louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06417931: Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD
Official title: A Pharmacist-Led Intervention on Medication Adherence and Inhaler Usage on Clinical Outcomes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease in Ibadan, Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma COPD
Lead sponsor: University of Ibadan
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-randomised control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria.

Detailed description: Medication non-adherence in asthma and COPD patients have been established to be very high, and along-side poor knowledge of proper use of inhaler devices, results in suboptimal disease control among these patients. Studies evaluating the impact of a comprehensive intervention on medication adherence and inhaler usage on disease control are scare in developing countries. This study was a prospective single-blind quasi-randomized-controlled study among asthma and COPD patients attending the chest out-patient clinic of the University College Hospital, Ibadan. The baseline questionnaire was administered to consenting patients to explore demographic and specific clinical characteristics, knowledge of the disease, current medications, medication adherence, knowledge of use of metered dose (MDIs) and diskus inhalers, and asthma/COPD control status using the asthma control test (ACT) and COPD assessment test (CAT) scales. Subsequently, patients were assigned into intervention or control groups using odd or even number assignation. Patients in the intervention group were followed up for two months via face to face interviews, short message services, and phone calls at one-weekly intervals, so as to provide education and counseling to resolve the identified gaps during the baseline interaction. Descriptive statistics were used to summarize the data, while chi-square, t-test, Fishers exact test and Wilcoxon-signed ranked tests were used as appropriate to test for associations at p \< 0.05.

Eligibility criteria: Inclusion Criteria:

Patients 18 years of age and older with a primary diagnosis of asthma or COPD by a physician who are willing to complete the study and have telephone access

Exclusion Criteria:

All non-consenting patients and patients who are not on any medications at any point in the study

Primary outcomes:
measure: Medication adherence
timeFrame: Two months
measure: Use of inhaler devices
timeFrame: Two months
Secondary outcomes:
measure: disease control
timeFrame: Two months
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital
state: Oyo State
Study officials:
References:
Clinical trial NCT00224731: Sleep Disorders in Children With ADHD
Official title: Sleep Disorders in Children With ADHD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Disorder With Hyperactivity (ADHD)
Keywords: Attention disorder with hyperactivity
sleep
stimulants
actigraphy
Lead sponsor: Hvolby, Allan, M.D.
Sponsor class: INDIV
First posted: 2005-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness.

In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances).

Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented.

The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.


Eligibility criteria: Inclusion Criteria:

- We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10

Exclusion Criteria:

mental retardation -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Child psychiatric department and University of southern Denmark
Study officials:
affiliation: child psychiatric department, Esbjerg
name: allan hvolby, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hvolby A, Jorgensen J, Bilenberg N. Actigraphic and parental reports of sleep difficulties in children with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2008 Apr;162(4):323-9. doi: 10.1001/archpedi.162.4.323.
Clinical trial NCT02870231: Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
Official title: A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-08-17
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America. The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity


Eligibility criteria: Inclusion Criteria:

* Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.
* Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent

Exclusion Criteria:

* Any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening
* Any prior obesity surgery or currently present gastrointestinal implant.
* Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
* Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
* Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
* A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
* Calcitonin above or equal to 50 ng/L
* History of pancreatitis (acute or chronic)

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: Day 1-112
Secondary outcomes:
measure: Area under the NNC9204-0530 serum concentration-time curve
timeFrame: Day 84-112
measure: Time to maximum serum concentration of NNC9204-0530
timeFrame: Day 84-112
measure: Change in HbA1C
timeFrame: Day -1, Day 85
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Lincoln
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
Study officials:
References:
Clinical trial NCT05739331: Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence
Official title: Automatic Segmentation of Mediastinal Lymph Nodes and Blood Vessels in Endobronchial Ultrasound (EBUS) Images Using a Deep Neural Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Artificial Intelligence
Endobronchial Ultrasound
Lung Cancer
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
name: SINTEF Health Research
First posted: 2023-02-22
Enrollment: 50
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: Patents with undiagnosed enlarged mediastinal and hilar lymph nodes who have been recommended for Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA).

Brief summary: To evaluate the usefulness of Deep neural network (DNN) in the evaluation of mediastinal and hilar lymph nodes with Endobronchial ultrasound (EBUS). The study will explore the feasibility of DNN to identify lymph nodes and blood vessel examined with EBUS.

Detailed description: Multi-center prospective feasibility study. The DNN model will be trained on ultrasound images with annotation to identifies lymph nodes and blood vessels examined with EBUS. The ability of the DNN to segment lymph nodes and vessels based on postoperative processing and static EBUS images will be evaluated in the first part of the study. In the second part of the study Real-time use of DNN in EBUS procedure will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Subjects referred to thoracic department in any of the participating hospitals with undiagnosed enlarged mediastinal and hilar lymph nodes.
* Subjects have to be ≥ 18 years of age

Exclusion Criteria:

* Pregnancy
* Any patient that the Investigator feels is not appropriate for this study for any reason.

Primary outcomes:
measure: Capability
timeFrame: 8 months
Secondary outcomes:
measure: Precision
timeFrame: 2 months
measure: Sensitivity
timeFrame: 2 months
measure: Specificity
timeFrame: 2 months
measure: Dice similarity coefficient
timeFrame: 2 months
measure: Run-time
timeFrame: 2 months
measure: Adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust
city: Trondheim
country: Norway
facility: Department of Thoracic Medicine, St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øivind Rognmo, Dr.philos
role: STUDY_DIRECTOR
References:
Clinical trial NCT01043276: A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355
Official title: A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 20
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: The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* A positive urine drug screen
* Pregnant or nursing females

Primary outcomes:
measure: plasma pharmacokinetics AUClast and Cmax
timeFrame: Day 1
Secondary outcomes:
measure: plasma pharmacokinetics, AUCinf and Tmax
timeFrame: Day 1
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06401876: Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes
Official title: Profiling Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glucose Intolerance
Insulin Resistance
Diabetes
Keywords: Bariatric Surgical Procedure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2024-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is open to patients aged 21 years or older who have a BMI of 35 kg/m2 or more and are planning to undergo bariatric surgery. Patients must have an A1c of 6.5 or higher measured within the last 6 months or if A1C is less than 6.5 must have a diagnosis of stable type 2 diabetes for more than 6 months.

Brief summary: The purpose of this research is to obtain blood samples before and after a bariatric procedure to better understand the reasons for glucose intolerance and insulin resistance (diabetes) in the obesity, and the reasons for improvement of diabetes after bariatric surgery


Eligibility criteria: Inclusion Criteria:

* Enrolled in the Bariatric Surgery Program.
* Patients with A1c of 6.5 or higher within the last 6 months. OR
* Patients with A1c less than 6.5; have diagnosis of stable type 2 diabetes for \> 6 months.

Exclusion Criteria:

* Disqualified for Bariatric Surgery.
* BMI \< 35 kg/m\^2.

Primary outcomes:
measure: Identify circulating EV-derived protein and RNA signatures associated with T2D
timeFrame: 1 year
measure: Identify changes in circulating EV cargo in patients whose T2D resolves after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) or duodenal switch procedures.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05610176: BIO|CONCEPT.Amvia Study
Official title: BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Heart Failure
Keywords: Cardiac pacemaker
CRT-P
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Biotronik SE & Co. KG
First posted: 2022-11-09
Enrollment: 52
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 goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.


Eligibility criteria: Inclusion Criteria:

* Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion Criteria:

* Planned for conduction system pacing
* Planned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Pregnant or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation according to the definition given in the study protocol
* Life-expectancy less than 12 months

Primary outcomes:
measure: Serious adverse device effect (SADE)-free rate after 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Justin Mariani, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00979927: SPC3649 Multiple Dose Study in Healthy Volunteers
Official title: A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Antisense
miR-122 antagonist
safety in healthy Volunteers
Hepatitis C
Lead sponsor: Santaris Pharma A/S
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years

Primary outcomes:
measure: Number of subjects experiencing adverse events
timeFrame: Up to 169 Days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of SPC3649
timeFrame: Up to 169 Days
measure: Effect on total Cholesterol
timeFrame: Up to 169 Days
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA international
Study officials:
affiliation: PRA Health Sciences
name: Salah Hadi, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00485927: The Effects of Stress on the Clinical Performance of Residents in Simulated Trauma Scenarios
Official title: The Effects of Stress on the Clinical Performance of Residents in Simulated Trauma Scenarios
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Stress
Keywords: Trauma
Stress
Simulation
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2007-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medical practice \& training are inherently stressful situations. However, the effects of stress on educational \& clinical performance are not well defined. The purpose of the current study is to examine the effects of stress on performance of residents in simulated trauma scenarios. The hypothesis is: 1) acutely stressful scenarios will be appraised as threat by residents and result in elevations of heart rate and salivary cortisol; 2) increased subjective \& physiological stress will result in impairments in performance; and 3) greater stress responses will result in greater clinical impairments.


Eligibility criteria: Inclusion Criteria:

* University of Toronto General Surgery \& Emergency medicine residents

Exclusion Criteria:

* No ATLS training
* Residents from other programs

Primary outcomes:
measure: performance - global ratings
measure: performance - ANTS
measure: performance - checklists
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michaels' Hospital
state: Ontario
Study officials:
affiliation: University of Toronto, University Health Network
name: Adrian M Harvey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, St. Michael's Hospital
name: Avery B Nathans, MD, PhD
role: STUDY_CHAIR
affiliation: University of Toronto
name: Vicki Leblanc, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01406327: Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
Official title: Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All Japanese subjects who have received ambrisentan for the first time for the treatment of pulmonary arterial hypertension (PAH) and have given their consent to participate in the study.

Brief summary: The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;

1. Unknown adverse drug reactions (ADRs)
2. Incidence of ADRs to medical products in actual clinical practice
3. Factors influencing safety of ambrisentan
4. Factors influencing efficacy of ambrisentan
5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)


Eligibility criteria: Inclusion Criteria:

* Must use ambrisentan for the first time

Exclusion Criteria:

* Subjects with hypersensitivity to ambrisentan
* Subjects who is pregnant or might be pregnant
* Subjects with severe hepatic disorder

Primary outcomes:
measure: The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan
timeFrame: 1 year
measure: The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage
timeFrame: 1 year
measure: The number of adverse events and clinical course in subjects with hepatic dysfunction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Takahashi T, Hayata S, Kobayashi A, Onaka Y, Ebihara T, Hara T. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report). Clin Drug Investig. 2018 Mar;38(3):219-229. doi: 10.1007/s40261-017-0602-4.