linjc16/ctgov huggingface dataset:
The Comparison of Tricuspid Replacement and Repair in Patients With Combined Heart Valve Disease

Study Overview
=================
Brief Summary
-----------------
Functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. The investigators retrospectively review patients with two or more heart valve disease and functional tricuspid regurgitation, and assess its long term outcomes.

Detailed Description
-----------------
we reviewed patients who admitted to our hospital due to combined heart valve disease, and underwent tricuspid valve replacement or repair from January,1998 to december,2009. we made a comparison between these two groups, in term of early results after operation and long term results.

Official Title
-----------------
The Institute of Cardiovascular Surgery

Conditions
-----------------
Tricuspid Valve Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant disorders in aortic and mitral valves Moderate ～ severe tricuspid regurgitation Underwent tricuspid repair or replacement operation Exclusion Criteria: Isolate tricuspid valve lesion Mild tricuspid valve regurgitation Tricuspid valve regurgitation was left without surgical treatment

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 67 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 |
| --- | --- |
| Repair group<br>patients in repair group underwent tricuspid repair for functional tricuspid regurgitation. | |
| replacement group<br>In this group, patients underwent tricuspid valve replacement for functional tricuspid regurgitation. | |

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
-----------------
tricuspid valve regurgitation, replacement, repair, outcomes
Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)

Study Overview
=================
Brief Summary
-----------------
This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.

Official Title
-----------------
Echocardiography and PEA Measurements in CRT Therapy

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: Echocardiography and SonR recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study. Exclusion Criteria: Inability to understand the patient information sheet. Minor patient or pregnant woman.

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 |
| --- | --- |
| CRT recipients<br> | Other: Echocardiography and SonR recording<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure - congestive, Cardiovascular imaging agents/Techniques], Echocardiography, Other diagnostic testing, Other Treatment, Recipients of cardiac resynchronization therapy systems
Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research

Study Overview
=================
Brief Summary
-----------------
The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.

Detailed Description
-----------------
Pregnant individuals carrying at least one HbS allele will be included in the study to collect the umbilical cord blood of the child at birth. Collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.

Official Title
-----------------
Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women, giving birth at CHSF and consenting to the collect and study of placental blood after delivery Age 18 to 45 years Biological testing of the participant includes hemoglobin electrophoresis and shows at least one HbS allele Exclusion Criteria: Lack of written consent Minors (not 18 years old) or under guardianship Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).

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

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

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 |
| --- | --- | --- |
| Number of samples with HbS/HbS genotype | Measured by DNA sequencing | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of samples with bio-experimental data | Consisting of cellular characterization, transduction and cell processing data | 4 years |
SOTO: Treatment Sensitivity of Organoids to Predict Treatment Outcome

Study Overview
=================
Brief Summary
-----------------
In this study, we aim to assess whether Patient Derived Organoids can be used to predict treatment sensitivity in HNSCC patients.

Detailed Description
-----------------
This is a prospective observation study to generate patient-derived organoids from patients' samples to assess treatment response and to correlate with patients' treatment outcomes and to collect preliminary data on the ability of PDOs to predict patients' treatment response and whether their radiosensitivity and chemosensitivity can be correlated with their survival outcome.

Official Title
-----------------
SOTO Study: Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Head and Neck Squamous Cell Carcinoma (HNSCC) Patients

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with head and neck squamous cell carcinoma (including oral cavity, oropharynx, paranasal sinuses, hypopharynx or larynx) undergoing curative treatment (primary surgery or radiotherapy) or presenting with recurrent or metastatic cancers Age > 18 years old Exclusion Criteria: Patients unable to give informed consent e.g. mental disability or vulnerable adults

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Surgically resectable disease, followed by adjuvant radiotherapy +/- chemotherapy | |
| Cohort 2<br>Primary radiotherapy +/- concurrent chemotherapy | |
| Cohort 3<br>Recurrent or metastatic HNSCC undergoing platinum based chemotherapy +/- cetuximab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Organoids | To assess the percentage of successful generated organoids from tissues in head and neck cancer patients | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | To assess the sensitivity of radiotherapy, platinum (cisplatin and/or carboplatin) chemotherapy or cetuximab or their combination in PDOs | 1 Year | 
| Treatment Outcome | To correlate the treatment sensitivities of PDOs with the treatment outcome of patients | 1 Year |
Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.

Official Title
-----------------
Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Duloxetine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology Exclusion Criteria: Have any current primary Axis I diagnosis other than major depressive disorder Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia) Have regional pain syndrome, multiple surgeries or failed back syndrome Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Disability Scale total score |  |  | 
| Average pain item of the BPI and the endpoint of the PGI-Improvement |  |  | 
| Reduction of pain severity |  |  | 
| Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores |  |  | 
| Quality of life |  |  | 
| Effect duloxetine on pain is independent of MDD or mood improvement |  |  | 
| Assess safety of duloxetine |  |  |
Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility. An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics. The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.

Official Title
-----------------
Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Assessment of hallucinations in Parkinson's disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years-old Absence of opposition from the patient himself/herself or his/her legal representant for his/her participation to the study Patient without superior age limit with a diagnosis of Parkinson's disease made according to the UKPDSBB criteria (UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria) Outpatient consulting in neurology at the Charpennes'hospital Exclusion Criteria: Opposition to the study Deafness or blindness which could compromise the interview

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 |
| --- | --- |
| Patients affected by Parkinson's disease<br>Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer | Other: Assessment of hallucinations in Parkinson's disease<br>* Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hallucinations Prevalence | Semi-structured questionnaire precisely describing hallucinations of all modalities and their characteristics, as well as minor hallucinations and delusions. Binary Yes/No possible answers. Unique 1 hour interview to assess semi-structured questionnaire for primary outcome measurement, and psychometric scales. | 1 hour |
Pilot Study for the NorCAPITAL Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects. A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.

Official Title
-----------------
Pilot Study for the NorCAPITAL Trial

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Drug: Clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persisting or constantly relapsing fatigue lasting 3 months or more Functional disability resulting from fatigue to a degree that prevent normal school attendance Age between 12 and 19 years Exclusion Criteria: Another disease process or current demanding life event that might explain the fatigue Another chronic disease Permanent use of drugs Permanently bed-ridden Positive pregnancy test Supine systolic blood pressure (SBP) < 85 mm Hg Fall in SPB upon standing > 30 mm Hg Supine HR < 50 beats/min Abnormal ECG

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 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 |
| --- | --- |
| Experimental: Clonidine<br> | Drug: Clonidine<br>* 50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration level (Cmax and Co) of clonidine |  | After 14 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic cardiovascular responses (head-up tilt test) |  | After 14 days of treatment | 
| Reports of adverse effects |  | Participants will be followed for the duration of treatment period, an expected average of 14 days | 
| Plasma concentration (Cmax) of clonidine |  | First day of treatment, approximately 5 hours after the first dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescents
Safety Study of Abatacept to Treat Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.

Official Title
-----------------
Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug Age 18 years or older Exclusion Criteria: Below 18 years of age

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 |
| --- | --- |
| Patients with rheumatoid arthritis (RA) who receive abatacept<br> | |
| Patients with RA who receive BDM drugs<br>biologic disease-modifying (BDM) | |
| Patients with RA who receive non-biologic DMARDs<br>disease-modifying anti-rheumatic drugs (DMARDs) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious infection |  | Every 2 years throughout the study | 
| Incidence rates of malignancy | (total, lymphoma, lung cancer, breast cancer, colorectal cancer) | Every 2 years throughout the study | 
| Total mortality |  | Every 2 years throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple sclerosis | To determine the incidence rate of multiple sclerosis (MS) in RA patients treated with abatacept and to compare this rate with the rate in RA patients matched for age, gender, RA duration and DMARD use, after adjusting for other potential confounders. | Every 2 years throughout the study |
A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.

Official Title
-----------------
A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.

Conditions
-----------------
Sleep Initiation and Maintenance Disorders, Mental Disorders

Intervention / Treatment
-----------------
* Drug: Org 50081
* Drug: Org 50081
* Drug: Placebo
* Drug: zopiclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has at least 3 years of car driving experience Subject signs the trial Informed Consent Form Subject is in a healthy condition as judged by the investigator Subject has a regular sleep pattern Exclusion Criteria: Subject has insomnia or any other sleep disorder Medication or drug use of any kind prior to the study Relevant history or presence of a significant medical illness

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br> | Drug: Org 50081<br>* 1.5 mg on day 1-7<br>|
| Experimental: Treatment 2<br> | Drug: Org 50081<br>* 4.5 mg on Day 1-7<br>|
| Placebo Comparator: Treatment 3<br> | Drug: Placebo<br>* Once daily on Day 1-7<br>|
| Active Comparator: Treatment 4<br> | Drug: zopiclone<br>* Single dose of 7.5 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Standard Deviation of Lateral Position |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor and cognitive performance tasks |  | Day 8 |