louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06399913: Cerebral Computed Tomography on Patients With Minor Head Injuries
Official title: Use of Cerebral Computed Tomography on Patients With Minor Head Injuries in a Danish Emergency Department: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Computed Tomography
Minor Head Injuries
Keywords: Emergency Department
S100B
Scandinavian Neurotrauma Committee Guideline
Traumatic Brain Injuries
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 7106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CTCs conducted from 01.01.2023 to 31.12.2023 at Odense University Hospital (OUH) Emergency Department (ED) in Denmark.

Brief summary: This observational study aims to calculate the prevalence of conditions or diseases requiring immediate medical attention in CTC scans with an indication of bleeding post trauma performed in the ED at Odense University Hospital. Secondary, we aim to evaluate the Scandinavian Neurotrauma Committee clinical guideline 2013 for minor head injury.

Detailed description: In this retrospective study, our primary objectives are threefold: first, to calculate the prevalence of conditions or diseases requiring immediate medical attention and to subdivide them to explore potential correlations with biochemical, clinical, and patient baseline variables using multiple regression analysis. Secondly, we wanted to analyze our use of SNC CPG and evaluate if a more stringent application could reduce the potentially unnecessary overuse of CTC. Lastly, we aim to evaluate the 30-day mortality and readmission rates to a hospital following CTC performed in the ED.

Eligibility criteria: Inclusion Criteria:

* CTCs conducted from 01.01.2023 to 31.12.2023 in the ED

Exclusion Criteria:

* unrelated to trauma
* scans performed on patients under the age of 18
* CTC scans without radiologic interpretation
* Previously undergone a CTC during the same hospitalization, only the first CTC was included

Primary outcomes:
measure: Positive CTC
timeFrame: 1 year
Secondary outcomes:
measure: Scandinavian Neurotrauma Committee clinical practice guideline evaluation
timeFrame: 1 year
Other outcomes:
measure: 30-day mortality and readmission rate
timeFrame: 1 year
measure: Neurological intervention
timeFrame: 1 year
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Syddanmark
Study officials:
affiliation: UNIFY, University Hospital Odense, Univeristy of Southern Denmark, OPEN
name: Jonas Junghans Jensen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131713: Preoperative Acetaminophen and Carbohydrate Loading
Official title: Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-melanoma Skin Cancer
Keywords: Mohs micrographic surgery
pain
functional status
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 101
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's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)

Exclusion Criteria:

* history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen

Primary outcomes:
measure: Maximum Pain Score
timeFrame: Day of surgery
Secondary outcomes:
measure: Thirst
timeFrame: Day of surgery
measure: Hunger
timeFrame: Day of surgery
measure: Anxiety
timeFrame: Day of surgery
measure: Fatigue
timeFrame: Day of surgery
measure: Number of Participants Using Post-operative Analgesic
timeFrame: 48 hours after surgery
measure: Maximum Post-op Pain Score
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Dermatology
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center/Tufts University School of Medicine
name: Bichchau Nguyen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06403319: Otitis Media With Effusion and Type 2 Inflammation Diseases
Official title: Otitis Media With Effusion Among Patients With Type 2 Inflammation Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media With Effusion
Lead sponsor: Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 100622
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study subjects with OME-confirmed by at least two outpatient visits or one hospitalization record within NHIRD database. We excluded cases that did not meet the following criteria: patients who had undergone OME surgery before the index date, individuals younger than 4 years old, patients with unknown demographic information, individuals in the comparison cohort with a history of T2I diseases, and patients with a history of ear surgery or congenital ear anomalies.

Brief summary: Otitis media with effusion (OME) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. Many of these comorbidities can be caused by type 2 inflammation (T2I). This study aims to characterize the risk of undergoing OME surgery. This retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the Taiwan National Health Insurance Research Database (NHIRD)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OME
* At least two outpatient visits or one hospitalization record
* Medical records within the database

Exclusion Criteria:

* Participants younger than 4 years old
* Participants with unclear demographic information
* Participants with a history of ear surgery or congenital ear anomalies
* Participants who had undergone OME surgery before the index date

Primary outcomes:
measure: The number of participants with OME who requiring surgical intervention
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04041219: Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients
Official title: Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunosuppression
Stem Cell Transplant
Bone Marrow Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.

Detailed description: Initial doses will be given via sublingual route and a steady state trough level will be collected after 4 consecutive doses. Participants will then switched to oral tacrolimus, the dose adjusted for a goal trough 8-12ng/mL, and another steady state trough will be drawn.

Eligibility criteria: Inclusion Criteria:

* Individuals will be identified from within the adult allogeneic BMT program at Mayo Clinic in Rochester, Minnesota
* Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease (GVHD)

Exclusion Criteria:

* Vulnerable populations
* Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced thrombotic microangiopathy
* Lacking the capacity to consent in English and declining to participate in research

Primary outcomes:
measure: Median Tacrolimus Sublingual Trough Level
timeFrame: 14 days
Secondary outcomes:
measure: Median Sublingual (SL) to Oral (PO) Ratio
timeFrame: 14 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Heather May, Pharm. D., R. Ph.
role: PRINCIPAL_INVESTIGATOR
References:
citation: May HP, Bartoo GT, Wolf RC, Shah MV, Litzow MR, Hogan WJ, Alkhateeb H. Use of sublingual tacrolimus in adults undergoing hematopoietic cell transplant: A pilot study. J Oncol Pharm Pract. 2022 Mar;28(2):387-394. doi: 10.1177/1078155221995230. Epub 2021 Feb 16.
Clinical trial NCT01486719: Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap
Official title: Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Finger pulp reconstruction
dorsal branch
proper digital nerve
palmar arterial arch
dorsal digital island flap
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: The Second Hospital of Qinhuangdao
First posted: 2011-12-06
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sensory reconstruction of the finger pulp is a challenging problem. This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

Detailed description: From February 2008 to May 2009, the flap harvested from the dorsum of the middle phalanx of the same finger was used in 12 fingers in 12 patients. The flaps ranged in size from 2.0 × 2.0 cm to 2.8 × 2.2 cm. The mean pedicle length was 1.2 cm. Neurorrhaphy between the dorsal branches of the PDN and PDN was performed in both sides in all cases. Sensibility of the reconstructed finger pulp was evaluated by static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test. The range of motion of the donor fingers was measured. The data were compared to those of the opposite sides.

Eligibility criteria: Inclusion Criteria:

1. a finger pulp defect \> 1.5 cm in length
2. necessity to preserve finger length
3. patients younger than 60 years .

Exclusion Criteria:

1. injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site
2. injury to the course of the vascular pedicle or opposite PDA
3. defects \< 1.5 cm in length.

Primary outcomes:
measure: static 2-point discrimination test
timeFrame: Patients were followed for 16-23 months (mean, 19 months)
Secondary outcomes:
measure: Semmes-Weinstein monofilament test
timeFrame: Patients were followed for 16-23 months (mean, 19 months)
Other outcomes:
Locations:
Study officials:
References:
citation: Bene MD, Petrolati M, Raimondi P, Tremolada C, Muset A. Reverse dorsal digital island flap. Plast Reconstr Surg. 1994 Mar;93(3):552-7.
citation: Pelissier P, Casoli V, Bakhach J, Martin D, Baudet J. Reverse dorsal digital and metacarpal flaps: a review of 27 cases. Plast Reconstr Surg. 1999 Jan;103(1):159-65. doi: 10.1097/00006534-199901000-00025.
citation: Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-1086. doi: 10.1097/PRS.0b013e318267ef99.
Clinical trial NCT04533919: Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia
Official title: Validation of Pre-Clinical Nano-Based Analgesics in Cells From Dorsal Root Ganglia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery to resect spinal tumors

Brief summary: This study investigates the pre-clinical nano-based analgesics in cells from human dorsal root ganglia (clusters of neurons). Collecting these neurons may help future research related to safe and effective pain treatment.

Detailed description: PRIMARY OBJECTIVE:

I. To identify translational mechanisms and therapeutics for neuropathic pain, a type of chronic pain that can arise due to injured nerves.

OUTLINE:

Patients' leftover dorsal root ganglia samples are collected during standard of care surgery.

Eligibility criteria: Inclusion Criteria:

---All patients undergoing surgery to resect spinal tumors

Exclusion Criteria:

---None

Primary outcomes:
measure: Viability assays
timeFrame: 3 years
measure: Functional assays
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Andrew J Shepherd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769519: AdheRence to Inhaled Corticosteroids in Asthma
Official title: AdheRence to Inhaled Corticosteroids in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Asthma
Keywords: health disparities
african american
adult
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is widely recognized that asthma in adult African American patients is a significant health problem, which is partly affected by relatively low inhaled corticosteroid (ICS) adherence rates. The goal of this study is to pilot test an ICS adherence intervention, ARICA, that aims to improve ICS adherence in adult African Americans.

Detailed description: The investigators will evaluate ARICA in Duke primary care clinics to study its feasibility and acceptability using a quasi-experimental pre-post study design. The study will enroll between 32 and 48 adult African Americans with persistent asthma and suboptimal ICS adherence, and their health care providers, to study the use of the intervention and key indicators of the intervention's potential effectiveness.

Eligibility criteria: Inclusion Criteria

* At least 18 years of age
* Self-identifying African American
* Self-reported current asthma
* Prescribed an inhaled corticosteroid (alone or combination) for ≥ 1 month
* Presented at a Duke Primary Care clinic visit within the past 3 years or is establishing care at Duke Primary Care
* Follow up Duke Primary Care visit within the next 6 months

Exclusion Criteria:

* Unable or unwilling to provide informed consent

Primary outcomes:
measure: Number of Participants Who Reported Experiences With the ARICA Program
timeFrame: 3 months
Secondary outcomes:
measure: Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire
timeFrame: 3 months
measure: Change in Asthma Control as Measured by the Asthma Control Test
timeFrame: 3 months
measure: Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Un.
state: North Carolina
Study officials:
affiliation: Duke Un.
name: Isaretta L Riley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776319: Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Non-invasive brain stimulation
tobacco use disorder
craving
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.


Eligibility criteria: Inclusion Criteria:

* Tobacco use disorder (DSM-V)

Exclusion Criteria:

* Other psychiatric disorders
* Contraindication to non-invasive brain stimulation and MRI

Primary outcomes:
measure: Tobacco craving
timeFrame: During experimentation
Secondary outcomes:
measure: Brain metabolites
timeFrame: During experimentation
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Social
state: Quebec
Study officials:
References:
Clinical trial NCT00267319: FOCUS Fatigue Outcome in Copaxone USers
Official title: Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.
* Secondary outcome measures are:disability, relapse rate, quality of life and depression.


Eligibility criteria: Inclusion Criteria:

* relapsing-remitting Multiple Sclerosis (MS),
* at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,
* ambulant patients i.e disability score EDSS MAX 5,5,
* clinically stable MS
* relapse free and steroid free at least 30 days prior to start copaxone treatment

Exclusion Criteria:

* hypersensitivity to glatiramer acetate or mannitol,
* pregnancy,
* fertile female not willing to use effective contraception,
* previous treatment with copaxone

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: fatigue impact scale
timeFrame: at baseline, month 6 and month 12
Secondary outcomes:
measure: relapse rate
timeFrame: at baseline, month 6 and month 12
measure: quality of life
timeFrame: at baseline, month 6 and month 12
measure: depression
timeFrame: at baseline, month 6 and month 12
measure: disability
timeFrame: at baseline, month 6 and month 12
measure: Adverse events
timeFrame: at baseline, month 6 and month 12
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Zuzana Priborska
role: STUDY_DIRECTOR
References:
Clinical trial NCT01373619: Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
Official title: Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart failure with normal ejection fraction
hemodialysis patients
ivabradine
Echocardiography
NYHA class
6-minutes walking test
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Heart failure with normal ejection fraction is often under diagnosed and certainly under treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine, a pure heart-rate lowering agent without effects on blood pressure, is of potential therapeutic utility.


Eligibility criteria: Inclusion Criteria:

* hemodialyzed patients
* signs and symptoms of heart failure with normal ejection fraction
* sinus rhythm

Exclusion Criteria:

* atrial fibrillation/atrial flutter
* valvular heart disease
* unstable angina
* hospitalization for heart failure prior 3 months

Primary outcomes:
measure: Echocardiofic changes of diastolic left ventricular function
timeFrame: baseline, 1, 3, 6, 9, 12 months
Secondary outcomes:
measure: changes in NYHA class
timeFrame: baseline, 1,3,6,9,12 months
measure: changes in 6-minutes walking test
timeFrame: baseline, 1,3,6,9,12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Chair of Cardiology Second Univesity of Naples
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Gennaro Cice, MD
role: PRINCIPAL_INVESTIGATOR
References: