louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03124654: Development of a Questionnaire to Assess Patient Knowledge About Non-vitamin K Anticoagulants (NOAC)
Official title: Development and Validation of a Novel Educational Program for Patients Prescribed Non-vitamin K Anticoagulants (NOAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Pulmonary Embolism
Deep Vein Thrombosis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2017-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having a prescription for NOACs

Brief summary: Pharmacists are in the best position to counsel and educate patients on anticoagulant agents such as NOACs. This should enable patients to play a more active role in their treatment and ultimately enhance adherence behaviour. However, educational elements should be targeted to knowledge. Thus, the investigators will develop and validate a questionnaire that can assess knowledge about NOACs


Eligibility criteria: Inclusion Criteria:

* Intake of a NOACs (Rivaroxaban, Edoxaban, Dabigatran, Apixaban)
* ≥18 years
* Able to give written Informed consent in German

Exclusion Criteria:

* NOACs for orthopaedic indication
* Dementia in medical history

Primary outcomes:
measure: Validation of the new questionnaire assessed by questionnaire
timeFrame: measured once at visit 1 (baseline)
measure: Sensitivity of the new questionnaire
timeFrame: 7 days after visit 1, before and after the educational program
measure: Test retest validity of the new questionnaire
timeFrame: 7 days
Secondary outcomes:
measure: Patient's adherence assessed by questionnaire
timeFrame: 14 days
measure: Patient's satisfaction assessed by questionnaire
timeFrame: 14 days
measure: Patient's health literacy assessed by questionnaire
timeFrame: assessed once at visit 1 (baseline assessment)
Other outcomes:
measure: Number of patients having an anticoagulation identification card
timeFrame: assessed once at visit 1 (baseline assessment)
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Pharmaceutical Care Research Group
state: Basel-Stadt
Study officials:
affiliation: University of Basel
name: Kurt Hersberger, Prof.
role: STUDY_CHAIR
affiliation: Pharmaceutical Care Research Group, University of Base
name: Isabelle Arnet, PD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03025854: Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma
Official title: Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guilin Medical University, China
name: First People's Hospital of Foshan
First posted: 2017-01-20
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly histologically confirmed nasopharyngeal carcinoma and no evidence of distant metastasis

Brief summary: The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.

Detailed description: Objectives:

Primary: Evaluation of failure-free survival after three years of patients of nasopharyngeal carcinoma.

Secondary: Evaluation of overall survival after three years of patients of nasopharyngeal carcinoma.

Outline: This is a multicenter observational study. Tumor tissue specimens are obtained from the Sun Yat-sen University Cancer Center and Affiliated Hospital of Guilin Medical University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).

The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of nasopharyngeal carcinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with newly histologically confirmed nasopharyngeal carcinoma
* No evidence of distant metastasis (M0)
* Written informed consent

Exclusion Criteria:

* Treatment with palliative intent

Primary outcomes:
measure: Failure-free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06823154: The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department
Official title: The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department: the De-Label Program Expansion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Allergy Amoxicillin
Beta-lactam Allergy Labels
Keywords: Beta-lactam allergy labels
Pediatrics
Oral challenge
Emergency department
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 191
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Beta-lactams are the most common antibiotics prescribed to children, including penicillin and amoxicillin. They are usually more effective and have fewer side effects than other ty antibiotics. Some children can have reactions to these antibiotics that can be mistaken as an allergy, especially rashes that develop days to weeks later. In such cases, when children take the antibiotic again, they have no problem tolerating it; this is called "delabeling an allergy" with an "oral challenge". Based on our experience with a similar program among inpatients, we are implementing and evaluating an allergy delabeling program for children in the SickKids ED, with the hope and intent to delabel most children of their "allergies" using an oral challenge.


Eligibility criteria: Inclusion Criteria:

* All paediatric patients aged 1 month to 18 years who present to the SickKids ED with a reported BLA will be eligible for the allergy history component of the study.

Exclusion Criteria:

* Parent/guardian and/or patient unable to consent or assent.

Primary outcomes:
measure: The primary outcome will be the proportion of patients delabeled among those given the OPC.
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: The proportion of patients with a reported BLA who are low risk (potential impact)
timeFrame: Day 1
measure: The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks)
timeFrame: Up to 2 weeks
measure: The proportion of patients who receive or are prescribed amoxicillin or a first-generation cephalosporin, among patients who undergo OPC
timeFrame: Day 1
measure: Feasibility based on proportion of eligible participants who consent to OPC
timeFrame: Up to 2 weeks
measure: Feasibility based on duration of allergy risk assessment and OPC (calculated using CRF timestamps)
timeFrame: Up to 2 weeks
measure: Patient and caregiver perspectives on BLA and OPC
timeFrame: Day 1
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Monica Caldeira-Kulbakas
state: Ontario
Study officials:
References:
Clinical trial NCT02902354: Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis
Official title: Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tocolysis With Nifedipine
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression

Detailed description: Only women whom have been prescribed nifedipine tocolysis by their covering obstetrician will be approached to participate in the study.

The patient will take their nifedipine as scheduled, we will attain central arterial pressure reading in addition to arterial waveform measurements. These will be collected:

Before administration of the medication Every 20 minutes for 3 hours (total of 10 measurements)

-This timing will allow measurements through approximately 2 half lives Routine sphygmomanometry will also be completed at the testing times All of these measurements will be collected for study purposes, although the nurses will have the opportunity to record the routine blood pressure measurements for their charting/vital signs assessment if they desire.

Once the patient has been monitored for 3 hours, her participation in the study is considered complete and no additional information will be collected. Each patient will serve as her own control (blood pressure prior to administration of medication), no randomization will occur.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Currently receiving tocolysis with nifedipine (10 or 20mg q4-6 hours)

Exclusion Criteria:

* Multiple pregnancy
* Diagnosis of hypertensive disorder in pregnancy or blood pressures 140/90 or higher on -more than 2 occasions.
* Currently on antihypertensive medications (Nifedipine XL, labetalol, hydralazine, methyl-dopa, etc)
* Currently on other tocolytic medications (exp: magnesium, Indocin)
* Narcotic use
* Renal diseaseI
* Irregular heart rhythms or arrhythmias
* Peripheral arterial disease, leg artery disease
* Reynaud's phenomena
* Intense cold/hypothermia
* If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
* Severe tachycardia (\>120)
* Greater than 1st degree heart block
* Severe asthma
* Congestive heart failure or heart disease
* Lupus, rheumatoid arthritis
* Inability to adequately monitor BP
* Magnesium treatment

Primary outcomes:
measure: To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.
timeFrame: every 20 min for 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Jennifer Goldkamp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771654: Phentermine/Gastric Band Weight Loss Study
Official title: Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-10-13
Enrollment: 0
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 is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.


Eligibility criteria: Inclusion Criteria:

* Adult age 18-65
* BMI 35-55
* Approved for gastric band operation

Exclusion Criteria:

* A known allergy to Phentermine
* Take medications for Attention Deficit Disorder (ADD)
* Monoamine oxidase inhibitors (MAOI)for depression
* Selective serotonin reuptake inhibitor (SSRIs)for depression
* History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias
* Hyperthyroidism
* Glaucoma
* Psychosis
* History of drug abuse
* Uncontrolled hypertension (diastolic \>85)

Primary outcomes:
measure: Primary outcomes are total weight loss and excess weight
timeFrame: one year
Secondary outcomes:
measure: Secondary outcomes is resolution of preoperative comorbidities
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Keith Gersin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914354: Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity T Cell Population
Official title: Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity: An Untargeted T Cell Population" (# 859869783).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Keywords: T cells
Human Alloimmune Reactivity
immunosuppression
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of 80 living and deceased donor kidney transplant recipients and 10 healthy volunteers

Brief summary: This is an observational multi-center study to determine whether any single immune monitoring test or a combination of tests obtained in the first 6 months after renal transplantation correlates with acute rejection or graft loss in renal allograft recipients receiving commonly used immunosuppressive.


Eligibility criteria: Inclusion Criteria:

* human kidney transplant recipients
* ATG or basiliximab induction therapy

Exclusion Criteria:

* induction therapy other than ATG or basiliximab

Primary outcomes:
measure: To document the prevalence and frequencies of CD4+ and CD8+ CD28null/NKG2Dpos T cells at the time of transplantation.
timeFrame: 6 months
measure: To test whether CD28null/NKG2Dpos T cells have unique rapid activation properties to allogeneic HLA antigens in vitro
timeFrame: 6 months
Secondary outcomes:
measure: To study the clinical correlations between the frequencies of alloreactive CD28null/NKG2Dpos T cells with kidney graft function and histopathology.
timeFrame: 6 months
measure: To test the effects of induction therapy with rabbit anti-thymocyte globulin (ATG) vs. IL-2 receptor blocker antibodies on circulating CD28null/NKG2Dpos T cells.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01204554: Microcirculation in Perforator Flaps. Enhancing Tissue Survival
Official title: Microcirculation in Perforator Flaps. Enhancing Tissue Survival
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Reconstructive Surgery
Microcirculation
Keywords: perforator flaps
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Detailed description: Perforator flaps are increasingly used in reconstructive surgery both as pedicled and free flaps, mostly because of reduced donor site morbidity and superior aesthetic result. However, the there is still much to learn about the hemodynamic changes within these flaps.The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Eligibility criteria: Inclusion Criteria:

* patients submitted to elective abdominoplasty

Exclusion Criteria:

* body mass index \< 30 kg/m2
* morbidly obese
* patients with comorbidity such as diabetes
* vascular disease
* smokers
* patients \< 18 years, and patients using anti-coagulant therapy
* pregnant
* severe hepatic insufficiency were excluded and a history of allergic reactions to ICG and iodide.

Primary outcomes:
measure: Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography
timeFrame: dec. 2008--des 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT01278654: Lottery Incentives for Moving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Sedentary Lifestyle
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 212
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: BASIC_SCIENCE

Brief summary: The purpose of the study is to learn more about effective ways to motivate people to increase their non-exercise energy expenditure exercise. This is an important research question because obesity and weight-related issues are increasingly becoming a problem in America. This project will address this research question by testing the effect of two different incentive schemes in motivating employees who are predominantly sedentary to use Walkstations at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles / hour) and are attached to a work station (i.e. with computer and telephone); they therefore are designed to increase energy spent not through heavy exercise, but through small changes in posture and movement associated with routines in daily life (called nonexercise activity thermogenesis or NEAT).

Subjects will be employees of Blue Cross Blue Shield of Massachusetts (BCBSMA). Subjects will be the control participants from the previous Walkstation study we ran with BCBSMA. All 120 control participants from this previous study will be told that they can now participate in a study that involves the Walkstations (up until now, they have not been given access to the Walkstations). These participants from the previous study will be sent an email informing them that they are eligible to participate in this new Walkstation pilot. Those who are interested in participating will then be invited to sign up for an enrollment session. There will be no incentives for participating in the initial enrollment session. For the 2 month follow-up session, participants will have a chance to win 1 of 3 prizes (1 \* $100, 2 \* $50) for completing the follow-up.


Eligibility criteria: Inclusion Criteria:

* must pass ParQ

Exclusion Criteria:

* if fail ParQ

Primary outcomes:
measure: Walkstation usage
timeFrame: after approx 60 days
Secondary outcomes:
measure: Biometric measures
timeFrame: baseline and 60 days
measure: Questionnaire
timeFrame: baseline and 45 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Blue Cross Blue Shield Massachusetts
state: Massachusetts
Study officials:
References:
Clinical trial NCT05203354: Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
Official title: Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients

Detailed description: Compare the effects of Narrowband Ultraviolet B versus acitretin on serum Omentin-1 level in psoriatic patients as case control study by dividing patients into 3 groups: group 1 include patients receive Narrowband Ultraviolet B, group II includes patients receive acitretin (0.5-1 mg/day) and control group. The duration of this study about 3 months after receving those interventions.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes with psoriasis vulgaris.

Exclusion Criteria:

* • Patients with history of malignancies, renal and liver diseases.

  * Patients received NB-UVB phototherapy in the last 6 months.
  * Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.

Primary outcomes:
measure: Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin
timeFrame: 3 months
Secondary outcomes:
measure: Decrease PASI score in psoriatic patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Faculty of medicine - Aswan university
Study officials:
References:
Clinical trial NCT02075554: Study of an Expandable Interbody Device for the Lumbar Spine
Official title: Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Mt. Sinai Medical Center, Miami
name: Carolina Neurosurgery & Spine Associates
First posted: 2014-03-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lumbar interbody cages
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.

Detailed description: Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status

Eligibility criteria: Inclusion Criteria:

* DDD at 1 or 2 levels between L2 and S1
* Between 18 and 80 years of age
* Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months
* Ability to provide a signed Informed Consent

Exclusion Criteria:

* Trauma at level(s) to be fused
* Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Immunosuppressive disorder
* History of substance abuse
* Any known allergy to a metal alloy

Primary outcomes:
measure: Fusion and Disc Height Maintenance
timeFrame: 24 months
measure: Fusion Assessment
timeFrame: 24 months
Secondary outcomes:
measure: Patient Self Assessment
timeFrame: Upto 24 mo
measure: Visual Analog Scale for Back Pain
timeFrame: 24 months
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: South Florida Spine Institute at Mt Sinai Medical Center
state: Florida
city: Charlotte
country: United States
facility: Carolina NeuroSurgery and Spine Associates
state: North Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Dan Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: