louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01246492: The Effect of Artificial Sweeteners on Blood Glucose Response
Official title: The Effect of Artificial Sweeteners on Blood Glucose Response
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Taste Receptors
Nutrient Sensing
Intestinal Absorption
Blood Glucose
Appetite
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether the presece of the artificial sweeteners aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally incested glucose solution.

Detailed description: Sweet taste receptors, similar to those located on the lingual taste buds have been located along in the lining of the gut. Recent studies have demonstrated that activation of these sweetness taste receptors, either by sugars such as glucose, fructose, lactose, or artificial sweeteners such as saccharin and aspartame can influence the way nutrients, including glucose are absorbed from the gut into the bloodstream. Studies in animal models have shown that activation of the sweet taste receptors can increase the expression of the sodium-dependant glucose transporter 1 (SGLT1) and glucose transporter 2 (GLUT2) which transport glucose from the lumen into the bloodstream. Thus providing a potential mechanism by which glucose uptake can be regulated. Although artificial sweeteners stimulate the sweet taste receptors, they have little nutritive value, so that when they are consumed in the absence of any other nutrients there is little effect on blood glucose response. However, the effects of consuming artificial sweeteners in combination with sugars such as glucose is unclear. The purpose of this study is to investigate whether the addition of artificial sweeteners to an orally consumed glucose solution affects the rate at which the glucose appears in the blood.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Aged 18-45 years
* BMI (19-25 kg/m2)
* Weight stable in past 3 months

Exclusion Criteria:

* Smoking
* Females who are pregnant of breastfeeding
* Regular intake of emdication, other than females taking oral contraceptives
* Medical illness
* Gastrointestinal disorders
* Food allergies

Primary outcomes:
measure: Blood glucose response
timeFrame: 90 min
Secondary outcomes:
measure: Subjective appetite
timeFrame: 90 min
Other outcomes:
Locations:
city: Newcastle-Upon Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre- Northumbria University
Study officials:
affiliation: Northumbria University
name: Nerys M Astbury, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04721392: Mental Fatigue and Industrial Work Performance
Official title: Mental Fatigue and Industrial Work Performance: The Influence of the Laevo Exoskeleton
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Mental Fatigue
Industrial Work
Robotics
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To investigate the effect of mental fatigue on industrial work performance, biomechanical determinants, (electro-)(psycho-) physiological measures and physical ergonomics. Additionally, the current project wants to evaluate whether or not the Laevo exoskeleton influences the aforementioned parameters when mental fatigue is acutely induced.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Males and Females
* 18-64 years

Exclusion Criteria:

* Musculoskeletal disorders
* Neurological disorders
* Cardiovascular disorders
* Pregnancy

Primary outcomes:
measure: VICON: Placement accuracy Box
timeFrame: 30 minutes
measure: Work performance: Percent accuracy Serial Seven Task
timeFrame: 30 minutes
measure: Ergonomics: EMG-data
timeFrame: 30 minutes
measure: Ergonomics: Joint angles
timeFrame: 30 minutes
measure: Mental fatigue: EEG-data
timeFrame: 60 minutes
measure: Mental fatigue: VAS-score
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Etterbeek
country: Belgium
facility: Vrije Universiteit Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT06972992: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Weight Management
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.


Eligibility criteria: Inclusion Criteria:

* Subject have provided informed consent before initiation of any study specific procedures
* Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
* Stable body weight (less than 5% self-reported change within the previous 3 months)

Exclusion Criteria:

* Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
* Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
* Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
* Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.

Primary outcomes:
measure: Adverse events
timeFrame: up to 71 days
Secondary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: up to 71 days
measure: Cmax of ASC47
timeFrame: up to 71 days
measure: AUC of ASC47
timeFrame: up to 71 days
measure: T1/2 of ASC47
timeFrame: up to 71 days
measure: CL/F of ASC47
timeFrame: up to 71 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Ascletis Clinical Site
state: Texas
Study officials:
References:
Clinical trial NCT03578692: Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)
Official title: Clinical Value of Inflammation-related Indicators of Blood and Fecal Calprotectin in Predicting the Surgery Rate of Acute Severe Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis Acute
Surgery
Keywords: acute severe ulcerative colitis
predictive indicator
surgery
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All acute severe ulcerative colitis patients were admitted in hospital and prospectively followed during the study period.

Brief summary: Acute severe ulcerative colitis \[ASUC\] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission.


Eligibility criteria: Inclusion Criteria:

The inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis.

Exclusion Criteria:

Patients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.

Primary outcomes:
measure: Colon operation
timeFrame: 30 days
Secondary outcomes:
measure: No response to medical treatments
timeFrame: 5 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04337892: Veracity Surgical: A Time/Motion and Quality of Care Study
Official title: Veracity Surgical: A Time/Motion and Quality of Care Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to enroll 40 patients undergoing future cataract surgery.

Brief summary: This study aims to compare the time required for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Detailed description: This study aims to compare the time commitment for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age with upcoming cataract surgery. At least 25% of enrolled eyes must be post-refractive, and 25% must require astigmatic planning (arcuate incision or toric IOL)
* Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence refractive outcome or interfere with postoperative refraction accuracy.

Exclusion Criteria:

* Patients with visually significant comorbidities (corneal, retina, optic nerve disease, not including prior refractive surgery) that could significantly affect their ability to have accurate preoperative biometry or postoperative refraction.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would interfere with postoperative refraction.
* Patients with \> grade 2 or greater posterior capsule opacity

Primary outcomes:
measure: Average number of minutes:seconds to plan surgery for a single eye
timeFrame: 1 day
Secondary outcomes:
measure: By each method the number of total data points where a human is required manually to transcribe data from one place to another.
timeFrame: 1 day
Other outcomes:
measure: Exploratory Endpoint: By each method the % of patients within 0.5 D of the intended postoperative manifest spherical equivalent refraction
timeFrame: 1 day
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
Study officials:
affiliation: Research Insight LLC
name: John Hovanesian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00277992: Growth in Children With HLHS
Official title: Growth in Children With HLHS
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: Pediatric
Cardiac
Norwood operation modification
GT/Nissen operation
Po feed
GT fed
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 100
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Children with HLHS have a history of poor enteral intake and growth. Over the past several years a modification to the Norwood operation was instituted (RV to PA shunt in place of the standard Blalock-Taussig shunt).

The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood.

Detailed description: The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood. Also, the standard of care has changed to GT/Nissen operation to facilitate "safe" feeding in those patients who are not able to feed by mouth (po feed).

A second aim of this study is to evaluate whether children who are GT fed have improved growth compared to those who are not.

We wish to review all patients who underwent Norwood procedure from January 1, 2001 to March 31, 2005.

Eligibility criteria: Inclusion Criteria:

* Patient at Children's Healthcare of Atlanta, Egleston Norwood procedure between Jan. 1. 2001 and March 31.2005

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta, Sibley Heat Center Cardiology
name: Janet Simsic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921492: Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Official title: Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Luteinizing hormone
Cortisol
HPA axis
HPO axis
Ovulation
Heart rate variability
Psychological distress and quality of life
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis The overall hypothesis is that non-obese (BMI \<30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.

Detailed description: Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.

Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.

Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.

Eligibility criteria: Inclusion Criteria:

* 18 - 39 years, inclusive
* 30 ≤ BMI
* History of irregular menstrual cycles
* Clinical and/or biochemical androgen excess (determined during screening)

Exclusion Criteria:

Medical Exclusion Criteria

* History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.
* Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.

Psychiatric and Behavioral Exclusion Criteria

* Pregnant or breast-feeding women

Primary outcomes:
measure: Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study.
timeFrame: 16 weeks
Secondary outcomes:
measure: Ovulation, health related quality of life
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Study officials:
References:
citation: Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.
Clinical trial NCT01675492: Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Astigmatism
refractive
error
LASIK
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 126
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: To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age at the time of pre-operative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at lest 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease,or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Primary outcomes:
measure: Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 3 Months
Secondary outcomes:
measure: Uncorrected Visual Acuity (UCVA) of 20/40 or Better
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Medical Optics
name: Kendra Hileman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01073592: Comparison Between Foresee Home and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)
Official title: Comparison Between Home Macular Perimeter (FORESEE HOME) and OCT Visual Field Defects in Patients With CNV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: HMP
CNV
AMD
PHP
HPHP
FORESEE HOME
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suspected to have CNV secondary to AMD in at least one eye

Brief summary: The Foresee Home is used in the recent years to detect age-related macular degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV). The Foresee Home demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT may be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The Foresee Home can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.


Eligibility criteria: Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed with CNV
* Did not perform more then 4 anti- VGEF injections
* VA with habitual correction better then 6/45 in the study eye
* Ability to understand instructions
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study

Primary outcomes:
measure: Size and location of lesions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Ruth Siegal, Prof.
role: PRINCIPAL_INVESTIGATOR
References: