linjc16/ctgov huggingface dataset:
King's Invasive Aspergillosis Study II

Study Overview
=================
Brief Summary
-----------------
Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation. This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.

Official Title
-----------------
Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis

Conditions
-----------------
Aplastic Anemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Bone Marrow Transplantation

Intervention / Treatment
-----------------
* Drug: Posaconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Adult ≥ 18 years Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT Able to swallow and retain orally administered medication EXCLUSION CRITERIA Refusal or inability to consent Autologous HSCT Contraindicated medications Current evidence of IFD diagnosis or treatment Enrolled in another study requiring alternative antifungal prophylaxis or treatment Women who are pregnant or lactating Women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posaconazole<br> | Drug: Posaconazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) |  | 24 weeks |
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.

Official Title
-----------------
A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

Conditions
-----------------
Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
-----------------
* Drug: Otamixaban (XRP0673)
* Drug: Unfractionated Heparin
* Procedure: Percutaneous Coronary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Due to undergo non-urgent percutaneous coronary intervention (PCI) Planned treatment with aspirin and clopidogrel Exclusion Criteria: Recent acute coronary syndrome Patients at risk for, or with prior recent, bleeding Patients have received recent prior treatment with an anticoagulant Creatinine clearance > 30 ml/min

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Otamixaban (XRP0673)|nan|
|Drug: Unfractionated Heparin|nan|
|Procedure: Percutaneous Coronary Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, myocardial infarction, and urgent and non-urgent target vessel revascularization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events |  |  |
The Northern Ireland Haemodialysis Vascular Access Database

Study Overview
=================
Brief Summary
-----------------
This is database designed to explore clinical outcomes related to vascular assess in the population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.

Detailed Description
-----------------
Vascular access is the conduit by which blood is transferred from the patient to the dialysis machine and back to the patient during therapy. There are three types of vascular access: Arteriovenous fistulas (AVF), Central venous catheters (CVC) and Arteriovenous grafts (AVG). AVFs are associated with the best patient survival in individuals undergoing dialysis therapy. However, Up 30-50% of AVFs thrombose or fail to mature sufficiently to support dialysis. The aim of this database is to further research in the area of AVF outcomes using routinely collected clinical data..

Official Title
-----------------
The Northern Ireland Haemodialysis Vascular Access Database

Conditions
-----------------
Hemodialysis Access Failure, Arteriovenous Fistula

Intervention / Treatment
-----------------
* Procedure: Vascular Access Creation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 105 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Vascular Access Creation|arteriovenous fistula creation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Arteriovenous Fistula Failure to Mature | Rates of Arteriovenous Fistula Failure to Mature | 1 year |
Atrial Fibrillation Research Database

Study Overview
=================
Brief Summary
-----------------
All patients with atrial fibrillation who are treated with vitamin-k antagonists (warfarin, phenprocoumon) or non vitamin K oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in real world settings will be recorded in this register. Within this register a characterization of patients and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.

Official Title
-----------------
Prospective Register Study to Record Safety and Efficacy of Oral Anticoagulants in Atrial Fibrillation Patients

Conditions
-----------------
Anticoagulants and Bleeding Disorders, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atrial fibrillation Indication for oral anticoagulant treatment Exclusion Criteria: Missing Informed Consent Form Missing Contact Informations for Follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 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 |
| --- | --- |
| Non Vitamin K Oral Anticoagulant<br>Dabigatran, Rivaroxaban, Apixaban, Edoxaban | |
| Vitamin K Oral Anticoagulant<br>Warfarin, Acenocoumarol. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic Events |  | 1 year | 
| Bleeding Events |  | 1 year |
Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs

Conditions
-----------------
Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Intervention / Treatment
-----------------
* Procedure: Microcoaxial Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age related, uncomplicated senile cataracts Exclusion Criteria: presence of glaucoma, shallow anterior chamber (ACD < 2.1mm), pupillary dilatation < 6mm, extremely dense cataracts, posterior polar cataract, subluxated cataract, white mature cataract, diabetic retinopathy, high myopia (defined as AL > 25mm), uveitis, or previous ocular trauma/surgery.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DiscoVisc<br>microcoaxial phacoemulsification performed with discovisc | Procedure: Microcoaxial Phacoemulsification<br> <br> |
| Active Comparator: Healon 5<br>microcoaxial phacoemulsification using healon 5 | Procedure: Microcoaxial Phacoemulsification<br> <br> |
| Active Comparator: Celoftal<br>microcoaxial phacoemulsification using celoftal | Procedure: Microcoaxial Phacoemulsification<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal clarity on postoperative day 1 |  | postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central corneal thickness on postoperative day 1 and week 1 |  | day 1 and week 1 |
Control of Leukocyte Function

Study Overview
=================
Brief Summary
-----------------
The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.

Detailed Description
-----------------
The proper regulation of leukocyte function is critical for immune defense and to prevent autoimmune diseases. Many aspects of immune cell regulation are unknown. A better understanding could lead to novel therapeutic approaches to improve immune function in patients suffering from various diseases. The investigators have found that hypertonic conditions regulate leukocyte functions through feedback mechanisms involving ATP release and purinergic receptors. The purpose of the proposed protocol is to obtain access to peripheral blood from healthy volunteers to study these complex regulatory mechanisms in more detail.

Conditions
-----------------
Inflammation, Brain

Intervention / Treatment
-----------------
* Other: No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any healthy volunteer Exclusion Criteria: pregnancy needing/using drugs inflammatory or infectious complications

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

| Intervention/Treatment |
| --- |
|Other: No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies|No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling. | The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept. | Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infection
Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

Study Overview
=================
Brief Summary
-----------------
The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP

Official Title
-----------------
Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

Conditions
-----------------
Doppler Echocardiography

Intervention / Treatment
-----------------
* Procedure: Echo-Doppler examination and left heart catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years Patient performing an echocardiography in the routine clinical practice Informed consent given Exclusion Criteria: Severe valve disease, valvular prostheses, calcification of the mitral valve, the history of myocardial infarction, atrial fibrillation, severe arrhythmias not allowing the Doppler analysis, pacemaker and any image by inadequate Doppler ultrasound Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echocardiography<br> | Procedure: Echo-Doppler examination and left heart catheterization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive evaluation of left ventricular end diastolic pressure | Left heart catheterization | D0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive evaluation of left ventricular end diastolic pressure | Echo-Doppler | D0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E/e' ratio, Doppler echocardiography, filling pressure, Left Ventricular end-Diastolic Pressure
Parkinson Progression Marker Initiative Online (PPMI Online)

Study Overview
=================
Brief Summary
-----------------
Parkinson Progression Marker Initiative Online (PPMI Online) is an observational study collecting participant reported information from people with and without Parkinson's disease (PD), for the goal of better understanding risk and predictive factors for PD. PPMI Online is part of the broader Parkinson Progression Marker Initiative aimed at identifying markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Detailed Description
-----------------
PPMI is a broad program that is expanding the goals of the original PPMI study, and will include this PPMI Online protocol, as well the PPMI Clinical [NCT04477785], PPMI Remote, PPMI Digital protocols (with external regulatory oversight). All participants in PPMI may be asked to participate in one or all of these protocols and their enrollment in these studies may occur in varying order. PPMI participants may also be asked to participate in additional PPMI companion studies (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation

Official Title
-----------------
Parkinson's Progression Markers Initiative Online Study (PPMI Online)

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson Disease (PD) Participants: Male or female age 18 years or older. Has received a diagnosis of Parkinson's disease Participants without PD: Male or female age 18 years or older. Has not received a diagnosis of Parkinson's disease

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

| Intervention/Treatment |
| --- |
|Other: Observation|Observation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale Ib & II | Evaluates self-reported motor and nonmotor Parkinson's disease symptoms | Baseline to 240 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson, Neurodegenerative Disorder, Prodromal, At Risk, Participant Reported Outcomes
A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.

Official Title
-----------------
An Open-Label, Stepwise Basal Insulin Dose Titration Study Using Continuous Subcutaneous Insulin Infusion (CSII) in Oral Antidiabetic Drug-Treated Type 2 Diabetes Mellitus Subjects Followed by a 10-Week Out-Patient Maintenance Phase

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: pump
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes diagnosis at least 2 years ago Body Mass Index (BMI): 26-40 kg/m^2 (both inclusive) HbA1c: 7.5-10% (both inclusive) FPG values at least 140 mg/dl (7.8 mmol/l) Exclusion Criteria: Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers) Current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use Known or suspected allergy to trial products or related products

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pump|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  |  | 
| Plasma glucose profiles |  |  | 
| Frequency of hypoglycemic events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pump, Diabetes