louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01886144: Effects of Bracing on Knee Osteoarthritis (OA)
Official title: Effectiveness of Decompressive and Stabilizing Knee Bracing in Individuals With Unicompartment Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: OA
arthritis
knee OA
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Townsend Design
First posted: 2013-06-25
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are currently living with Knee OA of one leg

Brief summary: Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness that commonly alter the way one will climb stairs and walk reducing an individual's function and the activities they may perform on a day-to-day basis. Providing a person with a knee brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain and lead to improved function. The purpose of this study is to determine if use of the Rebel Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve strength and balance, and enhance functional activities such as stair and level gait, and ultimately lead to increased participation in the community.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged between 35 and 70
* Present with diagnosed unicompartment osteoarthritis of the knee

Exclusion Criteria:

* Severe cardiac or pulmonary disease that limits ability to walk.
* Presence of hip, ankle or foot OA or other lower limb pathology that limits ability to walk.
* Bilateral knee OA
* Previous use of an OA knee brace
* Surgical procedure in either leg within the past 6-months
* Anthropometrics that are incongruent with manufacturer's specifications for the Rebel Reliever

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Score (KOOS)
timeFrame: Baseline, 1 week, 2 week, 2 months, 3 months, 6 months
measure: Change in Adductory knee force during stair climbing
timeFrame: Baseline, 2 weeks, 2 months
Secondary outcomes:
measure: Change in 6 Minute Walk Test
timeFrame: Baseline, 2 weeks, 2 months
measure: Change in Balance
timeFrame: Baseline, 2 weeks, 2 months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory
state: New York
Study officials:
affiliation: Stony Brook Univ
name: Eric Lamberg, EdD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06830044: Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Official title: A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder


Eligibility criteria: Inclusion Criteria:

* Male or female patient 18 to 65 years of age, inclusive;
* Meets DSM-5-TR criteria for MDD
* Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)

Exclusion Criteria:

* Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
* Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD that is a primary diagnosis
* Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

Primary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Richardson
country: United States
facility: Vanda Investigational Site
state: Texas
Study officials:
References:
Clinical trial NCT05546944: The SHIELD Study-silicosis
Official title: Silicosis-harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Silicosis
Keywords: Silicosis
Pneumoconiosis
lung diseases
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: The Prince Charles Hospital
name: Royal Prince Alfred Hospital, Sydney, Australia
name: The Alfred
name: Austin Hospital, Melbourne Australia
First posted: 2022-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Respirable crystalline silica (RCS) exposed workers with silicosis or silica induced bronchitis

Brief summary: An observational cohort study to derive biomarkers which are able to more accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery.

Detailed description: Background: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone. AIMS: To establish the SHIELD COHORT and associated SHIELD BIOBANK to drive further discovery including assessing the efficacy of whole lung lavage for accelerated silicosis, uncovering disease biomarkers, and druggable targets.

PARTICIPANTS: 75 participants who are respirable crystalline silica exposed workers, (this includes n=30 with silicosis, n=15 with progressive massive fibrosis and n=30 with no pneumoconiosis). METHODS: Advanced microscopy, 'omic platforms and single cell RNA sequencing. OUTCOME: The SHIELD study builds on the knowledge gap to accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery

Eligibility criteria: Inclusion Criteria:

* All workers with a history of significant engineered stone exposure will be potentially eligible.

Exclusion Criteria:

-

Primary outcomes:
measure: the SHIELD study primary outcome is to build up knowledge gap to accurately diagnose silicosis, as well as predict disease progress, assess response to treatment, hasten therapeutic discovery in 12 months.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
Study officials:
affiliation: The Prince Charles Hospital
name: Daniel Chambers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01336244: GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study
Official title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-04-15
Enrollment: 45
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 multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
* hypersensitivity to any of the test substances

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: Daily during treatment, up to 10 days postdose
measure: Evaluation of hematological, biochemical and cardiovascular parameters.
timeFrame: until 10 days postdose.
Secondary outcomes:
measure: Pharmacokinetics of repeated doses
timeFrame: 24 hours postdose
measure: Pharmacodynamics (PD) of GLPG0778
timeFrame: up to 10 days postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Gerben van 't Klooster, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Lien Gheyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04183244: Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery
Official title: Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery: A Randomized Controlled Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain
Shoulder Pain
Keywords: Erector Spinae Plane Block
Infraclavicular Subomohyoid Block
Shoulder Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 80
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: The study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Patients will be randomly divided into two groups, Group E will receive Erector spinae block and group I will receive infraclavicular subomohyioid block. The local anesthetic solution that will be used in both blocks will be a total volume of 30 mls 0.25%bupivacaine plus 3mg preservative free Dexamethasone. The time between recovery from anesthesia and first pain experienced, as verified by NRS ≥ 3 and first need of a rescue analgesic, will be defined as the duration of analgesia. The total dose of intravenous morphine (the rescue analgesic) used over 24 h postoperatively will be recorded.


Eligibility criteria: Inclusion Criteria:

* Adult patients, above 18 years old.
* ASA physical status I
* Scheduled for shoulder surgery

Exclusion Criteria:

* Morbid obese.
* Previous surgery in the same shoulder.
* History of psychiatric disorder.
* Pulmonary disease.
* Contraindication to regional nerve block (e.g. skin infection at the puncture site, coagulopathy).
* Allergy to any of medications that will be used

Primary outcomes:
measure: The block efficacy
timeFrame: 24 hours
Secondary outcomes:
measure: The incidence of expected complications ( Block safety)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Randa Ali Shoukry
state: Al-Nozha
Study officials:
References:
Clinical trial NCT02190344: Functionality of an 8-Channel Paddle Coil for Use With MRI
Official title: Study to Evaluate the Functionality of an Eight-Channel Paddle Coil System Using MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate in Healthy Males
Keywords: Eight
Channel
Paddle
Coil
MRI
Prostate
Healthy Male
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
First posted: 2014-07-15
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to determine the functionality of an eight-channel paddle coil system which is to be used in future MRI studies.

Detailed description: Prostate cancer is the most common malignancy among men and the second leading cause of cancer death in men. Currently, MRI is the best imaging modality for both detecting prostate cancer and determining the presence of extra-prostatic extension. Multiparametric Magnetic Resonance, combining T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging (DCE-MRI) is recommended as the minimum acceptable standard for prostate MRI examination. However, MPMRI still lacks diagnostic accuracy in the transition zone, where distinguishing cancer from proliferative nodules has proven difficult. DCE-MRI techniques evaluate the time course of signal intensities after administration of a contrast medium and have been used to successfully differentiate benign from malignant tumours, particularly in breast and prostate cancer. Unfortunately, current DCE approaches have high false-positive rates and are limited in distinguishing prostatitis and vascularized BPH nodules from cancer in active surveillance studies. Future studies that employ spectroscopic MR imaging of the prostate after administration of Hyperpolarized (13C) Pyruvate Injection, are expected to provide a robust, non-invasive method to assist in detecting and characterizing prostate cancer. The objective of this study is to determine the functionality of an eight-channel paddle coil system which is to be used in future Hyperpolarized (13C) Pyruvate Injection studies.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between 18 and 80 years of age

Exclusion Criteria:

* Any contra-indication for MR imaging (such as pacemakers, surgical implants, foreign metal objects in the body)

Primary outcomes:
measure: Ability of Coil to produce MRI images
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Charles Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04543344: Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept
Official title: A Phase 1, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single or Multiple Subcutaneous Doses of Lyophilized Formulation of Recifercept in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.


Eligibility criteria: Inclusion Criteria:

* Male participants and female participants of nonchildbearing potential
* Participants who are overtly healthy
* Capable of giving signed informed consent

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
measure: Accumulation Ratio (Rac)
timeFrame: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose
Secondary outcomes:
measure: Incidence of Anti-drug antibodies (ADA)
timeFrame: 6 months post-dose
measure: Incidence of Neutralizing antibodies (NAb)
timeFrame: 6 months post-dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brussels Clinical Research Unit
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00519844: Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
Official title: Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foetal Growth Problem
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.


Eligibility criteria: Inclusion Criteria:

* Children treated for 3 years with Maxomat® because of small for gestational age
* Postnatal growth failure by the age of 3 years or more
* No associated growth hormone deficiency
* Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
* Bone age no more than 13 years for girls and no more than 15 years for boys

Exclusion Criteria:

* Known, evolving tumour
* Hypertrophic cardiomyopathy
* Hypertension not controlled on maximum therapy
* Benign intracranial hypertension
* Known glucose intolerance or known diabetes mellitus
* Acute or active chronic hepatitis
* Chronic renal failure
* Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality

Primary outcomes:
measure: Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference
timeFrame: after 3 months of treatment
Secondary outcomes:
measure: Clinical (adverse events)
measure: Biological (fasting glucose, fasting insulin, liver enzymes)
measure: Tolerance of the treatment
measure: Compliance
Other outcomes:
Locations:
city: Lyon
country: France
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04336644: Continuous Versus Intermittent cARdiac Electrical moNitorinG
Official title: Continuous Versus Intermittent cARdiac Electrical moNitorinG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Torsades de Pointe Caused by Drug
Long QT Syndrome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL) and being initiated on standard of care arsenic trioxide OR Diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) OR Diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment)
* At least 18 years of age.
* No allergy to adhesive patches.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Younger than 18 years of age
* Allergy to adhesive patches

Primary outcomes:
measure: Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
timeFrame: Through Day 30
measure: Frequency of major arrhythmia occurrence
timeFrame: Through Day 30
measure: Trajectories of QT prolongation
timeFrame: Through day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joshua D Mitchell, M.D., FACC
role: PRINCIPAL_INVESTIGATOR
References: