louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01939080: Variation of Aortic Compliance Related to Exercise Training With or Without Supervised Sessions
Official title: Exercise Training in Patients With Cardiovascular Risk: Predictability of Aortic Compliance Normalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Keywords: moderate risk
high risk
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 308
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many conditions and cardiovascular diseases (including stroke) are better managed with regular exercise training. The expected effects are partial reversal of adverse effects on heart and blood vessel structure and function, improved glycemic, tension and weight control.

Physiologically, the aorta maintains low left ventricular after-load, promotes optimal sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow. Increased aortic stiffness may ultimately contribute to left ventricular dysfunction. Regular exercise training is likely to decrease the pulse wave velocity (a measure of the aortic compliance). Some subjects seem more responsive than others, and they may not expect the same benefit of exercise training. To the best of our knowledge, this has not been explained yet.


Eligibility criteria: Inclusion Criteria:

* patients aged 50-69 years, with moderate or high cardiovascular risk

Exclusion Criteria:

* any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.

Primary outcomes:
measure: Pulse wave velocity
timeFrame: With or without the exercise training
Secondary outcomes:
measure: Heart rate variability
timeFrame: within 12 weeks after exercise training
Other outcomes:
Locations:
city: Pointe à Pitre
country: Guadeloupe
facility: CHU de Pointe à Pitre
city: Fort de France
country: Martinique
facility: CHU de Fort de France
Study officials:
References:
Clinical trial NCT05488080: PAINED: Project Addressing INequities in the Emergency Department
Official title: PAINED: Project Addressing INequities in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Appendicitis
Bias, Racial
Fractures, Bone
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a pragmatic clinical trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.


Eligibility criteria: Inclusion Criteria:

* All Children's National Hospital Emergency Department clinicians

Exclusion Criteria:

* None

Primary outcomes:
measure: Pain reduction
timeFrame: Equity Report Cards provided monthly to clinicians over a 24-month period
measure: Analgesia use
timeFrame: Equity Report Cards provided monthly to clinicians over a 24-month period
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Monika Goyal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02245880: Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach
Official title: A Comparison of Glidescope and ILMA in Simulated Sercial Spine Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injury of Cervical Spine
Keywords: cervical spine
intubating laryngeal mask airway
Glidescope videolaryngoscope
collar
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.

Detailed description: inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring intubation exclusion criteria:

- pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* ASA I-II
* requiring intubation
* BMI\<35

Exclusion Criteria:

* less than 18 or higher than 65
* ASA III-IV
* BMI\> 35
* PREGNANT
* head and neck tumors

Primary outcomes:
measure: intubation times
timeFrame: From handling of the device till intıbation
Secondary outcomes:
measure: Heart rate
timeFrame: From Preoperative heart rate till 15 minutes After intubation
measure: Mean arterial pressure
timeFrame: From preinduction till 15 minutes after intubation
Other outcomes:
measure: minor complications
timeFrame: From the end of surgery till 2 hours postoperatively
measure: Mucosal damage
timeFrame: Bloodstain on the device after removal
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
Study officials:
affiliation: Anesthesiology and Reanimation
name: Zehra I ARSLAN, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05269680: STAR-LIFE: a Post-market Registry on MINIject
Official title: STAR-LIFE: a Post-market Registry on MINIject
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Angle Glaucoma
Keywords: Open Angle Glaucoma
Minimally Invasive Glaucoma Surgery
MINIject
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 750
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: patient diagnosed with open angle glaucoma

Brief summary: As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

Detailed description: The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.

Eligibility criteria: Inclusion Criteria:

* 18+ years
* diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
* able to give consent

Exclusion Criteria:

* eyes with angle closure glaucoma
* eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
* patients with known intolerance or hypersensitivity to silicone
* patients unable to give consent

Primary outcomes:
measure: QoL
timeFrame: 2 years after surgery
measure: ease of use
timeFrame: 1 day
measure: Number of participants with treatment-related incidents
timeFrame: up to 2 years after surgery (study completion)
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitatsklinik fur Augenheilkunde Inselspital
Study officials:
References:
Clinical trial NCT04669080: Asthma Clinics Helping Expand Cost Conversations
Official title: Developing and Evaluating an Intervention to Enhance the Work of Asthma Specialty Care Teams in Helping Families in Cost Navigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: cost of care
patient provider communication
financial burden
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Harvard Pilgrim Health Care
First posted: 2020-12-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomized pre-post test
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Healthcare costs are a critical barrier to U.S. families' ability to access the preventive care needed to manage their children's asthma. Asthma specialty care teams are uniquely positioned to help families navigate these cost barriers, but lack structured approaches to discussing this sensitive and complex topic. This study will train asthma specialty care teams to identify families at risk for financial burden and engage in conversations about strategies to manage asthma care costs. The study team will evaluate the impact of a health care provider training on the frequency of cost navigation conversations. The investigators hypothesize that the health care provider training will increase the frequency of parent-reported cost conversations in the clinic.


Eligibility criteria: Inclusion Criteria:

Eligible caregivers will:

* attend a routine asthma care appointment for a 4-17 year old child
* screen positive for possible financial burden related to the cost of asthma care

Eligible healthcare providers will:

* be members of a pediatric asthma specialty care team

Exclusion Criteria:

Caregivers will not be eligible if they:

* attend an appointment for conditions other than routine asthma care
* do not screen positive for possible financial burden related to the cost of asthma care

Healthcare providers will not be eligible if they:

* are not part of the pediatric asthma specialty care team in the participating clinic

Primary outcomes:
measure: Change in Frequency of Cost Conversations Occurring during Asthma Specialty Care Visits
timeFrame: Baseline, 6 weeks post intervention completion
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: North Carolina Children's Allergy and Asthma Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Melissa B Gilkey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04194580: Physical Activiy Intervention Programm
Official title: Effectiveness of a Physical Activity Intervention on the Overweight and Obesity of Chilean Schoolchildren
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Fitness
Overweight and Obesity
Lead sponsor: Universidad Autónoma de Chile
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 800
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention for reducing the prevalence of overweight/obesity and other cardiovascular risk factors

Detailed description: A greater intensity of the intervention, and a longer weekly duration that extends until the weekend, could improve the efficiency in obesity.

Eligibility criteria: Inclusion Criteria:

* The parents of the children will be informed about the objectives and methods of the study, and will give their written consent to the participation of the children. Similarly, the study will introduce children from classroom to class and their oral consent will be obtained

Exclusion Criteria:

* Participating children will be free from serious learning difficulties, or physical or mental disorders, that could prevent participation in scheduled physical activities.

Primary outcomes:
measure: Aerobic Capacity
timeFrame: 1 year
measure: Muscle Strength
timeFrame: 1 year
measure: Flexibility
timeFrame: 1 year
measure: Speed-agility
timeFrame: 1 year
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Laboratorio Fisiología del Ejercicio
state: La Araucanía
Study officials:
affiliation: Universidad Autónoma de Chile
name: José Bruneau, PhD
role: STUDY_DIRECTOR
References:
citation: Godoy-Cumillaf A, Fuentes-Merino P, Giakoni-Ramirez F, Duclos-Bastias D, Merellano-Navarro E. Effectiveness of a physical activity intervention on the overweight and obesity of Chilean schoolchildren. Medicine (Baltimore). 2022 Sep 30;101(39):e30908. doi: 10.1097/MD.0000000000030908.
Clinical trial NCT04003480: FRAME, External Support for Lower Limb Autologous Grafts
Official title: Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Artery Disease
Keywords: Saphenous vein graft
PAD
Peripheral bypass surgery
external support
Lead sponsor: Vascular Graft Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.

Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.


Eligibility criteria: Inclusion Criteria:

1. Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
2. Rutherford classification 3-6
3. Adequate revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
4. Patient is able and willing to give their informed written consent.
5. Patient is able and willing to comply with study follow up requirements.
6. Patient is ≥ 18 years of age

Exclusion Criteria:

1. Patients indicated for endovascular treatment
2. Prior surgical bypass procedure in ipsilateral lower limb.
3. Active ulcer/infection/gangrene at the intended distal anastomosis site.
4. Severe vein varicosity
5. Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
6. Spliced vein technique
7. In-situ vein technique
8. Pedal/plantar distal anastomosis
9. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
10. Patients with history of hypercoagulable conditions.
11. Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
12. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
13. Contraindication to recommended study medications
14. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Lutheran Hospital of Indiana
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00000180: AIT-082 Phase 1B Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Memory Disorders
Keywords: Memory
Mild cognitive impairment
Nerve growth factors
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 1999-11-01
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.

This study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Indianapolis
country: United States
facility: Indiana University Alzheimer's Center
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: University of California, San Diego
name: Michael Grundman, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53. doi: 10.1016/s0024-3205(03)00320-5.
Clinical trial NCT00828880: Restoration of Disc Height Reduces Chronic Low Back Pain
Official title: Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Axiom Worldwide, LLC
First posted: 2009-01-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age;
* consented for the 6 weeks treatment protocol;
* presented with discogenic low back pain of at least 3 out of 10; AND
* current CT scan not older than 2 months.

Exclusion Criteria:

* metastatic cancer;
* previous spinal fusion or placement of stabilization hardware;
* instrumentation or artificial discs;
* neurologic motor deficits, bladder, or sexual dysfunction;
* alcohol or drug abuse; OR
* litigation for a health-related claim (in process or pending for workers' compensation or personal injury).

Limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (\< 147 cm or \> 203 cm) and body weight (\> 136 kg).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: McAllen
country: United States
facility: Upper Valley Interventional Radiology
state: Texas
Study officials:
References:
citation: Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155. doi: 10.1186/1471-2474-11-155.
Clinical trial NCT05577780: Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty
Official title: Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Neck Fractures
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Femoral neck fracture between 45 and 64 years

Brief summary: The therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. This choice for patients aged between 45 and 64 years old remains a controversial subject.

The aim of our work was to describe the current situation in the management of femoral neck fractures in these patients and to evaluate the results of the two options

Detailed description: Our study was retrospective descriptive including patients aged between 45 and 64 years operated between January 2015 and December 2022 for femoral neck fracture. The patients will be divided into two groups: The internal fixation group and the arthroplasty group . Epidemiological, clinical and radiological data as well as therapeutic results and postoperative complications will be analysed.

Eligibility criteria: Inclusion Criteria:

* Femoral neck fracture between 45 and 64 years

Primary outcomes:
measure: The Parker Mobility Score
timeFrame: Baseline, Month 3
measure: The Parker Mobility Score
timeFrame: Baseline, Month 6
measure: GARDEN classification
timeFrame: Baseline
measure: Postel Merle d'Aubigné score(PMA)
timeFrame: Baseline, Month 3
measure: Postel Merle d'Aubigné score(PMA)
timeFrame: Baseline, Month 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: