louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02890173: Study of CS-3150 in Patients With Essential Hypertension
Official title: A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential hypertension
Mineralocorticoid receptor antagonist
Esaxerenone
Ambulatory blood pressure monitoring
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 1001
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

Detailed description: Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.

Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension satisfying the following blood pressure criteria;

  * Sitting SBP: ≥ 140 mmHg and \< 180 mmHg
  * Sitting DBP: ≥ 90 mmHg and \< 110 mmHg
  * Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetic nephropathy or diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L
* Reversed day-night life cycle including overnight workers
* eGFR \< 60 mL/min/1.73 m\^2

Primary outcomes:
measure: Change from baseline in sitting blood pressure
timeFrame: Baseline to end of Week 12
Secondary outcomes:
measure: Change from baseline in 24 hour average blood pressure
timeFrame: Baseline to end of Week 12
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
Study officials:
affiliation: Daiichi Sankyo Co., Ltd.
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Ito S, Itoh H, Rakugi H, Okuda Y, Yoshimura M, Yamakawa S. Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study). Hypertension. 2020 Jan;75(1):51-58. doi: 10.1161/HYPERTENSIONAHA.119.13569. Epub 2019 Dec 2.
Clinical trial NCT03256773: High Resolution Micro OCT Imaging
Official title: Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
COPD
PCD - Primary Ciliary Dyskinesia
Covid19
Sinusitis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.

Brief summary: The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Detailed description: Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.

Eligibility criteria: THE INCLUSION CRITERIA:

* Patients diagnosed with CF or healthy normal controls with no respiratory disease
* Patients must be over the age of 14
* Patient must be able to give informed consent

THE EXCLUSION CRITERIA:

* Patients with recent respiratory infection requiring antibiotics or corticosteroids in the last 4 weeks (excluding routine perioperative antibiotics)
* Patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares
* Any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room
* Female subjects who are pregnant

Primary outcomes:
measure: feasibility of uOCT probe
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Steven M Rowe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710331: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
Official title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cannabis
Alcohol Effect
Driving Under the Influence of Alcohol and Other Drugs
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Detailed description: To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.

Eligibility criteria: Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Exposed to cannabis at least once.
* Exposed to alcohol at least once.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naïve
* Alcohol naïve
* Positive pregnancy screen
* Hearing deficits
* Sesame oil allergy

Primary outcomes:
measure: Change from Baseline: Road Tracking Error
timeFrame: baseline, +100, +210 mins after start of dronabinol administration
Secondary outcomes:
measure: Change from Baseline: Biphasic Alcohol Effects Scale (BAES)
timeFrame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
measure: Change from Baseline: Visual Analog Scale (VAS)
timeFrame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
measure: Change from Baseline: Cognitive Test Battery
timeFrame: baseline, +120 mins after start of dronabinol administration
measure: Change from Baseline: Willingness to Drive Scale
timeFrame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
measure: Change from Baseline: Number of Joints Scale
timeFrame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
measure: Change from Baseline: Number of Drinks Scale
timeFrame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit, VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT03524131: Randomized Controlled Trial on Uptake of NHS Health Checks
Official title: Randomized Controlled Trial to Compare the Effect of Two New Behaviourally Enhanced NHS Health Check Leaflets and the Current Nationally Recommended Leaflet on Uptake of NHS Health Checks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2018-05-14
Enrollment: 12000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The National Health Service (NHS) Health Check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. Public Health England aspires to an uptake rate of 75% but national uptake is less than 50%. This study aims to assess the impact of two new behaviourally informed NHS Health Check leaflets on the uptake of NHS Health Checks, by randomizing patients in Lewisham and North East Lincolnshire to the different leaflets and comparing patient-level uptake data. The study will test whether a shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than the current national leaflet at encouraging uptake of the NHS Health Check.


Eligibility criteria: Inclusion Criteria:

* due to be invited for an NHS Health Check
* aged 40-74

Exclusion Criteria:

* have an existing Cardio-Vascular Disease-related medical condition
* have had an NHS Health Check in the last five years

Primary outcomes:
measure: attendance at NHS Health Check
timeFrame: up to 6 months from time of invitation
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Public Health England
Study officials:
References:
citation: Gold N, Durlik C, Sanders JG, Thompson K, Chadborn T. Applying behavioural science to increase uptake of the NHS Health Check: a randomised controlled trial of gain- and loss-framed messaging in the national patient information leaflet. BMC Public Health. 2019 Nov 14;19(1):1519. doi: 10.1186/s12889-019-7754-5.
Clinical trial NCT00891631: Primary Care iSBIRT to Reduce Serious Teen Health Risks
Official title: Primary Care Internet/Intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) System to Reduce Serious Teen Health Risks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Substance-related Disorders
Depression
High-risk Sex
Keywords: tobacco
alcohol
marijuana
drug use
seat-belt
weapons
depression
suicidality
sexual risk behaviors
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.

Detailed description: We have previously developed and tested a computerized substance use screening and feedback program for adolescents. We will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop Technological Extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.

Eligibility criteria: Inclusion Criteria:

* 12-21 years old
* arriving for non-urgent care
* provide informed assent/consent

Exclusion Criteria:

* less than 6th grade reading level
* unavailable for follow-up questionnaires

Primary outcomes:
measure: frequency of substance use and other risk behaviors
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002131: Exact Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography
Official title: Exact Three-dimensional Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Teeth
Keywords: Digital Volume Tomography
Cone Beam CT
impacted and supernumerary teeth
dental and maxillofacial radiology
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2009-10-27
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients at the St.Olavs University Hospital with impacted and supernummerary teeth in the maxilla who are scheduled to have surgery

Brief summary: The purpose of this investigation is an exact preoperative 3D-localisation of impacted and supernumerary teeth in the maxilla using Cone Beam Computer Tomography

Detailed description: An exact localisation of impacted teeth is often difficult to assume by using conventional radiological techniques like OPT or dental films. In contrast to these two-dimensional imaging methods the Cone Beam Computer Tomography (CBCT) respectively the Digital Volume Tomography (DVT) offers a three-dimensional imaging of the maxillofacial region, providing the opportunity to study objectives in all standard plans with 3D-reconstruction in multisection views.

A preoperative radiological investigation using CBCT on patients who are supposed to undergo surgery for impacted and supernumerary teeth in the frontal maxilla shall clarify the certainty and safeness of this 3D-imaging method. Therefore a comparison between the findings on the CBCT, on eventually former conventional x-rays and the intraoperative finding as gold standard is done.

Eligibility criteria: Inclusion Criteria:

* supernumerary and impacted teeth in the maxilla (wisdom teeth excluded)
* need for surgical removement
* uncertain clinical and conventional radiological finding

Exclusion Criteria:

* refused approval
* CBCT not practicable

Primary outcomes:
measure: exact localisation of impacted teeth
timeFrame: preoperative and under surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: NTNU / St.Olavs Hospital
name: Christoph M Ziegler, Professor
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Thomas R Klimowicz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziegler CM, Klimowicz TR. A comparison between various radiological techniques in the localization and analysis of impacted and supernumerary teeth. Indian J Dent Res. 2013 May-Jun;24(3):336-41. doi: 10.4103/0970-9290.117998.
Clinical trial NCT04029831: Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Comparing the Effect of Different Ratio of Propofol-Ketamine Mixture (Ketofol) (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 58
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: SUPPORTIVE_CARE

Brief summary: Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Detailed description: Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Eligibility criteria: Inclusion Criteria:

* Having ERCP procedures using sedatives
* ASA (American Society of Anesthesiologist) physical status Class I to III
* Body mass index (BMI) of 18-30 kg/m2
* Willing to participate in the study

Exclusion Criteria:

* Patients with a history of allergic reaction to medications used in the study
* Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
* Patients with unstable hemodynamic
* Patients with psychiatric medications
* Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women

Primary outcomes:
measure: Level of Propofol Usage
timeFrame: 1 hour
Secondary outcomes:
measure: Recovery Time
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
References:
citation: Coulter FL, Hannam JA, Anderson BJ. Ketofol dosing simulations for procedural sedation. Pediatr Emerg Care. 2014 Sep;30(9):621-30. doi: 10.1097/PEC.0000000000000222.
citation: Bahrami Gorji F, Amri P, Shokri J, Alereza H, Bijani A. Sedative and Analgesic Effects of Propofol-Fentanyl Versus Propofol-Ketamine During Endoscopic Retrograde Cholangiopancreatography: A Double-Blind Randomized Clinical Trial. Anesth Pain Med. 2016 Aug 22;6(5):e39835. doi: 10.5812/aapm.39835. eCollection 2016 Oct.
Clinical trial NCT01494831: Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo
Official title: Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-traumatic Stress Disorder
Depression
Conduct Disorder
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 58
Sex: MALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).

Detailed description: To the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. While CBT is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically.

Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. The treatment groups will receive a 15-session manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. After treatment and post-testing, the waiting-list controls then begin their intervention.

Eligibility criteria: Inclusion Criteria:

* War-affected children and adolescents

Exclusion Criteria:

* No traumatic war events experienced
* Psychosis
* Inability to speak Swahili, French or English

Primary outcomes:
measure: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI
timeFrame: Post-intervention and 3 month
Secondary outcomes:
measure: Change in psychosocial distress- measures by African Youth Psychosocial Assessment
timeFrame: Post-intervention and 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Queens University Belfast
name: Harry Dr Rafferty
role: STUDY_DIRECTOR
References:
citation: McMullen J, O'Callaghan P, Shannon C, Black A, Eakin J. Group trauma-focused cognitive-behavioural therapy with former child soldiers and other war-affected boys in the DR Congo: a randomised controlled trial. J Child Psychol Psychiatry. 2013 Nov;54(11):1231-41. doi: 10.1111/jcpp.12094. Epub 2013 Jun 6.
Clinical trial NCT01540331: Efficacy And Safety of Pneumatic Trabeculoplasty
Official title: Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.

Detailed description: A group of subjects affected by Primary Open Angle Glaucoma (POAG) underwent 3 PNT treatments to evaluate one-year efficacy in term of IOP reduction and one-year safety in term of incidence of adverse events

Eligibility criteria: Inclusion Criteria:

* Subjects affected by primary open angle glaucoma

Exclusion Criteria:

* Any local or systemic contraindication to timolol topical therapy
* Chronic iritis and/or uveitis in one or both eyes,
* History of inflammatory glaucoma,
* Hemorrhagic glaucoma,
* Post-traumatic glaucoma,
* Phacolytic glaucoma,
* Acute glaucomatocyclitic attack,
* Closed angle/narrow angle glaucoma in one or both eyes,
* Previous corneal transplantation,
* Proliferative diabetic retinopathy with/without iris neovascularisation,
* Significative disk cupping (90% of complete disk area),
* Large and severe perimetric defects (I. e. a central perimetric residual not above 10 central degrees),
* Dry/wet age related macular degeneration in one or both eyes,
* Previous glaucoma surgery (Laser therapy was not considered)
* Keratitis
* Severe dry eye disease,
* Corneal dystrophies
* High myopia (more than 6 dioptres)
* Peripheral retinal degenerations with risk of retinal detachment

Primary outcomes:
measure: intraocular pressure (IOP)
timeFrame: Patients will be followed for one year. Time-points:recruitment, Basal (30 days after recruitment), Follow-Up2 (30 days after basal), Follow-Up3 (3 months after basal), Follow-Up4 (6 months after basal), Follow-Up5 (one year after basal)
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University "Magna Graecia"
Study officials:
affiliation: University "Magna Graecia" of Catanzaro
name: Luigi Varano, M. D.
role: PRINCIPAL_INVESTIGATOR
References: