louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00601887: Bioequivalency Study of Meloxicam Tablets Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Anti-inflammatory
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Meloxicam or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04249687: Treatment of Moderate to Severe Lateral Canthal Lines
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lateral Canthal Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Moderate to severe LCL at maximum smile as assessed by the Investigator.
3. Moderate to severe LCL at maximum smile as assessed by the subject.

Exclusion Criteria:

1. Previous use of any Botulinum toxin treatment in facial areas within 9 months prior to study treatment.
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.

Primary outcomes:
measure: Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month.
timeFrame: Month 1
Secondary outcomes:
measure: Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.
timeFrame: One Month
Other outcomes:
Locations:
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute and Research Center
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates
state: California
city: Solana Beach
country: United States
facility: Art of Skin, MD
state: California
city: Boynton Beach
country: United States
facility: Siperstein Dermatology Group, PLLC
state: Florida
city: Baltimore
country: United States
facility: Facial Plastic Surgicenter, Ltd
state: Maryland
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetic & Laser Surgery
state: New York
city: Victor
country: United States
facility: Rochester Dermatologic Surgery, Ltd
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions, PA
state: North Carolina
city: Vancouver
country: Canada
facility: Dr. Shannon Humphrey, Inc
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics, Inc
state: British Columbia
Study officials:
References:
Clinical trial NCT04334187: NYCHA Mindfulness-based Smoking Cessation Intervention
Official title: Feasibility and Accessibility of a Mindfulness-based Smoking Cessation Intervention for NYCHA Residents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tobacco Use
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT).

Detailed description: The primary objective of this research is to examine the feasibility, accessibility and impact of a mindfulness-based smoking cessation program for NYCHA residents.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Current smoker (\>= 5 cigarettes per day). Dual tobacco users are eligible as long as their primary tobacco product is cigarettes.
* Ready to quit smoking cigarettes within 30 days
* Able to attend the 8 weekly MBAT sessions at the scheduled days/times
* NYCHA resident
* English language
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Patient Health Questionnaire-2 (PHQ-2) score indicating current risk for depression
* Self-reported diagnosis of schizophrenia, bipolar disorder, schizotypal disorder or other psychotic disorder

Primary outcomes:
measure: Number of participants who perceive the Mindfulness based addiction treatment as useful at time of Enrollment
timeFrame: Baseline
measure: Number of participants who perceive the Mindfulness based addiction treatment as useful after last MBAT session.
timeFrame: 2 months
measure: Number of participants who perceive the Mindfulness based addiction treatment as useful post treatment
timeFrame: 3 months
measure: Number of participants who perceive the Mindfulness based addiction treatment as effective
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants who adhered to the Mindfulness based addiction treatment
timeFrame: 3 months
measure: Number of participants who self reported abstinence
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Erin Rogers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06297187: Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
Official title: A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvar Intraepithelial Neoplasia
Condylomata Acuminata
Keywords: Gynecologic Oncology
VIN
Vulvar Intraepithelial Neoplasia
Condylomata Acuminata
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients identified as genetically female at birth between the ages of 18 and greater (inclusive) at the time they underwent treatment with CUSA for Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata between January 2010 and December 2022. Pregnant patients will be included.

Brief summary: The study is a single arm, retrospective, single-center, post market registry.

The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.

Detailed description: CUSA® Excel/Clarity Ultrasonic Surgical Aspirator System is indicated for use in the following surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:

* Neurosurgery
* Gastrointestinal and affiliated organ surgery
* Urological surgery
* General surgery
* Orthopedic surgery
* Gynecological surgery
* Laparoscopic surgery

This Registry adds data to support the safety and efficacy for a gynecological surgery indication expansion for the use of CUSA in Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.

Information obtained from this retrospective Registry will help inform a potential future prospective study for this indication in a real-world population.

Eligibility criteria: Inclusion Criteria:

* Subject had been diagnosed with primary or recurrent Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata, treated with CUSA and confirmed by a CUSA pathology report.
* Subject had post-operative visits completed at the gynecologic oncology practice.
* Subject had surgery with CUSA between January 2010 and December 2022.

Exclusion Criteria: Not Applicable

Primary outcomes:
measure: Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
timeFrame: During Surgery
Secondary outcomes:
measure: Primary Site Recurrence
timeFrame: Up to 12 months Postoperatively.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
Study officials:
affiliation: Private Practice, Dallas, Texas
name: DeEtte Vasques, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03040661: Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Official title: Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT \> 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if \< 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).


Eligibility criteria: Inclusion Criteria:

* Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure

Exclusion Criteria:

1. Pregnant patients.
2. Age \<18 years.
3. Patients who cannot provide consent in English.
4. Prisoners.

Primary outcomes:
measure: Time Required to Achieve Hemostasis
timeFrame: Time (minutes) from sheath removal till hemostasis achieved
measure: Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.
timeFrame: Time (minutes) from completion of procedure till patient leaves room
Secondary outcomes:
measure: Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group
timeFrame: Assessed after sheath removal till patient discharge
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References:
Clinical trial NCT02410161: Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma Fatty Acids
Official title: Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma n-3 Polyunsaturated Fatty Acids in Young Compared to Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: ketone
α-linolenic acid
flaxseed
aging
β-hydroxybutyrate
acetoacetate
omega-3 fatty acids
ketogenesis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dietary Supplement: alpha-linolenic acid-rich supplement
Primary purpose: BASIC_SCIENCE

Brief summary: Background: As the main alternative fuel to glucose for the brain, increased plasma ketones could potentially help compensate for brain glucose hypometabolism occurring during aging. The precursor long-chain n-3 polyunsaturated fatty acid (PUFA), α-linolenic acid (ALA), is normally mostly β-oxidized and so could potentially be used to stimulate ketogenesis in humans.

Objective: To compare the impact of an ALA-rich supplement on the ketogenic response in young and older healthy adults.

Design: Ten young and ten older adults will consume a flaxseed oil supplement providing 2 g/d of ALA for 4 weeks. Plasma ketones, free fatty acids, triglycerides, glucose and insulin will be measured over 6 h during two metabolic study days, one before and one at the end of the supplementation.

Hypothesis: ALA-rich supplement for 4 weeks will increase ketone production in both groups.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 30 or 65 years and more

Exclusion Criteria:

* non smoker
* pregnancy or breastfeeding
* diabetes or insulin resistance
* uncontrolled thyroid disease, hepatic or renal disease
* uncontrolled high blood pressure
* medical treatment influencing lipid or glucide metabolism
* ongoing or past severe drug or alcohol abuse
* dementia or psychiatric difficulties or depression
* chronic immune condition or inflammation

Primary outcomes:
measure: Ketone Production
timeFrame: After 4 weeks
Secondary outcomes:
measure: Plasma Glucose
timeFrame: After 4 weeks
measure: Plasma Triglycerides
timeFrame: After 4 weeks
measure: Plasma Free Fatty Acids
timeFrame: 4 weeks
measure: Insulin Concentration in Plasma
timeFrame: after 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Stephen Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03433261: Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
Official title: Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CNS Oxygen Toxicity, Ketogenic Diet
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-02-14
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will randomize to one of two arms and will crossover to the other arm at least one week later.
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to understand the effect of nutritional ketosis on CNS oxygen toxicity in undersea divers. The investigators hope this will provide a starting point to develop methods for improving the safety of Navy divers, warfighters and submariners.

Detailed description: Participants in the study will undergo a physical exam and testing as well as training on cognitive testing software as part of the screening process. Eligible subjects will be assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in carbohydrates) for three days before testing. Subjects will be immersed in water to the shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at increased atmospheric pressure, and doing cycling exercise. Testing on the cognitive software, as well as blood sampling and physical monitoring will be done while in the chamber. All tests and procedures will be completed again at least one week later with the diet not assigned for the first session.

Eligibility criteria: Inclusion Criteria:

* Males \& females between 18 and 50 years old
* Able to pedal a bicycle ergometer continuously for 15 minutes
* Non-smoker
* No history of cardiovascular disease, including coronary artery disease, valvular disease, cardiomyopathy or hypertension.
* No history of lung disease

Exclusion Criteria:

* Prolonged QTc on initial ECG
* Currently pregnant or attempting to become pregnant.
* Have a history of:

  1. Smoking
  2. Coronary artery disease
  3. Hypertension
  4. Seizures
  5. Exercise intolerance
  6. Psychiatric disorder
  7. Previous pneumothorax or pneumomediastinum
  8. Hypo or hyperglycemia
  9. Diabetes
* Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.

Primary outcomes:
measure: Time to First Manifestations of CNS Oxygen Toxicity
timeFrame: 2 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References:
Clinical trial NCT04855461: Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain
Official title: Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Physical Activity
Fear of Movement
Patterns of activity
Psychological status
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with chronic pain

Brief summary: The proposed research topic will investigate the determinants of physical activity (PA) levels in patients with chronic pain. The aim of the research project is to quantify the self-reported and free-living physical activity levels in people with chronic pain. Describe and explore the characteristics and relationships of these participants in terms of pain severity, fear of movement, patterns of activity, anxiety and depression, and number and differing types of long term conditions and how these all correlate with PA levels. Explore PA levels of chronic pain patients and the correlation of psychosocial factors.


Eligibility criteria: Inclusion Criteria:

* Individuals with pain lasting more than 12 weeks (chronic pain)
* 16 years or older

Exclusion Criteria:

* None

Primary outcomes:
measure: International Physical Activity Questionnaire - Short Form
timeFrame: Entire duration of study- 6 months
Secondary outcomes:
measure: Demographics questionnaire
timeFrame: Entire duration of study - 6 months
measure: Brief Pain Inventory - Short Form
timeFrame: Entire duration of study - 6 months
measure: The Patterns of Activity Measure - Pain
timeFrame: Entire duration of study - 6 months
measure: The Tampa Scale of Kinesiophobia
timeFrame: Entire duration of study - 6 months
measure: The Depression, Anxiety and Stress Scale - 42
timeFrame: Entire duration of study - 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
Study officials:
affiliation: Glasgow Caledonian University
name: Chee Wee Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492761: Family Impact of Polyhandicap: a Mixed Methodological Approach
Official title: Family Impact of Polyhandicap: Mixed Methodological Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polyhandicap
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 260
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - family member (parent, siblings, uncle / aunt) of a person with a severe multiple disability whose age is between 8 and 35 years old

Brief summary: Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families


Eligibility criteria: Inclusion Criteria:

* Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35 years old
* Patients: with severe polyhandicap defined by the combination of motor deficiency and intellectual impairment associated with everyday life dependence, restricted mobility and age at onset of cerebral lesion below 3 years old
* Written consent signed by caregivers for participation

Exclusion Criteria:

* caregivers refusing to participate

Primary outcomes:
measure: Qualite of life
timeFrame: 5 years
Secondary outcomes:
measure: interview content
timeFrame: 2 hours
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpiatuix de Marseille
Study officials:
affiliation: Assistance Publique Hôpitauix de Marseille
name: Jean Olivier ARNAUD
role: STUDY_DIRECTOR
References: