 510(k) cleared sensor<br>* Cleared Regional Oximetry sensor for Neonates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With rSO2 Collected | In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | Data collection period; alternating sensors every 5 minutes for up to 20 minutes. |
Evaluation of Radiology Resident Anxiety When Beginning Emergency Room (ER) Call

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify levels of resident anxiety under the current system (take call alone) and compare results to a modified system.

Detailed Description
-----------------
The study purpose is to quantify resident perceptions and feelings under the current 1700 call system (take call alone) and compare those with resident perceptions and feelings under a modified system where two partial shifts are taken with an experienced resident (buddy call) prior to taking call alone.

Official Title
-----------------
Evaluation of Radiology Resident Anxiety When Beginning ER Call

Conditions
-----------------
Stress, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first year radiology residents
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>First year University of Michigan Radiology residents will take call as scheduled without a buddy call experience. (Enrollment completed for the control group) | |
| Experimental Group<br>2009 class of first year Radiology residents who will be assigned two 5 hour shifts working side by side with a more senior resident (who has experience taking call). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve resident well-being by decreasing anxiety surrounding beginning ER call as a first year radiology resident. |  | 12 months |
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Study Overview
=================
Brief Summary
-----------------
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Detailed Description
-----------------
The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Official Title
-----------------
A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

Conditions
-----------------
Clostridium Infections, Diarrhea

Intervention / Treatment
-----------------
* Drug: PAR-101/OPT-80
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males/females with CDAD Females must use adequate contraception Signed informed consent Exclusion Criteria: Life-threatening CDAD Toxic megacolon Pregnant Concurrent use of diarrheal agents Participation in other trials

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Active Comparator: 1<br>Vancomycin | Drug: Vancomycin<br>* Capsules<br>|
| Experimental: 2<br>PAR-101/OPT-80 | Drug: PAR-101/OPT-80<br>* capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure Rate at End of Therapy | Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication. | Study day 10 (+/- 2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed. | Study days 11-40 | 
| Global Cure | Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit. | End of Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDAD, Clostridium difficile, diarrhea, Clostridium difficile-Associated Diarrhea
Montelukast in Children With Wheezing

Study Overview
=================
Brief Summary
-----------------
In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.

Detailed Description
-----------------
Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy. Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time. At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries. The final visit will be after four weeks with re-evaluation of the lung function

Official Title
-----------------
Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years

Conditions
-----------------
Wheezing

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 6-24 months Patients with recurrent wheezing (at least 2 episodes in the last 6 months) Patients with symptoms at enrollment Exclusion Criteria: Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

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: Montelukast<br>the single arm will receive montelukast | Drug: Montelukast<br>* the arm will be treated with Montelukast 4 mg die for 4 weeks<br>* Other names: antileukotrienes;Drug: Montelukast<br>* montelukast 4 mg day for 4 weeks<br>* Other names: antileukotrienes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function test (flow and resistance) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchodilator use Dairy symptoms |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wheezing, children, montelukast, bronchodilators, lung function, Rint
The Value of ctDNA on Chemotherapy Efficacy for mCRC

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.

Official Title
-----------------
Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA

Conditions
-----------------
Circulating Tumor DNA

Intervention / Treatment
-----------------
* Genetic: ct-DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function Exclusion Criteria: patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ct-DNA<br>The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy. | Genetic: ct-DNA<br>* The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.<br>* Other names: circulating tumor DNA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | the response rate predicted by ct-DNA | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 2 months | 
| Overall survival |  | 2 months |
Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

Study Overview
=================
Brief Summary
-----------------
Capnography provides noninvasive monitoring of ventilation and can allow early recognition of altered respiration patterns and apnea. The aim of this prospective study was to compare the detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography versus clinical surveillance during procedural sedation for percutaneous transhepatic cholangiodrainage (PTCD).

Conditions
-----------------
Apnea, Hypoxemia, Complications

Intervention / Treatment
-----------------
* Procedure: capnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18 Scheduled for PTCD with midazolam and propofol sedation Exclusion Criteria: age less than 18 years ASA class V allergy to narcotic drugs pregnancy pre-existing hypotension, bradycardia or hypoxemia

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: capnography<br> | Procedure: capnography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall number of detected episodes of apnea |  |  | 
| the occurrences of oxygen desaturation and hypoxemia |  |  |
Pulsatile and Steady State Hemodynamics in Diastolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Over the past few years, there has been a growing appreciation that a large number of patients with heart failure have a relatively normal (or preserved) ejection fraction (NFNEF). Epidemiologically, HFNEF is most prevalent among elderly women, most of whom have hypertension, diabetes, or both and often coronary artery disease (CAD). Increased arterial stiffness and/or wave reflections have been described in the same patient groups. Therefore, the investigators speculate that pulsatile hemodynamics, representing arterial stiffness and/or arterial wave reflections, 1) may be altered in HFNEF patients, 2) this may contribute to pathophysiology of HFNEF, and 3) this may be used for the diagnosis of the syndrome.

Official Title
-----------------
Diagnostic Value of Measures of Pulsatile Versus Steady State Hemodynamics in Diastolic Heart Failure

Conditions
-----------------
Diastolic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: exertional dyspnea undergoing heart catheterization for diagnosis or exclusion of coronary artery disease normal EF (> 50%) Exclusion Criteria: atrial fibrillation more than mild valvular heart disease pericardial disease no 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with diastolic heart failure | |
| 2<br>Patients without diastolic heart failure | |

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
-----------------
arterial stiffness, arterial wave reflections, diastolic heart failure