louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06796049: Behavioral Nudge in Colorectal Cancer Screening
Official title: Role of Behavioral Nudge as a Tool to Increase CRC Screening at an Urban Center Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Improving Fecal Immunochemical Test (FIT) Completion Rates
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if a behavioral nudge principle known as social norm driver can be implemented to improve fecal immunochemical test (FIT) completion rates for patients' age 45-75 years old due for colorectal cancer screening at Bellevue Hospital Medicine Ambulatory Care Clinic. The study's endpoints include FIT screening completion rate and timeliness. Secondary analysis will look at demographic information such as age group, gender, prior screening, number of prior visits at the clinic.


Eligibility criteria: Time Period 1 Inclusion Criteria:

1. Patient at Bellevue Ambulatory Care Medicine Clinic between 1/1/2024 and 7/1/2024
2. Age 45-75 years old

Time Period 2 Inclusion Criteria:

1. Patient at Bellevue Ambulatory Care Resident Clinic
2. Age 45-75 years old
3. Has not had a FIT test within the past year
4. Can read either English or Spanish
5. Is able and willing to provide consent

Time Period 3 Inclusion Criteria:

1. Patient at Bellevue Ambulatory Care Resident Clinic
2. Age 45-75 years old
3. Has not had a FIT test completed within the past year
4. Can read either English or Spanish
5. Is able and willing to provide consent

Time Period 1 Exclusion Criteria:

1. Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
2. Age outside of 45-75 years old

Time Period 2 Exclusion Criteria:

1. Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
2. Age outside of 45-75 years old
3. Has had a FIT test completed within the past year
4. Cannot read either English or Spanish

Time Period 3 Exclusion Criteria:

1. Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
2. Age outside of 45-75 years old
3. Has had a FIT test completed within the past year
4. Cannot read either English or Spanish

Primary outcomes:
measure: Time until the fecal immunochemical test (FIT) is returned to the clinic for processing
timeFrame: Month 3
measure: Percentage of participants who completed the FIT screening test
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aasma Shaukat, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01165749: Exercise Study Including Patients With Hypertrophic Cardiomyopathy
Official title: A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathy, Hypertrophic
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2010-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with hypertrophic cardiomyopathy

Brief summary: The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.


Eligibility criteria: Inclusion Criteria:

1. Ages 18 - 80 years old.
2. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) \> 13 mm in any wall segment.
3. Exercise £ 30 minutes, 1 day per week for the previous 3 months.
4. Agreement to be a participant in the study protocol and willing/able to return for follow-up.

Exclusion Criteria:

1. History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
2. Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
3. Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
4. Hypotensive response to exercise (\> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
5. Pregnancy.
6. ICD placement in last 3 months or scheduled.
7. Life expectancy less than 12 months.
8. Inability to exercise due to orthopedic or other non-cardiovascular limitations.

Primary outcomes:
measure: Improvement in ability to perform activities and tasks.
timeFrame: 4 months
Secondary outcomes:
measure: Improvement in heart size and function and quality of life (QOL).
timeFrame: 4 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Euan Ashley MRCP, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00021749: Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
Official title: Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
CLL
Keywords: CLL
Leukemia
Chronic
Cancer
Adult
Lymphocytic
Genasense
G3139
Genta
Bcl-2
Antisense
Oligonucleotide
oblimerson
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2001-08-06
Enrollment: 40
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: This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Detailed description: This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL.

Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.

Eligibility criteria: * Any age
* Must have received at least one chemotherapy regimen that included fludarabine
* Measurable disease
* At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia
* No previous stem cell transplantation
* At least 3 weeks since surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Cancer Institute
state: Texas
Study officials:
References:
citation: O'Brien SM, Cunningham CC, Golenkov AK, Turkina AG, Novick SC, Rai KR. Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia. J Clin Oncol. 2005 Oct 20;23(30):7697-702. doi: 10.1200/JCO.2005.02.4364. Epub 2005 Sep 26.
Clinical trial NCT04353349: Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer
Official title: Impact of Minimally Invasive Robotic Approach Compared to VATS and Open Approach on Quality of Life and Immune Response in Patients Candidated to Lobectomy or Anatomical Segmentectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Robotic Thoracic Surgery
Video-assisted Thoracis Surgery (VATS)
Open Thoracotomy Surgery
Keywords: Robotic surgery
Lung cancer
Early stage
Quality of life
Post-operative pain
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population should have the following Inclusion criteria: - known or suspected lung cancer clinical stage T1-T2, N0-N1 candidates for surgery lobectomy or anatomical segmentectomy; - ASA-1-2-3; - not severe heart disease; -no alcohol; -no renal impairment (creatinine \<2); -not obese (BMI \<30); no evidence of other serious comorbidities in the opinion of the investigator.

Brief summary: The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.


Eligibility criteria: Inclusion Criteria :

* known or suspected lung cancer clinical stage T1-T2;
* N0-N1 candidates for surgery lobectomy or anatomical segmentectomy;
* ASA-1-2-3;
* not severe heart disease;
* no alcohol;
* no renal impairment (creatinine \<2);
* not obese (BMI \<30);
* no evidence of other serious comorbidities in the opinion of the investigator.

Exclusion Criteria:

* severe heart disease;
* renal impairment (creatinine \>2.5);
* evidence of any serious comorbidities according to the investigator;
* malignant tumor in the previous 2 years;
* previous chest surgery.

Primary outcomes:
measure: Evaluation of quality of life by EORTC QOL-CC30.
timeFrame: 01/04/2016 - 01/12/2020
Secondary outcomes:
measure: Evaluation of postoperative pain by daily evaluation with visual numeric scale before and after surgery until discharge and at 1, 6 and 12 months
timeFrame: 01/04/2016 - 01/12/2020
measure: Intraoperative complications
timeFrame: 01/04/2016 - 01/12/2020
measure: Postoperative complications
timeFrame: 01/04/2016 - 01/12/2020
measure: Disease free survival at 24 months
timeFrame: 01/04/2016 - 01/12/2020
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
References:
Clinical trial NCT01445249: Medial Forefoot Block for Analgesia After Foot Surgery
Official title: A Randomised, Blinded Comparison of a Nerve Stimulator Guided Ankle Block Compared to a Landmark Guided Ankle Block for Pain Relief After Forefoot Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: regional anaesthetic techniques
surgery orthopaedic
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2011-10-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.

Detailed description: More extensive description not desired.

Eligibility criteria: Inclusion Criteria:

* Fit adults requiring forefoot surgery with bone cutting

Exclusion Criteria:

* Morbid obesity (BMI \> 40)
* Known contraindications to regional anaesthesia

Primary outcomes:
measure: Efficacy of local anaesthetic block.
timeFrame: Over ninety minutes from the start of the study.
Secondary outcomes:
measure: Intravenous opiate usage following surgery
timeFrame: 24 hours following surgery
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Castle Hill Hospital. Castle Road, Cottingham,
state: East Yorkshire
Study officials:
affiliation: Hull and East Yorks NHS Trust
name: Andrew J Coe, MbChB FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292849: Peer to Peer Delivery of Behavioral Activation
Official title: Peer to Peer Delivery of Behavioral Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-11-17
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants.

Detailed description: This project focuses on helping to solve a growing problem in health care today. Through increased screening in the older adult population, detection of depression has increased which has established a growing need for mental health resources. Unfortunately, there are limited resources to keep up with the steady increase of individuals in need. Training peers to work with older depressed adults in techniques such as behavioral activation provides an alternative model to help moderate the increased need and provide a unique intervention of care. Developing an innovative peer facilitated program has the potential to enhance the delivery of quality health care.

The specific aims of the study are 1) to train peer coaches and implement Peer to Peer in the community 2) to examine depression ratings over time.

Eligibility criteria: Inclusion Criteria:

* Age 60 and older
* Member of Lenox Hill Senior Center, St. Peter's Senior Center, or Beth Abe
* Score of 10+ on Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

* Presence of alcohol abuse, substance abuse, psychotic disorder, or bipolar disorder as observed on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID)
* Inability to speak English
* Dementia: Mini Mental State Examination (MMSE) score below 24
* High suicide risk, i.e. intent or plan to attempt suicide

Primary outcomes:
measure: Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification
timeFrame: 4 weeks prior to Baseline
measure: Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Hamilton Depression Rating Scale Scores
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Patrick Raue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raue PJ, Sirey JA, Dawson A, Berman J, Bruce ML. Lay-delivered behavioral activation for depressed senior center clients: Pilot RCT. Int J Geriatr Psychiatry. 2019 Nov;34(11):1715-1723. doi: 10.1002/gps.5186. Epub 2019 Aug 8.
Clinical trial NCT04794049: Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation
Official title: Oral Lactulose is Not Inferior to The Standard Bowel Preparation Regimen for Bowel Preparation Prior Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Disease
Keywords: colonoscopy
bowel preparation
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost.

Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.


Eligibility criteria: Inclusion Criteria:

* age 18-80 patients with intact colon and rectum

Exclusion Criteria:

* prior finding of severe colorectal stricture
* without the requirement of reaching cecum
* suspected colonic stricture or perforation
* use of prokinetic agents or purgatives within 7 days
* toxic colitis or megacolon
* pregnant women
* hemodynamically unstable
* patients who cannot give informed consent

Primary outcomes:
measure: Bowel preparation
timeFrame: 2 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 2 hours
measure: Willingness to repeat bowel preparation (BP)
timeFrame: 2 hours
measure: Adenoma detection rate
timeFrame: 2 hours
measure: Insertion time
timeFrame: 2 hours
measure: Withdrawal time
timeFrame: 2 hours
measure: Cecal intubation rate
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00968149: A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 413
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.


Eligibility criteria: Inclusion Criteria:

* Patient has a history of allergic rhinitis symptoms which flare up during the study season
* Patient is a non-smoker
* Patient is in otherwise good health
* Patient is able to chew a tablet

Exclusion Criteria:

* Patient is hospitalized
* Patient is pregnant or nursing mother, or \<8 weeks post partum
* Patient and/or parent intend to move or vacation away from home during the trial
* Patient has had a major surgical procedure within 4 weeks of the prestudy visit
* Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
* Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
* Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder

Primary outcomes:
measure: Number of Patients With Clinical Adverse Experiences (CAEs)
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Patients With Serious CAEs
timeFrame: 2 weeks
measure: Number of Patients With Drug-related CAEs
timeFrame: 2 weeks
measure: Number of Patients Who Were Discontinued Due to CAEs
timeFrame: 2 weeks
measure: Number of Patients With Laboratory Adverse Experiences (LAEs)
timeFrame: 2 weeks
measure: Number of Patients With Serious LAEs
timeFrame: 2 weeks
measure: Number of Patients With Drug-related LAEs
timeFrame: 2 weeks
measure: Number of Patients Who Were Discontinued Due to LAEs
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.
Clinical trial NCT00795249: Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Official title: Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atherosclerosis
Lead sponsor: Kurume University
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators hypothesized that circulating EMP is a useful surrogate marker of early stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP, from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were repeated.


Eligibility criteria: Inclusion Criteria:

* healthy individuals who have no coronary risk factors

Exclusion Criteria:

* hypertension
* dyslipidemia
* chronic kidney disease
* liver dysfunction
* obesity (BMI\>25.0)
* cerebrovascular disease
* other severe systemic diseases (cancer, inflammatory diseases, etc)

Primary outcomes:
measure: The number of circulating EMP
timeFrame: 2 weeks
Secondary outcomes:
measure: FMD
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
Study officials:
affiliation: Kurume University
name: Tsutomu Imaizumi, MD, PhD
role: STUDY_CHAIR
References: