louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06142838: Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators
Official title: Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Disease Prevention
Keywords: Medication adherence
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: Vrije Universiteit Brussel
name: Université de Liège
First posted: 2023-11-22
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate a community pharmacist intervention aimed at improving medication adherence in patients starting newly prescribed medication for cardiovascular disease prevention. The main questions it aims to answer are:

* Does this community pharmacist intervention improve medication adherence?
* Which patients benefit the most from the intervention?
* How do patients experience the start-up of newly prescribed medication (which questions do they have and do they experience side effects?)?
* How do patients and pharmacists experience the intervention?


Eligibility criteria: Inclusion Criteria:

* Patients presenting with a first prescription for one of the following drug classes: antihypertensive drugs (= low-ceiling diuretics, beta blocking agents (excl. non-selective beta-blocking agents), ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers), lipid-lowering drugs (= statins), antidiabetic drugs (= metformin, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter 2 (SGLT2) inhibitors), or any combination thereof.
* Age 18 years or older
* Community-dwelling

Exclusion Criteria:

* The drug is prescribed for a non-cardiovascular indication (e.g. beta-blocking agent for migraine prophylaxis)
* Communication with the patient is not possible (e.g. due to cognitive impairment, insufficient knowledge of Dutch or French language)

Primary outcomes:
measure: NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)
timeFrame: At 6 weeks and at 12 weeks follow-up
Secondary outcomes:
measure: Medication Possession Ratio (MPR)
timeFrame: Over 26 weeks post-baseline
measure: Discontinuation rate
timeFrame: Over 26 weeks post-baseline
measure: Medication knowledge questionnaire
timeFrame: At 6 weeks and at 12 weeks follow-up
measure: Beliefs about Medicines Questionnaire (BMQ-Specific)
timeFrame: At 6 weeks and at 12 weeks follow-up
measure: Treatment response
timeFrame: At baseline and at 12 weeks follow-up
measure: Healthcare utilization
timeFrame: Over 12 weeks post-baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Pharmaceutical Care Unit (Ghent University)
Study officials:
References:
Clinical trial NCT05219838: Binding and Effects of Lu AG06466 in the Brain of Healthy Men
Official title: Interventional , Open-label, Positron Emission Tomography (PET) Study With [18F]-T-401 Investigating MAGL Enzyme Occupancy After Multiple Oral Doses of Lu AG06466
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to learn about the binding of Lu AG06466 and its major breakdown product (Lu AG06988) in the brain of healthy men having received multiple doses of Lu AG06466. As the binding will result in inhibition of an enzyme in the endocannabinoid system called monoacylglycerol lipase (MAGL), the effects on this system will be evaluated both in the blood and cerebrospinal fluid and compared to the binding in the brain.


Eligibility criteria: Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit.
* The participant has a weight of ≥60 kg at the screening visit and baseline visit.
* The participant has a waist circumference ≤94 centimeters (cm) at the screening visit.

Exclusion Criteria:

* The participant has taken disallowed medication \<2 weeks prior to the first dose of study drug or \<5 half-lives prior to the screening visit for any medication taken.
* The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Plasma Concentration of Lu AG06466 and Lu AG06988
timeFrame: Day 5 (pre-dose, per hour before and after positron emission tomography [PET] imaging and per 30 minutes during PET imaging) and on Day 6 (3 hours post-dose)
measure: Cerebrospinal Fluid (CSF) Concentration of Lu AG06466 and Lu AG06988
timeFrame: Pre-dose and on Day 6 (3 hours post-dose)
measure: Central MAGL Occupancy (%) Measured Using [18F]MNI-1188 PET Imaging
timeFrame: 2 to 4 hours post-dose on Day 5
measure: CSF Concentrations of 2-arachidonolylglycerol (2-AG) (1-arachidonolylglycerol [1-AG]+2-AG), 2-oleoylglycerol (2-OG), and arachidonic acid (AA)
timeFrame: Day 6 (3 hours post-dose)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Invicro, LLC
state: Connecticut
Study officials:
References:
Clinical trial NCT06050538: Laparscopic Hernioplasty in Recurrent Inguinal Hernia
Official title: A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Inguinal Hernia
Keywords: TAPP
TEP
Laparoscopic Inguinal Hernia
Recurrent hernia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients diagnosed with recurrent inguinal hernia. The study population were randomly distributed into 2 groups by computer generating program; group (1) included patients who had Transabdominal preperitoneal (TAPP) approach while group (2) included patients who had Total extraperitoneal (TEP) approach.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.

Detailed description: The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
* Patients between 18 and 70 years old
* Fit for anesthesia.
* Agree to participate in the study
* Both genders were included.

Exclusion Criteria:

* Unfitness for general anesthesia and operation.
* Age \< 18 years or \>70 years.
* Complicated hernias (acute irreducible, obstruction or strangulation).
* The presence of mental or psychological disorders.
* Refusal to participate in the study.

Primary outcomes:
measure: Postoperative pain
timeFrame: 6 months
Secondary outcomes:
measure: operative time
timeFrame: 6 months
measure: complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitl
Study officials:
affiliation: Mansoura University Hospital
name: Islam Hisham, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04781738: Functional Capacity and Quality of Life in Patients With Vascular Ring
Official title: Functional Capacity and Quality of Life in Patients With Vascular Ring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Ring
Keywords: Cardiopulmonary exercise testing,
Double aortic arch
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with history of vascualr ring

Brief summary: To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.

Detailed description: Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed.

data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery.

Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).

Eligibility criteria: Inclusion Criteria:

* patients with history of vascular ring

Exclusion Criteria:

* refusal to participate
* inability to complete cardiopulmonary testing

Primary outcomes:
measure: Exercise capacity
timeFrame: Measured continuously during 15 minutes of the exercise test (CPET)
Secondary outcomes:
measure: Six minute walk test
timeFrame: Six minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
measure: Quality of life - SF-36
timeFrame: Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Head of Pediatric Pulmonary Institute
name: Lea Bentur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nir V, Bentur L, Zucker-Toledano M, Gur M, Adler Z, Hanna M, Toukan Y, Masarweh K, Hakim F, Bar-Yoseph R. Functional capacity and quality of life in patients with vascular ring. Pediatr Pulmonol. 2022 Dec;57(12):2946-2953. doi: 10.1002/ppul.26112. Epub 2022 Sep 14.
Clinical trial NCT00507338: Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI
Official title: A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: percutaneous coronary intervention
Lead sponsor: Archemix Corp.
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.

Detailed description: Adjunctive anti-thrombotic therapy for PCI of AMI may be improved by incorporation of a novel anti-platelet therapeutic principle, von Willebrand Factor antagonism. ARC1779 is a therapeutic oligonucleotide ("aptamer") which blocks the binding of the A1 domain of vWF to the platelet GPIb receptor, and thereby modulates platelet adhesion, activation, and aggregation under the high shear conditions of coronary arterial stenosis and plaque rupture. This study is intended to provide dose-ranging and clinical proof of concept for ARC1779 in a primary PCI population.

Eligibility criteria: Inclusion Criteria:

* troponin-positive NSTEMI, with diagnostic symptoms and/or ECG abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
* STEMI, with planned primary PCI

Exclusion Criteria:

* History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
* Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
* Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
* Severe hypertension (systolic blood pressure \>200 mmHg or diastolic blood pressure \>110 mmHg) not adequately controlled on antihypertensive therapy
* Major surgery or trauma within the preceding 6 weeks
* History of stroke within 30 days or any history of hemorrhagic stroke
* End-stage renal disease (ESRD) with dependency on renal dialysis

Primary outcomes:
measure: adequacy of reperfusion
timeFrame: 48 hours post-PCI
Secondary outcomes:
measure: bleeding
timeFrame: PCI to hospital discharge
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: Archemix Investigational Site
state: Russia
Study officials:
affiliation: Harvard Medical School, Beth Israel Deaconess Medical Center
name: Michael Gibson, MD
role: STUDY_CHAIR
affiliation: Herz-Zentrum Bad Krozingen
name: Franz-Josef Neumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Clinical trial NCT05607238: Patient Perspective Midline Catheter in the Emergency Department
Official title: Patient Perspective of Midline Catheters Versus Ultrasound Guided Peripheral IVs for Difficult IV Access in the ED
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patient Satisfaction
Patient Preference
Keywords: IV access
ultrasound guided IV
emergency care
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 0
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: This study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters.


Eligibility criteria: Inclusion Criteria:

* Patient in the emergency department
* Failed 2 or more conventional attempts at vascular access \*or\*
* history of requiring US guided vascular access
* US Fellowship trained physician available

Exclusion Criteria:

* basilic vein access is contraindicated
* patient undergoing advanced resuscitation

Primary outcomes:
measure: Patient Satisfaction with Procedure
timeFrame: Immediately after procedure/Baseline
measure: Patient Satisfaction with Procedure
timeFrame: At 48 Hours Post Baseline
Secondary outcomes:
measure: Number of needle punctures in a 24 hour period (patient reported)
timeFrame: up to 48 hours
measure: Duration of Successful Access
timeFrame: up to 48 hours
measure: Number of Needle Sticks
timeFrame: up to 48 hours
measure: Number of Insertion Attempts
timeFrame: up to 48 hours
measure: Emergency Department (ED) Length of Stay
timeFrame: up to 48 hours
measure: Hospital Length of Stay
timeFrame: up to 48 hours
measure: Patient Satisfaction
timeFrame: immediately post intervention/baseline and at 48 hours past baseline
measure: Number of Insertion Related Complications
timeFrame: up to 48 hours
measure: Number of Dwell Related Complications
timeFrame: up to 48 hours
measure: Time to Access
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Casey Glass, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522638: Advanced Characterization of Autosomal Dominant Optic Atrophy
Official title: Cross Sectional Study of Autosomal Dominant Opticus Atrophy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optic Atrophy, Autosomal Dominant
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with autosomal dominant optic atrophy in Denmark.

Brief summary: The purpose of this study is to determine the anatomy of the retina and the optic nerve in patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of the study is to determine why patients with the same type of genetic material, i.e. the same mutation, have such large variations of symptoms, spanning from unaffected subjects to blindness. The project requires examination of both healthy and affected family members.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with autosomal dominant optic atrophy

Exclusion Criteria:

* Age below 8 years old

Primary outcomes:
measure: visual acuity
timeFrame: 1 day
measure: vessel caliber
timeFrame: 1 day
measure: OCT
timeFrame: 1 day
measure: Microperimetry
timeFrame: 1 day
measure: Lifestyle questionnaire
timeFrame: 1 day
measure: General checkup
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University, Glostrup Hospital
Study officials:
affiliation: Glostrup University Hospital
name: Michael Larsen, MD, Prof. DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ronnback C, Larsen M. Macular sensitivity and fixation patterns in patients with autosomal dominant optic atrophy. Dan Med J. 2014 Sep;61(9):A4888.
Clinical trial NCT06015438: Physical Activity in Hidradenitis Suppurativa (HS)
Official title: Physical Activity and Hidradenitis Suppurativa: a Novel Controlled Trial Investigating Functional Performance and Activity Limitations and Assessing the Benefits of an Outcome Measures Driven Exercise Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) with evidence-based techniques and examine its outcome.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years old to 80 years old
* Have diagnosis of HS confirmed by a dermatologist
* Able to provide informed consent
* For the extended portion of the study: Classified as having moderate-to-severe HS as per the IHS-4 criteria

Exclusion Criteria:

* Individuals who are not yet adults
* Women known to be pregnant
* Prisoners
* Subjects, who in the opinion of the PI, cannot comply with the study procedures

Primary outcomes:
measure: Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
timeFrame: Baseline and up to 12 weeks
measure: Change in Functional Strength/Endurance as measured by six-minute walk test
timeFrame: Baseline and up to 12 weeks
measure: Change in Functional Strength as measured by hand grip strength test
timeFrame: Baseline and up to 12 weeks
Secondary outcomes:
measure: Quality of life impairment as measured by the DLQI
timeFrame: Baseline, up to 12 weeks
measure: Quality of life impairment as measured by the HiSQOL
timeFrame: Baseline, up to 12 weeks
measure: Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, up to 12 weeks
measure: Change in Level of Activity as measured by the average number of steps daily
timeFrame: Baseline, up to 12 weeks
measure: Change in Severity of HS score using the IHS-4
timeFrame: Baseline, up to 12 weeks
measure: Average pain as assessed by the Numerical Rating Scale (NRS)
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905138: First-in-Human Single Ascending and Multiple Dose of GLPG0259
Official title: Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of single and multiple dosing
timeFrame: up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of single and repeated doses
timeFrame: up to 10 days postdose
measure: Exploratory evaluation of TNF-alpha and IL6 in whole blood
timeFrame: up to 12 hours postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Johan Beetens, PharmD, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Eva Vets, MD
role: PRINCIPAL_INVESTIGATOR
References: