louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06004570: Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Official title: Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Abnormalities
Keywords: Retinal cells
Ocular diseases
Blue-light
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.

Detailed description: Randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life Questionnaire. The studied parameters will be measured before and after supplementation.

Eligibility criteria: Inclusion Criteria:

* Women and men, 25-45 years old.
* Signed informed consent.
* Volunteers who do not use glasses or contact lenses.
* Volunteers exposed to blue light for at least 6 - 8 hours a day.

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins.
* Participation in another clinical trial.
* Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
* Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).
* Current use of eye drops in the treatment of ocular diseases.
* Ocular diseases.

Primary outcomes:
measure: DEQS (Dry Eye-Related Quality-of-Life) index
timeFrame: Baseline, 6 weeks
measure: Visual Analogue Scale
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Optical Coherence Tomography
timeFrame: Baseline, 6 weeks
measure: Amsler test
timeFrame: Baseline, 6 weeks
measure: Schirmer test,
timeFrame: Baseline, 6 weeks
measure: Computerized Perimetry
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Centrum Zdrowia Eter-Med sp. z o.o.
Study officials:
References:
Clinical trial NCT06584370: Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation
Official title: Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Left Atrial Appendage Ligation
Pericardium
Epicardial Mapping
Heart Atria
Cardiac Surgical Procedures
Cardiac Catheterization
Pneumopericardium
Left Atrial Appendage Occlusion
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.

Detailed description: The Lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation. Subxiphoid needle access to the pericardium (a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone) during Lariat risks injury to the heart surface that requires surgical repair.

In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium. Before needle access, the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole. The investigators then inject gas to push the heart away from the pericardial needle. This reduces the risk of injuring the heart during the standard Lariat procedure.

Eligibility criteria: Inclusion Criteria:

* Undergoing subxiphoid access to the "empty" pericardial space as part of a Lariat left atrial appendage exclusion procedure
* Age ≥ 21 years

Exclusion Criteria:

• Does not consent to participate

Primary outcomes:
measure: Successful subxiphoid needle access without myocardial injury
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
citation: Cohn WE, Winkler JA, Tuzun E, Hjelle A, Bassett K, Ahmad A, Frazier OH. Contrast pericardiography facilitates intrapericardial navigation under fluoroscopy. Ann Thorac Surg. 2010 Nov;90(5):1537-40. doi: 10.1016/j.athoracsur.2010.06.025.
citation: Rogers T, Ratnayaka K, Schenke WH, Faranesh AZ, Mazal JR, O'Neill WW, Greenbaum AB, Lederman RJ. Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access. Catheter Cardiovasc Interv. 2015 Aug;86(2):E111-8. doi: 10.1002/ccd.25698. Epub 2014 Oct 28.
Clinical trial NCT02410070: A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
Official title: A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Frykman Type II Fracture of Right Radial Head
Keywords: Distal radial fracture
pronator quadratus
mini-approach
volar plating
open reduction and internal fixation
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

Detailed description: The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P \< 0.05 was statistically significant.

Eligibility criteria: Inclusion Criteria:

* Fernandez type II-IV radial fractures.

Exclusion Criteria:

* Fernandez type I radial fracture.
* Fernandez type V radial fracture.
* Open radial fractures.
* Surgery using K-wires or screws alone.
* The use of external fixators.
* multiple fractures, pathological fracture.

Primary outcomes:
measure: range of motion of the wrist
timeFrame: 2 years
Secondary outcomes:
measure: grip strength of the hand
timeFrame: 2 years
measure: pronation strength of the forearm
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Qinhunangdao
name: Xu Zhang, MD
role: STUDY_CHAIR
References:
citation: Skouras E, Hosseini Y, Berger V, Wegmann K, Koslowsky TC. Operative treatment and outcome of unstable distal radial fractures using a palmar T-miniplate at a non-specialized institution. Strategies Trauma Limb Reconstr. 2013 Nov;8(3):155-60. doi: 10.1007/s11751-013-0170-y. Epub 2013 Aug 6.
citation: Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.
Clinical trial NCT02779270: Test the Outdoor Usage for Sunscreen Products in Female Adults
Official title: Supervised Outdoor -Use Test for Sunscreen Products in Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the safety of a sunscreen product when used outdoor.


Eligibility criteria: Inclusion Criteria:

* Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
* Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
* Subjects must agree to restrict their sun exposure activities for at least five days.
* Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.

Exclusion Criteria:

* Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
* Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
* Subjects must not have significantly tanned skin.
* Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.

Primary outcomes:
measure: Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
timeFrame: After approximately three hours direct sun-exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00699270: A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Official title: A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Humeral Fractures
Keywords: Total Shoulder Arthroplasty
Total Shoulder Replacement
Shoulder Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 0
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: Patients that have already made the decision to undergo shoulder replacement surgery and will receive a Biomet humeral stem.

Brief summary: The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems


Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid Arthritis
* Correction of functional deformity

Exclusion Criteria:

Absolute contraindications:

- Infection, Sepsis, and Osteomyelitis

Relative contraindications:

* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
* Osteoporosis
* Metabolic disorders which may impair bone function
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

Primary outcomes:
measure: UCLA End Result Score
timeFrame: 3 months, 6 months, 1 year, 3 years, 5 years
measure: X-rays
timeFrame: 3 month, 1 year, 3 years, 5 years
Secondary outcomes:
measure: Incidence of revisions and removals
timeFrame: Any time
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research, Biomet Orthopedics, LLC
name: Kenneth J Beres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04397770: Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma
Official title: Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma：a Single-center, Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.


Eligibility criteria: Inclusion Criteria:

1. age:18-75 years, male or female.
2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
3. Has not received any systematic anti-tumor drug treatment.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 12 weeks.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in charge.

Primary outcomes:
measure: ORR
timeFrame: Through study uncompletion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03450070: Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100
Official title: Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Sensitization
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patch Testing for device cream on human subjects


Eligibility criteria: Inclusion Criteria:

* Male or Female
* 18+ years
* Good health
* Signed and datad Informed Consent
* Signed and dated HIPAA

Exclusion Criteria:

* On test at any other research lab or clinic
* Known allergy or sensitivity to cosmetics or toiletries
* Pre-existing other medical conditions
* Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
* Chronic medication which could affect the outcome of the study
* Known pregnant or nursing women
* Cancer diagnosis within the past 5 years

Primary outcomes:
measure: Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
timeFrame: approximately 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
facility: Harrison Research Laboratories
state: New Jersey
Study officials:
References:
Clinical trial NCT00690170: Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects
Official title: Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: ketamine
nicotine
schizophrenia
cognitive deficits
P300 oddball paradigm
Mismatch Negativity
P50 gating
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the interactive effects of ketamine and nicotine.


Eligibility criteria: Inclusion Criteria:

* 18-50 years old
* Smokers

Primary outcomes:
measure: ERP recording procedures: Brain wave activity during tasks involving in processing auditory and visual stimuli with different degrees of attentional and memory demands will be recorded.
timeFrame: +65
measure: IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function.
timeFrame: +25
measure: Positive and Negative Syndrome Scale will be used to measure psychotic symptoms.
timeFrame: -90, +10, +105, +180
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Veterans Administration Hospital
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Department of Psychiatry
name: Deepak C D'Souza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Souza DC, Ahn K, Bhakta S, Elander J, Singh N, Nadim H, Jatlow P, Suckow RF, Pittman B, Ranganathan M. Nicotine fails to attenuate ketamine-induced cognitive deficits and negative and positive symptoms in humans: implications for schizophrenia. Biol Psychiatry. 2012 Nov 1;72(9):785-94. doi: 10.1016/j.biopsych.2012.05.009. Epub 2012 Jun 19.
Clinical trial NCT01584570: The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: dexmedetomidine
heart rate variability
QTc interval
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.


Eligibility criteria: Inclusion Criteria:

* patient who are regarded as ASA class I
* age 20 to 60
* patient scheduled for Intubation for surgery

Exclusion Criteria:

* QTc interval \> 440 ms
* arrythmia
* Patient who is taking a medicine which effects QTc interval
* HTN
* DM
* renal disease
* hepatic disease
* pregnant
* illiterate

Primary outcomes:
measure: Change of QTc interval
timeFrame: T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT02954770: Long-term Usage of the Fitbit® Among Medical Residents
Official title: Fitbit® Challenge: Can we Motivate Residents to Improve Their Physical Well Being?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Fitbit® Use
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All TriHealth residents

Brief summary: This is a one year follow up survey study after a Fitbit® challenge study to determine if wearing a Fitbit® motivates residents to increase their physical activity. This study seeks to determine if residents continue to use the Fitbit® after one year.

Detailed description: Medical training is notoriously stressful. The combination of long work hours, sleep deprivation, clinical responsibilities, and academics leaves little time for residents and fellows to consider their own health maintenance, particularly with regards to physical activity. This is problematic for both the physician and the physician's patients. Numerous studies have shown that physicians who exercise regularly and maintain normal body mass are more likely to counsel their patients on these issues. Additionally, they are more experienced in the benefits of exercise and can counsel their patients on how to incorporate exercise into a busy schedule. This is a one year follow up survey study after a Fitbit® challenge study among TriHealth residents. The purpose of the initial Fitbit® challenge study was to to determine if wearing a Fitbit® motivates residents to increase their physical activity. This study seeks to determine the long-term usage of the Fitbit®.

Eligibility criteria: Inclusion Criteria:

* Residents in training 18 years of age or older
* Residents who participated the initial Fitbit® challenge study

Exclusion Criteria:

* Physical impairment inhibiting the ability to walk or complete the validated questionnaires

Primary outcomes:
measure: Status of Fitbit® use - descriptive measure
timeFrame: One year after the initial Fitbit® challenge study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References: