louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06476106: Human Research Program Flight Thigh Cuff
Official title: Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Lead sponsor: National Aeronautics and Space Administration (NASA)
Sponsor class: FED
First posted: 2024-06-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.


Eligibility criteria: Inclusion Criteria:

* Astronauts participating in missions that are ≥2 months

Exclusion Criteria:

* Having known allergies to proparacaine hydrochloride ophthalmic solution precludes participation in this study
* Use of ethinyl estradiol Combined Oral Contraceptive (COC) pills precludes participation in this study
* Having increased risk of venothromboembolism (VTE) based on preflight thrombosis/clotting related biomarkers precludes participation in this study

Primary outcomes:
measure: Internal Jugular Vein (IJV) area
timeFrame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
measure: IJV pressure
timeFrame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
measure: Intraocular Pressure (IOP)
timeFrame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
measure: stroke volume
timeFrame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Johnson Space Center, National Aeronautics and Space Administration
state: Texas
Study officials:
affiliation: National Aeronautics and Space Administration (NASA)
name: Brandon R Macias, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413906: Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
Official title: Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
* Men and woman, 20 years of age and above

Exclusion Criteria:

* Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
* Inability to swallow oral medication
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow function
* Inadequate hepatic function
* Inadequate renal function
* Pancreatitis

Primary outcomes:
measure: Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
timeFrame: Within the first 28 days of treatment
measure: Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
timeFrame: Up to 90 days additional treatment period plus 60 days of follow-up
Secondary outcomes:
measure: The number of subjects experienced DLT
timeFrame: Within the first 28 days
measure: Maximum observed concentration (Cmax) of BMS-833923 (XL139)
timeFrame: Day1 and Day 29
measure: Trough observed concentration (Cmin) of BMS-833923 (XL139)
timeFrame: Day1 and Day 29
measure: Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)
timeFrame: Day1 and Day 29
measure: Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)
timeFrame: Day1 and Day 29
measure: Effective half-life (T-half,eff) of BMS-833923 (XL139)
timeFrame: Day1 and Day 29
measure: Accumulation index (AI) of BMS-833923 (XL139)
timeFrame: Day1 and Day 29
measure: Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria
timeFrame: Up to120 days of treatment period
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03519906: Bariatric Surgery and Pharmacokinetics of Metoprolol
Official title: Bariatric Surgery and Pharmacokinetics of Metoprolol: BAR-MEDS Metoprolol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Metoprolol
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-05-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on metoprolol are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Metaprolol concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02769806: Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma
Official title: Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Glioblastoma Multiforme
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2016-05-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 25 patients diagnosed with GBM will be enrolled and stratified by the methylation status of their tumor; 17 MGMT-unmethylated and 8 MFMT-methylated will be enrolled.

Brief summary: The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.

Detailed description: Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.

Eligibility criteria: Inclusion Criteria:

* Histology: Glioblastoma (grade 4 astrocytoma)
* Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.
* Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.
* Methylation status of tumor available in medical record.
* Able to provide written informed consent.

Exclusion Criteria:

* Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).
* Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
* Special subjects such as minors, mentally disabled persons, or prisoners.

Primary outcomes:
measure: A novel high resolution DSC-PWI imaging method
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Alexey Samsonov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508806: Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Official title: A Single-centre, Open-label, Trial Investigating the Pharmacokinetics and the Tolerability of Liraglutide in Subjects With Normal Renal Function and in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Oceania. The aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.


Eligibility criteria: Inclusion Criteria:

* Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups
* Body Mass Index (BMI) maximum 40 kg/m\^2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Renal transplanted patients
* Haemodialysis patients
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
* Excessive consumption of food deviating from a normal diet as judged by the Investigator

Primary outcomes:
measure: Area under the Curve (AUC)
Secondary outcomes:
measure: AUC (0-t)
measure: Cmax, maximum concentration
measure: tmax, time to reach Cmax
measure: t½, terminal half-life
measure: CLR (renal clearance)
measure: Adverse events
Other outcomes:
Locations:
city: Christchurch
country: Australia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol. 2009 Dec;68(6):898-905. doi: 10.1111/j.1365-2125.2009.03536.x.
Clinical trial NCT02713906: Materialise X-ray Knee Guides for Total Knee Arthroplasty
Official title: Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Lead sponsor: Materialise
Sponsor class: INDUSTRY
First posted: 2016-03-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Physically and mentally able and willing to comply with the protocol
* Be treated for a primary total knee arthroplasty
* Are fluent in Dutch or French
* Sign the Informed Consent Form
* Comply with the indications listed in the Instructions for Use
* Be able to undergo a CT scan

Exclusion Criteria:

* Fulfilling one of the contraindications mentioned in the Instructions for Use
* Pregnant
* A prisoner
* Reported to have mental illness or belonged to a vulnerable population

Primary outcomes:
measure: Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
timeFrame: 2 Months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Reet
country: Belgium
facility: AZ Heilige Familie
Study officials:
affiliation: AZ Heilige Familie
name: Roger Jaeken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02894606: Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplant
Keywords: Kidney Transplant
Immunology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: kidney graft recipients from two French renal transplantation centers

Brief summary: The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* Recipient of a renal allograft
* Patient receiving either basiliximab or thymoglobulin as in induction therapy for renal transplant
* Patient presenting a low immunologic risk
* Patient not opposed to his (her) study participation

Exclusion Criteria:

* Patient participating in a clinical trial

Primary outcomes:
measure: The distribution of mature blood B cells subpopulations will be compared between the 2 groups
timeFrame: one year after renal transplant
measure: Proliferation of freshly isolated cells T in presence of autologous B cells will be compared between the 2 groups.
timeFrame: one year after renal transplant
Secondary outcomes:
measure: Serum B-cell activating factor (BAFF) concentration comparison between the two groups
timeFrame: one year after renal transplant
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: University Hospital, Brest
name: Yannick Le meur
role: STUDY_DIRECTOR
References:
Clinical trial NCT02902406: Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study
Official title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients come to the Department of Dentistry of National Taiwan University Hospital for oral health care or treatment.

Brief summary: This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.


Eligibility criteria: Inclusion Criteria:

* Subject with age over 20.
* Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (NCT01945697).
* Subjects agrees to sign the informed consent form.

Exclusion Criteria:

* Pregnant woman.
* Subject disagrees to sign the informed consent form.

Primary outcomes:
measure: DNA methylation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Dentistry National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05553106: Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Official title: Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Diseases
Keywords: intensive care
coronary artery disease
kinesiophobia
physical activity level
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in coronary intensive care unit who can take simple commands and whose condition is physiologically stable

Brief summary: The aim of our study is to evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care.

Detailed description: This study will be performed on patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research
* Being under surveillance in the coronary intensive care unit

Exclusion Criteria:

* Presence of neurological disease that may affect the cognitive status
* Not being clinically stable
* Not to cooperate

Primary outcomes:
measure: Functional Performance Assessment
timeFrame: 2 weeks
Secondary outcomes:
measure: Symptom Assessment
timeFrame: 2 weeks
measure: Cognitive Status Assessment
timeFrame: 2 weeks
measure: Physical Activity Level
timeFrame: 2 weeks
measure: Fear of Movement
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Hikmet Yorgun, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ahmet Hakan Ates, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Dilara Saklica, MSc
role: PRINCIPAL_INVESTIGATOR
References: