linjc16/ctgov huggingface dataset:
Peripheral Arteriopathy Rate In Stroke

Study Overview
=================
Brief Summary
-----------------
Purpose: To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients. Interventions: Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de). Design: Prospective, open, cohort study. Study size planned: 1500. Follow-up duration: 3 months.

Official Title
-----------------
Prevalence of Peripheral Arterial Disease in Acute Ischemic and Hemorrhagic Stroke Patients

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

Intervention / Treatment
-----------------
* Procedure: measuring the ankle brachial index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive adult patients with acute ischemic or hemorrhagic stroke. Exclusion Criteria: Congestive heart failure.

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 |
| --- | --- |
| 1<br>TIA | Procedure: measuring the ankle brachial index<br>* Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de).<br>|
| 2<br>Ischemic stroke | Procedure: measuring the ankle brachial index<br>* Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de).<br>|
| 3<br>Hemorrhagic stroke | Procedure: measuring the ankle brachial index<br>* Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome (modified Rankin Scale) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of peripheral arterial disease | Presence or not of PAD as assessed using ABI during hospital stay | during hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, Stroke, ICH, prevalence
Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.

Official Title
-----------------
An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: ATN-103
* Drug: ATN-103


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study. Exclusion Criteria: Pregnant or nursing women. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: ATN-103_30mg<br> | Drug: ATN-103<br>* A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)<br>|
| Experimental: Arm 2: ATN-103_80 mg<br> | Drug: ATN-103<br>* A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements. |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open-label, Long-term safety study of ATN-103 in RA
Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the Ophthalmologic Clinic of University G. d'Annunzio, Chieti-Pescara, Italy.

Official Title
-----------------
Macular Thickness and Vessel Density Changes After Dexamethasone Implant and Ranibizumab Intravitreal Injection in Diabetic Macular Edema: 6-month Follow-up

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Dexamethasone intravitreal implant 0.7 mg
* Drug: Ranibizumab Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old BCVA greater than 0.5 LogMAR in the study eye at baseline examination Presence of recent DME CMT > 300µm as measured using the SD-OCT at the baseline examination Exclusion Criteria: Any previous ocular surgery in the last 6 months Laser treatments Prior ocular trauma Retinal vascular diseases Vitreo-retinal interface diseases Medium lens opacities (according to Lens Opacities Classification System)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 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 |
| --- | --- |
| Dexamethasone group<br>Patients with diabetic macular edema receiving dexamethasone | Drug: Dexamethasone intravitreal implant 0.7 mg<br>* Intravitreal Implant of dexamethasone<br>|
| ranibizumab<br>Patients with diabetic macular edema receiving ranibizumab | Drug: Ranibizumab Injection<br>* Injection of ranibizumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness | Decrease of macular thickness | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | Increase of mean visual acuity | 6 months |
Study of High Risk Non Invasive Prenatal Test Population

Study Overview
=================
Brief Summary
-----------------
The investigator want to study the population of high risk (over 1/50) of Trisomy 21. According to french guidelines, these patients needs to have a invasive test (such as amniocentesis) but some patients prefer to have a Non Invasive Prenatal Test, with a potential lack of information.

Official Title
-----------------
Study of High Risk Non Invasive Prenatal Test Population

Conditions
-----------------
Trisomy 21

Intervention / Treatment
-----------------
* Biological: Prenatal test for Trisomy 21 screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prenatal screening of Trisomy 21 > 1/50 (high risk population) Exclusion Criteria: No exclusion criteria

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Prenatal test for Trisomy 21 screening|prenatal routine test for Trisomy 21 screening (blood test + nuchal translucency test)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of genetics anomalies |  | through study completion, an average of 9 months |
Brain MRI in Stroke Patients With Intracardiac Thrombus

Study Overview
=================
Brief Summary
-----------------
Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.

