louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06882252: Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes
Official title: Increasing Lean Protein Intake in Preschool-age Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower glycemic index.


Eligibility criteria: Inclusion Criteria:

* child 2-5 years old

Parent participants:

* Parents of at least one child aged 2-5 years old
* Parents can communicate in English.
* Parents in households who do not have a cultural/ religious reason to abstain from to consuming pork

Exclusion Criteria:

* Child participants:
* Food allergies
* Taking medication that affects food intake (such as stimulant medications),
* Children with diabetes or impaired glucose control.
* Children with digestive disease (such as Crohn's)
* Dietary/religious preferences that exclude consumption of pork

Parent participants:

- Dietary/religious preferences that exclude consumption of pork

Primary outcomes:
measure: Glycemic load of diet
timeFrame: 6 study days
measure: Hunger/Satiety self-reported on 4-point scale
timeFrame: 6 study days
Secondary outcomes:
measure: Blood pressure
timeFrame: 60 minutes after the meal.
measure: Blood glucose
timeFrame: 6 study days
measure: Executive function: focus and short-term memory
timeFrame: 6 study days
measure: Executive function: memory and focus
timeFrame: 6 study days
measure: Executive Function: Focus and Concentration
timeFrame: 6 study days
measure: Executive Function: Concentration
timeFrame: 6 study days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Varley BJ, Nasir RF, Skilton MR, Craig ME, Gow ML. Early Life Determinants of Vascular Structure in Fetuses, Infants, Children, and Adolescents: A Systematic Review and Meta-Analysis. J Pediatr. 2023 Jan;252:101-110.e9. doi: 10.1016/j.jpeds.2022.08.033. Epub 2022 Aug 24.
citation: Mikkila V, Rasanen L, Raitakari OT, Pietinen P, Viikari J. Consistent dietary patterns identified from childhood to adulthood: the cardiovascular risk in Young Finns Study. Br J Nutr. 2005 Jun;93(6):923-31. doi: 10.1079/bjn20051418.
Clinical trial NCT05770232: Retrospectively Analyze the Risk Factors of VTE in 5774 Patients With Thoracic Trauma From 33 Hospitals in China, and Established a Risk Prediction Model
Official title: In Order to Explore the Risk Factors of VTE After Acute Thoracic Trauma, we Collected the Diagnosis and Treatment Information of 5774 Patients With Thoracic Trauma From 33 Hospitals in China, Retrospectively Analyzed the Risk Factors of VTE in Patients With Thoracic Trauma, and Established a Risk Prediction Model.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thorax Injuries
Embolism Vein
Embolism, Pulmonary
Rib Fractures
Keywords: venous thrombus embolism
Thorax Injuries
risk factors
prediction model
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 5774
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18-80 years of age who were admitted within 3 days of chest trauma, did not have VTE prior to admission and were not receiving prophylactic anticoagulation. The chest trauma AIS score of QI patients with multiple injuries was greater than or equal to 3, and the chest trauma score of other combined injuries was less than or equal to 2.

Brief summary: Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33 hospitals in China, and established a risk prediction model

Detailed description: In order to explore the risk factors of VTE after acute thoracic trauma, we collected the diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals in China, retrospectively analyzed the risk factors of VTE in patients with thoracic trauma, and established a risk prediction model.

Eligibility criteria: Inclusion Criteria:

* admitted within three days of the chest trauma, VTE has not yet occurred, AIS score of thoracic injury was greater than or equal to 3, AIS score of other combined injuries was less than or equal to 2.

Exclusion Criteria:

* received preventive physical or chemical anticoagulation before admission, VTE occurred before admission

Primary outcomes:
measure: VTE
timeFrame: Peri-treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01534832: Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
Official title: Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Focus: Surgical Smoke During Laparoscopic Surgery
Keywords: surgical smoke
laparoscopic surgery
impaired vision
Lead sponsor: Asalus Medical Instruments Limited
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.

Detailed description: The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age
2. Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
3. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.

Exclusion Criteria:

1. \<18 years of age
2. Pregnant or lactating females
3. Previous extensive abdominal surgery, which in the opinion of the Investigator presents a \>5% risk of conversion to an open procedure being required
4. Current participation in another device or drug study
5. Unwilling or unable to provide informed consent

Primary outcomes:
measure: Maintenance of a clear visual field during surgery
timeFrame: 3m
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: University Hospital Llandough
state: Wales
Study officials:
affiliation: Cardiff and Vale UHB, Wales, UK
name: Jared Torkington, MBBS MS FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02148432: Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.

This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.


Eligibility criteria: Inclusion Criteria:

1. 20-60 years old patients with ASA class I-II
2. Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome

Exclusion Criteria:

1. Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale \< 15
2. Patients with severe cardiopulmonary dysfunction
3. Patients refusal

Primary outcomes:
measure: Desaturation rate
timeFrame: Baseline from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04502732: Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure
Official title: Direct Comparison of Short- And Long-Term Gastric Emptying By Nuclear Scintigraphy and Gastric Emptying Breath Test in Subjects Undergoing Endoscopic Gastric Remodeling For Weight Loss
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Weight Loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those eligible from relevant sub-studies.

Brief summary: The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).


Eligibility criteria: Inclusion Criteria:

* Subjects must be 22-65 years of age at time of enrollment
* Subjects must already be consented to 17-007934 or 19-001254
* Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.
* If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline
* Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits

Exclusion Criteria:

* Persons presently or soon to be incarcerated
* Females who are pregnant or suspect they may be pregnant
* Persons with nicotine and/or alcohol dependence
* Patients with cognitive impairment that limits their ability to make autonomous decisions
* Known allergies or sensitivities to study materials (eggs and spirulina)
* Assessed, by the physician or delegate, that enrollment would not be appropriate

Primary outcomes:
measure: Change of T1/2
timeFrame: Baseline, 2 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barham Abu Dayyeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04357132: Virtual Reality for Appendectomy Pain
Official title: Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendix Rupture
Pain
Pain, Postoperative
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
Primary purpose: OTHER

Brief summary: To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.


Eligibility criteria: Inclusion Criteria:

* Age 8 - 18 years
* Able to read, understand, and speak English
* Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix

Exclusion Criteria:

* Outside of age range (\<8 or \>18 years)
* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, and/or seizure disorders
* Conditions that would preclude the application of the VR headset, such as craniofacial deformities
* History of chronic pain, frequent opioid use and/or active cancer therapy

Primary outcomes:
measure: Effect on VR-biofeedback on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect on VR-biofeedback on anxiety
timeFrame: Immediately after VR session.
measure: Effect on VR-biofeedback on anxiety
timeFrame: 15 minutes after VR session.
measure: Effect on VR-biofeedback on anxiety
timeFrame: 30 minutes after VR session.
measure: Effect of VR-biofeedback on pain
timeFrame: Postoperatively 24 - 90 hours.
measure: Effect of VR-biofeedback on medication use
timeFrame: 24-90 hours
measure: Effect of VR-distraction on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect of VR-distraction on anxiety
timeFrame: Immediately after 10 minute VR session.
measure: Effect of VR-distraction on anxiety
timeFrame: 15 minutes after 10 minute VR session.
measure: Effect of VR-distraction on anxiety
timeFrame: 30 minutes after 10 minute VR session.
measure: Effect of VR-distraction on pain
timeFrame: Postoperatively 24 - 90 hours.
measure: Effect of VR-distraction on medication use
timeFrame: 24-90 hours
Secondary outcomes:
measure: Role of anxiety on changes in pain
timeFrame: One time prior to study visit
measure: Role of pain catastrophizing
timeFrame: One time prior to study visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Vanessa Olbrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05913232: Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Official title: A Phase 2b Randomized, Double-masked, Active-controlled, Dose-response Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma Open-Angle Primary
Ocular Hypertension
Lead sponsor: D. Western Therapeutics Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 201
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 trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 \[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae \>/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye

Note: Other inclusion/exclusion criteria apply.

Primary outcomes:
measure: Efficacy as Assessed by Change in Intraocular Pressure
timeFrame: Day 28
Secondary outcomes:
measure: Efficacy as Assessed by Intraocular Pressure
timeFrame: Day 28
measure: Safety as Assessed by Adverse Event Reporting
timeFrame: Screening through Day 28
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Colorado Springs
country: United States
facility: Skyline Vision Clinic and Laser Center
state: Colorado
city: Lakeland
country: United States
facility: Central Florida Eye Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Albany
country: United States
facility: Dixon Eye Care
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
Study officials:
affiliation: Dixon Eye Care
name: El-Roy Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03549832: Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure
Official title: Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HCV Coinfection
Keywords: HCV
DAAs
Non-responder
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Sohag University
name: South Valley University
First posted: 2018-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

Detailed description: HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.

Eligibility criteria: Inclusion Criteria:

* Patients with proven CHC genotype 4
* 18 years old or more,
* prior HCV treatment failure to sofosbuvir /daclatasvir
* compensated liver disease.

Exclusion Criteria:

* Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.

Primary outcomes:
measure: SVR rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hopsital
Study officials:
affiliation: Assiut University
name: Mohamed Mekky, MD
role: STUDY_DIRECTOR
References:
citation: Gutierrez JA, Lawitz EJ, Poordad F. Interferon-free, direct-acting antiviral therapy for chronic hepatitis C. J Viral Hepat. 2015 Nov;22(11):861-70. doi: 10.1111/jvh.12422. Epub 2015 Jun 17.
Clinical trial NCT03561532: Fecal Transplantation in Ulcerative Colitis
Official title: FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: University of Helsinki
First posted: 2018-06-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
Primary purpose: TREATMENT

Brief summary: Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

Detailed description: 80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).

The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.

Eligibility criteria: Inclusion Criteria:

* • • Diagnosis of CU based on clinical, endoscopic, and histological findings.

  * Remission assessed by Mayo score (0 to 1) and F-Calpro (\<100 ug/g).
  * Availability of consecutive fecal samples during one year after the diagnosis of CU.
  * Availability of blood sample to study the IBD associated genetic background
  * Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
  * 18-75 years

Exclusion Criteria:

* Unable to provide informed consent
* Need for any antibiotic therapy within 3 months
* Use of corticosteroids, immunosuppressive or biological medication at the baseline
* Use of any probiotics
* Pregnancy

Primary outcomes:
measure: Maintenance of remission of ulcerative colitis
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
References: