linjc16/ctgov huggingface dataset:
Therapy Optimization in Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.

Official Title
-----------------
TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years of age or older, with a diagnosis of MS. Being treated with Glatiramer Acetate (GA) or (IFN)-β Receiving therapy from a participating Specialty Pharmacy Exclusion Criteria: Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study Has received an experimental drug in the last thirty (30) days other than Fampridine SR (4-aminopyridine or 4-AP) Unlikely to be able to participate for the full two years of 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated MS Subjects<br>Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies | Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b<br>* MS therapies (listed above) used according to prescribers' instructions.<br>* Other names: Betaseron®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes |  | 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes |  | 12 months and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Specialty Pharmacy, Therapy Management, Medication Compliance, Medication Adherence, Medication Persistence, Health Outcomes
Lung Ultrasound to Diagnose COVID-19

Study Overview
=================
Brief Summary
-----------------
Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. During the COVID-19 pandemic, the use of this tool could be of interest in order to allow an early, simple and reliable triage in patients with suspected COVID-19 infection admitted in ER. In addition, the visualization of early signs in specific areas could be a predictive marker of the severity of the disease. The objective of this project will be to study the association between the signs on lung ultrasound and the result of RT-PCR in patients with suspected COVID-19 infection in the ER.

Official Title
-----------------
Use of Lung Ultrasound in Patients Suspected of COVID-19 Infection in the Emergency Room

Conditions
-----------------
Covid-19, Lung Ultrasound, Respiratory Complication

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 RT-PCR
* Procedure: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to Emergency Room for suspicion of COVID-19 infection with has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound Exclusion Criteria: patients < 18 years of age or under guardianship or curators, pregnancy poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.) patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ARDS)) chronic interstitial lung disease patients who will refuse to give their consent.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: COVID-19 RT-PCR|Polymerase chain reaction tests after reverse transcription for the detection of viral Covid-19 RNA (RT-PCR)|
|Procedure: lung ultrasound|lung ultrasound is standard practice to diagnose acute respiratory failure in Emergency room|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung ultrasound/biological correlation research modulating the severity of Covid-19 disease | Polymerase chain reaction tests after reverse transcription for the detection of covid-19 viral RNA will be done as biological test. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, lung ultrasound, Respiratory Complication
Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety

Official Title
-----------------
A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with moderate to severe Crohn's Disease. Failed prior infliximab therapy. Patient is judged to be in generally good health as determined by the principal investigator. Exclusion Criteria: Previous treatment with adalimumab. Patient considered by the investigator, for any reason, to be an unsuitable candidate

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory data, physical examinations and vital signs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy variables will be assessed from Outcomes Questionnaires |  |  |
The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.

Official Title
-----------------
The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

Conditions
-----------------
Transplantation, Kidney

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hb: >8 and <10 gr/dl Age: >18 and <55 years Cholesterol: <300 mg/dl Triglyceride: <400 mg/dl First Transplantation Protocol of Immunosuppression: CSA + MMF + Prednisolone Systolic BP: <14 Diastolic BP: <9 Exclusion Criteria: History of specified cardiac disease Second Transplantation or more Hb: <7gr/dl The patient needs to infusion of blood Evidence of local or systemic infection, at the time of EPO injection Presence of ATN / DGF after transplantation Presence of emergent hypertension High risk patients ( Like; PRA>50%) Past history of hypersensitivity

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Group of patient with anemia, that treated by erythropoietin | Drug: Erythropoietin<br>* sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.<br>|
| Placebo Comparator: 2<br>Patients group with anemia that treated by placebo | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival. |  | May,2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythropoietin, kidney allograft survival, Recombinant Erythropoietin, erythropoietin (Epo)-induced protein 29, human
Evaluation of Patients With Suspected Endofibrosis

Study Overview
=================
Brief Summary
-----------------
Define responses to exercise on both arterial bruits and oxymetry in patients referred for suspected endofibrosis.

Detailed Description
-----------------
Recording of oxymetry during exercise and recovery. Recording of vascular bruits at rest ajnd post exercise.

Official Title
-----------------
Enregistrement Des Bruits Vasculaires de l'artère Iliaque Externe Par STETHOscope électronique en Post - Effort Chez le SPORTif

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Other: Auscultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for exercise test - Exclusion Criteria: None -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Auscultation|Electronic stethoscope|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caracteristics of sound | recording of sounds | 1 day |
An Expanded Access Program for AM0010 (Pegilodecakin)

Study Overview
=================
Brief Summary
-----------------
This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.

Official Title
-----------------
An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection

Conditions
-----------------
Pancreatic Carcinoma, Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer

Intervention / Treatment
-----------------
* Biological: AM0010


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient is NOT eligible for other AM0010 clinical trials currently open in the region Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program. Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient. Patient has failed or progressed on standard of care (SOC) systemic therapy Patient is refusing SOC therapy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: AM0010|AM0010|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and nutritional methods.

Official Title
-----------------
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 1 to 13 Experiment group: Children with cerebral palsy, Control group: Normal children Patients who agreed to participate in the study Exclusion Criteria: do not agree with the study Those who find it difficult to participate under the judgment of the research director

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 13 Years

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 |
| --- | --- |
| Children with stiff cerebral palsy<br>Children with stiff cerebral palsy, aged 1 to 13 years | |
| Normal children<br>Normal children, aged 1 to 13 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric data (body length) | Measure the body length using a tape measure.(cm) | through study completion, an average of 1 year | 
| Anthropometric data (BMI) | weight and height will be combined to report BMI in kg/m^2 | through study completion, an average of 1 year | 
| Anthropometric data (body circumference ) | Measure the body circumference using a tape measure.(cm) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of hip dislocation | It is measured by migration index, which measures the proportion of femoral heads not covered by acetabulum | Use simple x-ray within 1 year prior to participation | 
| Progression of scoliosis | The degree of scoliosis is measured by Cobbs angle | Use simple x-ray within 1 year prior to participation | 
| Have hip dislocation surgery | Confirmation of hip dislocation surgery | through study completion, an average of 1 year |
The Effect of Tramadol on Interscalene Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.

Official Title
-----------------
The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.

Conditions
-----------------
Shoulder Fracture, Shoulder Dislocation, Rotator Cuff Injury, Shoulder Arthritis

Intervention / Treatment
-----------------
* Drug: Ropivacaine - Tramadol
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder surgery Exclusion Criteria: patients on opioids diabetes mellitus interscalene block contraindicated patient refusing regional anesthesia techniques

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: Ropivacaine - Tramadol<br> | Drug: Ropivacaine - Tramadol<br>* Interscalene block using ropivacaine plus tramadol<br>|
| Active Comparator: Ropivacaine<br> | Drug: Ropivacaine<br>* Interscalene block using ropivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent postoperative pain |  | 1 month postoperatively, 3 months postoperatively | 
| Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement |  | 24 hours postoperatively | 
| Evidence of sensory blockade resolution, confirmed by pin-prick test |  | 24 hours postoperatively |
The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary intervention). The aim is to add to the existing research field surrounding F-QRS. It is hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have incurred a higher degree of damage. As a result, it is hypothesised that these patients will have reduced LV (left-ventricular) systolic function, increased incidence of regional wall motion abnormalities (RWMAs), and increased troponin levels on admission. This study will additionally look for correlations between F-QRS and culprit vessels. To our knowledge there is minimal research regarding this.

Detailed Description
-----------------
This is a Physiological - Retrospective data collection from STEMI patients. Data from 100 STEMI patients treated with primary PCI will be extracted. Data will be collected from presentation / initial admission, 6-week post-MI (Myocardial Infarction) clinic and 6 month post-MI clinic from the hospital system at New Cross Hospital. Data from admission includes; 12-lead ECG, echo reports and blood test results. Additionally, the 12-lead ECGs undertaken at 6-week and 6-months will be assessed for the presence of F-QRS.

Official Title
-----------------
The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction

Conditions
-----------------
ST Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Look back to data at least 12 months old in order to ensure 6-week and 6-month follow up data is available. The inclusion criteria will be patients that presented with STEMI and were treated with primary PCI. Exclusion Criteria: From the cath lab reports and clinical letters exclusions apply to patients that did not present with STEMI. In addition, patients that were not treated with primary PCI, or patients that deceased prior, during or post procedure (during hospitalization).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI patients treated with primary PCI<br>Database analysis only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| F-QRS measurements | recorded from ECG | Over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) | recorded from ECG | Over 6 months | 
| T-Troponin tests | T-Troponin tests as cardiac biomarker of myocardial damage | Over 6 months |