louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01585389: Studying Gene Expression and Location in Samples From Patients With Brain Tumors
Official title: Expression and Subcellular Localization of NEIL3 in Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain and Central Nervous System Tumors
Keywords: adult brain tumor
childhood brain tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-25
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with brain tumors

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors.

PURPOSE: This research studies gene expression and location in samples from patients with brain tumors.

Detailed description: OBJECTIVES:

* To determine the expression and subcellular localization of nei endonuclease VIII-like 3 (NEIL3) in brain tumors.

OUTLINE: Tissue microarray samples are analyzed for NEIL3 expression and subcellular localization by immunohistochemical methods.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Tissue microarrays (TMA) samples from the Biopathology Core
* Samples from patients diagnosed with brain tumors

  * Progenitor, or blast, cell origin

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of NEIL3 expression and/or nuclear localization with tumor type or grade with respect to degree of differentiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Heithem M. El-Hodiri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06248489: Examination of Manual Skills in Individuals With and Without Chronic Neck Pain
Official title: Examination of Manual Skills in Individuals With and Without Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neck Pain
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neck pain

Brief summary: This study will determine whether manual dexterity is affected in individuals with neck pain compared to individuals without neck pain. It is thought that determining the changes in dexterity in individuals with neck pain compared to healthy individuals will shed light on future more detailed studies on the current subject.


Eligibility criteria: Inclusion Criteria:

- Experiencing neck pain for at least 3 months

Exclusion Criteria:

- Having another medical condition that may affect dexterity

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
measure: 9 hole peg test
timeFrame: Baseline
measure: The Bournemouth Questionnaire for Neck Pain
timeFrame: Baseline
measure: The Fremantle Neck Awareness Questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT01646489: Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
Official title: A Phase 1, Open-Label, Drug Interaction Study to Assess Safety, Tolerability, and Pharmacokinetics of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Chronic Hepatitis C
Keywords: Antisense
miR-122 antagonist
Safety in healthy volunteers
Hepatitis C
Lead sponsor: Santaris Pharma A/S
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Weight ≤ 85 kg
* Females of non-childbearing potential (postmenopausal or surgically sterile) or males who are surgically sterile or using an acceptable form of birth control

Exclusion Criteria:

* Current, clinically significant illness or medical condition

Primary outcomes:
measure: The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
timeFrame: Up to 24 hours after dosing.
measure: Safety and tolerability of co-administered miravirsen and telaprevir.
timeFrame: 12 weeks
Secondary outcomes:
measure: The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
timeFrame: Up to 24 hours after dosing.
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
affiliation: Spaulding Clinical Research LLC
name: Paul Rice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750789: The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It has been proven in in-vitro studies that dates decrease the oxidative stress in serum. There have been no in-vivo studies to this date. The current study aims to test whether dates consumption by healthy adults decreases serum oxidative stress and improves serum PON1 activity and serum lipid profile.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

Primary outcomes:
measure: serum oxidative stress
timeFrame: 30 days
Secondary outcomes:
measure: serum lipid profile
timeFrame: 30 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: Emek Medical Center
name: Wasseem Rock
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06228729: Association Between EEG Changes and Hormonal Response to Tracheal Intubation and Surgical Stimulation
Official title: Evaluation of the Association Between Electroencephalographic Changes and Hormonal Response to Tracheal Intubation and Surgical Stimulation in Abdominal Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abdominal Surgery
Endotracheal Intubation
Surgical Incision
Electroencephalogram
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing open abdominal surgery and endotracheal intubation under general anesthesia

Brief summary: This study aims to prospectively evaluate the relationship between changes in EEG and hormonal responses induced by endotracheal intubation and surgical incision following general anesthesia.

Detailed description: This study aims to investigate the relationship between changes in EEG patterns and stress hormone levels in patients undergoing open abdominal surgery under general anesthesia when subjected to endotracheal intubation and surgical incision stimuli.

Hormone measurements (cortisol, ACTH) are taken at four time points: before endotracheal intubation (T1), one minute after intubation (T2), and one minute after surgical incision (T3). The investigators evaluate the correlation between hormone levels (cortisol, ACTH) and EEG band power changes (alpha, beta, delta) before and after endotracheal intubation and surgical incision.

Eligibility criteria: Inclusion Criteria:

* 1) Patients scheduled to undergo open abdominal surgery under general anesthesia with endotracheal intubation.
* 2) Patients requiring invasive blood pressure monitoring during surgery

Exclusion Criteria:

* 1) Patients transferred to the intensive care unit after surgery
* 2) Surgery duration of less than one hour
* 3) Patients with neurological underlying conditions
* 4) Patients on chronic use of psychotropic medications and opioid drugs
* 5) Emergency surgery

Primary outcomes:
measure: Association between band power changes in EEG and hormone respones caused by endotracheal intubation
timeFrame: from the start of anesthesia induction to one minute after endotracheal intubation
Secondary outcomes:
measure: Association between band power changes in EEG and hormone respones caused by surgical incision
timeFrame: from the start of anesthesia induction to one minute after surgical incision
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01540929: Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
Official title: A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smallpox
Keywords: Smallpox
ACAM2000®
Smallpox vaccine
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 5001
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves a review of DoD Smallpox Screening Form 600 (2 part format) that had been redacted of all personal information by the DoD. No individuals were involved in this study."

Brief summary: This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s (SF600s) generated during screening of service members for possible immunization with the ACAM2000® smallpox vaccine.

Primary Objective:

* To evaluate the accuracy of the DoD smallpox vaccination screening process in military personnel.

Secondary Objective:

* To describe the number of subjects who are excluded from vaccination, stratified by the pre-defined categories for exclusion (separately for the Screened and Evaluable Populations).

Detailed description: Please note that we elected to post this study on the registry (clinicaltrials.gov) in the interests of transparency and because the study represented a post-licensure commitment to FDA for ACAM2000® smallpox vaccine. However, this study was not a clinical trial and did not involve the administration of any vaccine product nor the collection of any product performance or adverse event data. Rather, the purpose of the study was to determine the success rate for proper completion and use of Department of Defense (DoD) Screening Form 600s (SF600s). The SF600 is a form required to be completed prior to smallpox vaccination of DoD staff and is used to guide decision-making by DoD vaccination staff regarding offering, postponing, or denying vaccination. The study evaluated both the extent to which the SF600s were completed correctly and the extent to which they were correctly used to guide vaccination decision-making.

Eligibility criteria: Inclusion Criteria:

* Military personnel ≥17 years of age.
* Completion of the DoD Smallpox Screening Form 600 (2-part format).

Exclusion Criteria:

* None

Primary outcomes:
measure: The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate.
timeFrame: 1 year post-screening
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: United States
state: Virginia
Study officials:
affiliation: Emergent BioSolutions
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06413329: The Association Between Physical Activity Level and Post-operative Prognosis
Official title: The Association Between Physical Activity Level and Post-operative Prognosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Elective Operation Patients
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 324
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 undergoing elective surgery at Peking Union Medical College Hospital.

Brief summary: The study primarily focuses on adult patients who underwent elective surgery at Peking Union Medical College Hospital. The physical activity level before surgery within the past 3 months is the main exposure factor and postoperative quality of life score (EQ-5D-3L utility index) is the main outcome indicator. The correlation between patients' preoperative physical activity level and their surgical outcomes will be explored in this study.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective surgery at Peking Union Medical College Hospital

Exclusion Criteria:

* 1. Patients scheduled for surgery with minimal impact on overall health (including eye surgery, abortion, hysteroscopy, conization, gastroscopy, vascular angiography, and superficial surgery, etc.) 2. Orthopedic and cardiac surgery patients 3. Patients who are unable to live independently or have significant limitations in physical activity prior to surgery 4. Patients who have difficulty communicating verbally and cannot complete the questionnaire 5. Pregnant women.

Primary outcomes:
measure: Quality of life after the surgery
timeFrame: two weeks, one month and three months after surgery
Secondary outcomes:
measure: postoperative hospitalization days
timeFrame: one week after discharge
measure: ICU length of stay
timeFrame: one week after discharge
measure: postoperative complications
timeFrame: three months after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03002129: FLuid Responsiveness Prediction Using EXtra Systoles
Official title: FLuid Responsiveness Prediction Using EXtra Systoles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.

Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids


Eligibility criteria: Inclusion Criteria:

* Patients requiring elective CABG or OPCAB surgery
* Patient's age ≥ 18 years

Exclusion Criteria:

* Patient refusal
* Pregnancy
* EF \< 35%
* End stage kidney failure (defined by the need for haemodialysis)
* Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)

Primary outcomes:
measure: fluid challenge response in stroke volume
timeFrame: during operation
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Universitu Medical Center Groningen
Study officials:
References:
citation: Holmgaard F, Vistisen ST, Ravn HB, Scheeren TWL. The response of a standardized fluid challenge during cardiac surgery on cerebral oxygen saturation measured with near-infrared spectroscopy. J Clin Monit Comput. 2020 Apr;34(2):245-251. doi: 10.1007/s10877-019-00324-w. Epub 2019 May 28.
citation: Vistisen ST, Berg JM, Boekel MF, Modestini M, Bergman R, Jainandunsing JS, Mariani MA, Scheeren TWL. Using extra systoles and the micro-fluid challenge to predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2019 Oct;33(5):777-786. doi: 10.1007/s10877-018-0218-0. Epub 2018 Nov 9.
Clinical trial NCT06510829: Comparison Between Diode Laser and Bleomycin in Treatment of Hemangioma
Official title: Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bleomycin Adverse Reaction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma .

Brief summary: Assessment of the Effectiveness of Bleomycin Intralesional Injection and Diode Laser on Management of Infantile Hemangioma., with regard to :

* Clinically based on Change in the Size and Color of Hemangioma.
* Ultrasonography considering Vascularity ,Echogenicity , Height , and Morphology .
* Comparison of Complications associated with Bleomycin and Diode Laser.


Eligibility criteria: Inclusion Criteria:

* Age between 3 Months and 1 Year old.
* Non Complicated Infantile Hemangioma

Exclusion Criteria:

* Younger than 3 Months or older than 1 Year.
* Complicated Infantile Hemangioma

Primary outcomes:
measure: Effect of diode laser on hemangioma
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04455529: Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)
Official title: A Research of Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Embolic Stroke of Undetermined Source
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We recruited consecutive patients with Embolism Stroke of Unknown Cause.

Brief summary: Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

Detailed description: The purpose of this study is to evaluate the epidemiological characteristics, risk factors (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

Eligibility criteria: Inclusion Criteria:

- Patients diagnosed with acute cerebral infarction and treated in Peking University Third Hospital Neurology Department from January 2010 to June 2016.

Exclusion Criteria:

* Lacunar infarction
* Aortic atherosclerotic cerebral infarction
* Clear cardiogenic cerebral infarction
* Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)

Primary outcomes:
measure: Medication adherence
timeFrame: 1 year after recruitment
measure: Recurrence rate
timeFrame: 1 year after recruitment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04499729: Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
Official title: Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: Adaptive Health, Inc
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
First posted: 2020-08-05
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush.

Detailed description: This study is a pragmatic, system-wide rollout quality improvement evaluation design displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial. Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.

Patients Data from all patients, aged 18 or older, enrolled collaborative care from December 1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT patients who are 18 or older, and have a smartphone will be offered enrollment.

Eligibility criteria: Inclusion Criteria:

* Enrolled in Rush Collaborative Care service
* Owns a personal smartphone

Exclusion Criteria:

* None

Primary outcomes:
measure: Depression
timeFrame: Up to 20 Months
measure: Number of assessments
timeFrame: Up to 20 Months
Secondary outcomes:
measure: First to last assessment
timeFrame: Up to 20 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Adaptive Health
name: Carolyn MacIver
role: PRINCIPAL_INVESTIGATOR
References: