louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01023360: Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay
Official title: Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping™ Assay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: 30 Healthy People
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Haemonetics Corporation
First posted: 2009-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Currently, drugs commonly used for antiplatelet are aspirin and clopidogrel when encountering stroke or coronary heart disease. In this study, we would use VASP assay and thromboelastograph with platelet mapping assay kit to evaluate the antiplatelet resistance in general population and the relationship between clopidogrel and proton pump inhibitor.

Detailed description: This study intent is to search the standard to diagnose of the antiplatelet drug resistance and to discover the prevalence of drug resistance in Taiwanese population in Taiwan. The trial will enroll at least 30 healthy people after fulfilling the investigation questionnaire. All the participants will receive antiplatelet drugs in two separate period and measured the efficacy by VASP assay and thromboelastograph with platelet mapping assay. The health volunteer will receive clopidogrel and different types of proton pump inhibitor to see the interference of antiplatelet efficacy between each drug.

Eligibility criteria: Inclusion Criteria:

* 30 Healthy people, without major systemic disease, not under medication treatment

Exclusion Criteria:

* Systemic disease, under medication control with NSAID, anticoagulants, taking antiplatelet drugs before entering trial, Chinese herb, pregnant or breast feeding woman

Primary outcomes:
measure: Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Fu-Tien Chiang, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242060: Functional and Morphologic MRI in the Detection of Prostate Cancer in Patients With Prior Negative Biopsy
Official title: The Utility of Functional and Morphologic MRI in the Detection of Prostate Cancer for Patients With Elevated PSA and Prior Negative Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated PSA
Prostate Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-10-19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Detailed description: Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* prior ultrasound biopsy of prostate showing no cancer or only single microfocus of cancer

Exclusion Criteria:

* contraindication to contrast enhanced endorectal coil MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Masoom Haider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386591: Comparison of Naloxone Pharmacokinetics
Official title: Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2017-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.
Primary purpose: TREATMENT

Brief summary: Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.


Eligibility criteria: Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive
* Provide written informed consent
* BMI ranging from 18 to 32 kg/m2, inclusive
* Adequate venous access
* No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
* Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
* Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

* Contact site directly for more information

Primary outcomes:
measure: Pharmacokinetic parameters of naloxone
timeFrame: 11 days
Secondary outcomes:
measure: Safety Assessments
timeFrame: 16 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
Study officials:
affiliation: Vince and Associates Clinical Research
name: Debra Kelsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05079191: Impact of the CT Scan in Patients With Suspected Covid-19
Official title: Diagnostic Performance and Predictive Impact of the CT Scan in Patients With Suspected Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
SARS-COV-2
Chest scanner
CT scan
RT-PCR
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient admitted to Strasbourg University Hospitals for suspicion of Covid-19

Brief summary: The diagnostic performance of the scanner in the indication of suspected Covid-19 is not yet well known, especially in comparison with the results of RT-PCR.

The potential use of the scanner as a tool for quantifying the severity of Covid-19 disease is not yet well established, especially the variations between readers or between measurement techniques.

The impact of the scanner in predicting the fate of patients with confirmed Covid-19 is not yet known.


Eligibility criteria: Inclusion criteria

* Adult patient (≥18 years old)
* Patient admitted to Strasbourg University Hospitals for suspicion of Covid-19, between 03/01/2020 and 04/29/2020
* Availability of at least one chest CT scan during hospitalization
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Non-inclusion criteria

* Patient who expressed his opposition to participating in the study
* Patient under legal protection
* Patient under guardianship or guardianship

Primary outcomes:
measure: Retrospective study of the chest scanner in suspected Covid-19
timeFrame: Files analysed retrospectively from March 01, 2020 to April 29, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie B - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT00555191: Fructose Malabsorption in Northern Norway
Official title: Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Fructose Malabsorption
Keywords: fructose
Irritable bowel syndrome
malabsorption
Glut5 transporter gene
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Nordlandssykehuset HF
First posted: 2007-11-08
Enrollment: 182
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: Different published studies has shown a possible co-variation between leakage of fructose to the great bowel and exacerbation of irritable bowel syndrome (IBS) symptoms.

The aim of the FINN trial is to study the role of fructose malabsorption in patients with IBS in order to evaluate different diagnostic criteria for fructose malabsorption and at the same time study the effect of diet treatment in this cohort of patients and estimate the prevalence of fructose malabsorption.


Eligibility criteria: Inclusion Criteria:

* IBS patients satisfying ROME 2 diagnostic criteria

Exclusion Criteria:

* Seriously ill
* Organic abdominal disease
* Other functional bowel disease

Primary outcomes:
measure: VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints.
timeFrame: 12 weeks
Secondary outcomes:
measure: Estimate sensitivity,specificity,negative and positive predictive value using 50 gm fructose in breath test.Validate questionary for intolerance.Validate VAS in judging changes in abdominal complaint.Examine polymorphism i Glut5 transporter gene.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mo i Rana
country: Norway
facility: Hospital of Rana Medical Dep. Helgelandsykehuset HF
state: Nordland
Study officials:
affiliation: University Hospital of North Norway, Department of Gastroenterology
name: Jon Florholmen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg LK, Fagerli E, Myhre AO, Florholmen J, Goll R. Self-reported dietary fructose intolerance in irritable bowel syndrome: Proposed diagnostic criteria. World J Gastroenterol. 2015 May 14;21(18):5677-84. doi: 10.3748/wjg.v21.i18.5677.
Clinical trial NCT00572091: Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Official title: An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Mitral Regurgitation
Keywords: Heart Failure
Mitral Regurgitation
Lead sponsor: Viacor
Sponsor class: INDUSTRY
First posted: 2007-12-12
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device


Eligibility criteria: Inclusion Criteria:

* Symptomatic heart failure
* functional MR 2+ - 4+
* LVEF 20% - 50%

Exclusion Criteria:

* MR of organic origins
* significant co-morbidities

Primary outcomes:
measure: percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery
timeFrame: 30 days
Secondary outcomes:
measure: percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension
timeFrame: 30 days
measure: improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max.
timeFrame: 30 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
Study officials:
affiliation: Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
name: Rainer Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02490891: Study of the Angiogenesis by PET/CT in Patients With Lymphoma
Official title: Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: Lymphoma, angiogenesis, PET scan
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass

Detailed description: After inclusion PET scans with FDG tracer and with a specific tracer of angiogenesis will be performed on patient with lymphoma. After two cycles of chemotherapy PET scans with the same tracers will be performed.

Overall survival and disease free survival will be monitored during 18 months.

Eligibility criteria: Inclusion Criteria:

* Male or Female
* Age ≥ 18 years old
* OMS ≤ 1
* Histological diagnosis of diffuse large B-cell lymphoma what ever the subtype
* Presence of measurable tumor with at least a node mass superior to 3 centimeters
* Stage I to IV
* Inform consent signed

Exclusion Criteria:

* Primary cerebral lymphoma
* Absence of fixing on FDG-PET exam
* Pregnant , child bearing, breast feeding or without effective contraception method woman
* Hypersensitivity to RGD-K5
* Hypersensitivity to FDG
* Poorly controlled diabètes (glycemia ≥ 10 millimoles/liter)
* Neoplastic disease (less than 2 years or in progression)

Primary outcomes:
measure: Measure of angiogenesis with RGD K5 PET scan
timeFrame: 3 months
Secondary outcomes:
measure: Measure of angiogenic volume with K5 tracer
timeFrame: 3 months
measure: Overall survival
timeFrame: 18 months
measure: Disease-free survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Pierre Vera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758691: fMRI Study of Effects of Nasal Insulin on Memory
Official title: Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Memory
Intranasal Insulin
Keywords: memory
insulin
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Recent research has suggested insulin may be involved in how human's form and recall memories. This study is designed to look at how nasal insulin is used in the brain. Specifically, how insulin alters the various connections within brain regions that occur while adults perform simple attention and memory tasks. This study is divided into two parts: blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The blood draw procedure is designed to look at the effects of intranasal insulin using a Precision Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those asked to participate will receiving a low-dose saline solution and low-dose of insulin through a nasal spray followed by a blood draw session to measure your blood glucose and insulin levels over a 90 minute period.

Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI). During the scan, participants will complete a series of memory tasks reflected on a computer screen. The trial will be randomized and double-blinded.


Eligibility criteria: Inclusion Criteria:

* healthy adults over the age of 18

Exclusion Criteria:

* any existing health conditions: including diabetes, history of alcoholism or drug dependence
* contraindications to Magnetic Resonance Imaging (MRI): any non-titanium metal in the head or body

Primary outcomes:
measure: Change in Memory Recall Performance during functional Magnetic Resonance Imaging task
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04374591: The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia
Official title: The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia: A Preliminary Report of Short Term Follow up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Covid19
Keywords: COVID-19
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To report the possible role of S.B 8.4% in the treatment of COVID-19pneumonia.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Fever ≥ 38º C with upper respiratory tract manifestations, generalized bone ache with or without gastrointestinal symptoms as diarrhea.
* Chest CT with signs suggestive of COVID-19.
* Mild and moderate cases of COVID-19 pneumonia with respiratory and hemodynamic stability. - High C reactive protein (CRP).- With or without history of contact with index case who is isolated in a governmental hospital assigned for treatment of patients proved to have RT-PCR positive test for COVID-19
* With or without abnormalities in the total or differential white cell count.
* Welling to sign a fully informed consent.

Exclusion Criteria:

* Severe and critical illness with respiratory failure and/ or hemodynamic instability.
* CT with pleural effusion with or without lung cavitation.
* Other organ failure.

Primary outcomes:
measure: Time to clinical recovery
timeFrame: 7 days
Secondary outcomes:
measure: Pulmonary recovery status
timeFrame: 7 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gomhoria Street
state: Outside U.S./Canada
Study officials:
affiliation: Chest department Mansoura University Hospital
name: Mohammed K Elbadrawy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06713291: Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
Official title: Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fracture of Femoral Neck
Keywords: fracture of neck of femur, sliding compression locking plate, compression screws
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 1150
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 verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 years old, gender is not limited;
2. Patients diagnosed with femoral neck fracture;
3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion Criteria:

1. Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
2. The patient is known to have a history of allergy to one or more implanted materials;
3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
4. Active infection of the hip joint or other parts of the body is determined by the investigator;
5. Diagnosed as metabolic bone disease, radiation bone disease, etc.;
6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
9. Other conditions deemed unsuitable for inclusion by the investigator.

Primary outcomes:
measure: Femoral neck shortened
timeFrame: 1 year
Secondary outcomes:
measure: Neck shaft angle
timeFrame: 1 year
measure: The effectiveness of guide pin implantation
timeFrame: 1 day
measure: Time of operation
timeFrame: 1 day
measure: Blood loss
timeFrame: 1 day
measure: Bone union
timeFrame: 1 year
measure: Zarit Burden Interview（ZBI）
timeFrame: 1 year
measure: SF-36 Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hosptial
Study officials:
References: