linjc16/ctgov huggingface dataset:
Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan

Study Overview
=================
Brief Summary
-----------------
This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting. Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first. The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.

Official Title
-----------------
Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment. Exclusion Criteria: None

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 |
| --- | --- |
| Raltegravir group<br>This study will include subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment. A control group will be used for the evaluation of the primary and secondary objectives in comparison to patients treated with raltegravir (study patients). The control group will be constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV co-infection status yes/no). For control patients, the last antiretroviral regimen prescribed will be considered. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-Life | Primary endpoint is the proportion of patients with HIV-1 RNA<50 copies/ml at weeks 48 after treatment initiation (baseline). | baseline and week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-Life | Secondary endpoints are: Proportion of patients with HIV-1 RNA<50 copies/ml at the end of the treatment/last available visit Proportion of patients with HIV-1 RNA<400 copies/ml at week 48 Increase in absolute CD4 cell count from baseline Frequency of side effects associated with raltegravir treatment Frequency of reasons for starting/stopping raltegravir treatment | baseline and week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Raltegravir, efficacy, safety, raltegravir-containing regimens, HIV urban clinic setting
12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)

Study Overview
=================
Brief Summary
-----------------
This study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Arthritis, Rheumatoid, Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0782


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition Must be willing to limit alcohol use to no more than 2 drinks per day Avoid strenuous physical activity Exclusion Criteria: Mentally or legally incapacitated Has systemic lupus erythematosus, Paget's disease Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying Has uncontrolled hypertension Has uncontrolled diabetes Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months Has congestive heart failure Has had active liver disease within the last 2 years

Ages Eligible for Study
-----------------
Minimum Age: 45 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: MK0782|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio 1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the lateral decubitus position.

Detailed Description
-----------------
Increasing inspiratory time(e.g. Inverse ratio ventilation) has been known that had advantage of alveolar recruitment, preventing of ateletasis. On the contrary, it has disadvantange of intrinsic PEEP, air trapping. There is few study on one lung ventilation in lateral decubitus position about this ventilation method. We were going to investigate effecf of this ventilation method.

Official Title
-----------------
Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position

Conditions
-----------------
Lung Cancer, Lung Lobectomy

Intervention / Treatment
-----------------
* Procedure: I:E ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status class I, II Use of Double lumen tube Unilateral lung lobectomy Exclusion Criteria: COPD CAOD Unstable hemodynamic status Peak airway pressure > 30mmHg (Two lung ventilation)

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I:E ratio 1:1<br> | Procedure: I:E ratio<br>* I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intrapulmonary shunt fraction | T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt | T1 (10min before one lung ventibation)T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started)T4 (10min after two lung ventilation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory dynamic parameters | Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance | T1,T2,T3,T4 (same as primary outcome measure) |
Post Authorisation Safety Study With Raxone in LHON Patients

Study Overview
=================
Brief Summary
-----------------
This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®. No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.

Official Title
-----------------
A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)

Conditions
-----------------
Leber's Hereditary Optic Neuropathy (LHON)

Intervention / Treatment
-----------------
* Drug: Idebenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient prescribed Raxone® for the treatment of LHON; Patient has completed an Informed Consent Form (ICF) indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study and has agreed to participate in the study; Patient is not participating in any interventional study. Exclusion Criteria: No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.
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 who are treated with Raxone®<br> | Drug: Idebenone<br>* Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.<br>* Other names: Raxone®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care. | Safety will be assessed by the collection and analysis of adverse events of special interest (AESIs), frequency and nature of AEs and serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs) | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care | According to the Summary of Product Characteristics (SmPC) a patient's vision should be continually monitored therefore effectiveness will be assessed by measuring on-therapy changes in patients' visual acuity (VA), visual fields (VF), colour contrast sensitivity and Retinal Nerve Fibre Layer thickness (RNFL) where available. | up to 5 years |
Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

Detailed Description
-----------------
Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Official Title
-----------------
Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI): an Observational Study

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years Suspension laryngoscopy for diagnostic or therapeutic purposes Total intravenous anesthesia using propofol and remifentanil Exclusion Criteria: age <18 yrs or >75 yrs arrythmia administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes psychiatric diseases autonomic nervous system disorders (epilepsy)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes |  | Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia/nociception index, Bispectral index, Propofol, Remifentanil, Suspension laryngoscopy, Endoscopy, Ear-nose-throat
ICD Shock Detection by a Wearable

Study Overview
=================
Brief Summary
-----------------
Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD

Detailed Description
-----------------
Non-invasive, pain-free clinical evaluation of a wearable/proximity sensor designed to detect a high voltage therapeutic shock received by a patient from their Implantable Cardioverter Defibrillator (ICD) during defibrillation threshold testing (DFT), which is a routine part of the clinical procedure.

Official Title
-----------------
Clinical Evaluation of the LOIS Smartband in Patients Undergoing Elective ICD Implantation With Defibrillation (DFT) Threshold Testing.

Conditions
-----------------
Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest

Intervention / Treatment
-----------------
* Device: Device Wearers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable of understanding procedure and making informed consent Listed for elective ICD Implant Having routine DFT as part of elective ICD implantation Exclusion Criteria: Not indicated for ICD implant Incapable of making informed consent Pregnant Not on stabilised anti-coagulation

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICD Defibrillation<br>Detection of ICD shock during elective ICD implant using the investigational device | Device: Device Wearers<br>* The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of investigational device at detecting ICD shocks | The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, Defibrillator
BIOBANK Renal Transplantation University Hospitals Leuven

Study Overview
=================
Brief Summary
-----------------
This study aims to maintain a prospective biobank of human samples obtained from donors and recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine samples.

Detailed Description
-----------------
Clinical data and bio-specimens are prospectively collected and stored for undefined future translational research projects.

Official Title
-----------------
Biobank Renal Transplantation University Hospitals Leuven

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal transplant recipients/donors Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| renal allograft donors and recipients<br>All de novo renal allograft recipients transplanted at the University Hospitals Leuven | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal allograft survival |  | 50 years after transplantation |
Value of Prothrombin Fragment F1+2 in the Diagnosis of Pulmonary Embolism in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Study Overview
=================
Brief Summary
-----------------
To access the clinical usefulness of F1+2 in the diagnosis of PE in patients with AECOPD who require hospitalization. Specifically, to determine whether F1+2 may have an additional value in the subgroup of patients with an abnormal D-dimer,to determine whether it may increase the proportion of patients in whom PE can be safely ruled out and to determine the sensitivity, specificity and NPV of F1+2 at various cut-off values.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: CT pulmonary angio, blood tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD exacerbation Able to give informed consent Able to perform spirometry Exclusion Criteria: Known malignancy Known hypercoagulable state Receiving anticoagulant treatment Pregnancy Renal failure Allergy to iodine

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 |
| --- | --- |
| COPD Exacerbation<br>Patients admitted to hospital with COPD exacerbation | Other: CT pulmonary angio, blood tests<br>* CT pulmonary angiography to determine PE and laboratory blood tests to determine prothrombin fragments F1+2 in blood of COPD patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value of Prothrombin Fragment F1+2 | Blood test to determine predictive value of Prothrombin Fragment F1+2 in PE diagnosis in hospitalized COPD patients | Six months |
Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal

Study Overview
=================
Brief Summary
-----------------
There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. It has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. Blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. This primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. Secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Drug: pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pravastatin|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
-----------------
endothelial dysfunction