louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06917508: A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants
Official title: A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-323 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: RSV Infection
Drug Drug Interaction
Keywords: Drug Drug Interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive
* Screening body weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
* Positive for HIV or hepatitis
* Positive urine drug screen
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer.
* Drug sensitivity to midazolam, caffeine, rosuvastatin

Primary outcomes:
measure: Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
timeFrame: Up to 17 Days
measure: AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
timeFrame: Up to 17 Days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 22 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON, plc
state: Texas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02526108: Energy Expenditure of High Intensity Functional Training
Official title: Energy Expenditure of High Intensity Functional Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the energy expenditure and intensity of a High Intensity Functional Training (HIFT) session in overweight and obese adult men and women.

Detailed description: High Intensity Functional Training (HIFT), which alternates short periods of intense exercise using varied, multiple-joint movements, with less-intense active recovery periods, may offer an attractive, time efficient alternative to traditional aerobic exercise. Variations of HIFT such as Cross Fit, home workout videos (ie.P90x and Insanity), and boot-camp style group exercise classes have become increasingly popular.

The cardiovascular benefits of HIFT have been demonstrated; however, by doing this study researchers hope to get more information regarding the potential effectiveness of HIFT for weight management, such as the actual level of energy expenditure and exercise intensity elicited by a HIFT session.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 25.0 and 39.9
* Currently participating in HIFT (boot-camp) classes at Kirmayer Fitness Center

Primary outcomes:
measure: Energy expenditure measured using indirect calorimetry
timeFrame: Energy expenditure will be obtained across a 2 week period after each of 3 exercise sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willis EA, Szabo-Reed AN, Ptomey LT, Honas JJ, Steger FL, Washburn RA, Donnelly JE. Energy Expenditure and Intensity of Group-Based High-Intensity Functional Training: A Brief Report. J Phys Act Health. 2019 Jun 1;16(6):470-476. doi: 10.1123/jpah.2017-0585. Epub 2019 May 19.
Clinical trial NCT01243008: Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
Official title: A Single Centre, Randomized, Investigator Blinded, Placebo-controlled Ascending Dose Study to Assess the Local Safety, the Skin and Plasma Concentration of Azithromycin Dermal Formulation During Repeated Applications on the Skin of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lyme Disease
Keywords: Lyme disease
Borreliosis
Azithromycin
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Ixodes GmbH
name: Appletree AG
First posted: 2010-11-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.

Detailed description: In this study two consecutive cohorts will be treated:

* Cohort 1: 8 volunteers
* Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each

The study will be conducted in the following three phases:

1. Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation.

   1. Treatment of cohort 1 with azithromycin dermal formulation and follow up
   2. Assessment of local safety within the 7 days following the first treatment
   3. The maximal tolerated dose (MTD) will be determined
2. Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of SHB001 dermal formulation.

   1. Treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated dose (MTD), with a dose one or more concentrations lower than maximal tolerated dose (MTD) and with placebo
   2. Skin biopsies of treated skin areas will be taken for the PK assessment
3. Study completion examination

Eligibility criteria: Main inclusion criteria:

* Male or female healthy volunteers, age 18 - 70 years

Main exclusion criteria:

* A known hypersensitivity against azithromycin, erythromycin or any of the macrolide antibiotics
* A known hypersensitivity against lidocaine
* Treatment by any route with any macrolide antibiotic within the last 2 month

Primary outcomes:
measure: Local safety
timeFrame: April 2010 - November 2010
Secondary outcomes:
measure: Pharmacokinetics of SHB001
timeFrame: April 2010 - November 2010
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinical Trials Center, University and University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02903108: Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis
Official title: Clinical Efficacy of Subgingivally Delivered 0.75% Boric Acid Gel As An Adjunct to Mechanotherapy in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 39
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.

Detailed description: Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in with chronic periodontitis (CP) patients.

Methods: Thirty nine systemically healthy patients with CP are included in this study. They were divided into two groups: 1) SRP + 0.75% Boric acid gel (BA group); 2) SRP + Placebo gel (Placebo group). At baseline, 3 month, and 6 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
* Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion Criteria:

* Patients on systemic boron therapy
* Known or suspected allergy to boron supplementation
* Patients with aggressive periodontitis
* Tobacco use in any form, smokers, alcoholics
* Immunocompromised and systemically unhealthy patients
* Pregnant or lactating females

Primary outcomes:
measure: Defect depth reduction (%)
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: probing depth (mm)
timeFrame: Change from baseline to 6 months
measure: clinical attachment level (mm)
timeFrame: Change from baseline to 6 months
measure: modified sulcus bleeding index
timeFrame: Change from baseline to 6 months
measure: plaque index
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
state: Karnataka
Study officials:
References:
Clinical trial NCT01176708: Intact Liver Innervation and Glucose and Glucagon-like Peptide-1 (GLP-1) Induced Insulin Secretion
Official title: The Significance of Intact Liver Innervation for the Glucose and GLP-1 Induced Insulin Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Keywords: liver transplantation
kidney transplanted
glucagon-like peptide-1
insulin secretion
vagotomy
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.

The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.

Detailed description: GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers.

The aim of this study is to investigate the significance of intact liver innervation for the GLP-1 induced insulin secretion in liver transplanted patients; kidney transplanted control patients matched for immunosuppressive treatment, age, gender and body weight; and ten control persons matched for age, gender and body weight.

The insulin secretion will be evaluated from blood samples that will be analyzed for insulin and c-peptide.

Eligibility criteria: Inclusion Criteria:

* normal fasting plasma glucose
* normal hemoglobin
* informed consent

Exclusion Criteria:

* type 1 diabetes mellitus or type 2 diabetes mellitus
* body mass index \> 30
* inflammatory bowel disease
* intestinal surgery
* serum creatinine \> 250 µM and/or albuminuria
* ALAT \> 2 x normal value
* Severe cardiac insufficiency
* in treatment with medicine which cannot be paused for 12 hours

Primary outcomes:
measure: insulin secretion
timeFrame: four hours
Secondary outcomes:
measure: plasma glucose
timeFrame: 20 time points within four hours
measure: plasma GLP-1
timeFrame: 12 time points within four hours
measure: plasma GIP
timeFrame: 12 time points within four hours
measure: plasma glucagon
timeFrame: 12 time points within four hours
measure: plasma GLP-2
timeFrame: 12 time points within four hours
measure: plasma PYY
timeFrame: 12 time points within four hours
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal Medicine F' laboratory
state: Copenhagen
Study officials:
References:
Clinical trial NCT00555308: Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
Official title: Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Ultrasonography
Hydronephrosis
Keywords: urolithiasis
ultrasound
hydronephrosis
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2007-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is intended to be a readily assessable test performed at the bedside, to quickly and safely determine the presence of a disease state; it answers a binary question, as compared to formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.

The objective of this study is to determine the accuracy of EDTU in patients suspected of renal colic. By demonstrating excellent test characteristics, these investigators hope that this research will be used to incorporate EDTU for hydronephrosis into standard emergency care in Canada.


Eligibility criteria: Inclusion Criteria:

* Emergency Department patients
* Males and Females
* Age 16-65
* Undergoing CT scan of the abdomen or formal ultrasound of the abdomen at Kingston General Hospital or Hotel Dieu Hospital in Kingston, Ontario.

Exclusion Criteria:

* Hemodynamic instability
* Fever
* Leukocytes or nitrites on dipstick urinalysis
* Pregnancy
* Renal failure
* Single functioning kidney or renal transplant

Primary outcomes:
measure: Diagnostic accuracy of EDTU
timeFrame: 1 hour
Secondary outcomes:
measure: same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Eric A Bruder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University
name: Kieran M Moore, MD MMSc
role: STUDY_DIRECTOR
affiliation: Queen's University
name: Louise Rang, MD RDMS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02650908: Is Abrasion of the Suture Area Essential for Healing of a Meniscus Lesion?
Official title: Does the Avivement of Suturing Area is Essential for Healing a Meniscus Lesion ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meniscus Lesion
Keywords: Lesion
Meniscus
Avivement
Suturing area
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent meniscal suturing with or without avivement

Brief summary: The most common technique involves a suture meniscus avivement with a rasp or a motorized cutter the suture zone before actual implementation of the suture. But the imperative nature of this avivement is based only on theoretical considerations. The team has an old experience in conducting meniscus sutures without avivement. It therefore seems interesting to compare results with those of literature


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients who underwent meniscal suturing with or without avivement

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Healing meniscus suturing area
timeFrame: For the duration of hospital stay, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05016908: Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy
Official title: Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2021-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males ages 5 years and older with Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD). In addition, male and female family members without known muscular dystrophy ages 18 and older also are invited to participate.

Brief summary: Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.


Eligibility criteria: Inclusion Criteria:

* Subjects with DMD or BMD based on genetic testing. Control subjects are unknown to have any other muscular dystrophy by history and may have had no genetic testing.
* Able to provide informed consent or assent for participation in the study.
* Demographic characteristics for biofluid collection: Males age 5 years and older with DMD or BMD; males and females ages 18 years and older without muscular dystrophy.

Exclusion Criteria:

* Medical history of any of the following: State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive.
* Use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw.
* Inability or unwillingness of the subject to give written informed consent.

Primary outcomes:
measure: Extracellular RNA in biofluids
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Thurman M. Wheeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antoury L, Hu N, Balaj L, Das S, Georghiou S, Darras B, Clark T, Breakefield XO, Wheeler TM. Analysis of extracellular mRNA in human urine reveals splice variant biomarkers of muscular dystrophies. Nat Commun. 2018 Sep 25;9(1):3906. doi: 10.1038/s41467-018-06206-0.
citation: Antoury L, Hu N, Darras B, Wheeler TM. Urine mRNA to identify a novel pseudoexon causing dystrophinopathy. Ann Clin Transl Neurol. 2019 May 17;6(6):1106-1112. doi: 10.1002/acn3.777. eCollection 2019 Jun.
Clinical trial NCT03800108: Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
Official title: Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

Detailed description: Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.

Eligibility criteria: Inclusion Criteria:

1. Between 40 and 70 years of age,
2. Ability to provide informed consent,
3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
4. Disease duration of at least 4 years,
5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion Criteria:

1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
2. History of other central nervous system disease (excluding migraine),
3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
5. Current alcohol or substance abuse,
6. Lack of fluency in English which would invalidate cognitive testing,
7. Hearing or visual impairment precluding cognitive testing.

   Exclusion criteria for Day 2 procedures:
8. Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)

Primary outcomes:
measure: Reaction Time
timeFrame: 30-60 minutes after stimulation adjustment
measure: Verbal Fluency
timeFrame: 30-60 minutes after stimulation adjustment
measure: Finger Tapping Speed
timeFrame: 30-60 minutes after stimulation adjustment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Darlene Floden, PhD
role: PRINCIPAL_INVESTIGATOR
References: