louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05344118: Parental Perceptions on Prescription Opioid Use
Official title: Parental Perceptions on Prescription Opioid Use for Pain Control in Children Undergoing Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children scheduled for orthopedic surgery

Brief summary: This study involves an anonymous survey given to parents regarding their perceptions on prescription opioid use for pain control in children undergoing orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

* Parents of patients between 1-18 years of age scheduled for orthopedic surgery at Nationwide Children's Hospital.

Exclusion Criteria:

* Parents with children less than 1 or greater than 18 years of age or scheduled for surgery other than orthopedic.
* Non-English speaking parents.

Primary outcomes:
measure: Comfort With Child Receiving Opioids During Surgery
timeFrame: Baseline
measure: Comfort With Child Receiving Opioids After Surgery
timeFrame: Baseline
measure: Danger of Opioids
timeFrame: Baseline
measure: Opioid Education
timeFrame: Baseline
measure: Safe Storage of Opioids
timeFrame: Baseline
measure: Safe Disposal of Opioids
timeFrame: Baseline
Secondary outcomes:
measure: Employment Status
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: Gender of Child
timeFrame: Baseline
measure: Age of Child
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00467441: VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Excessive Somnolence
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with no medical, psychiatric, or current sleep disorders
* Subject must sign a written consent form

Exclusion Criteria:

* Evidence of excessive daytime sleepiness
* History of sleep disorders
* Psychiatric or neurological disorders

Primary outcomes:
measure: Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Secondary outcomes:
measure: Mood
measure: Psychomotor performance
measure: Safety and tolerability
Other outcomes:
Locations:
city: Dijon
country: France
facility: Vanda Investigational Site
Study officials:
affiliation: Vanda Pharmaceuticals
name: Gunther Birznieks
role: STUDY_DIRECTOR
References:
Clinical trial NCT06474741: Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly
Official title: Both Sides Now: Using Computer Vision and App-based Intervention for Prediction and Prevention of Infant Torticollis and Plagiocephaly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Torticollis
Keywords: prevention
Lead sponsor: College of Staten Island, the City University of New York
Sponsor class: OTHER
Collaborators: name: Duquesne University
First posted: 2024-06-26
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test whether an app-based intervention can reduce the likelihood of a torticollis diagnosis in infants. The main question\[s\] it aims to answer are:

* whether an app can successfully deliver an intervention to parents of young infants
* whether parents who learn about torticollis will increase behaviors intended to prevent torticollis compared to parents who learn about general infant development

Participants will complete a monthly survey for 6 months asking about their parenting behaviors. Researchers will compare parents who receive notifications about torticollis with parents who receive notifications about general infant development to see if increased knowledge of torticollis leads to preventive behavior.


Eligibility criteria: Inclusion Criteria:

* any parent with an infant under a month old who can answer a survey in English

Exclusion Criteria:

* infant already has a diagnosis of torticollis or plagiocephaly

Primary outcomes:
measure: symmetry score
timeFrame: baseline and 4 months
Secondary outcomes:
measure: gaze asymmetry score
timeFrame: 6 months
measure: time spent in focused attention
timeFrame: 6 months
measure: # of bouts of focused attention
timeFrame: 6 months
measure: correlation between computer vision algorithm & manual coding for infants' head turns
timeFrame: 4 months
measure: Correlate computer vision score with clinical test of symmetry
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00579241: Detection of Ultrasound Contrast Signals in the Cerebral Circulation
Official title: Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Vascular Disorders
Coronary Artery Disease
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To Determine whether transcranial ultrasound can detect the presence of intravenously injected microbubbles used routinely for dobutamine stress echocardiography.

Detailed description: The purpose of this study is to determine whether the intravenous microbubbles used to improve border delineation during dobutamine stress echocardiographies (DSE) can be detected within the cerebral circulation.

Eligibility criteria: Inclusion Criteria:

* male or female age \>19 years of age
* scheduled for a stress echocardiogram
* negative urine pregnancy test within two hours of ultrasound contrast administration required for females of childbearing age unless post-menopausal or with evidence of surgical sterilization
* be conscious and coherent, and able to communicate effectively with trial personnel

Exclusion Criteria:

* pregnant or lactation
* life expectancy of less than 2 months or terminally ill
* Known or suspected hypersensitivity to ultrasound contrast agent used for the study
* complicated hemodynamic instability
* Known left main disease

Primary outcomes:
measure: Detect abnormalities in cerebral blood flow
timeFrame: immediate
Secondary outcomes:
measure: if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities.
timeFrame: within 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska Medicial Center
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00385541: Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
Official title: The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: pain
morphine
hydromorphone
nausea
vomiting
pruritis
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2006-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug


Eligibility criteria: Inclusion Criteria:

* patients scheduled for abdominal surgery requiring post-operative PCA
* ASA = I or II

Exclusion Criteria:

* preoperative pain or use of pain medication
* narcotic allergy
* morbid obesity (Body Mass Index \> 30)
* diagnosis of sleep apnea
* hepatic or renal disease
* use of medications that would affect narcotic pharmacodynamics
* preoperative nausea, vomiting, or pruritis
* diagnosis of alcoholism

Primary outcomes:
measure: Nausea Assessment by Patient
timeFrame: 1 hour after surgery, 8 hours after surgery
Secondary outcomes:
measure: Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
timeFrame: 1 hour after surgery, 8 hours after surgery
measure: Pain Assessment by Patient
timeFrame: 1 hour after surgery, 8 hours after surgery
measure: The Number of Patients Who Vomited
timeFrame: 1 hour after surgery, 8 hours after surgery
measure: Mean Score on the Ramsey Scale of Sedation
timeFrame: 1 hour after surgery, 8 hours after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Pamela Flood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb.
Clinical trial NCT01472341: Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes (MK-0000-113)
Official title: Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 507
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants visiting a diabetologist as part of their routine care. Investigator's prescription is not influenced by the study: Investigator decides about what is the best treatment for any single participant independently of the study.

Brief summary: The purpose of this study is to evaluate the degree of beta-cell dysfunction among participants with type 2 diabetes and the association between beta-cell dysfunction and demographic, clinical, and treatment variables.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria
* Oral hypoglycemic drug therapy for ≥1 year
* Continuous care at the clinic (at least 2 visits) for at least one year
* Medical records completed with a minimum core data set
* Completed consent form

Exclusion Criteria:

* Participation in a clinical trial in the previous 1 year
* Currently using insulin
* Type 1 diabetes
* Pregnancy

Primary outcomes:
measure: Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years
timeFrame: Baseline and 4 years
measure: Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years
timeFrame: Baseline and Year 4
measure: Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02898441: Early Stage Lung Cancer Screening With Low-dose Computed Tomographic
Official title: Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer screening
low-dose CT
high-risk population
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 6000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.


Eligibility criteria: Inclusion Criteria:

* Eligible participants were those aged 45-70 years, and with either of the following risk factors:

  1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  2. malignant tumors history in immediate family members;
  3. personal cancer history;
  4. professional exposure to carcinogens;
  5. long term exposure to second-hand smoke;
  6. long term exposure to cooking oil fumes.

Exclusion Criteria:

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years

Primary outcomes:
measure: Lung cancer incidence rate
timeFrame: 5 years
Secondary outcomes:
measure: Lung cancer mortality
timeFrame: 5 years
measure: All-cause mortality
timeFrame: 5 years
Other outcomes:
measure: Nodule detection rate
timeFrame: One year
Locations:
city: Shanghai
country: China
facility: Shanghai Chest hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Baohui Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07006441: Cardiac Rehabilitation in Coronary Artery Bypass Graft Surgery
Official title: The Effects of Preoperative and Postoperative Cardiac Rehabilitation in Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery
Coronary Artery Disease
Keywords: Coronary Artery Disease
Coronary Artery Bypass Graft Surgery
Preoperative Cardiac Rehabilitation
Postoperative Cardiac Rehabilitation
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial investigates the comparative effects of a combined preoperative and postoperative cardiac rehabilitation program versus a postoperative-only program on functional capacity, pulmonary function, peripheral muscle strength, pain, kinesiophobia, and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery. The study aims to determine whether initiating rehabilitation prior to surgery improves short-term postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* Having undergone coronary artery bypass graft surgery
* Ejection Fraction (EF) \> 40%
* Being between the ages of 18-65
* Being able to speak, read and understand in their own language
* Volunteering to participate in the study

Exclusion Criteria:

* Having an active or suspected infection
* Presence of an active tumour
* History of thrombophlebitis or pulmonary embolism within the last 3 months
* Having an orthopaedic, neurological or cardiovascular disease that may affect the assessments

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 2 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 2 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 2 weeks
measure: Forced Expiratory Flow 25-75% (FEF25-75)
timeFrame: 2 weeks
measure: 6-minute Walk Test
timeFrame: 2 weeks
measure: M. Quadriceps Muscle Strength
timeFrame: 2 weeks
measure: M. Biceps Muscle Strength
timeFrame: 2 weeks
measure: Cough Peak Flow
timeFrame: 2 weeks
Secondary outcomes:
measure: Level of Pain
timeFrame: 2 weeks
measure: Level of Fear of Movement
timeFrame: 2 weeks
measure: Level of Quality of Life
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
Study officials:
affiliation: Atlas University
name: Hikmet Ucgun, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001519: Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy
Official title: A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.

Detailed description: First outcome measures (analysis) :at the time of surgery,

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically proven breast cancer
2. Age, at least 20 years
3. ER/PR/HER2 (negative/negative/negative

   * ER/PR negative: nuclear reaction \< 1%, Allred score 0 or 2
   * HER2 negative: HER2; IHC (immunohistochemistry) 0,1+ or FISH/SISH (-) in case of IHC 2+
4. Clinically stage II or III with histologically proven lymph-node involvement (T \>1.5 cm or lymph node \[LN\] \>1.5 cm)
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. No prior hormonal treatment, chemotherapy or radiotherapy is allowed.
7. Adequate hematologic, liver and kidney function
8. Written informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Prior chemotherapy or radiotherapy for any malignancy
3. Stage T4d; inflammatory breast cancer
4. No primary tumor (T0)
5. Documented history of cardiac disease contraindicating anthracyclines
6. Currently active infection

Primary outcomes:
measure: pathologic complete response (pCR) rate
timeFrame: up to 36 weeks
Secondary outcomes:
measure: Overall response rate (ORR) by radiologic evaluation
timeFrame: up to 36 weeks
measure: Complete metabolic response (CMR) rate after 2 cycles of AC
timeFrame: up to 12 weeks
measure: 3 year disease free survival (3yr-DFS)
timeFrame: 3 years
measure: Rate of breast conservation
timeFrame: up to 36 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Bae Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690219: Prevalence of Acute Injuries in Amateur and Elite Mountain Bikers
Official title: Prevalence of Acute Injuries in Amateur and Elite Mountain Bikers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Injury in Mountain Biking
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators included all mountain bikers participating in the Swiss Epic Mountain Bike Event in 2017, who agreed to attend in the survey.

Brief summary: The investigators intented to assess the prevalence of acute injuries in amateur and elite mountain bikers.

Detailed description: In order to assess the prevalence of acute injuries in amateur and elite mountain bikers a questionnaire was created in accordance to existing literature. The questionnaire was translated in several languages by bilingual people familiar with mountain biking. The questionnaire focussed on demographic data, training volume, number of races per year, number of injuries since practising mountain biking, wearing of protective gear items and accident mechanism. The survey was conducted during the Swiss Epic Mountain Bike Event in 2017. All riders were asked to voluntarily participate in the survey.

Eligibility criteria: Inclusion Criteria:

* mountain bikers participating in the Swiss Epic Mountain Bike Event in 2017

Exclusion Criteria:

* non-participators, non-mountain bikers in the Swiss Epic Mountain Bike Event in 2017

Primary outcomes:
measure: Prevalence of acute injuries in amateur and elite mountain bikers
timeFrame: During the Swiss Epic Mountain Bike Event 2017 lasting from the 11th to 16th September
Secondary outcomes:
measure: Differences in training and racing volume between amateur and elite mountain bikers.
timeFrame: During the Swiss Epic Mountain Bike Event 2017 lasting from the 11th to 16th September
measure: Differences in years practising mountain biking between amateur and elite mountain bikers.
timeFrame: During the Swiss Epic Mountain Bike Event 2017 lasting from the 11th to 16th September
measure: Differences in the amount of protective gear items between amateur and elite mountain bikers.
timeFrame: During the Swiss Epic Mountain Bike Event 2017 lasting from the 11th to 16th September
measure: Differences in demographics, training and racing volume, years practising mountain biking, the wearing of protective gear items and number of injuries between amateur and elite mountain bikers.
timeFrame: During the Swiss Epic Mountain Bike Event 2017 lasting from the 11th to 16th September
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: SUPSI
state: GR
Study officials:
References: