linjc16/ctgov huggingface dataset:
The Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the percentage of cases of acute treatment with Allopurinol in gout patients who have been previously treated.

Official Title
-----------------
To Examine the Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients as Secondary Treatment

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gout patients Exclusion Criteria: Pregnant women Chronic renal failure Patients with Allopurinal hypersensitivity

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Gout Patients<br>Allopurinol 100 mg-300mg/day as secondary treatment in gout patients | Drug: Allopurinol<br>* Treatment of gout patients by oral dosage of 100 mg-300mg/ day of Allopurinol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gout patients treated with Allopurinol | Retrospective identification through medical records of percentage of gout patients treated with Allopurinol | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with contraindication to Allopurinol | Retrospective identification through medical records of percentage of gout patients with contraindications to Allopurinol | Six months |
Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home

Study Overview
=================
Brief Summary
-----------------
The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases. The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment. The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.

Official Title
-----------------
Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home

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

Intervention / Treatment
-----------------
* Device: Non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No previous experience with domiciliary non-invasive ventilation Adult patients, ≥ 18 years of age Without tracheotomy No evolutive cancer No significant psychiatric disease Possible medical monitoring Exclusion Criteria: Evolutive cancer Inability to understand rationale and/or consent form for study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non-invasive ventilation|Home NIV installation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data leading to NIV device prescription | Age, blood gases, BMI, etiology, pulmonary function,comorbidities | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood gases |  | 4 months, 1 year and 2 years after inclusion | 
| Change in the possible comorbidities |  | 4 months, 1 year and 2 years after inclusion | 
| Treatment compliance |  | Initiation of treatment to 4 months | 
| Treatment compliance |  | 4 months to 1 year | 
| Treatment compliance |  | 1 year to 2 years (end of study) | 
| Hospitalizations | During the study period all hospitalizations will be notify | 4 months | 
| Hospitalizations | During the study period all hospitalizations will be notify | 1 year | 
| Hospitalizations | During the study period all hospitalizations will be notify | 2 years | 
| Survival rate |  | 4 months | 
| Survival rate |  | 1 year | 
| Survival rate |  | 2 years |
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Study Overview
=================
Brief Summary
-----------------
This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).

Official Title
-----------------
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Conditions
-----------------
Wrist Fractures, Forearm Fractures, Elbow Fractures, Ankle Fractures, Foot Fractures, Wounds and Injuries

Intervention / Treatment
-----------------
* Device: Cork splint materials (instead of plaster splint)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fractures of the wrist, forearm, elbow, ankle, foot Distortions of the wrist, elbow, ankle Wounds without tendon injuries

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 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 |
| --- |
|Device: Cork splint materials (instead of plaster splint)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality |  |  | 
| Added value |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fractures of the wrist, forearm, elbow, ankle, foot, Distortions of the wrist, elbow, ankle, Wounds without tendon injuries
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.

Official Title
-----------------
Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: V930


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between the ages of 18 and 35 Woman who are able to become pregnant must use an acceptable form of birth control Exclusion Criteria: You are breast feeding You have taken any type of pain reliever within 12 hours of electrostimulation You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study You have muscle atrophy, weakness or neuromuscular disorder

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>V930 | Biological: V930<br>* Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the tolerability of the MedPulser DDS device. |  | Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assess, Tolerability, MedPulser DDS device
The Physiological Impact of N95 Masks on Medical Staff

Study Overview
=================
Brief Summary
-----------------
Wearing N95 masks may have adverse physical effect on medical staff

Detailed Description
-----------------
Wearing N95 masks results in hypooxygenemia and hypercapnia which reduce working efficiency and the ability to make correct decision. Medical staff are at increased risk of getting 'Severe acute respiratory syndrome'(SARS), and wearing N95 masks is highly recommended by experts worldwide. However, dizziness, headache, and short of breath are commonly experienced by the medical staff wearing N95 masks. The ability to make correct decision may be hampered, too. The purpose of the study was therefore to evaluate the physiological impact of N95 mask on medical staff.

Official Title
-----------------
The Physiological Impact of N95 Masks on Medical Staff

Conditions
-----------------
Hypoxemia, Hypercapnia

Intervention / Treatment
-----------------
* Device: wearing N95 masks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical staff Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: wearing N95 masks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG change, ABG change, change in scores of attention test, etc |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms wearing N95 masks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N95 mask, medical staff, hypoxemia, hypercapnia, neurological study
The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum

Study Overview
=================
Brief Summary
-----------------
Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.

Official Title
-----------------
The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum

Conditions
-----------------
Pectus Excavatum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that received a three-dimensional optical surface scan to quantify their pectus deformity Exclusion Criteria: None
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 |
| --- | --- | --- |
| Patient position | The effect of patient position on the value of the external Haller Index, based on 3D scans. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual versus automatic alignment of patient position | If there is a significant effect of patient position on the external Haller Index, the ideal correction method is investigated (manual alignment versus automatic, computer-based alignment) | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Three-dimensional optical surface scanning, Patient position
Risk Factors for Medium-term Adverse Outcomes and Predictive Modeling for Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This subproject is included in a project coordinated between program groups Evaluation of Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is to evaluate different aspects of health care received by patients with breast cancer from the diagnostic process, treatment, complications, survival and quality of life, to provide information to improve the effectiveness of interventions, reduce variability, have best predictive rules and increase the quality of life. The main objective of the subproject is to create and validate prospectively predictive rules of recurrence, complications, mortality, changes in quality of life in these patients at admission and one/two years of treatment and to evaluate the external validity of our rules to predict relapses, complications and mortality in the retrospective sample of patients participating in screening programs. Observational methodology with information available from a retrospective cohort of women diagnosed between 2000 and 2009 and another 2-year prospective follow-up included 2040 incident cases of breast cancer in 18 hospitals of 5 regions. Cohorts will learn clinical and health care diagnosis, tumor, treatment, hospital, follow-up (complications, relapse, and vital status) cost and quality of life. Prediction rules are created by means of regression/Cox models at the prospective sample and also investigators will assess the external validity in the retrospective cohort in the case of recurrence, complications and mortality. Expected results: There are currently no results of cohort analysis of the diagnostic process of care that integrates different aspects. The study will create tools to assist prognostic and therapeutic decision making process in these patients

Official Title
-----------------
Risk Factors for Medium-term Adverse Outcomes and Predictive Modeling for Breast Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over the age of 18 with both incidental in situ and infiltrating breast cancer. Exclusion Criteria: Lymphoma, sarcoma, lobular carcinoma in situ and inflammatory carcinoma of the breast are excluded

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life questionnaire module for breast cancer patients |  | Change from baseline in quality of life at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality data |  | Mortality at 2 years |
Endogenous Opioid Modulation by Ketamine

Study Overview
=================
Brief Summary
-----------------
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

Detailed Description
-----------------
This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.

Official Title
-----------------
Endogenous Opioid Modulation by Ketamine

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Ketamine Hydrochloride
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 DSM-5 major depressive disorder Current moderate-to-severe, treatment-resistant, depressive episode Patient Health Questionnaire (PHQ-9) total score ≥ 10 PHQ-9 item score ≥ 2 on Little interest or pleasure item PHQ-9 item score ≥ 2 on Feeling down, depressed, or hopeless item Medical documentation of depression for at least 2 months Inadequate response to at least one adequate antidepressant medication trial in the current episode Exclusion Criteria: Current episode duration >5 years Moderate-to-severe DSM-5 substance use disorder (past year) Cognitive disorder (past year) Post-traumatic stress disorder (past year) Obsessive compulsive disorder (past year) Personality disorder (past year) Positive urine drug screen Psychotic symptoms Mania Significant neurologic disorder or injury Breastfeeding or pregnancy Imminent suicide risk Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin) Other unstable psychiatric or medical condition requiring a higher level of care Contraindication to ketamine, MRI, or PET

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total). | Drug: Ketamine Hydrochloride<br>* Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.<br>|
| Placebo Comparator: Placebo<br>Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total). | Other: Normal saline<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale at 24 hours, change from baseline | total score on the 17-item Hamilton Depression Rating Scale | 24 hr |
Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

Study Overview
=================
Brief Summary
-----------------
Morbidity and mortality of ICU patients is increased by the development of a immunosuppression systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

Detailed Description
-----------------
PCR for herpes simplex virus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results PCR for Cytomegalovirus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results

Official Title
-----------------
Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

Conditions
-----------------
Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalisation in intensive care unit Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale <= 12 Age between 18 and 75 years Mechanical ventilation > 24 hours Exclusion Criteria: encephalopathy post anoxy active cancer Immunosuppresseur treatment pregnancy history of autoimmune disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Ventilatory-free days at day 90 |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial hospital acquiered infection |  | 28 days | 
| organ failure |  | 28 days | 
| hospitalisation length of stay |  | 28 days | 
| Mortality |  | 28 days and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain injury, virus, immunosuppression, mechanical ventilation