louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02999685: Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients
Official title: Home-based Health Management of COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Emphysema
Pulmonary Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Minnesota HealthSolutions
First posted: 2016-12-21
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

Detailed description: This study consists of a home-based pulmonary rehabilitation system. The system consists of a tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls. The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A will complete the study activities during the first 8 weeks of the study followed by a period of observation. Group B will complete 8 weeks of observation followed by 8 weeks of rehabilitation.

Eligibility criteria: Inclusion Criteria:

* • Men and women age 40 years and older

  * Current or former smoker of at least 10 pack-years
  * Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function
  * Are eligible for Pulmonary Rehabilitation

Exclusion Criteria:

* • Unable to perform mild exercises

  * Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  * Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Primary outcomes:
measure: Quality of Life: Chronic Respiratory Questionaire
timeFrame: 8 weeks from the start of the intervention
measure: Daily Physical Activity measured by Actigraph
timeFrame: 8 weeks from the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benzo RP, Kramer KM, Hoult JP, Anderson PM, Begue IM, Seifert SJ. Development and Feasibility of a Home Pulmonary Rehabilitation Program With Health Coaching. Respir Care. 2018 Feb;63(2):131-140. doi: 10.4187/respcare.05690. Epub 2017 Oct 24.
Clinical trial NCT05697185: Safety and Efficacy of Evolocumab in Ischemic Stroke
Official title: Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Stroke, Acute
Lead sponsor: Second Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 200
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: The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).


Eligibility criteria: Inclusion Criteria:

1. Patient age between 18-80 years
2. Time of onset: within 1 week
3. NIHSS score ≤12
4. Acute ischemic stroke confirmed by head CT or MRI
5. Premorbid mRS ≤1
6. Signed informed consent

Exclusion Criteria:

1. Intracranial hemorrhage found by head CT
2. Severe hepatic or renal dysfunction
3. Pregnant females
4. Abnormal elevation of creatine phosphokinase
5. Blood sugar is out of control
6. Receiving statins within 1 month before onset
7. Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
8. Unsuitable for this clinical studies assessed by researcher

Primary outcomes:
measure: Percent change in LDL-C
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks after treatment
Secondary outcomes:
measure: Vascular events
timeFrame: 3 months, 6months
measure: mRS (0-2)
timeFrame: 3 months, 6months
measure: death of any causes
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The Second Affiliated Hospital of Guangxi Medical University, Nanning, China
name: Junli Liang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01546285: B40 Non-Invasive Blood Pressure Equivalency Study
Official title: B40 Non-Invasive Blood Pressure Equivalency Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Detailed description: Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.

The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
* Within the age range from older than 3 years old to 75 years old (adult and child)
* Ability to maintain proper placement of cuff and/or probe and/or sensor

Exclusion Criteria:

* Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
* Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
* Known dysrhythmias (when applicable)
* Known disease state that compromises circulation to the extremity
* Vigorous exercise prior to participating in the study
* Excessive movement or excitability causing false values or no determinations
* Known allergy to latex when latex products will be in contact with subject
* Pregnant females

Primary outcomes:
measure: Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
timeFrame: End of each blood pressure reading
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
References:
Clinical trial NCT01490385: The Effect of Light Emitting Diode Phototherapy on the Rate of Orthodontic Tooth Movement - A Clinical Study
Official title: The Effect of Light Emitting Diode Phototherapy on the Rate of Orthodontic Tooth Movement - A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Rate or Orthodontic Tooth Movement
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: LED Phototherapy will increase the velocity of Orthodontic tooth movement.


Eligibility criteria: Inclusion Criteria:

* bilaterally symmetric extraction of premolar teeth with residual extraction spaces large enough to ensure space closure is not complete prior to the subsequent orthodontic appointment
* no medicines or systemic illness
* full banding/bonding of teeth

Exclusion Criteria:

* pregnant
* non-extraction treatment
* systemic illness
* prior orthodontic treatment

Primary outcomes:
measure: Extraction space size
timeFrame: T0, T1, T2
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Faculty of Dentistry
state: Ontario
Study officials:
affiliation: University of Toronto
name: Bryan D Tompson, DDS, DipPaedo, DipOrtho, FRCDC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung SE, Tompson B, Gong SG. The effect of light emitting diode phototherapy on rate of orthodontic tooth movement: a split mouth, controlled clinical trial. J Orthod. 2015;42(4):274-83. doi: 10.1179/1465313315Y.0000000013. Epub 2015 Jul 28.
Clinical trial NCT02703285: Are Medical Personnel Can Correctly Recognize the Chest Sounds?
Official title: Are Medical Personnel Can Correctly Recognize the Chest Sounds?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiration, Artificial
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to validate the interpretation of breath sounds by medical personnel

Detailed description: task of the participants in the study to determine the chest sound based on specific sounds

Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria

Primary outcomes:
measure: breathing sounds measured by questionnaire
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
affiliation: Medical University of Warsaw
name: Lukasz Szarpak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00399685: Drug Interaction - Oral Contraceptive
Official title: Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.


Eligibility criteria: Inclusion Criteria:

* Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
* Documented acceptable Pap smear within 1 year of the start of the study
* BMI of 18-32 kg/m²

Exclusion Criteria:

* Males
* Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
* History of conditions in which oral contraceptives are contraindicated
* History of migraine with focal aura
* History of uncontrolled hypertension
* Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
* History of diagnosed mental illness or suicidal ideation

Primary outcomes:
measure: To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
timeFrame: throughout the study
Secondary outcomes:
measure: Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
timeFrame: throughout the study
measure: Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
timeFrame: throughout the study
measure: Assess the safety of efavirenz coadministered with Ortho Cyclen
timeFrame: throughout the study
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Covance Clinical Research Unit San Diego
state: California
city: Tacoma
country: United States
facility: Northwest Kinetics
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02314585: Fall Risk Reduction in Multiple Sclerosis (FIRMS)
Official title: Fall Risk Reduction in Multiple Sclerosis: Exercise Intervention vs. Attention Control Modification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study looks to see the effects of a home based exercise program on falls in people with MS.

Detailed description: The purposes of this project are four-fold: 1) to determine if a 6-month home-based targeted exercise program results in immediate and sustained reduction in falls risk and incidence ; 2) to identify the factors that contribute to a reduction in fall risk and incidence; 3) to determine if a decrease in physiological fall risk and/or fall incidence results in increased quality of life and participation in older adults with MS; and 4) to determine the association between cognition, environment and comorbidities on future falls and intervention efficacy.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria involve having an established definite diagnosis of MS
* Ability to walk 25 feet with or without aid
* Relapse free in the last 30 days
* Being ≥ 50 years of age
* Having fallen at least once in the past year
* Physician approval to engage in light physical activity
* Willingness and ability to attend the training sessions and testing sessions.

Exclusion Criteria:

* We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise.
* During the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire.
* Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.

Primary outcomes:
measure: Chagne in Fall Risk
timeFrame: 1 year
Secondary outcomes:
measure: Identification of Fall Risk Factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Motor control research lab
state: Illinois
Study officials:
affiliation: Motor Control Lab, University of Illinois
name: Jacob J Sosnoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780585: A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)
Official title: A Multi-center Cardiac Safety Study of Subjects Who Participated in Organon Sponsored Phase 1 and Phase 2 Completed and Discontinued Trials With Org 24448
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-27
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from subjects who participated in previous Org 24448 trials

Brief summary: This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.

Detailed description: All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.

Eligibility criteria: Inclusion Criteria:

Subjects must:

* be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial.
* sign an affirmative informed consent before evaluations are conducted;

Exclusion Criteria:

Subjects must not have:

* a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). If possible, evaluation of such subjects is deferred until resolution of such conditions.

Primary outcomes:
measure: Overall cardiac function by cardiologist evaluation including echocardiogram.
timeFrame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04871685: The ECOVITA Study - Validation of LUS Score in SARS-CoV-2 Disease, i.e COVID-19
Official title: ECOVITA Study. Observational Study on Sars-COV 2 Population Hospitalized in the Italian Country
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome
Keywords: lung ultrasound
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized due to COVID19 infection

Brief summary: Lung Ultrasound (LUS) has been revealing an extremely useful tool to identify and monitor complications from Sars-COV-2 disease. Recently, a research group has proposed a score, named LUS Score, able to optimize the use of this diagnostic technique. LUS Score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (B lines), the characteristics of the pleural line and the presence or not of consolidation areas.

The comparison between LUS and chest tomography (CT), the current gold standard for the diagnosis of interstitial pneumonia by COVID-19, has confirmed from the preliminary data, the reliability of such technique. Hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.


Eligibility criteria: Inclusion Criteria:

* men and women;
* confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
* any symptom at hospitalization
* any therapy
* any pre-existing comorbidity

Exclusion Criteria:

* pregnant women
* healthy subjects with other respiratory diseases different from COVID-19

Primary outcomes:
measure: validation of lung ultrasound score
timeFrame: 6 months
Secondary outcomes:
measure: Association of LUS score with clinical outcome
timeFrame: 6 months
measure: Association of LUS score with duration of hospitalization (days)
timeFrame: 6 months
measure: Association of LUS score with respiratory support required
timeFrame: 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania Luigi Vanvitelli
state: Campania
Study officials:
References:
Clinical trial NCT00241085: Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
Official title: A Multi-center, Double Blind, Randomized, Parallel Group Study to Evaluate the Effects of Valsartan on Proteinuria in Hypertensive Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PROTEINURIA
Hypertension
Type 2 Diabetes
Keywords: proteinuria
hypertension
valsartan
type 2 diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.


Eligibility criteria: Inclusion Criteria:

- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,

Exclusion Criteria:

Pregnant or breast feeding, Type 1 diabetes

Other protocol criteria apply

Primary outcomes:
measure: Change from baseline in urinary protein excretion after 30 weeks
Secondary outcomes:
measure: Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Weir MR, Hollenberg NK, Zappe DH, Meng X, Parving HH, Viberti G, Remuzzi G. Antihypertensive effects of double the maximum dose of valsartan in African-American patients with type 2 diabetes mellitus and albuminuria. J Hypertens. 2010 Jan;28(1):186-93. doi: 10.1097/HJH.0b013e328332bd61.