louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06468540: Combination of Micropulse Laser With or Without Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Official title: Comparative Study on the Efficacy of the Combination of Micropulse Laser With or Without Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinal Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Central Serous Chorioretinopathy
Micropulse Laser
Photodynamic Therapy
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient diagnosed with chronic central serous chorioretinopathy with a history of more than 6 months, who received single micropulse laser therapy or micropulse laser combined with drug-free photodynamic therapy.

Brief summary: In this study, patients with chronic central serous chorioretinopathy who were treated by micropulse laser alone or micropulse laser combined with photodynamic therapy without drugs are retrospectively included. The visual acuity changes, subretinal fluid absorption and choroidal characteristics of the two groups are compared 1 to 6 months after treatment. We will also analyze baseline characteristics that influence post-treatment outcomes to identify potential predictors of poor treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* The patient diagnosed with chronic central serous chorioretinopathy with a history of more than 6 months. The diagnostic criteria for chronic CSC were as follows: FFA examination showed leakage of strong fluorescent spots with the extension of angiography time, and late fluorescence accumulation, accompanied by decreased central vision, darkening of vision, and deformable microopia. Fundus examination showed superficial detachment of retinal neuroepithelium in macula.
* Patients received single micropulse laser therapy or micropulse laser combined with drug-free photodynamic therapy, and had not received other laser or surgical treatment in the six months prior to treatment.
* Patients had follow-up data before and after treatment for 1 month and at least 6 months.

Exclusion Criteria:

* Patients with other fundus diseases or refractive interstitial opacity.
* During treatment, other treatments other than micropulse laser or drug-free photodynamic therapy were received.
* Various reasons led to incomplete patient data.

Primary outcomes:
measure: BCVA
timeFrame: 1 month and 6 months
measure: CRT
timeFrame: 1 month and 6 months
Secondary outcomes:
measure: SFCT
timeFrame: 1 month and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03925740: MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.
Official title: The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prevention
Keywords: caries
interproximal caries
MI varnish
PreviDent varnish
Fluoride
1.23% APF Fluoride
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.

Detailed description: The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).

Eligibility criteria: Inclusion Criteria:

1. Patient is 7-10 mixed dentition
2. Patients with any incipient non cavitated posterior proximal caries
3. Patients with any incipient non cavitated anterior proximal cariesanterior
4. ICDAS Score 1 or 2

Exclusion Criteria:

1. Any patients with any serious chronic medical problem.
2. caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity
3. history of proximal restorations
4. history of resin infiltrate
5. ICDAS score of proximal caries more than two clinically or radiographically.

Primary outcomes:
measure: Radiographic outcome
timeFrame: 1 year
Secondary outcomes:
measure: Clinical examination
timeFrame: 1 year
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Adbulaziz University Dental Hospital
state: Makkah
Study officials:
affiliation: King Abdulaziz University
name: Heba J Sabbagh, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02771340: Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Official title: A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uveal Melanoma
Choroid Neoplasm
Lead sponsor: Iconic Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.


Eligibility criteria: Inclusion Criteria:

* Males or females of any race at least 18 years of age
* Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
* Planned enucleation or brachytherapy of the study eye due to uveal melanoma

Exclusion Criteria:

* Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
* Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
* Woman who is pregnant or lactating

Primary outcomes:
measure: Occurrence of Adverse Events
timeFrame: 30 days (plus or minus 5 days) after surgical procedure
Secondary outcomes:
measure: Changes in Plasma Levels of ICON-1.
timeFrame: Baseline to 1 day after last dose of ICON-1
measure: Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study
timeFrame: Baseline to on or 1 day prior to surgical procedure day
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Leawood
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Iconic Therapeutics, Inc.
name: Gabriela Burian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02368340: A Longitudinal Study of Hermansky-Pudlak Syndrome Pulmonary Fibrosis
Official title: A Longitudinal Study of Hermansky-Pudlak Syndrome Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hermansky Pudlak Syndrome
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-02-23
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with diagnosis of Hermansky-Pudlak Syndrome

Brief summary: Hermansky-Pudlak Syndrome (HPS) is a rare genetic disease that is associated with oculocutaneous albinism, bleeding, granulomatous colitis, and pulmonary fibrosis in some subtypes, including HPS-1, HPS-2, and HPS-4. Pulmonary fibrosis causes shortness of breath and progressive decline in lung function. In HPS patients with at-risk subtypes, almost all adults eventually develop fatal pulmonary fibrosis unless they undergo lung transplantation.

The purpose of this study is to identify the earliest measurable pulmonary disease activity in individuals at-risk for HPS pulmonary fibrosis. The study also aims to develop biomarkers that will aid in understanding of the causes of HPS pulmonary fibrosis and facilitate more rapid conduct of therapeutic trials in HPS patients with mild pulmonary disease in the future.


Eligibility criteria: Inclusion Criteria:

* Individuals ages 12-90 years with confirmed diagnosis of HPS as defined by verification of reduced or absent platelet dense granules by electron microscopy and/or genetic diagnosis
* Ability to provide informed consent, or consent of parent/guardian and assent for minors

Exclusion Criteria:

* Status-post lung transplantation
* Perceived unsuitability for participation in the study in the opinion of the investigator

Primary outcomes:
measure: Chest CT scan
timeFrame: change in CT Scan from baseline to 2.5 years
Secondary outcomes:
measure: Pulmonary function test
timeFrame: change in PFTs from baseline to 2.5 years
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital, Harvard
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Lisa R. Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763940: Efficacy of OmegaBoost to Increase Omega-3 Levels in Healthy Individuals
Official title: Efficacy of OmegaBoost to Increase Omega-3 Levels Particularly Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) in Healthy Individuals as Compared to the Leading Omega-3 Softgel and the Leading Omega-3 Gummy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Age-Related Macular Degeneration
Omega 3 Index
Keywords: Omega-3s
Docosahexaenoic acid
DHA
Eicosapentaenoic acid
EPA
OmegaBoost
Omega Index test
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Guardion Health Sciences, Inc.
First posted: 2023-03-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel treatment group participants will be randomly assigned either the experimental interventions;
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine increases in the Omega Index test indicating optimal Omega-3s particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels for overall systemic benefits including healthy cardiovascular health and cholesterol levels as shown in the OmegaIndex (OmegaQuant) research.


Eligibility criteria: Inclusion Criteria:

* not currently taking Omega-3 supplements or fish oils
* able to swallow softgel or chew gummies nutritional supplement daily for a 12 week period
* able to make four (4) follow-up visits

Exclusion Criteria:

* allergy to fish or seafood
* h/o Atrial fibrillation, or at risk of Afib
* h/o congestive heart failure, heart disease, or prior myocardial infarction and/or cerebrovascular accident
* noncompliance with study requirements

Primary outcomes:
measure: Mean Changes in Omega-3 Index (OmegaQuant)
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Mean Changes in omega 3 to omega 6 ratios
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes:
measure: Mean Changes in General Health Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Mean changes to Hb a1c with Omega Boost supplementation
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Mean changes to total cholesterol with Omega Boost supplementation
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Mean changes to low-density lipoprotein with Omega Boost supplementation
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Mean changes to high-density lipoprotein with Omega Boost supplementation
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Mean changes to triglycerides with Omega Boost supplementation
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
Study officials:
affiliation: Western University of Health Sciences
name: Pinakin Gunvant Davey, PhD, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03414840: Assessment of Change in Atherosclerotic Plaque by Serial CCTA
Official title: Assessment of Change in Atherosclerotic Plaque by Serial CCTA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Arteriosclerosis
Keywords: coronary artery disease
coronary computed tomography angiography
statins
coronary atherosclerosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Chong Kun Dang Pharmaceutical Corp.
First posted: 2018-01-30
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent clinically indicated CCTA and confirmed to have coronary atherosclerosis will be enrolled.

Brief summary: Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a prospective observational study which aim is to demonstrate the effect of statins on coronary atherosclerosis, assessed by quantitative analysis of CCTA.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent clinically indicated CCTA (index CCTA)
* Mild to moderate stenosis (25-69%) on CCTA
* ≥1 clinical risk factors (Smoking, HTN, HDL\<40, Premature FHx, M ≥45, F ≥55) for CAD

Exclusion Criteria:

* Acute coronary syndrome (unstable angina or MI)
* Positive (not equivocal) stress test
* Contraindications to statin

Primary outcomes:
measure: Difference in percent change of total atheroma volume assessed by CCTA between statin-taking and statin-naïve group
timeFrame: 24 months
Secondary outcomes:
measure: Change of total atheroma volume at 24 months compared with baseline total atheroma volume
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University
name: Hyuk-Jae Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06186440: Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma
Official title: Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme of Brain
Keywords: Glioblastoma MGMT promoter unmethylation
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temozolomide provided significant and clinically meaningful benefit in MGMT gene promoter methylation glioblastoma. However, in unmethylated patients, the effect of Temozolomide is limited. The aim of this study is to compare the effect of Cisplatin plus Temozolomide and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma

Detailed description: 60 Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.

60 patients were randomly divided into two groups and compared the difference of efficacy between the two groups

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma no cerebrospinal fluid and distant metastatic disease. adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* younger than 18 years; with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities

Primary outcomes:
measure: Overall survival
timeFrame: 1 YEAR
Secondary outcomes:
measure: PFS
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02823340: Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Axillary Hyperhidrosis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment. Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and 24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients before and after treatment. The satisfaction and adverse reactions of the research participants were recorded at every follow-up visit.

Detailed description: Hyperhidrosis Disease Severity Scale (HDSS)Score = 1 My sweating is never noticeable and never interferes with my daily activitiesScore = 2 My sweating is tolerable but sometimes interferes with my daily activitiesScore = 3 My sweating is barely tolerable and frequently interferes with my daily activitiesScore = 4 My sweating is intolerable and always interferes with my daily activities

Eligibility criteria: Inclusion Criteria: Meet the following conditions

* Diagnosed according to having a score of 3 or 4 on a Hyperhidrosis Disease
* Severity Scale (HDSS);
* Patients aged 18 to 40 years (to the date of screening);
* Not treatment in Axillary area before;
* Understanding the whole process of the study, voluntary participation and signed the informed consent;
* Patient compliance is good, can guarantee in course of observation.

Exclusion Criteria:One of the following is not included in this study:

* Pregnant women, ready to pregnant or lactating women;
* Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
* Need insulin control of diabetes; High blood pressure did not get good controller ;
* Patients with white blood cells \<4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets \<100 × 109 / L, or other blood disease;
* Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
* Patients suffering from malignant tumor;
* Patients suffering from acute and chronic infectious diseases;
* Mental disorders, history of alcohol abuse, drug or other substance abuse;
* Other cases which researchers believe that can not enroll.

Primary outcomes:
measure: The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: The improvement of visual analog scale(VAS) by patient
timeFrame: 0 week, 4weeks, 8weeks, 24 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospitial
state: Shaanxi
Study officials:
References: