louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02254148: The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)
Official title: The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.


Eligibility criteria: Inclusion criteria:

1. healthy male subjects
2. age of 18 to 55 years
3. body mass index of 18.5 to 29.9 kg/m2
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Primary outcomes:
measure: AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates
timeFrame: up to 143 hours postdose
measure: Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates
timeFrame: up to 143 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1307.19.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04217057: Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer
Official title: Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2020-01-03
Enrollment: 11
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: CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.


Eligibility criteria: Inclusion Criteria:

* Adult patient 18 years of age or older
* Cytology or biopsy-proven squamous cell head and neck cancer scheduled to be treated with standard of care surgery. Patients who are not surgical candidates should have adequate tissue from tumor biopsy for analysis of CCR2
* Lesion size of at least 1.5 cm (treatment naïve)
* Able to give informed consent
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 14 hour period immediately prior to administration of 64Cu-DOTA-ECL1i is negative

Exclusion Criteria:

* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years
* Unable to tolerate approximately 90 minutes (total time) of PET/CT imaging

Primary outcomes:
measure: Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale
timeFrame: At the time of scan (Day 1)
measure: Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Presence or Absence of Abnormal 64Cu-DOT-ECL1i Uptake in Pathologically Proven Site of Disease
timeFrame: At the time of scan (Day 1)
measure: CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining
timeFrame: At the time of standard of care surgery (estimated to be within 2 weeks of imaging)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Farrokh Dehdashti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800657: Stem Cells and Resynchronization Cardiac
Official title: Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Heart Failure
Keywords: Cardiac Resynchronization
Dilated Cardiomyopathy
Stem Cells Therapy
Heart Failure
Stem Cells/Cardiac Pacing, Artificial
Lead sponsor: Instituto de Molestias Cardiovasculares
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2008-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.

Detailed description: About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.

Eligibility criteria: * Dilated Cardiomyopathy
* Heart Failure
* Optimized Therapeutics
* Ventricular Desynchrony
* Functional Class III or IV
* Ejection Fraction(Echo/ Sympson) \< 35%

Primary outcomes:
measure: Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
timeFrame: 24 months
Secondary outcomes:
measure: Ejection Fraction (Echo/Sympson) and functional class(NYHA).
timeFrame: 24 months.
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: Imc - Instituto de Moléstias Cardiovasculares
state: São Paulo
Study officials:
affiliation: IMC - Institute of Hearth Diseases
name: Oswaldo Tadeu Greco, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMC- Institute of Hearth Diseases
name: Oswaldo Tadeu Greco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese.
Clinical trial NCT01892657: Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test
Official title: Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Irritation
Keywords: Cetaphil Daily Facial Moisturizer with SPF 50+
Hypoallergenicity
Skin Irritation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-07-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

Detailed description: The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.

Eligibility criteria: Inclusion Criteria:

* Men or women 18 to 70 years of age in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating

Primary outcomes:
measure: Area of Erythema and Elevated Responses of Skin to Product
timeFrame: 3 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens and Associates, Inc.
state: Colorado
Study officials:
affiliation: Galderma R&D
name: Ronald Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00895557: Assessing the Impact of Varenicline on Brain-Behavior Vulnerability
Official title: Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Varenicline and the Blunting of Cocaine Cues
Keywords: varenicline
cocaine
brain imaging
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-05-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Our proposal will enable us to study cocaine patients to determine whether varenicline can weaken brain arousal to drug cues in an fMRI imaging setting, which is what we theorize. This supplement supports a pilot imaging study in cocaine dependence. It will evaluate the impact of varenicline on the brain response to ultra-brief drug and comparison cues in an event-related fMRI paradigm. This is a pilot study.

We will additionally examine the impact of varenicline on addiction-relevant behavioral probes of impulsivity, inhibition, attentional and affective bias. The proposed study will provide the first brain-behavioral probes of varenicline's cocaine-relevant actions in humans, and will provide the critical scientific rationale to move the agent into future collaborative clinical trials.


Eligibility criteria: Inclusion Criteria:

* Physically healthy male substance abuse subjects age 18-55.

Exclusion Criteria:

* 1) Participation in clinical trial and receipt of investigational drug(s) during previous 60 days 2) Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities 3) History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes. 4) Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in subject's body (unless a radiologist confirms that its presence is unproblematic). A x-ray may be obtained to determine eligibility. 5) Claustrophobia or other medical condition disabling subject from lying in the MRI for approximately 60 minute

Primary outcomes:
measure: To determine whether varenicline, as compared to placebo, can blunt the limbic activation (e.g., amygdala, ventral striatum/ventral pallidum, etc.) by ultra-brief cocaine cues using fast event-related fMRI.
timeFrame: End of study
Secondary outcomes:
measure: Varenicline (vs. placebo) may reduce positive affective bias to drug (cocaine) cues.
timeFrame: End of study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Treatment Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anna Rose Childress, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758457: Zirconia and Metal-based Single Crown Posterior Restorations.
Official title: Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Crowns
Dental Prosthesis
Prosthodontics
Keywords: cad/cam
dental porcelain
zirconia
press on metal
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Male and female patients from 18-70 years of age
* Need for a single crown restoration
* Presence of antagonist
* minimum of 20 teeth
* moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing
* low to moderate caries risk, and no active periodontal disease.

Exclusion Criteria:

* Women who are pregnant at the date of inclusion
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Smoking more than 15 cigarettes a day
* Poor oral hygiene (Plaque Index over 30%)
* Bruxism
* vital teeth
* allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material

Primary outcomes:
measure: Technical complication rate
timeFrame: 5 years
Secondary outcomes:
measure: Survival rate
timeFrame: 1, 3, 5 years
measure: Survival rate
timeFrame: 1, 3, 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation
Study officials:
References:
citation: Monaco C, Llukacej A, Baldissara P, Arena A, Scotti R. Zirconia-based versus metal-based single crowns veneered with overpressing ceramic for restoration of posterior endodontically treated teeth: 5-year results of a randomized controlled clinical study. J Dent. 2017 Oct;65:56-63. doi: 10.1016/j.jdent.2017.07.004. Epub 2017 Jul 21.
Clinical trial NCT02195557: Retrospective Follow-up Study of Synvisc® in Patients With Knee Osteoarthritis
Official title: Synvisc® in Knee Osteoarthritis: Retrospective Follow-up in Treated Patients Since at Least Three Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 16
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: rheumatological practice

Brief summary: Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among the patients with knee osteoarthritis (OA) since at least three years.


Eligibility criteria: Inclusion Criteria:

* Patients with knee osteoarthritis using Synvisc® since at least three years

Exclusion Criteria:

* none

Primary outcomes:
measure: Reason for prescription
timeFrame: at least 3 years before start of observation period
measure: Number of other treatments per patient
timeFrame: at least 3 years of observation
measure: Time between two treatments
timeFrame: at least 3 years of observation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00545857: Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Official title: Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes
Insulin dependent diabetes
Juvenile onset diabetes
pioglitazone
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.

Detailed description: Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes mellitus diagnosed within 4 months
* Age \> 6 years of age
* Ability to swallow capsule
* Signed informed consent / assent

Exclusion Criteria:

* Other illnesses

Primary outcomes:
measure: C-peptide response to a Sustacal meal
timeFrame: 6 months
Secondary outcomes:
measure: Insulin requirement
timeFrame: 6 months
measure: Hemoglobin A1c
timeFrame: 6 months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Thomas A. Wilson, MD
state: New York
Study officials:
affiliation: State University of New York Stony Brook
name: Thomas A Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tafuri KS, Godil MA, Lane AH, Wilson TA. Effect of pioglitazone on the course of new-onset type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2013;5(4):236-9. doi: 10.4274/Jcrpe.981.
Clinical trial NCT06524557: Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors
Official title: Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Tumor
Keywords: liver tumors
benign
malignant
Differential diagnosis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 200 patients whose pathological diagnoses were confirmed by US-guided liver biopsy or surgery and who underwent preoperative conventional US between January 2018 and November 2025 were enrolled in the study.

Brief summary: To explore an effective noninvasive method for differential diagnosis of liver tumors.

Detailed description: A retrospective study was performed to assess the performance of certain ultrasound-based parameters, in distinguishing benign from malignant with liver biopsy as the gold standard. Demographic data, clinical information and serological data were obtained from participants who were retrospectively enrolled. Receiver operating characteristic (ROC) curve analysis was conducted, including calculation of the optimal area under the ROC curve (AUC), to assess the performance of these measures in distinguishing between benign and malignant in patients with or without chronic liver disease.

Eligibility criteria: Inclusion Criteria:

(1) age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.

Exclusion Criteria:

(1) unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.

Primary outcomes:
measure: The differential diagnosis of liver tumors
timeFrame: 2018.01-2025.12
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosptial
state: Xi'an
Study officials:
affiliation: Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
name: Zhou Huihui, M.M.
role: STUDY_CHAIR
References: