louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06862050: BREATHE Free: a Pilot Feasibility Trial
Official title: BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment: a Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation; Tobacco Dependence
E-Cig Use
Nicotine Dependence, Other Tobacco Product
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 90
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 overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL).

The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit.

The main questions it aims to answer are:

* Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use?
* Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day?

Researchers will assign participants to either BREATHE Free curriculum or usual care.

Participants will:

* Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line
* BREATHE Free group will attend 12 group meetings held on the university campus
* All participants will answer interview questions related to tobacco use, character strengths and resilience
* Expired Carbon Monoxide (CO) will be assessed in all participants.


Eligibility criteria: Inclusion Criteria:

* Daily use of one or more tobacco products
* Valid home address in Augusta or the CSRA
* Functioning telephone number
* Speak, read, write in English

Exclusion Criteria:

* Current use of tobacco cessation medications
* Enrolled in tobacco treatment program

Primary outcomes:
measure: Engagement
timeFrame: Weekly assessments, with first assessment in week 2 and last assessment in week 12.
measure: Acceptability
timeFrame: Program evaluation will be administered on last meeting (week 12).
measure: Acceptability
timeFrame: Program evaluation will be administered on last meeting (week 12).
Secondary outcomes:
measure: Average number of cigarette smoked per day
timeFrame: Measured in baseline and weeks 12 and 16
measure: Smoking abstinence
timeFrame: Measured in baseline and weeks 12 and 16
measure: Resilience
timeFrame: Measured in baseline and weeks 12 and 16
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References:
Clinical trial NCT02691650: Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma
Official title: Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Burns
Keywords: serum cholinesterase
plasma cholinesterase
pseudocholinesterase
systemic inflammation
SIRS
polytrauma
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: BG Trauma Center Ludwigshafen
First posted: 2016-02-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency unit of the trauma and burns center

Brief summary: Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.


Eligibility criteria: Inclusion Criteria:

* signed written consent
* 18 years and older
* severe trauma (ISS \> 15)
* burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface)
* SIRS

Exclusion Criteria:

* not fulfilling the inclusion criteria
* failure to adhere

Primary outcomes:
measure: Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement
timeFrame: after completed patient recruitment, 1 year
Secondary outcomes:
measure: correlation of the cholinesterase activity and the trauma/disease severity scores
timeFrame: after completed patient recruitment, 1 year
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen
state: Rheinland Pfalz
Study officials:
affiliation: Department of Anesthesiology, Heidelberg University Hospital
name: Stefan Hofer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany
name: Stefan Kleinschmidt, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00312650: Doxil and Gemcitabine in Recurrent Ovarian Cancer
Official title: A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Carcinoma
Keywords: ovarian cancer
recurrent
progressive
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Ortho Biotech, Inc.
First posted: 2006-04-10
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.

Detailed description: This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.

Eligibility criteria: Inclusion Criteria:

* recurrent platinum resistant ovarian cancer
* measurable disease

Exclusion Criteria:

* prior treatment with Doxil or Gemzar
* life expectancy \<3months
* cardiac ejection fraction \<50%

Primary outcomes:
measure: rate of hand-foot syndrome
Secondary outcomes:
measure: objective response rate
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants' Hospital
state: Rhode Island
Study officials:
affiliation: Program in Women's Oncology
name: Paul A DiSilvestro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05749250: Ultrasound Cavitation Therapy for CLI
Official title: Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 30
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: In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (PAD). The primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. A secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.


Eligibility criteria: Inclusion Criteria:

* Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (\<0.9) or non-compressible vessels
* Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.

Exclusion Criteria:

* Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV\]).
* Pregnant or lactating females
* Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
* Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors).
* Expected amputation or revascularization procedure within the ensuing 1 month.

Primary outcomes:
measure: Wound dimensions
timeFrame: 18 days
Secondary outcomes:
measure: Wound granulation
timeFrame: 18 days
measure: Tissue perfusion
timeFrame: 18 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT01819350: In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH
Official title: Avaliação in Vivo do Potencial cariogênico e Erosivo de Bebidas e Medicamentos pediátricos líquidos Intra-orais
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Biofilm pH
Keywords: Dental caries
Sucrose
Oral administration
Ion Concentration of Hydrogen
Pediatric medicines
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.

Detailed description: Te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 22 years;
* Having Oral hygiene adequate (OHI\<1.1);
* Having 20 natural teeth incluing molar;
* Not havind oral disease.

Exclusion Criteria:

* Biofilm baseline pH \> 5,5;
* Not signature consent term;
* Using orthodontic appliance;
* Having used medicines last 3 months;
* Pregant woman.

Primary outcomes:
measure: Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm
timeFrame: 12 months
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba
state: Paraíba
Study officials:
References:
Clinical trial NCT01927250: Influence of Multi-dimensional Wellness Program on Quality of Life
Official title: Influence of Multi-dimensional Wellness Program (Diet, Art and Biofield Therapy) on Quality of Life in Japanese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Physical Disorders
Mental Disorders
Keywords: cohort study
diet program
art therapy
laying-on-of-hands
quality of life
Lead sponsor: MOA Health Science Foundation
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 12166
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether multi-dimensional wellness program (diet, art and biofield therapy) influences the quality of life for those with different health status in Japan.

Detailed description: Combination of wellness programs may be one of the best approaches to improve quality of life; however, the effectiveness of a treatment that combines various programs is also yet to be clarified. This study investigated the influence of Okada Health and Wellness program on the quality of life for healthy people and those with illness in Japan. Okada Health and Wellness program consists of 3 components: diet, art and biofield therapy.

Eligibility criteria: Inclusion Criteria:

* Those who were interested in practicing the diet program and art therapy established by the MOA International Corporation.
* Able to receive Okada Purifying Therapy, a domain of biofield therapy at least once a week.
* Competent to answer the Japanese questionnaires for quality of life
* Aged 16 years or older

Exclusion Criteria:

* Those who did not match the inclusion criteria

Primary outcomes:
measure: change of quality of life
timeFrame: baseline and after 3 months
Secondary outcomes:
measure: Adjusted odds ratios of the factors associated with the change of quality of life.
timeFrame: in 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: MOA Health Science Foundation
Study officials:
affiliation: MOA Health Science Foundation
name: Kiyoshi Suzuki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suzuki K, Kimura T, Uchida S, Katamura H, Tanaka H. The Influence of a Multimodal Health Program with Diet, Art, and Biofield Therapy on the Quality of Life of People in Japan. J Altern Complement Med. 2019 Mar;25(3):336-345. doi: 10.1089/acm.2018.0291. Epub 2019 Feb 11.
Clinical trial NCT04069650: Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
Official title: Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Free Flap Reconstruction
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing free flap reconstruction of the oral cavity

Brief summary: Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.

Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.

Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.


Eligibility criteria: Inclusion Criteria:

* every consenting patients undergoing free flap reconstruction of the oral cavity

Exclusion Criteria:

* unable to give consent

Primary outcomes:
measure: Major complication occurency
timeFrame: 1 month
Secondary outcomes:
measure: Minor complication occurency
timeFrame: 1 month
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01803750: Community Primary Care Providers to Implement and Disseminate Cancer Prevention Interventions for Latino Populations
Official title: Building a Network of Community Primary Care Providers to Implement and Disseminate Cancer Prevention Interventions for Latino Populations
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: For New York State Registered Family Practitioners and Internal Medicine Physicians
Keywords: Primary Care Providers
Latino Populations
Disseminate Cancer Prevention
semi-structured interviews
13-031
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-03-04
Enrollment: 3
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: Participants will be primary care providers (PCPs) in the NYC Queens. Brooklyn ,Bronx and Staten Island, borough neighborhoods that serve large Latino populations.

Brief summary: The purpose of this study is to understand primary care provider's knowledge, attitudes, and barriers to promoting evidence-based cancer screening and prevention practices for physicians with large Latino patient populations. The investigators will ask providers information on cancer screening and prevention practices by conducting one-on-one interviews. In addition, they would like to develop a committee of community providers to help design and implement cancer screening and prevention programs specifically for Latino patients based on the interview findings.


Eligibility criteria: Inclusion Criteria:

* New York State registered family practitioners and internal medicine physicians
* Minimum one half of their patients are Latino (provider self-reported)
* Currently practice in a small clinical setting (defined by no more than 5 providers) including community clinics, and/or private practice in Queens, Brooklyn, Bron and Staten Island, New York
* No active affiliation with a major hospital or academic institution.

Exclusion Criteria:

* Practicing medicine for less than 2 years
* Practicing in a setting where no health insurance is accepted

Primary outcomes:
measure: assess attitudes and barriers
timeFrame: 1 year
Secondary outcomes:
measure: build the beginning of a Community-Based Participatory Committee
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Abraham Aragones, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04954950: An Epidemiological Study on Winter Sports Injury in Chinese Population
Official title: An Epidemiological Study on Winter Sports Injury in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sports Injury
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data for this retrospective study were collected from the resort clinic in Chongli during ski season. Chongli is a destination ski resort in Northern China which has various terrains and has the largest number of annual visits.

Brief summary: The aims of the study are to describe the injury patterns among recreational skiers and snowboarders in China and to provide primary data to guide the reconstruction of regional healthcare facilities to deal with the increasing number of participants in snow sports.

Detailed description: A retrospective study was performed in Ski Resorts in Chongli, China. 5000-10000 injured skiers and snowboarders will be recruited. Data of all injury patients in the resort clinic will be collected. Patients' information, including sex, age, equipment, skill level and injured body part, will be analysed.

Eligibility criteria: Inclusion Criteria:

* Skiing and snowboarding injuries

Exclusion Criteria:

* Skiing and snowboarding visitors without injuries

Primary outcomes:
measure: sex
timeFrame: 1 week after injury
measure: age
timeFrame: 1 week after injury
measure: Equipment
timeFrame: 1 week after injury
measure: Skill level
timeFrame: 1 week after injury
measure: Date of injury
timeFrame: 1 week after injury
measure: Causes of injury
timeFrame: 1 week after injury
measure: Slope difficulty
timeFrame: 1 week after injury
measure: Injured body parts
timeFrame: 1 week after injury
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: yingfang ao, M.D.
role: STUDY_CHAIR
References: