louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05491460: Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
Official title: Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anticoagulant Therapy
Keywords: anticoagulant
direct oral anticoagulant
apixaban
edoxaban
rivaroxaban
dabigatran
coagulation
point of care method
Lead sponsor: Doasense GmbH
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time \[PT\] and activated partial thromboplastin time \[aPTT\]) from plasma samples show a high variation. Special coagulation tests like hemoclot for dabigatran and chromogenic substrate assays for Rivaroxaban, Apixaban, and Edoxaban are time-consuming and can be performed only in specialized laboratories. In specific medical situations like in patients such as emergency procedures, stroke (before starting thrombolytic therapy), trauma, general surgery or other invasive procedures, it may be necessary for medical decision making to know the presence or absence of a DOAC in patient's body fluid. Until now there is no rapid, specific and sensitive coagulation test available in the market.

Detailed description: This prospective, open-label, controlled, not randomized trial in healthy volunteers to investigate comparatively the pharmacokinetics of the direct oral anticoagulants in plasma and in urine with LC-MS/MS and in urine by DOAC Dipstick.

Eligibility criteria: Inclusion Criteria:

* Fully signed and dated written informed consent

  * Age \>18 years
  * healthy

Exclusion Criteria:

* Patients not able to provide urine samples.

  * Patients not able to understand the informed consent or severe mentally disabled.
  * Patients in the end-stage of a severe disease.

Primary outcomes:
measure: Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS
timeFrame: up to 6 months
Secondary outcomes:
measure: Comparison of qualitative POCT with quantitative LC-MS/MS
timeFrame: up to 6 months
measure: Questionnaire on handling and usability
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Clincial Research Serivces
Study officials:
affiliation: Clinical Research Services
name: Armin Schultz, MD
role: STUDY_DIRECTOR
References:
citation: Harenberg J, Schreiner R, Hetjens S, Weiss C. Detecting Anti-IIa and Anti-Xa Direct Oral Anticoagulant (DOAC) Agents in Urine using a DOAC Dipstick. Semin Thromb Hemost. 2019 Apr;45(3):275-284. doi: 10.1055/s-0038-1668098. Epub 2018 Aug 22.
Clinical trial NCT02869360: Correlation Between PET and Advanced MRI in Multiple Sclerosis
Official title: Pilot Study of Positron Emission Tomography (PET) Imaging: Correlations With Advanced Magnetic Resonance Imaging in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2016-08-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA 40mg TIW

Brief summary: Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific.

This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
* Aged 18 to 60
* High or mixed affinity binder to rs6971 TSPO polymorphism

Exclusion Criteria:

* Pregnant or breastfeeding
* Suffering from an unstable medical condition
* Have a neurological or ocular disorder other than MS
* Any contra-indications to MRI

Primary outcomes:
measure: Whole Brain PBR28 binding
timeFrame: Baseline
Secondary outcomes:
measure: Lesional PiB binding
timeFrame: Baseline
measure: Myelin Water Imaging
timeFrame: Baseline
measure: MR Spectroscopy (Total NAA, NAA/Cr, mI)
timeFrame: Baseline
measure: Optical Coherence Tomography (RNFL thickness)
timeFrame: Baseline
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: MS Clinical Trials Group - UBC
state: British Columbia
Study officials:
References:
Clinical trial NCT01731860: Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
Official title: Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
Keywords: PET/CT
Philips
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
name: Case Western Reserve University
name: Imarc Research, Inc.
First posted: 2012-11-22
Enrollment: 51
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: A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system.

The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.


Eligibility criteria: Inclusion Criteria:

* Patients are at least 18 years
* Patients are medically stable
* Patients scheduled for clinically necessary PET/CT examination

Exclusion Criteria:

* Patients who are pregnant
* Patients who are unwilling/unable to sign the Informed Consent Form
* Patients who are cognitively impaired and unable to provide informed consent
* Patients who have experienced adverse events to PET/CT examinations

Primary outcomes:
measure: Imaging Capabilities and Performance of the Alpha Ring
timeFrame: Within 1 month of image acquisition
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Peter F Faulhaber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01887860: Patch Test Skin Irritation/Sensitization of Cetaphil Daily Facial Moisturizer SPF 50
Official title: Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Irritation
Keywords: Cetaphil Daily Facial Moisturizer SPF 50
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or irritant in certain individuals.


Eligibility criteria: Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating

Primary outcomes:
measure: Area of erythema and edema measured
timeFrame: 3 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New City
country: United States
facility: AMA Laboratories
state: New York
Study officials:
affiliation: AMA Laboratories
name: Mayya Tastene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06810960: A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease
Official title: A 6-Year Postmarketing Safety and Clinical Outcome Study of Lecanemab in the Treatment of Alzheimer's Disease Using Real-World Data From South Korean Patients Enrolled Into the South Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lecanemab
ARIA
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 3000
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: Participants prescribed with lecanemab by a physician in routine clinical practice.

Brief summary: The primary purpose of this study is to evaluate safety of lecanemab in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in participants treated with lecanemab.


Eligibility criteria: Inclusion Criteria:

* 18 years or older at consent
* Prior to JOY-ALZ enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in South Korea
* Has an identified study partner who provides separate written informed consent
* Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.

Exclusion Criteria:

* Currently participating in an interventional clinical study
* Has contraindications for lecanemab according to the approved prescribing information in South Korea

Primary outcomes:
measure: Incidence of Adverse Events of Special Interest (AESIs)
timeFrame: Up to 6 years
measure: Exposure-adjusted Incidence Rate of AESIs
timeFrame: Up to 6 years
Secondary outcomes:
measure: Incidence of Seizure, Anaphylaxis and Death
timeFrame: Up to 6 years
measure: Exposure-Adjusted Incidence Rate of Seizure, Anaphylaxis and Death
timeFrame: Up to 6 years
measure: Incidence of AESIs Based on Baseline Characteristics
timeFrame: Up to 6 years
measure: Exposure-adjusted Incidence Rate of AESIs Based on Baseline Characteristics
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Eisai Trial Site #1
state: New Jersey
Study officials:
References:
Clinical trial NCT03289260: Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
Official title: Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anogenital Human Papillomavirus Infection
Condyloma Anal
Keywords: Condylomata acuminata, Fulguration, Imiquimod
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 200
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: AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection.

Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.

100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy


Eligibility criteria: Inclusion Criteria:

* Ability to understand and willingness to sign and date a written consent document
* Male and female patients \>= 18 years of age
* Negative urine/serum pregnancy test
* Indication for surgical therapy of anal HPV lesions

Exclusion Criteria:

* Participation in another clinical study with experimental therapy
* Diagnosis and therapy of HPV associated lesions in the last 12 months
* Known intolerance of hypersensitivity to Imiquimod
* Women who are pregnant of lactating

Primary outcomes:
measure: Difference in recurrence rates between the two arms
timeFrame: 12 months
Secondary outcomes:
measure: CD4 (cluster of differentiation 4) cell count
timeFrame: 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Visceral-, Transplant- and Thoracic Surgery
state: Tyrol
Study officials:
affiliation: University Hospital for Visceral, Transplant and Thoracic Surgery
name: Dietmar Öfner-Velano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05239260: Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.
Official title: Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD/MAFLD
Liver Fibrosis
CMR
Keywords: NAFLD
CMR
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging

Brief summary: Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.


Eligibility criteria: Inclusion Criteria:

* Referred for Cardiovascular Magnetic Resonance Imaging

Exclusion Criteria:

* Non-compatible Devices

Primary outcomes:
measure: Impact of fluid status on liver elastography and T1-times
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Andreas Kammerlander
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02770560: Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters
Official title: Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Cuffed Catheters : a Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Vascular Access Devices
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Incident and prevalent patients on hemodialysis, more than 18y old, receiving dialysis via a tunneled cuffed catheter between 1st May 2010 and 31st October 2014.

Brief summary: Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to inadequate dialysis dose, need to catheter replacement with as consequence progressive exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution to dissolve the clotting formed in of around the catheter lumen. There are few studies on the optimal approach of TCC-related thrombosis with thrombolytic containing locking solution (dose, number of administrations, timing of administration - intra or interdialytic use). The primary objective of this retrospective study was to compare the efficacy of inter versus intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The investigators also assess the question of multiple administrations of Urokinase are more efficient than one single administration


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients over 18 years old, receiving hemodialysis between 1st May 2010 and 31st October 2014 via a tunneled cuffed catheter at the Hemodialysis Unit of Universitair Ziekenhuis Brussel Hospital.

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with a temporary dialysis catheter
* Patients who never received a tunneled hemodialysis catheter in this period
* Patients who didn't have a medical file at the Universitair Ziekenhuis Brussel Hospital

Primary outcomes:
measure: Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution
timeFrame: up to 54 months
measure: Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution
timeFrame: up to 54 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Florence Bonkain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730860: Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE
Official title: Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Liver
Keywords: radiofrequency ablation
Cancer of Liver
postoperative
transhepatic arterial chemoembolization
prospective
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
First posted: 2008-08-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.

Detailed description: A randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.

Eligibility criteria: Inclusion Criteria:

* patients with hepatocellular,confirmed by pathological examination
* patients with a live function test showed Child A or B
* Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE
* Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.
* without metastasis in lymphnode or other organs
* written consent inform assigned

Exclusion Criteria:

* preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava
* metastatic cancer of liver
* patients with a poor tolerance of RFA and TACE
* patients received other therapies.

Primary outcomes:
measure: disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Ma Kuansheng, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00334360: Dexmed/Buspirone Synergism on Shivering
Official title: Do Dexmedetomidine and Buspirone Synergistically Reduce the Threshold, Gain, and Maximum Intensity of Shivering?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2006-06-07
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.

The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration.

Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.


Eligibility criteria: Inclusion Criteria:

* 18-40 years
* normal weight (BMI \<35)
* healthy

Exclusion Criteria:

* obese (BMI \>35)
* taking any drugs
* thyroid disease, dysautonomia, or Raynaud's syndrome
* severe claustrophobia

Primary outcomes:
measure: Shivering threshold
timeFrame: 3 hours
measure: maximum intensity of shivering
timeFrame: 3 hours
measure: gain of shivering
timeFrame: 3 hours
Secondary outcomes:
measure: hemodynamic responses
timeFrame: 3 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Outcomes Research Institute, University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville School of Medicine
name: Rainer Lenhardt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: