linjc16/ctgov huggingface dataset:
Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care

Study Overview
=================
Brief Summary
-----------------
Dysfunctions radial arterial catheter are frequent. This was a prospective, randomized observational study monocentric in ICU in France. Patients are randomized in 2 groups : One to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B). The primary outcome was the incidence of catheter dysfunction (defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve). Investigators compared also the incidence of infection, satisfaction of doctors and nurses, the numbers of days with catheter and the cause of withdrawal.

Official Title
-----------------
Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care

Conditions
-----------------
Dysfunctions Arterial Catheter

Intervention / Treatment
-----------------
* Other: catheter insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted in ICU, older than 18 years and who required an arterial catheter are include

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: cathete to less than 4 four centimeters to the wrist joint<br> | |
| Active Comparator: catheter to more than four centimeters to the wrist joint<br> | Other: catheter insertion<br>* catheter insertion one to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of dysfunction motivating catheter removal as a function of the distance from the carpal radio joint. | The dysfunction is defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve | through study completion- 2 months |
Methodological Issues and Laser Speckle Contrast Imaging

Study Overview
=================
Brief Summary
-----------------
Microcirculation, especially skin microcirculation, is a window towards systemic vascular function in magnitude and underlying mechanisms. Different techniques have been developed to assess the microcirculation. Among these techniques, laser technology is used to perform non-invasive microvascular assessments. Although this technique is widely used, different methodological issues remain. This study aims at defining the way to use lasers for clinical use.

Official Title
-----------------
Methodological Issues of Laser Speckle Contrast Imaging for Studying Microcirculation.

Conditions
-----------------
Microvascular Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18years old subject without any known cardiovascular disease Exclusion Criteria: pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br> | |

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
-----------------
laser Doppler flowmetry, skin blood flow
Pulmonary Nodule Cohort

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the clinical features of pulmonary nodules and establish a cohort to identify biomarkers for lung cancer.

Official Title
-----------------
Pulmonary Nodule Cohort

Conditions
-----------------
Pulmonary Nodule, Solitary, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 pulmonary nodule(s) on chest CT, which satisfy at least one of the following two criteria, 4A or above in Lung-RADS v1.1 lung cancer risk >= 5% in Brock model Exclusion Criteria: already proven lung cancer

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 |
| --- | --- | --- |
| Incidence of lung cancer | incidence of pathologically proven lung cancer | up to 5 years |
Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This pilot study aims to assess a new device designed for an objective measure of sleep parameters. The purpose of the device is to assess, in a more simple and precise way, the impact of deep brain stimulation on patient's sleep.

Official Title
-----------------
Assessment of a Wrist Device Recording Sleep Parameters, Before and After Deep Brain Stimulation for Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Sleep Recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient > 18 years old with Parkinson disease scheduled for implantation of electrodes for deep brain stimulation Exclusion criteria: pregnant or breast feeding patient refusal to participate in the study patient under legal protection no health insurance coverage

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: Continuous Sleep Recording<br>Continuous Sleep Recording in Patients | Device: Sleep Recording<br>* the device records movements during patients' sleep<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean sleep duration per night |  | 15 days | 
| mean sleep onset latency |  | 15 days | 
| mean number of awakenings per night |  | 15 days |
Graft-versus-host Disease Associated Myelosuppression

Study Overview
=================
Brief Summary
-----------------
The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.

Official Title
-----------------
Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency

Conditions
-----------------
Abnormal Hematopoiesis, Allogenic Disease, Graft vs Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 acute myeloid leukemia myelodysplastic syndrome hematopoietic stem cell transplantation Exclusion Criteria: not willing to take part
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 |
| --- | --- | --- |
| Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation |  | up to 1 year after allogeneic hematopoietic stem cell transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myelosuppression, mesenchymal stromal cells
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.

Official Title
-----------------
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions

Conditions
-----------------
Therapeutic Equivalency

Intervention / Treatment
-----------------
* Drug: methylprednisolone
* Drug: methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs). Exclusion Criteria: Any condition possibly affecting drug absorption (eg, gastrectomy). A positive uring drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylprednisolone suspension<br> | Drug: methylprednisolone<br>* constituted powder for oral suspension 4 mg/mL single dose at 16 mg<br>|
| Active Comparator: methylprednisolone tablets<br> | Drug: methylprednisolone<br>* tablets 16 mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf (area under the concentration time curve to infinity) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Cmax (maximum concentration) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast (area under the concentration time curve to last time point) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Tmax (time at maximum concentration) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Half-life |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalence study, methylprednisolone, suspension, tablets, fasting
One-stage Bone Lengthening in the Management of Brachymetatarsia

Study Overview
=================
Brief Summary
-----------------
Brachymetatarsia is a shortening in length of a metatarsal exceeding 5mm. This congenital anomaly most often affecting women and the second metatarsal is associated with frequent aesthetic disorders leading patients to consult. The one-time lengthening technique is described for the management of brachymetatarsia with good functional results. However, the metatarsal elongation in one time is limited to 15 millimeters, to avoid complications. No study has presented the consequences of hypocorrection, especially cosmetic. Our hypothesis is that undercorrection (Hypocorrection) is associated with a higher rate of cosmetic dissatisfaction.

Official Title
-----------------
Cosmetic Satisfaction and Undercorrection After One-stage Bone Lengthening in the Management of Brachymetatarsia

Conditions
-----------------
Brachymetatarsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated on for a one-time lengthening for isolated brachymetatarsia Major patients Exclusion Criteria: Patient refusing to participate in research

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 |
| --- | --- | --- |
| satisfaction using a visual analog scale (from 0/10 to 10/10) | Cosmetic evaluation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological evaluation of surgical correction | metatarsal lengtening : mesured on a dorsoplantar radiograph | 1 day |
Transfer Impedance in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether respiratory system transfer impedance (Ztr) may fill an important clinical function by providing a reproducible, valid, and sensitive measure of airway obstruction in people with CF.

Official Title
-----------------
Transfer Impedance in Cystic Fibrosis (Ztr)

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 2 to 25 Confirmed diagnosis of Cystic Fibrosis Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 25 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ztr, transfer impedance, cystic fibrosis, pulmonary function test, pft
Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III)

Detailed Description
-----------------
Study Design:

Official Title
-----------------
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Idiopathic Parkinsons disease with or without fluctuations Indication for treatment with Sifrol® Male or female patients of age Presence of at least mild depressive symptoms (as judged by the treating physician) Ability to reliably complete a self-rating scale (HADS) Exclusion criteria: Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients. Ongoing treatment with Sifrol®.

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 |
| --- | --- | --- |
| Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease |  | 9-16 weeks | 
| Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline |  | 9-16 weeks | 
| Change in HADS subscores (anxiety and depression) from baseline |  | 9-16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline pattern of patient rated symptom list (HADS) |  | 9-16 weeks | 
| Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit |  | 9-16 weeks | 
| Frequency of adverse events |  | 9-16 weeks |
Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB

Study Overview
=================
Brief Summary
-----------------
This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.

Conditions
-----------------
Observation

Intervention / Treatment
-----------------
* Device: GeneXpert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old suspected of TB clinically. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced. BAL samples obtained following standard investigation procedure CXR or CT imaging available. Exclusion Criteria: Bronchoscopy is not planned as a necessary procedure for investigation. Diagnosis of active TB has been made by other means.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GeneXpert|Real time integrated and automated nucleic acid amplification test for detection of TB|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity, positive and negative predictive values |  | 18 months |
Acceptance of Telemedicine During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Currently, due to the effects of COVID-19 pandemic, there is an imperative need to change the healthcare model. In this regard, telemedicine has proved very useful in health crises, in which there is a possibility of infection between people, offering remote access to medical care. Telemedicine has been used in many chronic diseases such as asthma and chronic obstructive pulmonary disease, diabetes mellitus, and appears to be well accepted by patients. However, few studies have been conducted in surgical services and in other diseases. Therefore, the aim of this study is to assess the level of acceptance of the patients, in this pandemic situation, to a telemedicine follow-up in different departments. This is an observational, cross-sectional, multicenter and international study with prospective and retrospective data collection. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ). In addition, all patients will provide an overall satisfaction score for telemedicine on a scale from 1 to 5 (1=lowest; 5=highest satisfaction).

Official Title
-----------------
Acceptance of Telemedicine in Outpatient Clinic Consultations During COVID-19 Pandemic. An International, Cross-sectional Study

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients contacted by telemedicine (phone and/or video call) during the COVID-19 pandemic in outpatient clinics Follow-up of patients with any chronic disease and postoperative patients, preoperative and urgent consultation Age greater than or equal to 18 years Exclusion Criteria: Patients with cognitive or sensory difficulties or with insufficient comprehension of the language in which the survey is conducted Patients who decline to take part in the telephone survey

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of telemedicine | Acceptance of telemedicine in consultations during the COVID-19 pandemic. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ) as a model. The resulting questionnaire has 10 questions. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Global satisfaction score on a scale from1 to 5 (1=lowest; 5=highest satisfaction) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemedicine, patient acceptance, covid-19