louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05148689: A Study Comparing Oxymetazoline 1% Cream to RHOFADE
Official title: A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: randomized, double-blind, placebo controlled

Detailed description: Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
2. Provided IRB approved written informed consent;
3. A CEA score of ≥3 prior to study drug application
4. A PSA score of ≥3 prior to study drug application

Exclusion Criteria:

1. Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
2. History of hypersensitivity to the study product;
3. Presence of ≥3 facial inflammatory lesions of rosacea;
4. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
5. Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;
7. Presence of significant hypertension or circulatory disease

Primary outcomes:
measure: erythema response success
timeFrame: 21 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: WAYcro
state: Texas
Study officials:
affiliation: WayCro / Trial Clinsultants
name: Kelly Walker
role: STUDY_CHAIR
References:
Clinical trial NCT06898489: Adjunctive Yu-Tone Music Therapy for Systemic Lupus Erythematosus: a Prospective Cohort Study
Official title: Traditional Chinese Five-Tone Therapy As an Adjunctive Treatment for Systemic Lupus Erythematosus: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Systemic Lupus Erythematosus
Music Therapy
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
First posted: 2025-03-27
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population are Chinese

Brief summary: The goal of this observational study is to investigate the long-term adjunctive effects of Traditional Chinese Five-Tone Therapy (Yu Tone) in patients with systemic lupus erythematosus (SLE). The main question it aims to answer is:

Does Yu-tone music therapy improve psychological well-being and quality of life in SLE patients when used as a complementary intervention alongside standard pharmacotherapy? Participants already receiving Yu-tone music therapy as part of their integrative care for SLE will complete validated online questionnaires assessing psychological distress (e.g., anxiety, depression), disease-related quality of life, and medication adherence monthly for 2 years.


Eligibility criteria: Inclusion Criteria:

* Meet the 2019 ACR/EULAR classification criteria for SLE; ② Adults aged 18 years or older; ③ Provide informed consent to participate in the study.

Exclusion Criteria:

* Presence of severe organ dysfunction (e.g., renal failure, cardiac insufficiency) or psychiatric disorders; ② Diagnosed with hearing impairment or auditory disorders; ③ Inability to comprehend or complete study questionnaires (e.g., due to cognitive impairment or language barriers).

Primary outcomes:
measure: SLEDAI score
timeFrame: From enrollment to the treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou, 310053, China.
Study officials:
References:
Clinical trial NCT01721889: Radiostereometric Analysis of Spine Arthrodesis
Official title: Radiostereometric Analysis of Spine Arthrodesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: OAD Orthopaedics
Sponsor class: OTHER
Collaborators: name: Halifax Biomedical Inc.
name: Central DuPage Hospital
First posted: 2012-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 and 75 that are diagnosed with lumbar DDD (L1-L5, and also L5-S1) and scheduled for one or multi level spinal fusion surgery will be recruited for the study.

Brief summary: The primary objective of this pilot study is to determine the precision of post-operative radiostereometric measurements for the assessment of lumbar spinal fusion. This study will also determine the potential for RSA as a more precise and accurate means for assessment of lumbar spinal fusion and diagnosis of pseudarthrosis.


Eligibility criteria: Inclusion Criteria:

* Symptomatic degenerative disc disease of the lumbar spine indication surgical intervention
* Scheduled to undergo lumbar fusion surgery
* Patients between the ages of 18 and 75
* Ability to give informed consent

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Intervertebral motion post-op lumbar fusion
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Warrenville
country: United States
facility: OAD Orthopaedics
state: Illinois
Study officials:
affiliation: OAD Orthopaedics
name: John Andreshak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05876689: Swept Source OCT Imaging With the DREAM VG-OCT
Official title: Swept Source OCT Imaging With the DREAM VG-OCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Myopia
Glaucoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will be imaging 100 eyes (50 patients unless there are monocular patients) from all genders and ethnic backgrounds who are moderate-high myopes with or without the diagnosis of glaucoma.

Brief summary: The Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. The intention of this study is to see how the images differ on the same patients when compared to the Cirrus OCT and to test for the repeatability of the images on a single day.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18
* Myopes with a current or previously documented spherical equivalent refraction \< -4D
* At least half of the subjects should have had at least one Cirrus OCT RNFL and macula performed as well as a Humphrey visual field performed in those with OCT abnormalities

Exclusion Criteria:

* Unable to comply with study imaging
* unclear ocular media
* Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.

Primary outcomes:
measure: Assessing difference in intraocular structures
timeFrame: Baseline
measure: Assessing difference in intraocular vascular structures
timeFrame: Baseline
Secondary outcomes:
measure: Assessing repeatability of scans
timeFrame: Baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute
state: California
Study officials:
affiliation: Stanford University
name: Robert Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04749589: Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy
Official title: Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Iron Deficiency Anemia
Colorectal Cancer
Fatigue
Quality of Life
Cognitive Impairment
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: see inclusion criteria

Brief summary: The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.

Detailed description: Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.

The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.

Eligibility criteria: Inclusion Criteria:

* patients in whom endoscopy has raised suspicion of colorectal malignancy

Exclusion Criteria:

* non fluent in Danish language
* cerebral impairment (ex severe dementia) so that informed consent can not be obtained

Primary outcomes:
measure: Fatigue
timeFrame: up to one months after inclusion
Secondary outcomes:
measure: Quality of life
timeFrame: up to one months after inclusion
measure: Cognitive ability
timeFrame: up to one months after inclusion
measure: endurance
timeFrame: up to one months after inclusion
measure: peripheral muscular strengths
timeFrame: up to one months after inclusion
measure: mobility and balance
timeFrame: up to one months after inclusion
Other outcomes:
measure: post-operative run
timeFrame: 30-days postoperatively
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Sønderjylland
state: Region Of Southern Denmark
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland
state: Region Of Southern Denmark
city: Grindsted
country: Denmark
facility: Hospital of South West Jutland
state: Region Of Southern Denmark
Study officials:
affiliation: Institute of regional health research, regional of southern denmark
name: Torben Knudsen, ass. prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00844389: Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy
Official title: Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Open Angle Glaucoma
Keywords: Open Angle Glaucoma
Biophotomodulation
Near to Infrared light stimulation
Neuroprotection
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2009-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.

Detailed description: Ganglion cell dysfunction in glaucomatous optic neuropathy has been ascribed to ganglion cell electrophysiological inactivation and to apoptotic cell death. Near-to-infrared light stimulation has been used to induce mitochondrial activation and to prevent apoptotic death through mitochondrial cytochrome oxidase c stimulation. Near-to-infrared light stimulation might be useful to induce ganglion cell activation and inhibit apoptotic cell death.

We propose that near-to-infrared light stimulation can be used as an adjuvant treatment combined with ocular hypotensive treatment in glaucomatous patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnose of Ocular Hypertension (cup to disk ratio 0,6 or less, normal Humphrey 24-2 visual field with aplanatic IOP over 21 mmHg) or Mild Glaucoma (cup to disk ratio 0,6 to 0,8, characteristic Humphrey 24-2 visual field defect PSD between 3 and 6 dB).
* Visual acuity 20/40 or better

Exclusion Criteria:

* Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
* Refractive error of 3 diopters or more

Primary outcomes:
measure: Pattern electroretinogram response
timeFrame: Every two weeks for 4 months
Secondary outcomes:
measure: OCT ganglion cell layer average thickness, Visual Field defects
timeFrame: Every month for four months
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Servicio de Oftalmología Hospital Van Buren
Study officials:
affiliation: Universidad de Valparaiso
name: Tatiana E Cevo, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Valparaiso
name: Adrian Palacios, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04637789: The Whole Body Vibration for Sarcopenic Hospitalized Patients Aged 80+ Years
Official title: Effectiveness of The Whole Body Vibration for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 80
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resistance training have been recommended for sarcopenic patients. However, the whole body vibration training would further benefit for sarcopenic patients on the basis of resistance training remains unclear. The purpose of this study is to explore the effect of the whole body vibration training on improving the mobility of elderly patients with sarcopenia. The whole body vibration involves different frequencies that can improve muscle strength and keep aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.


Eligibility criteria: Inclusion Criteria:

* Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
* Agree to participant this study and sign the informed consent
* Aged 80 years or over

Exclusion Criteria:

* Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
* Severe heart and lung diseases;
* Renal insufficiency;
* Any type of tumor;
* Bedridden patients

Primary outcomes:
measure: The change of activities of daily living
timeFrame: 3 Months
Secondary outcomes:
measure: The change of usual gait speed
timeFrame: 3 Months
measure: The change of handgrip strength
timeFrame: 3 Months
measure: The change of the score of Short Physical Performance Battery
timeFrame: 3 Months
measure: The change of the score of Timed Up and Go test
timeFrame: 3 Months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: ming Yang
role: STUDY_DIRECTOR
affiliation: West China Hospital
name: jiaojiao Jiang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05273489: Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases.
Official title: Effect of Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases. A Single-centre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Metastatic
Liver Metastases
Lead sponsor: Hospital Maciel
Sponsor class: OTHER
Collaborators: name: University of Adelaide
First posted: 2022-03-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Australian citizens (most of them locals) treated at The Queen Elizabeth Hospital, Adelaide, SA.

Brief summary: Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.

Detailed description: This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020

Exclusion Criteria:

* Patients whose procedures were abandoned due to unresectable tumour burden

Primary outcomes:
measure: Recurrence
timeFrame: From surgery to recurrence, up to 16 years
measure: Survival
timeFrame: From surgery to death or end of the study, up to 16 years
Secondary outcomes:
measure: Resection margins
timeFrame: From surgery to death or end of the study, up to 16 years
measure: Neoadjuvant Chemotherapy
timeFrame: From surgery to death or end of the study, up to 16 years
Other outcomes:
Locations:
Study officials:
affiliation: Assitant Professor at Clinica Quirurgica 3. Universidad de la Republica. Monteviedo, Uruguay
name: Mauro A Perdomo, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02301689: SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register
Official title: SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure (HF)
Keywords: Heart failure
Chronic heart failure
Sleep disordered breathing
Sleep apnea
Positive Airway Pressure
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2014-11-26
Enrollment: 4749
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients with Heart failure (HF). HF is defined as a symptom complex of shortness of breath and rapid fatigability on the basis of cardiac disease (World Health Organisation).

Brief summary: The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions:

How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?


Eligibility criteria: Inclusion Criteria:

* diagnose chronic heart failure, at least 3 months prior to diagnosis
* Age 18 years
* Signed informed consent

Exclusion Criteria:

* Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy
* Lack of capacity to consent
* minors
* persons who are housed on judicial or administrative order in an institution
* pregnant and lactating women

Primary outcomes:
measure: Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)
timeFrame: 5 years
Secondary outcomes:
measure: Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment
timeFrame: 5 years
measure: Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment
timeFrame: 5 years
measure: Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours
timeFrame: 5 years
measure: Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing
timeFrame: 5 years
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Centre
state: North Rhine-Westphalia
Study officials:
affiliation: Heart and Diabetes Centre NRW
name: Olaf Oldenburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01298089: A Study of Flap Thickness Results Using the Carriazo Pendular Microkeratome - 130 Micrometers Head.
Official title: LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Flap Thickness (Micrometers)
Keywords: Flap
LASIK
Corneal
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to LASER refractive correction at the Eye Institute of Thrace, Democritus University

Brief summary: A study of flap thickness predictability in patients submitted to Laser in Situ Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).


Eligibility criteria: Inclusion Criteria:

* LASIK candidates treated with the Carriazo-Pendular microkeratome - 130 micron head

Exclusion Criteria:

* corneal irregularities \> 3D
* Thin corneal CCT \< 460μm
* Active anterior segment disease
* Previous intraocular or corneal surgery
* History of herpetic eye disease
* Corneal scarring
* Glaucoma
* Severe dry eye
* Topographic evidence of keratoconus

Primary outcomes:
measure: Corneal flap thickness (micrometers)
timeFrame: 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Eleftherios Paschalis
state: Euros
Study officials:
References:
citation: Paschalis EI, Aristeidou AP, Foudoulakis NC, Razis LA. Corneal flap assessment with Rondo microkeratome in laser in situ keratomileusis. Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):289-95. doi: 10.1007/s00417-010-1433-7. Epub 2010 Jun 25.
citation: Alio JL, Pinero DP. Very high-frequency digital ultrasound measurement of the LASIK flap thickness profile using the IntraLase femtosecond laser and M2 and Carriazo-Pendular microkeratomes. J Refract Surg. 2008 Jan;24(1):12-23. doi: 10.3928/1081597X-20080101-03.
citation: Kymionis GD, Portaliou DM, Tsiklis NS, Panagopoulou SI, Pallikaris IG. Thin LASIK flap creation using the SCHWIND Carriazo-Pendular microkeratome. J Refract Surg. 2009 Jan;25(1):33-6. doi: 10.3928/1081597X-20090101-06.