louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01968564: Oral Curcumin Supplementation in Middle-Aged and Older Adults Improves Vascular Function
Official title: Clinical Translation of Curcumin Therapy to Treat Arterial Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Aging
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 118
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will assess the ability of curcumin, the active ingredient in the Indian spice tumeric, to improve the function of arteries with age. Overall, the proposed research project has the long-term potential to influence clinical practice guidelines by establishing a novel, easy to deliver, cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk of cardiovascular disease with age.


Eligibility criteria: Inclusion Criteria:

* women must be postmenopausal
* body mass index (BMI) \<40 kg/m2
* weight stable in the prior 3 months
* absence of clinical disease as determined by medical history, physical examination, blood and urine chemistries, ankle-brachial index, and a graded exercise stress test with monitoring of blood pressure and 12-lead ECG

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: Nitric-oxide mediated endothelium-dependent dilation
timeFrame: 12 weeks
Secondary outcomes:
measure: Systemic oxidative stress and inflammation
timeFrame: 12 weeks
measure: Endothelial cell oxidative stress and inflammation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder, Clinical Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Jessica Santos-Parker, MS
role: STUDY_DIRECTOR
affiliation: University of Colorado, Boulder
name: Douglas Seals, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692364: Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty
Official title: Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty Complications
Keywords: biomaterials
Implant wear
hip arthroplasty
osteolysis
aseptic loosening
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2018-10-02
Enrollment: 104
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study
Primary purpose: TREATMENT

Brief summary: Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.


Eligibility criteria: Inclusion Criteria:

* primary osteoarthritis
* secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)

Exclusion Criteria:

* inflammatory arthritis
* hip joint infection

Primary outcomes:
measure: Osteolysis frequency change between 7 and 15 years
timeFrame: Change between 7 to 15 years after surgery
measure: Osteolysis size change between 7 and 15 years
timeFrame: Change between 7 and 15 years after surgery
Secondary outcomes:
measure: Articulation wear at 7 years
timeFrame: At 7 years after surgery
measure: Articulation wear at 15 years
timeFrame: 15 years after surgery
measure: Implant fixation at 7 years
timeFrame: 7 years after surgery
measure: Implant fixation at 15 years
timeFrame: At 15 years after surgery
measure: Clinical function at 7 years
timeFrame: 7 years after surgery
measure: Clinical function at 15 years
timeFrame: 15 years after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06222164: The Use of Residual De-identified Specimens and/or Samples From Patients for Clinical Research
Official title: The Use of Residual De-identified Specimens and/or Samples From Patients for Clinical Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Diseases
Keywords: residual samples hematologic diseases
Lead sponsor: Invivoscribe, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specimen/sample, peripheral blood (PB), bone marrow (BM), genomic DNA (gDNA) and/or formalin-fixed paraffin-embedded tissue (FFPE) from patients whose specimens/samples have been sent to LabPMM for clinical testing

Brief summary: Acquire residual human specimens and/or samples from patient samples which were sent for testing at LabPMM, LLC for Clinical Research

Detailed description: Residual specimen/sample collection study where peripheral blood (PB), bone marrow (BM), genomic (gDNA), and/or formalin-fixed paraffin-embedded tissue (FFPE) specimens/samples are obtained from patient samples sent to LabPMM, LLC for clinical testing. Samples may be used for Clinical Research at LabPMM, LLC or at partner institutions

Eligibility criteria: Inclusion Criteria:

1. Specimen/sample, peripheral blood (PB), bone marrow (BM), genomic DNA (gDNA) and/or formalin-fixed paraffin-embedded tissue (FFPE) from patients whose specimens/samples have been sent to LabPMM for clinical testing
2. Donor Age ≥ 18 years

Exclusion Criteria:

1. Sample/specimen has been obtained from a third-party vendor with a Materials Transfer Agreement (MTA) on file with LabPMM
2. The specimens/samples have previously been enrolled in a clinical study

Primary outcomes:
measure: Enrollment
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: LabPMM
state: California
Study officials:
References:
Clinical trial NCT01574664: Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
Official title: A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the Safety and Performance of the Health Beacons Radiofrequency Identification (RFID) Localization System for Marking and Retrieving Non-Palpable Breast Lesions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-palpable Breast Lesions
Lead sponsor: Health Beacons
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients

Brief summary: The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.


Eligibility criteria: Inclusion Criteria:

* Have had stereotactic or ultrasound-guided biopsy with marker placement
* Have a lesion or biopsy marker that is visible under ultrasound
* Have surgical target \< 6 cm from the skin when lying supine
* Have a discreet surgical target
* Have a lesion in which the center/focal area is defined
* Be at least 18 years of age or older

Exclusion Criteria:

* Have a palpable lesion that does not require localization
* Require more than one localization needle for localization of the surgical target
* Have undergone previous open surgical biopsy or lumpectomy in the operative breast
* Have an implant in the operative breast
* Have a cardiac pacemaker or defibrillator device

Primary outcomes:
measure: The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.
timeFrame: Within 96 hours after lumpectomy
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: Exempla Healthcare
state: Colorado
Study officials:
affiliation: Health Beacons
name: Murray Reicher, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02609464: The Use of Barbed Sutures in Total Hip Arthroplasty
Official title: The Use of Barbed Sutures in Total Hip Arthroplasty: A Prospective, Randomized, and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2015-11-20
Enrollment: 100
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 purpose of this study is to evaluate the role of new barbed suture for closure of wound during total hip arthroplasty in reducing the risk for wound healing problems.


Eligibility criteria: Inclusion criteria:

* All patients receiving elective primary THA through the direct anterior approach, treated by the primary investigator (JP) at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

* Prior surgical incision or scar in close proximity of the proposed incision (\<2 cm).
* Local skin conditions such as dermatitis, eczema, or psoriasis.
* Active or previous infection in the skin or the hip.
* Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical cortico-steroid use

Primary outcomes:
measure: Incidence of suture abscess or other wound related compilation
timeFrame: Within 30 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03983564: Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients.
Official title: Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients. A Preliminary Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population to validate the cutoff of the combination of scores

Brief summary: Derivation and Validation of a combination of BOSTON score and DES-OSA score to exclude OSA or to confirm OSA in patients.

Detailed description: The aim of this study is to derive and to validate a combination of BOSTON score and DES-OSA score.

Firstly, the investigators will use a retrospective cohort of 400 patients to determine this combination. It will allow classifying patients in 3 groups: 1) patients for whom OSA can be excluded with certitude, 2) patients for whom OSA can be diagnosed with certitude, and 3) an intermediate group.

Secondly, the 100 patients included in this study will serve to validate the cutoff of the abovementioned combination into a new population.

Eligibility criteria: Inclusion Criteria:

* All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: Validation of cutoff values for the combination of BOSTON score and DES-OSA score in order to classify patients following their risk to present an OSA Syndrome.
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc de Bouge
state: Namur
Study officials:
affiliation: Clinique Saint-Luc of Bouge
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02354664: Dynamic Respiratory Muscle Function in Late-Onset Pompe Disease
Official title: Dynamic Respiratory Muscle Function in Late-Onset Pompe Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pompe Disease
Keywords: respiratory test
respiratory muscle endurance
spirometry
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2015-02-03
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with late-onset Pompe disease, age 20-65 years, and age and gender-matched unaffected control subjects

Brief summary: This study intends to evaluate dynamic respiratory motor performance as a valuable measure of pulmonary function in adults with late-onset Pompe disease. The investigators will adopt a strategy that includes comprehensive evaluations of respiratory volume, flow, and timing parameters during resting and loaded breathing. These evaluations will then be associated to the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease will be contrasted to the function of age- and gender-matched control subjects. This approach will enable the investigators to evaluate the relationship between dynamic diaphragmatic function and respiratory motor function.

Detailed description: The following tests will be completed over a two-day period: Respiratory pressure tests, breathing test, magnetic resonance imaging and magnetic resonance spectroscopy (MRI and MRS).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Pompe disease OR
* Be an age and gender-matched unaffected control subject

Exclusion Criteria:

* Pre-existing obstructive lung disease or asthma
* Forced vital capacity (FVC) \<30% or \>80% of age/gender predicted values
* Inability to travel to the study site
* Requirement for positive pressure ventilator support when awake and upright
* Participation in longitudinal studies that may independently alter lung function
* Presence of any other chronic medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study

Primary outcomes:
measure: Inspiratory Load Compensation - Inspiratory Volume
timeFrame: Day 1
measure: Respiratory Muscle Endurance Task
timeFrame: Day 2
measure: Inspiratory Load Compensation - Inspiratory Flow
timeFrame: Day 1
measure: Inspiratory Load Compensation - Inspiratory Time
timeFrame: Day 1
Secondary outcomes:
measure: Thoracic MRI
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Barbara K. Smith, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802564: Musical Biofeedback for Sensorimotor Control Capacity of Hands
Official title: Multisensory Biofeedback with Musical Interface for Sensorimotor Control Capacity of Hands
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Injuries
Keywords: musical biofeedback
auditory
vibrotactile stimulation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators assumed that music support treatment, a multisensory-based framework for ameliorating brain plasticity, combined with low-amplitude vibration stimulation can prime motor system and change in motor performance for the patient with a peripheral injury or the loss of a limb. The specific aim of this study is to develop a Multisensory Biofeedback with Musical Interface system, with the aim of improving the sensorimotor impairment of patients' hands.The expected outcomes of this research are to clarify the effects of application Multisensory Biofeedback with Musical Interface on motor and hand function for patients with hand injuries.


Eligibility criteria: Inclusion Criteria:

* tendon and bone injury in hand, wrist, and forearm; peripheral nerve injury in upper extremity; replantation; a combination of nerve and tendon or vascular injury; the protective sensation of the hand is absent or impaired

Exclusion Criteria:

* patients with deficits in cognition, perception or language comprehension, as well as severe pain and swelling in the upper limbs

Primary outcomes:
measure: Change in the result of pinch-holding-up-activity test
timeFrame: 8 weeks, 12 weeks and 24 weeks
Secondary outcomes:
measure: Chang in the result of two-point discrimination (S2PD) test
timeFrame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
measure: Chang in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
measure: Chang in the result of active range of motion test
timeFrame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
measure: Change in the result of Purdue pegboard test
timeFrame: 8 weeks, 12 weeks and 24 weeks
measure: Change in the result of Minnesota manual dexterity test
timeFrame: 8 weeks, 12 weeks and 24 weeks
measure: Change in the result of Manual ability measurement
timeFrame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
measure: Change in the result of Near-Infrared Spectroscopy
timeFrame: 4 weeks and 12 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
citation: Hsu HY, Lin CW, Lin YC, Wu PT, Kato H, Su FC, Kuo LC. Effects of vibrotactile-enhanced music-based intervention on sensorimotor control capacity in the hand of an aging brain: a pilot feasibility randomized crossover trial. BMC Geriatr. 2021 Nov 23;21(1):660. doi: 10.1186/s12877-021-02604-0.
Clinical trial NCT01078064: Gastric Accommodation and Gastroesophageal Reflux
Official title: Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease, gastric motility
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD symptoms, such as epigastric pain, respiratory symptoms, heartburn, feeding difficulties, chest pain, nausea or vomiting.

Brief summary: Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.

Detailed description: Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.

This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.

Eligibility criteria: Inclusion Criteria:

* children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD\* symptoms

Exclusion Criteria:

* continuous feeding
* previous fundoplication

Primary outcomes:
measure: NUMBER OF REFLUX EPISODES
timeFrame: 1 day
Secondary outcomes:
measure: Gastric volume ratio: 10 min/baseline
timeFrame: 1 day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Rodrigo S Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Beth Skaggs, CCRC
role: STUDY_DIRECTOR
References: