louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00251069: Glucosamine Sulphate and Increased Level of Blood Cholesterol
Official title: Glucosamine Sulphate and Hypercholesterolaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: glucosamine sulphate, osteoarthritis, cholesterol,
Lead sponsor: Slidgigtinstituttet
Sponsor class: OTHER
Collaborators: name: Pharma Nord
First posted: 2005-11-09
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glucosamine sulphate causes no changes in blood levels of cholesterol

Detailed description: The effects on glucosamine sulphate on blood levels of choleterol is measuered in patients with mild to moderate osteoarthritis

Eligibility criteria: Inclusion Criteria: Osteoarthritic pain, normal blood cholesterol levels -

Exclusion Criteria: Systemic diseases, pregnancy, need of medication besides painkillers

-

Primary outcomes:
measure: Levels of blood cholesterol
Secondary outcomes:
measure: Effect of treatment on pain
Other outcomes:
Locations:
city: Ishøj
country: Denmark
facility: Slidgigtinstituttet
Study officials:
affiliation: Slidgigtinstituttet
name: Keld Ostergaard, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348369: The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens
Official title: The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Orthokeratology
Keywords: Myopia
Orthokeratology
Axial length
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 364
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Myopia children with orthokeratology lens and complete follow-up.

Brief summary: Orthokeratology lens is an effective method for myopia control. This study analyzed the relationship between the relative corneal refractive power shift and change of axial length in adolescents with orthokeratology lens.

Detailed description: Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the relationship between the relative corneal refractive power shift and changes of axial length in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Eligibility criteria: Inclusion Criteria:

* age from 8 to 15years
* spherical equivalent(SE) was range from -1.00D to -5.00D
* conform to the standard of wearing orthokeratology lens

Exclusion Criteria:

* ocular diseases and systemic diseases
* visual acuity was less than 20/20
* unable to follow visitors on time

Primary outcomes:
measure: The change of axial length
timeFrame: The change of baseline and 1years
Secondary outcomes:
measure: Relative corneal refractive power shift(RCRPS)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
citation: Vincent SJ, Cho P, Chan KY, Fadel D, Ghorbani-Mojarrad N, Gonzalez-Meijome JM, Johnson L, Kang P, Michaud L, Simard P, Jones L. CLEAR - Orthokeratology. Cont Lens Anterior Eye. 2021 Apr;44(2):240-269. doi: 10.1016/j.clae.2021.02.003. Epub 2021 Mar 25.
citation: Guo B, Cheung SW, Kojima R, Cho P. One-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: a prospective randomised clinical trial. Ophthalmic Physiol Opt. 2021 Jul;41(4):702-714. doi: 10.1111/opo.12834. Epub 2021 May 15.
Clinical trial NCT06368869: The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers
Official title: The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Color; Change Teeth, Posteruptive
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements.


Eligibility criteria: Inclusion Criteria:

* Good oral hygiene with compliance to perform strict oral hygiene measures (periodontal screening index 0-1).
* Slight malposition.
* Teeth with spacing.
* Teeth with discoloration

Exclusion Criteria:

* Advanced periodontitis, gingivitis, or recession.
* Abutments with subgingival restorations or root caries.
* Parafunctional habits.
* Undergoing orthodontic treatment.
* Presence of orthodontic appliance.
* Obvious dentition malalignment.
* Mandibular prognathism.
* Maxillary retrognathism.
* Smokers.

Primary outcomes:
measure: Color stability assessment
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02263469: A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
Official title: An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia B
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-10-13
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.


Eligibility criteria: Inclusion Criteria:

* Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.

Exclusion Criteria:

-

Primary outcomes:
measure: Amount of Factor IX Administered per Month (IU/KG)
timeFrame: 26 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576
city: Donetsk
country: Ukraine
facility: Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue
city: Kiev
country: Ukraine
facility: Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.
Study officials:
References:
Clinical trial NCT03325569: GLP-1 Response in Women With PCOS and Prediabetes
Official title: Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incretin Hormones in PCOS With Prediabetes
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Women with PCOS are more prone to obesity which exacerbates insulin resistance, the abdominal fat disposition and metabolic risk of these patients. With development of obesity these women have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in turn to type 2 diabetes.

Glucagon-like peptide 1 (GLP-1) is involved in body weight maintenance. Beside energy balance it is also involved in glucose homeostasis. Functional deficit in GLP-1 facilitates obesity. We investigated the link between the concentration of incretin hormones and glucose homeostasis, metabolic complications and the distribution of body composition in obese women with PCOS.


Eligibility criteria: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary sindrome (NICHD criteria)
* BMI of 30 kg/m2 or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins within 90 days prior to study entery

Primary outcomes:
measure: The main outcome was difference in fasting and after load GLP1 levels between two groups
timeFrame: 3h
Secondary outcomes:
measure: The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.
timeFrame: 3h
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Andrej Janez, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05305469: Early Identification and Prognosis Prediction of Sepsis Through Multiomics
Official title: Early Identification and Prognosis Prediction of Sepsis Through Multiomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: Prognosis
Inflammation
Immune
Multiomics
Machine learning
Lead sponsor: Yantai Yuhuangding Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cases are from the Department of Critical Care Medicine, a top-grade hospital in Yantai

Brief summary: This study aims to integrate multi-omics data and clinical indicators to reveal pathogen-specific molecular patterns in patients with sepsis and establish prognostic prediction models through multiple machine learning algorithms.

Detailed description: This study aims to quantify the plasma metabolome, single nucleotide polymorphisms (SNPs) of exons and immunocytokines of septic patients with different pathogen infections and prognostic outcomes. Multi-omics data, cytokines, and clinical indicators will be integrated through multiple machine learning algorithms to reveal pathogen-specific molecular patterns and multi-dimensional prognostic prediction models.

Eligibility criteria: Inclusion Criteria:

* Patients with sepsis or septic shock who meet the diagnostic criteria (2016 sepsis 3.0 standard);
* Age 18～85 years old.

Exclusion Criteria:

* ICU stay of the subjects less than 72 hours;
* Female subjects who are pregnant;
* The subjects not sure if infected;
* The subjects performed CPR;
* The subjects suffer from chronic renal disease;
* The subjects with incomplete clinical data.

Primary outcomes:
measure: Pathogen-specific patterns
timeFrame: March 2022 - December 2023
Secondary outcomes:
measure: Prognostic prediction models
timeFrame: March 2022 - December 2024
Other outcomes:
Locations:
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
affiliation: Yantai Yuhuangding Hospital
name: Jing Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, Sun Y, Teng S, Li K. Prediction of sepsis mortality using metabolite biomarkers in the blood: a meta-analysis of death-related pathways and prospective validation. BMC Med. 2020 Apr 15;18(1):83. doi: 10.1186/s12916-020-01546-5.
Clinical trial NCT06714669: Comparison of General Anesthesia Hemodynamics Between R and P in Patients Undergoing Laparoscopic Hepatectomy
Official title: Comparison of General Anesthesia Hemodynamics Between Remimazolam and Propofol in Patients Undergoing Laparoscopic Hepatectomy: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypotension During Surgery
Keywords: hypotension
hemodynamics
general anesthesia
remimazolam
propofol
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants in the experimental group used remimazolam as intravenous anesthetics while participants in the control group used propofol.
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. The experimental group receives remimazolam, while the control group receives propofol. The primary objective is to compare the hemodynamic responses of patients in both groups during the surgical procedure, aiming to provide insights into the potential differences in cardiovascular stability and anesthetic management associated with these two drugs


Eligibility criteria: Inclusion Criteria:

* Scheduled for LMH;
* Age 18-80 years, BMI 18-28 kg/m2;
* American Association of Anesthesiologists（ASA）I-III;
* Child-Pugh grade A or B;
* No serious heart, brain and other important organ lesions;
* Informed and consent, and signed informed consent.

Exclusion Criteria:

* ASA IV-V or Child-Pugh C;
* Left ventricular ejection fraction (EF) \<30%;
* Implanted with temporary or permanent pacemakers;
* Organic heart disease;
* Uncontrolled hypertension, diabetes and other chronic diseases;
* Prolonged use of sedative and analgesic drugs (such as opioid analgesics, benzodiazepines, antianxiety, antidepressants, antipsychotics, etc.);
* Alcohol addiction;
* Allergic to benzodiazepines or propofol, or to any ingredient in the studied drug;
* Known history of allergy to other anesthetics; difficulty in airway and intubation during induction.

Primary outcomes:
measure: Blood pressure
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Heart rate
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Mean arterial pressure
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-san University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00004769: Study of Muscle Wasting and Altered Metabolism in Patients With Myotonic Dystrophy
Official title: Myotonic Dystrophy:Muscle Wasting and Altered Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myotonic Muscular Dystrophy
Keywords: Genetic diseases
Myotonic muscular dystrophy
Facioscapulohumeral muscular dystrophy
CMT
Rare disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2000-02-25
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: National sample

Brief summary: OBJECTIVES: I. Examine the interrelationships between muscle wasting (phenotype), the degree of myotonic dystrophy (DM) gene expression (genotype) in patients with DM.

II. Characterize the insulin resistance in these patients. III. Assess the glucose uptake in the leg and forearm tissues of these patients.

IV. Determine the stability of the DM gene lesion in muscles over a 5-10 year period.

Detailed description: PROTOCOL OUTLINE: Patients are placed on a meatless diet 3 days prior to study entry.

During the first 5-day hospital stay, patients receive an oral glucose tolerance test, an intravenous glucose tolerance test, and an intravenous infusion of insulin and glucose (dextrose) to determine the degree of insulin resistance. Patients also receive dual x-ray absorptiometry (DEXA) scan and total body potassium count to measure muscle mass. Patients undergo strength testing and physical fitness screening. A needle biopsy is performed to investigate the genetic alterations associated with this disease.

During the second 3-day hospital stay, patients receive an intravenous infusion of insulin, stable isotopic glucose, and stable isotopic glycerol.

During the third 3-day hospital stay, a catheter is placed in the femoral artery, femoral vein, and in each arm. Patients receive an infusion of stable isotopic glucose, stable isotopic phenylalanine, and insulin. Measurements of the balance of amino acids and glucose across the forearm and leg are completed. Green dye is infused to measure blood flow in the leg.

Eligibility criteria: Inclusion Criteria:

* Clinically mild or moderate myotonic dystrophy (DM), proximal myotonic myopathy (PROMM), facioscapulohumeral muscular dystrophy (FSH) or, Charcot-Marie-Tooth (CMT)
* Mild or moderate DM defined as: Mild muscle weakness in the limbs, modest facial weakness, and mild grip myotonia; Moderate muscle weakness in the limbs, typical DM facies, and prominent grip myotonia

Exclusion Criteria:

* Prior or concurrent therapy
* Obese
* Concurrent acute illness

Primary outcomes:
measure: Quantitative myometry (QMT)
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Richard T. Moxley, III
role: STUDY_CHAIR
References:
Clinical trial NCT00327769: Faslodex Advanced Breast Cancer Local Chinese Study
Official title: A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Breast Cancer
Keywords: Advanced breast cancer
fulvestrant
anastrozole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-19
Enrollment: 234
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal advanced breast cancer with oestrogen receptor positive
* Progression under first-line anti-oestrogen therapy.

Exclusion Criteria:

* Life-threatening metastasis; contraindication to anastrozole
* \>2 regimens of hormonotherapy for advanced breast cancer

Primary outcomes:
measure: Time to Disease Progression (TTP)
Secondary outcomes:
measure: Objective Response Rate (ORR)
measure: Clinical Benefit Rate (CBR)
measure: Time to Treatment Failure (TTF)
measure: Safety & Tolerability.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hankou
country: China
facility: Research Site
city: He Fei
country: China
facility: Research Site
city: Huangzhou
country: China
facility: Research Site
city: Ji Nan
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi AN
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Breast Cancer Established Brands Team Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, Chen Z, Gu K, Yu S, Zhang Y, Wang C, Zhang F, Yang J. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):223-30. doi: 10.1007/s00280-010-1483-x. Epub 2010 Oct 12.
Clinical trial NCT04863469: Brain-Physical Optimization Conditioning
Official title: Neurocognitive Optimization and Enhancement for Brain Health and Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Performance
Keywords: cognitive fatigue
demand
endurance performance
perceived exertion
effort
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
First posted: 2021-04-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Brain-Physical Optimization Conditioning (B-POC) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (Staiano et al., 2015; Dallaway et al., 2017). The current study seeks to isolate neurocognitive mechanisms of performance, particularly under high stress (e.g., physical or cognitive load) conditions, and to develop corresponding cognitive optimization tools.

Detailed description: Brain-Physical Optimization Conditioning (B-POC) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (Staiano et al., 2015; Dallaway et al., 2017). B-POC uses an acute mentally fatiguing task during routine exercise with the aim of optimizing the effects of physical endurance (e.g., aerobic exercise). B-POC differs from other types of cognitive training by increasing the cognitive demands of a specific concurrent task rather than teaching a cognitive strategy and relying on task transfer effects. Similar to strengthening a muscle, cognitive trainings may be one means of increasing Soldier's cognitive capacity and improving performance (Walton et al., 2018).

Eligibility criteria: Inclusion Criteria:

* Healthy active duty Soldiers
* 18-40 years old
* Available for study duration

Exclusion Criteria:

* Failure of an Army Physical Fitness/Combat Test (APFT/ACFT) test
* On a physical profile that prevents them from 1) engaging in intense aerobic exercise, 2) running on a treadmill, 3) riding the stationary bike, and 4) performing a cognitive task on a computer screen.
* Medically non-deployable
* Impaired cognitive function due to medication, injury or illness,
* Have been advised by a medical professional not to engage in aerobic exercise
* Are a pregnant female

Primary outcomes:
measure: Time to Failure Test
timeFrame: 7 weeks
Secondary outcomes:
measure: Dynamic Marksmanship
timeFrame: Pre-to-post ruck time (~30-90 minutes)
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Medical Research Directorate - West
state: Washington
Study officials:
References: