louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06131970: The Effectiveness of Continuous Ketamine Infusion (KONTINUE)
Official title: Effectiveness of Continuous Ketamine Infusion Associated With Magnesium Sulfate for Management of Patient With Chronic Pain : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Pain
Neuropathic pain
Chronic pain
Fibromyalgia
Musculoskeletal diseases
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic pain treated with ketamine infusion

Brief summary: There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine.

Detailed description: Ketamine continuous intravenous infusion for 4 days in Hospital with 0.5 mg/kg/day associated with Magnesium Sulfate 1000mg/day.

Evaluation schedules will be performed at day 15,30 and 60.

Eligibility criteria: Inclusion Criteria:

- Pain lasting for more than six months without contraindication to treatment

Exclusion Criteria:

* Inability to give consent
* Severe psychiatric disorder

Primary outcomes:
measure: Long-term effectiveness
timeFrame: 1 month
measure: Long-term effectiveness
timeFrame: 1 month
Secondary outcomes:
measure: Pain relief
timeFrame: 15, 30, 60 days
measure: Variation of quality of life
timeFrame: 15, 30, 60 days
measure: Variation of quality of life
timeFrame: 15, 30, 60 days
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
Clinical trial NCT04074070: Prevalence of Sonographic Abnormalities of Joints and Entheses in Psoriasis Patients With or Without Musculoskeletal Complains
Official title: Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis
psoriatic arthritis
ultrasound
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients consulting the dermatology department of Ambroise Paré hospital for cutaneous psoriasis between September 2019 and December 2020.

Brief summary: The objectives of this study are:

* to estimate the prevalence and severity of inflammatory (synovitis, tenosynovitis, enthesitis, dactylitis) and structural (erosions, osteophytes, enthesophytes, cortical irregularities ) ultrasound lesions in psoriasis patients with or without related musculoskeletal symptoms;
* to compare them to healthy subjects or patients suffering from rheumatoid arthritis and osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Psoriasis diagnosed by a dermatologist;
* Able to participate in the study;
* Informed consent signed.

Exclusion Criteria:

- Chronic disease likely to cause musculoskeletal symptoms (connective tissue diseases, inflammatory bowel diseases, overload disorders, crystal related arthritis, septic arthritis...).

Primary outcomes:
measure: synovitis
timeFrame: through study completion, an average of 1 year
measure: enthesitis
timeFrame: through study completion, an average of 1 year
measure: joint erosion
timeFrame: through study completion, an average of 1 year
measure: osteophyte/ cortical irregularity
timeFrame: through study completion, an average of 1 year
measure: enthesophyte
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Rheumatology Department, Ambroise Paré Hospital
Study officials:
affiliation: Rheumatology Department, Ambroise Paré Hospital
name: Maria-Antonietta D'Agostino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05498870: iPACK for Post-op Pain Following ACL Reconstruction
Official title: Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ACL Injury
Post Operative Pain
Keywords: acl injury
acl repair
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 82
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Age 12 years and older
* Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.

Exclusion Criteria:

* Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
* Patients undergoing hamstring graft or allograft for ACL
* Pre-existing infection at the site of injury
* Patients on chronic opioid treatments
* Pre-existing sensory or motor deficit in operative extremity
* Patients having a revision of previous ACL reconstruction
* Pregnant and/or lactating women
* Weighs less than 40kg

Primary outcomes:
measure: Pain Scores
timeFrame: 0-72 hours post op
Secondary outcomes:
measure: Total Postoperative Opioid Consumption (Total MME)
timeFrame: up to 72 hours post-op
measure: Range of Motion (Degrees)
timeFrame: up to two months after surgery
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Carey Breabaker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04413370: Dry Eye Screening and Referral System
Official title: The Development of Artificial Intelligence Dry Eye Screening and Referral System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are equal or over 18 years old with or without dry eye symptoms and signs.

Brief summary: Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists.

The purpose of this study is to establish a case-control cohort of dry eye patients. Multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (OSDI), anterior segment photography, and treatment outcome of dry eye patients. The correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. The purpose of this study was to develop an artificial intelligence dry eye screening and referral system.


Eligibility criteria: Inclusion Criteria:

1. Subjects whose age are greater than or equal to 18 years old;
2. Subjects who can cooperate with the inspection;
3. Subjects who agree to participate in the study and sign the consent form.

Exclusion Criteria:

1. Subjects who cannot do the inspection.
2. Subjects who suffer from diseases that compromise the inspection.

Primary outcomes:
measure: Area under the curve (severe)
timeFrame: up to 1 month
Secondary outcomes:
measure: Area under the curve (each group)
timeFrame: up to 1 month
measure: Accuracy, true positive rate, and true negative rate
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT05637970: Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
Official title: A Prospective Randomized Study Comparing the Time to Ambulation (TTA) and Safety of Using a Closure Device Alone and in Conjunction With a Potassium Ferrate Pad (StatSeal Advanced) Following Transcatheter Aortic Valve Replacement (TAVR) Via the Transfemoral Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Occlusion
Cardiovascular Diseases
Hematoma
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 50
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 clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.


Eligibility criteria: Inclusion Criteria:

Delivery of a 14-16 French Transcatheter aortic valve replacement system

Exclusion Criteria:

* Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
* Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure.
* Any use of glycoprotein inhibitors or cangrelor.
* Use of sheathless guides.
* Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral leg.
* Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
* Inability of the patient to personally consent for the study. (no surrogate consent)
* Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.

Primary outcomes:
measure: Time to Hemostasis
timeFrame: 24 hours post procedure (± 1 hour)
Secondary outcomes:
measure: Patients With Hematoma
timeFrame: 24 hours post procedure (± 1 hour)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Ronald Reagan Medical Center
state: California
Study officials:
References:
Clinical trial NCT03596970: Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
Official title: A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Open-label
randomized
calcineurin-inhibitor
CNI
tacrolimus
MMF
maintenance liver transplant
RAD001H
CRAD001H
liver transplant
transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 0
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: A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)


Eligibility criteria: Inclusion Criteria:

* Patients willing and capable of providing written informed consent for study participation.
* Adults 18 to 70 years of age.
* Liver allograft from a deceased or living donor.
* Treated with a CNI containing immunosuppressive regimen.
* Liver transplant 6 to 24 months prior to screening.
* Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min \< eGFR \< CKD II/60 mL/min with deteriorating renal function.
* Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

Exclusion Criteria:

* Multiple solid organ transplant recipients
* Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
* Malignant diseases other than neoplasms of the skin.
* Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
* Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
* HIV positivity

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Renal Function
timeFrame: Randomization to Month 6
Secondary outcomes:
measure: Efficacy (tBPAR, graft loss, death, loss to follow-up)
timeFrame: To Month 6
Other outcomes:
measure: Number of participants with adverse events
timeFrame: at 24 months (end of study)
Locations:
Study officials:
References:
Clinical trial NCT04063670: Coping After Pediatric Scoliosis Surgery
Official title: Coping After Pediatric Scoliosis Surgery: How Does it Affect Pain and Function?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Pain
Function
Pediatric
Scoliosis
Scoliosis Surgery
Spinal Fusion
Idiopathic Scoliosis
Coping
Coping Skills
Education
Video Intervention
Randomized
Prospective
Satisfaction
Adolescent
Opioid
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized Controlled Clinical Trial
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.


Eligibility criteria: Inclusion criteria:

- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach

Exclusion Criteria:

* Non-English speaking
* Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic.
* Other comorbidity, including developmental delay.
* Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway.
* Unplanned admission within 6 weeks of index operation.
* Active treatment psychotherapy and/or cognitive behavioral therapy for any reason

Primary outcomes:
measure: Post-Operative Pain
timeFrame: Up to 6-weeks post-operatively
measure: Post-Operative Pain
timeFrame: Up to 6-weeks post-operatively
Secondary outcomes:
measure: Patient Reported Outcomes - Global Health
timeFrame: Up to 6-weeks post-operatively
measure: Patient Reported Outcomes - Mobility
timeFrame: Up to 6-weeks post-operatively
measure: Patient Reported Outcomes - Positive Affect
timeFrame: Up to 6-weeks post-operatively
measure: Patient Reported Outcomes - Physical Activity
timeFrame: Up to 6-weeks post-operatively
measure: Patient Reported Outcomes - Strength Impact
timeFrame: Up to 6-weeks post-operatively
Other outcomes:
measure: Pain-Related Disability and Post-Operative Functional Status.
timeFrame: Up to 6-weeks post-operatively
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: UCSF Department of Orthopaedic Surgery
name: Mohammad Diab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Department of Orthopaedic Surgery
name: Alex Gornitzky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05948670: Participant Satisfaction With the BUILD Mobile Application
Official title: An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Personal
Keywords: Woebot
LLM
Relational agent
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2023-07-17
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: OTHER

Brief summary: This study explores user satisfaction with the BUILD mobile application.

Detailed description: This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the BUILD app in order to access the intervention to which they were assigned. Participants will use the app as instructed and will complete assessments for the primary endpoint at Week 2 (EOT) with additional measures being collected at Baseline, Day 3, and Week 2. Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Must be 18+ years of age and older
2. Must own or have regular access to a smartphone with a recent operating system installed (Android: OS 8.0 or higher, Apple: iOS 13.0 or higher) with reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
3. Must be available and committed to engage with the program and complete assessments for a 2-week duration
4. Must be able to read and write in English
5. Must have primary residence in the United States

Exclusion Criteria:

1. Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
2. Previous Woebot use

Primary outcomes:
measure: User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-intervention at Week 2
Secondary outcomes:
measure: User Satisfaction Amongst a Sub-sample of Adults With at Least Mild Symptoms of Depression and/or Anxiety.
timeFrame: Post-intervention at Week 2
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Investigational Site
state: California
Study officials:
affiliation: Woebot Health
name: Tim Campellone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05485870: Early Screening and Identification for Panvascular Diseases
Official title: Early Screening and Identification for Panvascular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Panvascular Diseases
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
First posted: 2022-08-03
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with panvascular diseases

Brief summary: Identify the pathogenic factors involved in the occurrence and development of panvascular disease and its pathogenesis.

Detailed description: Identify the pathogenic factors involved in the occurrence and development of panvascular disease and its pathogenesis by a multi-omics study.

Eligibility criteria: Inclusion Criteria:

* 1. Patients with panvascular diseases; 2. Patients or guardians who agreed to join the study; 3. Patients who can complete the relevant examinations involved in this study;

Exclusion Criteria:

* patients with coagulation dysfunction.

Primary outcomes:
measure: Any new stroke events
timeFrame: Up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
References: