linjc16/ctgov huggingface dataset:
A Study of ResCure™ to Treat COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.

Detailed Description
-----------------
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.

Official Title
-----------------
A Phase I Study of ResCure™ to Treat COVID-19 Infection

Conditions
-----------------
COVID, Covid-19, Corona Virus Infection, Sars-CoV2, Coronavirus-19, SARS Pneumonia, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere

Intervention / Treatment
-----------------
* Biological: ResCure™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients with SARS from COVID-19 infection on respirators OR Patients with SARS from COVID-19 infection prior or after being placed on respirator Male or female patients 18 years of age and older Exclusion Criteria: 1. Patients less than 18 years of age

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: Treatment Group<br>This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status. | Biological: ResCure™<br>* Patients will be treated with nebulized ResCure™<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of recovery of mild or moderate COVID-19 in patients using ResCure™ | Number of days from COVID-19 diagnosis to recovery via RT-PCR | 12 Weeks | 
| Reduction or progression of symptomatic days | Reduction and/or progression of symptomatic days, reduction of symptom severity | 12 Weeks | 
| Assess the safety of ResCure™ via pulse | Pulse from baseline to 12 weeks | 12 Weeks | 
| Assess the safety of ResCure™ via oxygen saturation | Oxygen saturation from baseline to 12 weeks | 12 Weeks | 
| Assess the safety of ResCure™ via EKG | EKG from baseline to 12 weeks | 12 Weeks | 
| Assess Tolerability of ResCure™ | Assess Adverse Events and Serious Adverse Events due to ResCure™ | 12 Weeks |
A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice

Study Overview
=================
Brief Summary
-----------------
A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice

Detailed Description
-----------------
A multi-center, non-interventional study, including up to 700 subjects at approximately 70 sites in 5 European countries to evaluate the post-market safety profile of Pliaglis and the efficacy of Pliaglis in terms of pain reduction, satisfaction with the product and daily practice use prior to pre-defined aesthetic procedures.

Official Title
-----------------
A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice

Conditions
-----------------
Health Knowledge, Attitudes, Practice

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Patient treated with Pliaglis by the Investigator or other healthcare professional according to label (refer to SmPC) Patient had already consented to receive any one or more of the following aesthetic procedures after Pliaglis administration: Pulsed-dye laser therapy Laser-assisted hair removal Non-ablative laser resurfacing Dermal filler injection Vascular access Exclusion Criteria: Patient treated with other injectable or topical anaesthetic(s) for the pre-defined aesthetic procedure Previous participation in this study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions |  | After Pliaglis application and throughout the site visit (day of application) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Pliaglis | Pain intensity by VAS, satisfaction with pain reduction, willingness to re-use/recommend Pliaglis | After completing Pliaglis treatment and procedure, i.e. at the end of the site visit (day of application) |
Registry of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia: Vercise DBS Dystonia Registry

Study Overview
=================
Brief Summary
-----------------
To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

Detailed Description
-----------------
To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia. Subjects' improvement in disease symptoms and overall Quality of life will be assessed.

Official Title
-----------------
Registry of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia: Vercise DBS Dystonia Registry

Conditions
-----------------
Dystonia

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation (DBS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (IC): IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia. IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent. Exclusion Criteria (EC): EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep Brain Stimulation (DBS)|Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score |  | up to 3 years | 
| Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score |  | up to 3 years |
GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.

Official Title
-----------------
GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Behavioral: No treatment given
* Behavioral: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENTS WITH T2DM: Diagnosed with type 2 diabetes by a healthcare professional Currently being treated with insulin medication, excluding premix insulin treatment Age at least 40 years Diagnosed as having type 2 diabetes over the age of 40 HCPs: Primary care physician, diabetes specialist (diabetologist/endocrinologist) or diabetes specialist nurse/diabetes nurse educator Have a minimum of 2 years experience within current speciality See a minimum of 20 type 2 diabetes patients per month (40 for diabetes specialists), of which at least 10 per month must be on modern (analogue) inulins
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 2 diabetes mellitus (T2DM)<br> | Behavioral: No treatment given<br>* Completion of 90-item online questionnaire.<br>|
| Healthcare professionals (HCPs)<br> | Behavioral: survey<br>* Completion of 58-item online questionnarie.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire) |  | In the past 30 days prior to the day when responding to the online questionnaire | 
| Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire) |  | Day 1 (when responding to the online questionnaire) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intentional dosing irregularities and reasons for this behaviour |  | Day 1 (when responding to the online questionnaire) | 
| Impact of dosing irregularity on functional well-being |  | Day 1 (when responding to the online questionnaire) | 
| Frequency of self-treated hypoglycaemia |  | In the past 30 days prior to the day when responding to the online questionnaire |
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies

Study Overview
=================
Brief Summary
-----------------
In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: peginterferon alfa-2a [Pegasys]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >/=18 years of age previous participation in other donor protocol chronic hepatitis B no other anti-HBV treatment after completion of previous donor protocol female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study Exclusion Criteria: hepatic decompensation (Child-Pugh class B and C) antiviral, antineoplastic or immunomodulatory treatment evidence of alcohol and/or drug abuse

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: Single Arm<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA |  | assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications |  | assessed every 2 months on treatment and up to week 24 of follow-up |
Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and QRS morphology/duration, across clinical stages in patients with Rett syndrome. II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess arrhythmias, heart rate variability, and autonomic nervous system function in these patients using 24-hour Holter monitoring. IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and polygraph monitoring in patients who have more than 1 clinical seizure every 5 days. V. Characterize these events with respect to clinical manifestations, EEG correlates, and other physiologic data. VI. Determine the frequency of seizures vs. events without electrographic correlates in these patients. VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures and/or an epileptic syndrome.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive an electrocardiogram at baseline and every 6 months for 3 years. Clinical stage II patients undergo 24-hour Holter monitoring on the same schedule; age-matched controls are tested once. A group of patients with more than 1 seizure or possible seizure every 5 days undergo 5-day continuous electroencephalogram/polygraphic/video monitoring, with respiratory effort assessment, end tidal carbon dioxide and oxygen saturation levels, and a seizure log.

Conditions
-----------------
Rett Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria Age-matched girls without neurologic or cardiac problems entered as controls

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rett syndrome, neurologic and psychiatric disorders, rare disease
Antenatal Diagnosis of Coarctations of the Aorta.

Study Overview
=================
Brief Summary
-----------------
Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.

Official Title
-----------------
Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.

Conditions
-----------------
Coarctation of Aorta

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant or having given birth in the last 12 months in one of the participating centers have had an ultrasound screening in the 2nd or 3rd trimester addressed or being addressed to the Pluridisciplinary Center for Prenatal Diagnosis for suspected coarctation of isolated aorta in front of: ventricular asymmetry at the aegis of the left ventricle or the large vessels at the aorta, discovered during a screening ultrasound second or third quarter. be able to understand and follow the ins and outs of the study Have been informed of the study and have not objected to it Exclusion Criteria: Associated complex cardiac disease (transposition of large vessels, atrioventricular duct, right ventricle with double outlet) with the exception of inter ventricular communications Left ventricular hypoplasia Suspicion of interruption of the aortic arch

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy | Diagnostic Test: Ultrasound<br>* Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Search for ultrasound risk factors associated with diagnosis coarctation of the aorta | Calculation of sensitivity, specificity and ROC (Receiver Operating Characteristic) curves of the different ultrasound parameters according to post-natal confirma-diagnosis of coarctation of the aorta in order to create a score to improve the antenatal diagnosis of coarctation the aorta. | 24h after birth |
Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).

Detailed Description
-----------------
This is a crossover trial involving a total of 20 patients with Burning Mouth Syndrome, considered a chronic neuropathic pain. In two consecutive treatment periods, both 8 week long, each patient receives externally indistinguishable capsules (placebo or melatonin). A 4 weeks wash-out period is applied, between these two periods. The capsules contain either placebo or 3 mg-melatonin (4 time/day for a total of 12 mg/day of melatonin). The primary endpoint is the change in pain intensity at the end of each treatment period, measured using VAS, verbal intensity score and NRS, as well as number of oral sites affected by the burning sensation. Furthermore, data from quality of life, anxiety and sleep questionnaires are collected (sf-36, HAM-A, ESS, MOS). Adverse effects are carefully recorded as well as blood samples, in order to measure serum melatonin levels during the trial.

Official Title
-----------------
Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial

Conditions
-----------------
Burning Mouth Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 yrs suffering from burning mouth syndrome Exclusion Criteria: epilepsy pregnancy concomitant treatment with melatonin concomitant anticoagulants night time working persons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>tablet without melatonin | Dietary Supplement: melatonin<br>* Cross-over randomized clinical trials<br>|
| Experimental: melatonin<br>tablet with melatonin | Dietary Supplement: melatonin<br>* Cross-over randomized clinical trials<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction/resolution of symptoms in BMS |  | within the first 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in quality of life |  | within the first 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burning mouth syndrome, treatment, oral chronic pain
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

Study Overview
=================
Brief Summary
-----------------
Acute stress-induced (Takotsubo cardiomyopathy) presents like a heart attack and is triggered by intense emotional or physical stress. Although coronary arteries are unobstructed, it has been suggested that the risk of death is similar to a myocardial infarction. The purpose of the STARR study is to identify all cases of Takotsubo in Scotland since 2010 and assess its epidemiology and outcomes.

Detailed Description
-----------------
Public Health Scotland will identify all patients centrally coded under codes I42.8 (Other cardiomyopathies), I42.9 (Cardiomyopathy, unspecified) and I51.8 (Other ill-defined heart diseases), using the Community Health Index (CHI) numbers from January 2010. All identified CHI numbers will be thereafter cross-checked with their clinical data at participating health boards to confirm a diagnosis of takotsubo cardiomyopathy and a registry of all confirmed Takotsubo cases will be established. Clinical data will be collected for all Takotsubo patients retrospectively and prospectively. This will be compared to two contemporaneous gender and age matched control populations: a cohort of randomly selected individuals from the Scottish general population supplied by Public Health Scotland patients with myocardial infarction (extracted through collaboration with, the High-STEACS investigators, NCT01852123). Electronic data linkage will be performed by Public Health Scotland to assess outcomes, prescribing and scores of prediction.

Official Title
-----------------
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland - the STARR Study

Conditions
-----------------
Takotsubo Cardiomyopathy, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed with Takotsubo cardiomyopathy Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Takotsubo cardiomyopathy<br>All patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010. | |
| Myocardial Infarction<br>An equal number of myocardial infarction patients in NHS Grampian since 2010. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify number of Takotsubo cases in Scotland | Identify number of Takotsubo cases in Scotland | 13 years |