linjc16/ctgov huggingface dataset:
Safety Study for Beta Thalassemia Subjects on PTG-300

Study Overview
=================
Brief Summary
-----------------
In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia patients.

Detailed Description
-----------------
The PTG-300-03 study will study beta thalassemia patients on PTG-300 for two years. The dose and dose frequency for each subject enrolling in the PTG-300-03 study will be based on the last dose and frequency received by the subject in the previous study PTG-300-02 and the subject's response at that dose. Patients dose will be increased in a manner similar to that used on PTG-300-02 study. The maximum PTG-300 dose allowed is 80 mg/week.

Official Title
-----------------
An Open Label Extension Study of PTG-300 In Non-Transfusion Depenent (NTD) and Trasfusion-Dependent (TD) B-Thalassemia Subjects

Conditions
-----------------
β-thalassemia, Ineffective Erythropoiesis

Intervention / Treatment
-----------------
* Drug: PTG-300


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NTD and TD β-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02. Exclusion Criteria: Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD).

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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: Interventions<br>PTG-300 | Drug: PTG-300<br>* PTG-300 is a hepcidin Mimetic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with side effects and severity of side effects will be tabulated | the long-term safety and tolerability of PTG-300 in Beta Thalassemia. | Over two year Period after receiving PTG-300 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic anemia, β-thalassemia
Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be analyzed via a number of demographic lenses in order to find trends that could benefit future ALS sufferers.

Official Title
-----------------
In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients

Conditions
-----------------
ALS, Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lives in the United States Is 18+ years old Participant has a diagnosis of Amyotrophic Lateral Sclerosis (ALS) Participant has enrolled in an interventional clinical for ALS (self-reported) Exclusion Criteria Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form No diagnosis of Amyotrophic Lateral Sclerosis (ALS) confirmed

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 |
| --- | --- | --- |
| Number of patient decides to enroll in clinical trial |  | 3 months | 
| Rate of patients who remain in clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
als, als clinical trials, als diversity studies, amyotrophic lateral sclerosis
Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.

Official Title
-----------------
Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department

Conditions
-----------------
Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 37.5°C measured by axillary mercury thermometer Exclusion Criteria: otitis external/media soft-tissue infection over the axillary fossa and forehead complete occlusion by earwax severe illness trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- | --- |
| The body temperatures of fever patients measured by the infrared tympanic thermometer | Fever patients were measured by the infrared tympanic thermometer in the emergency department. Their tympanic temperatures were obtained from both sides of the body three times. Use statistical methods to evaluate the relevance and consistency between the tympanic temperatures and gold standard temperatures(measured by the glass mercury thermometer). | up to 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infrared tympanic thermometer, Axillary thermometer, Mercury glass thermometer, Adult emergency department
Vienna Vascular Liver Disease Study

Study Overview
=================
Brief Summary
-----------------
The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.

Detailed Description
-----------------
We will include patients with vascular liver diseases, including portal vein thrombosis (PVT) Budd-Chiari Syndrome (BCS) Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease) Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.

Official Title
-----------------
Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank

Conditions
-----------------
Vascular Liver Disease, Portal Vein Thrombosis, Budd-Chiari Syndrome, Non-Cirrhotic Portal Hypertension, Rendu Osler Weber, Cardiac Cirrhosis, Porto-sinusoidal Vascular Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology PVT: Portal vein thrombosis NCPH: non-cirrhotic Portal Hypertension PSVD: porto-sinusoidal vascular disorder BCS: Budd-Chiari-Syndrome SOS: sinusoidal occlusive disease HHT: hereditary hemorrhagic teleangiectasia CIRCAD: cirrhosis cardiaque Age >18 years and <100 years Written informed consent obtained Exclusion Criteria: - withdrawal of written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic Decompensation | Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice | Up to 10 years (=Study Period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver-related death | Death from a liver-related cause | Up to 10 years (=Study Period) | 
| Coagulation status | Coagulation status of the Patient as assessed by advanced coagulation tests (including TEG-ROTEM and TGA) | Up to 10 years (=Study Period) |
Extension Program for Bay 43-9006

Study Overview
=================
Brief Summary
-----------------
The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.

Official Title
-----------------
Extension Program for Bay 43-9006

Conditions
-----------------
Neoplasm, Metastasis

Intervention / Treatment
-----------------
* Drug: Nexavar (Sorafenib, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who had participated in a previous sorafenib study that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor still benefiting from treatment. Exclusion Criteria:- The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Nexavar (Sorafenib, BAY43-9006)<br>* Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumour Response Rate |  | Number of confirmed partial and complete responses | 
| Overall Response Duration |  | Time from the date of the first intake of sorafenib to the date that progressive disease is documented. | 
| Time to Objective Response |  | Time from the date of the first intake of sorafenib to the date that objective response is first documented. | 
| Time to Disease Progression |  | Time from first intake of sorafenib to disease progression | 
| Safety Parameters |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extension, Sorafenib, Survival
AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)

Study Overview
=================
Brief Summary
-----------------
AcQMap Registry is an observational study

Detailed Description
-----------------
AcQMap Registry is an observational, prospective, multi-center, multi-national, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

Official Title
-----------------
AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)

Conditions
-----------------
Ablation of Arrhythmia's

Intervention / Treatment
-----------------
* Device: AcQMap System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System. Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. Willing and able to give written informed consent. Exclusion Criteria: In the opinion of the Investigator, any known contraindications to an ablation procedure. Current enrollment in any study protocol sponsored by Acutus Medical. Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

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 |
| --- |
|Device: AcQMap System|To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Ablation Outcomes | • Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Outcome | • First-procedure freedom from any arrhythmia on and/or off AADs, throughout the follow-up period, excluding events in the initial 90 days following the procedure (blanking period). | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia's
Diabetes-Related Discrimination at Workplace and by Insurances

Study Overview
=================
Brief Summary
-----------------
Diabetic subjects often report of problems at the workplace or when contracting insurances because of their diabetes. By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic subjects we wanted to analyse the frequency of work- and insurance-related discrimination. Furthermore we wanted to detect socio-demographic and diabetes-related factors which are associated with increased discrimination at workplace and by insurances. We hypothesized that diabetes-related discrimination at workplace and by insurances exists and that certain factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight would be associated with more problems at work or with insurances.

Detailed Description
-----------------
Our self report questionnaire included 83 items to assess treatment goals, quality of life and discrimination at workplace or by insurances. 636 questionnaires were distributed and were answered and returned. Anonymity was ensured. Patients were recruited from the diabetes outpatient clinic of the University of Basel Hospital, 5 regional hospitals, specialist practices and general practitioner practices. The aims of this study are to investigate the prevalence of discrimination at workplace and by insurances due to diabetes mellitus. Furthermore we want analyse if socio-demographic factors (age,gender,origin) show an impact on diabetes-related discrimination at workplace and by insurances. We hypothesize furthermore that certain diabetes-related factors like having severe hypoglycemias, being type 1 diabetic, having diabetic complications or being overweight/obese is associated with more problems at work and with insurances. Data will be analysed by a multiple ordinal regression analysis. We will correct data for age, gender, employment status and diabetes type.

Official Title
-----------------
Discrimination of Insulin-Treated Diabetic Subjects at the Workplace and by Insurances

Conditions
-----------------
Insulin-Treated Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: german-speaking insulin-treated diabetic patients Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| 1<br>insulin-treated diabetic subjects of North-western part of Switzerland | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients

Study Overview
=================
Brief Summary
-----------------
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Detailed Description
-----------------
The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

Official Title
-----------------
Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

Conditions
-----------------
Ventricular Arrythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device ATP Auto-switch function is programmed ON Exclusion Criteria: Presence of a contra-indication to the ICD therapy Life expectancy less than 12 months

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paradym VR, DR and CRT models<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular Tachyarrhythmia episode | % of VT episode successfully reduced by the ATP Auto-switch | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia incidence | DEvice based data | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ATP,CRT, ICD PARADYM
Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians

Study Overview
=================
Brief Summary
-----------------
The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first before reimbursement and after reimbursement.

Detailed Description
-----------------
The aim of the study is to assess the acceptability of Hepatitis B immunization among general practitioners and open-care paediatricians. This is a national, repeated transversal epidemiological study with two data measurement time-points over a period of two years (T1 in 2009, T2 in 2011, two different samples of physicians) in order to assess immunization practices before introduction of the reimbursement of InfanrixHexa®, during the transition period and then during the period following reimbursement of the vaccine. At each collection time-point, two patient age groups will be investigated: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.

Official Title
-----------------
Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Children on the eligibility register complying with the investigator's immunization policy (children followed by the investigator since their birth, whose immunization regimen has been managed by the investigator). Exclusion Criteria: Children on the eligibility register not complying with the investigator's immunization policy. Refusal of the patient.
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 |
| --- | --- |
| Generalist physicians Cohort<br> | Other: Data collection<br>* Questionnaire, Vaccination book<br>|
| Paediatricians Cohort<br> | Other: Data collection<br>* Questionnaire, Vaccination book<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point. |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccination, Acceptability, Hepatitis B