louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05998369: Empowered Relief for Youth
Official title: Empowered Relief for Youth: a Feasibility Study of a Pain Management Class for Youth with Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Fibromyalgia
Neuropathic Pain
Complex Regional Pain Syndromes
Abdominal Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.

Detailed description: The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age at least 10 years old to 18 years
* Diagnosis of Chronic Pain
* English speaking

Exclusion Criteria:

* Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
* Severe affective disorder (e.g., severe depression/ anxiety) from medical record review.

Primary outcomes:
measure: Treatment Expectancy Credibility (TEC-C)
timeFrame: Immediately post class
measure: Program Feedback Scale
timeFrame: Immediately post class
Secondary outcomes:
measure: PROMIS Pain Interference
timeFrame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4 weeks, 8 weeks, and 12 weeks post class
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Other outcomes:
measure: Child Pain Self-Efficacy Scale (PSES-C)
timeFrame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
measure: PROMIS Anxiety
timeFrame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
measure: PROMIS Depression
timeFrame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
measure: Hope Scale
timeFrame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Laura Simons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01833468: Functional Limitations Due To The Foot Involvement In Spondyloarthritis
Official title: FUNCTIONAL LIMITATIONS DUE TO the FOOT INVOLVEMENT IN SPONDYLOARTHRITIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: ankylosing spondylitis
Psoriatic arthritis
Foot
FAOS
SpA-TRI
Lead sponsor: Vakif Gureba Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with SpA and foot pain

Brief summary: Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The functional status of the SpA patients are usually evaluated globally.The aim of this study is to assess specifically the foot -related functional limitations of the SpA patients.

Detailed description: SpA patients who had foot pain at least for 4 weeks and those having bilateral anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index (SpA-TRI). The foot related functional status of the patients will be determined by the Turkish version of the Foot and Ankle Outcome Score (FAOS).

Eligibility criteria: Inclusion Criteria:

* SpA patients who had foot pain at least for 4 weeks
* Those having bilateral anteroposterior and lateral feet x-rays will be included into the study

Exclusion Criteria:

* Patients who had flatfoot
* Previous foot surgery
* Any other disorder unrelated to the SpA will be excluded

Primary outcomes:
measure: The foot-related functional status of SpA patients
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem Vakif University
name: nihal ozaras, ass.prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826369: Use of Compressed Sensing in Breast MRI
Official title: Use of Compressed Sensing in Breast MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Algorithms
Image Processing, Computer-Assisted/methods*
Magnetic Resonance Imaging/methods*
Data Compression
Breast Neoplasms
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 13
Sex: FEMALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Breast MRI is increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.

These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.

It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.


Eligibility criteria: Inclusion Criteria:

* Patient to benefit a MRI in the assessment for a breast carcinoma
* Age \>18 years old
* Assessment on 3.0 Tesla in Magnetic Resonance Imaging
* ECOG performance status ≤ 3
* Ability to provide an informed written consent form

Exclusion Criteria:

* Age \< 18 years old
* Claustrophobia
* Contraindication to the injection of gadolinium contrast medium
* Contraindication to MRI
* Persons deprived of liberty or under supervision

Primary outcomes:
measure: Agreement between compressed sensing and standard image acquisition
timeFrame: 1 day
Secondary outcomes:
measure: Analysis of dammage contours
timeFrame: 1 day
measure: Image quality in compressed sensing acquisition
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-Lès -Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: OLDRINI Guillaume, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018368: Study of VX-770 and Rifampin in Healthy Male Subjects
Official title: An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

Detailed description: This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.

All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.

Eligibility criteria: Inclusion Criteria:

* Subject must be male and between 18 and 55 years of age
* Subject must have a body mass index (BMI) from 18 to 30 kg/m2

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
* Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B

Primary outcomes:
measure: VX 770 pharmacokinetic (PK) parameters
timeFrame: 17 days
Secondary outcomes:
measure: VX 770 metabolite PK parameters in plasma
timeFrame: 17 days
measure: Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin
timeFrame: 17 days
measure: Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments
timeFrame: 17 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
state: Florida
Study officials:
affiliation: Covance CRU, Inc.
name: H. Frank Farmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725646: An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Keywords: Hypertriglyceridemia, omega-3-acid ethyl ester
Lead sponsor: Excelsior
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 253
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Detailed description: The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.

Eligibility criteria: Inclusion Criteria:

* Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL

Exclusion Criteria:

* Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
* Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization

Primary outcomes:
measure: Change in Triglycerides from baseline
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: NTUH
name: Chuen-Den Tseng, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01334346: Footwear Minimalism Study
Official title: An Investigation on Footwear Minimalism and Injury Risk in Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Runners
Keywords: Running
Footwear
Injury incidence
injury risk
pain
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Nike
First posted: 2011-04-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.

The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).


Eligibility criteria: Inclusion Criteria:

* Minimum of 5 years experience running
* Have been running on a regular basis (minimum once per week) over the past 6 months
* Able to run for 60 minutes continuously
* Can tolerate 20-40km per week in training
* Neutral foot posture according to the Foot Posture Index.

Exclusion Criteria:

* Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months
* History of surgery to their plantar fascia or Achilles tendon
* Have already been running in a minimalist shoe
* Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity
* Are currently taking analgesic medication.

Primary outcomes:
measure: Number of Injury Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Foot and Ankle Disability Index (FADI)
timeFrame: Week 12
measure: Numerical Pain Scale (NPS) for Overall Running Related Pain
timeFrame: Week 12
measure: Regional Specific NPS: Shin and Calf Pain
timeFrame: Week 12
measure: Regional Specific NPS: Foot and Ankle Pain
timeFrame: 12 Week
measure: Regional Specific NPS: Knee Pain
timeFrame: 12 Weeks
measure: Regional Specific NPS: Pelvis and Groin Pain
timeFrame: 12 Week
measure: Regional Specific NPS: Lower Back Pain
timeFrame: 12 Week
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jack Taunton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02016846: Liraglutide Efficacy on Glucocorticoid Induced Hyperglycemia in Patients High Risk for Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glucocorticoid Induced Hyperglycemia
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity. However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will improve glucose metabolism in patients with high risk for diabetes morbidity, treated with glucocorticoids.


Eligibility criteria: Inclusion criteria:

* Planned treatment with T. Prednisone in dosage \>0.5 mg/kg for two weeks or more.
* Age \>18 years
* Body mass index \>27 kg/m2 OR 1st degree relative with type 2 diabetes mellitus OR hypertension OR hyperlipidemia OR gestational diabetes in the past OR diagnosis of polycystic ovary syndrome.

Exclusion criteria:

* Glycosylated hemoglobin A1c \>6.5%
* Diagnosis of diabetes mellitus or treatment with anti-glycemic drug
* Pancreatitis (acute or chronic) in the past
* Active malignancy
* Medullary thyroid carcinoma or multiple endocrine neoplasm type 2 of the patient or of 1st degree relative
* Pregnancy

Primary outcomes:
measure: Glucose levels 2 hours after 75 gr OGTT
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center, Beilinson Campus
Study officials:
References:
Clinical trial NCT01279746: The Diagnosis of Occult Deep Vein Thrombosis of the Lower Extremities in Patients Presenting With Hypoxia
Official title: The Diagnosis of Occult Deep Vein Thrombosis of the Lower Extremities in Patients Presenting With Hypoxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Keywords: DVT Ultrasound compression Hypoxia Pulmonary Emboli
Occult DVT in hypoxic patients
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with saturation under 94% room air

Brief summary: The purpose of this study is to prove that bedside Ultrasound Compression is a useful screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to the emergency room with hypoxia.

Detailed description: It is known that 30% of deep vein thrombosis of the extremities is belived to be the precedend of pulmonary emboli; an often fatal disease. It is known that DVT (deep vein thrombosis is often occult.

It is also known that pulmonary embolism is often difficult to diagnose and is often missed especialy in patients with chronic illnesses such as COPD and CHF.

Venous compression ultrsound is an exam that can be preformed bedside. It is preformed by placing a vascular ultrasound transducer on the femoral vein and popliteal and checking its compressibility. If DVT is present in the femoral or popliteal veins the veins will be noncompressible. It has been shown that US compression for DVT can be preformed by physicians in the ER with accuracy and speed.

Presently US compression is not a tool used for detection of occult DVT in the ER. I wish to explore the usefullness of compression US of the lower extremities as a screening tool for DVT In the hypoxic patient.

Eligibility criteria: Inclusion Criteria:

* Patients presenting to the Emergency room
* 18 years or older, saturation 94% and under on room air.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References:
Clinical trial NCT03702946: Oxytocin Infusion and Abdominal Myomectomy
Official title: Effect of Oxytocin Infusion on Reducing the Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oxytocin and Abdominal Myomectomy
Lead sponsor: Armed Forces Hospital, Pakistan
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss.

Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with intramural fibroids, candidate for elective abdominal myomectomy.

Methods: Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given.

Main outcome measure: Intra-operative blood loss


Eligibility criteria: Inclusion Criteria:

1. women of ASA class I-II with intramural fibroids,
2. women planned to undergo elective abdominal myomectomy

Exclusion Criteria:

1. Women with hemoglobin (Hb) \< 10g/dl
2. Women with any respiratory or cardiovascular disease.

Primary outcomes:
measure: Intra-operative blood loss
timeFrame: during the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Department of Pediatrics
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Military Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00472446: Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial
Official title: Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Thyroidectomy
Keywords: Surgery
Thyroid gland
cervical block
Pain, Postoperative
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).

The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.


Eligibility criteria: Inclusion Criteria:

* Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
* Informed consent

Exclusion Criteria:

* Intolerance to used medication
* Recurrent disease
* Neck dissection, sternotomy
* Emergency surgery

Primary outcomes:
measure: Post-operative Pain Measured by Visual Analogue Scale
timeFrame: 6 hours after surgery
measure: Pooled Relative Treatment Effect of VAS
timeFrame: 4 days after surgery
Secondary outcomes:
measure: Post-operative Pain Measured by Visual Analogue Scale
timeFrame: 24 hours after surgery
measure: Consumption of Post-operative Analgetics
timeFrame: 5 days after surgery
measure: Mean Consumption of Post-operative Analgetics
timeFrame: 5 days after surgery
measure: Hospital Stay
timeFrame: 90 days
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Surgery, Cantonal Hospital of St. Gallen
Study officials:
affiliation: Department of Surgery, Cantonal Hospital St. Gallen
name: Thomas Clerici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steffen T, Warschkow R, Brandle M, Tarantino I, Clerici T. Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery. Br J Surg. 2010 Jul;97(7):1000-6. doi: 10.1002/bjs.7077.