louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04104815: GI Tolerance and Acceptability of a New Thickener
Official title: A Study to Evaluate the GI Tolerance and Acceptability of a New Thickener for Dysphagia Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastro-intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.


Eligibility criteria: Inclusion Criteria:

* Subject has voluntarily signed and dated an ICF approved by an IRB/IEC, and provided applicable privacy authorization prior to any participation in the study.
* Subject is diagnosed with dysphagia.
* Subject is under the care of a Speech and Language Therapist and is currently using a thickener.
* Subject currently has normal GI function.
* Subject is interested in participating in the study, willing to comply with the study protocol and product.
* Subject who is able to consent and is able to evaluate the product.

Exclusion Criteria:

* Subject has a normal swallow.
* Subject at high risk of aspiration with oral fluids requiring nil by mouth and enteral tube feeding.
* Subject has impaired renal function.
* Subject has liver failure, decompensated chronic liver disease, active hepatitis B or C receiving treatment, or hepatic encephalopathy.
* Subject has severe dementia or unable to communicate or consent or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
* Participant is known to be allergic or intolerant to any ingredient found in the study product.
* Participation in another study that has not been approved as a concomitant study.
* Subject has a clinical condition that is contraindicated with this product such as hepatic and renal disease.
* Subject has a clinical condition which may interfere with gastrointestinal tolerance.
* Subject is pregnant.

Primary outcomes:
measure: Bristol Stool Scale
timeFrame: Study Day 1 to Study Day 7
measure: HCP Product Satisfaction Questionnaire
timeFrame: Study Day 7
measure: Palatability of Study Product
timeFrame: Study Day 1 and Study Day 7
measure: Product Compliance
timeFrame: Study Day 1 to Study Day 7
Secondary outcomes:
Other outcomes:
measure: Weight
timeFrame: Study Day 1 and Study Day 7
measure: Medications
timeFrame: Study Day 1 to Study Day 7
measure: Thickness of drinks prescribed
timeFrame: Study Day 1 to Study Day 7
measure: Medical aetiology of dysphagia
timeFrame: Study Day 1 and Study Day 7
Locations:
Study officials:
affiliation: Abbott Nutrition
name: Rebecca Stevenson
role: STUDY_CHAIR
References:
Clinical trial NCT03800615: Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.
Official title: Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Vaginal Agenesis
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A 59-year-old woman had previous history of hysterectomy due to nonfunctional uterine obstruction at 19 years old and urinary incontinence status post transvaginal tape procedure at 45 years old with clinical symptoms of difficulty in urethral coitus after midurethral sling procedure.

Brief summary: To report a case of impairment urethral coitus after the midurethral sling procedure

Detailed description: To report a case of impairment urethral coitus after the midurethral sling procedure.

Eligibility criteria: Inclusion Criteria:

* midurethral sling procedure for stress urinary incontinence
* woman with vaginal agenesis.

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Sexual function
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01859715: Emergency Department (ED) Drug Interaction in Emergency Department Patients
Official title: Hepatic Cytochrome Drug Interactions in Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Interactions
Keywords: Drug Interactions
CYP2D6
opioid efficacy
pain
nausea
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.

Detailed description: Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.

Eligibility criteria: Inclusion Criteria:

* self-reported pain or nausea identified by the initial nursing assessment

Exclusion Criteria:

* unable to speak English,
* \< 18 y.o.,
* previously diagnosed with chronic pain or cyclic vomiting

Primary outcomes:
measure: Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
timeFrame: Baseline and 90 minutes
Secondary outcomes:
measure: Adverse Drug Events
timeFrame: Duration of ED stay, <24 hours. (up to 24 hours)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Andrew A Monte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00601315: Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 250 mg Clarithromycin Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: MDS Pharma Services
name: Mark J Allison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811315: Flutiform in Treatment of Patients With Asthma in Daily Clinical Practice.
Official title: Flutiform Treatment in Patients With Asthma in Daily Clinical Practice; a Prospective Observational Non-interventional Study Assessing the Effect of Space Use and Adherence on Fluticasone/Formoterol FDC Efficacy Measured With the Asthma Control Questionnaire (ACQ-6).
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asthma
Lead sponsor: Mundipharma Pharmaceuticals B.V.
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows:

Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist.

The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study.

Brief summary: The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.


Eligibility criteria: Inclusion Criteria:

* Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows:

Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist.

The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study

Exclusion Criteria:

* There are no specific exclusion criteria as this is an observational study

Primary outcomes:
measure: Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice
timeFrame: This measurement will be taken after 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00744315: Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy
Official title: Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Cardiopathy
Keywords: myocardial revascularization
myocardial ischemia
genetics, medical
Angiogenesis Inducing Agents
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-08-29
Enrollment: 20
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Human Vascular Endothelial Grown Factor 165 (hVEGF165) administration is promising therapy induces a new vessels, arterioles and capillaries in regions whose revascularization surgery is not possible by direct or by percutaneous angioplasty. This study aims to evaluate the clinical effects and safety of gene therapy with hVEGF165 in patients with advanced coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis coronary artery disease and symptomatic, despite optimal pharmacologic therapy
* Left ventricular dysfunction - left ventricular ejection fraction between 60% and 25% by echocardiogram
* Non-conventional revascularization, as seen by cineangiocardiography, attested by interventional cardiologist and cardiac surgeon
* Age below 75 years
* Absence of neoplasm

Exclusion Criteria:

* No

Primary outcomes:
measure: Clinical finds
timeFrame: eighteen months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Institute of Cardiology of Rio Grande do Sul / FUC
state: Rio Grande do Sul
Study officials:
affiliation: Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC
name: Renato AK Kalil, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Giusti II, Rodrigues CG, Salles FB, Sant'Anna RT, Eibel B, Han SW, Ludwig E, Grossman G, Prates PR, Sant'Anna JR, Filho GF, Markoski MM, Nesralla IA, Nardi NB, Kalil RA. High doses of vascular endothelial growth factor 165 safely, but transiently, improve myocardial perfusion in no-option ischemic disease. Hum Gene Ther Methods. 2013 Oct;24(5):298-306. doi: 10.1089/hgtb.2012.221.
Clinical trial NCT00203515: Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter
Official title: A Prospective, Randomized, Controlled Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Urinary Catheterization
Lead sponsor: Tyco Healthcare Group
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 1000
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 the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.

Detailed description: Over 1 million catheter-associated urinary tract infections (CAUTIs) occur annually in U.S. healthcare facilities and account for approximately 40% of the nosocomial infections. This investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (Tyco Healthcare DOVER Silver Foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is expected to be catheterized with a 14, 16 or 18 French Foley catheter for at least 72 hours.
* Subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation.

Exclusion Criteria:

* Subjects who present with ongoing, active, symptomatic UTI.
* Subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
* Subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis.
* Subjects known to be pregnant.
* Prisoners.

Primary outcomes:
measure: Catheter associated urinary tract infection (UTI)
Secondary outcomes:
measure: Catheter tolerance
measure: Cost of care
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Tyco Healthcare Group/Kendall
name: Bethany A Quinn
role: STUDY_DIRECTOR
References:
citation: Tambyah PA, Maki DG. The relationship between pyuria and infection in patients with indwelling urinary catheters: a prospective study of 761 patients. Arch Intern Med. 2000 Mar 13;160(5):673-7. doi: 10.1001/archinte.160.5.673.
Clinical trial NCT03996785: Effectiveness of Nature Walks in Depressed Adults
Official title: Investigations of Immediate and Short-term Effects of Nature Walks on Stress and Depression-related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental
Keywords: Clinical depression
Stress
Group-walking
Walking condition (nature vs urban)
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
First posted: 2019-06-25
Enrollment: 47
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: SUPPORTIVE_CARE

Brief summary: Over the past few years, a growing number of campaigns from around the world, including Canada, are highlighting the positive impact of spending time in nature on well-¬being. Indeed, mounting evidence suggests that spending time with nature is associated with a myriad of affective and cognitive benefits. Surprisingly few studies to date have tested the assumption that walking in nature versus in urban settings could alleviate stress and depressive symptoms in clinically depressed adults.

The main purpose of this study is to investigate the effectiveness of walking in nature versus in urban settings to improve depression related symptoms and reduce stress. The trial initially included 2 primary outcomes: patients stress levels (salivary cortisol) and depression-related symptoms (eg, affect, rumination, executive functioning).

However, due to hygienic concerns in light of the COVID-19 pandemic in 2020, the collection of saliva samples (and in turn, the measurement of stress levels via salivary cortisol) was removed from the study's procedure. The main outcome was changed to effects on positive and negative affect.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 65 years, inclusively;
* Ability to speak French or English;
* Diagnosis major depressive disorder (DSM-IV);

Exclusion Criteria:

* Acute psychotic symptoms;
* Acute suicidal intent (within 48 hours);
* Unable to walk for 60 min or serious medical reasons (e.g. major surgery)
* Heart condition as per history or detected on electrocardiogram

Primary outcomes:
measure: Change in affect from baseline up to 48 hours post-walk
timeFrame: Day 1 to Day 3
Secondary outcomes:
measure: Change in Executive Functions
timeFrame: The Stroop test will be administered at 2 time points: 1) before the walk (between 9:45-10:30); 2) after the walk (between 11:30-11:50)
measure: Change in suicidal Ideations
timeFrame: Day 1
measure: Change in depressive symptoms
timeFrame: Day 1 to Day 2
measure: Change in rumination
timeFrame: Day 1
measure: Change in irritability
timeFrame: Day 1 to Day 3
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: McGill University
name: Marie-Claude Geoffroy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04562285: Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays
Official title: Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Keywords: SARS-CoV-2
Antibodies
Seroprevalence
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects will be identified from a retrospective data review and a laboratory information system (LIS) SunQuest identification of COVID-19 positive (RT-PCR SARS CoV-2) samples or who are already participating in the TCRC collection protocol. This study will recruit subjects in which a baseline serum sample was already obtained either through standard of care procedures or through voluntary participation in the TCRC biorepository.

Brief summary: The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.

Detailed description: The design strategy for this study is to validate the detection of COVID-19 antibodies in subjects at HFHS who test positive with RT-PCR for SARS-CoV-2 using fully automated test systems already in the core automated laboratory at HFH. This is a study of the immune response and kidney health of subjects who have recovered from COVID-19 infection.

There are 4 aims:

Aim 1. Assess detection of COVID-19 antibodies in subjects before discharge from HFHS who tested positive with RT-PCR for SARS-CoV-2 using fully automated immunoassays.

Aim 2. Evaluate emergence of immunity over a one-year period in subjects who tested positive with RT-PCR for SARS-CoV-2 using a fully-automated immunoassays.

Aim 3. Monitor renal function and kidney health at 6 and 12- months post diagnosis with COVID-19.

Aim 4. Determine if SAR-COV-2 can be detected in the saliva of patients over a one year period after a positive PCR test.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age
* Positive COVID-19 by RT-PCR SARS-CoV-2 assay
* Patients must have a serum sample stored by pathology or within the TCRC biorepository around the date of their COVID-19 RT-PCR positive test

Exclusion Criteria:

* \< 18 years of age
* negative for RT-PCR
* no serum sample

Primary outcomes:
measure: Detection of antibodies to SARS-CoV-2 in human serum and plasma
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: