louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01229085: Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis
Official title: CLINICAL ASSESSMENT OF THE EFFECTIVENESS OF ASSOCIATION MONETASONE FUROATE 0.1% SALICYLIC ACID AND 5% FOR SUBMISSION OF OINTMENT TOPICAL DERMATOLOGICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis, mometasone, salicylic acid.
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5% in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.

Detailed description: Phase III clinical trial, systematic sampling, open-label study that evaluated the efficacy of the combination of mometasone furoate 0.1% and 5% salicylic acid in 71 patients with lesions of mild to moderate psoriasis treated for up to 45 days or less than this, at the discretion of the investigator. The results were statistically analyzed and investigational data and their conclusions are referred to in this report.

Eligibility criteria: Inclusion Criteria:

* Adults of both sexes, regardless of color or social class;
* Age 18 or older, with good mental health;
* Psoriasis patients with mild to moderate;
* Patients who agreed to participate and signed the
* Clarified (appendix);
* Patients who agreed to return for follow-up visits.

Exclusion Criteria:

* Patients who were making use of biologics, corticosteroids or nonsteroidal anti-inflammatory and non-steroid, or who made use of these topical medications until 15 days before inclusion or 30 days before inclusion when the administration was orally;
* Patients who were exposed to the sun 15 days before the study began or during the course of the same;
* Patients who were making use of acetaminophen;
* Patients who did not agree to the terms described in the IC informed consent, - Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal;
* Lions and other types of skin damage that was not psoriasis;
* Pregnant and nursing women;
* Patients using oral anticoagulants.

Primary outcomes:
measure: To assess the safety in use as primary end point and end point as effectively isolated secondary association in patients with plaque psoriasis of mild to moderate.
timeFrame: 45 days of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda.
state: SP
Study officials:
References:
Clinical trial NCT01643785: Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection
Official title: Additive Effect of Endonase on the Efficacy of Bismuth-containing Quadruple Therapy as Second-line Treatment for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: therapeutic efficacy endonase addictive effect
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 30
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: Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.


Eligibility criteria: Inclusion Criteria:

Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori

Exclusion Criteria:

1. Patients Under 18 years, OR
2. Patients with active peptic ulcer, OR
3. Pregnant or Breast feeding women, OR
4. Patients with gastric malignancy, OR
5. Patients with a history of drug allergy or hypersensitivity, OR
6. Patients with severe renal, liver, or heart diseases

Primary outcomes:
measure: Eradication rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 4 weeks
measure: Number of participants taking over 85% of medicine
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon
Study officials:
affiliation: Chuncheon Sacred Heart Hospital
name: JinBong Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03346785: The Effect of Social Media Use on Eating Behaviours
Official title: The Effect of Social Media Use on Eating Behaviours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Photography
Non-Food Photography
No Phone Use
Keywords: External eating
Technology
Photography
Social media
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to explore how social media use, in particular food photography, influences eating behaviours. It will be approached through three methods - a correlational experience sampling method, an experimental experience sampling method, and an experimental laboratory method. This registration describes the experimental experience sampling method.

Detailed description: This project aims to explore how social media use, in particular food photography, influences eating behaviours.

The research question will be approached using a combination of methods. The first is the experience sampling method, where data is gathered from participants as they are going about their day-to-day lives. This method comprises two sub-sections - a correlational study, and an experimental study. This registration describes the experimental experience sampling method.

The study will experimentally control participants' engagement in the act of food photography, and measure their eating behaviours. Participants will be recruited via online platforms and participate in the study for one week. At the beginning of the week, they will be required to fill in some online questionnaires (e.g. demographic information). For the rest of the week, they will be prompted at specific time points in the day via smartphone to engage in food photography/ non-food photography/ no phone use, and then answer some questions about their eating behaviours.

The expected outcome of the project is to collectively evaluate the data from the various methods to conclude how social media use, and in particular the act of food photography, influences the various aspects of eating behaviours.

Eligibility criteria: Exclusion Criteria:

* Symptoms / history of any medical or psychiatric conditions
* Allergies to food products
* History of eating disorders
* Excessive exercise (≥ 5 times a week of self-reported exercise)
* Currently on a special diet or deliberating restricting caloric intake
* Currently on a weight loss program

Primary outcomes:
measure: Enjoyment of food consumed
timeFrame: 15 minutes
Secondary outcomes:
measure: Amount of food consumed
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
citation: Yong JYY, Tong EMW, Liu JCJ. Meal-time Smartphone Use in an Obesogenic Environment: Two Longitudinal Observational Studies. JMIR Mhealth Uhealth. 2021 May 6;9(5):e22929. doi: 10.2196/22929.
Clinical trial NCT01021085: Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies
Official title: Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Sex Determination
Keywords: Assisted Reproductive Technology
circulating cell free fetal DNA
First trimester
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age

Brief summary: Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.

Detailed description: This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.

Eligibility criteria: Inclusion Criteria:

* Subject is 18-45 years of age inclusive
* Subject is female
* Subject is pregnant
* Gestational age can be determined via IVF or IUI
* Subject is 36-42 days pregnant as determined by IVF transfer or IUI
* Subject agrees to provide 3 separate blood and urine samples

Exclusion Criteria:

* None

Primary outcomes:
measure: Develop a prenatal sex test using blood and/or urine samples from pregnant women.
timeFrame: 36 to 56 days of gestation
Secondary outcomes:
measure: Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance.
timeFrame: 36 to 56 days of gestation
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Fertility Center
state: California
city: Glenview
country: United States
facility: Fertility Centers of Illinois
state: Illinois
city: Las Vegas
country: United States
facility: Fertility Center of Las Vegas
state: Nevada
Study officials:
affiliation: Sequenom, Inc.
name: Allan Bombard, MD MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03177785: Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
Official title: Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 31
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to test the efficacy of the EverydayMatters Multiple Sclerosis (MS) program for individuals age 45 or older living with multiple sclerosis. The program involves a 6-week telephone-delivered program to promote resilience and happiness for individuals living with MS.


Eligibility criteria: Inclusion Criteria:

* 45 years of age
* Diagnosis of multiple sclerosis
* regular access to the phone and internet
* willing to join a moderated group on MSConnection.org

Exclusion Criteria:

* under 45 years of age
* no diagnosis of multiple sclerosis
* no access to the phone or internet
* unwilling to join moderated group on MSConnection

Primary outcomes:
measure: Change in Resilience using Connor Davidson Resilience Scale (brief)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in positive affect and well being using the Quality of Life in Neurological Disorders (NeuroQoL) Positive Affect and Well-Being Short Form
timeFrame: 6 weeks
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form
timeFrame: 6 weeks
measure: Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Dawn Ehde
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alschuler KN, Arewasikporn A, Nelson IK, Molton IR, Ehde DM. Promoting resilience in individuals aging with multiple sclerosis: Results from a pilot randomized controlled trial. Rehabil Psychol. 2018 Aug;63(3):338-348. doi: 10.1037/rep0000223. Epub 2018 Jul 19.
Clinical trial NCT00646685: Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
Official title: Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Transplantation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.

Detailed description: The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.

Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.

Eligibility criteria: Inclusion Criteria:

* patient with end-stage liver disease
* living donor liver transplantation using right hemi-liver as graft
* duct anastomosis possible at time of surgery
* donor and recipient aged 18 yrs or older
* written informed consent obtained

Exclusion Criteria:

* duct anastomosis not possible
* acute fulminant liver failure

Primary outcomes:
measure: Biliary complications defined as leaks and strictures within the first year post LDLT;
timeFrame: 1 year
Secondary outcomes:
measure: Graft and patient survival
timeFrame: 1 year post-transplant
measure: Length of hospital-stay and ICU-stay
timeFrame: within first 30 days after discharge
measure: Any infection or rejection episodes
timeFrame: 1 year post- transplant
measure: time to full oral nutrition
timeFrame: within 30 days of discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Markus Selzner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05357885: Quantitative COVID-19 SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass
Official title: Quantitative SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine

Brief summary: This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

Detailed description: This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

During CPB the patients' blood volume is removed from the body and sent through the CPB machine. CPB consists of a pump (to keep blood moving) and oxygenator (to oxygenate blood). The oxygenator or CPB circuitry may effect antibody levels. In addition, patients on CPB experience hemodilution from blood transfusion and priming volume from the CPB circuit. Hemodilution may effect antibody levels.

Prior to CPB, during standard of care lab drawn from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for pre-CPB quantitative antibody testing.

On morning of postoperative day 1, during standard of care lab draw from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing.

On morning of postoperative day 5, during standard of care lab draw, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing. If patient is discharged from the hospital prior to postoperative day #5, this immunoassay will be omitted.

Eligibility criteria: Inclusion Criteria:

* All patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine.

Exclusion Criteria:

* Age \< 18.
* Patients with indeterminant history of vaccination schedule.

Primary outcomes:
measure: assess antibody levels before and after CPB.
timeFrame: preop and up to 5 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01073085: Effectiveness of a French Automated Web-based Smoking Cessation Program
Official title: Effectiveness of a French Automated Web-based Smoking Cessation Program : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Consumption
Lead sponsor: Institut national de prevention et d'education pour la sante
Sponsor class: OTHER_GOV
First posted: 2010-02-23
Enrollment: 2478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the "coaching", by comparing it to an online self-help guide.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and older
* Smoker
* Willing to quit smoking in the next two weeks
* Having a regular access to Internet
* Having a personal e-mail address
* Not having benefited from the "coaching" the investigators want to assess yet

Exclusion Criteria:

* No personal e-mail address
* Not able to give the informed consent

Primary outcomes:
measure: Comparison of the percentage of abstinent people between the two arms of the trial, 6 months after inclusion
timeFrame: 6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: Institut national de prevention et d'education pour la sante
Study officials:
affiliation: Institut national de prevention et d'education pour la sante
name: Pierre Arwidson, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00018785: Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants
Official title: Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease
Keywords: kidney transplantation
immunosuppression
bone marrow
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetes and end-stage kidney, liver and heart disease are prominent health issues among veteran patients. Successful solid organ transplantation in the absence of chronic immunosuppressive therapy (specific acquired immunological tolerance) is a desirable therapeutic option. This project extends recent observations supporting the use of concommitant donor bone marrow cell infusion as a means of modulating the immune response in kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially toxic immunosuppressive drugs.


Eligibility criteria: Living related donor kidney transplant recipients and the living related donors.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: VAMC Miami
state: Florida
Study officials:
name: Camillo Ricordi, M.D.
name: Andreas Tzakis, M.D.
name: Violet Esquenazi, Ph.D.
name: Keith Zucker, Ph.D.
References:
Clinical trial NCT00238485: An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder
Official title: A 52-week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Bipolar I Disorder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.


Eligibility criteria: Inclusion Criteria:

* written informed consent provided prior to participation in the extension study.
* successful completion of the study CLIC477D2302
* willingness and ability to comply with all study requirements

Exclusion Criteria:

* premature discontinuation from the study CLIC477D2302
* failure to comply with the study CLIC477D2302 protocol

Primary outcomes:
measure: Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 862-778-8300
name: Novartis Customer Care information
role: STUDY_CHAIR
References: