louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01013701: Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center Study to Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patients With Nasal Polyps
Keywords: nasal polyps
nasal steroid
fluticasone furoate
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients 18-70 years of age, in general good health.
2. Current evidence of nasal polyps on physical exam. 3) Able to understand the protocol and comply with instructions. 4) Have a negative urine pregnancy test in women of childbearing potential. 5) Women of childbearing potential must be on an acceptable method of birth control or willing to remain abstinent through the duration of the study.

Exclusion Criteria:

1. Are pregnant and/or breast-feeding.
2. History of alcohol or drug abuse in the past year.
3. Signs and symptoms suggestive of fulminant bacterial sinusitis (fever \>101 F, persistent severe unilateral facial or tooth pain, facial swelling).
4. Allergies to nasal corticosteroids
5. .Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.

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Primary outcomes:
measure: To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.
timeFrame: 18 weeks
Secondary outcomes:
measure: To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01629901: Caloric Stimulation on Cerebral Blood Flow
Official title: The Effect of Vestibular Stimulation on Cerebral Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Keywords: Healthy volunteer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Scion NeuroStim
First posted: 2012-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.

Detailed description: Study activities include monitoring with bilateral transcranial Doppler (TCD), EEG and continuous EKG monitoring at 30 second intervals for 5 minutes. This is followed by placement of the caloric stimulator investigational device for 20 minutes. An additional 20 minutes of TCD and EEG monitoring will also be recorded. This will end study participation.

Eligibility criteria: Inclusion Criteria:

* no history of neurological disease

Exclusion Criteria:

* persons under the age of 18
* pregnant or nursing women
* history of neurological disease
* history of psychiatric disease
* congenital heart defect, known cardiac shunt
* inner ear or pulmonary disease

Primary outcomes:
measure: Changes in cerebral blood flow
timeFrame: 20 minutes
Secondary outcomes:
measure: Alterations in EEG readings
timeFrame: 40 minutes
measure: Alterations in regional cerebral brain flow (rCBF)
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniel Laskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00042601: Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled, Two-period, Crossover Study Evaluating the Acute Effect of Pramlintide on Satiety and Food Intake in Normal-weight and Obese Non-diabetic Subjects and in Insulin Treated Subjects With Type 1 and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-08-05
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.


Eligibility criteria: For Healthy Volunteers:

•BMI \>=20 to \<=25kg/m2 or \>=30 to \<=40 kg/m2

For Subjects with Type 1 or Type 2 Diabetes:

* Treated with insulin for at least 6 months prior to screening
* HbA1c value between 6.5-10% inclusive
* BMI between 20-40kg/m2

Primary outcomes:
measure: Change in satiety of participants on Pramlintide
timeFrame: 2 Weeks
measure: Change in food intake of participants on Pramlintide
timeFrame: 2 Weeks
Secondary outcomes:
measure: Effect of pramlintide on postprandial metabolic and hormonal responses
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
References:
Clinical trial NCT02551601: Subfoveal Choroidal Thickness in Thai Population
Official title: Subfoveal Choroidal Thickness in Thai Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Keywords: subfoveal choroidal thickness
optical coherence tomography
enhanced depth imaging
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, age 18 years or above, no ocular diseases

Brief summary: The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai eyes and study the associations with gender, age, refractive error and axial length using spectral-domain optical coherence tomography with enhanced depth imaging technique.

Detailed description: Alteration of choroidal blood supply causes changes in choroidal thickness and results in choroidal abnormalities. These are usually associated with retinal diseases and leading to severe visual dysfunction. Choroidal thickness is therefore helpful in diagnosis and treatment for many chorioretinal conditions. With the advent of spectral domain optical coherence tomography and enhanced depth imaging technique, choroidal thickness has been investigated widely in normal eyes and various chorioretinal diseases including central serous chorioretinopathy (CSC), age-related macular degeneration (AMD), highly myopia and Vogt Koyanagi-Harada disease. Similar to retinal thickness, a normal baseline choroidal thickness might be used for interpretation. This value might be affected by several variables including age, gender and ethnicity. Although there were previous studies on subfoveal choroidal thickness in normal eyes from many countries, there has been no such study in Thailand. The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai eyes and study the associations with gender, age, refractive error and axial length using SD-OCT and EDI technique.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or above
* Healthy subjects
* No ocular diseases
* Written informed consent form

Exclusion Criteria:

* patients with systemic diseases that may affect retinal or choroidal thickness including diabetes
* patients with history of refractive surgeries, intraocular surgeries or retinal laser treatments
* patients with history of macular, retinal, or optic nerve abnormalities

Primary outcomes:
measure: subfoveal choroidal thickness
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Eye outpatients department, Srinagarind Hospital, Khon Kaen University
Study officials:
affiliation: Department of Ophthalmology, Khon Kaen University
name: Yosanan Yospaiboon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132701: The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
Official title: The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Delirium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

Detailed description: Children \< 8 years old who scheduled for elective opthalmic surgery are randomly assigned to Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed, and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled ventilation is started.

In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of saline is infused.

Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30 minutes after surgery.

Eligibility criteria: Inclusion Criteria:

* Children aged between 2 and 7 years
* American Society of Anesthesiologist physical status 1 and 2
* Children scheduled for opthalmic surgery

Exclusion Criteria:

* Allergy history to any drugs
* Risk of malignant hyperthermia
* Neuromuscular disease
* With arrhythmia
* Any pulmonary, cardiac, hepatic and renal disease
* Obesity

Primary outcomes:
measure: Emergence delirium
timeFrame: 30 minutes after anesthesia
Secondary outcomes:
measure: Pain score
timeFrame: At each two points: during emergence in operating room and 30 minutes after surgery ends
measure: Nausea
timeFrame: At each two points: during emergence in operating room and 30 minutes after surgery ends
measure: vomiting
timeFrame: At each two points: during emergence in operating room and 30 minutes after surgery ends
measure: Duration of post-anesthetic care unit (PACU) stay
timeFrame: During 1 hour after surgery at PACU
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Choi S, Lee M, Jang YE, Kim EH, Kim JT, Kim HS. Effect of magnesium supplementation on emergence delirium and postoperative pain in children undergoing strabismus surgery: a prospective randomised controlled study. BMC Anesthesiol. 2020 Nov 18;20(1):289. doi: 10.1186/s12871-020-01192-7.
Clinical trial NCT01427101: Results of CRS and Debulking in PMP Patients
Official title: Comparison Between Cyotreductive Surgery and Debulking Surgery in Patients With Pseudomyxoma Peritonei
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudomyxoma Peritonei
Keywords: Pseudomyxoma Peritonei
Cytoreductive surgery
Debulking surgery
Intraperitoneal chemotherapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2011-09-01
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Pseudomyxoma Peritonei, sceduled for surgical treatment at Uppsala University Hospital.

Brief summary: The aim of this study was to compare debulking surgery and cytoreductive surgery in patients with Pseudomyxoma Peritonei with respect to efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Patients with radiology histopathology finding of Pseudomyxoma Peritonei

Exclusion Criteria:

* Preformance status WHO \>2 and histopathology shows other origin then Pseudomyxoma Peritonei

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: morbidity and mortality
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University
name: Haile Mahteme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200601: Pre-Market Algorithm Validation Study
Official title: Pre-Market Algorithm Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Seipher Wellness
algorithm
secure samples of SGC waveform
volunteers
validation
heart health algorithm
Lead sponsor: Heart Force Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle. These are specific parameters captured and analyzed by the device. A ratio of two specific timing parameters provides an assessment of the subject's overall heart health. The aim of this study is to validate the device algorithm across a range of subjects.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* able to understand the informed consent document
* willing to participate
* ambulatory volunteers

Exclusion Criteria:

* individuals with visible scar(s) or deformity in the test area of the chest
* non-ambulatory subjects
* enrolled in another concurrent study or trial
* exercised excessively within the last 4 hours
* unwilling to sign informed consent
* female subjects who are pregnant, suspected or planning to become pregnant or breast-feeding

Primary outcomes:
measure: Systolic Time Intervals (STI) value
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Integrative Naturopathic Medical Centre
state: British Columbia
Study officials:
affiliation: Heart Force Medical
name: Geoff Houlton, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06949501: The Effectiveness of Virtual Patient Simulation Versus Peer Simulation in Providing Sexual Counseling During Pregnancy
Official title: The Effectiveness of Virtual Patient Simulation Versus Peer Simulation in Enhancing Attitudes, Beliefs, and Skills in Providing Sexual Counseling During Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Sexuality
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2025-04-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare, in a multidimensional manner, the effectiveness of different educational methods-virtual patient simulation and peer simulation-in improving sexual counseling skills during pregnancy among nursing faculty students.

The study will evaluate three different training methods: virtual patient simulation, peer simulation conducted in a virtual environment, and face-to-face peer simulation. To determine the effectiveness of peer simulation and virtual patient simulation in sexual health counseling, multimodal data collection and analysis methods will be used. These methods will contribute to the development of counseling skills by examining in detail the verbal and non-verbal communication elements exhibited by participants during their interactions with virtual patients and peers. Throughout the research process, students' demographic characteristics, sexual attitudes and beliefs, sexual counseling skills, learning satisfaction and self-confidence levels, opinions on system usability, eye-tracking data, and body movements will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Having the ability to provide care for pregnant women - Providing informed consent to participate in the study

Exclusion Criteria:

* Having suspended enrollment or taken a leave of absence from education.
* Having received formal education aimed at developing sexual counseling skills.
* Wearing glasses (as it may interfere with the use of wearable eye-tracking systems).

Primary outcomes:
measure: Sexual Attitudes and Beliefs
timeFrame: immediately before the training-immediately after the training
measure: Learning Satisfaction and Self-Confidence
timeFrame: immediately after the training
measure: Sexual Counseling Skills
timeFrame: During simulation
measure: System Usability Opinions
timeFrame: immediately after the training
measure: Eye Tracking
timeFrame: During simulation
measure: Body Movements
timeFrame: During simulation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05589701: Comparing SBRT to CRT in Patients With Spinal Metastases
Official title: Prospective Registry Trail COMparing Stereotactic Body Radiotherpy (SBRT) to Conventional PAlliative RadioTherapy (CRT) in Patients With Spinal Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Metastases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving radiation therapy.

Brief summary: This is a single institutional registry-based, prospective, observational study to describe radiation oncologists' decision making during evaluation of patients and to compare real-world outcomes of SBRT vs CRT.

A registry-based trial involves observing the effect of something without manipulating it.

Detailed description: The purpose of this study is to study the differences between CRT and SBRT. The investigator's are assessing radiation oncologists' decision-making during the evaluation of patients with spinal metastases by requesting radiation oncologists complete a questionnaire. Additionally, the investigator's will compare outcomes, including local progression, pain response and overall survival between SBRT and CRT. By collecting this information, the investigator's will develop an evidence-based algorithm that may be used to support medical decision-making for others with spinal metastases in the future.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older.
* Patients seen at the Princess Margaret Cancer Centre with painful spinal metastases amenable to radiation treatment.
* Confirmation of diagnosis: a) Known/documented prior histological cancer diagnosis
* Able to provide written consent
* ECOG performance status 0-3

Exclusion Criteria:

* Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
* Lymphoma, myeloma or germ cell malignancies

Primary outcomes:
measure: Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.
timeFrame: 2 years
Secondary outcomes:
measure: Assess local progression free survival.
timeFrame: 2 years
measure: Measure pain response
timeFrame: 2 years
measure: Assess adverse events
timeFrame: 2 years
measure: Measure overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: