louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00172432: Aminoterminal Propeptide of Type III Procollagen and Severity of Coronary Artery Disease in Patients Without Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Background: Myocardial fibrosis is a major component in cardiac remodeling in patients with myocardial infarction or hibernation. However, the association of cardiac fibrosis and coronary artery disease (CAD) in patients without infarction or hibernation is still unclear. In the present study, we analyzed the relationship between serum concentrations of procollagen propeptides and severity of CAD in such patients. Patients and methods: Forty-six patients (32 men and 14 woman; mean age 64 years) with chest pain and normal left ventricular contractility were enrolled into this study. Myocardial infarction was excluded by history and electrocardiograms. All patients received stress thallium-201 single photon emission computed tomography (SPECT) and analysis of the serum levels of the aminoterminal propeptide of type I and III procollagen (PINP and PIIINP).


Eligibility criteria: Inclusion Criteria:

* We prospectively studied 46 consecutive patients aged 50 to 75 years (32 men and 14 women; mean age was 64 years) who were referred for chest pain evaluation.

Exclusion Criteria:

* MI was excluded by history and electrocardiograms. Regional wall motion abnormalities and impaired left ventricular contractility (left ventricular ejection fraction \< 50%) were excluded by routine echocardiography.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Lwun Ho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03267732: A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ARMO BioSciences
First posted: 2017-08-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.

Detailed description: This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.

Eligibility criteria: Inclusion Criteria:

1. Male or female between 18 and 55 years of age, inclusive
2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
3. Must be HIV negative by HIV 1/0/2 testing
4. Must be Hepatitis B (HBV) surface antigen negative
5. Must be Hepatitis C (HCV) antibody negative
6. Females must have a negative serum pregnancy test
7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug

Exclusion Criteria:

1. Pregnant or lactating subjects
2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
3. Have poor venous access and are unable to donate blood
4. Have been vaccinated within 90 days of study dosing
5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
6. Have history of significant drug sensitivity or drug allergy.

Primary outcomes:
measure: Pharmacokinetic parameters, Cmax
timeFrame: 43 days
measure: Pharmacokinetic parameters, Tmax
timeFrame: 43 days
measure: Pharmacokinetic parameters, AUC
timeFrame: 43 days
measure: Pharmacokinetic parameters, CL/F
timeFrame: 43 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 43 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00788632: Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Official title: Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
BMD
Bisphosphonates
Educational materials
Patient Stories
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2008-11-11
Enrollment: 12128
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to rigorously test the incremental impact of simple, generalizable interventions to improve healthcare among older women at high risk for osteoporosis. Building on the experience of our University of Alabama at Birmingham (UAB) interdisciplinary team we have designed an innovative, scientifically rigorous, and highly feasible implementation research project in partnership with two Kaiser Permanente (KP) research centers. Kaiser Permanente, one of the Nation's largest Healthcare Organizations, uses an integrated electronic medical record (EMR), with full capture of pharmacy, clinical (including BMD results), and claims data, and cares for a racially/ethnically, socio-economically, and geographically diverse population. To address innovative questions in implementation research, we will perform a multi-modal group randomized trial involving over 18,000 patients seen by over 330 primary care providers (PCPs) at 25 KP facilities in the Northwest and Southeast. If proven effective, our system-centered and patient-centered approach will advance the state of implementation science and be applicable to evidence implementation in other musculoskeletal disorders and to other health care settings.


Eligibility criteria: Inclusion Criteria:

* female
* age 65 or older

Exclusion Criteria:

* prior osteoporosis testing (BMD)
* prior osteoporosis treatment

Primary outcomes:
measure: Bone Mineral Density (BMD) testing
timeFrame: 12 months
Secondary outcomes:
measure: Osteoporosis prescription medications
timeFrame: 12 months
measure: Patient-Physician communication regarding osteoporosis treatment and testing
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Southeast
state: Georgia
city: Portland
country: United States
facility: Kasier Permanente Northwest
state: Oregon
Study officials:
affiliation: University of Alabama at Birmingham
name: Kenneth G Saag, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313932: The Effects of Sleep Deprivation on Physiological and Perceptual Responses During Exercise
Official title: The Effects of Partial Sleep Restriction on Physiological and Perceptual Responses During Submaximal and Maximal Exercise in Trained Runners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Deprivation
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results.


Eligibility criteria: Inclusion Criteria:

* Injury-free, trained, male runners

Exclusion Criteria:

* Female, untrained, injured

Primary outcomes:
measure: Oxygen uptake
timeFrame: From baseline to completion, up to 31 days
measure: Respiratory exchange ratio
timeFrame: From baseline to completion, up to 31 days
measure: Breathing frequency
timeFrame: From baseline to completion, up to 31 days
measure: Minute ventilation
timeFrame: From baseline to completion, up to 31 days
measure: Blood lactate concentration
timeFrame: From baseline to completion, up to 31 days
measure: Rating of perceived exertion
timeFrame: From baseline to completion, up to 31 days
measure: Heart rate
timeFrame: From baseline to completion, up to 31 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05347732: Predictors of Failed Thrombolysis in Acute Myocardial Infarction
Official title: Predictors of Failed Thrombolysis in Acute ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: STEMI - ST Elevation Myocardial Infarction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include all STEM patients who have received prehospital thrombolysis before hospital admission.

Brief summary: The purpose of this observational study is to assess why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in patients with acute ST-segment elevation myocardial infarction (STEMI). The study will include 200 STEMI patients at the time of arrival at Oslo University Hospital Ullevål after receiving prehospital thrombolysis. A blood sample will be taken immediately for the study of factors related to coagulation, fibrinolysis and inflammation. Levels of the biomarkers will be compared between patients with successful and failed thrombolysis.

Detailed description: This study aims to explore why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in up to 50 % of pasients with acute ST-segment elevation myocardial infarction (STEMI). This is important in Norway due to the long geographic distances and the fact that up to 70 % of STEMI patients in some Norwegian areas receive thrombolysis in stead of primary, invasive revascularization with percutaneous coronary intervention (PCI). Today, no well-defined biomarker or score can predict the successfulness of thrombolytic therapy during STEMI. As failed thrombolysis leads to larger myocardial infarctions and poorer outcome, defining factors for improved risk stratification is important.

The TROFAMI study is a prospective study which will include 200 STEMI patients given prehospital thrombolysis. A blood sample will be taken immediately after hospital admission for the analysis of potential relevant biomarkers related to coagulation, fibrinolysis and inflammation. The biomarkers will be evaluated against the successfullness or not of thrombolysis.

Oslo University Hospital is the largest STEMI center in Norway. Each year, approximately 100 STEMI patients given prehospital thrombolysis are hospitalized at Ullevål. The inclusion is anticipated to take place during the time period 2022-2024.

Eligibility criteria: Inclusion Criteria:

STEMI patients \> 18 years given prehospital thrombolysis.

Exclusion Criteria:

None.

Primary outcomes:
measure: Failed thrombolysis
timeFrame: Decided immediately after hospital admission.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of Cardiology, Oslo University Hospital Ullevål
name: Ragnhild Helseth, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02781532: Evaluation of Predictive Visual Analog Scale (VAS) for Determining the Ingesta of Patients Carrying a Digestive Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive System Neoplasms
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 100
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: The study has been proposed to all patients with a gastrointestinal cancer hospitalized in our service.

Brief summary: The main objective of our study is to determine if the evaluation of ingesta of cancer patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of patients during hospitalization (for patients malnourished, at risk of malnutrition or risk free).


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Admitted to hospital for systemic therapy of gastrointestinal cancer
* Signature of the non-opposition.

Exclusion Criteria:

* Patients who because of their affection will fasted more than 12:00 during the three days preceding hospitalization.
* Artificial nutrition Patients

Primary outcomes:
measure: Evaluation of ingesta
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT05675332: Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
Official title: Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-01-09
Enrollment: 280
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the behavioral and neural correlates of stress exposure. Results from this study will enrich the understanding of how sociocultural, behavioral, and neural factors combine to influence alcohol use.


Eligibility criteria: Inclusion Criteria:

* Between 21 and 35 years of age (inclusive);
* Fluent in English;
* Right-handed

Exclusion Criteria:

* Younger than 21 years of age;
* Left-handed

Primary outcomes:
measure: Blood oxygen-level dependent (BOLD) signal
timeFrame: Baseline
measure: Resting-state functional connectivity in brain regions
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Uraina Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06642532: A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
Official title: A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cranial Defect
TCD
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Age of 18 years or older;
2. Proposed polyetheretherketone cranioplasty;
3. Incomplete cranial bone in the lateral temporal window.

Brief summary: Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of brain tissue and ventricular morphology. Transcranial doppler ultrasound can obtain good images of cerebral hemodynamic parameters in patients through polyetheretherketone-covered temporal window. This trial is a clinical prospective observational study in which cases treated with polyetheretherketone cranioplasty, and transcranial doppler ultrasonography is performed preoperatively and 10 days postoperatively, and data were collected mainly including bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window.


Eligibility criteria: Inclusion Criteria:

1. Age of 18 years or older;
2. Proposed polyetheretherketone cranioplasty;
3. Incomplete cranial bone in the lateral temporal window;
4. Signed informed consent for surgery and informed consent for research.

Exclusion Criteria:

1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.

Primary outcomes:
measure: transcranial doppler ultrasonography parameters before and after cranioplasty
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT04840732: Virtual Reality Application in Chemotherapy Administration in Nurse Staff
Official title: Virtual Reality Application in Chemotherapy Administration in Nurse Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy Training
Keywords: 3D virtual reality
administration
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study wants to design a training program for chemotherapy with using VR among nurse staff. Then the investigators design a protocol to compare the training effects in the VR program and ISO document.

Detailed description: As technology advances, mobile devices have gradually turned into wearable devices. Furthermore, virtual reality (VR), augmented reality (AR), and mixed reality (MR) are being increasingly applied in medical fields such as medical education and training, surgical simulation, neurological rehabilitation, psychotherapy, and telemedicine. Research results demonstrate the ability of VR, AR, and MR to ameliorate the inconveniences that are often associated with traditional medical care, reduce incidents of medical malpractice caused by unskilled operations, and reduce the cost of medical education and training. What is more, the application of these technologies has enhanced the effectiveness of medical education and training, raised the level of diagnosis and treatment, improved the doctor-patient relationship, and boosted the efficiency of medical execution. The present study wants to design a training program for chemotherapy with using VR. Then the investigators design a protocol to compare the training effects in VR program and ISO document.

Eligibility criteria: Inclusion Criteria:

* The staffs who require to implement chemotherapy skill in the hospital. Age over 20 years.

Exclusion Criteria:

* Refuse to join the study.

Primary outcomes:
measure: Objective Structured Clinical Examination score (OSCE score)
timeFrame: One month
Secondary outcomes:
measure: Self-assessment skill score
timeFrame: One month
Other outcomes:
measure: Knowledge and attitude (pre test)
timeFrame: baseline data
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Medical University
Study officials:
References:
citation: Wang CY, Lu CY, Yang SY, Tsai SC, Huang TW. 3D Virtual Reality Smartphone Training for Chemotherapy Drug Administration by Non-oncology Nurses: A Randomized Controlled Trial. Front Med (Lausanne). 2022 Jun 20;9:889125. doi: 10.3389/fmed.2022.889125. eCollection 2022.
Clinical trial NCT00899132: Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
Official title: The Role of TAB3 Protein in Tumorigenesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-melanomatous Skin Cancer
Pancreatic Cancer
Small Intestine Cancer
Testicular Germ Cell Tumor
Keywords: skin cancer
small intestine cancer
pancreatic cancer
malignant testicular germ cell tumor
testicular teratoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care center

Brief summary: RATIONALE: Studying samples of tumor 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 research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.

Detailed description: OBJECTIVES:

* To identify TAB3 transcript/protein as a molecular marker of cancer, specifically testicular, skin, small intestine, and pancreatic cancer.
* To characterize TAB3 and its signaling networks that are involved in tumorigenesis.

OUTLINE: Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Paraffin tissue blocks from surgical pathology cancer cases, specifically testicular, skin, small intestine, and pancreatic cancer, available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification of TAB3 transcript/protein as a molecular marker of cancer
timeFrame: end of study
measure: Characterization of TAB3 and its signaling networks that are involved in tumorigenesis
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Ge Jin, PhD
role: STUDY_CHAIR
References: