linjc16/ctgov huggingface dataset:
Phase IIA Study in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia

Official Title
-----------------
A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: AZD2624
* Drug: Olanzapine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females of non-childbearing potential Diagnosis of Schizophrenia Exclusion Criteria: Clinically relevant disease and /or abnormalities. Alcohol or substance abuse not in remission Enrollment in another investigational study within 30 days

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD2624<br>AZD2624 40 mg | Drug: AZD2624<br>* Oral Suspension<br>|
| Other: Olanzapine<br>Olanzapine 15 mg | Drug: Olanzapine<br>* PO BID<br>* Other names: Zyprexa;|
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value. | Baseline, Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Influence of Hematocrit Level on the Visibility of the Venous Network in Magnetic Susceptibility Imaging

Study Overview
=================
Brief Summary
-----------------
Magnetic susceptibility imaging is a magnetic resonance imaging (MRI) technique that uses the magnetic properties of tissues and the BOLD (blood oxygen level-dependent) effect. It allows a better visualization of venous structures and hemorrhagic lesions. These sequences are now used in clinical routine. The extreme sensitivity of these sequences to the oxy/deoxyhemoglobin ratio makes it possible to describe a new MRI semiology, particularly in the context of cerebral ischemia. The interest of the analysis of the venous network signal, which can reflect cerebral perfusion, has been reported. However, the influence of the hematocrit level on the signal of the venous network in magnetic susceptibility imaging has not been evaluated at present. It seems important to better define the influence of hematocrit level on the signal of the veins with this sequence to avoid potential diagnostic errors.

Official Title
-----------------
Influence of Hematocrit Level on the Visibility of the Venous Network in Magnetic Susceptibility Imaging

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient whose age ≥ 18 years Patient referred to GHPSJ for suspected stroke Patient who had a brain MRI including the magnetic susceptibility sequence Patient for whom a blood count with hematocrit was performed at the same time (within 7 days between the MRI and the blood test) French-speaking patient Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Elimination of potential biases: recent injection (48 h) of gadolinium, pathology likely to modify the venous signal in magnetic susceptibility imaging (notably arterial occlusion or stenosis), high flow oxygenation, sickle cell disease, thalassemia. Patient objecting to the use of his/her data for this research

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 |
| --- | --- | --- |
| Specific influence of the hematocrit level on the visibility of the venous network | This outcome corresponds to the visibility of the venous network in magnetic susceptibility imaging using a visual scale allowing comparison between patients with normal hematocrit, anemia or polycythemia. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-observer agreement of the visual analysis of the venous network | This outcome corresponds to the correlation of visual scales between different observers. | Day 1 |
Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

Study Overview
=================
Brief Summary
-----------------
Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?

Official Title
-----------------
Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Other: Comprehensive ED syncope/presyncope management tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥16y Member of Kaiser Permanente Northern California (KPNC) health plan Presentation to the ED with an ED diagnosis of recent syncope or presyncope (<24h) without a serious etiology identified during the initial ED diagnostic assessment, that is, patients with unexplained syncope. Subjects who meet criteria will be identified electronically within the CDS tool in the electronic health record. Exclusion Criteria: Age <16 years old Non-members of KPNC Patients with obvious witnessed seizure, prolonged loss of consciousness (>5 minutes), post-traumatic loss of consciousness, and new mental status changes Patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope Patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Comprehensive ED syncope/presyncope management tool|This is a data-only, prospective observational cohort study to validate the performance metrics of the Canadian Syncope Risk Score in a diverse population of patients evaluated in community EDs of a U.S. integrated health care system.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with arrhythmic and nonarrhythmic serious outcomes | Serious outcomes include those which are arrhythmic (arrhythmias, interventions for arrhythmia, or unknown cause of death) and nonarrhythmic (e.g., myocardial infarction, structural heart disease, pulmonary embolism, or hemorrhage) | 30 days |
Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC

Official Title
-----------------
Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: Decitabine
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged between 18 years and 70 years old. Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-. Metastatic TNBC should not be treated with more than 1-line for metastatic disease. Patients can not be treated with carboplatin in the metastatic setting. For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting. Patients had at least one measurable lesion according to RECIST criteria version 1.1. ECOG Performance Status (PS) of 0-1. Adequate liver and renal organ function. Dated and signed IEC/IRB-approved informed consent. Exclusion Criteria: More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases. Less than four weeks since last radiotherapy. Pregnancy or lactation or unwillingness to use adequate method of birth control. Active or uncontrolled infection. Hypersensitivity to carboplatin or decitabine Male breast cancer. Treated with any DNA demethylating agents Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: DC<br>DNA demethylating agent decitabine plus carboplatin | Drug: Decitabine<br>* decitabine 7mg/m2, d1-d5, q3w<br>Drug: Carboplatin<br>* carboplatin AUC = 6, d6, q3w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | Partial response (PR) + complete response (CR) rate | At the end of Cycle 6 (each cycle is 21 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decitabine, triple negative breast cancer, carboplatin, metastatic
Assess the Absorption, Distribution, Metabolism and Excretion of AZD7325 After Intravenous and Oral Administration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose

Official Title
-----------------
A Phase 1, Open, Two Period, Single-Centre, Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After Intravenous and 14C-labelled Oral Administration of AZD7325 to Healthy Male Volunteers

Conditions
-----------------
Absorption, Distribution, Metabolism, Excretion

Intervention / Treatment
-----------------
* Drug: AZD7325
* Drug: AZD7325


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Day 1 Body Mass Index (BMI) > 18 and < 30kg/m2 Exclusion Criteria: Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study Use of prescription medication within 14 days of the first dose of the investigational product Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IV dose of AZD7325 | Drug: AZD7325<br>* IV Dose<br>|
| Experimental: 2<br>14C oral dose of AZD7325 | Drug: AZD7325<br>* oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration |  | Daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325 |  | Daily | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteer
The Contribution of Internal Maternal Resources to Creation of Motherhood. Comparison Among Mothers to Twins and Singleton

Study Overview
=================
Brief Summary
-----------------
Delivery of twins or preterm infant is a very stressful episode to mothers. The purpose of this study is to characterize maternal psychological resources in dealing with this situation and compare it to mothers giving birth to singleton at term

Conditions
-----------------
Preterm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study group: Mothers who give birth to twins or preterm infants Control: Mothers who give birth to singleton, full term infants Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delivery of preterm infant and/or twins
Coronary Flow Rate Measurement in T-Grafts

Study Overview
=================
Brief Summary
-----------------
Is the surgical treatment of patients with coronary heart disease using the T-graft technique an adequate solution that provides a sufficient myocardial flow reserve? A magnetic resonance examination (MRI) is required.

Official Title
-----------------
Comparison of Coronary Flow Reserve in Two Different Bypass Techniques (T-graft Technique Versus Isolated Graft Technique) Using Magnetic Resonance Technology (MRT)

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Procedure: T-Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary heart disease Age > 18 ys Ejection fraction > 45% Exclusion Criteria: myocardial infarction Re-Intervention

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgical procedure<br>T-graft bypass or conventional bypass | Procedure: T-Graft<br>* T-Graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary flow reserve |  | within 4-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients scheduled for bypass grafting
Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer

Study Overview
=================
Brief Summary
-----------------
This feasibility study investigates if frail elderly and hospitalized patients are able to perform unsupervised elastic band exercises as a supplement to their usual supervised physiotherapy sessions and how much training they perform during their hospitalization. It is also investigated how the frail elderly and the health personnel experiences the unsupervised elastic band exercises.

Official Title
-----------------
Feasibility Study of Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer as a Supplement to Usual Supervised Physiotherapy Sessions

Conditions
-----------------
Frail Elderly

Intervention / Treatment
-----------------
* Other: Elastic Band Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frail elderly and hospitalized patients with a minimal score of 5/15 measured by the Tilburg Frailty Indicator Able to read and understand Danish Exclusion Criteria: Frail elderly and hospitalized patients with a score of <5 measured by the Short Portable Mental Status Questionnaire Frail elderly and hospitalized patients where resistance training and physical activity is contraindicated (evaluated by a geriatrician and/or physiotherapist)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Elastic Band Exercises<br>Unsupervised Elastic band exercises performed once a day until the patient is discharged from the hospital. One exercise for the upper extremity (row exercise level 1-3) and one exercise for the lower extremity (knee extension level 1-3). The two exercises are both performed as 3 sets of 10 repetitions. | Other: Elastic Band Exercises<br> <br> * Other names: Bandcizer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of sets performed |  | From inclusion-discharge from hospital - up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of repetitions performed |  | From inclusion-discharge from hospital - up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frail Elderly, Elastic Band Exercises, Unsupervised Exercises, Monitoring Technology, Bandcizer, Adherence, Feasibility
Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the bile acid circulation is changed after gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences how the bile acid and food is mixed in the gut and how this is associated with the changes in gut hormone release after the surgery. Our hypothesis is that bile acid reabsorption from the gut is increased as animal models suggest so and bile acid blood concentration increases after surgery.

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 25 and 65 years For patients: uncomplicated Roux-en-Y Gastric Bypass surgery more than 12 months before study initiation For controls: Age, BMI and gender matched with patient group Exclusion Criteria: Previous removal of gall bladder or other abdominal surgeries except appendectomy (and gastric bypass surgery for patient group) Known liver disease or thyroid disease requiring antithyroid medication Chronic gastrointestinal symptoms Any chronic disease interfering with, or susceptive of interfering with appetite or gastrointestinal function Any medication interfering with, or susceptive of interfering with appetite or gastrointestinal function Smoking within the last month Alcohol consumption above 168 grams per week Currently pregnant or breast-feeding Anaemia with haemoglobin <6,5 mmol/L (<117 mg/dl) Loss or gain of more than 3 kg within the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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 |
| --- | --- |
| RYGB subjects<br>Morbidly obese patients who has undergone an uncomplicated gastric bypass surgery more than 12 months before study start. | |
| Control subjects<br>Age, sex and BMI-matched healthy controls | |
| SG subjects<br>Morbidly obese patients who has undergone an uncomplicated sleeve gastrectomy surgery more than 12 months before study start. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in time from food intake to mix of food in the gut with bile acid between patients and controls |  | Patients: >12 months after Gastric Bypass Surgery | 
| Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days |  | Patients: >12 months after Gastric Bypass Surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roux-en-Y Gastric Bypass Surgery, Bile Acid Circulation, Obesity, Bariatric Surgery