louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06250153: TAU vs m-SBIRT in Primary Care
Official title: In-Person Versus Text/Telephone Screening, Brief Intervention and Referral to Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Substance Use Disorders
Keywords: Substance Use Disorders
Social Determinants of Health
Screening, Brief Intervention, Referral to Treatment (SBIRT)
Telehealth
Mobile SBIRT (m-SBIRT)
Primary Care
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing

1. a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus
2. evidence-based, in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT; Treatment As Usual (TAU); control arm).

Primary Aim is to compare the efficacy of m-SBIRT to TAU in positive screens for substance use. Secondary Aim is to compare m-SBIRT to TAU on Substance Use Treatment Attendance.

Detailed description: This research study is looking at the use of technology in primary care clinics and seeing if it improves screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and attendance to treatment. To do so the study, Investigators will be comparing a text message based substance use screening and treatment program, called Mobile Screening, Brief intervention, and Referral to Treatment (m-SBIRT) to standard of care Screening, Brief Intervention and Referral Treatment which traditionally takes place in-person. Patients at the MUSC Bee Street Primary Care Clinic between the ages of 18-75 may be eligible.

Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Attended a primary care visit at the MUSC Family Medicine clinic on Bee St
* English fluency
* Owner of a cell phone with SMS text-message based capability
* Access to WIFI
* A device to allow audio and video teleconferencing if completing informed consent remotely
* Able to provide informed consent.

Exclusion Criteria:

- None

Primary outcomes:
measure: Positive screens for substance use
timeFrame: Immediately following screening.
measure: Change in treatment attendance
timeFrame: Within one month of referral to treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor-Faculty
name: Constance Guille, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198653: Newborn Thermal Care Practices: A Community Based Program to Prevent Hypothermia
Official title: Newborn Thermal Care Practices in Rural India: A Community Based Program to Prevent and Improve Recognition and Management of Hypothermia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypothermia
Keywords: Hypothermia
Newborn
India
Maternal/Child Health
Infant
Kangaroo Mother Care
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to train mothers/caretakers on how to prevent their babies from becoming too cold.

Detailed description: This study is designed to determine domiciliary care knowledge, attitudes and practices regarding essential newborn care, with a focus on newborn thermal control; develop behavior change communications to promote prevention, early recognition and effective management of newborn hypothermia, evaluate impact and cost-effectiveness of education/behavior change communications delivered by Community Health Workers and Community Health Promoters/Change Agents on essential newborn care practices, including care-seeking; prevalence, recognition and management of hypothermia, including adaptation, safety and utility of Kangaroo Mother Care; and neonatal morbidity and mortality; evaluate the feasibility and acceptability of using LCT ThermoSpot device in rural communities to enhance mothers' recognition and management of neonatal hypothermia; determine the influence of the neonatal hypothermia indicator (ThermoSpot) on recognition of and response to newborn hypothermia and health-seeking behavior of the caregivers; develop algorithms for recognition and management of hypothermia to inform neonatal IMCI and verbal autopsy protocols and gain insight into the potential roles of various cadres of workers in providing neonatal health services at the community level and inform the development of models of community-based essential newborn care.

Eligibility criteria: Inclusion Criteria:

* Uttar Pradesh
* Newborns at home

Exclusion Criteria:

* Hospitalized babies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow, Uttar Pradesh
country: India
facility: CSMMU at Lucknow; King Georges Medical College
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Gary Darmstadt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar V, Mohanty S, Kumar A, Misra RP, Santosham M, Awasthi S, Baqui AH, Singh P, Singh V, Ahuja RC, Singh JV, Malik GK, Ahmed S, Black RE, Bhandari M, Darmstadt GL; Saksham Study Group. Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial. Lancet. 2008 Sep 27;372(9644):1151-62. doi: 10.1016/S0140-6736(08)61483-X.
Clinical trial NCT00762853: Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Official title: Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to develop a method to determine active ingredient uptake in oral care products.


Eligibility criteria: Inclusion Criteria:

* Male or female volunteer 18 - 65 years of age (inclusive).
* Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
* Able and willing to sign the informed consent form.
* Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental procedures/visits
* Medical condition which precludes not eating/drinking for 2 hours
* Advanced periodontal disease (gum disease)
* 5 or more decayed, untreated dental sites (cavities)
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of drugs that can affect salivary flow
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc)
* Pregnant or breastfeeding.
* Participation in another clinical study in the month preceding this study
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Triclosan Concentration in Dental Plaque
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
state: Bangkok 10110
Study officials:
name: Terdphong Triantana, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639753: Transportation Safety in Adolescence
Official title: Promoting Transportation Safety in Adolescence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Automobile Accident
Keywords: teen driver safety
injury prevention
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: University of Alabama at Birmingham
name: Children's Hospital of Philadelphia
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Wake Forest University Health Sciences
First posted: 2018-08-21
Enrollment: 2400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents. If successful, research findings will lead to clear strategies to reduce motor vehicle crashes.


Eligibility criteria: Inclusion Criteria:

* Teens between 16 and 17 years and 4 months (17.33 years) of age
* Pennsylvania state learner's permits
* Will have their Pennsylvania state learner's permit for at least 6 months (self-report)
* Self-report of less than 10 hours of behind-the-wheel driving experience.
* Teen and parent/caregiver fluent in written and spoken English
* Access to at least one practice vehicle
* Email address and internet access to complete study procedures

Exclusion Criteria:

* Teens with self-reported or parent reported (of teen's) visual, medical, or physical impairments that would require a handicap placard or assistive device to drive.
* Teens with pervasive developmental delays
* Have a sibling enrolled in this study
* Enrolled in other teen driving studies

Primary outcomes:
measure: Police-reported motor vehicle crashes
timeFrame: Baseline to 12 months after licensure
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Wake Forest University Health Sciences
name: Leann Long, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Catherine McDonald, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Jessica Mirman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00587353: Tobacco Use Intervention Among Radiation Oncology Patients
Official title: Tobacco Use Intervention Among Radiation Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: tobacco use cessation
radiation oncology
smoking
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 26
Sex: ALL
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: Tobacco prevention and intervention strategies in the general population are ongoing and evolving. However, strategies to help cancer patients overcome tobacco dependence have been limited. Radiation oncology patients who continue to smoke despite their cancer diagnosis have a lower quality of life (QOL), increased frequency and severity of side effects during their cancer treatment, higher risks of developing a smoking-related primary cancer, and may have a poorer survival rate than their non-smoking counterparts. These are all compelling reasons to be more pro-active in helping cancer patients stop smoking. The overall objective of this project is to adapt a model of an effective tobacco use intervention that can be delivered by any trained radiation oncologist and their staff.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age;
* current cigarette smoker (smoked any cigarettes within the previous 7 days prior to their first visit) or recent ex-smoker (last cigarette smoked was \>7 but ≤ 30 days);
* planning to undergo radiation therapy (RT) that is to be delivered by the members of the Department of Radiation Oncology in Rochester, MN;
* be receiving a minimum of 5 weeks of RT and/or be willing to return for all 5 sessions.

Exclusion Criteria:

* patient is currently (in previous 30 days) using other formal behavioral tobacco cessation program \[i.e., behavioral therapy (Nicotine Dependence Consultation and treatment) or telephone quitline\];
* daily use of tobacco products other than cigarettes;
* hospitalized patients;
* Karnofsky Performance Status (KPS) score of \< 60 (KPS = 60 corresponds to a person who requires occasional assistance but is able to care for most of their own needs;
* presence of an unstable or untreated psychiatric disorder.

Primary outcomes:
measure: The primary aim is to pilot test the intervention in radiation oncology patients (N=30). The primary dependent measure is self-reported 7-day point prevalence tobacco abstinence confirmed with expired air carbon monoxide.
timeFrame: 6 months
Secondary outcomes:
measure: We will be collecting data on QOL and psychosocial measures. This data will be reported descriptively and will be collected on our future study with appropriate statistical analyses.
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yolanda I Garces, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01698853: Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy
Official title: The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bypass Complications
Disorder of Blood Gas
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass

Brief summary: Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ hypoperfusion.

Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde perfusion. However,whether the arterial oxygenation status from different parts of the body are the same in the condition of retrograde perfusion have not been studied.

The present study is aimed to determine if there is difference in the arterial oxygenation between peripheral arterial and aortic root during the period of retrograde perfusion.In addition, the impact of artificial ventilation on the difference of arterial oxygenation will also be investigated.

Detailed description: All patients included will be assigned into two different groups according to the surgical approach,one group is named "NP" with normal perfusion,and the other is named "RP" with retrograde perfusion.

For all the patients,we will obtain 0.5ml blood from both peripheral arterial and aortic root for blood gas analysis at some specific time points.

We will focus on the differences of arterial oxygenation between peripheral arterial and aortic root at each group.At the same time,we will analyse the impact of artificial ventilation on it.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* without informed consent
* pregnancy

Primary outcomes:
measure: The difference between peripheral arterial oxygenation and aortic root blood oxygenation
timeFrame: patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Anesthesiology, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: department director
name: Hailong Dong, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04877353: Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
Official title: Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure Post Surgical (Diagnosis)
Keywords: noninvasive ventilation
COPD
acute respiratory failure
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Postoperative NIV
Primary purpose: PREVENTION

Brief summary: In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.


Eligibility criteria: 1. Inclusion criteria:

   * Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
   * Moderate to very severe COPD (GOLD II to IV).
   * ASA functional status II or greater.
2. Exclusion criteria:

   * Contraindications to the application of NIV.
   * Sleep apnea syndrome.
   * Facial deformation.
   * Inability to follow the study.

Primary outcomes:
measure: acute respiratory events
timeFrame: 28days
Secondary outcomes:
measure: acute respiratory failure
timeFrame: 28 days
measure: intubation rate
timeFrame: 28 days
measure: ICU mortality
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: infectious and non infectious complications
timeFrame: 28 days
Other outcomes:
Locations:
city: Luxor
country: Egypt
facility: asmaa Mostafa
Study officials:
References:
Clinical trial NCT00649753: Algometer and Category II Pelvic Blocking and Cranial Protocol
Official title: An Investigation of Algometer Readings for DeJarnette Category II Indicators After Category II Blocking and Cranial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Sacroiliac Joint Dysfunction
Keywords: sacroiliac joint dysfunction
algometer
Chiropractic
Manual Therapy
indicator points associated with sacroiliac joint dysfunction
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relationship of pelvic blocking and protocol for cranial adjusting with specific pain areas as outlined by Dr. Bertrand DeJarnette in the Category II/sacroiliac protocol. An algometer will be used to determine the level of pain at specific points before and after each treatment of pelvic blocking with or without cranial adjusting.


Eligibility criteria: Inclusion Criteria:

* Logan student, staff or faculty
* Age 18 - 60
* No chiropractic adjustment 2 weeks prior to beginning the study
* Show the DeJarnette Category II indicators

Exclusion Criteria:

* Previous lower extremity, first rib and spine injury, surgery
* Local infection, injury or other malignancy affecting the lower extremity and the nervous system
* Unstable joints of the lower extremity and/or first rib and/or spine
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect the nervous system
* Contraindication to DeJarnette Category II Pelvis Blocking
* Pregnancy
* Significant lower lumbar involvement
* Diabetes, shortness of breath on light physical activity, cardiovascular disease
* Numbness and/or tingling in the lower extremities

Primary outcomes:
measure: Algometer readings
timeFrame: pre and post treatment intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT00761553: Dietary Supplements and Exercise in Aging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: The study is designed to determine the effects of food supplements and strength training.
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2008-09-29
Enrollment: 49
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effects of food supplements and strength training on appetite, the amount of energy used, and body composition.


Eligibility criteria: Inclusion Criteria:

* Adults age 55 and older
* Body mass index 20 to ≤35 kg/m2
* Weight stable (\<4kg change within the last 3 months)
* Constant habitual activity patterns (no deviation \> 1x/wk of 30 min/session within last 3 months)
* Clinically normal blood and urine profiles as determined by our study physician
* Not taking medications known to influence appetite nor any anti-inflammatory steroid medications
* No hip replacements

Exclusion Criteria:

* Adults with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded

Primary outcomes:
measure: Appetite questionnaire, urine collection, strength testing, body composition, resting metabolic rate, food records, breath sample, activity assessments, dietary supplements, nightly logs, and resistive exercise.
timeFrame: 23 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References: