louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04254003: Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Official title: Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: toric contact lens
daily disposable
silicone hydrogel contact lens
axis orientation
astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.

Detailed description: This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.

Eligibility criteria: Inclusion Criteria:

* Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
* Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
* Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
* Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
* Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
timeFrame: Day 1, 10 minutes after lens insertion, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site CT-11
state: Florida
city: Eden Prairie
country: United States
facility: Alcon Investigative Site CT-27
state: Minnesota
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05863403: Effect of Neuromuscular Training Versus Traditional Exercise on Balance and Fall in Geriatric Population With Fall Risk
Official title: Effect of Neuromuscular Training Versus Traditional Exercise on Balance and Fall in Geriatric Population With Fall Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Geriatric
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effect of neuromuscular training versus traditional exercise on balance and fall in geriatric population with fall risk

Detailed description: neuromuscular training versus traditional exercise for the balance messurement of fall population with geriatric

Eligibility criteria: Inclusion Criteria:

* Patients with balance and fall problem doing physical therapy with an age over 60 years old and willing to participate will be included in the study.

Exclusion Criteria:

* Patient with other serious comorbidities and suffering from heart or kidney disease will not be include or unwilling to participate and those who will aged under 60 years will be excluded from the study

Primary outcomes:
measure: Berg Balance Scale and Falls Efficiancy Scale international
timeFrame: 6 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT05396703: TOETVA Feasibility and Complications - Single Center First Experience
Official title: Feasibility and Complications After Transoral Endoscopic Thyroidectomy Via Vestibular Approach (TOETVA) - a Single-Center First Experience Case Series and Systematic Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Gland Disease
Surgery
Keywords: TOETVA
NOTES
Surgery
Endocrine
Thyroid
Case Series
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach at the investigators' center.

Brief summary: All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center

Exclusion Criteria:

* Patients who did not undergo (or will not undergo) a TOETVA at the investigators' center

Primary outcomes:
measure: Complications initial
timeFrame: Immediately postoperative (during hospitalization)
measure: Complications before follow-up
timeFrame: If premature presentation occurs (admission after discharge and before follow-up consultation at 1 month after surgery)
measure: Complications before follow-up
timeFrame: Data at first follow-up visit will be reported. First follow-up visit will be at (average) 1 month after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland MC
state: Limburg
Study officials:
affiliation: Zuyderland MC
name: Sam Kinet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04879303: Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
Official title: Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Social Engagement
Robotic Intervention
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context. The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework. Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework. Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework. With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of autism spectrum disorder
* aged between 5-11
* normal intelligence

Exclusion Criteria:

* with self-injurious or aggressive behavior
* with hearing or visual impairment

Primary outcomes:
measure: The Autism Diagnostic Observation Schedule
timeFrame: 1 week before the intervention
measure: The Autism Diagnostic Observation Schedule
timeFrame: 1 week after the intervention
measure: Social Responsiveness Scale
timeFrame: 1 week before the intervention
measure: Social Responsiveness Scale
timeFrame: 1 week after the intervention
measure: The Canadian Occupational Performance Measure
timeFrame: 1 week before the intervention
measure: The Canadian Occupational Performance Measure
timeFrame: 1 week after the intervention
measure: Short sensory profile
timeFrame: 1 week before the intervention
measure: Short sensory profile
timeFrame: 1 week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Education University of Hong Kong
Study officials:
affiliation: The Education University of Hong Kong
name: Eva Yin-han Chung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03904303: Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep
Official title: Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacological Action
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2019-04-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy

Detailed description: Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.

Study performed in health subjects.

Eligibility criteria: Inclusion Criteria:

- Healthy

Exclusion Criteria:

* Allergy to content of products

Primary outcomes:
measure: Boston Bowel preparation scale (BBPscale)
timeFrame: Performed during the endoscopy procedure
measure: Adverse events related to intervention
timeFrame: Assessed 4 hours after last intake of cleansing product
Secondary outcomes:
measure: Blood pressure
timeFrame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
measure: Saturation
timeFrame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
measure: Heart rate
timeFrame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
measure: Respiration frequency
timeFrame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zuh
state: Region Of Zealand
Study officials:
affiliation: Department of Surgery, Zealand University Hospital
name: Ismail Gögenur, Professor MD
role: STUDY_CHAIR
References:
Clinical trial NCT04918303: Skin Sympathetic Nerve Activity and Cardiac Arrhythmia
Official title: Skin Sympathetic Nerve Activity and Cardiac Arrhythmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Death
Ventricular Tachycardia
Persistent Atrial Fibrillation
Keywords: Skin sympathetic nerve activity (SKNA)
Electrocardiogram (ECG)
Cardiac arrythmia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 100
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: Sympathetic tone is important in cardiac arrhythmogenesis. The simultaneous recording of sympathetic nerve activity (SNA) and electrocardiogram (ECG) was obtained by invasive method. The purpose of this protocol is to further develop this recording method to turn it into a new non-invasive tool for arrhythmia prediction and detection. This method may also be useful in validating the results of surgical procedures aimed at sympathetic denervation


Eligibility criteria: Inclusion Criteria:

- patient hospitalized at Bordeaux University Hospital for sudden death, ventricular tachycardia, persistent or paroxysmal atrial fibrillation treated by ablation and/or vein of Marshall ethanol infusion

Exclusion Criteria:

* pregnancy,
* patient under 18 year old,
* patient with a cardiac stimulation device

Primary outcomes:
measure: Delay between the discharge of the sympathetic system and the rhythmic event.
timeFrame: Day 1
measure: Delay between the discharge of the sympathetic system and the rhythmic event.
timeFrame: Day 2
measure: Delay between the discharge of the sympathetic system and the rhythmic event.
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Mélèze Hocini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952703: Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
Official title: Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Use Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is:

Is Striving to Quit more effective in achieving postpartum smoking cessation than "First Breath," the current standard of care for pregnant women in Wisconsin who smoke?

250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 6-months postpartum.


Eligibility criteria: Inclusion Criteria:

* Pregnant;
* enrolled in First Breath;
* Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca;
* English speaking;
* willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery;
* daily smoking (at least 1 cigarette/day for at least 1 week in past 6 months;
* willing to provide updates in contact information

Exclusion Criteria:

* not pregnant;
* not smoking in past 6 months;
* involved in another smoking research study.

Primary outcomes:
measure: Biochemically verified smoking abstinence
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Motivation to quit/remain quit
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
References:
Clinical trial NCT05634603: Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants
Official title: Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Gastroenteritis
Keywords: diarrhea lactose-free diet
Lead sponsor: The Women and Children Hospital of An Giang
Sponsor class: OTHER
Collaborators: name: Can Tho University of Medicine and Pharmacy
First posted: 2022-12-02
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.

Detailed description: More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.

Eligibility criteria: Inclusion Criteria:

* Children 2- 24 months old on artificial milk formula
* Acute diarrhea (3 or more loose or liquid stools per day)

Exclusion Criteria:

* Used antibiotics within 3 days before admission
* Breastfeeding
* Severe dehydration, defined by a need of IV rehydration
* Malnutrition (weight/height\< -3SD)
* Chronic underlying disease, immunocompromised condition or systemic infection

Primary outcomes:
measure: Change in diarrhea duration
timeFrame: 7 days
Secondary outcomes:
measure: Weight gain
timeFrame: 7 days
measure: Severity of diarrhea according to the modified Vesikari score
timeFrame: 7 days
Other outcomes:
Locations:
city: Can Tho
country: Vietnam
facility: Can Tho Children Hospital
Study officials:
References:
citation: MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2.
citation: Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9.
Clinical trial NCT02096003: Intrathecal Hydromorphone for Pain Control After Cesarean Section
Official title: Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Cesarean Section
Keywords: Intrathecal hydromorphone
Intrathecal morphine
Primary cesarean section
Analgesia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.

Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.

Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.

In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.


Eligibility criteria: Inclusion Criteria:

* Elective primary cesarean section
* Females age 18-40

Exclusion Criteria:

* Emergency cesarean section
* Anesthetic other than spinal
* History of chronic pain or pre-op opioid use
* Allergy to morphine or hydromorphone
* BMI\>40

Primary outcomes:
measure: Post Operative Fentanyl PCA Consumption
timeFrame: at 24 hours
Secondary outcomes:
measure: Time to Initial PCA Use
timeFrame: up to 24 hours
measure: Pain Score
timeFrame: at 24 hours
measure: Patient Satisfaction Score
timeFrame: at 24 hours
measure: Symptom Scale for Two Specific Side Effects of Nausea and Pruritus
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yaakov Beilin, MD
role: PRINCIPAL_INVESTIGATOR
References: