linjc16/ctgov huggingface dataset:
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether fish oil supplements may be beneficial in preventing the recurrence of atrial fibrillation after cardioversion. Atrial fibrillation is a heart condition which can sometimes be successfully treated by a cardioversion. Cardioversion involves resetting the heart back to normal with the use of electric current. There is a tendency for the atrial fibrillation to recur , days weeks or even months after the cardioversion. Fish oil supplements may be of benefit to patients with heart problems Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

Official Title
-----------------
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Fish oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with persistent Atrial Fibrillation on Warfarin. Exclusion Criteria: paroxysmal atrial fibrillation with self terminating episodes. left atrial size>6.0cm myocardial infarction in the previous 6 months. contraindications to amiodarone use . cardiac surgery in the previous 3 months . an acute reversible illness contributing to the development of af a QTc interval > 480ms. pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No fish oil exposure | |
| Experimental: Fish oil<br>Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio. | Drug: Fish oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation followed cardioversion |  | 1 year |
Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma

Study Overview
=================
Brief Summary
-----------------
Background: Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and to assess asthma severity and control, is largely unknown. Objective: To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and controls. 2) the ability of these biomarkers to indicate asthma severity and control. Methods: 114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls (10.0±0.4 years). Condensate was collected using a glass condenser

Official Title
-----------------
Biomarkers in Exhaled Breath (Condensate) Indicate Presence, Severity and Control of Asthma

Conditions
-----------------
Asthma, Healthy, Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic and control children, aged 5 to 16 years Children with doctor-diagnosed asthma, known at the department of Paediatric Pulmonology, University Hospital Maastricht Exclusion Criteria: Presence of a disease that might interfere with the results of this study (e.g. recent upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases such as Crohns disease and rheumatoid arthritis) Mental retardation Inability to perform the EBC procedure properly Active smoking The use of one of the following medication: Papaverin, Sodium nitroprusside, ACE inhibitors, Oxymetazoline, L-arginine, or NOS inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammometry, exhaled breath condensate, fractional exhaled nitric oxide, asthma, children
Correlation of the Objective and Subjective Measures of the Nasal Obstruction Before and After Surgery of the Nasal Septum

Study Overview
=================
Brief Summary
-----------------
Nasal obstruction is a very subjective sensation but it's also a frequent reason of consultation. Two specific questionnaire NOSE and RhinoQOL were validated; but rhinomanometry value is still a question to debate. As well as the difference between acoustic rhinometry and rhinomanometry. Usually nasal obstruction due to a septal deviation is treated by septoplasty. If the anatomic result can be proved true, the patient's felt would be unsuccessful. The aim of this study is to assess the impact of septoplasty on the nasal obstruction, objectively by rhinometry and subjectively by questionnaire.

Official Title
-----------------
Correlation of the Objective and Subjective Measures of the Nasal Obstruction Before and After Surgery of the Nasal Septum

Conditions
-----------------
Nasal Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 with medical insurance programmed for septoplasty nasal obstruction with septal deviation accept participation Exclusion Criteria: nasal sine polyposis endonasal mass chronic sinusite previous nasal surgery

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 |
| --- | --- | --- |
| Nose Obstruction symptom Evaluation | scale about nose obstruction filled up by the patient | 3 months | 
| nasal resistance to airflow |  | 3 months |
Prediction of the Patient Pathway in Emergency Room in an Exceptional Sanitary Situation

Study Overview
=================
Brief Summary
-----------------
The COVID-19 outbreak leads to optimize the pathway in emergency departments. The length of time spent in the Emergency Department is linked to the morbi-mortality and the risk of COVID-19 transmission. The Amiens-Picardy University Hospital has developed an application (3P-U) that optimizes patient flow. It identifies the need of hospitalization and problems on the care path. Patients are categorized in high risk or not high probabilty of hospitalization. The main goal of this project is to evaluate the impact on the patient flow of the 3P-U application. Early lookup of bed for high probability hospitalization should be linked to a reduced time of length. This study will compare the time of length between this both groups.

Official Title
-----------------
Prediction of the Patient Pathway in Emergency Room in an Exceptional Sanitary Situation

Conditions
-----------------
Covid19, Emergencies

Intervention / Treatment
-----------------
* Other: hospital bedroom booking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: every patient that consults in the Adult Emergency Department Exclusion Criteria: patients directly transferred to Intensive Care Units

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 |
| --- | --- |
| high risk of hospitalization<br> | Other: hospital bedroom booking<br>* Patient in high risk of hospitalization group benefits a dedicated process to find and book a bedroom<br>|
| not high risk of hospitalization<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the length of stay between high probability of hospitalization group and not high risk of hospitalization group. | Variation of the length of stay between high probability of hospitalization group and not high risk of hospitalization group. | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, patient flow, emergency overcrowding
Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men

Study Overview
=================
Brief Summary
-----------------
Overweight increases the risk to develop chronic diseases including type-2 diabetes and cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects is thought to play an important role in disease development. The purpose of this study is to determine the role of inflammation on glucose metabolism and insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on markers of inflammation and on parameters of glucose metabolism will be studied.

Official Title
-----------------
Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men

Conditions
-----------------
Overweight, Obesity, Inflammation

Intervention / Treatment
-----------------
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI): 25.1 - 32.0 kg/m2 Normal Dutch eating habits Exclusion Criteria: diabetes, cardiovascular disease or hypertension Not suitable to receive diclofenac treatment Smoking Extreme physical activity (more than 6 hours/week) Reported slimming or medically prescribed diet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101

Detailed Description
-----------------
This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.

Official Title
-----------------
Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area

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

Intervention / Treatment
-----------------
* Drug: ATX-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or nonpregnant females Age 18 to 65 Sufficient submental fat for injections Signed informed consent Exclusion Criteria: Prior interventions in the chin or neck area History or presence of drug or alcohol abuse Treatment with an investigational agent within 30 days before the dose

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid | Drug: ATX-101<br>* ATX-101 single dose<br>|
| Experimental: Cohort 2<br>ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid | Drug: ATX-101<br>* ATX-101 single dose<br>|
| Experimental: Cohort 3<br>3 subgroups in Cohort 3: 3a: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 3b: ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 3c: ATX-101 (2 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid | Drug: ATX-101<br>* ATX-101 single dose<br>|
| Experimental: Cohort 4<br>3 subgroups in Cohort 4: 4a: ATX-101 (8 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 4b: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 4c: ATX-101 (4 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid | Drug: ATX-101<br>* ATX-101 single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by: Laboratory tests |  | 12 weeks | 
| Safety assessed by: medical evaluations |  | 24 weeks | 
| Safety assessed by: ECG results |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile | Cmax, tmax, AUC | 24 hours, before and after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
FASS (Facial Action Summary Score) Scale to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to assess postoperative children pain.

Official Title
-----------------
Does the FASS (Facial Action Summary Score) Scale Allow to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years?

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Behavioral: Assessment of pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children surgery Younger than 7 years old Elective surgery Patient whose parents will have given their non-opposition Exclusion Criteria: Psychological retardation Chronic pain

Ages Eligible for Study
-----------------
Maximum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Children surgery<br> | Behavioral: Assessment of pain<br>* Assessment of pain using FASS but without using this score to manage pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FASS (Facial Action Summary Score) |  | As soon as the child arrive in recovery room or / and the extubation, before and after the administration of analgesics | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychometric validity, Pain scale, Postoperative, Children
Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

Study Overview
=================
Brief Summary
-----------------
Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.

Detailed Description
-----------------
Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.

Conditions
-----------------
Dystonia

Intervention / Treatment
-----------------
* Procedure: Deep brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-anoxic generalised dystonia Idiopathic non-generalised dystonia Disease duration > 1 year Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI) Mini-mental status (MMS) < 24 Severe psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep brain stimulation<br>Paladin deep brain stimulation | Procedure: Deep brain stimulation<br>* internal pallidal deep brain stimulation<br>|
| Placebo Comparator: sham deep brain stimulation<br>no stimulation | |

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
-----------------
Dystonia, deep brain stimulation, globus pallidus, Post-anoxic dystonia
Fluorescence-guided Resection in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.

Official Title
-----------------
Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue

Conditions
-----------------
Breast Tumour

Intervention / Treatment
-----------------
* Drug: PD L 506


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Caucasian female postmenopausal patients Patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (T1 - T2) Exclusion Criteria: Suspicious lymphogenic metastases (cN1-3) Acute or chronic hepatic diseases Manifest renal diseases with renal dysfunction Relevant cardiac disease Preceding therapy of breast tumour under investigation Patients with multiple attempts of hook-wire placement in preparation of surgery Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD L 506 2nd dose<br>Different dosage | Drug: PD L 506<br>* Two different doses will be compared<br>|
| Experimental: PD L 506<br> | Drug: PD L 506<br>* Two different doses will be compared<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescence intensity in breast cancer tissue |  | 3 h after intake of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory data and adverse events |  | 14 days |
Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Study Overview
=================
Brief Summary
-----------------
This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.

Detailed Description
-----------------
[Sample acquisition] Informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance. The study will be conducted based on the purposes indicated in the master agreement signed by tissue donator [Clinical data acquisition] Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals) Lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites Lung cancer histologic information: pathology, histologic subtype, EGFR mutation profile, ALK-rearrangement result

Official Title
-----------------
Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged above or equal to 18 Histologically confirmed lung cancer patients Patient treated with immune checkpoint inhibitor Exculsion Criteria: NA

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 |
| --- | --- | --- |
| List of biomarkers | Neoantigen, tumor mutation burden, MHC compatibility, T-cell receptor and associated immune gene signature (IFN-r, interferons such as IL-2 and interleukin family), T-cell subset (T cell surface marker such as CD4+, CD7+, CD8+, CD16, CD34+, CD38+, CD56+, etc.), PD-1/PD-L1 expression, etc. | Baseline |