louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01948505: Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Craniotomy Patients
Carotid Endarterectomy and Carotid Artery Stenosis Patients
Post-op Spine Patients Admitted to the NCCU
Endovascular Patients Undergoing Intracranial Intervention
Traumatic Brain Injuries NPO for at Least 12 Hours
Keywords: Craniotomy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.

To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.

To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.


Eligibility criteria: Inclusion Criteria:

* \> 45 kg (amenable to adult dosing)
* all traumatic brain injuries NPO for at least 12 hours
* all post-operative craniotomy patients
* all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
* all carotid endarterectomy and carotid artery stenosis patients
* all endovascular patients undergoing intracranial intervention
* all post-op spine patients admitted to the NCCU

Exclusion Criteria:

* documented allergy to acetaminophen
* documented severe hepatic impairment (Child-Pugh score \> 6) or severe hepatic disease (hepatitis)
* documented severe renal impairment (CrCl \< 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
* patients who are pregnant or breast feeding

Primary outcomes:
measure: Narcotic Requirement After Surgery
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
measure: Frequency of Nausea, Vomiting, Urinary Retention & Constipation
timeFrame: 48 hours
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: Sivakumar W, Jensen M, Martinez J, Tanana M, Duncan N, Hoesch R, Riva-Cambrin JK, Kilburg C, Ansari S, House PA. Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial. J Neurosurg. 2019 Mar 1;130(3):766-722. doi: 10.3171/2017.10.JNS171464. Epub 2018 Apr 20.
Clinical trial NCT05669105: Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research
Official title: Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: lung cancer
NSCLC
Lead sponsor: Sanguine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll up to 200 participants. Recruitment will occur through Sanguine advertisements, partnerships with cancer foundations, and cancer centers. Participants may be contacted for future studies.

Brief summary: The study objective is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with active lung cancer to investigate the immune response to develop treatments and therapies.


Eligibility criteria: Inclusion Criteria:

* Participants willing and able to provide written informed consent
* Participants are willing and able to provide appropriate photo identification
* Participant's age 18 - 100 years old
* Participants diagnosed with active non-small cell lung cancer (Adenocarcinoma or Squamous Cell only. All stages are acceptable.)
* Participants must have associated tissue biomarker data (EFGR and MET mutations) in their medical records

Exclusion Criteria:

* Participants who are pregnant or nursing
* Participants with a known history of HIV, hepatitis, or other infectious diseases
* Participants who have taken an investigational product in the last 30 days
* Participants who have experienced excess blood loss, including blood donation defined as 250 mL in the last month or 500 mL in the previous two months
* Participants currently enrolled in a clinical trial
* Participants currently in remission

Primary outcomes:
measure: Biospecimen & Clinical Data Collection
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Sanguine Biosciences
state: Massachusetts
Study officials:
References:
Clinical trial NCT02757898: Transfusion of Biotinylated Red Blood Cells
Official title: RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Keywords: Red Blood Cell (RBC) transfusion
Biotin labeled red blood cells
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-05-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. Investigators will study this by collecting blood samples from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.

Detailed description: The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused.

In this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). Blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells.

This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back to autologous subjects without any adverse reactions. All participants will be followed to watch for the development of antibodies against biotin-labeled RBCs.

Eligibility criteria: Inclusion Criteria:

* in good health

Exclusion Criteria:

* anemia (defined as hemoglobin \< 8 g/dL)
* chronic disease, including diabetes, heart or lung disease, poorly managed hypertension, and peripheral vascular disease
* ongoing consumption of biotin or raw egg supplements
* history of a bleeding disorder
* evidence of anemia at initial screening
* women who are pregnant or plan to become pregnant

Primary outcomes:
measure: Number of Participants That Had bRBC Detectable at 70 Days Post-intervention
timeFrame: 70 days post-intervention
measure: Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another
timeFrame: Up to 112 days
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: John D Roback, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03665298: Needle-X: Usability Testing of a Smartphone Application
Official title: Needle-X: Usability Testing of a Smartphone Application
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Dependence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 0
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: TREATMENT

Brief summary: Mobile health interventions offer a longitudinal approach to reducing the burden of substance use disorders and may stem the rise of the opioid overdose epidemic. Smartphone applications are one of the most popular mobile phone features nationally, among patients in addiction treatment, and among criminal justice involved (CJI) patients enrolled in addiction treatment. This research conducted at Bellevue Hospital's inpatient detoxification program established attitudes and self-reported behaviors favorable to theoretical smartphone applications addressing opioid use, HIV, and HCV prevention and management strategies. This study aims to assess the feasibility and usability of a smartphone application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in New York City.


Eligibility criteria: Inclusion Criteria:

* Fluent in spoken and written English;
* Meets or has previously met DSM-5 criteria for current opioid use disorder, of at least moderate severity;
* Owns or has owned a smartphone

Exclusion Criteria:

* Any patient who does not meet the inclusion criteria as above, is clinically unstable per the unit admitting physicians, refuses to participate in the study, or is cognitively impaired.

Primary outcomes:
measure: Feasibility of Needle-X application
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Babak Tofighi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871698: On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
Official title: Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Dementia Alzheimers
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: Texas A&M University
name: Baylor Research Institute
name: Georgia Institute of Technology
First posted: 2021-05-04
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 65 and older with mild to moderate dementia.

Brief summary: The purpose of this research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses.


Eligibility criteria: Inclusion Criteria:

* Fluent in English to understand and sign the consent or assent documents.
* Adult over 65 years of age with no children under 18 years old living in residence.
* Adult anticipates they will be living primarily at designated residence over next 18 months.
* Must receive caregiver interaction at least 6 hours/week.
* Must undergo a Mini-Mental State Exam (MMSE) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study.
* Must be willing to have home or facility equipped with sensors to obtain activity and location data.

Exclusion Criteria:

-

Primary outcomes:
measure: Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment
timeFrame: 18 months
measure: Identify improved sensitivities for detection of early and moderate-stage AD/ADRD activities of daily living changes
timeFrame: 18 months
Secondary outcomes:
measure: Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research
timeFrame: 18 months
Other outcomes:
Locations:
city: Waco
country: United States
facility: Birkeland Current
state: Texas
Study officials:
References:
Clinical trial NCT06410898: Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo
Official title: Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vitiligo
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will aim to evaluate:

1. The presence of Hypoxia Inducible Factor in vitiligo patient
2. Defect of Autophagy Related Genes in vitiligo patient
3. The cross relation between Autophagy Related Genes and Hypoxia Inducible Factor in the pathogenesis of vitiligo among Egyptian patients in Sohag Governorate


Eligibility criteria: Inclusion Criteria:

* Adult \>18 years
* With non segmental vitiligo
* A group of participants will be included as a control group

Exclusion Criteria:

* Pregnancy
* Patient with chronic inflammatory skin disorders
* patient on anti-oxidant or anti-inflammatory drugs
* patient on topical or systemic treatment for vitiligo in last 4 weeks
* patients with other autoimmune diseases
* patients with diabetes mellitus

Primary outcomes:
measure: Assessment of Autophagy Related genes in Vitiligo patients
timeFrame: 2 months
measure: Assessment of Hypoxia Inducible Factor in Vitiligo patients
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Agarwal S, Ganesh S. Perinuclear mitochondrial clustering, increased ROS levels, and HIF1 are required for the activation of HSF1 by heat stress. J Cell Sci. 2020 Jul 9;133(13):jcs245589. doi: 10.1242/jcs.245589.
citation: Artika IM, Dewi YP, Nainggolan IM, Siregar JE, Antonjaya U. Real-Time Polymerase Chain Reaction: Current Techniques, Applications, and Role in COVID-19 Diagnosis. Genes (Basel). 2022 Dec 16;13(12):2387. doi: 10.3390/genes13122387.
citation: Bastonini E, Kovacs D, Raffa S, Delle Macchie M, Pacifico A, Iacovelli P, Torrisi MR, Picardo M. A protective role for autophagy in vitiligo. Cell Death Dis. 2021 Mar 25;12(4):318. doi: 10.1038/s41419-021-03592-0.
citation: Ezzedine K, Lim HW, Suzuki T, Katayama I, Hamzavi I, Lan CC, Goh BK, Anbar T, Silva de Castro C, Lee AY, Parsad D, van Geel N, Le Poole IC, Oiso N, Benzekri L, Spritz R, Gauthier Y, Hann SK, Picardo M, Taieb A; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012 May;25(3):E1-13. doi: 10.1111/j.1755-148X.2012.00997.x.
Clinical trial NCT04918498: Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation
Official title: Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Jiaxing University
name: Yuhang Hospital
name: Changxing People's Hospital
First posted: 2021-06-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Non-contemporaneous control
Primary purpose: SUPPORTIVE_CARE

Brief summary: Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients

Detailed description: This study is intended to construct early physiotherapy programs for VV-ECMO patients, including multidisciplinary team building, safety assessment, early active physiotherapy, respiratory physiotherapy, with a view to promoting early recovery of patients, early withdrawal of ventilator-assisted ventilation, shortening ECMO auxiliary time, improving patients' exercise level and respiratory function, reducing complications, and improving the quality of near-term and long-term survival.

Eligibility criteria: Inclusion Criteria:

* VV-ECMO assisted support
* lung failure (e.g. ARDS)
* age ≥18 years
* sober
* informed consent to this study

Exclusion Criteria:

* unstable blood flow mechanics
* active bleeding
* mental disorders that do not work together
* people waiting for lung transplants
* people at the end of life (e.g. advanced lung cancer)

Primary outcomes:
measure: VV-ECMO auxiliary time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Fei Zeng
role: STUDY_CHAIR
References:
Clinical trial NCT01266798: Effects of a Patient Directed Web-portal to Improve Health Literacy Skills
Official title: Effects of a Patient Directed Web-portal to Improve Health Literacy Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Health literacy, participation
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian Knowledge Centre for the Health Services
First posted: 2010-12-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Access to the best available evidence, and the ability to obtain and understand such information is seen as necessary to protect the public's interests and critical to empowerment, but is also a precondition for participation in the decision making.

A web portal serving as a generic (non disease- specific) tailored tool was developed in the conceptual framework of shared decision making and evidence based practice to improve the lay- public's critical and social literacy skills and activation. A randomized controlled parallel trial using a simple randomization procedure will be conducted, including 200 parents of children \<4 with internet access. Parents will be allocated to receive either the portal or no intervention. Primary and secondary outcomes include: the ability to find research based information, critical appraisal skills, perceived behavioural control, attitudes and perceived pressure associated with searching for information, and participation.


Eligibility criteria: Inclusion Criteria:

* Parents of children age \<4 will be recruited with access to internet.

Exclusion Criteria:

* Participants will be excluded if one other in the household already participates in the study (due to spill-over effect) and if they do not have children \<4.
* Since the recruitment will be done online, there is no need to screen for access to internet.

Primary outcomes:
measure: Changes in predictors of search and use of health information
timeFrame: Week 3
Secondary outcomes:
measure: The ability to find reliable answers to a health question
timeFrame: Week 1
measure: Critical appraisal of health information
timeFrame: Week 2
measure: Participation (activation)
timeFrame: Week 3
measure: Satisfaction with portal
timeFrame: Week 3
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University College, Faculty of Nursing
Study officials:
affiliation: Oslo University College
name: Sølvi Helseth, Professor
role: STUDY_DIRECTOR
affiliation: Oslo university
name: Arild Bjørndal, Professor
role: STUDY_DIRECTOR
affiliation: Oslo University College
name: Astrid Austvoll-Dahlgren, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Austvoll-Dahlgren A, Bjorndal A, Odgaard-Jensen J, Helseth S. Evaluation of a web portal for improving public access to evidence-based health information and health literacy skills: a pragmatic trial. PLoS One. 2012;7(5):e37715. doi: 10.1371/journal.pone.0037715. Epub 2012 May 31.
Clinical trial NCT06884098: A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-228B with AD-2284 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Primary Hypercholesterolaemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in other clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied

Primary outcomes:
measure: Maximum concentration of drug in plasma (Cmax)
timeFrame: pre-dose (0hour) to 72hours
measure: Area under the plasma concentration-time curve during dosing interval (AUCt)
timeFrame: pre-dose (0hour) to 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References: