linjc16/ctgov huggingface dataset:
Relationship Between Strain and Stroke Volume in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment. Aim: Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery Hypothesis: Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.

Official Title
-----------------
Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Right Ventricular Dysfunction, Stroke Volume Index, Longitudinal Heart Strain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring. Exclusion Criteria: Patients with contraindication to Swan-Ganz catheter placement, Pre-existing atrial arrhythmias, Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).

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 |
| --- | --- | --- |
| Change of right ventricular function during CABG assessed by right heart strain (%) | Assessing the change of RV function during CABG surgery using right heart strain as a percentage of change between RV shortening and RV end diastolic length. | during CABG surgery | 
| Change of right ventricular function during CABG assessed by stroke volume index (mL/m2) | Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2) | during CABG surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output measured with Swan-Ganz during CABG | Cardiac output (L/min) measured with the thermodilution technique | during CABG surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Echocardiography, Coronary artery bypass graft, Thermodilution
An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Study Overview
=================
Brief Summary
-----------------
Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.

Official Title
-----------------
An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: 49-channel optical spectrometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Breast Cancer Exclusion Criteria:

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduction Mammoplasty<br>Patients undergoing reduction mammoplasty | Device: 49-channel optical spectrometer<br> <br> |
| Experimental: Mastectomy<br>Patients undergoing mastectomy | Device: 49-channel optical spectrometer<br> <br> |
| Experimental: Lumpectomy<br>Patients undergoing a lumpectomy | Device: 49-channel optical spectrometer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the optical signatures of breast tissue. | The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue. | Day of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial Mastectomy, Lumpectomy, Mastectomy
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)

Study Overview
=================
Brief Summary
-----------------
In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the literature in terms of determining which treatment method is more effective by evaluating the changes in the needles muscles with the use of occlusal splints and LLL with USG and other parameters in certain periods, as well as evaluating which parameters are more effective.

Official Title
-----------------
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)

Conditions
-----------------
Low Level Laser and Occlusal Splint

Intervention / Treatment
-----------------
* Device: Low Level Laser Therapy
* Device: Occlusal Splint Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems Patients with pain in the joint and chewing muscle area Exclusion Criteria: Syndromic patients Patients under the age of 18 Patients with a history of orthognathic surgery Pregnants Antidepressant Users Patients Using Removable Dentures Patients who have had joint treatment in the past six months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of Low Level Laser Therapy<br> | Device: Low Level Laser Therapy<br>* Low Level Laser Therapy<br>|
| Experimental: Group of Occlusal Splint Treatment<br> | Device: Occlusal Splint Treatment<br>* Occlusal Splint Treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Pain Scale | Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Level Laser, Occlusal Splint, Temporomandibular Disfunction
Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis). The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.

Official Title
-----------------
Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy Exclusion Criteria: Age < 18 year Pregnancy Refusal to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Lung Cancer<br>All patients with advanced lung cancer candidate for chemotherapy or chemotherapy + radiation therapy will be enrolled and followed-up for 1 year clinically and radiologically (Chest CT) to verify whether or not central airway obstruction is present at the time of diagnosis or occurs in the year following diagnosis (or in the life span from diagnosis and death in patients who die before 1 year of diagnosis). Furthermore, predictor variables possibly associated with central airway obstruction will be studied. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of central airway obstruction | The incidence will be measured over a 12 month period after diagnosis (or over the life span from diagnosis to death in patients who die before 1 year from the diagnosis) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictor variables associated with the presence/occurrence of central airway obstruction |  | 12 months | 
| Prevalence of central airway obstruction | The prevalence of central airway obstruction will be evaluated at the time of diagnosis | 1 day |
Study Evaluating Epidemiology of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in Australia

Study Overview
=================
Brief Summary
-----------------
The study is a cross sectional, epidemiology study of disease severity for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).

Official Title
-----------------
Australian Descriptive Epidemiology Study of Severity of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) and Exposure to Biological Disease Modifying Anti-rheumatic Drugs (bDMARDs)

Conditions
-----------------
Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria include: Adult patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who have visited a primary care centre within one of the specified catchment areas for their condition within the last 24 months.

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis patients in defined disease severity categories |  | Single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients exposed to biological disease modifying antirheumatic drugs |  | Single visit |
Vienna HIV Infection Via Sex Study

Study Overview
=================
Brief Summary
-----------------
The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex practices.

Detailed Description
-----------------
We will include individuals at high-risk for HIV acquisition, i.e. HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex' within the past 12 months Important clinical information on possible vectors for transmission (including but not limited to high-risk sex practices and sexualized drug use), use of HIV pre-exposure prophylaxis, incidence of sexually transmitted infections will be assessed and laboratory parameters will be obtained from blood, urine and mucosal secretion.

Official Title
-----------------
Characterization of Patients at High Risk for the Acquisition of Sexually Transmitted Infection With the Human Immunodeficiency Virus (HIV) - a Clinical Study

Conditions
-----------------
HIV Infections, HIV Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Gonorrhea, Chlamydia, Syphilis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk for acquiring HIV defined as followed: HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex'. Age >18 years and <100 years. Written informed consent for this registry study. Exclusion Criteria: 1. Withdrawal of the written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Incidence of HIV | Time from inclusion to HIV infection | Up to 10 years (=Study Period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sexually transmitted infections | Time from inclusion to any sexually transmitted infections | Up to 10 years (=Study Period) |
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

Official Title
-----------------
A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Conditions
-----------------
Adjunctive Treatment of Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Pimavanserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059 May benefit from longer term therapy with open-label pimavanserin treatment If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception Exclusion Criteria: Is determined to be inappropriate for the study Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug - pimavanserin<br>Pimavanserin 34 mg tablets | Drug: Pimavanserin<br>* Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent Adverse Events (TEAEs) | Number of patients with treatment emergent AEs | 52 weeks |
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects

Official Title
-----------------
A Phase I, Single-center, Open-label, Single-dose Study to Evaluate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of Orally Administered SUVN-G3031 in Healthy Subjects

Conditions
-----------------
Cognitive Disorders

Intervention / Treatment
-----------------
* Drug: SUVN-G3031


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect Exclusion Criteria: History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Food Effect<br>SUVN-G3031 tablets single dose | Drug: SUVN-G3031<br> <br> |
| Active Comparator: Gender Effect<br>SUVN-G3031 tablets single dose | Drug: SUVN-G3031<br> <br> |
| Active Comparator: Age Effect<br>SUVN-G3031 tablets single dose | Drug: SUVN-G3031<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration (AUC) |  | 96 hours | 
| Maximum observed concentration (Cmax) |  | Day 1 |
Non-Invasive Chromosomal Evaluation of Trisomy Study

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.

Official Title
-----------------
Non-Invasive Chromosomal Evaluation of Trisomy Study

Conditions
-----------------
Aneuploidy, Trisomy 21, Trisomy 18, Trisomy 13, Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Subject is at least 18 years old and can provide informed consent; 2. Subject has a viable singleton or twin pregnancy; 3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw; 4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis. Exclusion Criteria: 1. Subject has known aneuploidy; 2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy; 3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent; 4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Euploid Subjects<br>Subject's with fetal euploidy confirmed by chromosome analysis | |
| Aneuploid Subjects<br>Subject's with fetal aneuploidy confirmed by chromosome analysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of aneuploidy |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneuploidy, Down Syndrome, amniocentesis, chronic villus sampling, Trisomy, non-invasive prenatal testing, Chromosome disorders