louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05002985: Tanglewood Trail Walking Program in Rural Kentucky 2020
Official title: Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Keywords: farmers market
Appalachia
physical activity
fruit and vegetable voucher program
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2021-08-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Tanglewood Trail Walking Program is a well established community health initiative that encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Saturday. The study aims to determine if walking to the market with a community health coach results in healthier options being selected at the market when compared to the driving group.

Detailed description: In the summer of 2017, community members of Whitesburg, KY were recruited to join the Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday, participants reported whether or not they walked the 1 mile trail to the farmers market and they reported which fruits and vegetables they purchased. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. The ClinicalTrials.gov record for the original trial in 2017 is NCT03495648.

Eligibility criteria: Inclusion Criteria:

* ability to walk 1 kilometer

Exclusion Criteria:

* pregnant
* institutionalized adults
* impaired consent ability
* prisoners

Primary outcomes:
measure: Self-reported Fruit Intake
timeFrame: 3 months
measure: Self-reported Vegetable Intake
timeFrame: 3 months
Secondary outcomes:
measure: Hours of Vigorous Exercise Per Week
timeFrame: 3 months
measure: Hours of Moderate Exercise Per Week
timeFrame: 3 months
measure: Hours of Sitting Per Week
timeFrame: 3 months
measure: Hours of Walking Per Week
timeFrame: 3 months
measure: Understanding of Plant-based Phytonutrients
timeFrame: 3 months
measure: Belief in the Benefit of Plant-based Nutrients
timeFrame: 3 months
measure: Belief in the Preventative Effects of Plant-Based Nutrients
timeFrame: 3 months
measure: Belief in the Role of Healthy Diet in Protecting Health From Pollutants
timeFrame: 3 months
measure: Knowledge of Which Foods Contain Phytonutrients
timeFrame: 3 months
measure: Knowledge of Environmental Pollutants
timeFrame: 3 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Dawn Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681785: Thrombophylaxis in Transurethral Surgery With Dalteparine
Official title: Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombophylaxis in Transurethral Surgery
Keywords: thrombophylaxis and transurethral surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40% among medical or general surgical patients. In urology the prevalence is 15-40%. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy1 recommend against specific prophylaxis in patients undergoing transurethral procedures. Our study is the first double-blind, placebo-controlled study with Dalteparine as thrombophrophylaxis in transurethral surgery. The aim of the study is to proof that thrombophrophylaxis causes not more complications in transurethral surgery than without.

Detailed description: The aim of our study is to proof that transurethral surgery under thrombophylaxis with dalteparine is safe. The study design is double-blind placebo controlled.

Eligibility criteria: Inclusion Criteria:

* transurethral surgery

Exclusion Criteria:

* oral anticoagulation

Primary outcomes:
measure: Blood loss
timeFrame: intraoperativ, 6 hours post op and 3 days postop
Secondary outcomes:
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Urologische Universitätsklinik beider Basel
Study officials:
affiliation: Department of Urology Liestal
name: Thomas C Gasser, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01183585: A Study of RO4917838 With Rosuvastatin in Healthy Volunteers
Official title: A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single centre, open-label study will investigate the effect of RO4917838 on the pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers. Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of Rosuvastatin.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, 18 to 65 years of age
* A body mass index (BMI) between 18 to 30 kg/m2

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis (Gilbert's Syndrome is allowed)
* Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs

Primary outcomes:
measure: To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin
timeFrame: 30 days
Secondary outcomes:
measure: To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination
timeFrame: 30 days
measure: To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838
timeFrame: 30 days
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01274585: Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Official title: Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment.

The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Able to provide informed consent
* Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
* Available to present for weekly treatments
* Available for follow-up at 3, 6, and 12 months

Exclusion Criteria:

1. Severe cardiopulmonary disease
2. Lesion of the Tibial Nerve
3. Use of a cardiac pacemaker or implantable defibrillator
4. History of inflammatory bowel disease
5. Active anal fissure, fistula, or abscess
6. Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy
7. Has a sphincter injury that needs sphincteroplasty
8. Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter
9. Severe distal venous insufficiency
10. Uncontrolled diabetes with peripheral nerve involvement
11. Immunosuppression
12. Pregnant or planning on becoming pregnant during treatment
13. Patients prone to bleeding

Primary outcomes:
measure: Frequency of Fecal Incontinence
timeFrame: Diary kept for 14 days following treatment
Secondary outcomes:
measure: Change in Fecal Incontinence Severity Index (FISI) Score
timeFrame: 12 weeks
measure: Change in Fecal Incontinence Quality of Life (FIQoL) Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Liliana Bordeianou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04512885: Study of Acceptability of a New Distance-learning Tool "MyFIT"
Official title: Study of the Acceptability of a New Distance-learning Tool for Functional Insulin Therapy "MyFIT" by Patients With Type 1 Diabetes (T1D) and by Healthcare Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with Type 1 diabetes followed in the department of Endocrinology, diabetology and nutrition (CHRU de Nancy)

Brief summary: The investigators developed an on-line learning tool "MyFIT" enabling to patients with T1D to acquire the knowledge and skills for practicing functional insulin therapy from their home.

The aim of the present study is to evaluate the acceptability of this new learning modality via the tool "MyFIT" by the patients and by the health professionnals.


Eligibility criteria: Inclusion Criteria:

* type one diabetes on intensified insulin therapy

Exclusion Criteria:

* Hearing loss
* Visual problems

Primary outcomes:
measure: success rate
timeFrame: 2 months
Secondary outcomes:
measure: satisfaction measured by auto-questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT01164085: Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study
Official title: Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Keywords: Inflammation
Macular Edema
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.

Detailed description: A Phase I safety study of intravitreal ketorolac in patients with chronic inflammation and complications due to inflammation who have either failed medical therapy or who cannot tolerate corticosteroids due to side effects.

Specific Aims

1. Test the safety of intraocular injection of 4mg of ketorolac in patients who have intractable uveitis or complications of uveitis such as chronic macular edema who are unable to tolerate corticosteroids due to their side effects.
2. Test the efficacy of intraocular 4m ketorolac of treating inflammation or structural complications of inflammation in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.

Eligibility criteria: Inclusion Criteria:

* Adult volunteers
* Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
* Unable to tolerate corticosteroids due to side effects

Exclusion Criteria:

* 18 years or younger
* Have active ocular infection
* Pregnancy

Primary outcomes:
measure: Safety
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Stephen J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SJ, Doherty TJ, Cherney EF. Intravitreal ketorolac for chronic uveitis and macular edema: a pilot study. Arch Ophthalmol. 2012 Apr;130(4):456-60. doi: 10.1001/archopthalmol.2011.2627.
Clinical trial NCT04290585: Technology and Health Communication in Improving Health Outcomes in Patients Scheduled for Mammography
Official title: Text for Health: Integrating Technology and Health Communication to Improve Health Outcomes (Part 2 of 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Breast Carcinoma
Healthy Subject
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-02
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot clinical trial studies how well technology and health communication works in improving health outcomes in patients scheduled for mammography screening. The Mobile Mammography Screening Program provides a vital health service and it is important that all women scheduled for an appointment show-up to be screened. Technology and health communication may help decrease no-show rates among patients scheduled for mammography screening.

Detailed description: PRIMARY OBJECTIVES:

I. To decrease the mobile mammography unit no-show rate by sending text message appointment reminders to patients.

II. To assess the efficacy of the text message reminders at addressing the no-show rate by collecting satisfaction survey data from patients that received the texts and that came to their scheduled appointment.

OUTLINE:

Patients receive 1-2 text messages a few weeks before and 1 text message 24 hours before their mammography screening appointment. Patients also receive a phone call reminder as per standard practice.

Eligibility criteria: Inclusion Criteria:

* Appointment is at a participating location
* Has a cell phone that can send and receive text messages
* Agrees to receive the text messages
* Can read either English or Spanish
* Not yet sent text messages to 100 patients in community or corporate sites
* Scheduled at least 1 week prior to the appointment date
* PATIENTS FOR FOLLOW UP: come to their scheduled appointment
* PATIENTS FOR FOLLOW UP: received the text message reminders
* PATIENTS FOR FOLLOW UP: can read either English or Spanish

Primary outcomes:
measure: Change in no-show rate pre- and post-intervention
timeFrame: Baseline to up to 1 year
Secondary outcomes:
measure: Acceptability of using text messaging as a reminder: survey
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Nestor Esnaola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993785: CoStar Catheter System Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Symptomatic Ischemic Heart Disease
Lead sponsor: Conor Medsystems
Sponsor class: INDUSTRY
First posted: 2009-10-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥18 years of age.
2. Eligible for percutaneous coronary intervention (PCI).
3. Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification \[CCS\] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia.
4. Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks.
5. Acceptable candidate for coronary artery bypass graft surgery (CABG).
6. Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
7. Willing to comply with all specified follow-up evaluations.

Inclusion Criteria (Angiographic):

1. A single de novo lesion per study subject may be treated with the study device.
2. Each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent.
3. Cumulative target lesion length per vessel is ≤24 mm based on a visual estimate.
4. RVD of ≥2.5 mm to ≤3.0 mm based on a visual estimate.
5. Target lesion diameter stenosis ≥50% and \<100% based on a visual estimate.
6. Target vessel has not undergone prior revascularization within the preceding 6 months.
7. Target lesion must be a minimum of 10 mm distance from any previously treated segment of the target vessel

Exclusion Criteria:

1. Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA.
2. Planned treatment with any other PCI device in the target vessel(s).
3. Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q wave, or creatinine kinase (CK) \>2 times the laboratory upper limits of normal and elevated MB.
4. The patient is in cardiogenic shock.
5. Cerebrovascular Accident (CVA) within the past 6 months.
6. Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L).
7. Contraindication to ASA or to clopidogrel.
8. Thrombocytopenia (platelet count \<100, 000/mm3).
9. Active gastrointestinal (GI) bleeding within the past three months.
10. Any prior true anaphylactic reaction to contrast agents.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Am Kurpark 1
country: Germany
facility: Herz-Kreislauf-Zentrum
state: Segeberger Kliniken GmbH
Study officials:
References:
Clinical trial NCT01075685: Evaluation of an Internet-based Intervention for Hazardous Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hazardous Alcohol Consumption
Lead sponsor: Institut national de prevention et d'education pour la sante
Sponsor class: OTHER_GOV
First posted: 2010-02-25
Enrollment: 1157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption.


Eligibility criteria: Inclusion Criteria:

* Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12

Primary outcomes:
measure: Change in Weekly Alcohol Intake
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Relative Change in Weekly Alcohol Intake
timeFrame: baseline and 6 weeks
measure: Category of Change in Weekly Alcohol Intake
timeFrame: baseline and 6 weeks
measure: Change in the Number of Excessive Drinkers
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Institut national de prevention et d'education pour la sante
name: Juliette Guillemont, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001285: Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation
Official title: Comparison of the Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Ordinary Tracheal and Double-lumen Endobronchial Intubation During Propofol-remifentanil Total Intravenous Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation, Intratracheal
Keywords: remifentanil
Lead sponsor: Jeju National University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is the comparison of the effect-site concentration of remifentanil for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial intubation during propofol-remifentanil total intravenous anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patient who is needed intubation for general anesthesia

Exclusion Criteria:

* patient who is anticipating difficult airway
* patient who takes any drug to influence this study
* cardiovascular disease, renal disease, liver disease

Primary outcomes:
measure: arterial blood pressure
timeFrame: Change from baseline in arterial blood pressure at intubation period
Secondary outcomes:
measure: heart rate
timeFrame: Change from baseline in heart rate at intubation period
Other outcomes:
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju Special Self-Governing Province
Study officials:
References: