linjc16/ctgov huggingface dataset:
Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)

Study Overview
=================
Brief Summary
-----------------
This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial. The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment. This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.

Official Title
-----------------
A Multinational, Multicenter, Single Visit, Exploratory Pharmacogenetic Trial and Long-term Follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis) Trial

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Was randomized in the PRISMS study Is willing and able to comply with the protocol Written informed consent given before any trial-related activities are carried out Exclusion Criteria: Is unwilling or unable to participate in the study

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 |
| --- | --- |
| PRISMS patients<br>This single group includes all the patients from the PRISMS study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current course of MS: RRMS or SPMS |  | 1 day | 
| Current EDSS score |  | 1 day | 
| Change in EDSS since randomization |  | 1 day | 
| Immunogenicity assessment |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Genetic markers
Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography

Study Overview
=================
Brief Summary
-----------------
To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography To evaluate its relationship to long term mortality.

Detailed Description
-----------------
Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate > 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .

Official Title
-----------------
Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Device: speckle tracking echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of acute pulmonary embolism Age: 20 - 70 years. Exclusion Criteria: coronary artery disease patient of Atrial fibrillation. Patient of impaired RV function due to chest disease (Cor-pulmonale) patient with impaired Ejection fraction (EF) <50% Moderate to severe valvular heart disease. Atrio-ventricular conduction disturbance. Poor echogenicity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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 acute pulmonary embolism<br>speckle tracking echocardiography for patient with acute pulmonary embolism | Device: speckle tracking echocardiography<br>* speckle tracking echocardiography of right ventricle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve management of acute pulmonary embolism | comparison between speckle tracking echocardiograpgy and conventional echocardiography in pulmonary embolism | baseline |
Circulating Tumor DNA in Surgical Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.

Detailed Description
-----------------
Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients. The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Official Title
-----------------
A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Lung Cancer Patients

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent Exclusion Criteria: Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of surgery on ctDNA of lung cancer patients | Changes of blood ctDNA of lung cancer patients before and after surgery. | before surgery and 7days after surgery |
Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

Study Overview
=================
Brief Summary
-----------------
To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.

Official Title
-----------------
Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

Conditions
-----------------
Pain Reduction

Intervention / Treatment
-----------------
* Drug: 1% preservative-free lidocaine
* Drug: Phenylephrine 1.0%/ Ketorolac 0.3%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a cataract in the surgical eye Exclusion Criteria: Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs) Those with a past medical history of asthma Those systemically using opioids or nonsteroidal anti-inflammatory drugs Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery Those with a history of alpha-1-adrenergic antagonist use Those with excisional, intraocular surgery in the planned surgical eye in the preceding year Those with a history of iris damage Those requiring iris expanding device or those with an acute or chronic uncontrolled eye condition, or those unable to effectively remember surgery or complete the post-operative assessment. Additionally, individuals less than 21 will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 95 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis | Drug: 1% preservative-free lidocaine<br>* Instillation of intracameral lidocaine after initial paracentesis incision.<br>|
| Experimental: Study Experimental Group<br>Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure | Drug: Phenylephrine 1.0%/ Ketorolac 0.3%<br>* Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale to measure pain | Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation | Day 1 of operation |
Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells

Study Overview
=================
Brief Summary
-----------------
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation. The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses, foreskin and umbilical cord.

Detailed Description
-----------------
The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc. The clinical grade donated feeders used in this project were developed under GMP conditions using animal-free reagents. For potential future clinical applications, the iPS cells will be developed under GMP conditions, using reagents and methods that will be acceptable for clinical applications.

Official Title
-----------------
Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells

Conditions
-----------------
Pregnant, Healthy Females, Healthy Male Newborns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, older than 18 Exclusion Criteria: non healthy, younger than 18

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-existing Fibroblast MCB<br>Pre-existing fibroblast donors for hESC derivation project | |

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
-----------------
termination of pregnancy, surgical circumcision, umbilical cord
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO5313534
* Drug: RO5313534
* Drug: RO5313534


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >/=50 years of age; probable Alzheimer's disease; MMSE score at screening of 13-22; under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline; not requiring nursing home care, but looked after by a caregiver/carer. Exclusion Criteria: dementia due to condition other than Alzheimer's disease; other significant neurological disorder; untreated/non-stabilized major depressive disorder; bipolar disorder, schizophrenia, or any other serious psychiatric condition.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* po daily for 24 weeks<br>|
| Experimental: RO5313534 15mg<br> | Drug: RO5313534<br>* 15mg po daily for 24 weeks<br>|
| Experimental: RO5313534 1mg<br> | Drug: RO5313534<br>* 1mg po daily for 24 weeks<br>|
| Experimental: RO5313534 5mg<br> | Drug: RO5313534<br>* 5mg po daily for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview |  | At intervals up to week 24, then at week 28 | 
| AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations. |  | At intervals to week 24, then at week 28 |
Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)

Study Overview
=================
Brief Summary
-----------------
As part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).

Official Title
-----------------
Alarm Relay Bracelet for Simplification and Security Respiratory Assistance at Home: Evaluation of the Nocturnal Awakening Capability in Ventilated Patients and Healthy Volunteers

Conditions
-----------------
Healthy Volunteers, Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance

Intervention / Treatment
-----------------
* Other: Vibrating bracelet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: speak french with social security For healthy volunteers : no sleep disorder, known neurological or respiratory pathology For patients : congenital central hypoventilation syndrome or ventilatory assistance whatever the indication, able to act on their ventilator, and in stable state on the respiratory level for at least 3 months. Exclusion Criteria: subjects taking treatment that may interfere with sleep patterns intake of alcohol or any substance (alcohol, drugs) that may interfere with sleep patterns the day before the polysomnography

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrating bracelet<br>A bracelet with vibrations triggered randomly overnight | Other: Vibrating bracelet<br>* A bracelet with vibrations triggered randomly overnight. The sleeper's awakening capability will be evaluated each time the bracelet vibrates (5 times in the night).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total awakening capability | Proportion of the activations of the bracelet causing an awakening sufficient for the subject to stop the application and do a cognitive task : note the wake-up time | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Awakening capability in each stage of sleep | Proportion of awakenings in different stages of sleep (slow wave sleep, Rapid Eye Movement sleep) relative to the total number of vibrations triggering by the bracelet | 1 night | 
| Awakening without capability to do the cognitive task | Proportion of the activations of the bracelet causing an awakening without the cognitive task | 1 night |
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram

Study Overview
=================
Brief Summary
-----------------
Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin concentration.

Official Title
-----------------
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram

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

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Male gender Age 20 to 30 years Healthy according to physical examination, ECG, MRI and blood chemistry Exclusion Criteria: Past or present psychiatric disease Past or present brain disorder or injury, including loss of consciousness for more than five minutes Past or present drug or alcohol abuse Past or present use of antidepressant or antipsychotic medications Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram Significant abnormality on ECG Structural abnormality in the brain confirmed by MR examination Claustrophobia Any metal devises or implants in the body Intolerance to escitalopram or any of the components of the formula Predisposition to motion sickness Inability to understand and comply with the study requirements Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Escitalopram|20 mg p.o.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition |  | One day (PET measurement before and after escitalopram administration on the same day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanism of Action of escitalopram
Position Changes During Colonoscope Insertion Increases Patient Comfort

Study Overview
=================
Brief Summary
-----------------
The investigators wish to study the effects of position changes during colonoscope insertion on patient comfort. The investigators hypothesize that early position changes would reduce colonoscope loop formation and patient discomfort.

Official Title
-----------------
Position Changes During Colonoscope Insertion Increases Patient Comfort: a Prospective Trial

Conditions
-----------------
Colonoscopy Technique

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 19 years or older outpatient colonoscopy Exclusion Criteria: inpatient unable to provide informed consent previous bowel resection, inflammatory bowel disease musculoskeletal disorder or other mobility issues limiting effective patient position changes. inadequate bowel preparation

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Intensity and frequency of abdominal pain | Abdominal pain during colonoscopy. | 30min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, position changes, patient comfort