louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02712918: Brief Behavioral Activation Treatment for Depression With Inpatients
Official title: An Evaluation of Brief Behavioral Activation Treatment for Depression With Moderate to Severely Depressed Inpatients - A Small Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Inpatient
Acute
Brief Behavioral Activation Treatment for Depression
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
First posted: 2016-03-18
Enrollment: 23
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: The purpose of the current study was to examine Brief Behavioral Activation Treatment for Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. The study is a systematic replication of a randomized controlled trail from 2003, that provided initial support for BATD With inpatients. The current study compared BATD to Treatment as Usual in a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe depression (BDI-II \> 28 Points).
* Admission length of at least 3 days
* Evaluated to benefit from depression treatment by unit psychiatrist.

Exclusion Criteria:

* Current psychotic disorder
* Previously diagnosis with psychotic disorder (including Bipolar disorder)

Primary outcomes:
measure: Change of Beck's Depression Inventory-II from baseline
timeFrame: Change from baseline (second day of admission) to discharge from the ward (maximum 21 days, expected average of 10 days).
Secondary outcomes:
measure: Credibility and Expectancies Questionnaire
timeFrame: Second day of admission. After first sessions of BATD.
measure: Treatment Evaluation Inventory - Short Form
timeFrame: Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..
Other outcomes:
Locations:
Study officials:
References:
citation: Lejuez CW, Hopko DR, Hopko SD. A brief behavioral activation treatment for depression. Treatment manual. Behav Modif. 2001 Apr;25(2):255-86. doi: 10.1177/0145445501252005.
citation: Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
citation: Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.
Clinical trial NCT01604018: An Optional Two Year Follow Up Study to Study CP005A
Official title: An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cat Allergy
Rhinoconjunctivitis
Keywords: Cat Allergy
Rhinoconjunctivitis
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Cetero Research, Toronto
First posted: 2012-05-23
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.

Brief summary: Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.

Detailed description: Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.

Eligibility criteria: Inclusion Criteria:

- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to cat allergen
* Subjects with an FEV1 \< 70% of predicted
* Subjects who cannot tolerate baseline challenge in the EEC
* Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
* Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: 102-106 weeks after the start of treatment in CP005
Secondary outcomes:
measure: Total Symptom scores for ocular and nasal symptoms
timeFrame: 102-106 weeks after the start of treatment in CP005
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Peter Couroux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06081218: Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users
Official title: Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis User
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The endocannabinoid system (ECS) is a complex endogenous signaling system made up of transmembrane cannabinoid receptors (CB1 and CB2 receptors), their endogenous lipid-derived ligands (the endocannabinoids - eCBs), and enzymes for ligand biosynthesis and degradation. Interestingly, exercise increase plasma AEA, one of the most famous endocannabinoid. This increase could be involved in exercise-induced neurogenesis and other beneficial exercise adaptations. Chronic cannabis use is associated with alteration of ECS activity. The aim of the study is to compare ECS response to exercise between chronic cannabis users and non-users.


Eligibility criteria: Inclusion Criteria:

Cannabis consumer group:

* Cannabis consumption \> 100 times in lifetime, last exposure \< 7 days, and recent exposure \> 10 times in the month.
* Positive toxicological urine test for ∆-9-THC.
* Having a cannabis use disorder according to the CAST.

Healthy group:

* Negative urine toxicological test for cannabis.
* No regular cannabis use for more than 6 months once in a lifetime.
* No cannabis consumption in the 6 months preceding the study.

Exclusion Criteria:

For all subjects :

* Disorders of use of other substances (alcohol, cocaine, opioid, or synthetic drugs).
* Alcohol consumption greater than 30g per day (averaged over one week) and/or alcohol abuse the week preceding the visit.
* Under medical treatment.
* Presence of diagnosed neurological disorders.
* Diagnosis of a psychotic picture entering axis I, DSM-5.
* Chronic progressive disease or in remission.
* Body mass index \> 30 kg/m2 (i.e. presence of obesity).

Primary outcomes:
measure: Plasma endocannabinoids levels (pmol/ml)
timeFrame: 2 weeks
Secondary outcomes:
measure: regulating hormone of endocannabinoids (plasma levels of cortisol, ng/ml)
timeFrame: 2 weeks
measure: Blood marker of neurogenesis and neuroplasticity (plasma levels and BDNF, pg/ml)
timeFrame: 2 weeks
measure: change in cerebral muscular, oxygenation (HHB), (HbO2), (Hbtot) (arbitrary unit)
timeFrame: 2 weeks
measure: Cognitive function (selective attention, stroop test)
timeFrame: 2 weeks
measure: Oxygen consumption (VO2) (ml/min/kg)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
Study officials:
References:
Clinical trial NCT00099918: Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 717
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Adverse event profile after 24 weeks of treatment
measure: Patients with endpoint HbA1c <7% at 24 weeks
measure: Patients with reduction in HbA1c >/= 0.7% after 24 weeks
measure: Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
facility: Novartis Investigative Sites
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX, Mills D, Dejager S. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab. 2008 Sep;10(10):931-8. doi: 10.1111/j.1463-1326.2007.00835.x. Epub 2007 Dec 17.
citation: Pratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007 Dec;30(12):3017-22. doi: 10.2337/dc07-1188. Epub 2007 Sep 18.
citation: Rosenstock J, Baron MA, Dejager S, Mills D, Schweizer A. Comparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trial. Diabetes Care. 2007 Feb;30(2):217-23. doi: 10.2337/dc06-1815.
Clinical trial NCT06493318: Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability
Official title: Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wrist Disease
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent ligamentoplasty for scapholunate instability

Brief summary: Prospective longitudinal multicenter observational cohort study conducted on a population of patients who underwent ligamentoplasty for scapholunate instability and agreed to be followed for a period of five years from the day of hospital discharge.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old who has been informed about the study and has not objected to the use of their personal data
* Patient who has undergone dorsal ligamentoplasty reinforced with an internal brace for scapholunate instability

Exclusion Criteria:

* Mental deficiency or any other reason that may interfere with understanding or strict application of the protocol
* Patient under legal protection, guardianship, or conservatorship

Primary outcomes:
measure: Ligamentoplasty failure
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clinique Monticelli - Vélodrome
Study officials:
References:
Clinical trial NCT04692818: 3D Ultrasound Breast Imaging
Official title: 3D Multimodal Ultrasound Imaging for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Tumor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-01-05
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.


Eligibility criteria: Inclusion Criteria:

* Adult women ≥ 18 years of age.
* solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)
* lesion size of 3mm or larger

Exclusion Criteria:

* \< 18 years of age.
* Lacking capacity to consent
* Pregnant or lactating
* Receiving cancer therapy such as chemotherapy or radiation therapy

Primary outcomes:
measure: BI-RADS Score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shigao Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic in Rochester
name: Christine Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05121818: Prospective Acute Myocardial Infarction Data Bank
Official title: Creation of a Prospective Acute Myocardial Infarction Data Bank
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myocardial Infarction
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai 10th People's Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2021-11-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myocardial infarction will be enrolled into the study based on the inclusion/exclusion criteria. No randomisation will be performed.

Brief summary: In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. All data are from patients treated in 5 centers in Shanghai，including Zhongshan Hospital of Fudan University, Shanghai Renji Hospital，Shanghai Tenth People's Hospital，Shanghai First People's Hospital, and Shanghai Tongji Hospital.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction was diagnosed based on the Fourth Universal Definition of Acute myocardial infarction criteria. The term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: Symptoms of myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; Identification of a coronary thrombus by angiography or autopsy.

Exclusion Criteria:

* life expectancy of less than 12 months
* malignant tumor
* pregnancy or plans of pregnancy in the one year
* any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling

Primary outcomes:
measure: Database of patients with acute myocardial infarction
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01749618: Closing the Gap in Care in Seronegative Inflammatory Arthritis
Official title: Closing the Gap in Care in Seronegative Inflammatory Arthritis: From Identification to Implementation of Treating to Target: A Randomized Trial of Feedback, Education, and Behavioural Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SpA
PsA
Keywords: Seronegative Inflammatory Arthritis
SpA
PsA
Randomized
Behavioural Change
Lead sponsor: Pope Research Corporation
Sponsor class: INDUSTRY
Collaborators: name: Academic Medical Organization of Southwestern Ontario
name: Abbott
First posted: 2012-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. Six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.


Eligibility criteria: Inclusion Criteria:

* Canadian Rheumatologist

Exclusion Criteria:

Primary outcomes:
measure: Improvement of Systematic Assessments
timeFrame: November 2012 - November 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Dr. Vandana Ahluwalia
state: Ontario
city: Burlington
country: Canada
facility: Dr. Sanjay Dixit
state: Ontario
city: Hamilton
country: Canada
facility: Dr Pauline Boulos
state: Ontario
city: London
country: Canada
facility: Dr. Nikhil Chopra
state: Ontario
city: Mississauga
country: Canada
facility: Dr Angela Montgomery
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology
state: Ontario
city: Peterborough
country: Canada
facility: The Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Dr. Arthur Karasik
state: Ontario
Study officials:
affiliation: Pope Research Corp., St. Joseph's Health Care, Western University
name: Janet E Pope, MD, MPH, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03771118: Drug Provocation Test (DPT) to Paracetamol
Official title: Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Keywords: Drug Hypersensitivity Reaction
Drug Provocation Test
Paracetamol
Reactive Doses
Reactive Times
Acetaminophen
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 498
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: Patient consulting in our allergy unit for a suspicion of drug hypersensitivity to Paracetamol and who underwent DPT.

Brief summary: Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).

Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.

Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).


Eligibility criteria: Inclusion criteria:

- Patients with a positive or negative DPT to paracetamol

Exclusion criteria:

* Patients refusing to take part in the study
* Patient under 10 years old

Primary outcomes:
measure: Detect of the reactive dose (RD)
timeFrame: 1 day
Secondary outcomes:
measure: Measure is a positive DPT to paracetamol
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Pascal DEMOLY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: