linjc16/ctgov huggingface dataset:
Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

Study Overview
=================
Brief Summary
-----------------
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Official Title
-----------------
A Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of Valsartan/Amlodipine 160/10 mg Versus Amlodipine 10 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Amlodipine 10 mg Monotherapy

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

Intervention / Treatment
-----------------
* Drug: valsartan/amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with uncomplicated, essential hypertension Exclusion Criteria: Severe hypertension History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Insulin dependent diabetes Allergy to certain medications used to treat high blood pressure Other protocol-defined exclusion criteria may apply.

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

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

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: valsartan/amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 8 weeks |  |  | 
| Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg after 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, high blood pressure, valsartan, amlodipine
Product Performance of a Toric Contact Lens

Study Overview
=================
Brief Summary
-----------------
Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

Official Title
-----------------
A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: SofLens DD Toric
* Device: Ciba Vision Focus Dailies Toric Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater Visual acuity (VA) correctable to 0.3 logMar or better (driving vision) Clear central cornea Exclusion Criteria: Systemic disease affecting ocular health Using systemic or topical medications Wears monovision or multifocal contact lenses Any grade 2 or greater slit lamp findings Adapted wearer of Ciba Focus Dailies Toric lens upon study entry

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SofLens DD Toric<br>Bausch & Lomb SofLens Daily Disposable Toric Contact Lens | Device: SofLens DD Toric<br>* daily disposable wear contact lens for 2 weeks<br>|
| Active Comparator: Ciba Vision Toric Lens<br>Ciba Vision Focus Dailies Toric Contact Lens | Device: Ciba Vision Focus Dailies Toric Contact Lens<br>* daily disposable wear contact lens for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and Complaints | 1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable. | Over-all follow-up visits for 2 week period | 
| Contact Lens High Contrast Visual Acuity | VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA. | Over-all follow-up visits, 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates | Over-all follow-up visits, 2 weeks |
Use of nMoABs for the Treatment of COVID-19 in Patients With HM.

Study Overview
=================
Brief Summary
-----------------
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.

Detailed Description
-----------------
This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.

Official Title
-----------------
Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)

Conditions
-----------------
Covid19, Hematological Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must meet all the following criteria for study entry: Age equal to or greater than 18 years of age. Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status. Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021 Treatment with anti SARS CoV 2 nMoAbs approved by AIFA Not hospitalized for COVID-19 at the time of nMoAbs administration Not on oxygen therapy at the time of nMoAbs administration At least one of the following symptoms for no more than 10 days: Fever Cough Anosmia Ageusia / dysgeusia Pharyngodynia Asthenia Headache Nausea Diarrhea Myalgia Dyspnea Tachypnea Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable). Exclusion Criteria: 1. Hematological diseases, other than HM. 2. Not tested positive for SARS-CoV-2 3. Patients in disease remission off therapy for more than 6 months 4. Immune plasma treatment in the previous two 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to SARS-nCov-2 test negativization | To assess the efficacy of nMoAbs in infected HM patients compared to the historical control | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neutralizing Monoclonal Antibodies
Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of this double blinded study is to assess the abilities of the SpineNav3DTM technology (Accuro) to identify the lumbar epidural space in parturients using as comparator a standar ultrasound (US) device.

Detailed Description
-----------------
SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. Assuming a Type I error rate of 5% (α = 0.05) and a Type II error rate of 20% (β=0.2), a minimum of 76 subjects will be required. All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two anesthesiologist, one expert in UD and the other a novice, previously instructed to the use of the Accuro device. All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. The expert operator will assess the lumbar spine by using both the devices (standard US and Accuro) while the novice will use only the Accuro. The primary end-point of the study will be the accuracy of the Accuro to determine the depth of the epidural space using a midline approach using as comparator the measurement obtained with the standard ultrasound device performed by the expert operator.

Official Title
-----------------
Accuracy of Real Time 3D Navigation Device to Identify Lumbar Epidural Spacy in Pregnant Patients. A Comparison With Standard Ultrasound.

Conditions
-----------------
Ultrasound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women undergoing antenatal anesthetic consultation Exclusion Criteria: -

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidural space depth | measurement of the depth of the epidural space | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidural block, ultrasound
Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen

Study Overview
=================
Brief Summary
-----------------
Objective: Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy. Question: Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?

Official Title
-----------------
Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.

Conditions
-----------------
Very Low Birth Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on Campus Charité Mitte or Charité Virchow - Klinikum. Neonates (calculated date of birth + 4 weeks) Exclusion criteria: Birth weight > 1500g

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 4 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br>Neonates with very low birth weight and surgery therapy of acute abdomen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Capillary Leakage | Postoperative Capillary Leakage (defined as weight gain within 48 hours or development of oedema within 48 hours) | 48 hours from Baseline (Operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of transfusions during surgery |  | Up to 5 hours | 
| Re-surgery rate |  | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | 
| Length of stay |  | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | 
| Mortality |  | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Capillary leakage, Acute Abdomen, Low birth weight
Chemoradiotherapy of NSCLC Stage IIIB

Study Overview
=================
Brief Summary
-----------------
To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Detailed Description
-----------------
Chemotherapy: C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m² Radiotherapy: 66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)

Official Title
-----------------
Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

Conditions
-----------------
NSCLC Stage IIIB, Concomitant Radiochemotherapy

Intervention / Treatment
-----------------
* Drug: Paclitaxel, vinorelbine, cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural PS = 0 or 1 Possibility of including all the targets in only one exposure field Slimming < 10% of the weight of the body Functions hepatic, renal and hematologic normal VEMS >40% and PaO2 >60 mmHg written and signed informed consent Exclusion criteria : - NSCLC stage IV or wet-IIIB

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel, vinorelbine, cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Time to progression |  |  | 
| Relapse rate (local control) |  |  | 
| Safety |  |  |
Counterpulsation Reduces Infarct Size Pre-PCI for AMI

Study Overview
=================
Brief Summary
-----------------
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

Detailed Description
-----------------
Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.

Official Title
-----------------
A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI

Conditions
-----------------
Acute Myocardial Infarction (AMI)

Intervention / Treatment
-----------------
* Device: Counterpulsation with IAB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand and sign an ICF ≥ 18 and ≤ 90 years of age General good health, in the opinion of the investigator ST elevation of 2mm in 2 contiguous anterior leads or ≥ 4mm total in anterior leads Scheduled for PCI < 6 hours from onset of symptoms of MI Exclusion Criteria: Known contraindication to MRI Prior thrombolytic therapy during the index event Known history of MI Known severe aortic insufficiency Known aortic aneurysm Known severe calcific aorta-iliac disease or peripheral vascular disease Experiencing cardiac shock Known end-stage renal disease Weight >400 lbs. or height <4 ft.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm of study<br> | Device: Counterpulsation with IAB<br>* IABC pre-reperfusion PCI<br>* Other names: CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. |  | 3-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of IABC before mechanical reperfusion on post PCI cardiovascular function and major adverse cardiac events (MACE) (ie, death, reinfarction, and CHF) at 30 days and 6 months. |  | 30 days and 6 months post randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IABC, AMI
Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

Study Overview
=================
Brief Summary
-----------------
CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis. This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery. The resection specimen will be compared to the preoperative imaging.

Official Title
-----------------
The Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis With Histological Examination of the Resected Specimen

Conditions
-----------------
Carcinoma, Non Small Cell Lung

Intervention / Treatment
-----------------
* Procedure: CT-scan, PET-scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery. Exclusion Criteria: age < 18 years pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CT-scan, PET-scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological validation of CT-PET image fusion. |  |  |
A Study of LY2181308 in Patients With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.

Official Title
-----------------
An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: LY2181308


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with hepatocellular cancer Discontinued all previous therapies At least 18 years of age Exclusion Criteria: Have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization. Transplanted liver HIV positive More than 2 previous systemic chemotherapy treatments

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: LY2181308<br>* Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation) Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Determine recommended dose |  | every cycle | 
| Phase 2: Time to progression |  | baseline to measured progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Safety |  | every cycle | 
| Phase 2: Overall Survival |  | Baseline to date of death from any cause | 
| Phase 2: Response rate |  | Baseline to measured PD | 
| Phase 2: Pharmacokinetics |  | Cycle 1 and Cycle 2 | 
| Phase 2: Safety |  | every cycle |