louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04280133: CAR T-CELL Therapy Educational Video Trial
Official title: A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancy
CAR-T Cell Therapy
Keywords: Hematologic Malignancy
CAR-T cell therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer.

- Educational video tool for patients receiving CAR-T cell therapy.

Detailed description: This research study is a Feasibility Study, which is the first-time investigators are examining this educational video tool for patients receiving CAR-T cell therapy.

The research study procedures include screening for eligibility, randomization and a series of questionnaires

Participants will be randomized to one of 2 groups:

* Group A: Educational video tool
* Group B: Standard care

Participants will be in the research study for a month after consent

It is expected that about 80 participants will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* 18 years or age or older
* Established diagnosis of a hematologic malignancy
* Under consideration for CAR T-cell therapy at Massachusetts General Hospital

Exclusion Criteria:

* Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study
* Undergoing CAR T-cell therapy for solid tumor malignancy
* Inability to comprehend English, as the video is currently only available in English at this time

Primary outcomes:
measure: Feasibility (enrollment and retention rates)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)
timeFrame: up to 1 month
measure: Psychological distress (Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 1 month
measure: Patient's self-efficacy (modified version of CASE-cancer)
timeFrame: up to 1 month
measure: Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)
timeFrame: up to 1 week
measure: Decision Satisfaction around receipt of CAR-T cell therapy
timeFrame: up to 1 month
measure: Acceptability of the video (intervention arm only)
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Patrick C Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538233: Pain After Buffered Vs Non Buffered Articaine
Official title: A Comparison of Pain Response During Administration of Buffered Articaine Versus Non-buffered Articaine Local Anesthetics for Dental Treatment in Adult
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pain
Lead sponsor: Cleveland Dental Institute
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after buffered versus non buffered articaine.


Eligibility criteria: Inclusion Criteria:

* Males and females, age- 18 to 60 yrs.
* Medically free.
* Need a dental treatment in the upper anterior region.

Exclusion Criteria:

* Periodontally affected teeth.
* Radiographic bone loss.
* Upnormal length of the teeth.

Primary outcomes:
measure: Numerical Rate Scale (NRS)
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Clevland Dental Institute
state: Ohio
Study officials:
affiliation: Cleveland Dental Institute
name: Ahmed H Khalifa, PhD
role: STUDY_CHAIR
affiliation: Cleveland Dental Institute
name: Waleed Elmallah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00441233: Clinical Performance of Extended Wear Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Menicon Co., Ltd.
name: Clinical Vision Research Australia
First posted: 2007-02-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.


Eligibility criteria: Inclusion Criteria:

* Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
* Is a current daily wear soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria:

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Clinical Vision Research Australia
state: Victoria
Study officials:
affiliation: Clinical Vision Research Australia, University of Melbourne
name: Carol Lakkis, BScOptom, PhD, PGCertOcTher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03579433: Postmarket Study of an Intraocular Lens Power Selection System
Official title: Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: IOL
Intraocular lens
Astigmatism
Cataract Surgery
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 124
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.

Detailed description: Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Eligibility criteria: Inclusion Criteria:

* Planned cataract surgery with IOL implantation
* Able to comprehend and sign the informed consent form
* Preoperative astigmatism of 0.75 to 3.00 Diopter
* Willing and able to complete all required postoperative visits
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Unclear intraocular media other than cataract
* Pregnant or lactating
* Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Dora
country: United States
facility: Alcon Investigative Site
state: Florida
city: Panama City
country: United States
facility: Alcon Investigative Site
state: Florida
city: Poughkeepsie
country: United States
facility: Alcon Investigative Site
state: New York
city: Kingston
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: Florence
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Alcon Investigative Site
state: South Dakota
city: Nashville
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Nacogdoches
country: United States
facility: Alcon Investigative Site
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Operations Lead, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT05379933: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
Official title: C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Quality of Life
Sleep Disturbance
Keywords: Family Caregiver
Well-being
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 33
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: The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy


Eligibility criteria: Inclusion Criteria:

* Eligible family caregivers will be:
* An unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage III or IV colorectal cancer at Moffitt Cancer Center
* Age 18+ years
* English or Spanish speaking
* Able to complete questionnaires and engage in short discussions with coaches
* Able to identify a primary care medical provider
* Willing/able to use a mobile device provided by the study team or their own their device.

Exclusion Criteria:

* Participants who do not meet the study inclusion criteria

Primary outcomes:
measure: Percentage of Participants Who Agree to Participate (Acceptability)
timeFrame: 12 Months
measure: Percentage of Participants Who Provide Data (Feasibility)
timeFrame: 12 Months
Secondary outcomes:
measure: Self Care Behaviors - Primary Efficacy
timeFrame: 8 Weeks
measure: Quality of Life -Secondary Efficacy
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Brian Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01164033: A Study of RO5045337 in Patients With Solid Tumors
Official title: An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Histologically confirmed solid tumor
* Life expectancy of \>/=12 weeks
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start
* Patients with pre-existing gastro-intestinal disorder
* Patients with uncontrolled intercurrent illness

Primary outcomes:
measure: Examination of potential food-effect on pharmacokinetics of RO5045337
timeFrame: 3 weeks
measure: Evaluation of relative bioavailability of RO5045337
timeFrame: 3 weeks
Secondary outcomes:
measure: Evaluation of safety and tolerability of RO5045337
timeFrame: 3 weeks
measure: Evaluation of pharmacodynamics and biomarkers
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Kansas City
country: United States
state: Kansas
city: Kensignton
country: United States
state: Maryland
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Patnaik A, Tolcher A, Beeram M, Nemunaitis J, Weiss GJ, Bhalla K, Agrawal M, Nichols G, Middleton S, Beryozkina A, Sarapa N, Peck R, Zhi J. Clinical pharmacology characterization of RG7112, an MDM2 antagonist, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):587-95. doi: 10.1007/s00280-015-2830-8. Epub 2015 Jul 26.
Clinical trial NCT06923033: Aim 1: App for Reducing Cravings to Smoke
Official title: Aim 1: Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)
* Functioning telephone number
* Owns a smart phone capable of supporting AR and willing to download the app
* Can speak, read and write in English

Exclusion Criteria:

* Has another household member already enrolled in the study

Primary outcomes:
measure: System Usability Scale (Aim 1)
timeFrame: At 1 week
Secondary outcomes:
measure: User Satisfaction (Aim 1)
timeFrame: At 1 week
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Christine Vinci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05032833: Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Official title: A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics in Healthy Adults
Lead sponsor: Beckley Psytech Limited
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects


Eligibility criteria: Inclusion Criteria:

\* Medically healthy based on medical records and study specific assessments

Exclusion Criteria:

\* Presence or history of severe adverse reaction to any drug or drug excipient

Primary outcomes:
measure: Percentage of subjects with treatment emergent AEs (TEAES)
timeFrame: From screening through to the follow up visit, up to 65 days
Secondary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: Day 1 (dosing day) and Day 2
measure: Time to reach Cmax (tmax)
timeFrame: Day 1 (dosing day) and Day 2
measure: Area under the plasma concentration- time curve
timeFrame: Day 1 (dosing day) and Day 2
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
Clinical trial NCT06031233: Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Official title: Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Oncology
Infusion Reaction
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.

Infusion times will be gradually shortened if tolerability allowes.

Detailed description: After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs.

Patient satisfaction will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.
* 18 years and older.
* No known history of increased susceptibility to immunological reactions.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

* Other research medication within 4 weeks of the start of the study.
* Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions
* Dosage deviates from standard protocol
* Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).

Primary outcomes:
measure: Incidence of infusion related reactions
timeFrame: During or within 30 minutes after the end of the infusion
Secondary outcomes:
measure: Plasma levels of the administered mAb
timeFrame: Within 15 minutes before start of the infusion
Other outcomes:
measure: Satisfaction with shortened infusion time assessed by the VAS
timeFrame: Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)
Locations:
city: Zwolle
country: Netherlands
facility: Isala Hospital
Study officials:
References:
Clinical trial NCT04360733: Precision Immunology to Determine the Immune Response in Patients With COVID-19
Official title: Precision Immunology Approach to Better Understand the Divergent Host Responses Towards Infection With SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV 2
COVID
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with different severity of COVID-19. From asymptomatic to critical illness

Brief summary: To better understand the immune response to SARS-CoV-2 infection, we devised a precision immunology approach to systematically study the immune function of different patient cohorts


Eligibility criteria: Inclusion Criteria:

* SARS-Cov2 positive PCR

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Immune response
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: Institute of Innate Immunity, Univeristy of Bonn
name: Eicke Latz, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06102733: Chronic Pelvic Pain in Females and Males
Official title: Chronic Pelvic Pain Management in Female and Male Adult Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Pain Syndrome
Sacroiliac Disorder
Piriformis Syndrome
Sacrococcygeal Disorder
Inguinal Hernia
Keywords: Pelvic pain
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic pelvic pain who undergo treatment in pain clinic

Brief summary: Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly.

This is a quantitative analysis of prospective clinical data. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.

Detailed description: Pelvic pain is common, but under-reported in healthy adults. Pelvic pain is reported more commonly in women than in men. Many patients with pelvic pain under-estimate the severity of the problem. Chronic pelvic pain can be managed successfully, if diagnosed properly. Many combinations of multimodal analgesia and rehabilitation therapy may be safe and effective for pelvic pain.

This study is a quantitative analysis of prospective clinical data. It is an evaluation of the prevalence and management of pelvic pain in a cohort population of chronic pain patients. This is an analysis of multimodal analgesia types, rehabilitation therapy types, treatment outcome, and complications.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic pelvic pain
* Patients with sacroiliac pain
* Patients with inguinal pain
* Patients with coccygeal pain
* Patients with piriformis pain

Exclusion Criteria:

* Patients with spinal pain
* Patients who had spine surgery

Primary outcomes:
measure: Pain score, objective measurement using the validated Numeric Pain Rating scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olumuyiwa Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: