linjc16/ctgov huggingface dataset:
The Place of Consultations Specializing in the Diagnosis of Mood Disorders in Strasbourg University Hospital

Study Overview
=================
Brief Summary
-----------------
Mood disorders (depressive disorders and bipolar disorders) are among the ten most worrying diseases of the 21st century according to the WHO. In order to support psychiatrists in their diagnostic reflection, structures have been created. Since 2009, the Psychiatry Service 2 within the Psychiatry, Mental Health and Addictology Pole of the University Hospitals of Strasbourg has offered specialized consultations in mood disorders. More than 10 years after the creation of these consultations, it seems interesting to study the profile of the users and to describe the nature of the reports of these in-depth evaluation consultations (diagnosis, therapeutic advice)

Official Title
-----------------
State of Play in Strasbourg University Hospital of the Place of Consultations Specializing in the Diagnosis of Mood Disorders

Conditions
-----------------
Mood Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject Specialized primary consultation highlighting symptoms of mood disorders with Prof. Berstchy in the psychiatry department 2 in the University Hospital of Strasbourg (patients whose consultation request was linked to symptoms or a diagnosis of ADHD will not be included in the study population). Consultation that took place in 2018 and 2019. Patient who did not express his opposition to the reuse of his data for scientific research purposes. Exclusion criteria: Patient opposition to the use of their personal data for scientific research purposes. Prior existence of a previous specialist consultation in mood disorders with Prof. Berstchy (the information collected during the first consultation is not accessible) Patient under curatorship, guardianship or legal protection

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 |
| --- | --- | --- |
| Descriptive study of the clinical characteristics of patients coming to consultations specializing in mood disorders in Strasbourg University Hospitals |  | Files analysed retrospectively from January 01, 2018 to December 31, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mood Disorders
SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access

Study Overview
=================
Brief Summary
-----------------
The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to: Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor; Identify or validate new molecularly defined subgroups of tumors; Investigate the prevalence of novel biomarkers to plan future clinical trials; Enable exploratory/future research; Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;

Official Title
-----------------
Screening Platform of EORTC for Clinical Trials Access in Brain Tumors

Conditions
-----------------
Brain Neoplasms

Intervention / Treatment
-----------------
* Genetic: Tumour markers testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors; Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional; At least three months life expectancy; Written informed consent according to ICH/GCP and national/local regulations; Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.

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 |
| --- | --- |
| Brain cancer<br>Patients with diagnosis of brain cancer at any stage | Genetic: Tumour markers testing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with brain malignancy |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain tumor, Biomarkers, Screening
Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a specific airway clearance technique, l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in infants under the age of one year. Infants referred to hospital for a multichannel intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is only possible after signing the informal consent by one of the parents.

Official Title
-----------------
Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year

Conditions
-----------------
Gastro-esophageal Reflux

Intervention / Treatment
-----------------
* Other: expiration lente prolongée


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants under the age of one year and on suspicion of GOR who were referred for 24h impedance-pH monitoring are included in this study. Exclusion Criteria: prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 365 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expiration Lente Prolongée<br>In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of 'Expiration Lente Prolongée (ELPr)' . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ). | Other: expiration lente prolongée<br>* l'Expiration Lente Prolongée (ELPr) is a passive technique to enhance the expiration used in infants, obtained by a slow and increasing manual thoraco-abdominal pression applied at the end of a spontaneous expiration till the residual volume. The aim is to obtain a bigger expired volume compared to a normal expiration and drain the mucus out of the airways (Postiaux 2003). This technique has been invented by Guy Postiaux and is used in the Chest Physiotherapy (CPT).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of refluxes |  | 20 minutes |
Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules

Study Overview
=================
Brief Summary
-----------------
In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.

Official Title
-----------------
Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment Containing Enfuvirtide (Fuzeon) Associated With Two Active Molecules

Conditions
-----------------
HIV1 Infection, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status. Exclusion Criteria: hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress

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 |
| --- | --- |
| enfuvirtide<br>all patients would received enfuvirtide and and optimised background | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| viral load compliance |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| statistical analysis of MOS HIV |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uncompliant patients with virological failure, Treatment experienced
Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery

Study Overview
=================
Brief Summary
-----------------
This trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia.

Official Title
-----------------
Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery: Comparing Continuous Infusion of Local Anesthetic With Systemic Multimodal Analgesia

Conditions
-----------------
Oropharyngeal Neoplasms

Intervention / Treatment
-----------------
* Device: Peri-Neuronal Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients scheduled for oro-pharyngeal carcinoma surgery with reconstruction by fibula free flap Exclusion Criteria: Allergy to propofol or local anesthetic (ropivacaine) Severe renal or cardiac failure

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Peri-Neuronal Catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the influence of locoregional anesthesia on postoperative morphine consumption |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scale on the free flap donor site |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oro-Pharyngeal Carcinoma Surgery
The GLOWING Study: Growing Life, Optimizing Wellness 2

Study Overview
=================
Brief Summary
-----------------
This study will help us learn more about how maternal health can influence child health.

Detailed Description
-----------------
This study follows people who are healthy and less than 36 weeks pregnant to see how the mother's health can impact their child's growth and development. Up to 300 people including the mother and their future child will be a part of this study. The study will follow the child until they are two years of age.

Official Title
-----------------
The GLOWING Study: Growing Life, Optimizing Wellness 2

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-pregnancy BMI 18.5-45 Singleton pregnancy at least 18 years of age conceived without assisted fertility treatments Exclusion Criteria: Preexisting medical conditions (e.g. DM, GDM, CRF, HTN, pre-eclampsia or eclampsia, malignancies, seizure disorder, lupus, serious psychiatric disorders) sexually transmitted diseases medications during pregnancy known to influence fetal growth smoking, alcohol drinking or drug use during pregnancy

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 |
| --- | --- | --- |
| Determine energy expenditure in children | Using stable isotope techniques to determine energy expenditure | 2 years | 
| Determine fat oxidation in children | Using stable isotope techniques to determine fat oxidation | 2 years |
Trial of Montelukast for Treatment of Acute Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Other: sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female infants aged 3 to 12 months of age Diagnosis by emergency physician of bronchiolitis Exclusion Criteria: Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma Any history of previous bronchodilator use prior to this illness Treatment with corticosteroids in the 14 days prior to the current illness Immunosuppression Immunodeficiency Caregiver does not speak English Diagnosis by the treating ED physician of croup Diagnosis by the treating ED physician of pneumonia Caregiver does not have access to a telephone

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: montelukast sodium<br>4mg granules PO QD for 14 days | Drug: montelukast sodium<br>* 4mg granules daily for 14 days<br>* Other names: singulair;|
| Placebo Comparator: Placebo<br>Sucrose granules PO QD for 14 days | Other: sucrose<br>* table sugar as placebo daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Cough |  | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis, montelukast, leukotriene inhibitor
Efficacy and Safety With Ziprasidone in First-episode Psychosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.

Official Title
-----------------
Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study

Conditions
-----------------
First Episode Psychosis

Intervention / Treatment
-----------------
* Drug: Ziprasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder Exclusion Criteria: Patients with previously prescribed antipsychotic medication in 2 weeks or more patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 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 |
| --- |
|Drug: Ziprasidone|8 week prospective study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms assessment by objective rating scales | PANSS total score, SANS, clinical global impression scale, GAF | week 1 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, clinical global impression scale, GAF | week 2 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, clinical global impression scale, GAF | week 4 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, clinical global impression scale, GAF | week 6 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, clinical global impression scale, GAF, DAS-S | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events by objective rating scales and self report scales | Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale | one-month | 
| Assessment of adverse events by objective rating scales and self report scales | Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale | two-month. |
Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access

Study Overview
=================
Brief Summary
-----------------
To compare a long axis approach versus short axis when placing peripheral IVs using ultrasound guidance.

Detailed Description
-----------------
Patients needing an USGPIV will be randomized into long or short axis orientation. Emergency Medicine residents will place the IV using an ultrasound.

Official Title
-----------------
Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access: A Randomized Control Trial

Conditions
-----------------
Venous Access

Intervention / Treatment
-----------------
* Procedure: Intravenous access method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodynamically stable patients requiring placement of an USGPIV. Exclusion Criteria: Hemodynamically unstable Unable to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long Axis approach<br>Utilize the longitudinal orientation when placing an USGPIV. | Procedure: Intravenous access method<br>* Comparing long and short axis approach to USGPIV access.<br>|
| Active Comparator: Short axis approach<br>Utilize the transverse orientation when placing an USGPIV. | Procedure: Intravenous access method<br>* Comparing long and short axis approach to USGPIV access.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First pass success | USGPIV access | 1 day | 
| Number of attempts | USGPIV access | 1 day | 
| Overall success | USGPIV access | 1 day | 
| Time to completion | USGPIV access | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | USGPIV access | 1 day |
A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Official Title
-----------------
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650 60 mcg/day
* Drug: sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c between 7.5%-10% on metformin monotherapy BMI between 25 & 45 kg/m2 Exclusion Criteria: taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months history of pancreatitis

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITCA 650 60 mcg/day<br> | Drug: ITCA 650 60 mcg/day<br>* exenatide in DUROS<br>|
| Active Comparator: sitagliptin<br>sitagliptin 100 mg/day | Drug: sitagliptin<br>* sitagliptin oral 100 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | 39-week treatment period followed by 65-week extension period | 39 weeks |