louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03594071: S&P of Q-Fix™ All-Suture Anchor System
Official title: Safety and Performance of Q-Fix™ All-Suture Anchor System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bankart Lesion
Acetabular Labrum Tear
SLAP Lesion
Acromioclavicular Sprain
Capsular Shift/Capsulolabral Reconstruction
Deltoid Repair
Rotator Cuff Repair
Bicep Tendinitis
Extra-capsular Repair
Medial Collateral Ligament
Lateal Collateral Ligament
Posterior Oblique Ligament
IBT
Vastus Medialis
Obliquus Advancement
Joint Capsule Closure
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 294
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: US sites

Brief summary: Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements


Eligibility criteria: Inclusion Criteria:

* Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
* Subject was ≥ 13 of age at time of surgery

Exclusion Criteria:

* Subject is ≤ 6 months post-operative
* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Primary outcomes:
measure: Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon
timeFrame: 12 months
measure: Hip Visual Analog Scale (VAS) - Pain
timeFrame: Screening, 6 months, and 12 months
measure: Knee Visual Analog Scale (VAS) - Pain
timeFrame: Screening, 6 months, and 12 months
measure: Shoulder Visual Analog Scale (VAS) - Pain
timeFrame: Screening, 6 months, and 12 months
measure: Hip Range of Motion (ROM)
timeFrame: Screening, 6 months, and 12 months
measure: Knee Range of Motion (ROM)
timeFrame: Screening, 6 months, and 12 months
measure: Shoulder Range of Motion (ROM)
timeFrame: Screening, 6 months, and 12 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: The Orthopaedic Center- Center for Advanced Orthopaedics
state: District of Columbia
city: Chicago
country: United States
facility: Northshore University Health System
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Medical Center /Tulane Institute of Sport Medicine
state: Louisiana
city: Oklahoma City
country: United States
facility: Oklahoma Sports and Orthopedics Institute
state: Oklahoma
city: Columbia
country: United States
facility: Palmetto Health USC Orthopedic Center
state: South Carolina
Study officials:
affiliation: GBR - T. J. Smith and Nephew Limited
name: Lisa Langone
role: STUDY_CHAIR
References:
Clinical trial NCT00001371: A Pilot Study of Topical Antiflammin-2 for Psoriasis
Official title: A Pilot Study of Topical Antiflammin-2 for Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Inflammation
Lipocortin
Phospholipase A-2
Skin
Uteroglobin
Psoriasis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

Detailed description: This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

Eligibility criteria: Patients must be age 18 or older.

Patients male or female must use contraception if of childbearing age. No men and women actively attempting to conceive a child during the time of drug testing. No pregnant or nursing women.

Patients must be otherwise healthy, immunocompetent, ambulatory patients with psoriasis who have more than 5 percent of their body surface area involved with the disease or who have localized disabling psoriasis.

Have failed one prior topical treatment regimen including topical cortiscosteroids, coat tar preparations, or ultraviolet light.

An ambulatory performance status of 0,1,2 (ECOG Scale).

Ability to participate in an out -patient study and to provide informed consent.

Creatinine less than 2.0 mg/100ml. Bilirubin less than or equal to 1.5 mg/100ml; prothrombin time less than or equal to 1.3 times control. WBC greater than 3000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 100,000/mm(3).

No clinically significant cardiac disease.

No patients with previously documented serious infectious diseases such as pneumocystis pneumonia, mycobacterium avium infection, etc. which would suggest clinically evident immunodeficiency.

No systemic treatment for psoriasis (methotrexate, PUVA, UVB, cyclosporine, etc.) and topical treatments (corticosteroids, tar, anthralin, etc.) during the four weeks prior to study entry, and topical treatment during the two weeks prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
Clinical trial NCT06608771: Outcome of Cardiac Arrest Patients Following Guidelines Implementation Over the Years
Official title: Implementation of the New Guidelines on the Management of Patients Resuscitated From Cardiac Arrest and Impact on Survival: a Multicenter Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Keywords: Out-Of-Hospital Cardiac Arrest
In-Hospital Cardiac Arrest
Guidelines Implementation
Resuscitation
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients resuscitated from cardiac arrest and admitted to ICU over a 14-year-period

Brief summary: The study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. During this time period, the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) introduced three new guidelines for post-cardiac arrest management, each five years apart: the 2010, 2015, and 2021 guidelines.

Detailed description: This study is a retrospective multicenter cohort observational study (two centers involved: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Fondazione IRCCS San Gerardo dei Tintori).

All patients admitted to the Intensive Care Units (ICU) of the hospitals involved in the study from January 1, 2011, to May 30, 2024, following cardiac arrest of any etiology, who meet the inclusion and exclusion criteria, will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Patients resuscitated from cardiac arrest and admitted to intensive care unit
* Age ≥ 18 years
* Out-of-hospital and in-hospital cardiac arrest
* Cardiac arrest of any etiology

Exclusion Criteria:

* Pediatric patients (\<18 years)
* Patients not admitted to one of the aforementioned intensive care units.

Primary outcomes:
measure: Intensive Care Unit (ICU) Survival
timeFrame: From cardiac arrest date to ICU discharge or death, up to 90 days
measure: Neurological recovery at ICU discharge
timeFrame: From cardiac arrest date to ICU discharge or death, up to 90 days
Secondary outcomes:
measure: Hospital discharge status
timeFrame: From cardiac arrest date to hospital discharge or death, up to 180 days
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Monza E Brianza
city: Milan
country: Italy
facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: IRCCS Cà Granda Ospedale Maggiore Policlinico
name: Giuseppe Ristagno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00797771: User Satisfaction Using the ADI Insulin Pump
Official title: Evaluation of User Satisfaction Using the ADI Insulin Pump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Insulin delivery
Lead sponsor: NiliMedix
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 20
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: Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events.

The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue.

This type of device requires extensive user interaction and education in order to ensure its safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin Pump, and to evaluate user's satisfaction.


Eligibility criteria: Inclusion Criteria:

* Male/female age 18 years and up.
* Subject is diagnosed as Type 1 Diabetes.
* Pump Users for at least 6 months
* HbA1c: less than 8.5%
* Capable of reading pump screens in English.
* Subject understands the study procedure.
* Subject is willing to sign the informed consent form and comply with the study requirements.

Exclusion Criteria:

* Major physical, motor, mental, behavioral, or psychiatric limitations.
* Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months.
* Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump.
* Concurrent additional major illness.
* Subject objects to the study protocol.
* Physician objection
* Concurrent participation in other study.

Primary outcomes:
measure: User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit
timeFrame: End of study
Secondary outcomes:
measure: Number of severe hypoglycemic events
timeFrame: during the study
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schnieder Children's Medical Center
Study officials:
affiliation: Schnieder Children's Medical Center Israel
name: Shlomit Shalitin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00679471: Brain Structure and Development in Pre-Term and Full-Term Infants
Official title: The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: pre-term infants
full-term infants
MRI
brain structure development
pre term
full term
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2008-05-16
Enrollment: 47
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-term or full-term infants who are admitted to the Neonatal Intensive Care Unit (NICU) at Christiana Hospital.

Brief summary: The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.


Eligibility criteria: Inclusion Criteria:

* Pre-term infants (\< 1 Kg Birthweight)
* Full-term infants (well)

Primary outcomes:
measure: To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age
timeFrame: 6 months
Secondary outcomes:
measure: To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age.
timeFrame: 6 months
Other outcomes:
measure: To determine the ability of data from learning and coordination impairments and brain MRI / MRS (magnetic resonance spectroscopy) to predict results from common clinical assessments from 3-24 months.
timeFrame: 24 months.
Locations:
city: Newark
country: United States
facility: University of Delaware: Infant Motor Beahvior Lab
state: Delaware
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Hospital
name: David A. Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gadin E, Lobo M, Paul DA, Sem K, Steiner KV, Mackley A, Anzilotti K, Galloway C. Volumetric MRI and MRS and early motor development of infants born preterm. Pediatr Phys Ther. 2012 Spring;24(1):38-44. doi: 10.1097/PEP.0b013e31823e069d.
Clinical trial NCT06412471: A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
Official title: A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: First-line Advanced NSCLC Patients
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.

Detailed description: This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Eligibility criteria: Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: ORR
timeFrame: 12 months
measure: Safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: PFS
timeFrame: 24 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of The Hunan Cancer Hospital
Study officials:
References:
Clinical trial NCT01485471: Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)
Official title: Spectroscopic Evaluation of Middle Ear Infection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Middle Ear Infection
Keywords: Middle Ear Infection
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-12-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UCI otolaryngology clinic

Brief summary: Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.

Detailed description: The research can use low energy laser signal light from Diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states

Eligibility criteria: Inclusion Criteria:

1. Male/ female at all age- newborn to adult.
2. Non- pregnant woman.
3. Diagnose of middle ear infection and plan for surgery procedure.

Exclusion Criteria:

1. Pregnant woman
2. Incompetent adults (i.e. individuals with cognitive impairment)
3. No diagnose of middle ear infection and no plan for surgery procedure.
4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Primary outcomes:
measure: Middle Ear exam
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beckman Laser Institute
name: Elliot Botvinick, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Laser Institute
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01442571: Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cartilage Injury
Keywords: Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 100
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 proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.


Eligibility criteria: Inclusion Criteria:

* Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).

Exclusion Criteria:

* Patients with known rheumatic disorders.
* Known hypersensitivity to HA.
* Synovial diseases like PVNS, under 18y old.

Primary outcomes:
measure: IKDC (the International Knee Documentation Committee)
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
Study officials:
References:
Clinical trial NCT00732771: Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
Official title: A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Hyperaldosteronism
Keywords: primary hyperaldosteronism
hypokalemia
hypertension
aldosterone synthase inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA).
* Hypertension at screening

Exclusion Criteria:

* Persistent hypokalemia
* Renal impairment
* Significant hepatic disease
* Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Systolic blood pressure over a 7-week forced titration treatment period
timeFrame: 7 weeks
Secondary outcomes:
measure: Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period
timeFrame: 7 weeks
Other outcomes:
Locations:
city: France
country: France
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.
citation: Amar L, Azizi M, Menard J, Peyrard S, Watson C, Plouin PF. Aldosterone synthase inhibition with LCI699: a proof-of-concept study in patients with primary aldosteronism. Hypertension. 2010 Nov;56(5):831-8. doi: 10.1161/HYPERTENSIONAHA.110.157271. Epub 2010 Sep 13.