louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03002883: STAND Community College Tobacco Cessation Trial
Official title: Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
name: Breathe California of Sacramento-Emigrant Trails
name: Sacramento City College
First posted: 2016-12-26
Enrollment: 113
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: Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.

This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.


Eligibility criteria: Inclusion Criteria:

* adult 18 years or older
* current smoker in the past 30 days
* smoker wants to quit
* smoker not currently participating in other smoking cessation activities, and
* smoker must be willing to accept randomization into any of the 3 study arms

Exclusion Criteria:

* students not proficient in communicating in English
* adults unable to consent

Primary outcomes:
measure: Biochemically validated smoking cessation
timeFrame: 6 months
Secondary outcomes:
measure: Self-reported smoking cessation
timeFrame: 6 months
measure: Self-reported smoking cessation
timeFrame: 3 months
measure: Self-reported smoking cessation
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Elisa Tong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01776983: Skin Aging in Renal Transplant Patients
Official title: Skin Aging in Renal Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Photosensitivity Disorders
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: individuals between 18 and 90 years of age

Brief summary: Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.

* Trial in the field of transplantation / xenotransplantation

Detailed description: Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.

Eligibility criteria: Inclusion criteria:

* Renal transplant recipients transplanted more than seven years ago and immunocompetent probands of the same age.

Exclusion criteria:

* Refusal of informed consent, physical or psychological inability to give informed consent.

Primary outcomes:
measure: skin aging defined by melanin, collagen and hemoglobin content
timeFrame: One Time measurement at the one and only time point of inclusion and measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Dermatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Department of Dermatology
name: Günther Hofbauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stimpfle DW, Serra AL, Wuthrich RP, French LE, Braun RP, Hofbauer GF. Spectophotometric intracutaneous analysis: an investigation on photodamaged skin of immunocompromised patients. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1141-7. doi: 10.1111/jdv.12771. Epub 2014 Oct 13.
Clinical trial NCT00785083: A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel, Time-lagged, Ascending, Multi-centre, Multiple-dose Study to Measure the Magnitude and Time Course of the Effect of FTY720 on FEV1 and Other Pulmonary Function Tests (FVC, FEF25-75%, and FEV1/FVC) in Patients With Moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma, adrenergic beta agonists, multiple sclerosis, pulmonary function tests, forced expiratory volume
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 36
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: This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma


Eligibility criteria: Inclusion Criteria:

* Forced Expiratory Volume in 1 second of at least 60%
* History of asthma for at least 6 months
* Current use of short-acting beta agonists, inhaled long-acting beta agonists and inhaled corticosteroids (up to a specified dose)

Exclusion Criteria:

* History of lung disease other than asthma
* Smokers
* Use of inhaled corticosteroid above specified dose
* Use of oral beta agonists or corticosteroids or other asthma medications
* Hypersensitivity to the drug
* Respiratory tract infections within 1 month of the study

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10
timeFrame: 10 days
measure: Safety of FTY720
timeFrame: 10 days
Secondary outcomes:
measure: Use of short acting beta agonists during treatment compared to pre-treatment
timeFrame: 10 days
measure: Pharmacokinetics of FTY720 and FTY720-P
timeFrame: 10 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boulton C, David OJ, Meiser K, Schmouder R. Tolerability and Pulmonary Pharmacodynamic Effects During Treatment Initiation of Once-Daily Oral Fingolimod in Subjects With Moderate Asthma. Clin Pharmacol Drug Dev. 2013 Jan;2(1):2-10. doi: 10.1002/cpdd.4. Epub 2013 Mar 4.
citation: Izquierdo G, O'Connor P, Montalban X, von Rosenstiel P, Cremer M, de Vera A, Sfikas N, Francis G, Radue EW, Kappos L. Five-year results from a phase 2 study of oral fingolimod in relapsing multiple sclerosis. Mult Scler. 2014 Jun;20(7):877-81. doi: 10.1177/1352458513513059. Epub 2013 Nov 30.
Clinical trial NCT04900883: Nurse Perspectives Regarding Use of the Labor Mirror
Official title: Nurse Perspectives Regarding Use of the Labor Mirror
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Second Stage Labor
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Labor \& Delivery Nurses who work at Mount Carmel East Hospital

Brief summary: The objective of the study is to examine the views of Labor \& Delivery nurses regarding use of the labor mirror during the active phase of the second stage of labor.

Detailed description: A survey link will be sent to Labor \& delivery nurses via hospital group email. The nurses will be asked to share their experiences regarding the following: if use of the labor mirror helps patients push more effectively, how often patients accept the labor mirror, why they feel patients may decline use of the labor mirror, how often they offer the labor mirror to eligible patients, and a range of how long they have been a labor \& delivery nurse at this facility. The survey is voluntary and the results are anonymous.

Eligibility criteria: Inclusion Criteria:

* Labor \& Delivery Nurses at Mount Carmel East Hospital

Exclusion Criteria:

* All others

Primary outcomes:
measure: L&D Nurse views regarding use of the labor mirror
timeFrame: survey will be open for one month
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
Study officials:
References:
Clinical trial NCT06060483: Effect of Patient Management Based on Continuous Continuous Glucose Monitoring on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes and Moderate to Severe Coronary Artery Stenosis
Official title: Effect of Patient Management Based on Continuous Continuous Glucose Monitoring on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes and Moderate to Severe Coronary Artery Stenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Major Adverse Cardiac Events
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with type 2 diabetes and moderate to severe coronary artery stenosis who were treated at Zhejiang Second Hospital and cooperative hospitals were randomly divided into a patient management group based on continuous continuous glucose monitoring (CGM) or a patient management group based on HbA1c. Both groups controlled cardiovascular risk factors according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020) and the ADA Guidelines for the Prevention and Treatment of Diabetes (2023), and conducted HbA1c testing every 3 months. In the CGM-based glucose management group, CGM measurements will be performed at baseline and at 6, 12, 18, and 24 months. In the CGM-guided treatment group, the target TIR\>70%, TBR\<4%, TAR\<25%, and HbA1c\<7.0%; in the HbA1c-guided treatment group, the target HbA1c\<7.0%. The primary endpoint was major adverse cardiovascular events (MACE: CV death, nonfatal myocardial infarction, nonfatal stroke).


Eligibility criteria: Inclusion Criteria:

Male or female between 35 and 75 years old type 2 diabetes HbA1C: 7.5%-10% Moderate to severe coronary artery stenosis (the degree of stenosis of any major coronary artery is ≥50% as assessed by coronary angiography or coronary CTA) The blood sugar lowering regimen has been stable in the past 3 months Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

Type 1 diabetes or other types of diabetes Acute myocardial infarction or stroke within the past three months Ketoacidosis, hyperosmolar hyperglycemic state Relative or absolute contraindications to contrast agent examinations such as severe renal insufficiency, contrast agent allergy, and hyperthyroidism Elective surgery planned within 2 years Preparing for pregnancy or becoming pregnant Life expectancy less than 2 years Skin allergies and other situations where CGM cannot be used Currently participating in other clinical studies

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital Zhejiang University Schoolof Medicine
Study officials:
References:
Clinical trial NCT01804283: Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement
Official title: Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiopulmonary Bypass
Ischemic Postconditioning
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral).
2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning.
3. Downstream effectors would also be affected.


Eligibility criteria: Inclusion Criteria:

* Consecutive eight patients with rheumatic heart valve disease undergoing elective double valve replacement(aortic and mitral)are considered for participation in this study.

Exclusion Criteria:

* insulin-dependent diabetes mellitus
* pulmonary, renal, or hepatic failure
* infective valve disease
* valve disease with coronary artery disease
* hypertension
* emergency and reoperations
* received aspirin,corticosteroids, or statin preoperatively
* received preoperative inotropic support

Primary outcomes:
measure: Change from Baseline in Cardiac MicroRNA Expression
timeFrame: before cardiopulmonary bypass and at 5 min after aortic de-clamping
Secondary outcomes:
measure: Change from Baseline in Downstream Gene Expression
timeFrame: before cardiopulmonary bypass and at 5 min after aortic de-clamping
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Wanjun Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao Y, Huang R, Chen R, Li J, Luo W. Ischemic postconditioning altered microRNAs in human valve replacement. J Surg Res. 2016 Jan;200(1):28-35. doi: 10.1016/j.jss.2015.07.010. Epub 2015 Jul 10.
Clinical trial NCT00171483: Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Official title: Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
PPI
heartburn
regurgitation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .


Eligibility criteria: Inclusion Criteria:

* Heartburn for at least 3 days in the week prior to screening
* Regurgitation for at least 3 days in the week prior to screening
* Stable dose PPI therapy \> 4 weeks
* Incomplete relief on daily PPI therapy \> 4 weeks

Exclusion Criteria:

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
* Previous gastrointestinal surgery that may influence esophageal motor function
* Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
Secondary outcomes:
measure: To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
measure: To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
measure: To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
measure: To assess patient satisfaction with treatment (end of treatment)
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research
state: Florida
city: Winston Salem
country: United States
facility: Department of Internal Medicine - Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Milwaukee
country: United States
facility: The Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT02247583: Investigating Patient Satisfaction With Oral Anti-Cancer Treatment
Official title: Investigating Patient Satisfaction With Oral Anti-Cancer Treatment. Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care in Patients With Advanced Renal Cell Carcinoma Treated With an Oral Anti-cancer Drug.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clear Cell Renal Cell Carcinoma
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Flemish League Against Cancer
name: Pfizer
name: Novartis
name: GlaxoSmithKline
First posted: 2014-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mRCC patients starting with an oral anti-cancer treatment

Brief summary: Prospective non-interventional non-controlled multicenter observational study to evaluate aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an oral anti-cancer drug.

The main objective of this study is to evaluate the patient perspective in the treatment of advanced renal cell carcinoma with an oral anti-cancer drug.

The following aspects will be investigated:

* Intrinsic desire for information about treatment.
* Patient satisfaction with treatment information.
* Patient satisfaction with treatment.
* Medication adherence.
* Health-related quality of life.
* The role of different health care professionals in the treatment of RCC with oral drugs

This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.


Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study

Exclusion Criteria:

* Patients who are not able to understand Dutch or French will be excluded from the study

Primary outcomes:
measure: Medication adherence
timeFrame: one year
Secondary outcomes:
measure: Extent of Information Desire (EID)
timeFrame: one year
measure: Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
timeFrame: one year
measure: Morisky Medication Adherence Scale (MMAS)
timeFrame: one year
measure: Cancer Therapy Satisfaction Questionnaire (CTSQ)
timeFrame: one year
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: one year
measure: Functional Kidney Symptom Index (FKSI)
timeFrame: one year
measure: Satisfaction With Pharmacist (SwiP)
timeFrame: one year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
Study officials:
affiliation: Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
name: Veerle Foulon, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04444583: Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
Official title: Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Heart Diseases
Cardiovascular Diseases
Lead sponsor: Precordior Ltd
Sponsor class: INDUSTRY
Collaborators: name: Turku University Hospital
name: Helsinki University Central Hospital
First posted: 2020-06-23
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting Turku University Hospital Heart Center or Heart and Lung Center at Helsinki University Hospital.

Brief summary: In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.

Detailed description: Heart Failure (HF) is a condition where heart is unable to maintain adequate volume of blood in circulation corresponding to prevailing physiological demand. Gyrocardiography is a technique that utilizes micro electromechanical sensors (MEMS), accelerometer and gyroscope, to detect vibrations and rotation of thorax caused by cardiac motion. The main purpose of this study is to test the ability of an app of a smartphone with embedded motion sensors, positioned on the chest which measures the movements and function of the heart, to identify patients with different types of heart failure and their characteristics, as compared with clinical diagnosis. Echocardiography will also be used to confirm changes in cardiac cardiac mechanics including strain, cardiac torsion, diastolic filling characteristics.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patients visiting hospital for heart failure, either outpatient clinic or cardiac ward
* Signed informed consent as an acceptance to participate to the trial

Exclusion Criteria:

* Age \<18 years

  * Severe cardiac valve disease
  * Previous prosthetic cardiac valve
  * Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
  * Patients with pacemaker
  * Informed consent form not signed.

Primary outcomes:
measure: HF specific motion sensor characteristics validation against echocardiography and other clinical features
timeFrame: From the hospital admission to study closure visit, on average 15 weeks
Secondary outcomes:
measure: HF decompensation specific motion sensor characteristics validation
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Heart and Lung Center at Helsinki University Hospital
city: Turku
country: Finland
facility: Heart Center at Turku University Hospital
Study officials:
affiliation: Heart Center Turku University Hospital
name: Antti Saraste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: