louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01971866: Camera Based System to Monitor Patient Movement During Radiation Treatment
Official title: Improving Safety and Accuracy of Proton Therapy by Use of Camera-Based Patient Localization System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Set up and Monitoring of Patients Receiving Proton Radiation
Keywords: Proton radiation
AlignRT
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing proton radiation therapy at UFPTI

Brief summary: This study aims to investigate the advantages of using AlignRT, a commercially available, FDA approved camera-based imaging system for proton therapy patients prior to and during their radiation treatment delivery.


Eligibility criteria: Inclusion Criteria:

Patients with tumors of the brain, head and neck, thorax, upper abdomen, posterior spine/sacrum and extremities

Primary outcomes:
measure: Paired difference between image accuracy plan data from the AlignRT system compared to the current x-ray based imaging system.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Maria Mamalui-Hunter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04868266: End Tidal Carbon Dioxide in Minimal Sedation
Official title: A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complication of Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 214
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing minimal sedation for procedure.

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence of oxygen desaturation
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
Secondary outcomes:
measure: number of Staff intervetions
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Severe oxygen desaturation
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Lowest oxygen saturation
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Episode of apnea
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: sedation level
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: inappropriate monitoring
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Airway obstruction
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Integrated pulmonary index
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: success of procedure
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Hemodynamic instability
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
measure: Medication
timeFrame: from immediately after sedation to end of procedure, up to 2 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT03539666: Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing
Official title: The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: South Dakota State University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

Detailed description: The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

Eligibility criteria: Inclusion Criteria:

* generally good health status based on one routine physical in the past 15 months, current health status
* normal HbA1C, weigh 110 lb or more
* Age 50 years or more, generally healthy, all races and both sexes
* generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
* willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

* medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
* impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* major gastrointestinal disorders in the past 3 months
* history of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition that would affect the ability to provide written informed consent.
* If they had not had a routine health checkup during the 12 months prior to recruitment.
* If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Primary outcomes:
measure: Microbiota-dependent TMAO-response, measured as serum concentration
timeFrame: 10 days per diet arm
measure: Serum concentration of biogenic amine metabolites
timeFrame: 10 days per diet arm
Secondary outcomes:
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University, Wagner Hall 416
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Moul Dey, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328766: Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Official title: An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-drug Interaction
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
* Capable of understanding provided information and complying with protocol requirements
* Provide written informed consent to participate in the study

Primary outcomes:
measure: Area under the plasma drug concentration-time curve
timeFrame: upto 48 hours postdose
measure: Peak Plasma Concentration (Cmax)
timeFrame: upto 48 hours postdose
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 19 days
Secondary outcomes:
Other outcomes:
Locations:
city: Queensland
country: Australia
facility: Nucleus Network (QPharm)
Study officials:
References:
Clinical trial NCT05523466: Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis
Official title: Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of Acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition.

Detailed description: A double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with MS will constitute the experimental group, paired by age and gender. All participants will undertake active or sham acupuncture sessions. Active-Sham group will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation. Meanwhile, Sham-Active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with Multiple Sclerosis
* Aged over 18 years
* Motor and intellectual capacity to understand the evaluations
* Light and moderate functional classification levels (EDSS scale)
* Who accept to participate in the study through agreement with informed consent form

Exclusion Criteria:

* Do not understand the evaluations
* Cardiac diseases that impede the assessment of HRV
* Have a cardiac pacemaker.

Primary outcomes:
measure: Changes in the Heart Rate Variability after intervention
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Celso Ferreira, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882466: The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction
Official title: Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: erythropoietin
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 58
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 purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction \<12hr
* Age \>18yrs
* First myocardial infarction
* culprit lesion : proximal to mid left anterior descending artery
* Baseline coronary flow : TIMI Grade 0\~1

Exclusion Criteria:

* Patients with previous myocardial infarction
* History of thrombotic complication
* History of cerebral infarction
* Uncontrolled hypertension
* Increased hemoglobin level \>17g/dL
* Patients with mechanical valve
* Cardiogenic shock

Primary outcomes:
measure: Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
timeFrame: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr
Secondary outcomes:
measure: Infarct size assessed by cardiac MRI
timeFrame: day 4
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong-Ju Choi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suh JW, Chung WY, Kim YS, Kim KI, Jeon EJ, Cho YS, Youn TJ, Chae IH, Kim CH, Choi DJ. The effect of intravenous administration of erythropoietin on the infarct size in primary percutaneous coronary intervention. Int J Cardiol. 2011 Jun 2;149(2):216-220. doi: 10.1016/j.ijcard.2010.02.002. Epub 2010 Mar 2.
Clinical trial NCT02523066: Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Official title: Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mitral Valve or Aortic Valve Replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2015-08-14
Enrollment: 215
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who had the heart valves (Type: 7300TFX and 3300TFX), and are willing to participate in the study.

Brief summary: Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.


Eligibility criteria: Inclusion Criteria:

* The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China.
* The patients agree to sign the inform consent form (ICF).

Exclusion Criteria:

* No specific exclusion criteria.

Primary outcomes:
measure: Echocardiography to evaluate the performance of heart valve
timeFrame: Up to five years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Chinese academy of medical sciences fuwai hospital cardiovascular disease
state: Beijing
Study officials:
References:
Clinical trial NCT05264766: The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery
Official title: The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: cooling helmet
neuron specific enolase
delirium
open heart surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 26
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: To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery

Detailed description: Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)

Eligibility criteria: Inclusion Criteria:

* Patient undergoing their first open heart surgery using cardiopulmonary bypass
* Age ≥18 year-old
* Patient with American Society of Anesthesiologists (ASA) III
* Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented
* Patient fluent in Indonesia

Exclusion Criteria:

* Patients did not give consent to participate in the study
* Patients with central nervous system disease (stroke, intracranial tumor)
* Patients with psychiatric problem (schizophrenia, depression)
* Patients with cognitive problem
* Blind and deaf patient
* Patient on psychotrophic or narcotics medication

Drop out criteria

* Surgery without cardiopulmonary bypass
* Patient demise after surgery
* Patients decided to refrain from the study

Primary outcomes:
measure: Neuron-specific enolase
timeFrame: 6 hours post cardiopulmonary bypass off
measure: Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
timeFrame: Changes of CAM-ICU from 12 hours to 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT00899366: DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia
Official title: Molecular Mechanisms of NOTCH Induced Transformation in T-ALL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: T-cell adult acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E2993

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* Identify the transcriptional signatures associated with the presence of NOTCH1 mutations in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide microarrays.
* Characterize the global changes on gene expression resulting from the inactivation of NOTCH signaling in human T-ALL lymphoblasts.

OUTLINE: This is a multicenter study.

Frozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by microarray analysis and activated NOTCH1 protein by western blot analysis.

PROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Confirmed diagnosis of T-cell acute lymphoblastic leukemia
* Frozen lymphoblast samples available

  * NOTCH1-mutated or wild type sample available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Transcriptional signatures associated with NOTCH1 mutations in T-cell acute lymphoblastic leukemia (T-ALL) cells
timeFrame: 1 month
measure: Global changes on gene expression resulting from inactivation of NOTCH signaling in T-ALL cells
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Adolfo A. Ferrando, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00859066: Evaluation of Radiology Resident Anxiety When Beginning Emergency Room (ER) Call
Official title: Evaluation of Radiology Resident Anxiety When Beginning ER Call
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anxiety
Stress
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First year radiology residents

Brief summary: The purpose of this study is to quantify levels of resident anxiety under the current system (take call alone) and compare results to a modified system.

Detailed description: The study purpose is to quantify resident perceptions and feelings under the current 1700 call system (take call alone) and compare those with resident perceptions and feelings under a modified system where two partial shifts are taken with an experienced resident ("buddy call") prior to taking call alone.

Eligibility criteria: Inclusion Criteria:

* first year radiology residents

Primary outcomes:
measure: Improve resident well-being by decreasing anxiety surrounding beginning ER call as a first year radiology resident.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Richard Cohan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: