louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03504553: The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
Official title: The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Noise Exposure
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will investigate whether reduction in ambient light and elimination of noise on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic premedication. In addition, the investigators will assess the cumulative level of nose exposure that patients experience during the perioperative period.


Eligibility criteria: Inclusion Criteria:

* Undergoing general anesthesia for tonsillectomy/adenoidectomy, tympanomastoidectomy, or general abdominal laparoscopic surgical procedures lasting at least 30 minutes.
* Receiving midazolam prior to the procedure as part of standard of care.

Exclusion Criteria:

* Patients that are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs.
* Allergy to midazolam.
* History of emergence delirium.
* Cardiac disease, other than functional heart murmurs.
* Developmental delays.
* Parent refusal of midazolam for standard clinical care.

Primary outcomes:
measure: Anxiety during induction
timeFrame: First 5 minutes of surgical procedure
Secondary outcomes:
measure: Compliance during induction
timeFrame: First 5 minutes of surgical procedure
measure: Presence of post anesthesia emergence delirium
timeFrame: Average of 30 mins - 1 hr
measure: Post-discharge behavior disturbances
timeFrame: Post-op day 1
measure: Post-discharge behavior disturbances
timeFrame: Post-op day 2
measure: Post-discharge behavior disturbances
timeFrame: Post-op day 7
measure: Noise exposure
timeFrame: Average of 30 mins - 3 hrs
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Richard Cartabuke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05925153: Vision Screening Study for College Students at Nankai University
Official title: Vision Screening Study for College Students at Nankai University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoma
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 8500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All 1st-year freshmen at Nankai University with no significant systemic or eye diseases are eligible for vision screening

Brief summary: The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. This study aims to investigate the prevalence of myopia and education-related influencing factors among college students at Nankai University.


Eligibility criteria: Inclusion Criteria:

* All 1st year students

Exclusion Criteria:

* No eye diseases such as cataracts, glaucoma,keratoconus, etc.
* No psychiatric disorders
* Astigmatism ≤ -6.00D

Primary outcomes:
measure: Prevalence of myopia
timeFrame: One day measurement
measure: Prevalence of high myopia
timeFrame: One day measurement
Secondary outcomes:
measure: Blood pressure
timeFrame: One day measurement
measure: Pulse
timeFrame: One day measurement
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
References:
citation: Wei S, Sun Y, Li S, Hu J, Yang X, Lin C, Cao K, Du J, Guo J, Li H, Wang N. Refractive Errors in University Students in Central China: The Anyang University Students Eye Study. Invest Ophthalmol Vis Sci. 2018 Sep 4;59(11):4691-4700. doi: 10.1167/iovs.18-24363.
citation: Wei S, Sun Y, Li SM, Hu J, Cao K, Du J, An W, Liang X, Guo J, Li H, Wang N. Visual Impairment and Spectacle Use in University Students in Central China: The Anyang University Students Eye Study. Am J Ophthalmol. 2019 Oct;206:168-175. doi: 10.1016/j.ajo.2019.04.026. Epub 2019 May 10.
citation: Huang L, Kawasaki H, Liu Y, Wang Z. The prevalence of myopia and the factors associated with it among university students in Nanjing: A cross-sectional study. Medicine (Baltimore). 2019 Mar;98(10):e14777. doi: 10.1097/MD.0000000000014777.
Clinical trial NCT02398253: Effects of Cognitive Behavioral Therapy (CBT) on Weight Maintenance After Successful Weight Loss
Official title: Effects of Cognitive Behavioral Therapy After a Successful Weight Loss by a Comprehensive Weight Loss Plan (NovinDiet Plan) on Weight Maintenance in Healthy Obese Female Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: weight maintenance
cognitive behavior therapy
successful weight loss
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
name: University of Nottingham
First posted: 2015-03-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
* Must be able to have moderate exercise.
* Must be interested to keep weight loss.

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Primary outcomes:
measure: Weight loss
timeFrame: 24 Weeks
Secondary outcomes:
measure: Fasting plasma glucose level
timeFrame: 24 weeks
measure: lipid profiles
timeFrame: 48 weeks
measure: Insulin resistance(HOMA)
timeFrame: 24 weeks
measure: Waist circumference
timeFrame: 24 Weeks
measure: Body mass index reduction
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Hamid R Farshchi, MD, PhD
role: STUDY_CHAIR
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Ameneh Madjd, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Life Sciences, The University of Nottingham
name: Ian A Macdonald, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Life Sciences, The University of Nottingham
name: Moira A Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences
name: Reza Malekzadeh, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences
name: Alireza Delavari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605653: Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 1
Official title: Individualized Diet Improvement Program for Weight Loss and Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Diet Habit
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study design
Primary purpose: TREATMENT

Brief summary: This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) \>28 kg/m2;
* not currently pregnant or lactating;
* have Wi-Fi at home, a working email, and an iPhone or Android smartphone;
* no self-reported severe metabolic, cardiovascular or musculoskeletal disease;
* not using insulin injection;
* able to attend the 22 (1 hour) diet improvement sessions;
* willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year;
* keep weighing their weight for one and a half years;
* fluent in reading and writing English.

Exclusion Criteria:

* age \<18 or \>64 years;
* body mass index of \<28 kg/m2;
* currently pregnant;
* currently lactating;
* self-reported with severe metabolic, cardiovascular, or musculoskeletal disease;
* use insulin injection;
* not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
* failed to set up a Wi-Fi scale;
* failed to submit a FFQ.

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline (0 month) to 6 month, 12 month, and 18 month
Secondary outcomes:
measure: Waist circumference
timeFrame: Change from baseline (0 month) to 12 month
measure: Hip circumference
timeFrame: Change from baseline (0 month) to 12 month
measure: Protein intake
timeFrame: Change from baseline (0 month) to 12 month
measure: Protein intake
timeFrame: Periodically from baseline (0 month) to 12 month
measure: Fiber intake
timeFrame: Change from baseline (0 month) to 12 month
measure: Fiber intake
timeFrame: Periodically from baseline (0 month) to 12 month
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References:
Clinical trial NCT06264453: A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-designed, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentin Hypersensitivity
Keywords: Dentin Sensitivity
Denin Hypersensitivity
Lead sponsor: HysensBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 171
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

Detailed description: This study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of KH001. The total duration of the study will be approximately 7 to 11 weeks. Clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and Adverse Event monitoring.

Eligibility criteria: Inclusion Criteria:

* Is at least 19 years old by the time of the screening visit
* Be in good general health as determined by the investigator
* Have at least 2 non-adjacent teeth and is diagnosed with hypersensitive

Exclusion Criteria:

* Is allergic to the active drug substance or other excipients used in the investigational product
* Has any history of alcohol or drug abuse
* Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
* Has active dental caries or history of dental caries

Primary outcomes:
measure: Change from baseline in Schiff sensitivity score
timeFrame: Baseline and Day 36
Secondary outcomes:
measure: Change from baseline in a Schiff sensitivity score
timeFrame: Baseline, Day 8, 15, 22 and 43
measure: Change from baseline in a Tactile threshold
timeFrame: Baseline, Day 8, 15, 22, 36 and 43
measure: Change from baseline in Visual Analogue Scale
timeFrame: Baseline, Day 8, 15, 22, 36 and 43
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Dental Hospital
Study officials:
affiliation: Kyung Hee University Dentistry Hospital
name: Kyoung-Kyu Choi, D.D.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335853: Association Between Metabolic Syndrome and Serum Nerve Growth Factor Levels in Women With Overactive Bladder
Official title: Association Between Metabolic Syndrome and Serum Nerve Growth Factor Levels in Women With Overactive Bladder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder
Keywords: urinary bladder
nerve growth factor
overactive bladder
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2015-01-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: women with overactive bladder

Brief summary: Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for the development of overactive bladder.

Detailed description: Overactive bladder is a clinical syndrome characterized urgency, frequency and nocturia. Infection or other obvious causes must be excluded. The overactive bladder is loss of inhibition of the detrusor muscle during the filling or emptying of the bladder.

Specific receptors and neurotransmitters have role in development of overactive bladder. These includes adrenergic, cholinergic, non-adrenergic, non-cholinergic receptors and interstitial cells.

Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for the development of overactive bladder. The investigators believe that our findings will shed light on treatment.

Eligibility criteria: Inclusion Criteria:

* women with urgency, nocturia and frequency
* Abdominal obesity, defined as a waist circumference in men ≥88 cm
* Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
* Serum HDL cholesterol \<40 mg/dL (1 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL-C
* Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
* Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose

Exclusion Criteria:

* Chronic obstructive pulmonary disease allergy
* Psychiatric disorders
* Urinary tract infection
* Neurological diseases
* Metabolic diseases
* Pure stress or mixed urinary incontinence
* History of pelvic surgery
* Diabetes mellitus

Primary outcomes:
measure: nerve growth factor levels
timeFrame: 3 months
Secondary outcomes:
measure: urge incontinence
timeFrame: 3 months
measure: overactive bladder symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Training and Research Hospital
state: Bakirkoy
Study officials:
References:
Clinical trial NCT00505453: A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
Official title: A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.

Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.

This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults, 18 years of age and older.
* Female subject of non-childbearing potential. Written informed consent obtained from subject.

Exclusion Criteria:

* Acute disease at the time of enrollment.
* Blood pressure abnormalities.
* Any immunosuppressive condition, such as HIV or cancer.
* Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
* Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
* Any demyelinating disease, including Guillain-Barré syndrome.
* Alcohol consumption and/or drug abuse.
* Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
* Any known or suspected allergy to the Fluviral vaccine.

Primary outcomes:
measure: To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Evaluate safety & reactogenicity: Solicited AEs
timeFrame: 4 days
measure: Evaluate safety & reactogenicity: Unsolicited AEs
timeFrame: 21 days
measure: Evaluate safety & reactogenicity: SAEs
timeFrame: entire study
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00725153: Evaluation of Deposits on Contact Lenses Worn Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Contact lens deposits
Soft contact lenses
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses prior to enrollment in the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
* One functional eye or a monofit lens.
* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
* Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
* Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Front Surface Lens Deposits
timeFrame: 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT06733753: Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules
Official title: Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Nodule
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-13
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: PROBABILITY_SAMPLE
Study population: patients with Bethesda III/IV thyroid nodules

Brief summary: To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules

Detailed description: To evaluate and predict the long-term clinical outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules

Eligibility criteria: Inclusion Criteria:

1. confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
2. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
3. refusal or ineligibility for surgery
4. follow-up time ≥12 months

Exclusion Criteria:

1. follicular neoplasm or malignancy findings on biopsy
2. no suspicious of malignancy in US
3. patients with contra-lateral vocal cord paralysis
4. follow- up time less than 12 months

Primary outcomes:
measure: volume reduction rate
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: rate of complications
timeFrame: 1 week
measure: rate of nodule regrowth
timeFrame: through study completion, an average of 6 months
measure: rate of change of thyroid function
timeFrame: through study completion, an average of 6 months
measure: rate of delayed surgery
timeFrame: through study completion, an average of 1 year
measure: cosmetic score
timeFrame: through study completion, an average of 6 months
measure: symptom score
timeFrame: through study completion, an average of 6 months
measure: rate of disappearance
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Yukun Luo
role: PRINCIPAL_INVESTIGATOR
References: