linjc16/ctgov huggingface dataset:
The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.

Official Title
-----------------
The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD stage II-III GOLD At least 2 exacerbations in the previous 2-12 months Exclusion Criteria: Acute exacerbations in the 2 months prior to enrolment Diagnosis of asthma and/or other relevant lung diseases COPD stage IV Unstable concurrent diseases

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erdosteine<br>600 mg/day for 12 months | Drug: Erdosteine<br>* One 300 mg capsule twice a day<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 months | Drug: Placebo<br>* One capsule twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of acute exacerbations |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spirometry parameters |  | 12 months | 
| COPD symptoms |  | 12 months | 
| Quality of life |  | 12 months | 
| Safety and tolerability of erdosteine |  | 12 months |
Early Access Program of Lazertinib in Republic of Korea

Study Overview
=================
Brief Summary
-----------------
This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs Therapy.

Detailed Description
-----------------
Lazertinib is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. This is a Multi-center, Prospective, Early Access Program of Lazertinib in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with T790M mutation-positive after 1st/2nd generation EGFR TKIs therapy to assess the safety and efficacy of real world evidence as second-line treatment.

Official Title
-----------------
Multi-center, Prospective, Early Access Program of Lazertinib in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients With T790M Mutation-positive After 1st/2nd Generation EGFR TKIs Therapy to Assess the Safety and Efficacy of Real World Evidence.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Lazertinib 240 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged at least 19 years Patients who have written consent for use of personal and medical information for the study purpose Patients who are prescribed and administered with approved indication for Lazerinib in Korea and not been treated with Lazertinib previously. Exclusion Criteria: Patients with hypersensitivity to Lazertinib or its any ingredients Patients who belong to contraindication listed on lazertinib label in Korea Patients who are treated for an indication not approved for the use of Lazertinib Women who are pregnant or may possibly become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lazertinib 240 mg|The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
APAP +/- Oxycodone

Study Overview
=================
Brief Summary
-----------------
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

Official Title
-----------------
A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Oxycodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity Exclusion Criteria: Use of an non-steroidal anti-inflammatory drug within the previous six hours Use of acetaminophen within the previous six hours Use of an opioid within the previous ten days Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain Gout

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: Acetaminophen<br>Acetaminophen alone | Drug: Acetaminophen<br>* Acetaminophen 650mg<br>|
| Active Comparator: Oxycodone/ acetaminophen<br>Oxycodone + acetaminophen | Drug: Acetaminophen<br>* Acetaminophen 650mg<br>Drug: Oxycodone<br>* Oxycodone 10mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment with numeric rating scale (NRS). | The Numeric Rating Scale (NRS) for evaluating pain. The rating is verbal, and the subject is asked to estimate current pain intensity on an 11-point scale, where 0 indicates no pain at all and 10 the worst imaginable pain. | 2 hours | 
| Pain assessment with four-item ordinal scale | The rating is verbal and the subject is asked to describe their pain using descriptors (1)severe, (2)moderate, (3)mild or (4)none | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of analgesia | This is a single question: Did the medication we gave you control your pain? Answer choices: Yes (it did); No (It did not); and Not sure | 2 hours |
Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.

Official Title
-----------------
Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial

Conditions
-----------------
Intraoperative Hypotension

Intervention / Treatment
-----------------
* Drug: Remimazolam
* Drug: Balanced Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo elective extracranial-intracranial bypass surgery American Society of Anesthesiologists grade 1,2,3 Age > 18 years old Exclusion Criteria: Refuse to participate to the study American Society of Anesthesiologists grade 4 Body Mass Index < 18.5 kg/m2 or > 35 kg/m2 Allergic history of benzodiazepine Pregnant Acute narrow-angle glaucoma Shock or Coma Acute alcohol addicted Obstructive sleep apnea dependency on alcohol or drug Severe acute respiratory insufficiency Hypersensitivity to Dextran 40

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remimazolam group<br>General anesthesia is induced and maintained with remimazolam. | Drug: Remimazolam<br>* Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h<br>|
| Active Comparator: balanced group<br>General anesthesia is induced with propofol and maintained with desflurane. | Drug: Balanced Anesthesia<br>* Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hypotension | Target Systolic Blood Pressure < 80% | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inotropic requirements | Dose of inotropics administered during surgery | During surgery | 
| Incidence of bradycardia | heart rate < 40 /min | During surgery | 
| Incidence of tachycardia | heart rate > 100 /min | During surgery | 
| Maximum systolic blood pressure | Maximal systolic blood pressure during surgery (mmHg) | During surgery | 
| Minimum systolic blood pressure | Minimal systolic blood pressure during surgery (mmHg) | During surgery | 
| Brain relaxation score | 1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain | Immediately after dura opening |
In-line Filters on ICU

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.

Conditions
-----------------
Micropore Filters

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients Exclusion Criteria: Younger than 18 years

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 |
| --- | --- |
| 0.2/1.2 microliter filter<br>Use of 0.2/1.2 microliter filters for intravenous drug administration | |
| 5 mircroliter filter<br>Use of 5 microliter filters for intravenous drug administration | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe vasoplegia |  | participants will be followed for the duration of intensive care unit stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ dysfunction | Severity of organdysfunction (SOFA-Score), incidence and severity of respiratory failure (Horovitz- Index), incidence and severity of acute kidney failure (RIFLE criteria), incidence and severity of delirium | participants will be followed for the duration of intensive care unit stay, an expected average of 1 week | 
| Inflammation | Interleukin-6 | participants will be followed for the duration of intensive care unit stay, an expected average of 1 week | 
| Duration of ICU and hospital stay |  | participants will be followed for the duration of intensive care unit/ hospital stay, an expected average of 1 or 4 week (s), respectively | 
| In-hospital mortality |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Morbidity | Incidence of preoperative myocardial infarction, stroke, pneumonia, sepsis and acute kidney failure according to routine documentation | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Treatment of Acute Myeloblastic Leukemia in Younger Patients

Study Overview
=================
Brief Summary
-----------------
study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.

Detailed Description
-----------------
The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.

Official Title
-----------------
Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

Conditions
-----------------
Acute Myeloblastic Leukemia

Intervention / Treatment
-----------------
* Drug: chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age< or =65 years. ECOG<=3. AML of new diagnose. Consent for chemotherapy.

Ages Eligible for Study
-----------------
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chemotherapy|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
-----------------
Acute Myeloblastic Leukemia
Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure the blood levels of the medicine called ropivacaine (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not the subject of this study, but the investigators are studying how much of the drug can be found in the patient's blood, known as the blood level, of this medicine. Too much ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve catheter is removed, local anesthetic toxicity is no longer a potential problem. However, there is little data on what ropivacaine blood levels are after having the catheter in for a long period of time(up to one month).

Official Title
-----------------
Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy Written informed consent must be obtained from each patient prior to entering the study Patients must be scheduled to receive a continuous peripheral nerve catheter Exclusion Criteria: Refusal to have serial blood drawn Contraindication for a continuous peripheral nerve catheter (allergy to local anesthetic, infection at site of injection, elevated coagulation times (international normalized ratio (INR)>1.5, partial thromboplastin time (PTT)>38; these values are drawn as part of routine standard of care and those values will be checked prior to initial catheter insertion), therapeutic dosing of anticoagulation medication, moderate to severe head injury and moderate to severe traumatic brain injury Patients with a hematocrit < 20. Complete Blood Counts (CBCs) are drawn as part of routine standard of care and will be followed by the Acute Pain Service. Although the CBCs and ropivacaine blood draws will not always coincide, we will always check the last hematocrit obtained prior to our blood draw Severe liver or renal disease (values greater than two times normal range)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Plasma Ropivicaine Levels | Blood will be drawn every 0, 3, 5, 7, and 10 days. Blood is drawn every 3 days thereafter. | up to 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ropivacaine Level, continuous peripheral nerve blocks.
Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
The investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.

Detailed Description
-----------------
The investigators perform an observational study in patients undergoing pulmonary vein ablation to treat atrial fibrillation. Additionally, electrophysiological procedures not related to pulmonary vein isolation are also followed. The aim of the study is finding biomarkers that are able to predict short-term outcome of the procedure.The primary endpoint is defined as reoccurrences of atrial fibrillation within the first three months after pulmonary vein isolation.

Official Title
-----------------
A Single-center Observational Study to Find Biomarkers for the Outcome of Catheter Ablation in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Catheter Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon patients scheduled for an electrophysiological study without ablation patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter Exclusion Criteria: patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus Acute myocardial infarction, coronary artery bypass graft surgery or open heart surgery within less than 3 months prior to inclusion

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 |
| --- | --- |
| Atrial fibrillation ablation group<br>Patients undergoing catheter ablation for the treatment of atrial fibrillation. | Procedure: Catheter Ablation<br> <br> |
| Electrophysiological study group<br>Patients undergoing a diagnostic electrophysiological study without ablation. | |
| Atrial flutter ablation group<br>Patients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus. | Procedure: Catheter Ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with short term reoccurrences of atrial fibrillation after ablation. | Holter ECGs and ECGs after atrial fibrillation ablation | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate after pulmonary vein isolation | Heart rates are recorded at admission and release from the hospital. | 3 days. |
Effect of Skanlab Regarding Knee Arthrosis

Study Overview
=================
Brief Summary
-----------------
The purpose is to find out the effect of Skanlab at knee arthrosis.

Detailed Description
-----------------
The patients diagnosed with knee arthrosis will be treated With Skanlab twice a week for four weeks.

Official Title
-----------------
Effect of Skanlab Regarding Knee Arthrosis

Conditions
-----------------
Arthrosis

Intervention / Treatment
-----------------
* Other: Skanlab bodywave


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee arthrosis in one or both legs Exclusion Criteria: Pacemaker infusion pump cancer diabetes pregnancy blood clots bacteriological inflammation reduced sensitivity in the treatment area.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment with Skanlab Bodywave<br>Treatment with Skanlab Bodywave twice a week for four weeks at the affected knee. | Other: Skanlab bodywave<br>* The intervention will be done twice a week<br>|
| No Intervention: No treatment<br>Treatment with Skanlab Bodywave without function twice a week for four weeks. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | changes in pain | 15 months |