louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03395158: Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage.
Official title: Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala-Örebro Regional Research Council
First posted: 2018-01-10
Enrollment: 2200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients subject to trauma where a trauma alert was initiated OR registered patients subject to trauma without an alert call, but with an Injury Severity Score \>15.

Brief summary: New trauma alert criteria has been introduced in Sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. The Swedish trauma registry is used to identify eligible patients.

Detailed description: The Swedish trauma registry (SweTrau) was initiated in 2011, and has up to date 40.000 registered patients. In order to evaluate trauma alert criteria implemented during 2017, we plan a prospective stepped wedge trial at six hospitals in the Uppsala/Örebro region. These hospitals register in SweTrau and all had the same alert criteria prior to the implementation of new alert criteria.

A power estimation show the need for 588 patients in each group in order to show a statistical difference between 2-5% undertriage at a 95% CI.

The including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000.

The registry has information about time of trauma, initiated alerts, Injury Severity Score and mechanism of injury suitable for analysis for our hypothesis.

Eligibility criteria: Inclusion Criteria:

- All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017

Exclusion Criteria:

* Patients registered due to secondary referral where the initial assessment was performed at another hospital

Primary outcomes:
measure: Number of alerts initiated
timeFrame: One year data with intervention
Secondary outcomes:
measure: Analysis of over- and undertriage with the Matrix method
timeFrame: One year data with intervention
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University
name: Kevin Mani, Ass prof
role: STUDY_CHAIR
References:
Clinical trial NCT03679858: Platelet Antisedimentation Rate and Multiplate Exams in Patients on Antiplatelet Therapy and Controls
Official title: Platelet Antisedimentation Rate and Multiplate ex Vivo Examinations in Cerebrovascular Patients Treated With Antiplatelet Therapy and Healthy Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Disorders
Platelet Refractoriness
Platelet Aggregation, Spontaneous
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebrovascular disorders on antiplatelet therapy as a secundary prevention.

Brief summary: To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists.


Eligibility criteria: Inclusion Criteria:

* Written informed consent

Exclusion Criteria:

* Declined informed consent

Primary outcomes:
measure: Major cerebrovascular event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
state: Baranya
Study officials:
affiliation: University of Pécs Medical School
name: Tihamer Molnar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792358: Wet Cupping Therapy in Ankylosing Spondylitis
Official title: Wet Cupping Therapy in Ankylosing Spondylitis: a Multicenter Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Wet cupping therapy
Basfi
Basdai
Vas
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics

Detailed description: In addition to the medical treatment, WCT will be applied once a month, 3 times (Day 0, 30, 60) to the intervention group whereas the control group will not receive any intervention. The BASFI, BASDAI, VAS and Schober test will be applied to both groups at 0 and 3 months.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of ankylosing spondylitis 18-65 years of age Consent to participate

Exclusion Criteria:

Any ongoing medical treatment other than NSAIDs Pregnancy At least one contraindication to WCT that was detected in subject's history or in the routine blood examinations prior to enrollment (Hgb \<9.5; INR\> 1.2; history of hemophobia, bleeding disorder, malignant disorder).

Primary outcomes:
measure: BASFI
timeFrame: At 0 and 3 months
measure: BASDAI
timeFrame: At 0 and 3 months
measure: VAS
timeFrame: At 0 and 3 months
Secondary outcomes:
measure: Schober
timeFrame: At 0 and 3 months
Other outcomes:
Locations:
city: Karabuk
country: Turkey
facility: Karabuk University
Study officials:
References:
Clinical trial NCT00838058: A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
Official title: An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Healthy Volunteers
Keywords: pharmacology formulation normal healthy volunteers food effect
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.


Eligibility criteria: Inclusion Criteria:

* aged 18-55 and healthy

Exclusion Criteria:

* severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
* pregnant or wanting to become pregnant

Primary outcomes:
measure: pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
timeFrame: 48 hrs
Secondary outcomes:
measure: safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
timeFrame: 48 hrs
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01091558: Study of Effects of L-Arginine in Colitis and Colon Cancer
Official title: Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Colon Cancer
Keywords: ulcerative colitis
colon cancer
endoscopy
screening
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-03-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient scheduled to have a colonoscopy as part of medical care for either ulcerative colitis or as a routine screening colonoscopy.

Brief summary: The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell.

The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.

Detailed description: Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (HPLC). Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (PCR) analysis of mRNA expression.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis)
* Screening for cancer

Exclusion Criteria:

* refusal to participate
* age less than 18 years at time of colonoscopy

Primary outcomes:
measure: L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity
timeFrame: 24 months
Secondary outcomes:
measure: L-Arg intake in the diet of UC patients and control subjects
timeFrame: 24 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Keith Wilson, MD, AGAF
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gobert AP, Latour YL, Asim M, Barry DP, Allaman MM, Finley JL, Smith TM, McNamara KM, Singh K, Sierra JC, Delgado AG, Luis PB, Schneider C, Washington MK, Piazuelo MB, Zhao S, Coburn LA, Wilson KT. Protective Role of Spermidine in Colitis and Colon Carcinogenesis. Gastroenterology. 2022 Mar;162(3):813-827.e8. doi: 10.1053/j.gastro.2021.11.005. Epub 2021 Nov 10.
Clinical trial NCT03180658: Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
Official title: The Effect of Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concentrated Growth Factors
Periodontal Regeneration
Furcation Defects
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars will be included and randomly divided into two groups. The experimental group will accept GTR + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The clinical examination and cone beam computed tomography (CBCT) will be performed at baseline and 1 year post-surgery.


Eligibility criteria: Inclusion Criteria:

* II° furcation involvements in mandibular molars
* after periodontal therapy.

Exclusion Criteria:

* not healthy

Primary outcomes:
measure: clinical measurement
timeFrame: 1 year
measure: clinical parameter
timeFrame: 1 year
Secondary outcomes:
measure: radiographic parameter
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university School and Hospital of Stomatology
state: Beijing
Study officials:
affiliation: dean
name: yan zu zhang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT05784558: RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
Official title: RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 2500
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)

Brief summary: The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of symptomatic BPH

Exclusion Criteria:

* Prior surgical intervention for treatment of BPH
* Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments

Primary outcomes:
measure: To identify responders of IPSS change
timeFrame: 3 months post-treatment visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05620758: Laser Therapy and Temporomandibular Disorders
Official title: Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TMD
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation


Eligibility criteria: Inclusion Criteria:

* Pain at TMJ area.
* Pain at masseter and temporalis muscles.
* Age ranges between 20 and 40 years old.
* Presence of full or nearly full complement of natural teeth

Exclusion Criteria:

* Patients who have radiographic evidence of degenerative conditions of TMJ.
* Patients under current dental or physical therapy that could affect TMD.
* History of recent trauma.
* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
* Pregnant and lactating females

Primary outcomes:
measure: Change in Pain
timeFrame: Baseline and 1 month
measure: Chaneg in pressure pain threshold
timeFrame: Baseline and 1 month
measure: Change in Oral-health Related Quality of life (OHRQoL)
timeFrame: Baseline and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04302558: Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
Official title: Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 29
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.


Eligibility criteria: Inclusion Criteria:

* Subjects must be between 13 and 40 years old
* Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
* Subjects must be able to understand study procedures and comply with them for the entire duration of the study
* Subjects must have normal contralateral limb strength

Exclusion Criteria:

* Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
* Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
* Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
* Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent

Primary outcomes:
measure: Change in muscle diameter (hypertrophy)
timeFrame: 2 weeks pre-operative, 8-10 days post-operative
Secondary outcomes:
measure: Change in muscle strength
timeFrame: 2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Anikar Chhabra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00775658: Olopatadine Eye Drops and Allergy Skin Testing
Official title: Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Allergic Conjunctivitis
Keywords: allergy
skin testing
eye drops
antihistamines
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 75 years
* Healthy volunteers (no major illnesses or active symptoms)

Exclusion Criteria:

* Known allergy or hypersensitivity to the drugs or components
* Pregnant or nursing women
* Women wishing to become pregnant during the study's duration
* Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization
* Dermatographism as evidenced on skin testing on visit 1
* Chronic urticaria active within the past 6 months
* Severe hypertension
* Psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history
* Inability to provide informed consent

Primary outcomes:
measure: The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
timeFrame: at baseline and at return visit (between study day 7-10)
measure: The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
timeFrame: at baseline and at return visit (between study day 7-10)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Asthma, Sinus and Allergy Program Research
state: Tennessee
Study officials:
References:
Clinical trial NCT03159858: Compassionate Use Treatment for a Single Patient With a Custom Made Branched/Fenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm
Official title: Compassionate Use Treatment for a Single Patient With a Custom Made Branched/Fenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Complex Abdominal Aortic Aneurysm
Keywords: Complex Abdominal Aortic Aneurysm
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-05-19
Sex: MALE
Minimum age (years): 70
Maximum age (years): 70
Standard ages: OLDER_ADULT

Brief summary: The FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE H\&L-B ONE-SHOT™ INTRODUCTION SYSTEM is neither commercially available or available as part of a clinical trial. IRB approval of this protocol was requested so that Cook, Incorporated may apply to the FDA for approval for one-time use of this patient-specific device for compassionate use for patient AO. It is a custom made endovascular device consisting of4 fenestrations for the celiac, SMA (superior mesenteric) and left and right renal arteries.

Detailed description: The Custom Made Branched/Fenestrated Endovascular Device to be used in this treatment plan is not Food and Drug Administration (FDA)-approved, and is approved for use only in a clinical study. However, the FDA has allowed the use of this device for compassionate use.

The devices used are tubular grafts made of polyester fabric sewn to metal stents. The upper part of the grafts includes fenestrations (holes) that allow the grafts to be located above or near major arteries that branch off of the aorta (celiac artery, superior mesenteric artery (SMA), and renal arteries) without blocking blood flow to them. The celiac artery supplies blood to internal organs including the liver and stomach. The SMA supplies blood to internal organs as well, including parts of the large and small intestines. The renal arteries supply blood to the kidneys. Grafts with branches and/or fenestrations are needed when the aneurysm is located near these major arteries. The major arteries that branch off of the aorta (celiac artery, SMA, and renal arteries) may also be treated using stents (small tubular metal structures) to help keep the arteries open and aligned with the graft fenestrations (holes).

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Neal Cayne, MD
role: PRINCIPAL_INVESTIGATOR
References: