louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00979550: The Effects of Aldara as an Adjunct to Laser Treatment
Official title: The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Port Wine Stains
Keywords: laser
pediatric
skin pigmentation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Graceway Pharmaceuticals, LLC
First posted: 2009-09-18
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.

Detailed description: This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

Eligibility criteria: Inclusion Criteria:

* Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
* All races will be included as well as male and female.
* Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
* The majority of port wine stains are initially treated during childhood
* In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.

Exclusion Criteria:

* Patients under the age of 2 or over the age of 60.
* Patients that have serious medical problems that would put them at risk of the anesthesia.
* Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
* Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.

Primary outcomes:
measure: Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Division of Plastic Surgery
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Henry C. Vasconez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05772650: The Online Mood Booster Challenge to Support Physical and Mental Health
Official title: Healthier Together Mood Booster Challenge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Wellness 1
Keywords: web based health promotion
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: McGill University faculty, staff, students and invited family members

Brief summary: Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.

Detailed description: An 8-week web-based health promotion program to learn strategies and use digital tools that will give participants a physical, mental, and emotional boost, with exercise remaining a key component of the mission.

Each week participants will learn and practice evidence-based strategies that they will master to improve their physical and mental health.

Techniques will be focused on: spending time exercising outdoors, practicing daily gratitude, practicing good posture, building social connection, deep breathing, listening to music, limiting time on social media and focusing on better sleep.

Eligibility criteria: Inclusion Criteria:

* Affiliated with McGill University or family member

Exclusion Criteria: None

Primary outcomes:
measure: Improvement in Physical Activity Levels
timeFrame: Feb 20 - April 16, 2023
measure: Adherence to Program
timeFrame: Feb 20 - April 16, 2023
measure: Improvement in Stress
timeFrame: Feb 20 - April 16, 2023
measure: Improvement in Sleep
timeFrame: Feb 20 - April 16, 2023
measure: Improvement in Mood
timeFrame: Feb 20 - April 16, 2023
measure: Improvement in Burnout
timeFrame: Feb 20 - April 16, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Dr. Steven Grover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02630550: Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study
Official title: Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Peripheral Arterial Disease
Keywords: Cardiac output
Intraoperative Monitoring
Echocardiography, Transesophageal
Vascular cross-clamping
Endarterectomy
Monitoring, Physiologic/instrumentation
Cardiography, Impedance
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing either an open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.

Brief summary: The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. The present study will evaluate the precision and validity of the measures taken by the device during open vascular surgery procedures. The measurements will be compared to the those calculated by transesophageal echocardiography at various key points during the surgeries. The validity of the cardiac output, stroke volume and stroke volume variation measurements will be evaluated, as well as the device's ability to track rapid changes in cardiac output.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.
* ASA 1-3

Exclusion Criteria:

* Refuses general anesthesia
* Contraindication to transesophageal echocardiography
* Allergy to the glue of the Cheetah NICOM probes
* Severe aortic valve regurgitation
* Thoracic aorta anatomy anomaly
* Unipolar pacemaker

Primary outcomes:
measure: Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM
timeFrame: Per vascular surgery procedure
Secondary outcomes:
measure: Stroke Volume (SV) with a vascular cross-clamp
timeFrame: Per vascular surgery procedure when a cross-clamp is installed
measure: Stroke Volume (SV) trending ability
timeFrame: Per vascular surgery procedure
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Louis-Philippe Fortier, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05702450: Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310
Official title: A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Detailed description: This study includes screening and treatment and follow-up periods.

Eligibility criteria: Inclusion Criteria:

* Have the ability to understand the study.
* Voluntarily participate in the study and sign the ICF.
* 18 years ≤ age ≤ 65 years, male and female.
* Willing to take effective contraceptive measures during the study period.

Exclusion Criteria:

* Plan to receive any major surgery during the study period.
* With malignant tumors within 5 years before screening.
* Positive results of alcohol breath test or urine drug abuse screening during screening period.
* Any reason that the investigator believes that will prevent the subject from participating in the study.

Primary outcomes:
measure: Pharmacokinetic: the maximum concentration (Cmax)
timeFrame: up to 57 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
Study officials:
affiliation: Peking University Care Luzhong Hospital
name: Jie Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Care Luzhong Hospital
name: Hong Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02131350: Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macula Edema
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.


Eligibility criteria: Inclusion Criteria:

* stable medication for the management of diabetes within 3 months
* visual impairment due to focal or diffuse diabetic macula edema
* decreased vision due to diabetic macula edema and not other causes

Exclusion Criteria:

* concomitant conditions in the study eye that could prevent the improvement in VA on the study
* active intraocular inflammation or infection in either eye
* uncontrolled glaucoma in either eye
* treatment with antiangiogenic drugs in the study eye within 3 months
* history of stroke and uncontrolled hypertension

Primary outcomes:
measure: best corrected visual acuity
timeFrame: every month, up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Department ou Ophthalmology Shinshu University School of Medicine
state: Nagano
Study officials:
References:
Clinical trial NCT06383650: Use of 81 vs 325mg of ASA in Treatment of BCVI
Official title: Use of 81 vs 325mg of ASA in Treatment of BCVI: A Feasibility RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Carotid Artery Injuries
Traumatic Injury
Vertebral Artery Injury
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Western University
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.

Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.

This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age
* Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center

Exclusion Criteria:

1. ≤18 years old
2. Known Pregnancy
3. Diagnosis of BCVI made based on imaging from another hospital (non-LTH)
4. Known pre-existing carotid/vertebral artery disease
5. Stroke on presentation/before BCVI diagnosis
6. Determined to require immediate surgical or interventional management of BCVI
7. Known allergy to ASA
8. Unable to consent OR absence of a Substitute Decision Maker (SDM)

Primary outcomes:
measure: Study feasibility
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of stroke
timeFrame: 30 days
measure: Incidence of Bleeding Complications
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02327650: To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations
Official title: The Examinations Whether or Not the Primary Causes of Osteoarthritis or Rheumatoid Arthritis in Joints Might be Bone Alterations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Progression of Rheumatoid Arthritis
Osteoarthritis of Multiple Joints
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who have OA with accompaying joint pain or the patients who have RA with accompaying joint pain

Brief summary: Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and others have previously reported, a portion of OA might be caused primarily by bone alterations. In this study, we prospectively and retrospectively show that the bone altertations may affect OA primarily in all of the joints.

In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone, instead of cartilage. Here we prospectively and retrospectively show that the bone altertations may affect RA primarily in all of the joints.


Eligibility criteria: Inclusion Criteria:

* RA and/or OA

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The bone signal changes detected by MRI in OA and/or RA patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
city: Matsumoto
country: Japan
facility: Yukio Nakamura
Study officials:
References:
Clinical trial NCT00857350: The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
Official title: The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Positive
Opioid Dependence
Opioid Agonist Treatment
HIV Infections
Keywords: HIV
resistance
opioid dependence
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV+, opioid dependent

Brief summary: HIV drug resistance presents a significant public heath problem. This proposal is designed to explore the association between ongoing illicit drug use and the prevalence of HIV drug resistance among HIV+ opioid dependent patients receiving opioid agonist treatment with the following hypotheses:

1. Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.
2. Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to have HIV drug resistance.


Eligibility criteria: Inclusion Criteria:

* HIV+
* Opioid dependent
* Receiving methadone or buprenorphine for at least one month

Exclusion Criteria:

* age \< 18 years
* current dementia;
* inability to read or understand English
* inability to provide written informed consent

Primary outcomes:
measure: HIV drug resistance
timeFrame: Cross sectional
Secondary outcomes:
measure: Illicit drug use
timeFrame: 6 months
measure: HIV transmission risk behaviors
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: David Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Jeanette Tetrault, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tetrault JM, Kozal MJ, Chiarella J, Sullivan LE, Dinh AT, Fiellin DA. Association between risk behaviors and antiretroviral resistance in HIV-infected patients receiving opioid agonist treatment. J Addict Med. 2013 Mar-Apr;7(2):102-7. doi: 10.1097/ADM.0b013e31827f9bdf.
Clinical trial NCT00146250: The Effect of N2O Administration on Arterial Oxygenation
Official title: Relationship of Oxygenation During Anaesthesia in the Presence of N2O or N2 to Mode of Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
Collaborators: name: Monash University
name: La Trobe University
name: The Alfred
name: University of Melbourne
First posted: 2005-09-07
Enrollment: 20
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: Nitrous oxide is a standard part of most anaesthetic breathing mixtures. It has often been assumed that it reduces the amount of oxygen reaching the lower parts of the lung. However the results of previous studies and of some computer modelling suggests the opposite may be true, and that oxygen levels in the blood are actually higher with nitrous oxide. This study seeks to determine whether nitrous oxide increases or decreases blood oxygen levels in anaesthetized patients.

Detailed description: The concentrating and second gas effects of nitrous oxide (N2O) uptake have been well described, and are produced by rapid uptake of N2O during the first several minutes of an inhalational anesthetic. This significantly increases alveolar and arterial O2 partial pressure. Theoretical modelling of alveolar gas exchange has predicted that these effects may not be transient but may be a persisting phenomenon. However, N2O is known to promote absorption atelectasis in poorly ventilated lung units.

This study, carried out pre-cardiopulmonary bypass in 20 patients undergoing coronary artery surgery, measures change in PaO2 after a minimum of 30 minutes of relaxant general anesthesia with a FIO2 of 30%. Patients are randomised to two groups. The intervention group has N2O introduced following baseline blood gas measurements, while the control group continued breathing an identical FIO2 in N2. The change in PaO2 in the two groups is the primary endpoint for comparison.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective coronary artery bypass surgery

Exclusion Criteria:

* Age under 18 years, emergency surgery

Primary outcomes:
measure: PaO2
timeFrame: Minimum of 30 minutes after induction of anaesthesia
Secondary outcomes:
measure: Change in pulmonary deadspace and shunt fractions
timeFrame: Minimum of 30 minutes after induction of anaesthesia
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Anaesthesia, Austin Health
name: Philip J Peyton, MD FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018850: 5HT3 Antagonism and Auditory Gating in Schizophrenia
Official title: 5HT3 Antagonism and Auditory Gating in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
ondansetron
nicotine
haloperidol
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The target groups in this study are brain waves and neurotransmitters (chemical messengers) in the brain. Subjects with diagnosed with schizophrenia will be studied. The study will help understand more about normal brain functioning and how that functioning differs in people with schizophrenia. Another purpose of this study is to determine how the altered brain functioning in schizophrenia contributes the symptoms found in the illness.


Eligibility criteria: Subjects with diagnosed with schizophrenia will be studied.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VAMC
state: Colorado
Study officials:
References: