linjc16/ctgov huggingface dataset:
Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.

Official Title
-----------------
Analysis of Events of Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation

Conditions
-----------------
Sars-CoV2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Subject (≥18 years) Subject with COVID 19 (radiological suspicion or microbiological confirmation) Subject hospitalised in the intensive care unit at the NHC of the University Hospitals of Strasbourg between 01/03/2020 and 03/04/2020. Subject treated by mechanical ventilation Subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research Translated with www.DeepL.com/Translator (free version) Exclusion Criteria: Subject who expressed opposition to participating in the study Subject under guardianship, curatorship or safeguarding of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of risk factors for intubation tube obstruction |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endotracheal Tube, ETT, Intubation, Mechanical ventilation, Endotracheal tube obstruction, ICU, Covid-19, SARS-CoV-2, ARDS
Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

Study Overview
=================
Brief Summary
-----------------
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.

Detailed Description
-----------------
Methods: Randomized, single-blinded, controlled trial Setting: Office practice of two academic otolaryngologists at a community hospital. Primary Outcomes: Patient pain and discomfort, Optical quality Secondary Outcomes: Physician and nursing staff satisfaction Cost-analysis Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy

Official Title
-----------------
Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial

Conditions
-----------------
Otorhinolaryngologic Diseases

Intervention / Treatment
-----------------
* Device: Endosheath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy Exclusion Criteria: Known sinonasal masses or nasal polyposis Unable to complete VAS surveys Significant septal deviation Unable to tolerate in-office flexible nasopharyngoscopy Patients who refuse consent

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional flexible nasopharyngolaryngoscopy<br>No sheath procedure | |
| Active Comparator: Sheath flexible nasopharyngolaryngoscopy<br>Flexible nasopharyngolaryngoscopy using endosheath | Device: Endosheath<br>* Flexible sheathed nasopharyngolaryngoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient pain and discomfort | Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician and staff satisfaction | Physician and support staff satisfaction with easy and efficiency of sheathed scopes. | 1 week | 
| Optical quality | Image quality of flexible endoscopy with or without endosheath. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sheath, flexible, endoscopy, otolaryngology, office
Clinical Evaluation of the Serum Free Light Chain Analysis

Study Overview
=================
Brief Summary
-----------------
Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective. A new assay has the possibility only to measure part of this protein, namely the light chains, which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy. Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma. Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.

Official Title
-----------------
Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of multiple myeloma abnormal serum free light chains medical needs of anti-myeloma therapy receiving standard anti-myeloma therapy Exclusion Criteria: dialysis normal serum free light chains dementia
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 |
| --- | --- | --- |
| Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein |  | 1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy, | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, Free light chains
Executive Functions and Reinforcement Sensitivity in Women With Obsessive Compulsive Symptoms

Study Overview
=================
Brief Summary
-----------------
Methods: The study population consisted of all adult women living in Sabzevar city (Iran). Using cluster sampling, 365 women were selected as the study sample. Participants completed Obsessive-Compulsive Inventory, Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Revised and Clarified (SPSRQ-RC) as well as Behavior Rating Inventory of Executive Function (BRIEF). Data analysis was conducted using correlation and regression tests.

Official Title
-----------------
University of Bojnord

Conditions
-----------------
Obsessive-Compulsive Symptom, Executive Dysfunction

Intervention / Treatment
-----------------
* Other: descriptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having age between 18 to 54, be female, be literacy, Exclusion Criteria: be male, be illiteracy, having psychotic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: descriptive|correlation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| executive functions | It was measured by behavior rating inventory of executive function. it consists of 75 items that are measured on a 5-point Likert scale. subscales include inhibition, shift, emotional control, self-monitoring, initiation, working memory, planning/organization, task monitoring and organization of materials. min and max scores are 0 and 150. respectively. the higher scores indicate problems in executive functions. | 1 month | 
| obsessive-compulsive symptom | it was measured by the Obsessive-Compulsive Inventory. This inventory contains 42 items that are measured on a 5-point Likert scale. It consists of the sub-scales of washing, controlling, doubting, ordering, obsession, hoarding, and neutralizing. the higher scores are probably an indicator of obsessive-compulsive disorder. | 1 month | 
| reinforcement sensitivity | it was measured by Sensitivity to Punishment and Sensitivity to Reward Questionnaire: This 20-item scale measures sensitivity to reward and sensitivity to punishment, which is scored on a 5-point Likert scale (from totally correct to totally incorrect). the higher scores in subscales of sensitivity to punishment and Sensitivity to Reward indicate high activity in punishment and reward systems. | 1 month |
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items; Unknown adverse reactions (especially, significant adverse reactions) Adverse reaction onset status under practical drug use conditions Factors possibly influential on safety Factors possibly influential on efficacy Patient's prognosis, efficacy and safety in long-term use

Official Title
-----------------
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Epoprostenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with cardiovascular disease Exclusion Criteria: Subjects with hypersensitivity to epoprostenol Subjects with right cardiac failure during an acute exacerbation Subjects with severe left ventricular systolic dysfunction Subjects with serious left ventricular dysfunction Subjects whose pulmonary edema getting worse during dose initiation
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed epoprostenol<br>Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period | Drug: Epoprostenol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection |  | 12 weeks |
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Official Title
-----------------
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Drug: Metvix and natural daylight PDT
* Drug: Metvix and conventional PDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female above 18 years; Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs); Exclusion Criteria: Subject with clinical diagnosis of at least one severe AK on TAs Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; Subject with pigmented AK on the TAs

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metvix and daylight<br> | Drug: Metvix and natural daylight PDT<br>* Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.<br>|
| Active Comparator: Metvix and lamp<br> | Drug: Metvix and conventional PDT<br>* Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Response | Percent of lesions treated at Baseline, in complete response at Week 12 | Week12 | 
| Pain Score | Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain) | Baseline (during procedure), assessed after procedure |
The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics

Study Overview
=================
Brief Summary
-----------------
In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

Detailed Description
-----------------
In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

Official Title
-----------------
The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics

Conditions
-----------------
Landing Biomechanics, Fatigue

Intervention / Treatment
-----------------
* Other: 3D analysis of landing task


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volleyball, basketball of handball players male Exclusion Criteria: history or surgery of the lower extremities history of fractures of the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy basketball, volleyball and handball players<br>Healthy basketball, volleyball and handball players | Other: 3D analysis of landing task<br>* Landing tasks (anticipated, unanticipated and cognitive dual task) are investigated with 3D analysis by using an opto-electronic system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint angles lower extremity | Joint angles will be extracted with an opto-electronic system and synchronised force plate | The same day/test moment, immediately after fatiguing exercises | 
| Joint moments lower extremity | Joint moments will be extracted with an opto-electronic system and synchronised force plate | The same day/test moment, immediately after fatiguing exercises | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
landing, biomechanics, fatigue, dual task
Prediction Model for Multiple Pulmonary Nodules

Study Overview
=================
Brief Summary
-----------------
This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.

Detailed Description
-----------------
It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.

Official Title
-----------------
Prediction Model for Multiple Pulmonary Nodules

Conditions
-----------------
Multiple Pulmonary Nodules

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans Patients with at least two nodules resected for pathological evaluation Exclusion Criteria: History of malignancy within 5 years Presence of pneumonia or pleural effusion on thoracic CT scans Patients with none or only one nodule resected Patients with initial chemo-radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Performance of PKUM model | Area under receiver operating characteristic curve (AUC) of PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between PKUM model and clinicians | Comparison of sensitivity and specificity of radiologists, thoracic surgeons, and PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules. | 3 months | 
| Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians | Sensitivity and specificity of PKUM model in predicting malignant probability of equivocal nodules judged by radiologists and thoracic surgeons. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple pulmonary nodules; predictive model
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block

Study Overview
=================
Brief Summary
-----------------
Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding the ESPB use in the aforementioned patient group is limited.

Official Title
-----------------
Comparison of Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block in the Management of Postoperative Analgesia in Patients Who Had Cesarean Section Under Spinal Anesthesia

Conditions
-----------------
Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block, Transversus Abdominis Plane Block

Intervention / Treatment
-----------------
* Procedure: Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)
* Procedure: Procedure/Surgery: Erector Spinae Plane Block (ESPB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 45 years ASA2 Undergoing cesarean section under spinal anesthesia Exclusion Criteria: History of chronic pain Body mass index > 35 Urgent/emergent surgeries Major bleeding Any additional surgical procedure Contraindication for any drugs used in the protocol The presence of any instrumentation in the procedure sites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Transversus Abdominis Plane Block (TAPB)<br>patients received TAPB postoperatively | Procedure: Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)<br>* Patients received TAPB postoperatively<br>|
| Experimental: Experimental: Erector Spinae Plane Block (ESPB)<br>patients received ESPB postoperatively | Procedure: Procedure/Surgery: Erector Spinae Plane Block (ESPB)<br>* Patients received ESPB postoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients needed for rescue analgesic agent (diclofenac) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients needed for rescue analgesic agent (opioid) |  | 24 hours | 
| the dose of the opioid used |  | 24 hours | 
| Percentage of patients experienced chronic pain |  | 2 months |