louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05927428: Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
Official title: An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neurotrophic Keratitis
Lead sponsor: BRIM Biotechnology Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, Randomized Study
Primary purpose: TREATMENT

Brief summary: The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);

Exclusion Criteria:

* Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK;
* Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;

Primary outcomes:
measure: Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
timeFrame: at or before 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leland
country: United States
facility: Wilmington Eye
state: North Carolina
Study officials:
References:
Clinical trial NCT01322828: Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures
Official title: Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Bicep Tendon Rupture
Keywords: Bicep
Tendon
Distal
Ruptures
Randomized
Surgery
Lead sponsor: Hand and Upper Limb Clinic, Canada
Sponsor class: NETWORK
First posted: 2011-03-25
Enrollment: 92
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: The purpose of this study to to determine whether a single incision technique or a double incision technique is more effective in the surgical treatment of distal bicep tendon ruptures. Patients will be randomized to one of the two techniques upon consenting to the study. Prior to surgery patients will have their elbow flexion, extension, pronation, and supination strength measured. Elbow Range of motion will also be measured in each of these four movements. A number of subjective questionnaires will also be administered to the patient prior to surgery. The identical objective tests and subjective questionnaires will be completed by the patient at intervals of three months, six months, one year, and two years following their surgery. Additional information from patients clinical visits may also be collected throughout the study.


Eligibility criteria: Inclusion Criteria:

* Complete rupture of the Distal Bicep tendon
* Acute bicep tendon rupture (\< 10 days since rupture)
* 18 years of age and older

Exclusion Criteria:

* Partial rupture of the Distal Bicep tendon
* Chronic bicep tendon Ruptures (\>10 days since rupture)
* Under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Hand and Upper Limb Centre, St. Joseph's Health Care
state: Ontario
city: London
country: Canada
facility: Hand and Upper Limb Centre
state: Ontario
Study officials:
affiliation: Hand and Upper Limb Centre, St Joseph's health Care
name: Joy MacDermid, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01646528: The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
Official title: The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Intestinal Metaplasia
Keywords: Gastric Intestinal Metaplasia
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without any disease of heart, liver or kidney.

Brief summary: The study aims to:

1. Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE).
2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.

Detailed description: Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.

Eligibility criteria: Inclusion Criteria:

* Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.

Exclusion Criteria:

* Patients who are allergic to fluorescein sodium
* Patients who are unwilling to sign or give the informed consent form
* Patients with impaired cardiac, liver or renal function
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding

Primary outcomes:
measure: Accuracy of black spots in diagnosis of gastric intestinal metaplasia
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital
name: Yanqing Li, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00457028: Efficacy of Treatment for Obsessive Compulsive Disorder
Official title: Efficacy of Treatment for Obsessive Compulsive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
Anxiety
Treatment efficacy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the study will be recruited from individuals receiving treatment at the Anxiety Disorders Clinic of UBC Hospital.

Brief summary: The purpose of these questionnaires is to give us an overview of how OCD has affected your life and perhaps also to give us some clues about things that may have set you up to experience OCD.

Detailed description: For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your obsessive-compulsive disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your OCD (e.g., depression, personal standards). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Eligibility criteria: Inclusion Criteria:

* Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Obsessive Compulsive Disorder, and are accepted for treatment at the clinic.

Exclusion Criteria:

* Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Obsessive Compulsive Disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Anxiety Disorders Clinic, University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Maureen Whittal, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03370328: Reducing Up-set Stomach and Vomiting After Surgery Using Essential Oils
Official title: Essential Oils to Reduce Post-Operative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 143
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: The purpose of this study is to determine if aromatherapy (essential oil) is effective at reducing up-set stomach and vomiting after surgery and in reducing the need for up-set stomach medications

Detailed description: If participants decide to take part in this study, they will be asked to use choose a small nasal inhaler from a bag, open the sealed package, and inhale from the nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth, just prior to entering the operating room. During recovery in the Post-operative acute care unit (PACU), nausea severity will be rated using a 0-3 scale where zero indicates no nausea.

If your score is 1-3, participants will be instructed/assisted in using a nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth. After 5 minutes, nausea scores will be collected again and if the score is the same or higher, participants will be asked to use the nasal inhaler again in the same manner as before. If their nausea has not resolved after the second use, they will be give anti-nausea medication that a surgeon ordered. This process will be repeated again whenever you complain of nausea, until they are discharged from the hospital.

Eligibility criteria: Inclusion Criteria:

* post-op surgical patients at least 18 years of age or older
* the ability to understand and follow directions for use of essential oils
* the ability to understand and give informed consent to study
* the ability to understand, read and write English
* ambulatory or short-stay/23-hour patients

Exclusion Criteria:

* History of any pulmonary disease, including but not limited to: asthma, COPD, OSA, chronic bronchitis, pulmonary and ear, nose, throat (ENT) surgery patients
* Allergy to any of the ingredients in the essential oils
* Sensitivity to strong odors

Primary outcomes:
measure: Mean change in nausea score
timeFrame: baseline to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester, Strong Memorial Hospital
name: Maxine Fearrington, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05317728: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Keywords: IOL
Intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 175
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

Detailed description: In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.

This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.

This study will be conducted in Central America.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects taking medications that may affect accommodation;
* Clinically significant eye abnormalities as specified in the protocol;
* Previous eye surgery as specified in the protocol;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)
timeFrame: Month 6 post second eye implantation
measure: Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)
timeFrame: Up to Year 1
measure: Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Clinica 20/20
city: Santo Domingo
country: Dominican Republic
facility: Laser Center SA
city: Zapopan
country: Mexico
facility: Centro de Retina Medica y Quirurgica SC
state: Jalisco
city: Mexico City
country: Mexico
facility: Asociación Para Evitar la Ceguera en México
city: Mexico City
country: Mexico
facility: Salauno Salud SAPI de CV
city: Panama
country: Panama
facility: Panama Eye Center
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04098861: Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma
Official title: Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A single-center, randomized open-labeled, prospective, crossover study.
Primary purpose: TREATMENT

Brief summary: Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss.

Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control.

Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.


Eligibility criteria: Inclusion Criteria:

1. Age 18 and above
2. Able to provide informed consent
3. Diagnosed as having unilateral or bilateral, mild to moderate POAG
4. The POAG treated with only two antiglaucoma

Exclusion Criteria:

1. Advanced POAG
2. Patient with contraindication for topical use of a-blocker and prostaglandin analogue
3. Patient with contraindication for systemic use of a-blocker
4. Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol
5. History of orbital or ocular trauma.
6. History of cataract surgery less than 6 months.
7. History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery
8. Any active eye infections or corneal ulceration.
9. Patient with ocular surface disease
10. Other ocular disease that might interfere with IOP measurements or result
11. Precious eye i.e patient with only one good eye
12. Contact lens is not allowed within 1 week before the start of study and during the study

Primary outcomes:
measure: Efficacy: Intraocular pressure reduction
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety: Side effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References:
Clinical trial NCT06152861: Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension
Official title: Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 250
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: The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older at the Screening Visit;
* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
* Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
* Qualifying IOP in the study eye;
* Best-corrected visual acuity of approximately 20/80 Snellen in each eye

Exclusion Criteria:

* Sensitivity or allergy to travoprost or timolol;
* Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
* History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
* History of cerebrovascular insufficiency;
* Any form of glaucoma other than open-angle glaucoma
* Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
* Non-qualifying prior surgeries or procedures in either eye

Primary outcomes:
measure: change from baseline in mean diurnal IOP in the study eye
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Glaukos Clinical Study Site
state: California
Study officials:
affiliation: Glaukos Corporation
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02463461: Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
Official title: Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Insomnia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Weill Cornell Medical College in Qatar
First posted: 2015-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).

Detailed description: The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.

Eligibility criteria: Inclusion Criteria:

* Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old

Exclusion Criteria:

* Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.

Primary outcomes:
measure: Total sleep time (TST)
timeFrame: 1 night
Secondary outcomes:
measure: Wake After Sleep Onset (WASO)
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ana Krieger
role: PRINCIPAL_INVESTIGATOR
References: