louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05458258: Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
Official title: Investigating The Prognostic Significance Of Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Leukemia, Myeloid
Keywords: AML
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 239
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with acute myeloid leukemia over the age of 60 who plan to receive induction therapy and/or cancer drugs for treatment.

Brief summary: This study will explore how malnutrition (poor nutrition/diet) and sarcopenia (a condition that causes a loss of muscle and bone mass) affects study participants over the age of 60 with acute myeloid leukemia (AML) who will receive induction chemotherapy (chemotherapy given as the first treatment to help cancer go into remission) and/or cancer drugs as part of standard care for AML. By studying how these nutritional and skeletal factors, doctors leading this study hope to learn how malnutrition and sarcopenia may be able to predict certain outcomes --such as how long study participants with poor nutrition and muscle loss can live after chemotherapy- for older (age 60+) individuals with AML.


Eligibility criteria: Inclusion Criteria:

* Older Adult patients (greater than or equal to 60 years of age)
* New diagnosis of acute myeloid leukemia (AML)
* Receiving induction therapy (intensive or low intensity therapy)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of a pacemaker or defibrillator.
* Participants who are pregnant at the time of enrollment.
* Anyone unable/unwilling to follow protocol requirements

Primary outcomes:
measure: Treatment-Related Mortality Rates Based on Incidence of Sarcopenia in All Study Participants
timeFrame: 60 days
Secondary outcomes:
measure: The prognostic impact of malnutrition and sarcopenia on treatment-related mortality rates and overall survival in study participants with AML
timeFrame: 60 days
measure: Incidence of Malnutrition Among Participants in Group 1 Compared to Incidence of Malnutrition in Healthy Control Group
timeFrame: 60 days
measure: Incidence of Sarcopenia Among Participants in Group 1 Compared to Incidence of Sarcopenia in Healthy Control Group
timeFrame: 60 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Wendy Stock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04674358: The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Official title: The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye
Dry Eye Syndromes
Keywords: reproxalap
ADX-102
Tranquility
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 329
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: The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.


Eligibility criteria: Inclusion Criteria:

* 18 years of age (either gender and any race);
* Reported history of dry eye for at least 6 months prior to Visit 1;
* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* Eye drop use within 2 hours of Visit 1;
* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
* Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1

Primary outcomes:
measure: Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber
timeFrame: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.
Secondary outcomes:
measure: Schirmer Test Change From Baseline After the First Dose on Day 1
timeFrame: The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University Clinical Health
state: Tennessee
Study officials:
References:
Clinical trial NCT00657358: The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers
Official title: The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers (Carl Koller Grant) (The Effect of Intravenous Lidocaine on Allodynia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: lidocaine
allodynia
chronic regional pain syndrome
pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Society of Regional Anesthesia
First posted: 2008-04-14
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Detailed description: Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Eligibility criteria: Inclusion Criteria:

* Healthy Adult Volunteers, age \>19 years

Exclusion Criteria:

* History of Substance Abuse
* Coronary Artery Disease (CAD): unstable
* Congestive Heart Failure (CHF): unstable
* Heart Arrhythmia: symptomatic
* Chronic Obstructive Pulmonary Disease (COPD)
* Lidocaine Allergy
* Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders,bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
* Presence of Contraindications for MRI
* Presence of electronically, magnetically, and mechanically activated implants
* Electronically, magnetically, and mechanically activated implants
* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
* Cardiac pacemakers
* Metallic splinters in the eye
* Ferromagnetic haemostatic clips in the central nervous system (CNS)
* Claustrophobia
* Pregnancy

Primary outcomes:
measure: Ischemic Pain
timeFrame: baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
measure: Electrical Pain
timeFrame: Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
measure: Heat Pain
timeFrame: baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
measure: Cold Pain
timeFrame: baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
measure: Tactile Sensation
timeFrame: baseline, during 20 minute infusion, and 30 minutes after completion of infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael Froelich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441058: Retrospective Database Study: Influence of Post-endodontic Restoration Placement on Survival of Root Canal-treated Teeth
Official title: Influence of the Timing of Post-endodontic Restoration Placement on the Survival of Root Canal-treated Teeth
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Root Canal Treatment
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999.

Brief summary: The aim of this study is to assess the influence (i.e. type and timing) of post-endodontic restorations on the survival of root canal-treated teeth and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.

Patients who received a root-canal treatment between 1998 and 1999 with subsequent placement of an indirect restoration (e.g. crown, partial crown) will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records.

Survival and success of the root-canal treatments will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.


Eligibility criteria: Inclusion Criteria:

* Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Success of endodontic treatment
timeFrame: 1998-2023
Secondary outcomes:
measure: Survival of the tooth
timeFrame: 1998-2023
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
state: Lower Saxony
Study officials:
References:
Clinical trial NCT05824858: A Study of the Effect of Food on LY3537982 in Healthy Participants
Official title: A Phase 1 Study to Evaluate the Effect of Food on the LY3537982 Pharmacokinetics in Health Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-04-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 after meals and on an empty stomach. The study will also evaluate the safety and tolerability of LY3537982. Participants will stay in the research center during the study, which will last about one week, not including screening.


Eligibility criteria: Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf])
timeFrame: Day 1 and Day 4 of each study period
measure: PK: Maximum Observed Concentration (Cmax) of LY3537982
timeFrame: Day 1 and Day 4 of each study period
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON
state: Utah
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05642858: Text Education About Cardiovascular Health and HIV (TEACH-HIV)
Official title: Text Education About Cardiovascular Health and HIV (TEACH-HIV)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Human Immunodeficiency Virus
Cardiovascular Diseases
Atherosclerosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-12-08
Enrollment: 260
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).


Eligibility criteria: Inclusion Criteria:

* HIV positive
* At least 40 years of age
* English-speaking

Exclusion Criteria:

* Existing clinical atherosclerotic cardiovascular disease (ASCVD)
* Pregnant
* Unwilling/unable to provide informed consent
* Does not own a smartphone

Primary outcomes:
measure: Proportion of participants with controlled blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Number of cardiovascular risk factors controlled
timeFrame: 6 months
measure: Self-perceived cardiovascular risk
timeFrame: 6 months
measure: Systolic blood pressure
timeFrame: 6 months
measure: Cholesterol
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Mediterranean diet
timeFrame: 6 months
measure: Proportion of current smokers
timeFrame: 6 months
measure: Blood sugar control
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
measure: Proportion of patients on guideline-based therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Megan McLaughlin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06780358: Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02
Official title: Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Cystotech
Sponsor class: INDUSTRY
Collaborators: name: Aarhus University Hospital
First posted: 2025-01-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Premarket Confirmatory, National, single-center, randomized, prospective, non-inferiority trial
Primary purpose: OTHER

Brief summary: This study is being conducted to investigate if an artificial intelligence support tool is non-inferior in detecting bladder cancer compared to the traditional method, standard white light cystoscopy (WLC). The researchers will compare how well the artificial intelligence tool and WLC perform in detecting bladder cancer through a controlled, organized testing process.

Detailed description: This clinical investigation aims to confirm that an artificial intelligence model utilizing a Convolutional Neural Network (CNN) can achieve sensitivity in detecting bladder cancer that is non-inferior to traditional white light cystoscopy (WLC) in a randomized controlled trial. The investigational artificial intelligence device leverages the advanced capabilities of CNNs, a type of deep learning model designed to analyze visual imagery with high precision.

Eligibility criteria: Inclusion Criteria:

* Men and women adults, age \>18 years old

Suspicion of primary or recurrent bladder cancer

Willingness to sign the Informed Consent Form (ICF) for the CI

Ability to comprehend the oral and written Patient Information Leaflet (PIL)

Exclusion Criteria:

* Not able or willing to sign the Informed Consent Form

Primary outcomes:
measure: Sensitivity of standard WLC compared to WLC assisted by the AI model evaluated with a non-inferiority margin of 5%.
timeFrame: 7 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Urology, Aarhus University Hospital
Study officials:
affiliation: Department of Urology, Aarhus University Hospital, denmark
name: Jakobsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292058: Comparing Telepsychiatry and In-person Outcomes
Official title: Comparing Patient Outcomes and Cost of Psychiatric Care Provided Through Videoconferencing With Psychiatric Care Provided In-person.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disorders
Keywords: Telepsychiatry
Videoconference
Psychiatric consultation
Equivalence trial
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
name: NORTH Network
First posted: 2006-02-15
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes and be less costly when provided via videoconferencing (telepsychiatry) than when provided in-person.

Detailed description: We predict that patients referred by their family physician for a psychiatric consultation and, if needed, short-term follow-up will have equivalent clinical outcomes when seen via telepsychiatry as compared to those patients seen in-person. We also predicted that telepsychiatry will be cheaper than in-person care.Study Design: a single-centre equivalence trial.We will use a sample size calculation and analytical methods that are specifically tailored for equivalence trials.

Eligibility criteria: Inclusion Criteria:

* patients referred by their family physicians for psychiatric consultation
* scores in the dysfunctional range on the Brief Symptom Inventory

Exclusion Criteria:

* patients incapable of consenting to the research
* patients referred for medico-legal or insurance reports

Primary outcomes:
measure: Brief Symptom Inventory
measure: Cost of providing the psychiatric services
Secondary outcomes:
measure: Quality of Life Inventory
measure: Client Satisfaction Questionnaire
measure: Hospital Utilization
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Richard L O'Reilly, M.B.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00701558: A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
Official title: An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
* no previous systemic chemotherapy, radiation therapy or immunotherapy;
* Eastern Cooperative Oncology Group (ECOG) \>=2.

Exclusion Criteria:

* prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
* active, non-controlled systemic disease;
* any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Primary outcomes:
measure: Time to Disease Progression
timeFrame: From the time of randomization until disease progression or death (up to 193 weeks)]
measure: Overall Response Rate (ORR)
timeFrame: From the time of randomization until disease progression or death (up to 193 weeks)
Secondary outcomes:
measure: Overall Survival
timeFrame: From the time of randomization until death (up to 193 weeks)
Other outcomes:
Locations:
city: Bucuresti
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: