louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01935713: Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure
Official title: Novel Methods to Reduce Children's Secondhand Smoke Exposure I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Smoke
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 89
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: PREVENTION

Brief summary: The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.


Eligibility criteria: Inclusion Criteria: In order to be included in the study, participants must:

1. be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more \> 1 child between 3-11 years, we will include the youngest)
2. smoke at least 10 cigarettes per day for the past year
3. indicate that they smoke around their child or in the car or home at least one time per week\]
4. have no intention of quitting smoking in the next 12-weeks
5. aged 18-65 years
6. be fluent in English
7. have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension)
8. not currently pregnant, planning to become pregnant, or breastfeeding
9. do not use non-cigarette tobacco (cigars, chewing tobacco)
10. have no prior use of any potential reduced exposure product
11. have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence

Exclusion Criteria:

* Does not meet all of the requirements of inclusion criteria

Primary outcomes:
measure: Change in child salivary cotinine
timeFrame: 2, 4, 8, and 12 weeks
Secondary outcomes:
measure: Change in Parent and Child Lung Function
timeFrame: 2, 4, 8, and 12 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The Children's Hospital at OU Medical Center
state: Oklahoma
Study officials:
References:
Clinical trial NCT01849913: Laser Therapy on Neck Pain in Adolescents
Official title: Evaluation of the Effect of Low-level Laser Therapy on Neck Pain In Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
hydrocortisone
stress
electromyography
adolescent
low-level laser therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-05-09
Enrollment: 75
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the proposed study is to investigate the effects of low-level laser therapy on neck pain.


Eligibility criteria: Inclusion Criteria:

* age 14 to 20 years;
* chronic neck pain;
* no use of corticoids for at least 15 days prior to the onset of treatment;
* agreement to participate; and
* signed statement of informed consent by legal guardian.

Exclusion Criteria:

* Currently undergoing physical therapy;
* inability to participate in sessions;
* specific diagnosis of infection, osteoporosis, polyarthritis or rheumatic disease; and
* constant use of corticoids or analgesics.

Primary outcomes:
measure: Neck Disability Index - NDI
timeFrame: One Year
Secondary outcomes:
measure: Surface electromyography (EMG) of neck extensors
timeFrame: baseline and 6 weeks
measure: Analysis of salivary cortisol
timeFrame: baseline and 6 weeks
measure: Neck extensor endurance test
timeFrame: baseline and 90 days
measure: Evaluation of cervical range of motion
timeFrame: baseline and 90 days
measure: Postural evaluation
timeFrame: baseline and 90 days
measure: Postural evaluation with photogrammetry using Postural Evaluation Software Program-SAPO
timeFrame: baseline and 90 days
measure: International Physical Activity Questionnaire - IPAQ
timeFrame: baseline and 90 days
measure: Assessment of pain intensity using pressure algometry
timeFrame: baseline and 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Deise S Araujo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.
citation: Verhagen AP, Schellingerhout JM. Low-level laser therapy for neck pain. Lancet. 2010 Feb 27;375(9716):721; author reply 722. doi: 10.1016/S0140-6736(10)60296-6. No abstract available.
citation: Gross AR, Aker PD, Goldsmith CH, Peloso P. Patient education for mechanical neck disorders. Cochrane Database Syst Rev. 2000;1998(2):CD000962. doi: 10.1002/14651858.CD000962.
Clinical trial NCT01899313: A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
Official title: A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amphetamine-Related Disorders
Keywords: methamphetamine dependence
texting
short message service
addiction
amphetamine
outpatient
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I behavior therapy development study seeks to improve treatment outcomes for methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention.


Eligibility criteria: Inclusion Criteria:

* English-speaking adults ≥ 18 years who are seeking treatment for MA addiction.
* Own a cellular phone with SMS text messaging capability and have an unlimited text messaging plan.
* Available to attend CBT therapy groups.
* Agreeable to conditions of the study and signed an informed consent form.

Exclusion Criteria:

* Projected to be unavailable \> 12 hours/day to read and send text messages.
* Any medical or psychosocial condition that would preclude safe, useful, or consistent participation,

Primary outcomes:
measure: Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: New Leaf Treatment Center
state: California
city: San Francisco
country: United States
facility: Addiction & Pharmacology Research Laboratory
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Gantt Galloway, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05984017: A Non-interventional Study With Advanced Lung Squamous Cell Carcinoma
Official title: A Non-interventional Study and Its Clinical Relevance With Advanced Lung Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Lung Squamous Cell Carcinoma
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: advanced or metastatic (stage IV) lung squamous cell carcinoma

Brief summary: This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.


Eligibility criteria: Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology.
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06702917: GSI Cardiac on Revolution Apex - US
Official title: Wide Coverage GSI Cardiac Data Collection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Computed Tomographic Angiography
Myocardial Infarction (MI)
Cardiac Catheterization
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2024-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will consist of adults that are 18-years of age or older, and who are undergoing either a scheduled CCTA, a scheduled cardiac catheterization due to known history of pathology or is a patient with known history of myocardial infarction.

Brief summary: The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system.

Two groups of participants will be enrolled:

A) Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care

B) Participants scheduled to undergo a cardiac catheterization or have a history of heart attack

Participants in Group A will:

-Have a standard of care CCTA immediately followed by a research GSI Cardiac scan

Participants in Group B will:

-Have a research CCTA immediately followed by a research GSI Cardiac scan

Both groups will be in the study for approximately 1 day. There are no follow-up visits after the day of scan.


Eligibility criteria: Inclusion Criteria:

Subjects may be included in this study if they meet the following criteria:

1. Who are ≥18 years of age;
2. Able to sign and date the informed consent form; AND,
3. Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
4. Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.

Exclusion Criteria:

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject;
7. Who are unwilling to have GEHC personnel present for the CT exam; AND,
8. Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)

Primary outcomes:
measure: Evaluable GSI Cardiac Raw Scans
timeFrame: 12 months
Secondary outcomes:
measure: Safety Assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: GE Healthcare
name: Brian Thomsen
role: STUDY_DIRECTOR
References:
Clinical trial NCT01317017: Cell Responses to IFN-gamma
Official title: Cellular Responses To Intradermal-Gamma (IFN-gamma) in Normal and Psoriatic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: IFN-gamma is a central player in the development of psoriasis lesions, which can be involved a variety of cellular processes in the skin. Dendritic cells are important cells in driving inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis. Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize that the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing T cells.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Normal volunteers with no evidence of skin disease OR diagnosis of plaque type psoriasis for at least 6 months
* 18 years of age or greater
* For women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study. Acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap; or a sterile sexual partner

Exclusion Criteria:

* Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
* Clinically significant psoriasis flare during screening or on the first treatment day
* Hypersensitivity to IFN-g or E. coli derivatives
* Pre-existing, uncontrolled myelosuppression, cardiac disease, seizure disorders, compromised central nervous system function or multiple sclerosis
* History of malignancy, clinically significant renal insufficiency, poorly controlled medical conditions that would increase the risks
* Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
* Pregnancy or lactation. As the risk of IFN-g in pregnancy is unknown, pregnant women will be excluded from the study.
* Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug

Primary outcomes:
measure: Function of dendritic cells from IFNg-injected skin
timeFrame: 6 months
Secondary outcomes:
measure: Flow cytometry analysis of circulating leukocyte populations
timeFrame: 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: The Rockefeller University
name: Michelle Lowes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071117: EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER
Official title: EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER(A RANDOMIZED CONTROLLED CLINICAL TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present study aims to assess and compare the effectiveness of distraction technique using virtual reality glasses and white noise with basic behavior guidance techniques on dental anxiety in children with Attention Deficit/ Hyperactivity Disorder.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.
* All children should be on stimulant medication.
* No previous dental experience.
* Written consent of the legal guardian.

Exclusion Criteria:

* Children with physical disabilities or other psychiatric disorders.
* Children with visual or hearing disabilities.
* Patients requiring emergency treatment

Primary outcomes:
measure: Dental anxiety assessment
timeFrame: up to one week
measure: Pulse rate
timeFrame: up to one week
measure: Level of cooperation
timeFrame: up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt
Study officials:
affiliation: Alexandria University
name: Nahla A Aly, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Amina M AbdElrahman, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Karin ML Dowidar, PhD
role: STUDY_CHAIR
affiliation: University of Alexandria
name: Tarek Omar, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02488317: Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)
Official title: Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Hemodialysis
Peritoneal Dialysis
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Henry Ford Health System
name: National Kidney Foundation, United States
name: American Association of Kidney Patients
name: Patient-Centered Outcomes Research Institute
First posted: 2015-07-02
Enrollment: 234
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: Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

For Aim 3, the investigators are going to compare measures related to the decision-making process between patients receiving and not receiving a decision aid focusing on Peritoneal Dialysis and Hemodialysis.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Speaks English
* Has access to the internet

Exclusion Criteria:

Primary outcomes:
measure: Preference for Shared Decision Making
timeFrame: 6 months
measure: Decisional Conflict
timeFrame: 6 months
measure: Decision Self-efficacy
timeFrame: 6 months
measure: Knowledge
timeFrame: 6 months
measure: Preparation for Decision Making
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Arbor Research Collaborative for Health
state: Michigan
Study officials:
affiliation: Arbor Research Collaborative for Health
name: Francesca Tentori, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Subramanian L, Zhao J, Zee J, Knaus M, Fagerlin A, Perry E, Swartz J, McCall M, Bryant N, Tentori F. Use of a Decision Aid for Patients Considering Peritoneal Dialysis and In-Center Hemodialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Sep;74(3):351-360. doi: 10.1053/j.ajkd.2019.01.030. Epub 2019 Apr 4.
Clinical trial NCT01175317: Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum
Official title: Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Carcinoma
Keywords: Hemodynamic optimization
Enhanced recovery after surgery
Goal-directed fluid
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 58
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: 58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut).

The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective colorectal surgery with anastomosis;
* Minimum age 18 years;
* Giving informed consent.

Exclusion Criteria:

* Other causes of intestinal damage: eg. IBD, occlusive disease;
* Steroid use;
* Esophageal varices and other esophageal disease;
* Aortic valve disease.

Primary outcomes:
measure: Peak Value of I-FABP
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Average Intraoperative CO2 Gap
timeFrame: Average intraoperative CO2 gap
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Maarten F Von Meyenfeldt, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Martijn Poeze, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Hospital
name: Geerard L Beets, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University
name: Wim A Buurman, PhD
role: STUDY_DIRECTOR
References: