louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01947504: Early Intervention Following Mild TBI
Official title: Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2013-09-20
Enrollment: 30
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 objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine a model of outcome prediction following mild TBI.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Mild TBI

Exclusion Criteria:

* Psychiatric diagnosis

Primary outcomes:
measure: Recurrence of post-concussive symptoms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
citation: Audrit H, Beauchamp MH, Tinawi S, Lague-Beauvais M, Saluja R, de Guise E. Multidimensional Psychoeducative and Counseling Intervention (SAAM) for Symptomatic Patients With Mild Traumatic Brain Injury: A Pilot Randomized Controlled Trial. J Head Trauma Rehabil. 2021 Jul-Aug 01;36(4):E249-E261. doi: 10.1097/HTR.0000000000000653.
Clinical trial NCT06518304: Effectiveness of GentleWave System in Endodontic Treatment
Official title: Randomized Controlled Trial: Effectiveness of GentleWave System in Endodontic Treatment and Its Impact on Reducing Post- Operative Pain.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Root Canal Infection
Endodontically Treated Teeth
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of the GentleWave® System compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment.

Detailed description: New irrigation modalities such as the GentleWave® System, which integrates advanced multisonic ultrasound technology, have been developed to overcome limitations and improve root canal treatments success rates, by ensuring comprehensive cleaning while minimizing mechanical instrumentation. This system, featuring CleanFlow technology, optimizes the delivery of irrigants and promotes efficient root canal debridement. Postoperative pain is common, usually peaking within the first 24 hours after treatment and decreasing thereafter.

In the presence of necrosis, microorganisms can colonize anatomical complexities, such as isthmuses, ramifications and dentinal tubules causing symptoms such as pain, inflammation, and in some cases even odontogenic sinusitis. Conventional Syringe Irrigation (CSI), which delivers irrigants (NaOCl, EDTA) through a needle-syringe system, often fails to reach the entire working length and the intricate anatomy of the root canal. This inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure; furthermore, positive pressure exerted during CSI may cause the extrusion of irrigants beyond the apex, leading to complications.

Eligibility criteria: Inclusion Criteria:

* Male and female patients from 18 years age or older (maximum of 80 years of age), both genders.
* The patients in need of an endodontic intervention.
* All dental groups in both arches were eligible.
* Patients who do or do not experience symptoms after the endodontic intervention.
* Patient-signed informed consent/assent form

Exclusion Criteria:

* Patients\< 18 years old.
* fractured teeth.
* Patients who were recommended extraction after the endodontic evaluation.

Primary outcomes:
measure: To evaluate whether using the Gentlewave system demonstrates a significant reduction in the level of postoperative pain after endodontic treatment measured by the VAS (Visual Analog Scale).
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: City Endodontics
state: New York
Study officials:
References:
Clinical trial NCT00695604: Repeated High-dose Inhaled Corticosteroids for Asthma
Official title: Repeated High-dose Inhaled Corticosteroids for Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Keywords: Acute asthma
fluticasone
inhaled corticosteroids
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.


Eligibility criteria: Inclusion criteria:

* Physician diagnosis of asthma.
* Age ≥18 years and ≤50 years
* Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.
* Treatment for asthma with:

  * daily inhaled corticosteroids and long-acting beta2-agonists, AND
  * as-needed use of a short-acting beta2-agonist

Exclusion criteria:

* History of \>10 pack-year tobacco use
* Other pulmonary or cardiac diagnosis that is actively being treated
* History of adverse events or allergy to fluticasone
* Systemic corticosteroid therapy within 7 days of study visit
* Inability to obtain written informed consent

Primary outcomes:
measure: Airflow inflammation.
timeFrame: Pre-study and post-study drug administration
Secondary outcomes:
measure: Airflow obstruction.
timeFrame: Pre-study and post-study drug administration
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jerry Krishnan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03701204: Contingency Management for Alcohol Use Disorder
Official title: Integrating Contingency Management Into Routine Care for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: DynamiCare Health
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2018-10-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations \[21 Code of Federal Regulations 812.2(c)

Detailed description: To test the feasibility/acceptability and efficacy of a minimum viable product (MVP) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).

Eligibility criteria: Inclusion Criteria:

Participants in the pilot study will be 60 new intakes to Gosnold's outpatient Substance Use Disorder (SUD) program who:

* are \>18 years old;
* meet DSM-5 criteria for current (past year) alcohol use disorder, at least moderate severity;
* identify alcohol as the primary drug problem;
* Currently use alcohol (past 7 days) or have been in treatment 14 days or less and used alcohol within 7 days of treatment entry;
* have and use an Android or iOS smartphone with acceptable
* capability;
* are willing to participate in home testing and use of the smartphone,
* speak and read the English language adequately to understand smartphone commands and responses and
* are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature.

Exclusion Criteria:

• Participants must not currently be suicidal or actively psychotic, by clinician judgement.

Primary outcomes:
measure: Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
timeFrame: 12-week intervention period
Secondary outcomes:
measure: Percent of participants abstinent from all drugs at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
timeFrame: 12-week intervention period
measure: Longest continuous period of abstinence from alcohol and from drugs and alcohol
timeFrame: 12-week intervention period
measure: Retention in treatment
timeFrame: 12-week intervention period
Other outcomes:
Locations:
city: Centerville
country: United States
facility: Gosnold on Cape Cod
state: Massachusetts
city: Falmouth
country: United States
facility: Gosnold
state: Massachusetts
Study officials:
affiliation: DynamiCare Health
name: Eric Gastfriend, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05155904: Outcomes of Veno Arterial ECMO
Official title: In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mortality
Extra Corporeal Membrane Oxygenation
Keywords: veno arterial
mortality
extra corporeal membrane oxygenation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in Amiens hospital university beneficing of a veno arterial (VA) extra corporeal membrane oxygenation (ECMO).

Brief summary: veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.


Eligibility criteria: Inclusion Criteria:

* age : ≥ 18
* Patient with a VA ECMO

Exclusion Criteria:

* age\<18

Primary outcomes:
measure: In-hospital mortality
timeFrame: Up to hospital discharge, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT03868904: INSPIRE Continuation Post-Approval Study
Official title: OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated in TransMedics OCS Lung System INSPIRE Trial

Brief summary: To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.


Eligibility criteria: Inclusion Criteria:

* Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion Criteria:

* None

Primary outcomes:
measure: Brochiolitis Obliterans Syndrome (BOS) -free survival
timeFrame: 5 years post transplant
Secondary outcomes:
measure: Survival
timeFrame: 5 years
measure: Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Leuven
country: Belgium
facility: University of Leuven Hospital
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Strasbourg
country: France
facility: N.H.C Hospital Civil
city: Berlin
country: Germany
facility: German Heart Institute Berlin
city: Hannover
country: Germany
facility: Hannover Medical School
city: Padua
country: Italy
facility: University of Padua
city: Madrid
country: Spain
facility: Hospital Universitario Puerta De Hierro
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Middlesex
country: United Kingdom
facility: Harefield Hospital
Study officials:
References:
Clinical trial NCT02145104: Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension
Official title: Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-05-22
Enrollment: 286
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy


Eligibility criteria: Inclusion Criteria:

* essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)

Exclusion Criteria:

* sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers

Primary outcomes:
measure: change from baseline in mean sDBP
timeFrame: 8 weeks
Secondary outcomes:
measure: change from baseline in mean sDBP
timeFrame: 4 weeks
measure: change from baseline in mean sSBP
timeFrame: 4, 8 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyung-gi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong Ju Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769804: Gene Polymorphism in Tinea Versicolor
Official title: Detection of IL1-7A and IL-17F Gene Polymorphism in Pityriasis Versicolor and Its Relation to Susceptibility to Infections.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Pityriasis Versicolor
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with history of disseminated TV, with 2 or more episodes of TV per year.

Brief summary: Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F.

In addition , serum samples from patients and controls will be tested for 25(OH)2 D3


Eligibility criteria: Inclusion Criteria:

* - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it.
* Patients of both genders.
* Age ≥18 years old.

Exclusion Criteria:

* - Patients with other cutaneous diseases.
* Patient's having dandruff (scaly scalp) even if not symptomatizing.
* Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects.
* Patients with autoimmune diseases.
* Patients with immunodeficiency diseases.
* Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.

Primary outcomes:
measure: IL 17A gene polymorphism
timeFrame: 6months-1 year
measure: IL 17 F gene polymorphism
timeFrame: 6months-1 year
Secondary outcomes:
measure: Vitamin D
timeFrame: 6months-1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy Hospital, Cairo university
state: El Manial
Study officials:
References:
Clinical trial NCT05850104: Comparison of Classical Prosthesis and Silicone Prosthesis
Official title: Comparison of Classical Prosthesis and Silicone Prosthesis in Patients With Chopart Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Amputation
Keywords: amputation
chopart
satisfaction
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 24 patients with unilateral Chopart amputation

Brief summary: The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

Detailed description: The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.

This study will be useful for prescribing the appropriate prosthesis in patients with Chopart amputation.

Eligibility criteria: Inclusion Criteria:

* Aged between 18-65
* Having a unilateral traumatic Chopart amputation
* To have completed prosthesis training
* Using prosthesis for at least 6 hours a day
* Being at K3-K4 activity level

Exclusion Criteria:

* Bilateral lower extremity amputation
* Presence of wound on stump
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: through study completion, an average of one and a half months
measure: Short Form 36 (SF-36)
timeFrame: through study completion, an average of one and a half months
measure: Locomotor capacity index
timeFrame: through study completion, an average of one month
measure: Likert scale
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: associate professor
name: Merve Örücü Atar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692104: US-CT Fusion for Post Implant Dosimetry
Official title: Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
brachytherapy
Quality assurance
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 25
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.

Brief summary: Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.

Detailed description: 25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.

Eligibility criteria: Inclusion Criteria:

* localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost

Exclusion Criteria:

* Unable to undergo MRI

Primary outcomes:
measure: Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion
timeFrame: 1 month
Secondary outcomes:
measure: Comparison of prostate volume assessed by 2 different imaging modalities
timeFrame: 1 month
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: BC Cancer
name: Francois Bachand, MD
role: STUDY_CHAIR
References: