louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07000110: Anifrolumab Malignancy and Serious Infections Study
Official title: A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: malignancies, infections, anifrolumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2025-06-02
Enrollment: 3506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care (SOC) who do not initiate anifrolumab.

Brief summary: This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.

Detailed description: This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.

Eligibility criteria: Inclusion Criteria:

* First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date
* A minimum data availability of 12 months prior to index date
* Age ≥18 years at index date
* SLE severity: patients with moderate to severe SLE at index date
* SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date

Exclusion Criteria:

* A diagnosis of any malignancy prior to index date
* A diagnosis of HIV/AIDS or congenital immunodeficiency prior to index date
* Organ or bone marrow transplant procedure prior to index date
* A diagnosis of serious infection in the previous 6 months

Primary outcomes:
measure: Malignancies
timeFrame: Indexdate to November 2031
measure: Serious infection
timeFrame: Indexdate to November 2027
measure: Infections leading to hospitalisation
timeFrame: Index date to November 2027
measure: Infection-related death
timeFrame: Indexdate to November 2027
Secondary outcomes:
measure: Specific types of malignancies
timeFrame: Indexdate to November 2031
measure: Serious infection components
timeFrame: Indexdate to November 2027
measure: Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately)
timeFrame: Indexdate to November 2027
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02114710: Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Official title: Study of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coagulation Dysfunction in Septic Shock
Hemodynamic Improvement Induced by Hydrocortisone
Keywords: coagulopathy
hydrocortisone
organ failure
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

Detailed description: Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Eligibility criteria: Inclusion Criteria:

* All patients(age≧18y)
* Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1\~3)

Exclusion Criteria:

* Lactation
* Mental disorders
* Disseminated cancer
* Secondary cancers
* Inflammatory bowel disease, or diseases hindering epidural analgesia

Primary outcomes:
measure: death
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: clinical perioperative complications
timeFrame: 30 days after inclusion
measure: clinical complications
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05072210: Mobile Interventions for the Prevention and Detection of Distress
Official title: Could Mobile-based Interventions Aid To "Understand and Flatten the Curve" of Stress, Anxiety, Distress and Depression Among Healthcare Providers at Unity Health Toronto During and After the COVID-19 Pandemic?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress
Loneliness
Keywords: Depression
Anxiety
Stress
Loneliness
Mobile Intervention
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
name: University of Toronto
First posted: 2021-10-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon logging into the study platform, half of the participants will be automatically randomized to receive (for 4 weeks) daily-personalized automated alerts (The mobile intervention). This feature will be made available to all participants after 4 weeks. Hence, for the first 4 weeks, this study can be described as having a parallel group study model. After 4 weeks, the study switches to a single group study model, and can therefore be described as having a single group interventional model after 4 weeks from the start date until the rest of the duration of the study.
Primary purpose: OTHER

Brief summary: Stress, anxiety, distress and depression are exceptionally high among healthcare providers at the frontline of the COVID-19 pandemic. Knowledge of factors underlying distress and resilience and evidence based interventions to impact the mental wellbeing of frontline healthcare providers is limited. This study will evaluate a novel mobile platform to gather the "distress experience" of healthcare workers at Unity Health Toronto in real time during and after the COVID-19 pandemic, use automated personalized mobile interventions (e.g. routine, sleep, exercise) to nudge active/passive parameters to manage distress.


Eligibility criteria: Inclusion Criteria:

* Staff or healthcare providers working at Unity Health Toronto
* 18 years of age or older
* Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher)

Exclusion Criteria:

* Non-Unity Health Toronto staff

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: At 4 weeks from baseline
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: At 12 weeks from baseline
measure: Active Data - Short UCLA Loneliness Scale
timeFrame: At 4 weeks from baseline
measure: Active Data - Generalized Anxiety Disorder Scale
timeFrame: At 4 weeks from baseline
measure: Active Data - Patient Health Questionnaire
timeFrame: At 4 weeks from baseline
measure: Passive Data - GPS Sample Point Metrics
timeFrame: At 4 weeks from baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Venkat Bhat, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823210: Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Disorders
Official title: Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Neoplasms (CTIM3)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myeloproliferative Neoplasms
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Philadelphia-negative Myeloproliferative neoplasms (MPN)

Brief summary: Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples


Eligibility criteria: Inclusion Criteria:

* Patients suffering from Myeloproliferative neoplasms (MPN) diagnosed between 2005 and 2013
* Sample DNA diagnostics available: 500 mcg
* Untreated or treated with hydroxyurea, ruxolitinib, alpha interferon,
* Patient has given his(her) own consent for the use of the sample for research on the pathology and genetic analyzes

Exclusion Criteria:

* Refused to participate
* Patient treated with another molecule that hydroxyurea, ruxolitinib, or alpha interferon

Primary outcomes:
measure: cumulative incidence or progression
timeFrame: inclusion
Secondary outcomes:
measure: Disease phenotype according to WHO classification
timeFrame: 3 years
measure: Treatment response/resistance
timeFrame: 3 years
measure: Mean life-years gained
timeFrame: 3 years
measure: Quality-adjusted life years gained
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigations Cliniques
city: Paris
country: France
facility: Centre d'Investigations Cliniques
Study officials:
References:
Clinical trial NCT03426410: National Recommendations and the Actual Rehabilitation Provided for Low Back Pain Patients
Official title: Concordance Between the National Recommendations and the Actual Rehabilitation Provided for Low Back Pain Patients Referred to Primary Care Rehabilitation. A Survey of Public and Private Health Care Providers in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Guideline Adherence
Low Back Pain
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes physical therapists in Central Denmark Region working with low back pain rehabilitation in the primary sector, either as a public or a private provider.

Brief summary: Purpose and background:

The purpose of the study is to investigate physiotherapeutic courses of rehabilitation in the primary sector for low back pain patients. This is done by identifying both how physiotherapeutic rehabilitation is organized in the primary sector and further what different types of physiotherapeutic interventions are offered for this patient group. Furthermore the study aims to evaluate to what extent existing physiotherapeutic rehabilitation practice adheres with the national and international guidelines and recommendations for low back pain rehabilitation.

Methods:

A quantitative survey is carried out, which includes development and validation of a questionnaire for the purpose, and this is subsequently distributed electronically to private and public providers of physiotherapy rehabilitation in all 19 municipalities in Central Denmark Region. Approximately 500 physiotherapists will be asked to participate in the survey in the period February to March 2018.


Eligibility criteria: Inclusion Criteria:

* physical therapists working with low back pain rehabilitation in the primary sector in Central Denmark Region

Exclusion Criteria:

* physical therapists that have less than 1 consultation per week with low back pain patients.

Primary outcomes:
measure: Guideline adherence
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Silkeborg Regional Hospital
name: Nanna Rolving, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012310: Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
Official title: A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetics safety tolerability multiple dosing
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects btween the ages of 18-55 years
* Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
* Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
* Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.

Primary outcomes:
measure: Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
timeFrame: days 1-15
measure: Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
timeFrame: days 1-15
Secondary outcomes:
measure: pharmacokinetics of alternative formulations
timeFrame: days 1-15
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05740410: Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
Official title: Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Lead sponsor: Klinikum Arnsberg
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated in the vascular center of the clinic

Brief summary: The aim of the study is to evaluate the safety and performance of the ClotTriever catheter in the treatment of patients with symptomatic iliofemoral deep vein thrombosis (DVT)

Detailed description: Data from patients in whom the ClotTriever catheter was used for treatment of iliofemoral DVT was retrospectively collected for up to 6 months after the procedure for evaluation of safety and effectiveness.

Eligibility criteria: Inclusion Criteria:

* uni or bilateral iliofemoral DVT

Exclusion Criteria:

* previously stented in treatment vein

Primary outcomes:
measure: Procedural success
timeFrame: directly after treatment of the vein (Day 0)
Secondary outcomes:
measure: Incidence of ClotTriever related major adverse events (MAE)
timeFrame: 1 month
measure: Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)
timeFrame: directly after treatment of the vein (Day 0)
measure: Vilallta score
timeFrame: Day 0, month 1 and 6
measure: Venous clinical severity score (VCSS)
timeFrame: Day 0, month 1 and 6
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland GmbH
Study officials:
affiliation: Klinikum Hochsauerland GmbH
name: Michael H Lichtenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219310: RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
Official title: A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Genital Herpes (RGH)
Keywords: Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.


Eligibility criteria: Inclusion Criteria:

* • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.

  * Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR).
  * Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes

Exclusion Criteria:

* • Female patients who are pregnant or breast-feeding.

  * Current, history or suspicion of liver disease or kidney disease.
  * HIV infected (as confirmed by positive HIV serology).

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
Secondary outcomes:
measure: Change in total score of the Recurrent Genital Herpes Quality of Life.
measure: Safety assessed by adverse events.
measure: Time to first recurrence of genital herpes.
measure: Number of genital herpes recurrences confirmed by PCR.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Bartlett BL, Tyring SK, Fife K, Gnann JW Jr, Hadala JT, Kianifard F, Berber E. Famciclovir treatment options for patients with frequent outbreaks of recurrent genital herpes: the RELIEF trial. J Clin Virol. 2008 Oct;43(2):190-5. doi: 10.1016/j.jcv.2008.06.004. Epub 2008 Jul 14.
Clinical trial NCT05494710: Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
Official title: Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Malformations
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Teesside University
First posted: 2022-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group of patients receiving same treatment
Primary purpose: TREATMENT

Brief summary: The aim of the BEST study is to examine the feasibility of assessing patient and clinician reported outcome of a single electrosclerotherapy treatment of vascular malformations.

* Sclerotherapy = injection of Bleomycin into vascular birthmarks to seal off abnormal vascular channels
* Electroporation = application of an electric field to vessels treated with a handheld needle electrode
* Electrosclerotherapy = a combination of Bleomycin sclerotherapy and electroporation


Eligibility criteria: Inclusion Criteria:

* New patients presenting with a vascular malformation suitable for Bleomycin sclerotherapy treatment
* Existing patients presenting with a poor response to treatment, performed more than 6 months ago
* Placement of a needle electrode into the vascular malformation is technically possible
* Evaluation of response to treatment is possible on photo documentation
* Patients agreeing to participate in the study
* The ability to understand written and spoken English

Exclusion Criteria:

* Patients not agreeing to participate in the study
* Pregnancy
* Breastfeeding
* Previous high systemic Bleomycin exposure (more than 3000 IU)
* Patients unable to provide written, informed consent
* Patients in which needle electrode placement is not possible
* Response to treatment not evaluable by photo documentation
* Patients unable to speak English

Primary outcomes:
measure: Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment
timeFrame: 8 weeks
measure: Clinician assessment tool of treatment response
timeFrame: 8 weeks
Secondary outcomes:
measure: To collect documented side effects following electrosclerotherapy treatment.
timeFrame: 2 years
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
Study officials:
References: