louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02616939: Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd
Official title: Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Multidetector computed tomography
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
Collaborators: name: Arineta Ltd.
First posted: 2015-11-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical indication for cardiac CT

Brief summary: Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.

Detailed description: The study will evaluate a new twin source relatively compact CT scanner with advanced technology which is optimized for cardiovascular imaging. Eligible patients with a clinical indication will undergo coronary or cardiac CT scans using the new SpotLight CT from Arineta Ltd. Image quality and usefulness of the new system will then be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Symptomatic patients with a clinical indication for cardiac CT
2. Patients with a clinical indication for CT
3. Estimated GFR \> 60 mL/min

Exclusion Criteria:

1. No clinical indication for CT scanning
2. Contra-indication for CT scanning or for IV contrast administration
3. Pregnancy
4. Inability to give an informed consent

Primary outcomes:
measure: Image quality (subjective) of the new SpotLight CT scanner from Arineta Ltd.
timeFrame: 2 years
measure: Image quality (objective) of the new SpotLight CT scanner from Arineta Ltd.
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd.
timeFrame: 2 years
measure: The effect of cardiac CT results (with SpotLight CT) on patients triage
timeFrame: 5 years
measure: The predictive value of cardiac CT results (with SpotLight CT) for patients outcome
timeFrame: 5 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Ronen Rubinshtein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03117439: Beta-Glucan Driven vs. Empirical Antifungal Therapy in Critically Ill Patients
Official title: (1-3)-Beta-D-Glucan Driven vs. Empirical Antifungal Therapy in High Risk Critically Ill Patients A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antifungal Agents
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is aimed to compare the duration of standard anti fungal therapy in high risk ICU patients with a strategy driven by BetaDGlucan test result


Eligibility criteria: Inclusion Criteria:

* ICU admission (minimum of 48 hours in ICU with an expected length of stay of at least 48 hours)
* Ongoing Mechanical Ventilation
* Presence of CVC
* Sepsis/Septic Shock development while receiving broad spectrum antibiotics
* Positivity of Candida Score or Candida Colonization Index in absence of septic shock

Exclusion Criteria:

* Complicated Candida Infection
* Already ongoing anti fungal therapy
* Beta Glucan test not available
* Absence of informed consent
* Immunesuppressive status (long-term immunesuppresive or steroids therapy; AIDS; WBC \<1000/mmc or neutrophils \<500/mmc)
* Pregnancy
* Already enrolled in other interventional studies

Primary outcomes:
measure: Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach
timeFrame: First 30 days from enrollment
Secondary outcomes:
measure: Clinical Cure of Invasive Canididiasis
timeFrame: 90 days
measure: Microbiological eradication of Invasive Candidiasis
timeFrame: 90 days
measure: 30-day mortality
timeFrame: 30 days
measure: ICU mortality
timeFrame: 90 days
measure: Hospital mortality
timeFrame: 90 days
measure: Duration of ICU length of stay
timeFrame: 90 days
measure: Duration of mechanical ventilation
timeFrame: 90 days
measure: Number of invasive Candida Infections and Beta-Glucan accuracy
timeFrame: 90 days
measure: Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Gennaro De Pascale
Study officials:
References:
citation: De Pascale G, Posteraro B, D'Arrigo S, Spinazzola G, Gaspari R, Bello G, Montini LM, Cutuli SL, Grieco DL, Di Gravio V, De Angelis G, Torelli R, De Carolis E, Tumbarello M, Sanguinetti M, Antonelli M. (1,3)-beta-D-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial. Crit Care. 2020 Sep 5;24(1):550. doi: 10.1186/s13054-020-03265-y.
Clinical trial NCT04345939: Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary Infection Based on GenSeizer Platform
Official title: Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mycobacterium Pulmonary Infection
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Suspected cases of mycobacterial lung infection

Brief summary: Comparison of rapid detection methods of mycobacterial pathogens, GenSeizer v.s. PCR reverse hybridization.

Detailed description: The investigators developed a new platform called GenSeizer, which combines bioinformatics analysis of a large dataset with multiplex PCR-based targeted gene sequencing, to identify eleven major Mycobacterium species implicated in human disease. Simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in M. abscessus, is also feasible. This platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity.

In this study, the investigators plan to verify the detection efficiency of GenSeizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (PCR reverse hybridization) and gold standard method (target sequencing after incubation)

Eligibility criteria: Inclusion Criteria:

* Suspected cases of mycobacterial lung infection

Exclusion Criteria:

* No sputum
* Refused or unable to tolerate bronchoscopy

Primary outcomes:
measure: Detection accuracy
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Haiqing Chu
Study officials:
References:
Clinical trial NCT02720939: ASD-specific Induced Pluripotent Stem Cells for Disease Modeling
Official title: ASD-specific Induced Pluripotent Stem Cells for Disease Modeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample will consist of 10 ASD patients and 10 healthy controls.

Brief summary: Specific Aims:

1. To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear cells (PBMCs) isolated from whole blood of ASD probands and healthy controls.
2. To derive neural progenitor cells (NPCs) and neurons from iPSCs of ASD probands and healthy controls and compare differences between patients and healthy controls to investigate the cellular phenotype of ASD and uncover the pathophysiology of the disease.

Detailed description: Autism spectrum disorders (ASDs) is a common, lifelong impairing childhood-onset neurodevelopmental disorder with clinical and genetic heterogeneity. The etiology of ASD is complicated and remains largely unknown. Evidences indicate the high heritability (54-77%) in ASD, and researchers also found copy number variations (CNVs) play an important role in the etiology of ASD. However, due to the ethical issue, researchers haven't had an appropriate platform to investigate the copy number change effect to date. In the following study, researchers are going to derive ASD-specific induced pluripotent stem cells and neurons for disease modeling.

10 ASD patients and 10 healthy controls will be included in the present study and iPSCs and neurons will be generated from their PBMCs. Electrophysiological recording and analysis of neuronal morphology will be conducted to reveal the cellular phenotype of ASD after comparing differences between patients and healthy controls.

The study will provide a platform to reveal the etiology of genetic basis and molecular mechanism of ASD. The cellular phenotype of ASD will be revealed by comparing differences between patients and healthy controls. The findings from this work are expected to contribute to the basic and clinical research on ASD.

Eligibility criteria: Inclusion Criteria:

* ASD group: Subjects who met the diagnostic criteria of either autistic disorder or Asperger's disorder defined by the DSM-IV criteria.

Exclusion Criteria:

* TD group: Subjects with any current or lifetime DSM-IV psychiatric disorders.

Primary outcomes:
measure: iPSC derivation and characterization
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Univeristy Hospital
Study officials:
affiliation: National Taiwan University Hospital & College of Medicine
name: Susan Shur-Fen Gau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06839339: Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD
Official title: A Phase II, Randomized, Positive-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Single Suprachoroidal Space Injection of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Wet Age-related Macular Degeneration (wAMD)
Lead sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.


Eligibility criteria: Inclusion Criteria:

1. Age≥ 50 and ≤ 85.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. The study eye has response to anti-VEGF injections.
4. The subject or their legal representative agrees to participate in this study and signs a written ICF.

Exclusion Criteria:

1. Non-wAMD induced CNV or macular edema in the study eye.
2. Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
3. Uncontrolled glaucoma in the study eye.
4. History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
5. Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
6. Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
7. Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
8. None of intraocular inflammation in the study eye.
9. Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.

Primary outcomes:
measure: Evaluate the effect of AL-001 on BCVA
timeFrame: Week 24
Secondary outcomes:
measure: Safety
timeFrame: Week 56
measure: Evaluate the effect of AL-001 on central retinal thickness (CRT)
timeFrame: Week 56
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Hospital
Study officials:
References:
Clinical trial NCT01678339: Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
Official title: Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Coronary Syndrome
Acute Myocardial Infarction
Keywords: ACS
AMI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients discharged alive from an hospitalization for Acute Myocardial Infarction (AMI) between January, 1st 2008 and December, 31st 2010 (inclusion period) will be included into analysis. The discharge date will be defined as "inclusion date".

Brief summary: Thi is an observational, non interventional, cohort analysis by using administrative databases (drugs treatment, laboratory and diagnostic tests, specialist visits and hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute Coronary Syndrome (ACS) event.

Detailed description: HEALTH-DB ACS

Eligibility criteria: Inclusion Criteria:

* Subjects discharged alive from hospitalization for ACS

Exclusion Criteria:

* All patients that don't have a continuative presence as beneficiaries of the region between January 1st, 2007 and December 31st 2011 will be excluded from analysis.

Primary outcomes:
measure: The diagnostic path for each patient included in the analysis will be described by using all prescription for laboratory test (eg. total cholesterol, LDL cholesterol) and/or diagnostics tests (eg. electrocardiogram) during the observation period.
timeFrame: up to 2 years
measure: The drugs treatment path will be described by using all prescriptions of antihypertensive drugs, lipid-lowering drugs and antiplatelet drugs during the observation period.
timeFrame: up to 2 years
measure: Adherence to treatment will be calculated in the manner suggested by the literature and used in previous publications. Different methods of assessment will, however, used in order to study the variability of results. The analysis will be conducted over
timeFrame: up to 2 years
measure: The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions.
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca CLINICAL RESEARCH DIRECTOR
name: Flore La Tour
role: STUDY_CHAIR
affiliation: AstraZeneca Italy - VP MEDICAL
name: Raffaele Sabia
role: STUDY_DIRECTOR
affiliation: Department of Pharmaceutical Health - SICILIAN REGION
name: Rosalia Traiana, Doctor of Pharmacology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03175939: Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma
Official title: Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Cancer
Keywords: adjuvant chemotherapy
NPC
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

Detailed description: The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Eligibility criteria: Inclusion Criteria:

* (1) biopsy-proven carcinoma of the nasopharynx,
* (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
* (3) normal renal function (Cr \< 1.6 mg/dl),

Exclusion Criteria:

* open-neck lymph node biopsy
* previous chemotherapy or radiotherapy to the head and neck region
* distant metastasis or other malignant diseases except skin cancer

Primary outcomes:
measure: Distant-metastasis-free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: disease-free survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Koo Foundation Sun Yat-Sen Cancer Center
name: Skye Hung-Chun Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873639: Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 417
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 diabetes patients from diabetes centres who have been deemed appropriate to receive NovoRapid® and Levemir® as new treatment in basal-balus regimen and as part of routine care by the prescribing physician.

Brief summary: This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.


Eligibility criteria: Inclusion Criteria:

* Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen

Exclusion Criteria:

* Subjects currently being treated with insulin aspart and insulin detemir
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin aspart or to any of the excipients
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients
* Women who are pregnant or have the intention of becoming pregnant within next 6 months

Primary outcomes:
measure: Change in HbA1c
timeFrame: at 24 weeks from baseline
Secondary outcomes:
measure: Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in FPG (glucose variability)
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in PPG (postprandial control)
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in insulin dose and number of injections
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in body weight
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in number of hypoglycaemic events
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Number of adverse drug reactions (ADR)
timeFrame: at 12 weeks and 24 weeks of treatment
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01755039: Course and Complications of Invasive Out-of-hospital Ventilation
Official title: Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indication for Invasive Out-of-hospital Ventilation
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indication for out-of-hospital ventilation

Brief summary: The purpose of the study is to determine the frequency and management of respiratory incidence in patients with invasive out-of-hospital ventilation, either living at home for elderly people allay to a weaning centre or at home. Further, the mortality and the frequency of hospital admission will be analyzed.

Detailed description: Background: There has been arise in a number of patients requiring long term ventilation both in the in-hospital as well as the out-of-hospital setting. Despite this, little is known about the subsequent political course of this patients following hospital discharge.

Interventions: This is an observational prospective study over a period of one year in a sample of 50 to 70 invasively ventilated patients living either in a nursing home specialized in the care of ventilated patients or at home. Protocol had been developed containing 20 suspected emergency incidences in respiratory care. The nursing staffs are instructed about the study and how to complete the protocol. The protocol was placed at each patient and every time an emergency occurred, the nursing staff registered the incidence. If an emergency fulfils more than one criterion in the protocol, every applicable criterion was marked. The data will be analyzed using non-parametric descriptive statistics.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* existing out-of-hospital ventilation \>6h in 24h

Exclusion Criteria:

* Age \<18 years
* absence of declaration of consent

Primary outcomes:
measure: Respiratory Incidences
timeFrame: Over a 12-month period, monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien e.V.
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: