linjc16/ctgov huggingface dataset:
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

Study Overview
=================
Brief Summary
-----------------
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.

Official Title
-----------------
AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Macitentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent prior to any study-mandated procedure. Patients with PAH who completed study AC-055-401 Women of childbearing potential must: Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests. Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation. Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-055-401 Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study Known hypersensitivity to macitentan or its excipients or drugs of the same class

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macitentan<br>Macitentan tablet, dose of 10 mg, once daily. | Drug: Macitentan<br>* Macitentan tablet, dose of 10 mg, once daily.<br>* Other names: ACT-064992;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident Rate of Adverse Events (AEs). | Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit. | From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Arterial Hypertension (PAH), psychometric instrument, PAH-SYMPACT
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.

Official Title
-----------------
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Tenofovir + emtricitabine + efavirenz
* Drug: Tenofovir + emtricitabine + lopinavir/ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HIV-1 infection Age 18 or above Antiretroviral-naive Criteria for antiretroviral therapy in accordance with current guidelines Plasma LDL-cholesterol below 190 mg/dL Not receiving lipid-lowering agents Written informed consent Exclusion Criteria: Use of phytosterol-enriched food previous month. Pregnancy or breastfeeding Cardiovascular disease Secondary Hypercholesterolemia Plasma creatinine above 1,2 mg/dL) Aminotransferases above 5 times ULN Current treatment for hepatitis C coinfection Diabetes mellitus (fasting glycemia > 124 mg/dL) Illegal drug use or alcohol abuse Active AIDS-defining opportunistic disease

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 |
| --- | --- |
| Active Comparator: 1<br>Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) | Drug: Tenofovir + emtricitabine + efavirenz<br>* Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily<br>|
| Active Comparator: 2<br>Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV) | Drug: Tenofovir + emtricitabine + lopinavir/ritonavir<br>* Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total cholesterol and HDL and LDL fractions |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Naïve
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

Study Overview
=================
Brief Summary
-----------------
To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).

Detailed Description
-----------------
Please see above.

Official Title
-----------------
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

Conditions
-----------------
Corneal Dystrophies, Hereditary

Intervention / Treatment
-----------------
* Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal endothelial disorders Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Intervention arm DSEK<br>Intervention: DSEK | Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)<br> <br> * Other names: Please see www.niios.com;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle corrected visual acuity |  | 1998 - 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cell density |  | 1998-2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal transplantation, Descemet membrane, endothelium
Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies

Study Overview
=================
Brief Summary
-----------------
Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.

Detailed Description
-----------------
Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety. in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test. Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.

Official Title
-----------------
Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: Information sheet
* Other: No information sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms. Exclusion Criteria: inability to complete the questionnaire due to mental disorders patients who had undergone Urodynamic study previously

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Information sheet, Applied<br>In this group, all patients will receive the information sheet one month before the procedure | Other: Information sheet<br> <br> |
| Information sheet, not applied<br>In this group, patients will not receive a pre-procedural information sheet | Other: No information sheet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Anxiety Inventory | Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress. The SAI is a validated questionnaire composed of 20-items measures of anxiety (e.g. ''I am anxious''). Respondents will be requested to rate their endorsement of each item on a four-point scale. | 10 minutes before the test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Urodynamics
Immune Resolution After Staphylococcus Aureus Bacteremia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia. We hypothesize that patients with prior immune dysfunction will have greater reductions in HLA-DR and other markers of immune function after an episode of sepsis than people who do not have prior immune dysfunction.

Conditions
-----------------
Immune Response To Sepsis, Staphylococcus Aureus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one blood culture positive for S. aureus Patients aged ≥18 years At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are: Body temperature less than 36°C(96.8°F) or greater than 38°C(100.4°F) Heart rate greater than 90 beats per minute Tachypnea (high respiratory rate), with greater than 20 breaths per minute; or, an arterial partial pressure of carbon dioxide less than 32 mmHg WBC less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L); or the presence of greater than 10% immature neutrophils (band forms) Exclusion Criteria: Sequential Organ Failure Assessment (SOFA) score > 12 on day of positive blood cultures Survival expected to be < 7 days from positive blood cultures

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 |
| --- | --- |
| Immunosuppressed<br>Immunosuppressed includes patients with any one of the following: a diagnosis of a hematological malignancy a diagnosis of HIV myelosuppressive chemotherapy in the previous 90 days immune-modulating medications in the previous 90 days | |
| Non-Immunosuppressed<br>Subject does not fit immunosuppressed criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HLA-DR and cytokines | Percent expression of HLA-DR on monocytes will be measured by flow cytometry. Cytokine levels will be measured by ELISA. | 0-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Infections |  | 0-90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunosuppressed, Sepsis, Staphylococcus Aureus, Bacteremia, HLA-DR
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients

Study Overview
=================
Brief Summary
-----------------
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.

Official Title
-----------------
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients

Conditions
-----------------
Fontan Procedure

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults who have Fontan repair of single ventricle Exclusion Criteria: Persons with the following history, conditions, or behavior will be excluded Active protein losing enteropathy within the past three years Congestive heart failure Active arrhythmias Taking Coumadin (Warfarin) Bleeding disorder Known esophageal varicies Consuming more than 10 alcoholic drinks per week. Pregnant Planning to become pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: aspirin<br>650 mg. Twice a day for 8 weeks | Drug: Aspirin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol | Change will be measured from baseline to retest after 8 weeks of treatment | 8 weeks | 
| Change in HDL (High-Density Lipoprotein)-Cholesterol | Change will be measured from baseline to retest after 8 weeks of treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Sensitivity CRP(C-Reactive Protein) | Change will be measured from baseline to retest after 8 weeks of treatment | 8 weeks | 
| Quality of Life | The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status. | 8 weeks |
A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).

Study Overview
=================
Brief Summary
-----------------
The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.

Official Title
-----------------
An Open Label Non-Comparative Study of the Safety and Efficacy of Intravenous Anidulafungin Plus AmBisome® [(Amphotericin B) Liposome for Injection] as a Treatment for Invasive Aspergillosis.

Conditions
-----------------
Aspergillosis

Intervention / Treatment
-----------------
* Drug: Anidulafungin, VER002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA Life expectancy: greater than 72 hours Exclusion Criteria: Pregnant female Hypersensitivity to anidulafungin or echinocandin therapy Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk. Aspergilloma-in the absence of invasive disease Abnormal blood chemistries: Bilirubin > 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)> 5 times the upper limit of normal Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable. Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anidulafungin, VER002|nan|

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
-----------------
Invasive Aspergillosis
Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.

Detailed Description
-----------------
Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen.

Official Title
-----------------
Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

Conditions
-----------------
Metastatic Melanoma, Nausea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis metastatic melanoma 18 years and older undergoing chemotherapy with Dartmouth regimen medically stable to receive chemotherapy per physical and clinical laboratory tests Exclusion Criteria: No medical conditions that interfere with assessment of nausea and vomiting during chemotherapy No cognitive disorder that impairs symptom assessment No other investigational agent Inability to swallow medications for nausea and vomiting No gastric outlet obstruction

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 |
| --- | --- |
| A<br>Metastatic melanoma treatment with Dartmouth regimen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma |  | Week of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients |  | week of treatment |