louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03848390: Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
Official title: Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.


Eligibility criteria: Inclusion Criteria:

* Motivated obese fatty liver patients aged 8 -18yrs with ALT \>80

Exclusion Criteria:

* Patients with metabolic disorders,
* On certain medications (i.e., amiodarone, corticosteroids, methotrexate, select antipsychotics /antidepressants, HAART, valproic acid),
* Kwashiorkor
* Alcohol abuse,
* Rapid surgical weight loss,
* History of parenteral nutrition and
* Hepatitis C.

Primary outcomes:
measure: Change in Alanine Amino Transferase (ALT) levels
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Body Mass Index (BMI) Z-score
timeFrame: Baseline, 3 months
measure: Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver
timeFrame: Baseline, 3 months
measure: Change in fibrosis on Magnetic Resonance Elastography of the Liver
timeFrame: Baseline, 3 months
measure: Change in diastolic blood pressure
timeFrame: Baseline, 3 months
measure: Change in systolic blood pressure
timeFrame: Baseline, 3 months
measure: Change in LDL
timeFrame: Baseline, 3 months
measure: Change in HDL
timeFrame: Baseline, 3 months
measure: Change in TRIGLYCERIDE
timeFrame: Baseline, 3 months
measure: Change in TOTAL CHOLESTEROL
timeFrame: Baseline, 3 months
measure: Hemoglobin A1C
timeFrame: Baseline; 3 months
measure: Fasting serum insulin
timeFrame: Baseline; 3 months
measure: Fasting serum glucose
timeFrame: Baseline; 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Sciences Center in Houston
name: Essam M Imseis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05400590: Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
Official title: Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aniridia
Keywords: Growth factor rich plasma
Conjunctival impression
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-06-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aniridia patients and controls without aniridia

Brief summary: Keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). Treatment with autologous serum is usually undertaken to promote epithelial healing.

However, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. This study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.

Detailed description: Blood collection from aniridia patients and healthy controls, half of which will be used to make autologous serum and the other half to make growth factor rich plasma, used for in vitro studies.

A conjunctival impression will also be taken at the inclusion of the patients.

Eligibility criteria: Inclusion Criteria:

For patients with aniridia:

* With aniridia
* Patient weighing more than 43 kg
* If the patient is being treated with autologous serum, a delay of 8 weeks after the last blood collection
* If a blood donation has been made, a delay of 8 weeks must be respected after the last donation

For controls:

* Non-aniridia (no clinical signs)
* Weighing more than 43 kg
* Matched to a case for sex and age +/-10 years
* No known diabetes
* If a blood donation has been made, a delay of 8 weeks must be respected after the latter

Exclusion Criteria:

* Insufficient sample volume
* No conjunctival print
* HBV, HCV, HIV serology positive
* Aniridia not genetically confirmed for cases For each patient excluded, a new patient will be included in order to maintain the number of patients required for data analysis.

Primary outcomes:
measure: In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients
timeFrame: Sampling done at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschild
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Eric GABISON
role: STUDY_CHAIR
affiliation: Hôpital Fondation A. de Rothschild
name: Damien GUINDOLET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654390: The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus
Official title: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 270
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
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 determine the efficacy and safety of DWP16001 compared to active drug in the treatment of type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 to 80 years
2. Subjects with 7% ≤ HbA1c ≤ 11% at Screening
3. Subjects with BMI of 20-45 kg/m2

Exclusion Criteria:

1. Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
2. Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
3. Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
4. eGFR \< 60 mL/min/1.73 m2
5. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
6. Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)

Primary outcomes:
measure: Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
timeFrame: at Week 24
Secondary outcomes:
measure: Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP
timeFrame: at weeks 6, 12, and 18
measure: Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
timeFrame: at weeks 6, 12, 18, and 24
measure: Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
timeFrame: at weeks 6, 12, 18, and 24
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
Study officials:
affiliation: The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
name: Sungrae KIm, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05732090: Effect of Diaphragmatic Myofascial Release on Thoracic Angle and Pulmonary Functions in Hyperkyphotic Adolescents
Official title: Effect of Diaphragmatic Myofascial Release on Thoracic Curvature Angle and Pulmonary Functions in Hyperkyphotic Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Kyphosis
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 102
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent kyphotic girls will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. They will be assessed at baseline and after three successive months of interventions for the following outcomes: Cobb angle by x-ray and pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer

Detailed description: Adolescent kyphotic girls with an age range of 12-15 years old will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. Both groupss will receive intervention for three three successive months. They will be be assessed at baseline and after three three successive months of interventions for the following outcomes:

Primary outcome: Cobb angle by x-ray Secondary outcome: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer

Eligibility criteria: Inclusion Criteria:

* Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree.
* Age ranged from 12 to 15 years old.
* selected from preparatory and secondary schools.

Exclusion Criteria:

* free from any associated deformities other than the thoracic kyphotic deformity.

Primary outcomes:
measure: Cobb angle
timeFrame: Change from Cobb angle at 3 months
Secondary outcomes:
measure: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume)
timeFrame: Change from pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) at 2 months
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT01886690: A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bilateral LASIK Surgery
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.


Eligibility criteria: Inclusion Criteria:

-Patients scheduled for LASIK surgery in both eyes.

Exclusion Criteria:

* Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
* Use of topical eye medication other than prescribed for use in pre- or post-operative care
* Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
* Eye infection, inflammation, or allergy
* Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.

Primary outcomes:
measure: Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
timeFrame: Day 90
Secondary outcomes:
measure: Change From Baseline in Corneal Staining in the Worse Eye
timeFrame: Baseline, Day 90
measure: Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye
timeFrame: Baseline, Day 90
measure: Change From Baseline in the Schirmer Test in the Worse Eye
timeFrame: Baseline, Day 90
measure: Change From Baseline in Uncorrected Visual Acuity in the Worse Eye
timeFrame: Baseline, Day 90
Other outcomes:
Locations:
city: New South Wales
country: Australia
city: Kelowna
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wallerstein A, Jackson WB, Chambers J, Moezzi AM, Lin H, Simmons PA. Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose. Clin Ophthalmol. 2018 May 7;12:839-848. doi: 10.2147/OPTH.S163744. eCollection 2018.
Clinical trial NCT04991064: Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
Official title: Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture Retention
Complete Dentures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of the addition of titanium dioxide nanoparticles to denture base materials on their retention compared to that of the unmodified denture base materials.

Detailed description: All patients will be randomly allocated to two equal groups either with the protocol I or II (5 in each group) with an allocation ratio of 1:1 through a computer-generated sequence by a spreadsheet (Excel, Microsoft Office 2010; Microsoft Corp). The group with the protocol I will use the modified dentures with titanium dioxide nanoparticles (TiO2NP) during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the unmodified dentures for 1 month; the group with the protocol II will use the unmodified dentures during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the modified dentures TiO2NP for 1 month. Assessment of retention will be done immediately and 1 month after denture insertion.

Eligibility criteria: Inclusion Criteria:

* patients requiring new removable complete dentures, with class I edentulous arches based on the American College of Prosthodontists (ACP) classification15, with an average age of 45-55 years old, with healthy temporomandibular joint, being without systemic disease that could affect the neuromuscular control or salivary flow

Exclusion Criteria:

* Patients with ACP Class II, III, or IV, and xerostomia.

Primary outcomes:
measure: Assessment of the change in the retention within each type of complete denture.
timeFrame: Assessment will be done Immediately and 1 month after denture insertion within each type of denture.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine
state: Manyal
Study officials:
References:
Clinical trial NCT00524264: A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract Extraction
Pain
Inflammation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 248
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: This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cataract surgery

Exclusion Criteria:

* Uncontrolled ocular disease in cataract surgery eye

Primary outcomes:
measure: Resolution of Post Operative Inflammation
timeFrame: Day 14
Secondary outcomes:
measure: Ocular Pain
timeFrame: Day 1
measure: Mean Pupil Area
timeFrame: Day 0
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.
Clinical trial NCT04931264: Clinical Trial of YuWell YE660D Blood Pressure Monitor in General Population According to the ISO 81060-2:2018
Official title: Validation of the YuWell YE660D Oscillometric Upper-arm Blood Pressure Monitor for Clinic and Home in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: blood pressure monitor
blood pressure measurement
validation study
AAMI/ESH/ISO Universal Standard
ISO 81060-2:2018
YuWell YE660D
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu Yuyue medical equipment & supply Co., Ltd.
First posted: 2021-06-18
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).


Eligibility criteria: Inclusion Criteria:

* 12 Years and older;
* Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

* Disturbance of consciousness;
* Patients requiring hemodialysis;
* Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
* Pregnant and lactating women;
* Patients with cardiac arrhythmias;
* Other conditions that the investigator considers ineligible for clinical trial.

Primary outcomes:
measure: Blood pressure measurement data
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Mingzhi Long, MD，PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00641264: Quality of Life Validation in Laryngitis
Official title: Laryngopharyngeal Reflux Health Related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric Testing in Patients Receiving Omeprazole 20 mg Bid as Treatment for Laryngopharyngeal Reflux.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laryngopharyngeal Reflux (LPR)
Keywords: Laryngopharyngeal reflux (LPR)
Omeprazole
Losec
Quality of Life
Laryngitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).


Eligibility criteria: Inclusion Criteria:

* New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment

Exclusion Criteria:

* Unable to comply with study requirements.

Primary outcomes:
measure: LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux
timeFrame: 2 monthly
Secondary outcomes:
measure: Safety assessments via adverse event recording and physical examinations
timeFrame: 2 monthly
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References: