louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00588978: Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors
Official title: Longitudinal Impact of Diet and/or Exercise-induced Weight Loss on Metabolic Markers of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: c-reactive protein
obesity
women's cardiovascular health
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* obese postmenopausal women
* able to exercise
* non-smokers

Exclusion Criteria:

* cardiovascular disease
* medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
* known diabetes

Primary outcomes:
measure: c-reactive protein
timeFrame: baseline, every 1-2 weeks during intervention , then end-of-study
Secondary outcomes:
measure: HOMA (measure of insulin resistance) and sex steroids
timeFrame: baseline, every 1-2 weeks during intervention, then end-of-study
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale Univeristy School of Medicine
name: Barbara I Gulanski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01114178: Walking Impairment Questionnaire in PAD
Official title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour un Test de Marche Sur Tapis Roulant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Artery Disease
Keywords: questionnaire
peripheral artery disease
exercise
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2010-05-03
Enrollment: 340
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 referred for treadmill testing

Brief summary: Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication

Detailed description: Questionnaires (WELCH and WIQ) submitted to patients referred for treadmill walking test Comparison of sore to MWD on treadmill. Comparison with WIQ will be performed

Eligibility criteria: Inclusion Criteria:

* informed consent signed, french language fluent patients

Exclusion Criteria:

* rejection of the questionnaire

Primary outcomes:
measure: scoring of the WELCH questionnaire
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital
name: denise Jolivot, MD
role: STUDY_CHAIR
References:
citation: Fouasson-Chailloux A, Abraham P, Vielle B, Laporte I, Omarjee L, Ouedraogo N. The correlation of the "Walking Estimated-Limitation Calculated by History" (WELCH) questionnaire with treadmill maximal walking time is not impaired by age, in patients with claudication. Qual Life Res. 2015 Aug;24(8):1857-64. doi: 10.1007/s11136-015-0915-9. Epub 2015 Jan 13.
citation: Abraham P, Godet R, Harbonnier M, Laneelle D, Leftheriotis G, Ouedraogo N. External validation of the "walking estimated limitation calculated by history" (WELCH) questionnaire in patients with claudication. Eur J Vasc Endovasc Surg. 2014 Mar;47(3):319-25. doi: 10.1016/j.ejvs.2013.11.010. Epub 2013 Dec 3.
citation: Mahe G, Ouedraogo N, Marchand J, Vielle B, Picquet J, Leftheriotis G, Abraham P. Self-reported estimation of usual walking speed improves the performance of questionnaires estimating walking capacity in patients with vascular-type claudication. J Vasc Surg. 2011 Nov;54(5):1360-5. doi: 10.1016/j.jvs.2011.05.048.
citation: Mahe G, Ouedraogo N, Vasseur M, Faligant C, Saidi K, Leftheriotis G, Abraham P. Limitations of self-reported estimates of functional capacity using the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):104-9. doi: 10.1016/j.ejvs.2010.10.002. Epub 2010 Nov 30.
Clinical trial NCT01549678: Plantar Fasciitis Foot Insole
Official title: Effect of Plantar Fasciitis Foot Insole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Plantar fasciitis
foot pain
insoles
foot function
electronic baropodometer
plantar pressure
gait analysis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-03-09
Enrollment: 74
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 hypothesis to be tested is that the use of total contact insoles for six months reduces foot pain, improves function and quality of life of patients diagnosed with plantar fasciitis.

Detailed description: Patients diagnosed with plantar fasciitis, foot pain with VAS between 3 - 8 for walk, over 18 years, regardless of gender who agreed to participate and signing the consent form. Pacietes We excluded patients with other symptomatic lower limb musculoskeletal diseases, diabetes mellitus, rigid deformities in the feet, which made use of insoles, physiotherapy or injections in feet and ankles in the last three months, and previous surgery or planned within the next twelve months.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with a diagnosis of PF and foot pain while walking ranging from 3 to 8 points on a 10-point pain scale were analyzed

Exclusion Criteria:

* Patients with other musculoskeletal conditions in symptomatic lower limbs, inflammatory conditions of the central or peripheral nervous systems, diabetes mellitus or an inability to walk.

Primary outcomes:
measure: Visual analog scale of pain in feet during walking (VAS)
timeFrame: Six months
Secondary outcomes:
measure: FFI
timeFrame: 6 months
measure: FHSQ-Br
timeFrame: 6 months
measure: Visual analog scale of pain in feet at reset (VAS)
timeFrame: 6 months
measure: 6-MINUTE WALK TEST
timeFrame: 6 months
measure: SF-36
timeFrame: 12 months
measure: Likert scale
timeFrame: 6 months
measure: Baropodometric tests
timeFrame: 6 months
measure: Time use of insole
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Hilda PT Oliveira
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Anamaria PT Jones, PHD
role: STUDY_DIRECTOR
affiliation: Chief of Rheumatology, Federal
name: Jamil MD Natour, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03205878: Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea
Official title: Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Obstructive Sleep Apnea
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls.

First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown.

The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years.


Eligibility criteria: Inclusion Criteria:

* AHI \> 15 events/hour, measured by polysomnography
* \< 7,500 steps per day
* Willing to start CPAP treatment
* Age between 18 and 65 years
* Signing the written informed consent

Exclusion Criteria:

* Patients with neuromuscular diseases
* Patients with chronic obstructive pulmonary disease and interstitial lung disease
* Patients with cardiac failure and ischemic heart failure
* Patients with comorbidities which could interfere with a normal biomechanical gait pattern and the possibility of increasing physical activity
* Patients with mental disability making it impossible to understand the study protocol and the use of electronic devices.

Primary outcomes:
measure: Change in steps per day after 3 months
timeFrame: The change will be measured after 3 months
Secondary outcomes:
measure: The proportion of patients with an increase > 1,000 steps per day
timeFrame: After 3 months (end of telecoaching) and after 12 months
measure: The proportion of patients with > 7500 steps/day
timeFrame: Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months
measure: Change in functional exercise capacity
timeFrame: 3 months and 12 months compared with baseline
measure: Change in daytime sleepiness
timeFrame: 3 months and 12 months compared with baseline
measure: Change in sleep quality
timeFrame: 3 months and 12 months compared with baseline
measure: Change in endothelial function
timeFrame: 3 months and 12 months compared with baseline
measure: Change in body composition
timeFrame: 3 months and 12 months compared with baseline
measure: Change in quality of life
timeFrame: 3 months and 12 months compared with baseline
measure: Change in steps per day after 12 months
timeFrame: The change will be measured after 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00399178: A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
Official title: A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Norspan versus Tramadol
Randomised
Efficacy and safety
OA pain of the hip and/or knee
Lead sponsor: Mundipharma AB
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.


Eligibility criteria: Inclusion Criteria:

* OA diagnosis
* BS11 greater than or equal to 4 at base line
* Not adequately pain relieved with 4,000 mg paracetamol daily

Exclusion Criteria:

* Treated with high potent opioids for their OA pain
* Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
* Other chronic conditions requiring frequent analgesic therapy

Primary outcomes:
measure: Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.
Secondary outcomes:
measure: Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.
Other outcomes:
Locations:
city: Falkoping
country: Sweden
facility: Dr Mats Karlsson
state: Parkgatan 6C
Study officials:
name: M Karlsson, Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702078: Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
home-based treatment
early intervention
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Community Health Network
First posted: 2008-06-20
Enrollment: 172
Sex: ALL
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.

The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of COPD (III-IV)
* receive help from homecare nurse
* not suffering from any other serious disease, with expected lifespan less than 6 months

Exclusion Criteria:

-

Primary outcomes:
measure: Number of hospitalizations
timeFrame: 2011
Secondary outcomes:
measure: quality of life
timeFrame: 2011
measure: lung function
timeFrame: 2011
measure: use of medication
timeFrame: 2011
measure: cost-effectiveness
timeFrame: 2011
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept. of Lung Diseases, St.Olavs Hospital
Study officials:
affiliation: St.Olavs Hospital HF
name: Anne Hildur Henriksen, MD,PhD
role: STUDY_CHAIR
References:
citation: Titova E, Salvesen O, Bentsen SB, Sunde S, Steinshamn S, Henriksen AH. Does an Integrated Care Intervention for COPD Patients Have Long-Term Effects on Quality of Life and Patient Activation? A Prospective, Open, Controlled Single-Center Intervention Study. PLoS One. 2017 Jan 6;12(1):e0167887. doi: 10.1371/journal.pone.0167887. eCollection 2017.
Clinical trial NCT02687178: Canrenone as Add-on in Patients With Essential Hypertension
Official title: Efficacy and Safety of Canrenone as Add-on in Patients With Essential Hypertension-Italy (ESCAPE-IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy on blood pressure reduction, safety and tolerability of two different dosages of canrenone as add-on therapy in patients already treated with Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics at the maximum dosage.

Detailed description: To evaluate the efficacy on blood pressure reduction, safety and tolerability of two different dosages of canrenone as add-on therapy in patients already treated with Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics at the maximum dosage.

In this multi-centre, phase IV, randomized, controlled, open-label, parallel groups trial, 180 Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage will be enrolled.

At baseline patients will be randomized to canrenone, 50 mg, or canrenone 100 mg once a day, in addition to their current therapy, for three months.

At the baseline, and after 3 months will be evaluated: systolic (SBP) and diastolic blood pressure (DBP), pulse pressure (PP), heart rate, fasting plasma glucose (FPG), homeostasis model assessment insulin (HOMA-index), total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, sodium, potassium, calcium, magnesium, uric acid, estimated glomerular filtration rate (eGFR), plasmatic urea, brain natriuretic peptide (BNP), aldosterone, and galectin-3.

Eligibility criteria: Inclusion Criteria:

* Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage.

Exclusion Criteria:

* diabetes mellitus
* secondary hypertension
* pregnancy

Primary outcomes:
measure: Systolic (SBP) and Diastolic blood pressure reduction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Derosa G, Maffioli P, D'Avino M, Sala C, Mugellini A, Vulpis V, Felis S, Guasti L, Sarzani R, Bestetti A, Vanasia M, Gaudio G; ESCAPE-IT Trial Investigators group. Efficacy and safety of two dosages of canrenone as add-on therapy in hypertensive patients taking ace-inhibitors or angiotensin II receptor blockers and hydrochlorothiazide at maximum dosage in a randomized clinical trial: The ESCAPE-IT trial. Cardiovasc Ther. 2017 Feb;35(1):47-54. doi: 10.1111/1755-5922.12235.
Clinical trial NCT00479778: Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms
Official title: An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Keywords: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.


Eligibility criteria: * Postmenopausal women, aged 40 to 65 years.
* Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.
* A history or active presence of clinically relevant important medical disease.

Primary outcomes:
measure: Pharmacokinetic analyses.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00170378: The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
Official title: The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Injury
Venous Thrombosis
Keywords: Enoxaparin
Safety
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-09-15
Enrollment: 300
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: To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.

Detailed description: Venous thromboembolic (VTE) prophylaxis in trauma patients is a critical clinical problem. Patients with traumatic brain injury usually have effective VTE prophylaxis withheld secondary to concerns of exacerbating intracranial hemorrhage. This study examines the safety and efficacy of early administration (within 24 hrs of admission) of low molecular weight heparin to this patient population with very high VTE risk.

Eligibility criteria: Inclusion Criteria:

* Blunt traumatic brain injury (Marshall II-V)
* Stable 6 hr. head CT
* Stable hemoglobin

Exclusion Criteria:

* Premorbid coagulopathy
* Pregnancy
* \< 18 y.o.
* Need for therapeutic anticoagulation
* Heparin allergy

Primary outcomes:
measure: Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.
Secondary outcomes:
measure: Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center/MinneapolisMRF
name: John K. Cumming, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim J, Gearhart MM, Zurick A, Zuccarello M, James L, Luchette FA. Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury. J Trauma. 2002 Jul;53(1):38-42; discussion 43. doi: 10.1097/00005373-200207000-00008.
citation: Norwood SH, McAuley CE, Berne JD, Vallina VL, Kerns DB, Grahm TW, Short K, McLarty JW. Prospective evaluation of the safety of enoxaparin prophylaxis for venous thromboembolism in patients with intracranial hemorrhagic injuries. Arch Surg. 2002 Jun;137(6):696-701; discussion 701-2. doi: 10.1001/archsurg.137.6.696.
citation: Norwood SH, McAuley CE, Berne JD, Vallina VL, Kerns DB, Grahm TW, McLarty JW. A potentially expanded role for enoxaparin in preventing venous thromboembolism in high risk blunt trauma patients. J Am Coll Surg. 2001 Feb;192(2):161-7. doi: 10.1016/s1072-7515(00)00802-4.