Official Title
-----------------
Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus

Conditions
-----------------
Stroke, Intracardiac Thrombus

Intervention / Treatment
-----------------
* Other: No intervention,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period. Brain MRI (including diffusion-weighted imaging [DWI]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight [TOF], gadolinium-enhanced magnetic resonance angiography [MRA], or computed tomographic angiography [CTA]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring). Exclusion Criteria: opt-out patient

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 |
| --- | --- |
| Atrial fibrillation<br>stroke patients with atrial fibrillation | Other: No intervention,<br>* pure observational study<br>|
| Intracardiac thrombus<br>stroke patients with intracardiac thrombus | Other: No intervention,<br>* pure observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain MRI characteristics | infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions [SCCI] or non-SCCI; cortical/subcortical/corticosubcortical) | Day of inclusion (Day 1) | 
| Brain MRI characteristics | lesion number | Day of inclusion (Day 1) | 
| Brain MRI characteristics | subcortical lesion size (><15 mm) | Day of inclusion (Day 1) | 
| Brain MRI characteristics | total infarction volume. | Day of inclusion (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain MRI
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

Study Overview
=================
Brief Summary
-----------------
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.

Detailed Description
-----------------
A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.

Official Title
-----------------
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age, heart defect, heart surgery and type of palliation/correction, informed consent Exclusion Criteria: non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum 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 |
| --- | --- |
| Patient group<br>Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation. | |
| Control group<br>Age- and gender-matched healthy individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic status | Status as found by invasive and non-invasive assessment | Current at time of inclusion | 
| Structural and functional hepatic changes | Status as found by non-invasive assessment | Current at time of inclusion | 
| Cardio-pulmonary function and functional reserve | Status as found by non-invasive assessment | Current at time of inclusion | 
| Quality of life and psycho-social outcome | Status as found by questionnaire | Current at time of inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Univentricular heart defect, Fontan circulation
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.

Official Title
-----------------
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation

Conditions
-----------------
Liver Transplantation, Blood Loss

Intervention / Treatment
-----------------
* Drug: Iron Carboxymaltose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients listed for OLT with positive screening for IDA Exclusion Criteria: Age <18 years Hemochromatosis Iron utilization disorders Non-IDA Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks prior to screening Previous allergic reactions against intravenous iron formulations Transfusion within 2 weeks prior to screening Complete portal vein thrombosis High-urgency OLT Pregnancy Sepsis or severe infection Immunosuppressive therapy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks. | Drug: Iron Carboxymaltose<br>* see above<br>* Other names: IRON;|
| Placebo Comparator: Group B<br>IV administration of 1000ml 0.9% NaCl every 4 weeks. | Drug: Placebo<br>* see above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin at OLT | Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion requirement | Transfusion of PRBCs during and within the first 24 hours following OLT | 6 months | 
| Hemoglobin after 4 weeks | Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplantation, liver, anemia
Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Study Overview
=================
Brief Summary
-----------------
Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

Detailed Description
-----------------
This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters

Official Title
-----------------
Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Conditions
-----------------
Hypoxemia, Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: VibroLUNG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults P/F less 300 torr ARDS by Berlin convention COVID 19 bilateral pneumonia Exclusion Criteria: children acute brain stroke acute coronary syndrome pulmonary embolism implanted pacemaker

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective\retrospective study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Time-day of respiratory fail<br>Objective data | Device: VibroLUNG<br>* Lungs intensive therapy<br>* Other names: Vibroacustic device;|
| Active Comparator: Oxygen status<br>Facultative data | Device: VibroLUNG<br>* Lungs intensive therapy<br>* Other names: Vibroacustic device;|
| Active Comparator: Oxugen support<br>FiO2 | Device: VibroLUNG<br>* Lungs intensive therapy<br>* Other names: Vibroacustic device;|
| Active Comparator: Adverse outcomes<br>Complication | Device: VibroLUNG<br>* Lungs intensive therapy<br>* Other names: Vibroacustic device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery respiratory fail | Regression of respiratory failure under the influence of vibroacoustic therapy | 5-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vibroacustic therapy, COVID19, Pneumonia
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

Study Overview
=================
Brief Summary
-----------------
To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients

Detailed Description
-----------------
To investigate headache score and accompanying symptoms during and after infusion of PACAP38 Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

Official Title
-----------------
Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients

Conditions
-----------------
Migraine Without Aura

Intervention / Treatment
-----------------
* Drug: PACAP38


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy migraine patient without aura Aged 18-50 50-100 kg Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen. Exclusion Criteria: Tension type headache more than five times/month Other primary headaches Daily medication except contraceptives Drug taken within 4 times the halflife for the specific drug except contraceptives Pregnant or lactating women Exposure to radiation within the last year Headache within the last 48 hours before start of trial Hypertension Hypotension Respiratory or cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PACAP38|10 pmol/kg/min given one time|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |