linjc16/ctgov huggingface dataset:
A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.

Official Title
-----------------
A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: anti-Abeta
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable AD according to the NINCDS-ADRDA Criteria Approved AD treatments (AchE inhibitors+/-memantine) must be stable for ≥ 3 months prior to screening Other prescription medications must be stable for ≥ 1 month prior to screening Exclusion Criteria: Female patients with reproductive potential History or presence of any clinically significant CNS disease History of treatment with any protein therapeutic targeting Abeta

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 86 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: anti-Abeta|Intravenous single and multiple doses|
|Drug: placebo|Intravenous single and multiple doses|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single and multiple doses of MABT5102A |  | Through study completion or early study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of MABT5102A after single and multiple doses |  | Through study completion or early study discontinuation | 
| Immunogenicity of MABT5102A after single and multiple doses |  | Through study completion or early study discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AD, Alzheimer's, Alzheimers
Low Implanted Second Trimester Placenta and Placenta Previa

Study Overview
=================
Brief Summary
-----------------
Placenta Previa is defined as a placenta implanted in the lower segment of the uterus, presenting ahead of the leading pole of the fetus (over or near the internal os). The prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies, and this increase correlates to the elevated cesarean section rate . In Egypt, the prevalence of placenta previa is around 1.3% in Sohag Governorate and 1.5% in Aswan region according to. Although various studies have tried to address risk factors associated with Placenta Previa development, the etiology of placenta previa still remains obscure. Several risk actors have been identified as strong contributors to placenta previa development. It is also a significant contributor to severe postpartum hemorrhage.Risk factors include; history of previous cesarean section, advanced maternal age, history of previous abortions, high parity and substance abuse during pregnancy (cigarette smoking), placental size (multiple pregnancy), endometrial damage (previous dilatation and curettage), uterine scars and pathology (previous myomectomy or endometritis), placental pathology (marginal cord insertions and succenturiate lobes), previous placental Previa, and curiously.

Official Title
-----------------
The Prediction of Risk Factors of Progression of Low Implanted Placenta at 18- 24 Weeks to Placenta Previa at Term

Conditions
-----------------
Placenta Previa

Intervention / Treatment
-----------------
* Radiation: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between 18-24 weeks. Diagnosed to have low implanted placenta by ultrasound Exclusion Criteria: Patient refused to follow-up in our setting. Patient refused to perform Trans-vaginal ultrasound in the second trimester of gestation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Low implanted placenta group<br> | Radiation: ultrasound<br>* to detect the placental site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distance between lower edge of the placenta and internal os by ultrasound (millimeter) |  | 12 weeks |
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil

Study Overview
=================
Brief Summary
-----------------
Durvalumab as maintenance in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real World Data from an Expanded Access Program in Brazil

Official Title
-----------------
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unresectable stage III NSCLC who completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression Patients who have participated in the Durvalumab EAP in Brazil and have received at least one dose of Durvalumab in the EAP..

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 |
| --- | --- | --- |
| Describe real world data on PFS of patients treated with Durvalumab in stage III NSCLC in the EAP in Brazil |  | June of 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Non-Small-Cell Lung
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.

Official Title
-----------------
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

Conditions
-----------------
Rotator Cuff Injury

Intervention / Treatment
-----------------
* Device: Baxter INFUSOR System
* Drug: Single Injection of Local Anesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form. Inclusive criteria are: 18-75 years of age ASA physical status I-III BMI < 35 kg/m2 Exclusion Criteria: all open shoulder procedures patient having difficulty understanding the instruction on using the anesthetic infusion pump contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy) significant neurologic disorders of the upper extremity psychiatric or cognitive disorders history of substance abuse or chronic opioid use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baxter INFUSOR System<br>Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia | Drug: Single Injection of Local Anesthetic<br>* Single injection of 20 ml ropivacaine 0.5%<br>|
| Active Comparator: Single Injection of Local Anesthetic<br>Single injection of 20 ml ropivacaine 0.5% | Device: Baxter INFUSOR System<br>* Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, shoulder arthroscopy, 24-week follow-up, rehabilitation achievement, rotator cuff repair
A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

Detailed Description
-----------------
Influenza vaccination is the primary method for preventing influenza and its severe complications. Previous clinical studies demonstrated that delivery of vaccines intradermally (into the skin) can achieve good efficacy even with lower doses of the vaccine. Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular needle.

Official Title
-----------------
A Pilot, Controlled, Comparative and Single Blinded Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines Administered Intradermally Using Microneedle Injectors as Compared With Standard Dose Intramuscular Flu Vaccines as Reference.

Conditions
-----------------
Influenza, Human

Intervention / Treatment
-----------------
* Biological: Flu Vaccine (FLUARIX®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed an Informed Consent No previous immune-related disease Important Exclusion Criteria: Significant illness within the previous 4 weeks Subjects who have received an influenza vaccine within the previous 6 months An active viral diseases Pregnant or nursing women Any known contraindication to the study vaccine or vaccine ingredients

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low dose flu vaccine delivered intradermally using microneedles | Biological: Flu Vaccine (FLUARIX®)<br>* Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula<br>|
| Experimental: 2<br>Medium dose flu vaccine delivered intradermally using microneedles | Biological: Flu Vaccine (FLUARIX®)<br>* Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula<br>|
| Active Comparator: 3<br>Standard dose flu vaccine delivered intramuscularly with a regular needle | Biological: Flu Vaccine (FLUARIX®)<br>* Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluate the Predictive Impact of the EHMRG

Study Overview
=================
Brief Summary
-----------------
External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

Detailed Description
-----------------
It is a prospective cohort study carried out in the ED of Monastir which included patients admitted to the ED with a discharge diagnosis of AHF.

Official Title
-----------------
Evaluate the Predictive Impact of the EHMRG Score for Patients Admitted to the Emergency Department With Final Diagnosis of Acute Heart Failure

Conditions
-----------------
Emergencies, Heart Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: EHMRGscore


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients consulted for acute dyspnea and were diagnosed with acute heart failure. Major patient. Subject who accept to participate in the research. Exclusion Criteria: Patient who refuse to participate in the study. Impossibility of giving the patient informed information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| EHMRGscore<br>validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department | Diagnostic Test: EHMRGscore<br>* validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EHMRGscore | The primary outcome of interest is the EHMRG predictive accuracy to prognosticate 7-day mortality was measured by the athe area under the receiver operating characteristic curver (AUROC) with 95% confidence intervals. | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-admission rate 30-day re-admission rate | 30day ré-admission rate | 30days | 
| Mortality rate Mortality rate at 30 days | Mortality rate at 30 days | 30day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EHMRGscore, ACUTE HEART FAILURE
Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description
-----------------
A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Official Title
-----------------
A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.

Conditions
-----------------
Anthracycline-pretreated Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female ≥ 18 years old ECOG 0-2 Exclusion Criteria: brain metastasis

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group:vinorelbine plus capecitabine<br> | |
| Control group:docetaxel plus capecitabine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RECIST 1.1 |  | -7 days |
Effects of Kinesiotape on Quadriceps and Hamstring Muscle Strength

Study Overview
=================
Brief Summary
-----------------
Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr Kenso Kase for prevention and treatment of sports injuries. Research shows that through activation of skin receptors KT improves blood and lymph flow, increases proprioception, helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function. Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its effectiveness in improving strength. Purpose: The purpose of the current study was to investigate the short-term effects of KT on muscle strength when applied to the quadriceps muscles of healthy subjects. Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four different sessions. The parameters of interest were: quadriceps and hamstrings maximal strength and power using vertical jump tests (squat jump and countermovement jump), and peak concentric and eccentric knee torque (using isokinetic test protocol).

Official Title
-----------------
Effects of Kinesiotape on Quadriceps and Hamstring Muscle Strength

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Kinesiotape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age allowed to perform jumps Exclusion Criteria: pregnancy history of cardio-vascular disease antecedents of lower extremity injuries use of any doping substances listed by the World Anti-doping Agency any contraindication to exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Kinesiotape<br> | Other: Kinesiotape<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical jump height change with different tapes |  | Week 1, week 2, week 3, and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic knee strength change with different tapes |  | Week 1, week 2, week 3, and week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Facilitating kinesiotape, Inhibiting kinesiotape, Classical tape, No tape
A Crossover Safety Study of Ferumoxytol Versus Placebo

Study Overview
=================
Brief Summary
-----------------
This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.

Detailed Description
-----------------
This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.

Official Title
-----------------
A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: ferumoxytol or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients > 18 years. Have chronic kidney disease per K/DOQI guidelines. Baseline hemoglobin of > 9.0 and < 12.5 g/dl Exclusion Criteria: Women who are pregnant or lactating. Received another investigational drug or device within 30 days. Recent parenteral or oral iron therapy. Patients that have other causes of anemia. Major surgery within 30 days or anticipated or planned surgery during the study. Patients with active infections. Recent blood transfusions. Patients with known allergies to iron products.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ferumoxytol or placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia