louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00943033: Study of Mindfulness-Based Cognitive Therapy
Official title: Toward Identifying the Mechanisms of Action in Mindfulness-Based Cognitive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: MBCT
Mindfulness-Based Cognitive Therapy
Mindfulness
Meditation
Relapse Prevention
Recurrent Depression
Depression
Major Depressive Disorder
Lead sponsor: Binghamton University
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research aimed at assessing changes in depressogenic thinking and the ability to disengage from depressogenic thinking following Mindfulness-Based Cognitive Therapy


Eligibility criteria: Inclusion Criteria:

* History of two or more Major Depressive Episodes or history of a Major Depressive Episode lasting at least one year
* Can speak, read, and understand English

Exclusion Criteria:

* Meet Criteria for Current Major Depressive Episode or are in partial remission
* BDI-II score above 19
* Abuse alcohol or drugs
* Current Dysthymic Disorder
* History of: psychosis when not depressed or intoxicated, Mania, Hypomania, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, Bulimia Nervosa

Primary outcomes:
measure: Sustained Attention to Response Task
timeFrame: zero to four weeks pre-treatment and zero to three weeks post-treatment
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire
timeFrame: zero to four weeks pre-treatment and zero to three weeks post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Binghamton University SUNY
name: Sean M. Barnes, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06928233: Association of TNFAIP3 With Immune-mediated TTP
Official title: Association of the TNFAIP3 Genomic Locus With Immune-mediated TTP
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thrombotic Thrombocytopenic Purpura, Acquired
Keywords: A20
iTTP
TNFAIP3
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.


Eligibility criteria: Patients:

Inclusion Criteria:

* Diagnosis of iTTP
* Above 12 years of age
* Caucasian, Italian origin
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients who do not meet the above-listed criteria will be excluded from participation in the study.

Controls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.

Primary outcomes:
measure: Allele frequency of TNFAIP3 variants in cases vs controls
timeFrame: Baseline
Secondary outcomes:
measure: TNFAIP3 (A20) mRNA expression levels in peripheral blood
timeFrame: Baseline
measure: Association between TNFAIP3 genotype and gene expression
timeFrame: Baseline
measure: Clinical relapse rate of iTTP during follow-up
timeFrame: Baseline
measure: Severity of acute iTTP episodes
timeFrame: Baseline
measure: Age at iTTP onset
timeFrame: Baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Ilaria Mancini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01256151: Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Official title: Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety Disorder
Keywords: Bioequivalence
sublingual
alprazolam
pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Signed informed consent.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities
* Positive drug screen, excessive alcohol and tobacco use

Primary outcomes:
measure: Area under the curve (AUC) from time zero to last measurable time of alprazolam
timeFrame: 72 hours
measure: Peak concentration of alprazolam
timeFrame: 72 hours
Secondary outcomes:
measure: Area under the curve from time zero to infinity
timeFrame: 72 hours
measure: AUC% extrapolated
timeFrame: 72 hours
measure: Time of Cmax
timeFrame: 72 hours
measure: half-life of alprazolam
timeFrame: 72 hours
measure: Clinically significant safety laboratory tests
timeFrame: Screening, Day 0, Day 4
measure: Clincally significant vital signs
timeFrame: Screening, Day 4
measure: Clinically significant adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03977051: Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients
Official title: Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence, Medication
Transplantation, Kidney
Keywords: Kidney transplantation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant patients

Brief summary: To describe the beliefs, understanding and experience of immunosuppressant medication adherence in our current transplant patient population through a series of patient focus groups

Detailed description: The investigators want to understand more about why some of our kidney transplant patients find it difficult to take their anti-rejection medicines as intended. It is hoped that if the investigators can improve their understanding of why some patients struggle with their anti-rejection medicines, the investigators will be able to find better ways to help our transplant patients and so fewer patients may develop problems with their transplant. This study will collect qualitative data from a series of focus groups with kidney transplant recipients to explore their beliefs, understanding and experience of anti-rejection medication adherence. The focus groups will also explore the support that participants have received to help them with their medication adherence and what support they feel should be available to them and to others in the future to optimise anti-rejection medication adherence in transplant patients. Five focus groups will be undertaken. Each focus group will include six patients and will last for approximately 1.5 hours. All participants will be kidney transplant recipients transplanted and followed up at Imperial College Renal and Transplant Centre.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients transplanted and under the active follow up of ICRTC.
* Speak and understand English
* 18 years and above

Exclusion Criteria:

* Unable to speak and understand English
* Below 18 years

Primary outcomes:
measure: Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant
timeFrame: 4 months
measure: Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence
timeFrame: 4 months
measure: Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Renal and Transplant Centre
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Dawn Goodall, MSC, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168051: Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
Official title: A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hemophilia A
Keywords: Hemophilia A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.


Eligibility criteria: Inclusion Criteria:

* Severe hemophilia A
* Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria:

* Hypersensitivity to any recombinant Factor VIII product
* History of or current Factor VIII inhibitor
* Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study

Primary outcomes:
measure: Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary outcomes:
measure: Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Atlanta
country: United States
state: Georgia
city: Iowa City
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: Brussels
country: Belgium
city: Paris
country: France
city: Berlin
country: Germany
city: Munster
country: Germany
city: Milano
country: Italy
city: Amsterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Christchurch
country: New Zealand
city: Manchester
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For New Zealand, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03350451: An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1
Official title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients With Primary Hyperoxaluria Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PH1
Primary Hyperoxaluria
RNAi Therapeutic
siRNA
AGT
Keywords: Hyperoxaluria, Primary
Hyperoxaluria
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with Primary Hyperoxaluria Type 1.


Eligibility criteria: Inclusion Criteria:

* Enrollment within 12 months of completion of Study ALN-GO1-001
* In the opinion of the investigator tolerated the study drug
* If taking Vitamin B6 (pyridoxine), willing to remain on a stable regimen for the study duration
* Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Clinically significant health concerns (with the exception of PH1)
* Clinically significant cardiovascular abnormality
* Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant
* Requirement for chronic dialysis

Primary outcomes:
measure: Number of Participants With at Least One Adverse Event (AE)
timeFrame: Baseline (Day -1) up to 54 months
Secondary outcomes:
measure: Change From Baseline in 24-hour Urinary Oxalate Corrected for Body Surface Area (BSA) at 54 Months
timeFrame: Baseline (Day -1) up to 54 months
measure: Change From Baseline in 24-hour Urinary Oxalate:Creatinine Ratio at 54 Months
timeFrame: Baseline (Day -1) up to 54 months
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 54 Months
timeFrame: Baseline (Day -1) up to 54 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinical Trial Site
city: Lyon
country: France
facility: Clinical Trial Site
city: Paris
country: France
facility: Clinical Trial Site
city: Bonn
country: Germany
facility: Clinical Trial Site
city: Haifa
country: Israel
facility: Clinical Trial Site
city: Jerusalem
country: Israel
facility: Clinical Trial Site
city: Amsterdam
country: Netherlands
facility: Clinical Trial Site
city: Birmingham
country: United Kingdom
facility: Clinical Trial Site
city: London
country: United Kingdom
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00697151: Patent Foramen Ovale in Cryptogenic Stroke Study
Official title: Patent Foramen Ovale in Cryptogenic Stroke Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Patent Foramen Ovale
Keywords: cerebrovascular diseases
ischemic stroke
patent foramen ovale
warfarin
aspirin
transesophageal echocardiography
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-06-13
Enrollment: 630
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.


Eligibility criteria: Inclusion Criteria:

* Age 30-85
* Ischemic stroke within 30 days
* Glasgow outcome scale ≥ 3
* No contraindications to warfarin/aspirin

Exclusion Criteria:

* Basal INR \> 1.4
* Post-procedural stroke
* Severe carotid atherosclerosis
* Cardioembolic stroke
* Contraindications to transesophageal echocardiography

Primary outcomes:
measure: Recurrent ischemic stroke and death
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Shunichi Homma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP; PFO in Cryptogenic Stroke Study (PICSS) Investigators. Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study. Circulation. 2002 Jun 4;105(22):2625-31. doi: 10.1161/01.cir.0000017498.88393.44.
citation: Homma S, DiTullio MR, Sacco RL, Sciacca RR, Mohr JP; PICSS Investigators. Age as a determinant of adverse events in medically treated cryptogenic stroke patients with patent foramen ovale. Stroke. 2004 Sep;35(9):2145-9. doi: 10.1161/01.STR.0000135773.24116.18. Epub 2004 Jul 1.
citation: Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP. Atrial anatomy in non-cardioembolic stroke patients: effect of medical therapy. J Am Coll Cardiol. 2003 Sep 17;42(6):1066-72. doi: 10.1016/s0735-1097(03)00907-0.
citation: Di Tullio MR, Russo C, Jin Z, Sacco RL, Mohr JP, Homma S; Patent Foramen Ovale in Cryptogenic Stroke Study Investigators. Aortic arch plaques and risk of recurrent stroke and death. Circulation. 2009 May 5;119(17):2376-82. doi: 10.1161/CIRCULATIONAHA.108.811935. Epub 2009 Apr 20.
Clinical trial NCT01224951: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
Official title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of the study are:

-to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids)

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.
3. these subgroups have different responses to anti-inflammatory treatment.


Eligibility criteria: Inclusion Criteria:

* steroid naive asthmatics

Exclusion Criteria:

* viral/bacterial/fungal infection +fever(\<1month)
* asthma exacerbation (\<3months)
* other airway diseases (CF, ciliary dyskinesia, bronchiectasis)

Primary outcomes:
measure: sputum cytokine mRNA levels
timeFrame: 6 and 10 weeks
Secondary outcomes:
measure: steroid-responsiveness
timeFrame: 6 and 10 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Dominique MA Bullens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Sven F Seys, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT04285151: Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes
Official title: Evaluation of Nd:YAG Laser Hyaloidotomy for Management of Premacular Subhyaloid Hemorrhage in Eyes With Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has been used to evacuate the premacular hemorrhage


Eligibility criteria: Inclusion Criteria:

* Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.
* Eyes with proliferative diabetic retinopathy

Exclusion Criteria:

* Dense media opacity (corneal/cataract)
* Patients with bleeding tendency or on anti-coagulant drugs

Primary outcomes:
measure: Visual acuity improvement
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: