louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01716624: Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Official title: A Pilot Study Comparing the Effects of Botulinum Toxin A and Standard Oxybutynin Therapy as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neurogenic Bladder
Keywords: Pediatric
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of spina bifida and neurogenic bladder
* Performing clean intermittent catheterization (CIC)
* Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder
* Has not had previous bladder surgery
* Has had a urodynamic or videourodynamic study done within the last 6 months
* Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study
* Urodynamic study (UDS) showing either detrusor leak point pressure \>40cm H2O; 30cm below capacity \<60% of total bladder capacity, 20 cm capacity \<70% of bladder capacity
* Able and willing to complete CIC Diaries and Quality of Life Questionnaires
* Consent and assent given to participate in trial

Exclusion Criteria:

* History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia
* Positive urine culture
* Known allergy to Botox

Primary outcomes:
measure: To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
timeFrame: Primary outcomes will be assessed at 3 and 6 months
Secondary outcomes:
measure: Calculate accrual rate
timeFrame: Secondary outcomes will be assessed at 6 months
measure: Calculate cross over rate
timeFrame: Secondary outcomes will be assessed at 6 months
measure: Calculate adverse event rates
timeFrame: Secondary outcomes will be assessed at 6 months
measure: Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
timeFrame: Secondary outcomes will be assessed at 6 months
measure: Calculate drop out rate
timeFrame: Secondary outcomes will be assessed at 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Laweson Health Research Institute
name: Sumit Dave, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00267124: Brain Aging Project--Kansas University
Official title: KU Brain Aging Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: cognitive decline
dementia
neuroimaging
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: National Institute on Aging (NIA)
First posted: 2005-12-20
Enrollment: 172
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: KU memory clinic patients, volunteers from the community, and the states of Kansas and Missouri

Brief summary: The purpose of this study is to determine the effects of exercise and cardiorespiratory fitness on age-related brain changes.

Detailed description: The mission of the KU Brain Aging Project is to promote healthy brain aging. How the brain changes with age is not well-characterized and even less is known about the factors influencing the rate of brain aging. Thus, we are using MRI scans to examine the structure of the brain in relation to important lifestyle factors. This will allow us to better understand the processes influencing the brain as it ages. In turn, this will help identify specific ways to promote healthy brain aging and, perhaps, prevent the onset of Alzheimer's disease.

Participants complete 4 visits over several months. The first visit entails a clinical evaluation and memory testing involving the use of paper and pencil testing. The second visit is an MRI brain scan which lasts approximately one hour. The third visit involves drawing blood for laboratory testing and blood banking for future lab studies, lasting roughly 4 hours. The glucose tolerance test is administered. The fourth and final visit is an assessment of the participant's metabolism and exercise testing. This visit lasts approximately two hours.

Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* Healthy male or female
* Normal control volunteers and early Alzheimer's disease patients
* Clinical Dementia Rating of 0, 0.5, or 1.0
* On stable doses of medications

Exclusion Criteria:

* Unstable angina
* Schizophrenia
* Clinical signs of depression; major depression; mental health disorder; nervous system disorder
* Significant visual/auditory impairment
* Significant system illness; cancer
* Pacemaker/metal
* Thyroid problems
* Kidney dialysis
* Organ transplant
* Alcoholism
* Heart surgery
* Insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center, Landon Center on Aging
name: Jeffrey Burns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03732924: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
Official title: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement: the Impact of a 5 Minute Rest Time on AOBP Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: KMH Cardiology and Diagnostic Centres
First posted: 2018-11-07
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. In uncontrolled hypertension, AOBP is typically higher than the daytime readings from ambulatory blood pressure monitoring (ABPM), but this is not the case for patients with controlled hypertension.

Detailed description: Objective:

Does a 5 minute rest or no rest before measurement using AOBP provide the most accurate reading in patients with controlled and uncontrolled hypertension, and in patients with white coat hypertension compared to daytime ABPM?

Implications:

Through this study, we hope to:

(i) Advance the understanding of the role of AOBP in measuring blood pressure. (ii) Determine whether a 5-minute rest, or no rest at all is needed prior to AOBP measurement.

(iii) Assess the relationship of AOBP to daytime ABPM for patient with controlled and uncontrolled hypertension and in patients with white coat hypertension.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Referred for ABPM
* Written informed consent

Exclusion Criteria:

* Unable to perform AOBP or ABPM for some reason

Primary outcomes:
measure: Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement.
timeFrame: 4 months - 1 yr
Secondary outcomes:
measure: Difference in systolic and diastolic BP between the AOBP and daytime ABPM in patients randomized to zero or five minutes wait before the AOBP measurement.
timeFrame: 4 months - 1yr
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Sheldon W Tobe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tobe SW, Dubrofsky L, Nasser DI, Rajasingham R, Myers MG. Randomized Controlled Trial Comparing Automated Office Blood Pressure Readings After Zero or Five Minutes of Rest. Hypertension. 2021 Aug;78(2):353-359. doi: 10.1161/HYPERTENSIONAHA.121.17319. Epub 2021 Jun 28.
Clinical trial NCT02865824: Polypectomy in Patients Taking Dual Antiplatelet Agents
Official title: Effects of Antiplatelets Discontinuation in Patients Receiving Polypectomy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyps
Keywords: Colonoscopy
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days in patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding risks during polypectomy and if b) discontinuation of these drugs increases the occurence of thromboembolic events.

Detailed description: Patients taking dual antiplatelets (DAT) and who visited for colonoscopy were eligible for enrollment in this study. On enrollment, patients were randomized to two groups. One group continued DAT and the other group discontinued antiplatelets (i.e. clopidogrel, ticagrelor, prasugrel) for 7 days before colonoscopy. If polyps (≤1 cm) were observed during colonoscopy, they were removed by cold snare polypectomy. The primary aim was to compared the delayed bleeding rates of the two groups.

Eligibility criteria: Inclusion Criteria:

* patients over the age of 20 years undergoing routine colonoscopy
* patients who are taking DAT (dual antiplatelet therapy)

Exclusion Criteria:

* patients not abiding to the study protocol
* history of inflammatory bowel disease
* severe comorbidities
* American Society of Anesthesiology class III or more
* pregnancy

Primary outcomes:
measure: Delayed bleeding requiring hemostasis after polypectomy
timeFrame: 2 weeks
Secondary outcomes:
measure: immediate bleeding requiring hemostasis after polypectomy
timeFrame: 1 day
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Joon Sung Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Won D, Kim JS, Ji JS, Kim BW, Choi H. Cold Snare Polypectomy in Patients Taking Dual Antiplatelet Therapy: A Randomized Trial of Discontinuation of Thienopyridines. Clin Transl Gastroenterol. 2019 Oct;10(10):e00091. doi: 10.14309/ctg.0000000000000091.
Clinical trial NCT00520624: Treatment of Exercise-induced Laryngomalacia in Elite Athletes
Official title: Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise-induced Laryngomalacia
Keywords: EIL
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2007-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical activity) in elite athletes using two different treatments. The study is randomized with control groups.


Eligibility criteria: Inclusion Criteria:

* Laryngoscopically verified EIL,
* Elite athlete for a minimum of 1 year and continuing for a minimum 6 months after start of treatment

Exclusion Criteria:

* Has to be able to run on treadmill

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Lungemedicinsk Forskningsenhed
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer
role: STUDY_DIRECTOR
References:
Clinical trial NCT05992324: A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Official title: A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shortness of Breath
Keywords: Lung Ultrasound
B-Lines
POCUS by non-expert user
Lead sponsor: Caption Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 220
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: The purpose of this study is to assess the efficacy of Caption LungAI.

Detailed description: After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.

Exclusion Criteria:

* Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities

Primary outcomes:
measure: Diagnostic Image Quality (Trained Healthcare Professional)
timeFrame: Up to 24 weeks from completion of the study.
measure: B-Lines Detection
timeFrame: Up to 24 weeks from completion of the study.
measure: B-Line Significance
timeFrame: Up to 24 weeks from completion of the study.
measure: Remote Reader Performance
timeFrame: Up to 24 weeks from completion of the study.
Secondary outcomes:
measure: Sub-group Analyses
timeFrame: Up to 24 weeks from completion of the study.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Greensboro
country: United States
facility: The Moses H. Cone Memorial Hospital
state: North Carolina
Study officials:
References:
Clinical trial NCT02907424: Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM
Official title: Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Children
Treatment
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Agriculture, Forestry and Fisheries Cambodia
name: UNICEF
First posted: 2016-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.


Eligibility criteria: Inclusion Criteria:

* discharged from hospital after admission for SAM
* WHZ \<2.8 Z-score or MUAC\<11.5 cm
* no complications
* passing the appetite test

Exclusion Criteria:

* \<6 mo of age
* complications related to SAM

Primary outcomes:
measure: weight gain
timeFrame: 2 months
Secondary outcomes:
measure: body composition
timeFrame: 2 months
measure: Fatty Acid composition
timeFrame: 2 months
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
Study officials:
References:
citation: Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Angkeabos N, Moniboth D, Berger J, Stark KD, Roos N. Whole-blood PUFA and associations with markers of nutritional and health status in acutely malnourished children in Cambodia. Public Health Nutr. 2020 Apr;23(6):974-986. doi: 10.1017/S1368980019003744. Epub 2020 Jan 24.
Clinical trial NCT03275324: Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients
Official title: Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 600
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: Surgical patients

Brief summary: The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.

The integrated pulmonary index (IPI) is an algorithm driven parameter derived from non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal range.

The purpose of this observational study is to determine if the IPI is associated with complications in the immediate postoperative period.

The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to the IPI therefore this device will not be used to guide care in any way.


Eligibility criteria: Inclusion Criteria:

18 years or older Planned to undergo general anesthesia for surgery

Exclusion Criteria:

Pregnant Inability to consent Mechanically ventilated prior to surgery

Primary outcomes:
measure: Postoperative Respiratory Event
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05905224: Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement
Official title: A Randomized Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthodontic Tooth Movement
Keywords: clear aligners
wear protocol
3-day wear
7-day wear
rate and amount of tooth movement
accuracy
outcomes
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Align Technology, Inc.
First posted: 2023-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system


Eligibility criteria: Inclusion Criteria:

* Physically healthy with no relevant allergies or medical problems
* Male or female between the age of 18 and 30.
* Full permanent dentition except for the third molars
* Class I crowded dentition primarily for the lower anterior teeth (moderate crowding - 4-6 mm - according to Little's Irregularity Index)
* Good oral hygiene and absence of periodontal disease
* Malocclusion to be treated with Invisalign aligners (SmartTrack)
* Any ethnic group

Exclusion Criteria:

* Orthognathic surgical cases
* An extraction treatment plan
* Poor oral hygiene
* Patients with syndromes or craniofacial anomalies.
* The use of any other orthodontic appliance than clear aligners' (Invisalign)

Primary outcomes:
measure: predictability of the different orthodontic tooth achieved in each of the studies groups movements achieved at the end of treatment in each of the studied groups (3-day wear vs 7-day wear).
timeFrame: 14 months
measure: rate of tooth movement for the lower anterior teeth as detected by the consecutive scans captured by the scan box (Dental Monitoring®) in the first 8 weeks of treatment
timeFrame: 2 months
Secondary outcomes:
measure: duration of treatment
timeFrame: 14 months
measure: number of refinements and visits needed for each wear protocol.
timeFrame: 14 months
measure: Occlusal outcomes
timeFrame: 14 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida _ Department of Orthodontics
state: Florida
Study officials:
affiliation: University of Florida
name: Sarah Abu Arqub, DDS
role: PRINCIPAL_INVESTIGATOR
References: