louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05790590: Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT
Official title: Comparison of Image Quality Between "Double Low Dose" Liver CT Using AI-based Iodine Boosting Reconstruction and Standard Contrast-enhanced Liver CT in Patients With Colorectal Cancer: Prospective, Randomized, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastasis to Liver
Colorectal Cancer
Keywords: CT
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2023-03-30
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.


Eligibility criteria: Inclusion Criteria:

* colorectal cancer (CRC) patients
* on surveillance or monitoring for liver metastasis (of CRC)

Exclusion Criteria:

* any relative or absolute contra-indication of CECT
* diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions

Primary outcomes:
measure: lesion conspicuity on portal venous phase
timeFrame: 6 months after primary study completion.
Secondary outcomes:
measure: lesion conspicuity on arterial phase
timeFrame: 6 months after primary study completion.
measure: lesion detectability
timeFrame: 12 months after primary study completion.
measure: Radiation dose
timeFrame: 1 month after primary study completion
measure: Contrast media (CM) dose
timeFrame: 1 month after primary study completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013390: Evaluation of Treatment Methods for Clinically Significant Tinnitus
Official title: Evaluation of Treatment Methods for Clinically Significant Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Keywords: Auditory, tinnitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose to evaluate two different approaches to the alleviation of tinnitus symptoms by comparing changes from baseline performance on the Tinnitus Severity Index. They propose to provide an unbiased evaluation of competing methodologies. The design is one in which pairs of prospective subjects are randomly assigned to one of two treatment groups. Changes in group performance will be compared for selected measures.


Eligibility criteria: Inclusion Criteria:

Patients with significant tinnitus

Exclusion Criteria:

Primary outcomes:
measure: Tinnitus Severity Index
timeFrame: Baseline, 3 mo., 6 mo., 12 mo., 18 mo.
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
Study officials:
affiliation: VA Medical Center, Portland
name: James Henry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00929890: Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs
Official title: Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Exercise
Diet
Lifestyle
Vascular reactivity
Body composition
Lipids
Glucose
Insulin resistance
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study tests the hypothesis that exercise training can confer additional benefit to patients in weight-loss programs in the form of improvements in either metabolic or vascular parameters or both. Patients will be randomized to either diet plus conventional physical activity or diet plus a planned exercise training. The interventions will be carried out until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end, all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin, c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and abdominal visceral fat (CT-scan). Both groups will be compared.


Eligibility criteria: Inclusion Criteria:

* BMI\> 30 and \<40

Exclusion Criteria:

* Diabetes mellitus
* Active endocrine disease
* Active heart disease
* Active smoking
* Medical contra-indications for exercise
* Using anti-obesity drugs

Primary outcomes:
measure: Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 6 months
measure: Change in lipid profile
timeFrame: 6 months
measure: Reduction in abdominal (visceral) fat
timeFrame: 6 months
measure: Change in vascular reactivity
timeFrame: 6 months
Secondary outcomes:
measure: C-reactive protein
timeFrame: 6 months
measure: Fibrinogen
timeFrame: 6 months
measure: vonWillebrand factor
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
name: Rogério Friedman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopes AL, Macedo RCO, Kruger RL, Friedman R, Carteri RB, Reischak-Oliveira A. Fasted exercise does not improve postprandial lipemia responses to different meals in lean and obese subjects: A crossover, randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:160-167. doi: 10.1016/j.clnesp.2020.11.013. Epub 2020 Dec 30.
Clinical trial NCT01111890: Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.


Eligibility criteria: Inclusion Criteria:

1. Must be at least 18 years of age.
2. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
3. Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
4. Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
5. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
6. For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.

Exclusion Criteria:

1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
2. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
3. Any abnormality preventing reliable applanation tonometry in study eye(s).
4. Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
5. Progressive retinal or optic nerve disease from any cause.
6. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study.
7. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
8. Participation in any other investigational study within 30 days prior to Visit 1.

Primary outcomes:
measure: Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
state: Ontario
Study officials:
References:
Clinical trial NCT06852690: The Effect of Virtual Exercises on Glycemic Control and Body Composition in Type 2 Diabetic Patients
Official title: The Effect of Virtual Exercises on Glycemic Control, Body Composition, Psychological Status and Quality of Life in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: diabetes, glycemic control, virtual reality, quality of life
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to evaluate the effect of exercises with VR goggles in patients with type 2 diabetes.

The effect of exercise in virtual reality goggles on glycemic control, body composition, quality of life and psychological status.

Detailed description: For virtual reality applications, a screen will be worn on the user's head that provides a three-dimensional visual image, thus creating a sense of space and depth. Blood glucose levels, vital signs and oxygen consumption capacity measurements will be monitored with the smart watch throughout the VR exercise application.

Eligibility criteria: Inclusion Criteria:

Being over 18 years old able to communicate Volunteering to participate in the research

Exclusion Criteria:

Those with psychiatric problems Being unconscious

Primary outcomes:
measure: Glycemic Control Analysis
timeFrame: 3 months
measure: Analysis of Body Composition Values
timeFrame: 3 months
measure: fat mass
timeFrame: 3 months
measure: lean mass
timeFrame: 3 months
measure: muscle mass
timeFrame: 3 months
measure: visceral fat content
timeFrame: 3 months
measure: basal metabolic rate
timeFrame: 3 months
Secondary outcomes:
measure: Depression Anxiety Stress Scale
timeFrame: 3 months
measure: SF-36 Quality of Life Scale
timeFrame: 3 months
measure: Satisfaction Survey
timeFrame: 3 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Sabahattin Zaim Üniversitesi, Sağlık Bilimleri Fakültesi
Study officials:
References:
Clinical trial NCT00701090: A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus, Non Insulin Dependent
Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 Diabetes Mellitus
Non Insulin Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosed with type 2 diabetes
* On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

* History of type 1 diabetes
* Pregnant
* HIV positive
* On a weight loss program or medication
* Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 30
timeFrame: Week 0 to Week 30
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30
timeFrame: Week 0 to Week 30
measure: Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30
timeFrame: Week 0 to Week 30
measure: Change From Baseline in Body Weight at Week 30
timeFrame: Week 0 to Week 30
measure: Percent of Patients With A1C <7.0% at Week 30
timeFrame: Week 30
measure: Percent of Patients With A1C <6.5% at Week 30
timeFrame: Week 30
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.x.
citation: Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
Clinical trial NCT05066490: Effect of Exercise on Vitamin d in Obese
Official title: Effect of Exercise-induced Lipolysis on Vitamin D Status in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Vitamin D Deficiency
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 30
Sex: MALE
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 obese children who suffered from vitamin d deficiency were randomly assigned into three groups. group I (15 children) received endurance exercises and group II (15 children) received endurance exercises preceded by resistance exercises which have a stronger lipolytic effect. group III (10 children) acted as a control group.
Primary purpose: TREATMENT

Brief summary: The aim of the current study was to investigate the effect of exercise-induced lipolysis on vitamin D status in obese children. Two types of exercises that have different effects on lipolysis were used. Lipolysis was assessed via monitoring the level of plasma level of the free fatty acids and glycerol. Vitamin D was assessed through 25 (OH)D plasma levels.

Detailed description: vitamin D status was monitored through 25 (OH)D levels, and the lipolysis status via the plasma level of the free fatty acids and glycerol immediately after the exercise. All subjects who participated in the study were under supervision for controlling the fat contents and vitamin D in their food for one week prior to the exercise. the subjects fasted eight hours before the exercise. All the exercises were performed between 9 am and 11 am.

Eligibility criteria: Inclusion Criteria:

* Body mass index percentile equal to or greater than the 95th percentile
* All did not receive strength or balance training or involvement in competitive sports emphasizing muscular strength.
* All participants had balance deficiency and mobile flat foot.
* 25(OH) D was ranged from 10-20ng/ml

Exclusion Criteria:

* Injury to the lower limb required medical care.
* Deformity of or surgery in the lower limb.
* Visual impairment, or neuromuscular disorders.
* Engagement in obesity treatment programs, three months prior to the study.
* Epileptic fits
* Thyroid medications
* Autoimmune disease
* Take calcium or vitamin d3 supplements, medications for osteoporosis

Primary outcomes:
measure: Free fatty acids
timeFrame: After 60 min of training
measure: Glycerol
timeFrame: After 60 min of training
measure: Vitamin D
timeFrame: After 60 min of training
Secondary outcomes:
Other outcomes:
Locations:
city: Taif
country: Saudi Arabia
facility: College of applied medical sciences
state: Mecca
Study officials:
affiliation: Assisstant professor
name: Hatem H Allam, Doctoral
role: STUDY_DIRECTOR
References:
Clinical trial NCT00803790: A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
Official title: A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.


Eligibility criteria: Inclusion Criteria:

* Male or nonpregnant female age 18 to 85 years
* female of childbearing potential on appropriate method of contraception and not nursing
* Body Mass Index (BMI) less than or equal to 30 kg/m2
* subject is in good health

Exclusion Criteria:

* mental or legal incapacitation
* received bisphosphonate treatment within 3 months of enrollment.
* unable to sit or stand upright for at least 2 hours
* unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration
* unwilling to limit alcohol consumption to no more than 2 drinks per day
* unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent.
* unwilling to refrain from smoking during the study

Primary outcomes:
measure: Part 1: Urinary Excretion of Alendronate
timeFrame: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)
measure: Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
timeFrame: Day 1 across the 80-hour plasma collection period (Period 1 and 2)
Secondary outcomes:
measure: Part II : Maximum Concentration (Cmax) of Vitamin D
timeFrame: Day 1 across the 80-hour plasma collection period (Periods 1 and 2)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
Clinical trial NCT00750464: Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Official title: Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Real Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 575
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy

Brief summary: Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy.

Exclusion Criteria:

* Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being "imaged" by RI3.0.
* Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
* Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
* Subjects who have undergone a mastectomy.
* Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who have a fever on the day of their biopsy.
* Subjects who are pregnant.
* Subjects who are breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center - Lin
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Hadassah Medical Organization, Jerusalem
name: Miri Sklair-Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: