linjc16/ctgov huggingface dataset:
Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia

Study Overview
=================
Brief Summary
-----------------
Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. In our study, we specifically evaluated molecular testing in a critical care setting and measured its impact on the therapeutic management of critically ill with positive blood cultures. Through the analysis of 110 positive blood culture episodes included in both pre- and post intervention period, we measured a drastic 14h-reduction of the time to administration of the optimal antimicrobial treatment with the use of the molecular approach.

Official Title
-----------------
The Impact of a Rapid Molecular Identification Test on Positive Blood Cultures From Critically Ill With Bacteremia: a Pre-post Intervention Study

Conditions
-----------------
Septicemia

Intervention / Treatment
-----------------
* Diagnostic Test: FilmArray blood culture identification panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult intensive care unit patients with positive blood cultures Exclusion Criteria: palliative care patients

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: FilmArray blood culture identification panel|FilmArray blood culture identification panel is performed 24 hours on 24hours and 7 days a week on positive blood cultures to accelerate pathogens detection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turn Around Time to optimal treatment of septicemia | Time in minutes | From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FilmArray, bacteremia, septicemia, clinical impact, molecular testing, identification, positive blood culture, optimal antimicrobial treatment
Candidate Gene Association Study With Injury in Elite Male Youth Football Players

Study Overview
=================
Brief Summary
-----------------
Understanding how candidate genes, previously associated with injury susceptibility, influence the incidence of muscle, bone, ligament, and tendon injuries across the development pathway of elite footballers may provide valuable insight into inherent injury predisposition to support the long-term development of every individual. Therefore, the aim of the present study was to investigate the association between candidate genetic variants and muscle, bone, ligament, and tendon injuries in elite football with sub-analysis of the influence of age and maturation on injury susceptibility.

Detailed Description
-----------------
Genetic variants in several candidate genes which code for structural constituents (COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722 and ACTN3 rs1815739), regulatory components (ACE rs1799752, ESR1 rs2234693 and MMP3 rs679620) and transcription factors (VDR rs2228570 and GDF5 rs143383) affecting the form, function and injury susceptibility of muscle, bone, ligament, and tendon tissue will be associated with overall injury, non-contact, bone, ligament, tendon and apophysitis injury risk in elite male youth and adult footballers.

Official Title
-----------------
Candidate Gene Association Study With Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury in Elite Male Youth Football Players

Conditions
-----------------
Genetic Change, Injuries

Intervention / Treatment
-----------------
* Genetic: Genetic variants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elite Male Footballer Player Registered at Fulham Football Club Exclusion Criteria: Female no longer registered at Fulham Football Club

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Genetic variants|COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of non-injured and injured participants with injury risk alleles | Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury | 8 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNP, Apophysitis, Fracture, Strain, Sprain, Genetic, Injury
Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.

Study Overview
=================
Brief Summary
-----------------
The incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. Behaviors with verbal agression and, less frequently, physical agressions, are described. These behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression. It is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. Such questionnaires are very rare, and none have been validated in French. The objective of this study is to develop a questionnaire in French that aims to assess anger, hostility and aggression after acquired brain injury. The psychometric qualities of this questionnaire will be evaluated using the Rasch probabilistic model. The development of such a tool will be of major interest for clinical practice and future clinical research.

Official Title
-----------------
SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.

Conditions
-----------------
Cerebral Lesion

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of the CHU Brugmann Hospital Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year). Exclusion Criteria: Pregnant or lactating women Presence or antecedents of psychiatric disease Degenerative pathology (ex: Parkinson...) Antecedents of other neurologic pathologies before the acquired lesion Oral or written comprehension dysfunctions.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with acquired brain injury<br> | Other: Questionnaire<br>* questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire evaluation by Rasch methodology | questionnaire validity | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acquired cerebral lesion, Anger, Agression
Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Oocyte Aspiration needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fertility treatment Antral follicle count Exclusion Criteria: Women who refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oocyte aspiration with 17G needle<br>Oocyte Aspiration with 17G needle. | Device: Oocyte Aspiration needle<br>* Oocyte aspiration in women go through an IVF procedure,.<br>|
| Active Comparator: Oocyte aspiration with (20-17G) needle<br>Oocyte Aspiration (20-17G) needle. | Device: Oocyte Aspiration needle<br>* Oocyte aspiration in women go through an IVF procedure,.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte Quality microscopic description. | Aspirated oocytes from both needle gauges will be compared for quality according to 5 parameters: Polar body, Zona pellucida, Dark cytoplasm, Perivitelline space and Vacuoles. | One year |
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment (PEARL STUDY)

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

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to provide written informed consent before beginning any study related procedures Patient has a documented clinical diagnosis of major depressive disorder Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: Patients with a history of non-compliance as judged by the study investigator Patients with a known lack of response to previous treatment with quetiapine Patients who have participated in a clinical trial within 4 weeks of randomization

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone |  |  | 
| To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Depression
Blood, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.

Official Title
-----------------
Relationship Between Blood, Hair and Lung Metals/Metalloids Concentration (Cadmium, Iron, Copper, Nickel, Chrome, Arsenic, Vanadium, Beryllium, and Zinc) and Lung Cancer or Chronic Obstructive Pulmonary Disease.

Conditions
-----------------
Lung Cancer, Chronic Obstructive Pulmonary Disease, Emphysema, Lung Surgery

Intervention / Treatment
-----------------
* Procedure: Lung surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of 18 to 75 years of age. Patients admitted for lung resection (either cancerous or non-cancerous) or lung transplant Exclusion Criteria: Patients with mental or physical conditions that prevent them giving their agreement for the study

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary cancer<br> | Procedure: Lung surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metals/metalloids concentration |  | Blood, hair and lung tissue are sampled during lung surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hair, Metals, Metalloids, Blood, Lung, Lung cancer, Chronic obstructive pulmonary disease
Application of ERAS Protocol in Emergency Surgery

Study Overview
=================
Brief Summary
-----------------
This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety

Official Title
-----------------
Application of ERAS Protocol in Emergency Surgery

Conditions
-----------------
Enhanced Recovery After Surgery, Emergency Surgery

Intervention / Treatment
-----------------
* Other: Application of ERAS protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis. Exclusion Criteria: age <18 emergency surgery for post-operative complications of post diagnostic procedures

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 |
| --- | --- |
| Study population<br>All patients undergoing emergency abdominal surgery for infection or occlusion and treated with bowel resection with or without anastomosis; intestinal bypass or adhesiolysis | Other: Application of ERAS protocol<br>* Application of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: % of application of post-operative ERAS items | Compliance to the standardize protocol for each item | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: complications rate within 30 days | Complication rate and mortality | 30 days |
Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

Study Overview
=================
Brief Summary
-----------------
The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.

Official Title
-----------------
Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.

Conditions
-----------------
Low Tension Glaucoma

Intervention / Treatment
-----------------
* Procedure: Water drinking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software) IOP ≤ 21mmHg without therapy normal open angle in a gonioscopic examination age > 40 years Exclusion Criteria: IOP > 21 mmHg in patients' history ametropia > 6 diopters cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification presence of corneal opacities uncontrolled hypertension with systolic blood pressure (SBP) > 165mmHg and/or diastolic blood pressure (DBP) > 100mmHg

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Water drinking test|Ingestion of 800 ml water in less than 5 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ONH blood flow induced by water drinking test | ONH blood flow evaluated by laser speckle flowgraphy | baseline, after 15, 30 and 45 minutes |
Butyrate Adjuvant Therapy for Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.

Detailed Description
-----------------
This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in this population. Insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.

Official Title
-----------------
Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects

Conditions
-----------------
Type1diabetes

Intervention / Treatment
-----------------
* Drug: BKR-017


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and <80 years of age recruited from the Mayo Clinic Endocrinology Clinic; Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4. Exclusion Criteria: Except for the use of insulin, no other treatments for T1D will be permitted. Pregnancy Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Interventional Model Description: BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Therapy / Butyrate<br>Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months | Drug: BKR-017<br>* BKR-017<br>* Other names: Butyrate tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Change in Insulin sensitivity | (Day 0) to Day 28 and Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Variability and Triglycerides | Changes in glucose measurements and triglycerides | (Day 0) to Day 28 and Day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Butyrate