linjc16/ctgov huggingface dataset:
ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.

Official Title
-----------------
Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients With Advanced Mycosis Fungoides and Sézary Syndrome

Conditions
-----------------
Mycosis Fungoides, Non-Hodgkin's Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosis of advanced stage MF or SS (Stages IIB - IVB) within 6 months of presentation to the participating center Patients that are expected to have care administered at the participating center or jointly with referring physician(s) where follow-up data would be available Exclusion Criteria Patients diagnosed with early stage MF/SS (Stages IA-IIA) before progressing to advanced stage Patients diagnosed with advanced MF/SS more than 6 months prior to initial presentation to the participating center Exclude one-time consultation type of new patients.
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 |
| --- | --- | --- |
| Overall survival (OS) |  | date of diagnosis to death from any cause, up to two years |
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.

Official Title
-----------------
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Aerosolized iloprost
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IPAH > 3 months treatment with bosentan 6 minute walk distance 150 - 425 m Exclusion Criteria: other forms of pulmonary hypertension severe comorbidities cotreatment with sildenafil or investigational drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Aerosolized Iloprost<br> | Drug: Aerosolized iloprost<br> <br> |
| Placebo Comparator: Bosentan monotherapy<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic pulmonary arterial hypertension
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function

Study Overview
=================
Brief Summary
-----------------
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function

Official Title
-----------------
An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function

Conditions
-----------------
Pharmacokinetics, Renal Impaired, Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: LCZ696A
* Drug: LCZ696A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Renal Impaired Subjects<br>once daily administration of 400 mg LCZ696 for 5 days | Drug: LCZ696A<br> <br> |
| Experimental: Healthy Volunteers<br>once daily administration of 400 mg LCZ696 for 5 days | Drug: LCZ696A<br>* once daily administration of 400 mg LCZ696 for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |  | 1 and 5 days | 
| (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |  | 1 and 5 days | 
| AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |  | 1 and 5 days | 
| T1/2 After Multiple Dose Administration (Day 5) | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 | 5 days | 
| CL/F After Multiple Dose Administration (Day 5) | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 | 5 days | 
| CLr After Multiple Dose Administration (Day 5) | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LCZ696, pharmacokinetics
Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.

Conditions
-----------------
Subclavian Vein Catheterization

Intervention / Treatment
-----------------
* Procedure: position of shoulder retraction
* Procedure: position of neutral shoulder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization Exclusion Criteria: infection over the puncture site history of prior clavicular fracture anatomical anomaly of subclavian vein

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 82 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: neutral shoulder<br>neutral shoulder position during subclavian vein catheterization | Procedure: position of neutral shoulder<br>* neutral shoulder position during subclavian vein catheterization<br>|
| Experimental: shoulder retraction<br>position of shoulder retraction during subclavian vein catheterization | Procedure: position of shoulder retraction<br>* position of shoulder retraction by placing a saline bag between the scapula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheterization success rate | Subclavian vein catheterization will be performed after the induction of anesthesia and before the start of surgery. | immediately after catheterization (an expected average of 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| location of catheter tip | Postoperative chest X-ray will be taken to check for the location of catheter tip immediately after surgery. | an expected average of one day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subclavian vein catheterization success rate
A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

Study Overview
=================
Brief Summary
-----------------
To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.

Official Title
-----------------
A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

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

Intervention / Treatment
-----------------
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: HIV infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active opportunistic infection or neoplasm. High likelihood of death during study. Significant ophthalmologic, renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric,respiratory, or metabolic disease. Donation of > 1 unit blood or acute loss of blood within one month of study entry. Patients with the following prior conditions are excluded: History of opportunistic infection. Previous allergic reaction to ciprofloxacin, norfloxacin, or any other quinolone. Prior Medication: Excluded: Use of any investigational agent within 7 days of entry into study. Use of any medication within 3 days prior to entry (7 days for AZT). Alcohol or drug abuse.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levofloxacin|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
-----------------
Anti-Infective Agents, Quinolone, Ofloxacin, Acquired Immunodeficiency Syndrome
Hyperoxemia and Ventilator-associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence. SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia. Patients with VAP will be prospectively identified. Patient characteristics and risk factors for VAP will be prospectively collected. Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence. Patients with VAP will be compared with those with no VAP

Official Title
-----------------
Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia

Conditions
-----------------
Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients admitted to the ICU Expected duration of mechanical ventilation > 48h Signed informed consent Social insurance Exclusion Criteria: Pregnancy or breast feeding No informed consent Hyperbaric oxygen treatment Prisoners and patients under guardianship

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 |
| --- | --- | --- |
| VAP occurrence | hyperoxemia at ICU admission (PaO2 >120 mmHg) | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of time spent with hyperoxemia during ICU stay | hyperoxemia is defined as peripheral O2 saturation (SaO2)>98%, SaO2 will be measured every 30 seconds, and the percentage of time spent with hyperoxemia will be calculated per day. | 28 days after ICU admission | 
| relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI) | the presence of hyperoxemia at ICU admission will be determined using blood gazes (arterial PaO2>120 mmHg). The percentage of patients with hyperoxemia will be compared between patients with Ali, and those with no ALI | 28 days after ICU admission | 
| percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury | the percentage of time spent with hyperoxemia during ICU stay will be calculated as mentioned above (outcome 2). This percentage will be compared between patient with ALI and those with no ALI | 28 days after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperoxemia, ventilator-associated, pneumonia, critical illness
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.

Official Title
-----------------
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study

Conditions
-----------------
HIV

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include: Stable HAART with maintenance of plasma HIV RNA levels below level of detection (< 40-75 copies/mL) for ≥ 12 months > 90% adherence to HAART within preceding 30 days Exclusion Criteria include: Screening systolic blood pressure < 110mm Hg or diastolic blood pressure < 60mm Hg Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease Pregnant/breastfeeding women.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACE Inhibitor<br>Active group | Drug: Lisinopril<br>* Lisinopril 20mg QD x 24 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo group | Drug: Placebo<br>* Placebo QD x24wks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV RNA (Copies/Million Rectal Cells) | Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV DNA (Copies/Million Rectal Cells) | Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline | 22 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Lymphoid fibrosis
Application of Radiomics in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.

Official Title
-----------------
Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer

Conditions
-----------------
Breast Cancer, Ultrasound, Elastography, Pathology, Radiomics

Intervention / Treatment
-----------------
* Combination Product: Endocrine therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of breast cancer Exclusion Criteria: Missing pathology Missing follow-up results Missing data

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| disease free survival<br>Time from randomization to relapse or death due to disease progression | Combination Product: Endocrine therapy<br>* Endocrine therapy<br>|
| non-disease free survival<br>Time of metastasis or death | Combination Product: Endocrine therapy<br>* Endocrine therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metastasis | lymph node metastasis and/or distant metastasis | through study completion, an average of 1 year | 
| death | death | through study completion, an average of 1 year |
Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).

Detailed Description
-----------------
Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients. The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.

Official Title
-----------------
Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

Conditions
-----------------
Attitude to Computers

Intervention / Treatment
-----------------
* Device: EEG Recording (Emotiv)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers male or female aging over 18 Signed informed consent Passed the preliminary exam Registered in the national database for persons willing to participate in Biomedical research Exclusion Criteria: Visual or hearing problems Cognitive problems Illiterate persons Persons under Guardianship or Trusteeship Having Epilepsy Pregnant women Not covered by the social security system

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extraction of P300 ERPs<br>Extract P300 ERPs with Emotiv EEG headset | Device: EEG Recording (Emotiv)<br>* Record EEG during auditory oddball paradigms: with Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com) with 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm)<br>* Other names: EEG recording;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wilcoxon statistic (Area Under the Curve) | An Linear Discriminant Analysis (LDA) will be used to discriminate target and Algorithm performance (Wilcoxon statistic) for discrimination between occurrent and non-occurrent stimuli. Signals will adequately be pre-processed: denoised and spatialy filtered (xDAWN). The Area Under the Receiver Operator Characteristic Curve (AUC) also called wilcoxon statistic will be used to identify the signals of best quality. | T0+2h (end of each technique) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain computer interface, EEG recording, Electrodes