louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01915836: Quit IT: Development of a Web-based, 3D Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Official title: Quit IT: Development of a Web-based, 3D Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: 11-043
MSKCC Tobacco Cessation Program
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Muzzy Lane Software
First posted: 2013-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test a web-based video game to help cancer patients quit smoking. The investigators are interested in what participants like and do not like about the game.


Eligibility criteria: Inclusion Criteria:

* Treated by the MSKCC Tobacco Cessation Program
* At least 30 years of age

Exclusion Criteria:

* Insufficient manual dexterity and vision to use a computer and mouse as per self-report
* Unstable medical or psychiatric condition as determined by the PI and Co-PI.

Primary outcomes:
measure: Usability (10-item Game Usability Scale)
timeFrame: 1 time
measure: Satisfaction
timeFrame: 1 time
Secondary outcomes:
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: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krebs P, Burkhalter J, Fiske J, Snow H, Schofield E, Iocolano M, Borderud S, Ostroff JS. The QuitIT Coping Skills Game for Promoting Tobacco Cessation Among Smokers Diagnosed With Cancer: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10071. doi: 10.2196/10071.
Clinical trial NCT03551236: Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
Official title: Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Lead sponsor: Revenio Research
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Srebrnjak
First posted: 2018-06-11
Enrollment: 40
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young children screened to have small probability of asthma or wheezing

Brief summary: This is an observational study for the assessment of normal overnight variation in small healthy children using the Ventica Lung Function Testing System. The study is carried out to establish reference ranges for overnight lung function variation using the Ventica test, and to assess the impact of the demographic factors on the Ventica results.


Eligibility criteria: Inclusion Criteria:

* 18 months-6 years, both sexes
* Healthy at the time of inclusion
* Laboratory analyses in the reference range or not clinically relevant according to the investigator judgement
* Lung function in the reference range with a negative bronchodilator test result
* Signed informed consent

Exclusion Criteria:

* Preterm birth
* Chronic respiratory disorder of prematurity
* Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
* Primary immunodeficiency
* Chronic rhinosinusitis, synonasal polyposis
* Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing
* Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
* Personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
* Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
* Implanted or external active medical devices such as pacemakers

Primary outcomes:
measure: Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)
timeFrame: 1-3 nights per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Children's Hospital Srebrnjak
Study officials:
affiliation: Children's Hospital Srebrnjak
name: Davor Plavec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06412536: Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility
Official title: Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility (SWIFT-CORE-101)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Obesity
PreDiabetes
Diabetes Type 2
Metabolic Syndrome
Lead sponsor: Brooklyn Clinical Research
Sponsor class: NETWORK
First posted: 2024-05-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In year one of the program, we anticipate 4000 participants of any sex, age 18+, who have expressed interest in participating in an industry-sponsored clinical trial of an investigational product for indications in cardiovascular, obesity, and endocrine-related therapeutic areas will be screened for clinical appropriateness for a study trial.

Brief summary: SWIFT-CORE-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, comorbidities, and current symptoms. Site staff may collect vital signs, urine drug screens, blood draws, and urine pregnancy tests. A doctor will review medical history with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians and pharmacies to determine eligibility for clinical trials.


Eligibility criteria: Inclusion Criteria:

1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
2. Participant is at least 18 years old.

Exclusion Criteria:

1. Participant is pregnant, breast-feeding, or planning to become pregnant.
2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
3. Moderate or severe substance use disorder within 90 days prior to screen
4. Any condition that in the investigator's opinion makes a participant unsuitable for the study.
5. Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.

Primary outcomes:
measure: Number of participants who are interested in industry-sponsored clinical research
timeFrame: 5 years
Secondary outcomes:
measure: Characteristics associated with patient populations interested in clinical trials
timeFrame: 5 years
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn Clinical Research
state: New York
Study officials:
affiliation: Brooklyn Clinical Research
name: Ammara Mushtaq, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05470036: Improving Germline Testing in At-Risk Patients With Prostate Cancer
Official title: IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Germline testing
Education
Video
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.

Detailed description: This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.

Eligibility criteria: Inclusion Criteria:

1. Men, age greater than or equal to 18 years of age.
2. Diagnosis of prostate cancer of any histology.
3. Must meet NCCN guidelines for germline testing

Exclusion Criteria:

1. Have had prior germline testing.
2. Have somatic genetic testing that is positive for a possible germline variant.

Primary outcomes:
measure: Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.
timeFrame: 1 year
measure: Rate of germline genetic testing rate among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
timeFrame: 1 year
Secondary outcomes:
measure: Patient baseline knowledge of germline testing and the change in knowledge of germline testing with the educational intervention.
timeFrame: 18 months
measure: Patient baseline attitudes towards germline testing and assess the impact of an education interventional on patient perceptions of germline testing
timeFrame: 18 months
measure: Impact of germline testing results on prostate cancer management
timeFrame: 18 months
measure: Prevalence of pathogenic germline mutations in patient population
timeFrame: 18 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Rana McKay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00545636: The Influence of Education of Medical Team on Duration of Fasting Before Elective Medical Interventions Performed Under General Anesthesia in Children
Official title: The Influence of Education of Medical Team on Duration of Fasting Before Elective Medical Interventions Performed Under General Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Duration of Preoperative Fasting
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-17
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to examine if an education program of the medical teams can help implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory medical interventions under anesthesia and decrease unnecessary long fasting. We shall ask parents of such children to fill in a questionnaire regarding pre-anesthesia fasting and regular eating and drinking habits. Thereafter, all medical teams involved with the administration of NPO orders will receive an educational program to explain and implement the NPO orders as are recommended by the American Society of Anesthesiologists. We will examine if the educational program was successful in reducing unnecessary long period of fasting, and if such a program is not associated with increased rate of delay of cases.


Eligibility criteria: Inclusion Criteria:

* Children who are about to undergo anesthesia for elective medical interventions,
* Age 0-18 years

Primary outcomes:
measure: Education of the medical teams as to preoperative fasting time will aid in shortening of an unnecessary prolonged fasting
timeFrame: Immediate pre-anesthesia period (to assess lenth ofpreoperative fasting time)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center, Department of Anesthsia C and Department of Anesthesia
name: Ze'ev Shenkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Haim Berkenstadt, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05590936: Dimenydrinate vs Ondansetron for PONV (DONV)
Official title: Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PONV in Laparoscopic Cholocystectomies
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.

Detailed description: Dimenydrinate has been extensively used for motion sickness. However, as far as postoperative nausea and vomiting is concerned the results are still conflicting.

This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old
* ASA PS I-III
* Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations

Exclusion Criteria:

* Refused to participate
* Age other than 18-75 years old
* Pregnant patients
* Non-elective operations
* Patients that are not able to receive p.os agents
* Medical history of Brugada Sdr or Brugada-like/related ECG abnormalities
* Long-Qt Sdr or concurrent use of medications that may cause long-QT ECG abnormalities
* Medical or family history of psychosis
* Allergy in dimenydrinate or in dimenydrinate drug versions
* Perioperative use of dexamethasone

Primary outcomes:
measure: PONV
timeFrame: 30 minutes postoperative
measure: PONV
timeFrame: 60 minutes postoperative
measure: PONV
timeFrame: 12 hours postoperative
measure: PONV
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: preoperative anxiety
timeFrame: 24 hours before operation
measure: preoperative anxiety
timeFrame: 30 minutes before operation
measure: Awaken time
timeFrame: on extubation
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larisa, Department of Anesthesiology
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Elena Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Konstantinos George Stamoulis, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06415136: Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
Official title: Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Disc Herniation
Lead sponsor: Research Source
Sponsor class: NETWORK
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the SeaSpine Shoreline device during the surgical procedure. If the surgeon decides intra-operatively not to utilize the SeaSpine Shoreline device, the patient will be considered a screen failure.

Brief summary: The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.

Detailed description: This is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the SeaSpine Shoreline device. Patients will be identified by the Investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria.

Eligibility criteria: Inclusion Criteria:

1. Appropriate patient, as determined by the Investigator, scheduled for an elective cervical spine fusion to treat adjacent level cervical disc herniation or degeneration resulting in cervical radiculopathy or myelopathy
2. At least 18 years of age
3. Failure of nonoperative care
4. Previous anterior cervical plating
5. Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements

Exclusion Criteria:

1. Pregnancy or anticipated to become pregnant during the course of the study
2. No previous cervical spine surgery
3. Non-instrumented cervical fusion
4. Cervical fusion with separate plate fixation
5. Unwilling or unable to sign consent
6. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
7. Currently a prisoner

Primary outcomes:
measure: Cervical fusion assessed via CT scan
timeFrame: 12 months post surgery
measure: Clinical outcome via neck visual analog scale (VAS)
timeFrame: 12 months post surgery
measure: Clinical outcome via neck disability index (NDI)
timeFrame: 12 months post surgery
measure: Clinical outcome via Dysphagia score
timeFrame: 12 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Michigan Orthopaedic Surgeons
state: Michigan
Study officials:
References:
Clinical trial NCT05678036: Effects on Mortality and Clinical Course of a Patient's Choice Model for Opioid Maintenance Treatment for Opioid Dependence - Evaluation of a System Enabling a Large Expansion of Treatment Providers and Treatment Access
Official title: Effects on Mortality and Clinical Course of a Patient's Choice Model for Opioid Maintenance Treatment for Opioid Dependence - Evaluation of a System Enabling a Large Expansion of Treatment Providers and Treatment Access
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Dependence
Overdose
Keywords: opioid dependence
opioid maintenance treatment
methadone
buprenorphine
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-01-10
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in opioid maintenance treatment in Skåne region since 2014

Brief summary: Opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications, social problems and crime. Opioid maintenance treatment (OMT) has proven effective in opioid dependence. In 2014, a patient's choice reform in Skåne county, Sweden, was introduced and led to a vast extension of OMT in the region, including a large number of treatment providers and high access to treatment. Still, opioid-related mortality in the region remains high. While patients' access to treatment has been increased, the content and nature of treatment in the present system has been questioned. The present system, which dramatically altered treatment conditions and access for OMT in this region, has never been formally evaluated in any large-scale study. This study aims to assess clinical course of patients receiving OMT before and during the patient choice reform system, and effects on the extent and nature of opioid-related mortality in the region.


Eligibility criteria: Inclusion Criteria:

* Patients included in opioid maintenance treatment in Skåne region.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Mortality
timeFrame: study inclusion through 2022
measure: Hospitalization for substance use disorder treatment
timeFrame: study inclusion through 2022
Secondary outcomes:
measure: Mental health disorder
timeFrame: study inclusion through 2022
measure: Physical disorder
timeFrame: study inclusion through 2022
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Addiction Center
Study officials:
affiliation: Region Skåne
name: Anders Håkansson, PhD
role: PRINCIPAL_INVESTIGATOR
References: