louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04739878: SUBSUS (SUBglottic Secretion at Ultrasound Score)
Official title: Prospective Study On Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube(ETT) Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Keywords: subglottic secretion
airway ultrasound
ventilator associated pneumonia
Lead sponsor: Hospital Raja Permaisuri Bainun
Sponsor class: OTHER_GOV
First posted: 2021-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan.

Detailed description: Airway ultrasound will be performed at the bedside prior to CT scan in all intubated patients who fulfiled the criteria. The image of subglottic secretion was then compared to the plain CT cervical. The findings of the CT was examined by a radiologist.

Eligibility criteria: Inclusion Criteria:

* age more than 18 years old
* ETT in situ
* indicated for CT cervical scan

Exclusion Criteria:

* neck subcutaneous emphysema
* neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.

Primary outcomes:
measure: Prospective Study on Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube Cuff
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: Raja Permaisuri Bainun Hospital
state: Perak
Study officials:
affiliation: Hospital Raja Permaisuri Bainun
name: Adi Osman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694078: Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers
Official title: Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Tear
Hand Injuries
Splints
Keywords: Lumbrical
Sport Climbing
Hand Therapy
Hand Injuries
Relative Motion
Lead sponsor: Hand Therapy Barcelona
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 50
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: This study aimes to analyze the effectiveness of a Hand Therapy protocol in the management of patients who suffer from a tear of a lumbrical muscle, regarding on the symptoms during the clinical examination, the disability in their activities of daily living and the sports-specific function.

Detailed description: A prospective intervention study is performed on 50 adult climbers suffering from an injury of the 4th lumbrical muscle. They wear during 3 weeks a 5th finger extension relative motion orthosis, while pain-free sport activities are permitted using a 4th and 5th fingers buddy-taping. After three weeks, patients are told to progressively remove the splint and, after six weeks, the splint is totally removed. Symptoms in the lumbrical stress test are evaluated during the 6 weeks period using dynamometry and goniometry, Finally, Quick-Disabilities of the arm shoulder and hand questionnaire is also analyzed.

Eligibility criteria: Inclusion Criteria:

* Adult climbers suffering from an injury of the 4th lumbrical muscle

Exclusion Criteria:

* Patients with previous treatments.
* Patients with concomitant injuries or illness

Primary outcomes:
measure: Dinamometry in lumbrical stress test
timeFrame: It will be evaluated at 6 weeks
Secondary outcomes:
measure: Goniometry in lumbrical stress test
timeFrame: It will be evaluated at 6 weeks
measure: Quick-Disabilities of the arm shoulder and hand questionnaire
timeFrame: It will be evaluated at 6 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hand Therapy Barcelona
state: Catalonia
Study officials:
affiliation: Hand Therapy Barcelona
name: Núria Carnicero
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lutter C, Schweizer A, Schoffl V, Romer F, Bayer T. Lumbrical muscle tear: clinical presentation, imaging findings and outcome. J Hand Surg Eur Vol. 2018 Sep;43(7):767-775. doi: 10.1177/1753193418765716. Epub 2018 Mar 28.
citation: Schweizer A. Lumbrical tears in rock climbers. J Hand Surg Br. 2003 Apr;28(2):187-9. doi: 10.1016/s0266-7681(02)00250-4.
Clinical trial NCT02139878: Short-term Health Effects of Wild Blueberry Juice Consumption
Official title: Short-term Health Effects of Wild Blueberry Juice Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: University of Prince Edward Island
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals at risk for type 2 diabetes

Exclusion Criteria:

* have a body mass index of less than 20 and greater than 45 kg/m2.
* are less than 21 and greater than 65 years old at beginning of study
* have smoked or used tobacco within 6 months prior to the start of the study
* are pregnant, plan to become pregnant or become pregnant during the study
* have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes
* have type 2 diabetes and need to use oral diabetic drugs or insulin
* have an allergy or adverse reaction to blueberries

Primary outcomes:
measure: Blood Pressure
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Glucose
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Charlottetown
country: Canada
facility: University of Prince Edward Island, Health Sciences
state: Prince Edward Island
Study officials:
affiliation: University of Prince Edward Island
name: Katherine Gottschall-Pass, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017.
Clinical trial NCT05811078: Metabolic Control Adolescents Type 1 Diabetes
Official title: The Effect of Education Including Peer Interactive Group Support on Metabolic Control ın Adolescents wıth Type One Diabetes a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 13-18 Year
Diagnosed at Least 6 Months Ago
HbA1C> 7.5
Being Able to Read and Write
Keywords: Type 1 diabetes
metabolic control
adolescence
nursing
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 46
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlling trail
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of the research; The aim of this study is to examine the effect of education including peer-interactive group support to be given to adolescents diagnosed with Type 1 diabetes with poor glycemic control in the 13-18 age group on metabolic control of adolescents.

Detailed description: The lack of a certificate program specific to pediatric diabetes nursing of the Ministry of Health in our country and the insufficient number of diabetes education nurses show that the pediatric population is not adequately trained to provide diabetes management. Along with these obstacles, the lack of use of an evidence-based standard education program reveals the need for effective intervention programs that include approaches specific to adolescents, who are a particularly risky group. Peer interaction can be used as an effective approach to increase adolescents' adherence to treatment. Thus, adolescents who isolate themselves are given the opportunity to cope with the disease and to share with other children. It has been determined that there is no study in the literature that includes peer-interactive group support on adolescents with a diagnosis of Type 1 diabetes who have poor glycemic control but have repeated hospitalizations. This situation shows that there is a need for a study to evaluate the effect of educational intervention including peer-interactive group support on repeated hospitalizations in adolescents with Type 1 diabetes.

Eligibility criteria: Inclusion Criteria:

* be between 13-18 years old
* Diagnosed at least 6 months ago
* HbA1C level \> 7.5
* Having repeated hospitalizations at least twice
* Living in Mersin city center
* Being able to communicate in Turkish
* Being able to read and write

Exclusion Criteria:

* - Using an insulin pump
* Having a chronic disease other than diabetes,
* Diseases that affect cognitive functions, hearing and vision impairments

Primary outcomes:
measure: Implementation of trainings containing peer interactive group support to adolescents and application of scales
timeFrame: 7 weeks
Secondary outcomes:
measure: Evaluation of Data
timeFrame: one year
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Toros Üniversty
Study officials:
References:
Clinical trial NCT05353478: Reducing Opioid Prescription After Kidney Stone Removal Surgery
Official title: Reducing Opioids After Percutaneous Stone Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Stone
Keywords: Percutaneous Nephrolithotomy (PCNL)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.

Brief summary: The purpose of this study is to implement and assess a standard way of prescribing opioid pain medication following PCNL (a kidney stone removal surgery) to ensure patients are being discharged with an appropriate quantity of pain management medication.

Detailed description: Participants in this study will have their opioid pain medication prescription at discharge following PCNL (Percutaneous Nephrolithotomy, a kidney stone removal surgery) determined by an algorithm in addition to physician judgement. The goal of the algorithm is help physicians refine pain medication prescribing patterns for patients who have undergone PCNL in order to discharge patients with an appropriate quantity of pain management medication. The effectiveness of the algorithm will be assessed through participant surveys. Participants will complete a brief online survey on Days 3, 7, and 14 following hospital discharge and another phone-based survey 26-30 days after hospital discharge.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.

Exclusion Criteria:

* Unable or unwilling to provide informed consent.
* Patients who require Intensive Care Unit admission after surgery.
* Patients who have Clavien grade III or greater postoperative complications requiring additional intervention \< 30 days after index procedure.

Primary outcomes:
measure: Unused opioid prescriptions
timeFrame: 30 days
Secondary outcomes:
measure: Unfilled opioid prescriptions
timeFrame: 30 days
measure: Opioid prescription refills
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kevin Koo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522678: Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers
Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GW685698X Containing Magnesium Stearate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Healthy Volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 36
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: GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry powder containing either lactose alone or lactose and cellobiose octaacetate. However, future dry powder GW685698X formulations will contain lactose and magnesium stearate. This study will be the first administration of this new GW685698X dry powder formulation in man and will provide safety and tolerability data to support the further development of this formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers,
* Aged 18-65
* Male and females (females of non-child bearing potential or who meet the contraception criteria).
* BMI - 19-31 kg/m2

Exclusion Criteria:

* History of breathing problems

Primary outcomes:
measure: Safety and tolerability: Vital signs: systolic and diastolic blood pressure (BP), heart rate (HR) 12-lead ECG including QT, QTc, PR and QRS intervals PEFR Laboratory safety tests (clinical chemistry, haematology, urinalysis) Adverse events
timeFrame: Up to Day 16
Secondary outcomes:
measure: Plasma concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) for GW685698X on Day 1 and Day 14. Weighted mean serum cortisol, (0-24 h) on Day 14.
timeFrame: Weighted mean serum cortisol, (0-24 h) on Day 14
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT06744478: Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens
Official title: Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myopia
Anisometropia
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 23
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enroll the clinical patients who was diagnosed with anisometropia (meaning that myopia exceeds 100 degree diopters during the refraction examination, and the difference between the other eye is more than 100 degree diopters). Age limit was 8 to 23 years old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.

Brief summary: The effectiveness of Misight 1 Day Contact Lens in retarding anisometropic progression has not been investigated before. This study is aimed to elucidate the efficacy of Misight 1 Day Contact Lens for anisometropia control.


Eligibility criteria: Inclusion Criteria:

* 8-23 years old children diagnosed with anisometropia and are willing to accept MiSight® 1 Day contact lens wearing treatment.
* No congenital eye diseases or eye diseases such as strabismus and amblyopia.
* Those who have been stated to be willing to participate in the program for at least 24 months and accept various evaluations.

Exclusion Criteria:

* Ocular surface disease( dry eye, keratoconus..)
* Allergy to contact lens
* Received eye surgery before
* The cornea is infected (bacterial, fungal or viral infection).
* Strabismus
* Premature birth

Primary outcomes:
measure: Changes of the visual acuity in myopic children with different Misight 1 Day Contact Lens
timeFrame: From the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.
Secondary outcomes:
measure: Changes of axial length in myopic children with different Misight 1 Day Contact Lens
timeFrame: From the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Shang-Yen WU
Study officials:
References:
Clinical trial NCT00071578: Comparing Two Group Therapy Treatments for Binge Eating Disorder
Official title: Comparison of Dialectical Behavior Therapy and Supportive Therapy for Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Psychotherapy
Treatment
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare two different approaches for the treatment for Binge Eating Disorder.

Detailed description: Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.

Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Binge Eating Disorder
* Reside in the San Francisco Bay Area
* Willing to commit to the study requirements

Exclusion Criteria:

* Unstable medical problems
* History of bipolar illness or schizophrenia
* Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
* Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
* Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
* Breast-feeding
* Require gastric-bypass surgery

Primary outcomes:
measure: frequency of binge eating
timeFrame: prior 4 weeks
Secondary outcomes:
measure: Emotional Eating Scale
timeFrame: prior 7 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University Dept of Psychiatry
name: Debra L Safer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514578: Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
Official title: A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TRV130A in Healthy Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
TRV130A
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 74
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male 19 - 50 years of age
* Body weight \>/= 50 kg
* Capable of giving written informed consent

Exclusion Criteria:

* Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
* Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
* Major surgery within 4 weeks of screening

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Baseline to 8 days after dose administration
measure: Area under the plasma concentration versus time curve of TRV130A
timeFrame: Baseline to 24 hours after dose administration
Secondary outcomes:
measure: Effect of TRV130A on pain perception using cold pain test
timeFrame: Baseline to 3 hours after dose administration
measure: Effect of TRV130A on pupil diameter
timeFrame: Baseline to 3 hours after dose administration
measure: Effect of TRV130A on eye movements
timeFrame: Baseline to 3 hours after dose administration
measure: Effect of TRV130A on sedation
timeFrame: Baseline to 3 hours after dose administration
Other outcomes:
Locations:
city: Omaha
country: United States
facility: ICON Development Solutions
state: Nebraska
Study officials:
affiliation: Trevena Inc.
name: David G. Soergel, MD
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions
name: Alan S. Marion, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28.
citation: Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29.