louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00208299: ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Official title: A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Lexiscan
Regadenoson
Adenoscan®
Adenosine
SPECT Myocardial Perfusion Imaging
Reversible Perfusion Defect
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2005-09-21
Enrollment: 1231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.

Detailed description: ADVANCE MPI 1 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed:

* to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and
* to compare the safety and tolerability of the two stress agents.

Eligibility criteria: Inclusion Criteria:

* Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study

Exclusion Criteria:

* Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
* Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control

Primary outcomes:
measure: Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
timeFrame: After radiopharmaceutical administration
Secondary outcomes:
measure: Safety and tolerability comparison of regadenoson to Adenoscan
timeFrame: Up to two weeks
measure: Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
timeFrame: After radiopharmaceutical administration
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Multiple study locations (see Central Contact); CV Therapeutics, Inc.
state: California
Study officials:
References:
Clinical trial NCT00004199: Prinomastat and Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Non-small Cell Lung Cancer
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-07-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Compare the overall survival, progression free survival, symptomatic progression free survival, and one year survival of patients with metastatic or recurrent non-small cell lung cancer treated with prinomastat (AG3340) or placebo in combination with gemcitabine and cisplatin. II. Compare the disease response and duration of response in these patients on these regimens. III. Compare the quality of life of these patients on these regimens. IV. Evaluate the safety of these regimens in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine IV on days 1 and 8 and cisplatin IV on day 1. Courses repeat every 3 weeks.

PROJECTED ACCRUAL: Approximately 420 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Stage IV or recurrent or T4 lesion non-small cell lung cancer Measurable or evaluable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Agouron Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: Agouron Pharmaceuticals
name: Mary Collier
role: STUDY_CHAIR
References:
Clinical trial NCT00013299: Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
Official title: Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: Foot ulcers, amputation prevention, diabetes, footwear, insoles
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.

Detailed description: This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.

Eligibility criteria: Diabetics with foot ulcerations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VAMC, Seattle, WA
state: Washington
Study officials:
affiliation: Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D. Asst. Director
affiliation: Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Wijegupta Ellepola, Program Analyst
References:
Clinical trial NCT01289899: Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects
Official title: BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: BR-A-657
Fimasartan
multiple-dose
pharmacokinetic
pharmacodynamic
safety
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2011-02-04
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.

Detailed description: BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects.

Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.

PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Eligibility criteria: Inclusion Criteria:

* male of 18-55 years old
* BMI 19-29kg/m2
* subjects in good health
* subjects with written informed consent

Exclusion Criteria:

* subjects with multiple drug allergy or allergy to ARB
* subjects with medication that affect drug absorption or elimination within 30days.
* subjects with orthostatic hypotension of \>20mmHg decrease of sbp
* subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder

Primary outcomes:
measure: No of subjects with Adverse events(AE) from each observations
timeFrame: up to 5~7days post final(7th) dose
Secondary outcomes:
measure: Area under the plasma concentration time curve (AUC)
timeFrame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
measure: Maximum observed plasma concentration (Cmax).
timeFrame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
measure: parent plasma terminal elimination half life (t½)
timeFrame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
measure: Apparent total plasma clearance (CL/F)
timeFrame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
measure: Accumulation ratio (RA)
timeFrame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Other outcomes:
Locations:
Study officials:
affiliation: Covance Clinical Research Unit
name: E Engmann, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05390099: Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes
Official title: Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes Among a Group of Egyptian Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to assess and compare the anti-plaque and anti-gingivitis effects of Moringa plant extract and Fluoride toothpastes among a group of Egyptian Children.

Detailed description: In the last few years, the use of plant extracts in alternative medicine has evolved widely. Various herbal products, including mouthwash and toothpaste, are now available and have been shown to possess a beneficial effect on oral health .Moringa plant is used to treat various diseases including the treatment of the oral cavity or dentistry .

Eligibility criteria: Inclusion Criteria:

* Children of 12-14 years of age.
* Presence of gingivitis-calculus, and plaque (gingival index \[GI\]score ≥1/plaque index \[PI\] score ≥1).
* Children willing to participate.
* Children whose parents/caretakers gave informed consent.

Exclusion criteria

* Children having fixed or removable orthodontic appliances or removable prostheses.
* Children suffering from any systemic illness.
* Children who were already using mouthwashes.
* History of oral prophylaxis within 6 months.
* Children using any other oral hygiene aids.

Primary outcomes:
measure: gingival index (Loe and Sillness, 1963)
timeFrame: 6 weeks
Secondary outcomes:
measure: plaque index (Sillness and Loe, 1964)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
affiliation: marwaaly2003@yahoo.com
name: marwa m elchaghaby, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632799: Airway Pressure During Nasal High Flow and CPAP in Neonates
Official title: Airway Pressure During Nasal High Flow and CPAP in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Nasal High Flow
CPAP
airway pressure
newborn
Lead sponsor: Research Center of Maternal and Child Health Protection, Armenia
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2015-12-17
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.

Detailed description: Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher \& Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).

Eligibility criteria: Inclusion Criteria:

* Healthy term newborns

Exclusion Criteria:

* Newborns with any medical problems after birth
* Absent of parents consents

Primary outcomes:
measure: Upper airway pressure generated by NHF compared to CPAP
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health
city: Yerevan
country: Armenia
facility: RCMCHP
Study officials:
affiliation: Research Center of Maternal and Child Health Protection, Armenia
name: Pavel Mazmanyan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02121899: Registry Measuring Impact of RNA Expression Testing on Treatment Decisions in Early Stage Lung Cancer and Assessing the Disease-free Survival With Long-term Follow-up (ONC006)
Official title: LUNG CAncerREgistry: An Open Registry to Measure the Impact of Adding RNA Expression Testing (myPlan Lung Cancer) on Treatment Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients (LUNG CARE Registry)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
NSCLC
NSCLC Adenocarcinoma
Keywords: Registry
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-24
Enrollment: 44
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: Recently diagnosed treatment-naïve patients with early stage NSCLC (lung adenocarcinoma)

Brief summary: This registry is intended to measure the effect of myPlan Lung Cancer™ test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC.

The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006). This registry is specific to Oncologists (ONC006).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of early stage non-small cell lung adenocarcinoma
* Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site
* Resection of tumor within previous 2 months of enrollment
* ECOG performance of 0-2
* A minimum life expectancy of six months

Exclusion Criteria

* Previous myPlan Lung Cancer test performed
* Pre-operative radiation or chemotherapy for NSCLC
* Post-operative radiation or chemotherapy for NSCLC
* Enrollment in a separate clinical trial restricting treatment options
* Unable to provide informed consent

Primary outcomes:
measure: Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of disease free survival from resection to relapse or death
timeFrame: 3 years
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
Study officials:
affiliation: Myriad Genetic Laboratories, Inc.
name: Richard Wenstrup, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01079299: Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Official title: Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: venous ulcer
secondary lymphedema
chronic lower leg ulceration
Lead sponsor: Calvary Hospital, Bronx, NY
Sponsor class: OTHER
Collaborators: name: RTS Family Foundation
name: New York State Department of Health
First posted: 2010-03-03
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with secondary lymphedema
* Presence of a venous ulcer that has not healed in more than 6 months
* Localized wound pain greater than 3 with VAS
* Ulcer must be on lower leg (below knee)
* Ulcer must be of venous etiology
* CVI proven by duplex studies
* Subject must have adequate arterial blood flow (ABI \> 0.70)
* Subject must be able to tolerate compression bandages
* Subject must be ambulatory
* Capable of understanding consent process

Exclusion Criteria:

* Wound infection
* Ulcer of non-venous etiology
* Ulcer on toes or plantar surface of the foot
* Subject taking any medication that in the opinion of the investigator affects wound healing
* Alcohol or drug abuse
* Active deep venous thrombosis (DVT)
* Subject has a cancer diagnosis
* Diabetic with hemoglobin A1C\>12
* Arterial insufficiency ABI\<0.70
* Subject is not capable of walking (wheelchair-bound or bed-bound)
* Subject currently enrolled in another clinical trial
* Moderate to severe congestive heart failure

Primary outcomes:
measure: Median Time to Wound Closure at 9 Months
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Calvary Hospital, Center for Curative and Palliative Wound Care
state: New York
Study officials:
References:
Clinical trial NCT01412099: Nutrition and Physical Activity Counseling for Nontraditional College Students
Official title: Feasibility of a Health Promotion Program for Nontraditional College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Exercise
Fast Foods
Fruits
Vegetables
Beverages
Non-traditional college students
Motivational Interviewing
Peer Counselors
Cancer Prevention
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to evaluate the effectiveness of two methods of delivering information about nutrition and physical activity to non-traditional college students. Participants will receive either a printed feedback report alone, or the feedback report in addition to a series of phone calls from a peer counselor. The peer counselors will provide nutrition and physical activity counseling using motivational interviewing techniques. Nutrition and physical activity outcomes will be measured for both groups and compared.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled undergraduate student at UMass Boston,
* Have completed high school,
* 24yrs old or older AND/OR part time students,
* Noncompliant in at least 1 of 4 behaviors: fruit \& vegetable intake, sugar sweetened beverage intake, fast food intake, or physical activity),
* Willing to randomized into either study group,
* Be able to give informed consent.

Exclusion Criteria:

* Have any contraindications to physical activity

Primary outcomes:
measure: physical activity and diet behaviors (fruit and vegetable intake, sugary drink intake, and fast food intake)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: University of Massachusetts Boston
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Lisa M Quinitiliani, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: