linjc16/ctgov huggingface dataset:
haMSter: a Novel Smartphone Communication Tool for People With MS

Study Overview
=================
Brief Summary
-----------------
haMSter is a smartphone app that tracks validated patient reported outcome measures (PROMs) in people multiple sclerosis (MS). In this study, 50 patients with MS will receive this app for 6 months and be asked to fill out the PRO questionnaires on their Smartphone. Endpoints include the adherence to this app and satisfaction with this Intervention.

Official Title
-----------------
haMSter: a Novel Smartphone Communication Tool for People With MS

Conditions
-----------------
M-health, Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: haMSter smartphone app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any MS according to MacDonald criteria informed consent Exclusion Criteria: - language barriers
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: haMSter app<br>Patients receiving the app for personal use for 6 months | Device: haMSter smartphone app<br>* the app tracks patient reported outcomes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to device | Percentage (Number) of participants having completed all necessary questionnaires per study period. Max: 6 completions. | over the course of this study (over 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with this application in telemedicine | TMPQ (Telemedicine Perception Questionnaire). Min: 0 points. Max: 80 Points. Higher scores indicate a better outcome | after study completion (after 6 months) | 
| General satisfaction with specific Features of the haMSter app | Empirical questionnaires. We will Report frequencies of answers given. There is no Overall score in a larger sense. | after study completion (after 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
m-health, multiple sclerosis, patient reported outcomes
Myocardial Perfusion Imaging in Liver Transplantation Candidates

Study Overview
=================
Brief Summary
-----------------
The optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (ESLD) is unclear. Although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (OLT), no prospective studies are available to inform the clinician on perioperative risk stratification. This observational cohort study was designed to determine the prognostic utility of single photon emission computed tomography (SPECT) imaging in OLT candidates.

Detailed Description
-----------------
Controversy over whether SPECT imaging offers clinical utility in ESLD has been fuelled by conflicting reports on its accuracy to diagnose CAD in this setting. Moreover, there are no studies examining whether SPECT imaging provides any incremental prognostic value beyond functional testing in this high-risk cohort. We sought to determine the relative importance of CV risk factors, functional capacity and SPECT perfusion results as independent predictors of cardiovascular mortality in OLT candidates.

Official Title
-----------------
Exercise Capacity and Single Photon Emission Computed Tomography in Liver Transplantation Candidates Study

Conditions
-----------------
Myocardial Perfusion Imaging, Liver Failure

Intervention / Treatment
-----------------
* Procedure: Myocardial perfusion imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Liver transplantation candidates with one or more of the following: inability to perform >4 METs by history insulin-treated diabetes mellitus serum creatinine >152μmol/l history of MI, PCI or CABG stable angina cerebrovascular disease peripheral vascular disease Exclusion Criteria: Age < 18 years Pregnancy Contraindication to liver transplantation

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 |
| --- | --- |
| Orthotopic liver transplantation candidates<br>No intervention, imaging test and risk stratification as part of routine clinical care. | Procedure: Myocardial perfusion imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event |  | 10 years | 
| All-cause mortality |  | 10 years |
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Orthokeratology has the benefit for slowing down myopia progression and enabling unaided vision during the day. To investigate proposed possible changes of conventional and multifocal orthokeratology in the cornea and choroid this study will image both structures with high resolution optical coherence tomographs over a six month period. Findings will help to plan larger trials over a longer period of time in adults and teenagers.

Official Title
-----------------
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Orthokeratology lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged over 18 years Myopia defined as between -1D and -6 D with an increase of 0.5D within the last 18months prior to inclusion Prospect orthokeratology contact lens wearers Normal findings in the slit lamp examination, no corneal pathologies Exclusion Criteria: Participation in a clinical trial in the previous 3 weeks Presence of any abnormalities (such as refractive surgery) preventing reliable measurements as judged by the investigator Current contact lens wearers Pregnancy, planned pregnancy or lactating

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orthokeratology contact lens group<br> | Device: Orthokeratology lens<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative changes in the corneal thickness |  | 1 year | 
| Qualitative changes in the corneal structure |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative changes in the choroidal thickness |  | 1 year | 
| Qualitative changes in the choroidal structure |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthokeratology
EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn

Study Overview
=================
Brief Summary
-----------------
This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.

Official Title
-----------------
Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor

Conditions
-----------------
Exposure of Member of Staff to Medical Diagnostic X-Ray

Intervention / Treatment
-----------------
* Radiation: Plain X-ray protection shield
* Radiation: Protection shield & X-ray protective strips
* Radiation: Protection shield & protective strips & patient cut-outs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for coronary angiography Exclusion Criteria: none

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain X-ray protection shield<br> | Radiation: Plain X-ray protection shield<br>* Coronary angiography with mere X-ray protection shield<br>|
| Experimental: Protection shield & X-ray protective strips<br> | Radiation: Protection shield & X-ray protective strips<br>* Coronary angiography with X-ray protection shield & X-ray protective strips<br>|
| Experimental: Protection shield & protective strips & patient cut-outs<br> | Radiation: Protection shield & protective strips & patient cut-outs<br>* Coronary angiography with X-ray protection shield & X-ray protective strips & X-ray protection patient cut-outs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator dose | Dose of radiation measured | Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scattered radiation, X-ray protection, Radiation in cath lab
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.

Detailed Description
-----------------
Methods: microdialysis, blood sampling, bronchoalveolar lavage

Official Title
-----------------
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients

Conditions
-----------------
Pneumonia, Abdominal Infection, Urinary Tract Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection Exclusion Criteria: allergy to doripenem, hemodialysis

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care patient, intubation, (please change wording as you like!)
German Epicardial Collateral CTO Registry

Study Overview
=================
Brief Summary
-----------------
The EPIC registry is an observational multicentre registry evaluating the technical feasibility of retrograde CTO-PCI using epicardial collateral connections. It will evaluate the frequency, effectiveness, safety and outcomes of patients who underwent CTO-PCI using this approach. The EPIC registry retrieves data from CTO centres across Germany.

Detailed Description
-----------------
The EPIC registry is the first German-wide observational multicentre registry evaluating the technical feasibility, clinical success and safety of retrograde CTO-PCI using epicardial collateral connections. The EPIC registry retrieves data from CTO centres across Germany. All patients will be followed-up to 30 days after inclusion.

Official Title
-----------------
German Multicentre Registry to Evaluate the Technical Feasibilty of Epicardial Collateral Connections in CTO PCI

Conditions
-----------------
Coronary Artery Disease, Chronic Total Occlusion, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Procedure: Retrograde Percutaneous Coronary Intervention of Chronic Total Occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Retrograde Percutaneous Coronary Intervention of Chronic Total Occlusion|Retrograde CTO-PCI using epicardial collateral connections|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of technically successful retrograde CTO-PCI using epicaridal collaterals | defined as the rate of successful CTO-PCI with reestablished antegrade coronary flow (thrombolysis in myocardial infarction (TIMI) flow III) with less than residual stenosis of 50%. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals | Clinical success is defined as the rate of successful CTO-PCI by technical success without MACCE and without major periprocedural complications, including pericardial tamponade and contrast induced dialysis. | 30 days | 
| Rate of failed retrograde CTO-PCI using epicaridal collaterals | is defined as the rate of CTO-PCI without technical success defined as residual stenosis >50% (by visual estimation) and TIMI flow grade <3 after CTO-PCI. | 30 days |
Association of Thyroid Autoimmunity and Chronic Urticaria

Study Overview
=================
Brief Summary
-----------------
Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.

Detailed Description
-----------------
There is no such report on the association of thyroid autoantibodies and chronic urticaria in Taiwan population yet. This study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. We also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.

Official Title
-----------------
Association of Thyroid Autoimmunity and Chronic Urticaria in Taiwan

Conditions
-----------------
Skin Itching, Chronic Urticaria

Intervention / Treatment
-----------------
* Behavioral: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and above skin itching for more than 6 months Exclusion Criteria: pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| skin itching<br> | Behavioral: blood sampling<br>* blood sampling 10ml from the study subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of thyroid autoimmunity in chronic urticaria in Taiwan |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urticaria, goiter
Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental. Also, describe the stage of the disease, and whether if they are under medical treatment or not.

Detailed Description
-----------------
The hepatitis B virus ( HBV ) is a global health problem . It is estimated that in the world there are about 350-400 million carriers of HBV surface antigen ( HBsAg ) 1 . The prevalence in Spain is estimated at a 2-7 % and is considered a second intermediate prevalence. For over 20 years, has carried out a program of primary prevention through universal vaccination against hepatitis B including it in the childhood vaccination schedule and has already been observed that in some estudi3 the prevalence has declined . For this reason , we want to evaluate what is the currently prevalence in our area of influence. There aren't recent studies to assess what is the current status of these patients ( how many , what risk factors which needs of treatment and with answer ...)

Official Title
-----------------
Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study

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

Intervention / Treatment
-----------------
* Other: Not apply


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HBsAg + visited in Digestive/Hepatology outpatient visits and Hepatology of the participating hospitals Exclusion Criteria: Patients < 18 aged Duplicity on record

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Not apply|None. Just registration epidemiology dates|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence hepatitis B |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stage of the disease and if they are in treatment or not |  | 1 day |
Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
This is an open label expanded access protocol for the treatment of up to approximately 250 adult patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing oral riluzole tablets and may be able to derive benefit from treatment with an alternative oral formulation of riluzole.

Detailed Description
-----------------
Riluzole is indicated in the U.S. for the treatment of patients with amyotrophic lateral sclerosis (ALS). The commercially available dosage form is a 50mg oral tablet. This expanded access protocol (EAP) is designed to provide access to a dissolving tablet formulation of riluzole designed for sublingual (SL) administration, in patients with ALS who, in the opinion and clinical judgement of the treating physician, would benefit from treatment with BHV-0223.

Official Title
-----------------
BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis

Conditions
-----------------
ALS, Lou Gehrig Disease, Lou Gehrig's Disease, Lou-Gehrigs Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: Riluzole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed ALS of any type or duration Current or previous treatment with oral riluzole tablets, or patients who have never taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events Swallowing difficulties, or patient or caregiver report choking one or more times per week, or investigator deems appropriate to treat with sublingual BHV-0223 because (s)he deems the patient cannot be satisfactorily treated with Rilutek® Adequate hepatic function Exclusion Criteria: Patient with history of severe hypersensitivity reaction to riluzole oral tablets or BHV-0223 Patient is known to have any other acute or chronic liver disease

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 |
| --- |
|Drug: Riluzole|For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).|

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
-----------------
Amyotrophic Lateral Sclerosis, ALS, Lou Gehrig Disease, Lou Gehrig's Disease, Lou-Gehrigs Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Riluzole, Rilutek®, Sublingual, Oral formulation, Neuroprotective Agents, Administration, Sublingual, Administration, Oral, Biological Availability