linjc16/ctgov huggingface dataset:
Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Study Overview
=================
Brief Summary
-----------------
Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument. Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.

Official Title
-----------------
Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Conditions
-----------------
Sepsis, Sepsis Bacterial

Intervention / Treatment
-----------------
* Device: Blood Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis; Male or female, 18 years of age or older; Patient admitted to hospital Need for venous and arterial blood samples as part of standard of care Covered by a social security scheme. Exclusion Criteria: Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure; Subject under juridical protection.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Blood Sampling|Blood samples will be collected for the PSP measurement using the abioSCOPE.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary assessment | Pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated arterial whole blood, represented as percent recovery of arterial whole blood compared to venous whole blood, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots. | through study completion, an average of 1.5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoassay, Abionic, Pancreatic Stone Protein, Point-of-care device, IVD
Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.

Detailed Description
-----------------
Our long-term goal is to develop and disseminate clinically relevant, and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral injured mucosa .

Official Title
-----------------
Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration

Conditions
-----------------
Allogeneic Hematopoietic Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Xylitol
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age undergoing SCT. Exclusion Criteria: Prior proton or photon radiation treatment for cancer of the oral cavity, head or neck; cranial boost in patients receiving total body irradiation; known history of allergy to xylitol; inability to use a mouth rinse or dental wipes.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1, randomized, double-blind, placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol wipes<br> | Drug: Xylitol<br>* Xylitol dental wipes<br>|
| Placebo Comparator: Placebo wipes<br> | Other: Placebo<br>* Placebo dental wipes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bacteremia in the first 30 days post-HSCT with oral organisms |  | 30 days | 
| Incidence of bacteremia in the first 30 days post-HSCT with any organism |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dental plaque |  | 30 days | 
| Incidence of gingival inflammation |  | 30 days | 
| Incidence of mucosal ulceration |  | 30 days | 
| Incidence of oral mucositis |  | 30 days | 
| Incidence of oral microbiome diversity |  | 30 days | 
| Incidence of oral pathogenic bacteria burden |  | 30 days |
The Role of Emotional Stress in Patients With Stress-induced Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The event-related potentials may be different in patients with Takotsubo cardiomyopathy than in patients without Takotsubo.

Detailed Description
-----------------
In patients with Takotsubo diagnosed by coronary angiography, the event-related potentials are investigated and compared with a control group, which consists of subjects without Takotsubo.

Official Title
-----------------
Event-related Potentials in Patients With Takotsubo Cardiomyopathy

Conditions
-----------------
Takotsubo Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Written informed consent Takotsubo cardiomyopathy for group 1. ACS for group 3. Exclusion Criteria: Psychiatric diseases Impaired versus, non compliant patients, heart disease for group 2. Takotsubo-like syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Takotsubo<br> | |
| Healthy<br> | |
| ACS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-related potentials |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERP, Stress-induced cardiomyopathy
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases

Official Title
-----------------
A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases

Conditions
-----------------
Prostate Cancer, Bone Metastases

Intervention / Treatment
-----------------
* Drug: MCS110


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment 18 years old and over Exclusion Criteria: Plan to be on cytotoxic or biologic therapy during study Active dental problems Active heart complications Active infection Patients with moderate to severe swelling due to fluid Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: MCS110<br> | Drug: MCS110<br>* Anti-M-CSF antibody<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase |  | every cycle - (cycle = 28 days) | 
| Type and frequency of adverse drug reactions and serious adverse drug reactions |  | every cycle - (cycle = 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in markers of bone resorption and formation (pre- vs. post-treatment) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, bone metastases, anti-M-CSF, M-CSF antibody, M-CSF, Prostate Cancer with bone metastases
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.

Official Title
-----------------
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Motexafin gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy ECOG performance status score either 0 or 1 Willing and able to provide written informed consent Exclusion Criteria: Laboratory values of: Platelet count < 50,000/µL AST or ALT > 2 x the upper limit of normal (ULN) Total bilirubin > 2 x ULN Creatinine > 2.0 mg/dL and Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression) Uncontrolled hypertension Known history of porphyria, G6PD deficiency, HIV

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin gadolinium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Duration of clinical response |  |  | 
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Non-Hodgkin's Lymphoma, Indolent lymphoma, Relapsed lymphoma, Refractory lymphoma, Motexafin gadolinium
Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women

Study Overview
=================
Brief Summary
-----------------
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.

Official Title
-----------------
A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 in Healthy Young Chinese Men and Women

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

Intervention / Treatment
-----------------
* Drug: Lu AA21004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a Chinese man or woman The subject is, in the opinion of the investigator, generally healthy If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit Exclusion Criteria: The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and exclusion criteria may apply.

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

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

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

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: Lu AA21004<br> | Drug: Lu AA21004<br>* 10 mg immediate-release (IR), one single dose, orally<br>* Other names: Vortioxetine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK AUC determination of Lu AA21004 (Vortioxetine) | Area under the curve (AUC) | 11 days | 
| PK Cmax determination of Lu AA21004 (Vortioxetine) | Maximum observed concentration (Cmax) | 11 days |
Growth of Healthy Term Infants Fed Formula Containing DHA-B

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.

Conditions
-----------------
Growth, Tolerance, Infant Development

Intervention / Treatment
-----------------
* Other: infant formula with DHASCO
* Other: infant formula with DHASCO-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full term infant (gestational age 37-42 weeks) birth weight > or equal to 2500 g singleton infant < or equal to 14 days of age in good health parent must be >21 years of age parental consent Exclusion Criteria: congenital malformation or genetic disorder metabolic anomalies maternal infectious diseases, alcoholism, substance abuse mothers with gestational diabetes participation in another clinical study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 14 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: infant formula with DHASCO<br>standard infant formula with docosahexaenoic acid (DHA) | Other: infant formula with DHASCO<br> <br> |
| Experimental: infant formula with DHASCO-B<br>standard infant formula with DHA-B | Other: infant formula with DHASCO-B<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain (gm/day) | gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits. | through day of life 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length (cm) | Length in cm | through day of life 120 | 
| head circumference (cm) | head circumference (cm) | through day of life 120 | 
| fatty acid levels (wgt %) | red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset | at day of life 120 | 
| Formula intake and tolerance | assessed by analyzing three-day dietary intake and tolerance forms | Day of life 30 and 120 |
EBUS/Spectrum Analysis

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.

Official Title
-----------------
Spectrum Image Analysis of Lymph Nodes During Endobronchial Ultrasound-Guided (EBUS) Transbronchial Needle Aspiration (TBNA) in Patients With Lung Cancer

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

Intervention / Treatment
-----------------
* Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 years or older Patients with known or suspected lung cancer who require EBUS-TBNA for lymph node staging Exclusion Criteria: Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy Inability to give informed consent Patients who are pregnant

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 |
| --- | --- |
| Spectrum Image Analysis<br> | Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph Node Staging | The lymph node staging will be determined by the pathology report of the biopsy taken from the patients lymph node(s). | Pathology report will be completed as soon as possible after the procedure. (Within one year) |
Comparison of a Minimally Invasive Technique for Total Knee Replacement to a Standard Technique

Study Overview
=================
Brief Summary
-----------------
Comparison of a minimally invasive technique for total knee replacement to a standard technique

Official Title
-----------------
Minimally Invasive Total Knee Arthroplasty Versus a Standard Surgical Technique: a Single-blinded Single-centre Randomized Controlled Trial

Conditions
-----------------
Osteoarthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No inflammatory arthritis, no other lower limb problem, no major comorbidity Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: knee surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life at 2 years |  |  |
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the potential benefits, safety, and tolerability of AB-2004 in participants with irritability associated with autism spectrum disorder.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population

Conditions
-----------------
Autism Spectrum Disorder (ASD)

Intervention / Treatment
-----------------
* Drug: AB-2004
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Clinically diagnosed, documented ASD (Diagnostic and Statistical Manual of Mental Disorders [DSM-5] criteria) Aberrant Behavior Checklist - Irritability (ABC-I) score ≥18 at the Screening Period Clinical Global Impression - Severity (CGI-S) scale score ≥4 at the Screening Period Key Exclusion Criteria: Use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. Prophylactic oral antibiotic use of no more than 1 dose will be permitted Current use of an oral controlled or extended-release medication Have a comorbid major psychiatric condition (eg, schizophrenia or bipolar disorder) at screening that in the opinion of the Investigator may interfere with the subject's ability to complete study procedures/comply with study requirements Current use of antipsychotics (eg, aripiprazole or risperidone)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 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
Interventional Model Description: Double Blind, Randomized, Placebo Controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB-2004<br> | Drug: AB-2004<br>* Taken 3 times daily with food<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Take 3 times daily with food<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004 |  | From baseline to Week 8 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in the Clinical Global Impression-Severity (CGI-S) from Baseline to Week 8 for AB-2004 High Dose and AB-2004 Low Dose |  | From baseline to Week 8 visit | 
| Number of participants who reported treatment emergent adverse events (TEAEs) |  | From baseline to Week 8 visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritability, Anxiety