louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06096987: Teen-to-Teen Videos to Improve Electronic Medical Record Portal Knowledge and Personal Health Information Engagement
Official title: Examining the Effects of MyChart Peer Education on Adolescent Health Literacy and Engagement With Personal Health Information
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Huang, Jeannie, M.D.
Sponsor class: INDIV
Collaborators: name: North American Society for Pediatric Gastroenterology Hepatology and Nutrition
First posted: 2023-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare whether videos help teens better understand medical topics. The main questions answered in this trial are:

1. whether videos can improve teen knowledge about electronic medical record portals
2. whether videos can improve teen knowledge about general health issues

Participants will answer surveys and watch videos as part of this study.

Detailed description: Investigators performed a randomized controlled trial of education videos addressing one of two topics: A) electronic medical record portals and information shared therein and B) general adolescent health issues among adolescents and young adults with inflammatory bowel diseases. Investigators evaluated the efficacy of each in increasing participant knowledge in that arena.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Inflammatory Bowel Disease
* English proficient

Exclusion Criteria:

- Unable to give consent

Primary outcomes:
measure: Electronic medical record (EMR) portal knowledge assessment
timeFrame: Baseline and Immediately after video watching (all done SAME DAY - 1 day)
measure: General adolescent health knowledge assessment
timeFrame: Baseline and Immediately after video watching (all done SAME DAY - 1 day)
Secondary outcomes:
measure: Short Test of Functional Health Literacy in Adults
timeFrame: At baseline
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: University of California San Diego/Rady Children's Hospital
name: Jeannie Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04998487: A Single-Dose Study of LY3471851 in Healthy Participants
Official title: A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2021-08-10
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history and physical examination.
* Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing)
* Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment
* Are immunocompromised per investigator judgment.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
timeFrame: Predose up to 56 days postdose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851
timeFrame: Predose up to 56 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: LabCorp CRU, Inc.
state: Florida
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04396587: Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone
Official title: Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in female patients. Methods: A total of 60 patients were randomly divided into 4 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) ,saline(10ml)was administered before anesthesia induction. Bispectral Index (BIS), Respiratory rate(RR), other non-analgesic effects at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists GradeⅠ-II;
* Patients undergo low-risk elective surgery for benign diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, breast operation, thyroid operation, etc) ;
* Aged 18-45 years;
* Body Mass Index 18-25kg/m2, weight 40-65 kilograms;
* Agreed to participate in the research

Exclusion Criteria:

* Difficult airway;
* upper respiratory tract infection within 2 weeks;
* history of allergy or long-term use of propofol and opioids;
* self-rating anxiety scale before operation indicates anxiety;
* pregnancy or lactation.

Primary outcomes:
measure: Respiratory rate
timeFrame: 20 minutes after administration
measure: Bispectral Index
timeFrame: 20 minutes after administration
measure: dizziness
timeFrame: 20 minutes after administration
Secondary outcomes:
measure: itch
timeFrame: 20 minutes after administration
measure: nausea or vomiting
timeFrame: 20 minutes after administration
measure: drowsiness
timeFrame: 20 minutes after administration
measure: sweating
timeFrame: 20 minutes after administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05118087: Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
Official title: Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Humeral Fractures
Keywords: Sarmiento Brace
Coaptation Splint
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 66
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: The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.


Eligibility criteria: Inclusion Criteria:

1. Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture
2. Age above 18 and skeletally mature
3. Isolated Injury
4. Treated non-operatively first 2 weeks

Exclusion Criteria:

1. Open fractures
2. Poly trauma
3. Injuries deemed operative by attending surgeon
4. Patients undergoing treatment for malignancy
5. Prisoners

Primary outcomes:
measure: Score on Pain Visual Analogue Scale (VAS)
timeFrame: Week 1 post-treatment
measure: Score on Pain Visual Analogue Scale (VAS)
timeFrame: Week 2 post-treatment
measure: Number of Tramadol Pills Taken
timeFrame: Week 1 post-treatment
measure: Number of Tramadol Pills Taken
timeFrame: Week 2 post-treatment
Secondary outcomes:
measure: Incidence of cutaneous complications
timeFrame: Week 2 post-treatment
measure: Score on PROMIS - Physical Function - Short Form 10b
timeFrame: Week 1 post-treatment
measure: Score on PROMIS - Physical Function - Short Form 10b
timeFrame: Week 2 post-treatment
Other outcomes:
Locations:
city: Garden City
country: United States
facility: NYU Winthrop Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Queens
country: United States
facility: Jamaica Hospital Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Abhishek Ganta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06229587: Furlow With Buccinator and Velopharyngeal Function
Official title: Speech and Middle Ear Outcomes Following Primary Cleft Palate Repair by Furlow Z-plasty Technique With a Buccinator Myomucosal Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap


Eligibility criteria: Inclusion Criteria:

* - Age 3 to 7 years
* 1ry cleft repair by furrolow with buccal myomucosal flap
* Non syndromic previously treated children
* Cleft repaired by the same surgeon

Exclusion Criteria:

* - Syndromic patient
* Cleft palate repair by any technique except furlow with buccal myomucosal flap

Primary outcomes:
measure: speech assessement
timeFrame: 3years
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Hearing Institution
Study officials:
References:
Clinical trial NCT05038787: A Study of LY3473329 in Healthy Japanese Participants
Official title: A Phase 1, Randomized, Investigator- and Participant-Blind, Placebo-Controlled Study of LY3473329 Multiple-Ascending Dosing in Healthy Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to about 71 days, inclusive of screening period.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined through medical history and physical examination.
* Are males who agree to follow contraception requirements or females not of childbearing potential.
* Are 1st generation Japanese defined as the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

Exclusion Criteria:

* Have a history or presence of medical illness.
* Have significant history of or current psychiatric disorders.
* Have abnormalities in the 12-lead ECG and blood pressure.
* Have received treatment with siRNA within the past 12 months or any antisense oligonucleotide within the past 6 months for lipoprotein(a) \[Lp(a)\].

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 43
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329
timeFrame: Predose on Day 1 through Day 43
measure: PK: Maximum Concentration (Cmax) of LY3473329
timeFrame: Predose on Day 1 through Day 43
measure: PK: Time to Maximum Concentration (Tmax) of LY3473329
timeFrame: Predose on Day 1 through Day 43
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06629987: Determining the Most Efficient Screening Cut Off Levels for Phenylketonuria (PKU)
Official title: Determining the Most Efficient Screening Cut Off Levels for Phenylketonuria (PKU) by Assessing Two Years of Screening with Tandem Mass Spectrometry (MS) : a French National Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PKU
Keywords: screening
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: Hospices Civils de Lyon
name: University Hospital, Strasbourg, France
name: CHU de Reims
name: Centre Hospitalier Universitaire, Amiens
name: Centre Hospitalier Universitaire Dijon
name: Nantes University Hospital
name: University Hospital, Tours
name: Clinical Research Center of Reunion island
name: University Hospital, Caen
name: Rennes University Hospital
name: University Hospital, Bordeaux
name: University Hospital, Toulouse
name: University Hospital, Montpellier
First posted: 2024-10-08
Enrollment: 360
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all french population born who had a screening

Brief summary: studying the screening of PKU in france with the new tandemMS

Detailed description: Nationwide cohort study of the new pku screening for patient beetwen 180 and 360 µmol/L.

Eligibility criteria: Inclusion Criteria:

* having screening in france

Exclusion Criteria:

* refusing neonatal screening

Primary outcomes:
measure: developping an PKU: id phenylanine over 360µmol/L
timeFrame: 1 year
Secondary outcomes:
measure: screening value
timeFrame: 2 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU NANCY hopital enfant
Study officials:
References:
Clinical trial NCT00488787: Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of 10 mg, 30 mg, and 50 mg of Transnasal Ketamine Hydrochloride (PMI-100) for the Treatment of Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: dental
surgery
analgesia
2-4 impacted third molars
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.


Eligibility criteria: Inclusion Criteria:

* Healthy patients at least 16 years of age requiring two or more third molar extractions

Exclusion Criteria:

* Less than 16 years old
* Other exclusion criteria may apply

Primary outcomes:
measure: total pain relief over 0-3 hours following dosing
timeFrame: 3 hours
Secondary outcomes:
measure: other pain assessments
timeFrame: 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: Jean Brown Associates
name: Kyle Christensen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06819787: Patient Experiences With Contraceptive Care Provided by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform
Official title: Patient-Reported Outcomes of Contraceptive Services Rendered by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform: The PRISM-CS Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contraception
Keywords: Contraception
Pregnancy Prevention
Digital Health
Pharmacist
Community Pharmacy Services
Patient-reported Outcomes
Lead sponsor: OvaryIt, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: University of Utah
First posted: 2025-02-11
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first seeing another healthcare provider. The Pharmacist Resource to Implement Services as Modules (PRISM) is an Electronic Health Record platform designed to streamline workflows and provide clinical decision support, making it easier and safer to deliver clinical services in community pharmacies. This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community pharmacies across the United States over a 12-week period. The study will assess the quality of care, contraception continuation and failure rates, side effect rates, preventative healthcare utilization, and overall patient experience with pharmacy contraceptive services.


Eligibility criteria: Inclusion Criteria:

• Women presenting for hormonal contraceptives

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Unable to become pregnant
* Not English speaking
* Suspected coercion
* Unable to consent

Primary outcomes:
measure: Person-Centered Contraceptive Counseling (PCCC) Measure
timeFrame: Within 7 days post-intervention
Secondary outcomes:
measure: Three-month Contraceptive Continuation Rate
timeFrame: Within 97 days post-intervention
Other outcomes:
measure: Contraceptive Failure Rate
timeFrame: Within 97 days post-intervention
measure: Contraceptive Side Effect Rate
timeFrame: Within 97 days post-intervention
measure: Patient Contraceptive Satisfaction
timeFrame: Within 97 days post-intervention
measure: Patient Perception, Attitudes, and Satisfaction Regarding Pharmacist Contraceptive Services
timeFrame: Within 97 days post-intervention
measure: Preventative Health Services Utilization
timeFrame: Within 97 post-intervention
Locations:
Study officials:
References:
Clinical trial NCT05484687: Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
Official title: Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Tumors
Lidocaine
Keywords: Radical resection of colorectal tumor
lidocaine
stress
immunity
vascular tumor regeneration
inflammation
micrometastasis
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment play important roles in tumor recurrence and metastasis, and modulating the tumor microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor growth in animal experiments.

Detailed description: Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the postoperative microenvironment and micrometastasis of the patients was observed by detecting the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.

Eligibility criteria: Inclusion Criteria:

* colorectal tumor patients

Exclusion Criteria:

* Weight \<45kg and \>100kg
* Sensitivity or hypersensitivity to lidocaine
* Second or third degree heart block
* Severe heart failure (ejection fraction \< 20%)
* History of active rhythm disorder
* Acute severe liver and kidney injury
* History of uncontrolled seizures
* History of acute porphyria.

Primary outcomes:
measure: the concentration of tumor micrometastasis markers were determined by ELISA
timeFrame: 3 days after surgery
Secondary outcomes:
measure: the concentration of stress hormones were determined by ELISA
timeFrame: 3 days after surgery
measure: the concentration of inflammatory factor were determined by ELISA
timeFrame: 3 days after surgery
measure: the concentration of angiogenesis factors were determined by ELISA
timeFrame: 3 days after surgery
measure: the concentration of immune indexes were determined by ELISA
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Chair
name: hongsheng chen
role: PRINCIPAL_INVESTIGATOR
References: