linjc16/ctgov huggingface dataset:
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire

Official Title
-----------------
An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: methotrexate prefilled pen
* Drug: methotrexate prefilled syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age between 18 and 75 years Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010 Disease activity score (DAS) 28 > 2.6 Main Exclusion Criteria: Prior or other current subcutaneous treatment with self-injection Prior or concomitant treatment with biologics Contraindications to MTX treatment History or diagnosis of a dermatological disease at the injection site Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: prefilled pen then prefilled syringe<br>weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks | Drug: methotrexate prefilled pen<br> <br> Drug: methotrexate prefilled syringe<br> <br> |
| Other: prefilled syringe then prefilled pen<br>weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks | Drug: methotrexate prefilled pen<br> <br> Drug: methotrexate prefilled syringe<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients preferring the MTX pre-filled pen to the pre-filled syringe |  | after 6 weeks of treatment |
Transfusions and Nitric Oxide Level in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants. The long term goal of the project is to identify variation in the SNO-Hb between packed red blood cell units, and between and among individual preterm infants pre and post-transfusion. Duke investigators are developing methods to replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical trial testing treated vs. untreated RBC transfusions in extremely premature infants. AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb [Fe] NO, SNO-Hb (a calculated value = (total Hb-NO - Hb [Fe] NO) in blood to be transfused in extremely preterm babies, and in samples pre and post- transfusion from the babies. Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm infants and will be decreased in the post-transfusion samples from the infants compared with the pre-transfusion samples. AIM 2. Collect clinical data about study participants, including oxygen saturation and measures of perfusion pre and post-transfusion. Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely preterm infants.

Official Title
-----------------
Transfusions and Nitric Oxide Level in Preterm Infants

Conditions
-----------------
Prematurity, Anemia, Necrotizing Enterocolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant < 28 weeks gestation at birth Undergoing PRBC transfusion with a volume ≥ 10 cc/kg Availability and willingness of the parent/legally authorized representative to provide written informed consent. Exclusion Criteria: Any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study Previous participation in the study.

Ages Eligible for Study
-----------------
Maximum Age: 365 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>< 28 weeks gestation, < 30 days of age, < 3 previous transfusions | |
| 2<br>< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOHgB Levels | levels were never run by the laboratory | beginning and end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. | data not appropriately collected for the analysis due to machine malfunctions. | prior to, during, after transfusion |
Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A controlled clinical study and prospective developed at the School of Physiotherapy Clinic / UFPI. Forty students were randomized into four distinct groups of the modulation frequency TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off), group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60 minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration of TENS application was 20 minutes and all protocols were performed in a single session. The analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify differences between experimental groups for each variable analyzed. The level of significance was p< 0,05.

Official Title
-----------------
Investigation of the Effectiveness of Different Modulations of Pulse Frequency Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Device: transcutaneous electrical nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be the first or second day of menstruation dysmenorrhea present at the time of application of TENS not having undergone any procedure analgesic six hours before the application of TENS Exclusion Criteria: not to mention dysmenorrhea at the time of evaluation pregnant women were using some method of hormonal contraception on an ongoing basis had sensory deficits or cognitive and cases of contraindication to TENS application.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 33 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: transcutaneous electrical nerve stimulation|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
-----------------
dysmenorrhea, transcutaneous electrical nerve stimulation (TENS, analgesia, pain visual analog scale, McGill pain questionnaire
High Frequency Jet Ventilation for Percutaneous Interventional Radiology

Study Overview
=================
Brief Summary
-----------------
Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation. The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.

Official Title
-----------------
High Frequency Jet Ventilation for Percutaneous Interventional Radiology

Conditions
-----------------
Percutaneous Tumor Ablation

Intervention / Treatment
-----------------
* Procedure: Jet ventilation group
* Procedure: Standard ventilation group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: use of percutaneous ablation tumor techniques (<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion Exclusion Criteria: Severe chronic obstructive pulmonary disease Recent pneumothorax (one month) Recent thoracic surgery (one month) Body Mass Index > 40

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jet ventilation/ group A<br>Frequency : 120-200/min Pressure : 1-2 bars Inspiratory fraction of oxygen : 100% and 50% if Expiratory pressure : 5 -10 cmH2O | Procedure: Jet ventilation group<br>* MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)<br>* Other names: Frequence: 120-200/min; Pressure: 1-2 bars; Inspiratory fraction of Oxgen: 50%; Expiratory pressure: 5-10 cmH2O;|
| Sham Comparator: Standard ventilation/ group B<br>Apnea made by the anesthesiologist to the request of the radiologist. | Procedure: Standard ventilation group<br>* apnea made by the anesthesiologist to the request of the radiologist<br>* Other names: apnea made by the anesthesiologist with Primus DRAGER Medical;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hit the target | Estimated the time for a puncture needle under High Frequency Jet Ventilation compared to the conventional mode of mechanical ventilation | during the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High frequency jet ventilation
Aminoglycosides and Duct

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms

Official Title
-----------------
The Effect of Aminoglycosides on Ductus in Preterm Infants

Conditions
-----------------
Patent Ductus Arteriosus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants born at or above 32 weeks of gestation - Exclusion Criteria: infants who are unlikely to survive or have congenital heart defects

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 3 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exposure to aminoglicosides<br>preterm receiving aminoglycosides | Diagnostic Test: echocardiography<br>* echocardiography exam of the infant<br>|
| non exposure to aminoglycosides<br>preterm not receiving aminoglycosides | Diagnostic Test: echocardiography<br>* echocardiography exam of the infant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ductal closure | closure of ductus arteriosus | 3 weeks |
Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.

Official Title
-----------------
A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol) Male or female patients at least 18 years of age at time of informed consent T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study Planned initiation with Tresiba® Exclusion Criteria: Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products Previous participation in this study (i.e. provision of informed consent) Patients who have previously been treated with Tresiba® Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

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 |
| --- | --- |
| Insulin degludec<br> | Drug: insulin degludec<br>* Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of any hypoglycaemic episodes |  | End of 4 week baseline period, end of 12 month observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c (glycosylated haemoglobin) |  | 0- 12 months | 
| Change from baseline in FPG (Fasting Plasma Glucose) |  | 0-12 months | 
| Change from the baseline period in the number of severe hypoglycaemic episodes |  | 0-12 months | 
| Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire )) |  | 0-12 months |
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.

Official Title
-----------------
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT+NAVH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted with a functioning SJM Quadripolar CRT Pacing System QRS duration > 140 ms Left bundle branch block documented Ability to provide informed consent for study participation Willing to comply with the study evaluation requirements At least 18 years of age Exclusion Criteria: CRT Pacing System implanted less than 1 week at time of enrollment CRT Pacing System implanted more than 24 months at time of enrollment CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms Resting ventricular rate >100 bpm Intrinsic PR interval > 300 ms Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator Women who are pregnant or who plan to become pregnant during the study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT+NAVH<br>Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings. | Device: CRT+NAVH<br>* Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis |  | 1 day |
Medtronic RevElution Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.

Official Title
-----------------
Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Polymer-free DES (Drug Eluting Stent)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery Must have evidence of ischemic heart disease Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent Target lesion(s) must be de novo lesion(s) in native coronary artery(ies) Exclusion Criteria: Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative History of a stroke or transient ischemic attack (TIA) within the prior 6 months Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months History of bleeding diathesis or coagulopathy or will refuse blood transfusions Concurrent medical condition with a life expectancy of less than 5 years Currently participating in an investigational drug or another device trial that has not completed the primary endpoint Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polymer-free DES (Drug Eluting Stent)<br> | Device: Polymer-free DES (Drug Eluting Stent)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography. |  | 9 months |