louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00285168: A Randomized Controlled Trial of a Bone Density Decision Aide
Official title: A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoporosis
Keywords: Osteoporosis
Fractures, Bone
Bone Mineral Density
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of physicians involved in referring patients for DXA bone density testing

Brief summary: This research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis.

Detailed description: This observational research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis. Physicians who only receive the conventional BMD reports without the supplemental information will be the control group.

To compare the rates of pharmacological interventions for osteoporosis in post-menopausal women, family / primary care physicians are randomized to receive either:(i) a conventional BMD report (absolute bone density, T-score result, Z-score result, qualitative statement indicating the BMD results classification of risk for fracture from osteoporosis according to the World Health Organization (WHO) criteria) versus (ii) a conventional BMD report plus a supplemental information sheet (all the information contained in the conventional BMD report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the WHO criteria - the number needed to treat (in person years) to prevent one fracture.

Eligibility criteria: Inclusion Criteria:

* physicians involved in referring patients for DXA bone density testing

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: William D Leslie, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536068: Platelet Inhibition by Aspirin, Acetaminophen and NSAID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Keywords: platelet
aggregation
aspirin
Lead sponsor: Kantonsspital Graubünden
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.

Detailed description: An in vivo study on healthy volunteers with combinations of well established drugs

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Administration of drugs affecting platelets
* History of bleeding
* Gastrointestinal disorders
* Hypersensitivity to aspirin and/or NSAID
* Pregnancy and breast feeding

Primary outcomes:
measure: platelet aggregation
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden, Department of Internal Medicine
Study officials:
affiliation: Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland
name: Walter H Reinhart, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517868: Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Official title: URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Painful Bladder Syndrome
Interstitial Cystitis
Bladder Pain Syndrome
Keywords: bladder
pain
urgency
frequency
Lead sponsor: Urigen
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.


Eligibility criteria: Inclusion Criteria:

* male and female subjects \>= 18 years of age
* moderate to severe symptoms of PBS/IC
* minimum pain/urgency/frequency scores
* female subjects on hormone therapy must be on stable dose for \>= 3 months

Exclusion Criteria:

* positive pregnancy test or pregnant or lactating
* narcotics or medical marijuana within 3 months
* use of any investigational drug or device within 30 days
* bacterial cystitis within 30 days

Primary outcomes:
measure: Change in Daytime Bladder Pain Intensity
timeFrame: Through 12 hours
Secondary outcomes:
measure: Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire
timeFrame: Through 12 hours
measure: Change in Total Symptom Score
timeFrame: Through 12 hours
measure: Change in Daytime Urinary Urgency Score
timeFrame: Through 12 hours
Other outcomes:
Locations:
city: Glendora
country: United States
facility: Citrus Valley Medical Research
state: California
city: San Diego
country: United States
facility: SD Uro-Research
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: Scripps Clinic Medical Group
state: California
city: Cartersville
country: United States
facility: Georgia Urology
state: Georgia
city: San Antonio
country: United States
facility: Urology San Antonio Research, P.A.
state: Texas
Study officials:
affiliation: Georgia Urology
name: Jeff Proctor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14.
Clinical trial NCT02473068: Non Invasive Ventilation Comfort Study
Official title: Non Invasive Ventilation Comfort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: CPAP
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.

Detailed description: Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.

Eligibility criteria: Inclusion Criteria:

* Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form

Exclusion Criteria:

* Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet.
* Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form

Primary outcomes:
measure: Participant Comfort Questionnaire
timeFrame: 30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher and Paykel Healthcare
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Geoff Bold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04676568: Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula
Official title: A One Year Interventional Study in Patients With Vesicovaginal Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesico Vaginal Fistula
Lead sponsor: Armed Forces Institute of Urology, Rawalpindi
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.


Eligibility criteria: Inclusion Criteria:

* all patients with Vesicovaginal fistula

Exclusion Criteria:

* uretrovaginal fistula

Primary outcomes:
measure: operative time
timeFrame: 3 months
measure: complications
timeFrame: 3 months
measure: recurrence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Urology
state: Punjab
Study officials:
References:
Clinical trial NCT01010568: Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official title: Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: CLL
SLL
Bendamustine
Ofatumumab
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Cephalon
First posted: 2009-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed CLL or SLL requiring therapy
* Age 18 years of age or older
* ECOG performance status 0, 1, or 2
* Normal organ and bone marrow function
* Resolution of toxic effects from prior therapies
* Ability to adhere to the study schedule and give written informed consent

Exclusion Criteria:

* Any serious medical, psychiatric illness or laboratory abnormality
* Chemotherapy or radiotherapy within 4 weeks of entering the study
* Currently receiving other treatment for CLL/SLL or other malignancies
* Active other malignancies
* History of allergic reactions to bendamustine or ofatumumab
* Ongoing corticosteroid use
* Pregnant or lactating
* HIV positive
* Active hepatitis B
* Allogeneic transplant within 6 months of entering study or graft-versus-host disease.

Primary outcomes:
measure: Overall Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: Complete Response Rate
timeFrame: 6 months
measure: Median PFS
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Bruce Cheson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ujjani C, Ramzi P, Gehan E, Wang H, Wang Y, Cheson BD. Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2015 Apr;56(4):915-20. doi: 10.3109/10428194.2014.933217. Epub 2014 Aug 6.
Clinical trial NCT00825968: Data Collection and Analysis of Patients Who Have Had an Electrophysiological Procedure
Official title: Data Collection and Analysis of Patients Who Have Had an Electrophysiological Procedure Performed at the Ross Heart Hospital
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Disease
Atrial Fibrillation
Keywords: Electrophysiological
Heart Disease
Cardiology
Atrial Fibrillation
Risk Factors
Follow-up
Outcomes
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 58
Sex: FEMALE
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 having procedures completed at the electrophysiology Laboratories at the Ross Heart Hospital at The Ohio State University Medical Center.

Brief summary: The purpose of the database is to complete outcomes research of electrophysiological procedures.

Detailed description: The purpose of the database is to complete outcomes research (risk factors, follow-up, procedural data) Perhaps the most important research for any busy clinical laboratory is to appreciate the tendencies and trends that are occurring in their own laboratory setting. This will have a tremendous impact on educating the OSU staff as well as perhaps other centers on best medical practices.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* have or had a procedure preformed in the Electrophysiology Laboratories at the Ross Heart Hospital
* Ability to consent

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Emile Daoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04781868: Multi-Nutrient Supplement for Radio-Protection
Official title: Multi-Nutrient Supplement for Radio-Protection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Oxidative Stress
DNA Damage, Radiation Induced
Radiation Exposure
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in patients who are constantly exposed to this radiation. Currently, there is no way to prevent DNA damage during a medical scan. One potential way to fight the oxidative stress caused by radiation is to take an antioxidant before a scan. The purpose of this study is to see if a combination of antioxidants can protect someone from the damage that radiation causes to the DNA of their white blood cells.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 76 years.
* Scheduled for bone scan procedure at the Juravinski Hospital.

Exclusion Criteria:

* History of smoking within six months prior to study enrollment.
* Known hypersensitivity reactions to any of the ingredients in the MNSRP.
* Chemotherapy or radiation therapy within six months prior or one month following study enrollment.
* Individuals currently taking vitamin or mineral supplements that contain antioxidants will be considered on a case-by-case basis but will be asked to refrain from intake for at least two weeks prior to partaking in this study.

Primary outcomes:
measure: Number of gamma-H2Ax foci per PBMC nucleus
timeFrame: Three hours following radiation exposure
Secondary outcomes:
measure: Amount of amplifiable mtDNA in PBMC's
timeFrame: Three hours following radiation exposure
measure: Abundance of mtDNA deletions in PBMC's
timeFrame: Three hours following radiation exposure
measure: Abundance of phosphorus-ATM in PBMC's
timeFrame: Three hours following radiation exposure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01759368: Heart at Home- a Self-care Study
Official title: Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: self-care, heart failure, telemonitoring, health care utilization
Lead sponsor: VTT Technical Research Centre of Finland
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2013-01-03
Enrollment: 94
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: TREATMENT

Brief summary: In the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.


Eligibility criteria: Inclusion Criteria:

* diagnosis of systolic heart failure
* NYHA (New York Heart Association) classification \> 1
* left ventricular ejection fraction ≤ 35%
* need for a regular control visit
* time from the last visit no longer than 6 months

Exclusion Criteria:

* Patients who were known to enter a major medical operation
* severe comorbidity,
* participation in other clinical trial during last three months-
* poor compliance in terms of familiarity with mobile phone

Primary outcomes:
measure: Number of HF-related Hospital Days
timeFrame: From baseline until the end of the study at six months
Secondary outcomes:
measure: Death
timeFrame: From baseline until the end of the study at six months
measure: Heart Transplant
timeFrame: From baseline until the end of the study at six months
measure: P-proBNP
timeFrame: From baseline until the end of the study at six months
measure: EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores
timeFrame: From baseline until the end of the study at six months
measure: Left Ventricular Ejection Fraction
timeFrame: From baseline until the end of the study at six months
measure: Utilization of Health Care Resources
timeFrame: From baseline until the end of the study at six months
Other outcomes:
measure: Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study
timeFrame: From baseline to the end of the study at six months
Locations:
city: Espoo
country: Finland
facility: VTT Technical Research Centre of Finland
Study officials:
References:
citation: Vuorinen AL, Leppanen J, Kaijanranta H, Kulju M, Helio T, van Gils M, Lahteenmaki J. Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial. J Med Internet Res. 2014 Dec 11;16(12):e282. doi: 10.2196/jmir.3651.
Clinical trial NCT04709068: Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
Official title: Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Keywords: wearable
at-home
Lead sponsor: Current Health
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2021-01-14
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.


Eligibility criteria: Inclusion Criteria:

* Living in the United States (contiguous states)
* Aged 21 years or older
* Able to provide documentation of +Polymerase Chain Reaction (PCR) or +antigen test for COVID-19 within the past 48 hours
* Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily
* Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.

Exclusion Criteria:

* Under the age of 21
* Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19
* Cannot confirm a PCR or antigen positive test for COVID-19
* Is unable to read English
* Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire
* Is unwilling or unable to provide baseline data required for entry into the study
* Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up
* Heavy tattooing on both upper arms
* Known atrial fibrillation (permanent or paroxysmal)
* Has taken/is taking part in a COVID-19 vaccine or treatment trial

Primary outcomes:
measure: Participant Compliance
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Current Health
state: New York
Study officials:
affiliation: Current Health
name: Adam Wolfberg, MD
role: PRINCIPAL_INVESTIGATOR
References: