louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06579729: Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease
Official title: Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Low-free Sugar Dietary
Child Obesity
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 146
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.


Eligibility criteria: Inclusion Criteria:

* Age: above 5 years old and below 14 years old;
* Guardian's consent and signing of informed consent;
* WHO growth and development curves as the reference standard, overweight is defined as BMI greater than or equal to the 85th percentile of the WHO growth curves for children, and obesity is defined as BMI greater than or equal to the 95th percentile of the WHO growth curves for children;
* Liver imaging performance meets the diagnostic criteria of diffuse fatty liver.

Exclusion Criteria:

* Age \<5 years or \>14 years;
* Previous history of alcohol consumption;
* Non-cooperation with the study, inability to comply with the study treatment or study visit.
* Past or active hepatitis B virus infection;
* Past or active hepatitis C virus infection;
* Chronic or acute liver failure;
* Cholestasis;
* Hepatomegaly;
* Cystic fibrosis;
* α1-antitrypsin deficiency;
* Autoimmune hepatitis;
* Tyrosinemia;
* Galactosemia or any recognized liver disease, any physical condition deemed by a physician to be unable to complete the trial. Physical Condition.

Primary outcomes:
measure: NAFLD
timeFrame: At weeks 1, 12 and 24
measure: Dietary
timeFrame: At weeks 1, 12 and 24
measure: Physical activity level
timeFrame: At weeks 1, 12 and 24
Secondary outcomes:
measure: Height
timeFrame: At weeks 1, 12 and 24
measure: Body weight
timeFrame: At weeks 1, 12 and 24
measure: BMI
timeFrame: At weeks 1, 12 and 24
measure: Waist circumference
timeFrame: At weeks 1, 12 and 24
measure: Waist-to-height ratio
timeFrame: At weeks 1, 12 and 24
measure: Blood pressure
timeFrame: At weeks 1, 12 and 24
Other outcomes:
Locations:
city: Shenyang
country: China
facility: China Medical University
Study officials:
References:
Clinical trial NCT04642729: Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery
Official title: Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Macular Corneal Dystrophy
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.

Detailed description: Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by bilateral cloudy regions within hazy stroma and eventually severe visual impairment.

Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in the production of keratan sulfate, which plays a role in the maintenance of corneal transparency.

According to biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.

Eligibility criteria: Inclusion Criteria:

* indications for penetrating keratoplasty
* low transparec of corneae
* low visual acuity

Exclusion Criteria:

* active anterior segment pathology
* previous corneal or anterior segment surgery
* any infection

Primary outcomes:
measure: Increase of corneal transparency
timeFrame: 12 months
Secondary outcomes:
measure: Increase of visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT01326429: Frequency and Origin of Dysnatremias in the Emergency Department
Official title: Frequency and Origin of Dysnatremias in the Emergency Department
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hyponatremia
Hypernatremia
Keywords: Sodium
Hyponatremia
Hypernatremia
Emergency department
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Steering committee of the NCCR
First posted: 2011-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the emergency department of a large tertiary university hospital with a serum sodium below 135 mmol/L (hyponatremia) or exceeding 145 mmol/L.

Brief summary: Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Only little data is available on the frequency and the mechanisms leading to hypo-/hypernatremia.

Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital and B.) explore the mechanisms leading to the development of dysnatremias by detailed clinical and laboratory examinations.


Eligibility criteria: Inclusion Criteria:

* Serum sodium below 135 mmol/L (i.e. hyponatremia); serum sodium exceeding 145 mmol/L (hypernatremia)

Exclusion Criteria:

* Patients below age 18 years; patients declining study participation.

Primary outcomes:
measure: Frequency of hypo- and hypernatremia in the emergency department
timeFrame: approx. 6 months
Secondary outcomes:
measure: Origin of hypo- and hypernatremia in the emergency department
timeFrame: approx. 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern
name: Gregor Lindner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern
name: Felix J Frey, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05451329: A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
Official title: A Phase 2, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of VVN539 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Lead sponsor: VivaVision Biotech, Inc
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked, randomized, parallel
Primary purpose: TREATMENT

Brief summary: This is a prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days, each.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are untreated, or if treated, in the opinion of the investigator are well controlled on 2 or fewer ocular hypotensive medications prior to Visit 1.
* Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2.
* Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic Retinopathy Scale in each eye (equivalent to Snellen 20/200)

Exclusion Criteria:

* Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the formulation or to topical anesthetics or fluorescein.
* Unmedicated IOP of \> 36 mm Hg in either eye at any time point at Visit 2.

Primary outcomes:
measure: Mean Intraocular Pressure
timeFrame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Secondary outcomes:
measure: Mean Change in Intraocular Pressure From Baseline
timeFrame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Other outcomes:
Locations:
city: Durham
country: United States
facility: Lexitas
state: North Carolina
Study officials:
affiliation: VivaVision
name: Xiao-Yan Li, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01864629: Optimizing Postpartum Contraception in Women With Preterm Births
Official title: Optimizing Postpartum Contraception in Women With Preterm Births
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Method of Contraception
Preterm Birth Recurrence
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 134
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery.

The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.


Eligibility criteria: Inclusion Criteria:

* Women who deliver a premature infant that is between the gestational ages of 24 weeks 0 days and 36 weeks 6 days at our institution.

Exclusion Criteria:

* Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.

Primary outcomes:
measure: Use of highly effective method
timeFrame: Three months
Secondary outcomes:
measure: Pregnancy outcomes
timeFrame: 12 months, 18 months, 24 months, 36 months
measure: Use of highly effective method
timeFrame: 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: David K Turok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490229: Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients
Official title: Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: nutraceuticals
statin
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Detailed description: Background

Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.

Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Eligibility criteria: Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Recent (\< 12 months) percutaneous coronary intervention
* Class I indication to receive statin treatment
* Previous (\< 12 months) withdrawn of a statin due to side effects
* Unwilling to receive treatment with an alternative statin
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Primary outcomes:
measure: Evaluation of treatment tolerability
timeFrame: Up to 12 months
Secondary outcomes:
measure: Evaluation of drug effects on lipid and metabolic features
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Raffaele Pisana
Study officials:
References:
Clinical trial NCT03892629: Baduanjin Exercise for Patients With GOLD 2-3 Stable COPD on Pulmonary Rehabilitation
Official title: Baduanjin Exercise for Patients With GOLD 2-3 Stable Chronic Obstructive Pulmonary Disease on Pulmonary Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2019-03-27
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.

Detailed description: To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II\~III. A prospective, randomized, controlled clinical trial was designed.

Eligibility criteria: Inclusion Criteria:

* Aged from 40 to 80 years
* Diagnosed with stable chronic obstructive pulmonary disease
* Phase II\~III

Exclusion Criteria:

* The condition was serious or movement restrained by other diseases
* In the acute exacerbation of chronic obstructive pulmonary disease
* Participants who have contraindications to exercise training
* Patients who have other serious acute, chronic organic disease or mental disorders

Primary outcomes:
measure: St. George's respiratory questionnaire (SGRQ)
timeFrame: Baseline, 3 months, 6 months
measure: Six-minute walk test (6MWT)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Pulmanory function indicators (FEV1/FVC, FEV1pred%)
timeFrame: Baseline, 3 months, 6 months
measure: Modified British medical research council questionnaire (mMRC)
timeFrame: Baseline, 1 month, 2 months, 3 months, 6 months
measure: COPD assessment test (CAT)
timeFrame: Baseline, 1 month, 2 months, 3 months, 6 months
measure: Times of acute exacerbation
timeFrame: Baseline, 1 month, 2 months, 3 months, 6 months
measure: Self-rating anxiety scale (SAS)
timeFrame: Baseline, 3 months, 6 months
measure: Self-rating depression scale (SDS)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: The main TCM symptoms
timeFrame: Baseline, 1 month, 2 months, 3 months, 6 months
Locations:
city: Shanghai
country: China
facility: Shanghai Shuguang Hospital
Study officials:
affiliation: Shanghai Shuguang Hospital
name: Wei Zhang, Master
role: STUDY_CHAIR
References:
Clinical trial NCT02183129: Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee
Official title: Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 91
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: To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks


Eligibility criteria: Inclusion Criteria:

- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

- none

Primary outcomes:
measure: Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)
timeFrame: Baseline, 8 weeks after first drug administration
Secondary outcomes:
measure: Change from baseline in Lequesne index
timeFrame: Baseline, 8 weeks after first drug administration
measure: Change from baseline in global assessment by the patient and doctor on a 3-point scale
timeFrame: Baseline, 8 weeks after first drug administration
measure: Number of patients with significant changes from baseline in Laboratory values
timeFrame: Baseline, 8 weeks after first drug administration
measure: Number of patients with significant changes from baseline in physical examinations
timeFrame: Baseline, 8 weeks after first drug administration
measure: Number of patients with Adverse Events
timeFrame: Up to 8 weeks after first drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03163329: The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
Official title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aortic Valve Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2017-05-23
Enrollment: 300
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: Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.


Eligibility criteria: Inclusion Criteria:

1. Severe, calcific bicuspid aortic stenosis.
2. Heart team agrees the patient has a risk of operative mortality and has an STS \<8 and \>3.
3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:

1. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
3. Severe aortic regurgitation (\>3+).
4. Severe mitral regurgitation (\>3+).

Primary outcomes:
measure: All-cause mortality, all stroke, and re-hospitalization
timeFrame: 1 year post procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00144729: Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
Official title: Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anemia, Aplastic
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: University of California, Los Angeles
name: City of Hope National Medical Center
name: University of Utah
name: Oregon Health and Science University
name: Baylor University
name: Ohio State University
First posted: 2005-09-05
Enrollment: 85
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.


Eligibility criteria: Inclusion Criteria:

* Life-threatening marrow failure of nonmalignant etiology;
* failure to respond to the best available immunosuppressive treatment;
* lack of a HLA-identical family member

Exclusion Criteria:

* Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure;
* HIV seropositive patients;
* clonal abnormalities or myelodysplastic syndrome;

Primary outcomes:
measure: Sustained engraftment; survival
Secondary outcomes:
measure: Acute and chronic GVHD
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Joachim Deeg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: