louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06650761: A Phase I Study of CDX-622
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part, Phase 1a Dose Escalation Clinical Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-622 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine the safety of CDX-622 in healthy participants.

Detailed description: CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in healthy participants.

Eligibility criteria: Key Inclusion Criteria:

* An informed consent signed and dated by the participant.
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18 kg/m2 to ≤ 32 kg/m2.
* No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
* Both males and females of childbearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker (or regular user of any nicotine containing product).
* Willing to follow all study rules.

Key Exclusion Criteria:

* Women who are pregnant or nursing.
* History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication.
* History of asthma requiring the use of inhaled medication within the past 5 years.
* Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
* Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
* Positive urine test for alcohol and drugs of abuse.

Additional protocol defined inclusion and exclusion criteria could apply.

Primary outcomes:
measure: Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Day 1 up to Day 127
Secondary outcomes:
measure: CDX-622 serum evaluations over time
timeFrame: Day 1 up to Day 127
measure: CDX-622 biomarker evaluations over time
timeFrame: Day 1 up to Day 127
measure: Measurement of anti-drug antibody development over time
timeFrame: Day 1 up to Day 127
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
References:
Clinical trial NCT03090061: Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
Official title: Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microleakage Around Resin Composite Restorations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the margins of resin composite restorations

Detailed description: Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods.

Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients should be over 18 years of age.
* Patients should have an acceptable oral hygiene level.
* Patients must have at least one posterior resin composite restoration.

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease.
* Heavy bruxism or a traumatic occlusion.

Primary outcomes:
measure: Repeatability for both diagnostic methods
timeFrame: 20 minutes
measure: Reproducibility for both diagnostic methods
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine, Cairo University
Study officials:
References:
Clinical trial NCT04195061: Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Official title: Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Insulin Resistance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with overweight or obesity

Brief summary: The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.


Eligibility criteria: Inclusion Criteria:

* Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria
* Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)

Exclusion Criteria:

* Unstable heart or lung disease
* Exercise \>150 minutes/week
* Participation in college sports

Primary outcomes:
measure: Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise
timeFrame: Pre- to 3 hours post-exercise
Secondary outcomes:
measure: Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise
timeFrame: Pre- to 2 hours post-exercise
measure: Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise
timeFrame: Immediately post to 2 hours post-exercise
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Melanie S Haines, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01922661: Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women between the ages of 18 and 55
2. Positive allergen skin prick test
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Exclusion Criteria:

1. Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
2. Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
3. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
4. Hospitalization for any reason within 60 days prior to the screening visit
5. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit
6. Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Primary outcomes:
measure: Safety
timeFrame: day 1 to day 113
Secondary outcomes:
measure: Serum concentration
timeFrame: day 1 to day 113
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Kamal MA, Dingman R, Wang CQ, Lai CH, Rajadhyaksha M, DeVeaux M, Orengo JM, Radin A, Davis JD. REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Clin Transl Sci. 2021 Nov;14(6):2440-2449. doi: 10.1111/cts.13112. Epub 2021 Aug 26.
Clinical trial NCT05030961: Team-based Virtual Pediatric Cochlear Implant Clinic
Official title: Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Stanley J. Glaser Foundation
First posted: 2021-09-01
Enrollment: 86
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to see if remote visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted.


Eligibility criteria: Inclusion Criteria:

New patients undergoing CI evaluation:

1. English speaking patients (parents can speak English and/or Spanish)
2. Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process

Established CI recipients:

1. English speaking patients (parents can speak English and/or Spanish)
2. Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity

Exclusion Criteria:

1. Patients with families who speak languages other than English or Spanish
2. Patients who do not live in Florida
3. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Primary outcomes:
measure: Electrode Impedances
timeFrame: Up to 1 year
measure: Electrically evoked compound potential values
timeFrame: Up to 1 year
measure: Datalogging
timeFrame: Up to 1 year
measure: Threshold/Upper stimulation levels
timeFrame: Up to 1 year
measure: LittleEars questionnaire scores
timeFrame: Up to 1 year
measure: Auditory Skills Checklist (ASC) scores
timeFrame: Up to 1 year
Secondary outcomes:
measure: Behavior Assessment System for Children version 3 (BASC-3) scores
timeFrame: Up to 1 year
measure: Patient Health Questionnaire version 8 (PHQ-8) scores
timeFrame: Up to 1 year
measure: Generalized Anxiety Disorder version 7 (GAD-7) scores
timeFrame: Up to 1 year
measure: Quality of Life- CI (QoL-CI) scores
timeFrame: Up to 1 year
measure: Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
timeFrame: Up to 1 year
measure: Parenting Stress Index/Short Form (PSI) scores
timeFrame: Up to 1 year
measure: Parenting Stress-CI scores
timeFrame: Up to 1 year
measure: Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Chrisanda M Sanchez, AuD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02607683: Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)
Official title: A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Steatoblepharon
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).


Eligibility criteria: Inclusion Criteria:

* Moderate to severe, bilateral lower eyelid steatoblepharon
* Must understand and provide informed consent
* Healthy facial skin

Exclusion Criteria:

* Pregnant or lactating women
* Clinically significant eye disease
* Best corrected visual acuity worse than 20/40 in either eye
* History of eye surgery in past 6 months
* History of lower eyelid surgery

Primary outcomes:
measure: LESS score (Clinician-Reported)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: David Wirta, MD, Inc.
state: California
city: Santa Ana
country: United States
facility: OC Clinical Trials
state: California
city: Danbury
country: United States
facility: Danbury Eye Physicians
state: Connecticut
city: Boston
country: United States
facility: Opthalmic Consultants of Boston
state: Massachusetts
city: Wantagh
country: United States
facility: South Shore Eye Care, Inc.
state: New York
city: Cincinnati
country: United States
facility: Cincinatti Eye Institute
state: Ohio
Study officials:
affiliation: Allergan
name: Julie Roth, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01559883: Study on Thrombosis Therapy in German Cancer Patients
Official title: Study on Thrombosis Therapy in German Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Deep Vein Thrombosis
Pulmonary Embolism
Keywords: cancer
thrombosis
pulmonary embolism
anticoagulation
low molecular weight heparin
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 76
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: Cancer patient with acute deep vein throbosis/ pulmonary embolism in ambulatory oncology care/practice

Brief summary: The study aims to document the flow of German patients with cancer and acute deep vein thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures, and therapy modalities.


Eligibility criteria: Inclusion Criteria:

* patient with cancer and acute deep vein thrombosis and/or pulmonary embolism

Exclusion Criteria:

* life expectancy less that 6 months
* age less that 18 years

Primary outcomes:
measure: treatment time on low molecular weight heparin
timeFrame: 1 year
Secondary outcomes:
measure: patient pathways
timeFrame: 1 year
measure: risk factors for DVT
timeFrame: 1 year
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Prof. Dr. Axel Matzdorff
state: Saarland
Study officials:
affiliation: Caritasklinikum Saarbrücken, St. Theresia
name: Axel Matzdorff, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06022783: Effect of Virtual Reality Intervention on Stress Levels of Surgical Nurses
Official title: The Effectiveness of Virtual Reality Intervention on Stress Levels of Surgical Nurses: A Crossover Designed Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse
Stress
Virtual Reality
Keywords: surgical nurses
stress
virtual reality intervention
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover designed randomized controlled study
Primary purpose: PREVENTION

Brief summary: The aim this crossover designed study is to examine the effect of watching a relaxing video with using virtual reality glasses (VR-G) during the break period of a working shift on the stress levels of surgical nurses.

Nurses will be asked to watch a relaxing video with using VR-G for 20 minutes at their break time (the first procedure).

After one-week wash-out period, researchers will compare second procedure (no video watch with VR-G) to see if there is any difference on the stress levels of the nurses.

Detailed description: Allocation of the nurses to the procedure groups (with VR-G and no VR-G procedures) is done with using Random Allocation Software program.

Among the with VR-G procedure:

The nurses were asked to watch a relaxing video with using VR-G for 20 minutes at their break time. The researcher visited the nurses at the beginning of the working shift and asked the nurse stress scale items to them in the nursing room, scheduled a break period with them individually and visited them again at the scheduled time. Then, the researcher prepared the video and googles, asked nurses to sit on the chair in the nursing room at the surgical unit, helped them to wear the VR-G and let them alone to watch the video for 20 minutes.

At the end of their working shift, the researcher visited them and asked the scale items once again.

Among the no VR-G procedure:

The nurses did not watch any video and copleted their routine working shift and break times. The researcher visited the nurses at the beginning and at the end of their working shift and asked the nurse stress scale items to them in the nursing room.

Eligibility criteria: Inclusion Criteria:

* working in a surgical unit for at least one year
* able to use virtual reality glasses
* volunteering to participate in this study

Exclusion Criteria:

* having a visual and/or audial problems
* leaving surgical unit for any reason

Primary outcomes:
measure: Stress level
timeFrame: At the beginning and end of nurses daily working shift through study completion, an average of six months.
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Seher Ünver
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Seher Ünver
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Seda C Yeniğün
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231283: NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Official title: A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female patients 18 years of age
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
3. Treatment of a single de novo target lesion in a major native coronary artery;
4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
5. Target lesion is 30mm in length (visual estimate);
6. Target lesion stenosis is \> 50% and \< 100% (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
3. Significant (\> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Documented Left ventricular ejection fraction 25%;
5. Totally occluded vessel (TIMI 0 level);
6. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;

Primary outcomes:
measure: Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
timeFrame: From post-procedure up to hospital discharge
Secondary outcomes:
measure: Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later
timeFrame: From post-procedure up to 30 days
measure: Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge
timeFrame: From post-procedure up to hospital discharge
measure: Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later
timeFrame: From post-procedure up to 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
Study officials:
affiliation: Texas Heart Institute
name: Emerson Perin, MD
role: PRINCIPAL_INVESTIGATOR
References: