louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04597073: Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease
Official title: Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels in Serum, Saliva, and Gingival Crevicular Fluid of Patients With Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis, Generalized
Gingivitis
Keywords: Chronic Periodontitis
Gingival Crevicular Fluid
Leukemia Inhibitory Factor
Oncostatin M
Interleukin-11
Periodontal Therapy
Gingivitis
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: This study aims to determine Oncostatin M (OSM), Leukemia inhibitory factor (LIF), and Interleukin-11 (IL-11) levels in gingival crevicular fluid (GCF), saliva, and serum in periodontally healthy individuals and those with gingivitis and chronic periodontitis before and after periodontal treatment and to evaluate the relationship between these cytokine levels and clinical periodontal parameters.


Eligibility criteria: Inclusion Criteria:

* systemically healthy
* non-smokers

Exclusion Criteria:

* smokers
* pregnancy or lactation
* individuals with any systemic disease
* individuals who have had periodontal treatment in the last six months

Primary outcomes:
measure: Clinical attachment level baseline
timeFrame: baseline (before treatment)
measure: Plaque index baseline
timeFrame: baseline (before treatment)
measure: Gingival index baseline
timeFrame: baseline (before treatment)
measure: Probing of depth baseline
timeFrame: baseline (before treatment)
measure: Biochemical outcomes baseline
timeFrame: baseline (before treatment)
Secondary outcomes:
measure: Clinical attachment level after 8 weeks
timeFrame: 8 weeks after treatment
measure: Plaque index after 8 weeks
timeFrame: 8 weeks after treatment
measure: Gingival index after 8 weeks
timeFrame: 8 weeks after treatment
measure: Probing of dept after 8 weeks
timeFrame: 8 weeks after treatment
measure: Biochemical outcomes after 8 weeks
timeFrame: 8 weeks after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06128473: Clinical Evaluation of the Safety and Efficacy of Yung Sheng 38% Color Contact Lens
Official title: Clinical Evaluation of the Safety and Efficacy of Yung Sheng 38% Color Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Yung Sheng Optical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 38% color contact lens for vision correction.


Eligibility criteria: Inclusion Criteria:

1. The subject must sign the informed consent form.
2. The subject must be at least 20 years of age as of the date of evaluation for the study.
3. The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
4. The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
5. The subject must have normal eyes, except ametropia.
6. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
7. The subject must appear able and willing to fill the daily card.

Exclusion Criteria:

1. The subjects who need to use ophthalmic medicine for therapy.
2. The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
3. The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
4. The subjects who have clinically significant tear secretion abnormal.
5. The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.

Primary outcomes:
measure: The effectiveness of corrected visual acuity
timeFrame: 3 Months
Secondary outcomes:
measure: Lens fitting (Lens position)
timeFrame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
measure: Lens fitting (Lens movement)
timeFrame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
measure: Lens fitting (Lens edge)
timeFrame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Other outcomes:
measure: Safety evaluation
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Yi-Yu Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Mei-Ling Peng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02743273: Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics
Official title: Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 37
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Preterm infants with gestational age\<32 weeks or birth weight\<1,500 g who enrolled our institutional prospective cohort study for biorepository.
2. Preterm infants with gestational age\<32 weeks or birth weight\< 1,500 g who need ibuprofen treatment for closing patent ductus arteriosus.

Brief summary: Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability.

Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level.

Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.


Eligibility criteria: Inclusion Criteria:

* Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital

Exclusion Criteria:

* Congenital heart disease
* Known major congenital anomalies of the kidney and urinary tract
* Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist

Primary outcomes:
measure: change the level of novel urinary biomarkers after ibuprofen administration
timeFrame: change from 1 day before ibuprofen administration to 1 day after ibuprofen administration
Secondary outcomes:
measure: The level of novel urinary biomarkers in initial urine
timeFrame: within 24 hours after birth
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Children's Hospital
name: Han-Suk Kim, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724473: A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris
Official title: A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2021-01-26
Enrollment: 1030
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.

Detailed description: A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Primary outcomes:
measure: Demonstration of Bioequivalence
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Catawba Research
name: Zaidoon A. Al-Zubaidy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01636973: Effects of Humidified Ventilation on Arterial Oxygenation and Respiratory Mechanics During One Lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation .


Eligibility criteria: Inclusion Criteria:

* ASA physical status class I,II
* Unilateral lung lobectomy
* Use of one-lung ventilation

Exclusion Criteria:

* COPD
* CAOD
* Unstable cardiovascular status
* Peak inspiratory pressure \> 30 mmHg

Primary outcomes:
measure: arterial oxygenation
timeFrame: T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation)
Secondary outcomes:
measure: Respiratory dynamic parameters
timeFrame: T1,T2,T3,T4 (same as 'primary outcome measure')
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University
name: Young Jun Oh, M.D.,PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT06215573: Effect of a Novel Melatonin Supplement on Sleep Quality
Official title: Effect of a Novel Melatonin Supplement on Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: melatonin
pharmacokinetics
sleep quality
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Ritual Inc.
First posted: 2024-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cross over trial counterbalanced for trial order
Primary purpose: BASIC_SCIENCE

Brief summary: Melatonin is a hormone naturally found in our body that increases in our blood at night and controls how we sleep. Melatonin can also be taken as a pill and numerous clinical trials have documented improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night.

The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Aged 18-40
* Sometimes have trouble sleeping (Pittsburgh sleep quality index score \>5)

Exclusion Criteria:

* Routinely taking melatonin supplements or other drugs known to affect sleep
* A diagnosed sleep disorder
* Major psychiatric illness
* Current physical injury
* Known or suspected hypersensitivity to melatonin
* Presence of major sleep disruptors at home (e.g. new born baby)
* Night shift/rotational-shift work
* Receiving non-pharmacological treatment for sleep disorder (e.g. cognitive behavioral therapy)
* Substance use disorder
* Recent (\<1 month) increase in daily caffeinated drink consumption
* Consuming \>14 standard alcoholic drinks per week
* Pregnant or lactating

Primary outcomes:
measure: Pharmacokinetic
timeFrame: 10 hours
measure: Sleep efficiency
timeFrame: 2 weeks
Secondary outcomes:
measure: Sleep diary
timeFrame: 2 weeks
measure: Recovery and well being
timeFrame: 2 weeks
measure: Sleep quality
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Francis B Stephens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059473: Treatment of Small Acute Cuff Tears, a Randomized Study
Official title: Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

Detailed description: In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery.

This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair.

Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.

Eligibility criteria: Inclusion Criteria:

* Trauma to the shoulder
* Full thickness cranial rotator cuff tear
* Operation possible within 3 months

Exclusion Criteria:

* 2 or more rotator cuff tendons involved
* Fracture
* Dislocation
* Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
* Malignancy
* Rheumatic disease
* Inability to understand swedish
* Substance abuse

Primary outcomes:
measure: Constant-Murley Shoulder Assessment score
timeFrame: Twelve months
Secondary outcomes:
measure: Western Ontario Rotator Cuff score
timeFrame: Twelve months
measure: MRI
timeFrame: Twelve months
Other outcomes:
measure: Euro-Qol-five-Dimensions (EQ-5D)
timeFrame: Twelve months
measure: Patient Global Impression of Change (PGIC)
timeFrame: Twelve months
Locations:
city: Linköping
country: Sweden
facility: Orthopedic Clinic, Linköping University Hospital
Study officials:
affiliation: Linkoeping University
name: Lars Adolfsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02816073: Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy
Official title: Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Lasers
Treatment Outcome
Lead sponsor: United Christian Hospital
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2016-06-28
Enrollment: 17
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 randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots


Eligibility criteria: Inclusion Criteria:

* All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November

Exclusion Criteria:

* significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
* any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
* those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
* clinically significant macular oedema on clinical examination.

Primary outcomes:
measure: Regression of neovascularization
timeFrame: 3 months
Secondary outcomes:
measure: Activity of neovascularization
timeFrame: 3 months
measure: Best corrected visual acuity
timeFrame: 1 week, 1 month, 3 months, 6 months
measure: Complications
timeFrame: 1 week, 1 month, 3 months, 6 months
measure: Central foveal thickness
timeFrame: 1 week
measure: Retreatment rate
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: United Christian Hospital; The University of Hong Kong
name: Kenneth KW Li, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05052073: Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Various Forms of Skeletal Muscle Dystrophy
Keywords: muscle dystrophy
energy metabolism
calorimetry
metabolic chamber
microdialysis
exercise
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * out-patient clinic at Charité Universitätsmedizin Berlin, Campus Buch
* University Campus of Charité Universitätsmedizin Berlin

Brief summary: The aim of this project to characterize systemic and organ-specific (subcutaneous adipose tissue and skeletal muscle) metabolic responses at rest and during standardized, moderate exercise after an oral glucose load in patients with various geneticaly heritable foms of skeletal muscle dystrophies. Metabolic responses will be monitored by indirect calorimetry (canopy and/or metabolic chamber at rest and during exercise) and microdialysis (adipose tissue and skeletal muscle at rest) before and after an oral glucose load (75 g).


Eligibility criteria: Inclusion Criteria:

* controls: healthy, no metabolic, endocrine, neurologic or other diseases
* patients: genetically confirmed diagnosis of muscle dystrophy

Exclusion Criteria:

* known hemorrhagic diseases / coagulopathies
* intake of oral anti-coagulant drugs (control of PTT, INR and platelet count before study entry)
* insulin-dependent Diabetes mellitus
* pregnancy and lactation period
* chronic use of non-steroidal antiphlogistics
* alcohol and drug abuse
* Claustrophobia • gleichzeitige Teilnahme an einer anderen Studie; Teilnahme an einer Studie vor weniger als zwei Monaten Unfähigkeit, die mündlichen und schriftlichen Informationen zur Studie zu verstehen und das schriftliche Einverständnis zu geben

Primary outcomes:
measure: muscle dialysate lactate
timeFrame: 15 minutes intervals after glucose over three hours
measure: muscle dialysate pyruvate
timeFrame: 15 minutes intervals after glucose over three hours
Secondary outcomes:
measure: muscle tissue perfusion
timeFrame: 15 minutes intervals after glucose over three hours
measure: energy expenditure
timeFrame: 15 minutes intervals after glucose over three hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, ECRC
Study officials:
References: