louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06401473: Using the Gate Control Theory of Pain to Decrease Pain During Trigger Finger Corticosteroid Injections
Official title: Closing the Gate: Investigating a No-Cost, Noninvasive, Patient-Driven Approach to Pain Reduction for Trigger Finger Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Finger
Pain
Keywords: Gate Control Theory of Pain
Injection
Lead sponsor: Grand Canyon University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment into one of three parallel groups: control, distraction, or experimental
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate a new noninvasive technique that patients may use to help reduce the pain that they experience during cortisone injections for trigger fingers. It will also help provide information that may help support the gate control theory of pain as a framework for understanding and managing acute pain.The main questions it aims to answer are:

Can a physical stimulus near the site of cortisone injection reduce the pain experienced by the patient during the injection? Does the physical stimulation or the cognitive distraction contribute more to pain relief?

Researchers will compare a physical stimulus near the injection site to a placebo (a similar task that theoretically should not reduce the experience of pain) to see if physical stimuli work to improve pain during injections.

Participants will:

Estimate how much pain they expect to experience during a cortisone injection Receive a cortisone injection for a trigger finger while performing one of three possible actions (control, placebo task, or the investigated physical stimulus near the injection site) Express how much pain they actually experienced during the injection


Eligibility criteria: Inclusion Criteria:

* Are at least 18 years of age.
* Have been diagnosed with one or more "trigger fingers" of the index, middle, ring, or small fingers.
* Have decided to try a cortisone injection for one or more trigger fingers today as advised by your physician.
* Are able to read and understand these study procedures.

Exclusion Criteria:

* Are severely visually impaired.
* Have a history of spinal cord injury.
* Have taken opioid pain medications in the last 28 days.
* Are currently pregnant.

Primary outcomes:
measure: Visual Analog Scale (VAS) Score
timeFrame: Immediately after injection (within 10 seconds)
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: OrthoArizona
state: Arizona
Study officials:
affiliation: Grand Canyon University
name: Aidan Crislip, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00132873: Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
Official title: Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Narcolepsy
Keywords: Narcolepsy
Cataplexy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 59
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Detailed description: This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Eligibility criteria: Inclusion Criteria:

* Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
* Signed and dated an informed consent

Primary outcomes:
measure: Adverse Experiences
timeFrame: continuous
measure: Vital Signs
timeFrame: At 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Brain and Sleep Diagnostic Centre
state: Ontario
Study officials:
References:
Clinical trial NCT03664973: Serratus Plane Block for Rib Fractures
Official title: Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Trauma
Chest Pain
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2018-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.

Detailed description: Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures, will be randomized as described above. All patients will receive the serratus block with a ropivacaine 0.37% solution 20 ml. Then, they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line, or nothing. In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia (PCA) of morphine set out as follow: bolus 1 mg, loch out 15 min, max 4 boluses each hour. In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block, after 1 hour and at 72h.

Eligibility criteria: Inclusion Criteria:

* 2 o more ipsilateral rib fractures
* Trauma within 24h from hospital admission
* Informed consent

Exclusion Criteria:

* Chest drain
* head trauma
* bilateral rib fractures
* Intensive care admission

Primary outcomes:
measure: Pulmonary change function
timeFrame: day 0 and day 3
Secondary outcomes:
measure: Numerical rating scale (NRS) of pain
timeFrame: day 0, day 1, day 2, day 3, day 4
measure: Morphine
timeFrame: day 0, day 1, day 2, day 3, day 4
measure: hospital stay
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day7
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS Reggio Emilia
Study officials:
References:
Clinical trial NCT04867473: Feasibility of Teleyoga for Treatment of Lyme Disease
Official title: Teleyoga for Lyme Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lyme Disease
Keywords: yoga
telehealth
chronic pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Primary purpose: TREATMENT

Brief summary: Primary Aims: Modify an existing teleyoga intervention to use with Lyme disease (LD) patients and address the technical challenges of at-home teleyoga

Detailed description: Participants with symptoms of Lyme disease (n=15) will participate individually in a weekly tele-yoga class using an iPad loaned by the study. Participants will choose where to attend these remote treatment sessions. Yoga treatment will last 12 weeks. Participants' subjective pain will be rated at baseline and end-of-treatment using a standard pain scale. Also assessed will be participant adherence to study protocol by tracking treatment attendance

Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Lyme disease
* Has not begun new pain medications or other treatments in the last month
* English literacy
* Wireless internet connection at home

Exclusion Criteria:

* Participation in another concurrent clinical trial
* Back surgery within the last 12 months
* Unstable, coexisting mental illness or psychiatric condition
* Active, current suicidal intent or plan
* Attended or practiced yoga ≥ 1 x in the past 12 months

Primary outcomes:
measure: Change of Pain Score From Baseline
timeFrame: Measured at baseline and again at the end of 12 weeks of treatment
Secondary outcomes:
measure: Adherence to the Treatment Protocol
timeFrame: at study completion, an average of 7 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: VA Palo Alto Health Care System and Stanford University
name: Peter J Bayley, Ph.D.
role: STUDY_DIRECTOR
affiliation: Stanford University and VA Palo Alto Health Care System
name: Jerome A Yesavage, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00691873: Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
Official title: A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab) on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Allergic
Asthma
Immunotherapy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-06-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Detailed description: Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis and history of moderate persistent allergic asthma
* body weight \>/= 20kg and \</= 150kg
* Total serum IgE \>/= 30 and \</= 700IU/mL
* on a stable asthma treatment including corticosteroids for the preceding 4 weeks
* non smoker for at least 1 year prior to visit 1

Exclusion Criteria:

* patients with severe asthma
* history of immunotherapy to any allergen within the past 3 years
* history of anaphylactic allergic reaction
* upper respiratory tract infection

Primary outcomes:
measure: Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids
timeFrame: 2005-2007
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D. Marshall, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604273: Unravelling Intestinal Fibrosis in Ulcerative Colitis
Official title: Unravelling Intestinal Fibrosis in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis (UC)
Inflammatory Bowel Disease (IBD)
Fibroblast Activation Protein Inhibitor
Keywords: PET CT
FAPI
IBD
Ulcerative colitis
Filgotinib
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.
Primary purpose: BASIC_SCIENCE

Brief summary: The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients using FAPi-PET/CT imaging


Eligibility criteria: Inclusion Criteria:

* Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender
* Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females
* Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2)
* Indication to start treatment with filgotinib

AND one of the following criteria:

* Active disease confirmed by intestinal ultrasound (BWT \&gt; 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
* Increased CRP (\&gt;5 mg/L) and/or fecal calprotectin levels (\&gt;250 mg/kg)

Exclusion Criteria:

* Pregnancy
* Unable to provide informed consent
* Colorectal carcinoma or high-grade dysplasia

Primary outcomes:
measure: Candidate fibrotic cellular pathways
timeFrame: From enrollment to end of study participation at 24 weeks
Secondary outcomes:
measure: 68Ga-FAPi-PET/CT imaging feasibility
timeFrame: From enrollment to end of study participation at 24 weeks
measure: Correspondance 68Ga-FAPi uptake and STAT expression
timeFrame: From enrollment to end of study participation at 24 weeks
measure: Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters
timeFrame: From enrollment to end of study participation at 24 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam University Medical Centers
name: Mark Lowenberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635773: Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)
Official title: The Role of a Visual Alexa Enabled Visual Device in Aiding Performance in Emergency Front-of-Neck Access (eFONA-A) Within a Simulated 'Can't Intubate Can't Oxygenate' Scenario
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 34
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomisation will be carried out using a randomization table made at www.randomizer.org to even/odd allocation numbers corresponding to 'Alexa first' vs 'No Alexa first' group with equal allocation between each arm. The randomisation sequence will be known only to the investigators issuing the initial grouping to the candidate, and allocations will be concealed from the video recording assessors and the statistical analysis team.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to investigate whether a voice activated cognitive aid can improve performance in a simulated emergency front-of-neck access scenario. This skill is ideally practiced on an annual basis by anaesthetists in training, with a variety of usually low-fidelity simulation used.

The addition of the Alexa cognitive aid is a novel step with the aim of improving adherence to the recommended steps required to successfully complete the procedure. One arm of this study will be introduced to the Alexa checklist in advance of performing the procedure prior to crossover, whereas the second arm will not (subject to standard anaesthetic training).


Eligibility criteria: Inclusion Criteria:

* CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC)

Exclusion Criteria:

* Anaesthetists without the above criteria, refusal

Primary outcomes:
measure: The number of critical steps missed.
timeFrame: 6 months
Secondary outcomes:
measure: All critical steps completed
timeFrame: 6 months
measure: Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)
timeFrame: 6 months
measure: A measure of participant workload (e.g. NASA-TLX) as perceived and completed by the participant after each arm.
timeFrame: 6 months
measure: A measure of team working (e.g. ANTS score) for each individual procedure
timeFrame: 6 months
measure: A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Trust
Study officials:
affiliation: Guy's & St Thomas' NHS Trust
name: Craig Johnstone, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002073: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Official title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Injections, Subcutaneous
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

* Must not have previously participated in any other r-HuEPO clinical studies.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS and related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.
* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: Ortho Pharmaceutical Corp
state: New Jersey
Study officials:
References:
Clinical trial NCT01040273: Management of Postoperative Pain After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis of Hip
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-12-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.

We design a prospective randomized study for postoperative pain control following total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* diagnosed for surgery of osteoarthritis of hip
* ability to tolerate surgery under general anesthesia.

Exclusion Criteria:

* refusal or the lack of mental ability to provide informed consent
* neuropathic pain or sensory disorders in the leg requiring surgery
* previous surgery of the hip joint
* coagulation abnormalities
* severe renal or hepatic impairment
* chronic opioid users
* known history of intolerance to the drugs used in the study

Primary outcomes:
measure: Pain VAS score
timeFrame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
Secondary outcomes:
measure: Functional score: WOMAC hip score, SF-36
timeFrame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks
Other outcomes:
Locations:
city: Kweishian
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
References:
citation: Chen DW, Hu CC, Chang YH, Lee MS, Chang CJ, Hsieh PH. Intra-articular bupivacaine reduces postoperative pain and meperidine use after total hip arthroplasty: a randomized, double-blind study. J Arthroplasty. 2014 Dec;29(12):2457-61. doi: 10.1016/j.arth.2013.12.021. Epub 2013 Dec 19.