louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06397716: Public Health Initiative on Alcohol Flushing
Official title: A Public Health Education and Awareness Initiative on Alcohol Flushing and Alcohol-related Cancer in Asian Communities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Toxicity
Keywords: Alcohol Flushing
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Stanford Center for Asian Health Research and Education
First posted: 2024-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the study is to raise awareness of alcohol flushing and its health risks to the general population.

The primary objective is to see if spreading awareness of the health risks of alcohol flushing and understanding personalized genotype information will lead to changes in alcohol consumption behavior.


Eligibility criteria: Inclusion Criteria:

* Adult age over 18
* Native English speaker

Exclusion Criteria:

* None

Primary outcomes:
measure: Alcohol Flushing Awareness
timeFrame: Baseline, 1 month, 3 month
measure: Alcohol Consumption Habits 1
timeFrame: Baseline, 1 month, 3 month
measure: Alcohol Consumption Habits 2
timeFrame: Baseline, 1 month, 3 month
measure: Alcohol Consumption Habits 3
timeFrame: Baseline, 1 month, 3 month
measure: Alcohol Consumption Habits 4
timeFrame: Baseline, 1 month, 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kevin Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548716: A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
Official title: A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
End Stage Renal Disease
Keywords: Pruritis in hemodialysis patients
25-Vitamin D in chronic kidney disease
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2012-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD patients on hemodialysis

Brief summary: Hypothesis:

25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching

25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.

Detailed description: 25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to 25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary endpoints for both studies are continuous variables. Student's t test will be used to test for statistical significance. Multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis treatment for \> 3 months No complaints of itching within 1 month prior to study enrollment

Exclusion Criteria:

* Age \< 18 years
* Failure to provide informed consent
* Intact PTH \< 70 pg/ml or \> 1,000 pg/ml
* Serum phosphorus \> 7.0
* Serum calcium (adjusted for albumin)\> 11
* Active malignancy
* Likelihood of imminent renal transplantation
* Current ergocalciferol treatment

Primary outcomes:
measure: 25 hydroxy vitamin D level
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital Dialysis Unit
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Mary Schanler, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06997016: Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
Official title: Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: transplantation, kidney
renal transplantation
Enhanced Postsurgical Recovery
Recovery, Enhanced Postsurgical
pain, postoperative
postsurgical pain
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are:

Does the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain.

Participants will be asked to:

* Drink a pre-surgery carbohydrate drink two hours before your surgery.
* Take a pre-surgery dose of Tylenol by mouth.
* Take a pre-surgery dose of Gabapentin by mouth.
* The surgeon will administer a local numbing medication at the surgery site by injection during the surgery.
* Begin walking with assistance about 12 hours after your surgery.
* Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.


Eligibility criteria: Inclusion Criteria:

* Adult patients, over 18 years of age, receiving a kidney transplant from a living donor.

Exclusion Criteria:

* delayed gastric emptying, severe type I diabetes, allergy to interventional medications, pregnancy (this is a normal exclusion for kidney recipients)

Primary outcomes:
measure: Pain Scores
timeFrame: From enrollment to the end of treatment at 30 days
measure: Narcotic Use
timeFrame: From enrollment to the end of treatment at 30 days
Secondary outcomes:
measure: Adverse Events
timeFrame: From enrollment to the end of treatment at 30 days
measure: Hospital readmission
timeFrame: From enrollment to the end of treatment at 30 days
measure: Length of Stay
timeFrame: From enrollment to the end of treatment at 30 days
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints Medical Center
state: Texas
Study officials:
affiliation: Baylor Scott & White All Saints Medical Center
name: Richard Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02681016: Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE
Official title: Prospective rAndomized, Single-blind, multicenTral Control Clinical Trial of Sirolimus-eluting coRonary Stent "Calypso" (Angioline) vs Everolimus-elutIng cOronary stenT "Xience Prime" (Abbott Vascular)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Atherosclerosis
Coronary Artery Disease
Coronary Artery Stenosis
Keywords: Calypso
Xience
Coronary stenosis
Drug-eluting stent
Coronary angioplasty with stenting
Ischemic Heart Disease
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-02-12
Enrollment: 610
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: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary stent "Calypso" (Angioline, Russia) in comparison with everolimus-eluting coronary stent "Xience" (Abbott Vascular, USA)


Eligibility criteria: Inclusion Criteria:

* Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
* Target vessel lesion in coronary artery with diameter measurements \>2.5 mm \& \< 4.5 mm.
* Signed, documented informed consent prior to admission to the study

Exclusion Criteria:

* Age \<18 years or \>75 years
* Renal insufficiency (GFR/MDRD \<30 ml/min)
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
* Known non-adherence to DAPT
* LVEF \<30%
* Known oncology
* Severe cardiac valvular pathology, requiring operative treatment within 1 year
* Anemia (HB\<100 g/l)
* Continuing bleeding
* Acute coronary syndrome (ST-elevation Myocardial infarction)
* Anamnesis of previous coronary angioplasty/stenting or CABG
* NYHA class (dyspnoea) IV or hospitalization during last year due to Chronic cardiac failure as a primary diagnosis.
* Pregnancy
* Coronary pathology requiring CABG or staged scheduled coronary angioplasty/stenting except cases of unscheduled staged coronary angioplasty/stenting within 4 weeks after primary procedure.

Primary outcomes:
measure: Target lesion failure
timeFrame: during 1 year after procedure
Secondary outcomes:
measure: 1 year major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: during 1 year after procedure
Other outcomes:
measure: Angiographic endpoint
timeFrame: 1 year after procedure
measure: Device success
timeFrame: procedure
measure: Lesion success
timeFrame: procedure
measure: In-hospital procedure success
timeFrame: Within 5-day hospitalization
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References:
Clinical trial NCT05157516: Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients
Official title: Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 76
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients


Eligibility criteria: Inclusion Criteria:

* ASA I-II.
* Scheduled to undergo hip or proximal femur surgeries.

Exclusion Criteria:

* Refusal of participation by parents or caregivers
* Known local anesthetic (LA) drug sensitivity
* Bleeding disorders with INR \> 1.5 and/or platelets \< 100,000/mm3.
* Skin lesions or wounds at the site of proposed needle insertion.

Primary outcomes:
measure: Pain score
timeFrame: 2 hours post-operatively
Secondary outcomes:
measure: pain scores
timeFrame: at 2 hour intervals during the first 24 hours postoperatively
measure: Block failure rate
timeFrame: First hour postoperatively
measure: Block performance time
timeFrame: Preoperative
measure: The incidence of adverse effects
timeFrame: Up to one week after the block
measure: Duration of the block
timeFrame: UP to 48 hours postoperatively
measure: Degree of contralateral motor blockage and lower limb weakness
timeFrame: UP to 48 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini hospital
Study officials:
References:
Clinical trial NCT05595616: Comparison of Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing CABG
Official title: Comparison of Core Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients over 18-year-old undergoing coronary artery bypass surgery using pulmonary artery catheter

Brief summary: In anesthesia, monitoring of core body temperature is one of important factors. Measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. The core temperature by a pulmonary artery catheter is compared with the tracheal temperature by an endotracheal tube with thermometer. This study was designed to confirm the accuracy of the endotracheal tube thermometer.

Detailed description: All patients undergoing general anesthesia are monitored core body temperature. Coronary artery bypass graft surgery needs general anesthesia with endotracheal intubation and insertion of pulmonary artery catheter. Using endotracheal tube with thermometer and pulmonary artery catheter, the investigators will measure tracheal temperature and pulmonary artery temperature every 5 minutes for 1 hour after induction of general anesthesia.

Standard monitoring devices (non-invasive BP, electrocardiogram, pulse oxygen saturation) are applied to participants in an operation room, and 1% propofol 1-2 mg/kg and rocuronium 0.8 mg/kg are administered intravenously for induction of general anesthesia. An endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) is inserted. After inserting a 9Fr central venous catheter with a pulmonary artery catheter insertion port, core body temperature is measured by a pulmonary artery catheter (Swan-Ganz CCOmbo V, Edwards Lifesciences, Irvine, California, USA).

Tracheal temperature will be compared with pulmonary artery temperature by using Bland-Altman method.

Eligibility criteria: Inclusion Criteria:

* Adult patients over 18-year-old undergoing coronary artery bypass surgery

Exclusion Criteria:

* Emergency surgery

Primary outcomes:
measure: Comparison of tracheal temperature versus pulmonary artery temperature
timeFrame: Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyungnam
Study officials:
affiliation: PNUYH, 20 Geumo-ro, Beomeo-ri, Mulgeumeup, 50612, Yangsan, Korea
name: Seyeon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05862116: Impact of Health Literacy on Chronic Non-specific Low Back Pain
Official title: The Impact of Health Literacy on Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic non-specific low back pain that gave consent to participate in the study.

Brief summary: This prospective cohort study aims to assess the impact of health literacy on the quality of life in patients with chronic non-specific low back pain.

Detailed description: This prospective cohort study will enroll patients with chronic non-specific low back pain. Patients will be assessed using Turkey Health Literacy Scale-32, Short Form-36 Health Survey, and Oswestry Disability Index. The correlation between health literacy and quality of life will be assessed with statistical tests.

Eligibility criteria: Inclusion Criteria:

-Chronic non-specific low back pain

Exclusion Criteria:

* Acute low back pain
* Radicular pain
* Spinal stenosis

Primary outcomes:
measure: The correlation between health literacy and quality of life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06951516: How Simplified Language Affects Comprehension and Learning in Young Children With Down Syndrome
Official title: How Single-Word and Telegraphic Simplification Affects Language Processing and Word Learning in Young Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
language development
language processing
language input
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with Down syndrome (DS). The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with DS (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with DS will process grammatical utterances faster and more accurately than telegraphic or single-word utterances. Aim 2 will test the hypothesis that overall, children will demonstrate better word learning in the grammatical compared to the single-word and telegraphic conditions. Aim 3 will test the hypothesis that receptive language and nonverbal cognitive abilities will be significant moderators, such that children with stronger linguistic and cognitive skills will show the greatest benefit from grammatical input but children with lower linguistic and cognitive scores will perform similarly across conditions.


Eligibility criteria: Inclusion Criteria:

* Down syndrome

English as primary language

2-7 years old

Exclusion Criteria:

* Acquired brain injury

Cerebral palsy

Uncorrected vision or hearing impairment

Primary outcomes:
measure: Gaze location on Looking-While-Listening (LWL) tasks
timeFrame: Baseline
Secondary outcomes:
measure: Gaze location in Teaching Phase of Study 2b (Fast Mapping)
timeFrame: Baseline
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Courtney Venker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768416: Measuring Depth of Unconsciousness at the End of Life Using Bispectral Index (BIS)
Official title: Measuring Depth of Unconsciousness at the End of Life: the Reliability of the BIS Monitoring as an Assessment Tool Versus Sedation Scales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Loss of Consciousness at End of Life
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pre-terminal palliative patients

Brief summary: The purpose of this study is to use the BIS monitor to assess the degree of consciousness in pre-terminal palliative patients admitted to our palliative care unit and to ascertain if this tool provides a more accurate assessment of consciousness in this specific group of patients than clinical observation of consciousness and the use of sedation scales.

We hypothesize that the measured BIS results provide a more accurate assessment of the patient's level of consciousness than routine clinical observation or the use of sedation scales.


Eligibility criteria: Inclusion Criteria:

* Pre-terminal palliative patients with a life expectancy of 72 hours or less at the start of the observation.

Exclusion Criteria:

* lack of consent of patient or representative

Primary outcomes:
measure: Measuring the accuracy of BIS monitoring in assessing the evolution of the level of consciousness in pre-terminal patients
timeFrame: 72 hours
Secondary outcomes:
measure: Determining the evolution of BIS values, measured in pre-terminal patients
timeFrame: 72 hours
Other outcomes:
measure: Determining the evolution of sedation scores, measured with the Observer's Assessment of Alertness/Sedation scale and the Richmond Agitation and Sedation Scale in pre-terminal patients
timeFrame: 72 hours
measure: Determining if and in what degree the measured BIS values correspond to the measured sedation scores.
timeFrame: 72 hours
measure: Determining if there is a noticeable difference between the BIS scores and sedation scale scores of patients with medically induced sedation
timeFrame: 72 hours
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Martine De Laat, MD
role: PRINCIPAL_INVESTIGATOR
References: