louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04179539: Ga68 V/Q PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study Vs CT Pulmonary Angiography
Official title: Gallium68 Ventilation/perfusion PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study Vs CT Pulmonary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Embolism
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the diagnostic accuracy (sensitivity, specificity) of V/Q PET/CT for the diagnosis of pulmonary embolism (PE), using CT pulmonary angiography as a reference standard.

Detailed description: V/Q PET/CT imaging is now possible by substituting 99mTc with 68Ga, a positron-emitting radionuclide, using the same carrier molecules as conventional V/Q imaging. Ventilation imaging can be performed with 68Ga-carbon nanoparticles using the same synthesis device as Technegas. Perfusion imaging can be performed with 68Ga-macroaggregated albumin (68Ga-MAA).Technical advantages of PET compared to SPECT include higher sensitivity, higher spatial and temporal resolution and superior quantitative capability. This offers the opportunity to improve the accuracy of V/Q imaging in patients with suspected PE, while decreasing the acquisition time.

The aim is to perform a formal diagnostic accuracy study of V/Q PET/CT for PE, using CTPA as a reference standard.

Patients with suspected acute PE undergo CTPA and V/Q PET/CT imaging within 24 hours.

V/Q PET/CT images are not used for patients management.

After completion of inclusion, central readings of scans will be conducted independently.

Eligibility criteria: Inclusion Criteria:

* Patient with suspected first episode of acute PE,
* Age ≥ 18 years .
* Insured patient.

Exclusion Criteria:

* Patients with a clinically suspected massive PE.
* Contraindication to contrast media (including renal insufficiency with creatinine clearance \< 30 ml/min).
* Inability to perform CTPA and V/Q PET/CT within 24 hours.
* History of deep vein thrombosis or PE
* Unable/unwilling to give informed consent.
* Pregnancy / breast-feeding.
* Patient under guardianship or curatorship

Primary outcomes:
measure: Sensitivity of V/Q PET/CT for PE diagnosis
timeFrame: Baseline
measure: Specificity of V/Q PET/CT for PE diagnosis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de BREST
Study officials:
References:
Clinical trial NCT01008839: Protein Synthesis in Midthigh Muscles PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: study sarcopenia, which muscle becomes weaker with age
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: healthy women

Brief summary: The purpose of this study is to test a new imaging technique to help scientists study sarcopenia, the process by which muscle becomes weaker with age.


Eligibility criteria: Inclusion Criteria:

* young healthy women aged 25-35 years and older healthy women above 70 years old.

Exclusion Criteria:

* no cardiac disease, not taking medication for high blood pressure Asthma HIV any other cardiac conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00504439: A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects
Official title: A Randomised, Double-blind, Placebo Controlled, Dose Ascending, Parallel Group Study to Evaluate the Safety, Tolerability, Steady State Pharmacokinetics and Pharmacodynamics of SB-656933-AAA Following Repeated Doses in Healthy Adult Subjects. The Pharmacokinetic Interaction Between Repeated Doses of SB-656933-AAA and Single Dose of Simvastatin Will Also be Assessed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD,
CD11b,
CXCR2,
safety,
repeat dose,
tolerability.
SB-656933,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess safety of SB-656933 following repeat dosing for 14 days.

Detailed description: A randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy adult female, aged 18-65 years.
* Female must not be able to have children.
* Non-smoking for the last 6 months.

Exclusion Criteria:

* Any serious medical condition.
* Hepatitis B or C and/or HIV positive.
* Currently on HRT, or other medication except paracetamol.
* Body Mass Index \>30.

Primary outcomes:
measure: Assess safety of SB-656933 after repeat doses.
timeFrame: after repeat doses
Secondary outcomes:
measure: Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.
timeFrame: 14 days of repeat dosing.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00390039: Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
Official title: Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Pain, postoperative
Surgery, orthopedic
Morphine
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 256
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: Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Detailed description: Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
* Moderate to severe pain within 8 hours following completion of the required surgery

Exclusion Criteria:

* Previous anaphylactic or serious allergic reaction to shellfish or opioids
* History of sleep apnea

Other Inclusion/Exclusion Criteria May Apply

Primary outcomes:
measure: Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
timeFrame: Multiple
Secondary outcomes:
measure: Other measures of pain
timeFrame: Multiple
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Bakersfield
country: United States
facility: Vertex Clinical Research
state: California
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Austin
country: United States
facility: SCIREX Corporation
state: Texas
city: San Marcos
country: United States
facility: SCIREX Corporation
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Javelin Pharmacueticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00716625: Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
Official title: Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 1674
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6181176 prescribes the sunitinib malate (Sutent).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered sunitinib malate (Sutent).

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: MAX 2 Years
measure: Objective Response Rate
timeFrame: MAX 2 Years
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events in Pediatric Population
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events in Elderly Population
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
timeFrame: MAX 2 Years
measure: Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
timeFrame: MAX 2 Years
Other outcomes:
measure: Number of Participants With Treatment-Related Serious Adverse Events
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)
timeFrame: MAX 2 Years
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06532825: Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure
Official title: Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: heart failure
decompensated
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2024-08-01
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: Patients admitted to the hospital with acute decompensated heart failure, regardless of measured left ventricle ejection fraction.

Patients will be grouped according to rhythm: sinus rhythm and atrial fibrillation.

Brief summary: The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.

Detailed description: If the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six months.

Eligibility criteria: Inclusion Criteria:

* 18-years age or older
* admitted with acute decompensated heart failure for less than 48 h

Exclusion Criteria:

* pacemaker
* not signed informed consent
* other heart rhythm than sinus rhythm or atrial fibrillation

Primary outcomes:
measure: number of rehospitalizations
timeFrame: up to six months after discharge from index admission
Secondary outcomes:
measure: Heart rate Variability change from admission to discharge
timeFrame: repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)
Other outcomes:
measure: Diastolic function
timeFrame: six months
Locations:
city: Frederiksberg
country: Denmark
facility: Cardiology department Y, Bispebjerg-Frederiksberg Hospital
Study officials:
References:
Clinical trial NCT00636025: Cellulite and Magnetic Resonance Imaging
Official title: Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cellulitis
Lead sponsor: Brazilan Center for Studies in Dermatology
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females patients with cellulite on the buttocks.

Brief summary: The purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, Magnetic Resonance Imaging.

Detailed description: A cross-sectional study was performed at a single center, in accordance with good clinical practice. Thirty women aged 18 to 50 were included in this study. An experienced dermatologist evaluated all of the subjects in a standing position, with relaxed gluteus muscles, using the CSS classification. An area with cellulite and another without cellulite on the contralateral buttock were selected. The area with cellulite had an evident depressed lesion, whereas the area without cellulite had no depressed or raised lesions, The selected cellulite depression was marked with a positive symbol using a skin marking pen.

Eligibility criteria: Inclusion Criteria:

* Written Informed Consent;
* Subjects agreeing to take part of all procedures of the study, after being fully informed on the objectives and nature of the investigations;
* Healthy female subjects over 18 years;
* Subjects presenting cellulite on the buttocks;
* Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
* Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollment until the end of the study);
* Availability of the subject throughout the duration of the study (180 days);
* Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

Exclusion Criteria:

* Pregnant women or women intending to become pregnant during the study (next 3 months);
* Subjects participating in other clinical trials;
* Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Primary outcomes:
measure: The presence and characteristics of the fibrous septa in areas with and without cellulite.
timeFrame: at baseline
Secondary outcomes:
measure: The characteristics of the subcutaneous tissue in areas with and without cellulite.
timeFrame: at baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03221725: The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
Official title: The Effect of Sacrospinous Ligament Fixation After Vaginal Hysterectomy to Development of De-novo Stress Urinary Incontinence and Postoperative Vaginal Length in Treating Stage II-III Pelvic Organ Prolapse Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: sacrospinous ligament fixation
stress urinary incontinence
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgery for Stage II-III Pelvic organ prolapse


Eligibility criteria: Inclusion Criteria:

* Pelvic organ prolapse stage II-III
* has no incontinence before surgery

Exclusion Criteria:

* had surgery before
* Pelvic organ prolapse stage I or IV

Primary outcomes:
measure: development of stress urinary incontinence
timeFrame: in one year
Secondary outcomes:
measure: postoperative vaginal length
timeFrame: in one year
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kerem Doga Seckin
Study officials:
References:
Clinical trial NCT01540825: First in Man Trial of BI 113608
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test
timeFrame: From administration of study drug until end-of-study visit, up to 10 days
measure: Percentage of Participants With Drug-related Adverse Events
timeFrame: From administration of study drug until end-of-study visit, up to 10 days
measure: Assessment of Tolerability by the Investigator
timeFrame: End of study visit, up to day 10
Secondary outcomes:
measure: Cmax
timeFrame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
measure: Tmax
timeFrame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
measure: AUC0-tz
timeFrame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
measure: AUC0-infinity
timeFrame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
measure: t1/2
timeFrame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04331925: Impact of Journal Program on Wellbeing of NICU Parents
Official title: Impact of Journal Program on Wellbeing of NICU Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: NICU parents
Journaling
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to investigate the impact of a journaling program on rates of anxiety and depression in neonatal intensive care unit (NICU) parents.


Eligibility criteria: Inclusion Criteria:

* Mother, father, and/or legal guardian of infant
* \> 28 weeks gestation
* At least 5 days anticipated admission in Vanderbilt NICU

Exclusion Criteria:

* \< 28 weeks gestation
* Expected death or discharge within 5 days of admission
* Primary medical team feels that participation would be disruptive or detrimental to infant's care

Primary outcomes:
measure: Change in HADS anxiety score
timeFrame: Baseline to 2-4 weeks
measure: Change in HADS depression score
timeFrame: Baseline to 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Amy Weitlauf, PHD
role: STUDY_CHAIR
References:
citation: Russell LN, Gregory ML, Warren ZE, Weitlauf AS. Uptake and impact of journaling program on wellbeing of NICU parents. J Perinatol. 2021 Aug;41(8):2057-2062. doi: 10.1038/s41372-021-00983-1. Epub 2021 Mar 1.