louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02879890: Comorbidities and Indirect Health State Utility in Hip and Knee Osteoarthritis
Official title: Impact of Comorbidities on Measure of Indirect Utility Change in Hip and Knee Ostearthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 878
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population-based

Brief summary: National cohort study aimed to investigate the impact of comorbidities (number and type of comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).

Detailed description: The concept of health utility state was developed by economists to explain individual choices and preferences for health states. It is expressed as the "desirability or preference that individuals exhibit for the condition". This health utility state can be measured indirectly using health-relation quality of life questionnaires.

Chronic diseases such as OA are known to be associated with impairment of quality of life. Given that OA prevalence increases with age, OA is often associated with other diseases (comorbidities). A cross-sectional study showed that comorbidities are associated with lower health utility state in OA. Investigation of longitudinal impact of comorbidities on health utility state change is need.

Main objective: Determine the impact of comorbidities on change in health utility state among patients with lower limb OA.

Secondary objective: Determine the Minimal Clinically important Difference in health utility state among patients with lower limb OA.

The COMUTAR study uses longitudinal data from the Knee and Hip Osteoarthritis Longitudinal Assessment (KHOALA) cohort study. Health utility state is measured indirectly using Medical Outcome Study Short Form-36 quality of life questionnaire Comorbidities are assessed using the Functional Comorbidity Index

Eligibility criteria: Inclusion Criteria:

* age: 40-75 years
* Uni or bilateral lower limb osteoarthritis (OA) according to the American College of Rheumatology (ACR) and European league against rheumatism (EULAR) criteria

Exclusion Criteria:

* Hip or knee prothesis
* Antecedent of osteotomy
* Severe comorbidity
* Adult under legal protection

Primary outcomes:
measure: Change in health utility state
timeFrame: Five years
Secondary outcomes:
measure: Minimal Clinically Important Difference (MCID) of health utility state
timeFrame: Five years
Other outcomes:
Locations:
Study officials:
affiliation: CHRU Nancy
name: Francis GUILLEMIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01536990: Sensitivity to Change of the Lower Extremity Functional Scale in Patients With Stroke
Official title: Sensitivity to Change of the Lower Extremity Functional Scale and a Single-Item Functional Assessment Tool in Patients With Neurological Impairments Secondary to Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Extremity Dysfunction
Stroke
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-02-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke.

Brief summary: The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke.

Detailed description: The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke. Patients were measured with the LEFS at the beginning and end of physical therapy treatment, or at 8 weeks of physical therapy treatment.

Eligibility criteria: Inclusion Criteria:

* Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke

Exclusion Criteria:

* Unable to understand English
* More than moderate assist for bed mobility and coming to sitting from the supine position
* Lower extremity amputation
* Unable to reach overhead, grasp an object, or feed self with an upper extremity

Primary outcomes:
measure: LEFS
timeFrame: 36 days average (range 4-76 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Joseph L Verheijde, PhD MBA PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06687590: Serranator POINT FORCE Registry
Official title: POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease (PAD)
Dysfunctional AV Fistula
Dysfunctional AV Graft
Lead sponsor: Cagent Vascular LLC
Sponsor class: INDUSTRY
Collaborators: name: Peachtree BioResearch Solutions Inc.
name: Yale Cardiovascular Research Group
First posted: 2024-11-13
Enrollment: 500
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: The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.

Brief summary: The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.


Eligibility criteria: Inclusion Criteria:

* Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
* Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
* Age of subject is \> 18.
* Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.

Exclusion Criteria:

* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
* Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Primary outcomes:
measure: Performance Endpoint
timeFrame: Peri-procedural
Secondary outcomes:
measure: Safety Endpoint
timeFrame: Peri-procedural
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
References:
Clinical trial NCT00901290: Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects
Official title: A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: oral contraceptive
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive


Eligibility criteria: Inclusion Criteria:

* If previously pregnant, must be \> 6 month post-partum at the time of randomization
* Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2

Exclusion Criteria:

* Use of any prescription medication within 14 days of screening
* current smoker or history of smoking within the last 3 months prior to enrollment
* Abnormal pap smear exam result within one year of enrollment.

Primary outcomes:
measure: To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN
timeFrame: weekly
Secondary outcomes:
measure: Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325
timeFrame: weekly
measure: To characterize the steady-state pharmacokinetics of AZD7325
timeFrame: weekly
measure: To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)
timeFrame: weekly
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles Phase I Services
name: Eleanor Lisbon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194090: Efficacy of Celecoxib vs Placebo to Prevent Pain in a Paced Walk
Official title: A Double-blind, Placebo-controlled, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg qd in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: pain
osteoarthritis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis

Detailed description: This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk.

40 subjects will be enrolled

Eligibility criteria: Inclusion Criteria:

Knee osteoarthritis by ACR clinical criteria Pain of at least 40 mm by VAS at baseline

-

Exclusion Criteria:

Non-pregant, non-lactating Able to stop active arthritis medication for washout Cardiovascular risk factors Abnormal EKG -

Primary outcomes:
measure: time to onset of severe pain
Secondary outcomes:
measure: time to onset of moderate pain
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Michele M Hooper, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522690: Assessment of Accelerometric Measurement Devices for Gait Analysis
Official title: Assessment of Accelerometric Measurement Devices for Gait Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Accelerometer
gait analysis
Healthy subjects
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.


Eligibility criteria: Inclusion Criteria:

* healthy ambulant subject
* subject affiliated to a social security system
* subject who signed an informed consent

Exclusion Criteria:

* surgery or recent trauma to the lower limbs (under 6 months)
* high performance sport
* chronic treatment alters the strength in the month before inclusion
* pregnant or nursing woman
* person under guardianship or curatorship
* orthopedic, neuromuscular or neurological disease having an impact on the quality of walking

Primary outcomes:
measure: Accelerometric variables measured for each walk test
timeFrame: At baseline
measure: Accelerometric variables measured for each walk test
timeFrame: 1 hour after baseline
Secondary outcomes:
measure: Gait speed measured for each walk test
timeFrame: At baseline
measure: Knee flexion and extension strength
timeFrame: At baseline
measure: Gait speed measured for each walk test
timeFrame: 1 hour after baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Myologie - GH Pitié Salpêtrière
Study officials:
References:
Clinical trial NCT01020890: Prevalence of Gastroesophageal Reflux Disease in Primary Care Patients With Upper Gastrointestinal Symptoms
Official title: A Cross-sectional Study on the Prevalence of GERD in Primary Care Patients With Upper GI Symptoms Using the GERD-Q. The Bulgarian GERD-Q Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD diagnosis
GERD-Q
GERD patients' characteristics
GERD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 2210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to provide data on the gastroesophageal reflux disease (GERD) prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are identified with GERD using the Gerd-Q Questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients with upper gastrointestinal symptoms

Exclusion Criteria:

* History of oesophageal, gastric or duodenal surgery
* Current treatment with antiinflammatory drugs, including OTC
* Current treatment with proton pump inhibitors ang H2-blockers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Dobrich
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Turnovo
country: Bulgaria
facility: Research Site
city: Vratsa
country: Bulgaria
facility: Research Site
city: Yambol
country: Bulgaria
facility: Research Site
Study officials:
References:
Clinical trial NCT00781703: Evaluation of a Natural Experiment to Improve Statewide Depression Care in Minnesota (MN)
Official title: DIAMOND Study: Evaluation of a Natural Experiment to Improve Statewide Depression Care in MN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-10-29
Enrollment: 2631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will evaluate a unique natural experiment that aims to transform the primary care of patients with depression. The experiment's aim is to cause statewide implementation of an evidence-based care model for depression by changing the reimbursement system and by using an established regional collaborative (the Institute for Clinical Systems Improvement) to both facilitate the model's widespread use and certify that medical groups have implemented it. Study hypotheses include the following:

1. Newly treated depressed patients in medical groups that have implemented the new reimbursement and facilitation will report receiving higher rates of best care processes than such patients in these medical groups before implementation.
2. Rates of best care practices reported to be received by newly treated depressed patients two years after each medical group implements changes will be maintained at least at the rate reported by patients one year post implementation.
3. Newly treated depressed patients in medical groups that have participated in the new reimbursement and facilitation will have greater improvement in depression symptoms and work productivity and lower healthcare costs than such patients in groups before participation.
4. Medical group measures of priority for improving depression care, capability to manage change, and practice systems will be predictive of more patient-reported best care processes, both at one point in time and in change over time.

Detailed description: The study will use a multiple baseline across settings with staggered implementation to test the effects of changed reimbursement and facilitated organizational change on the use and sustainability of evidenced-based care processes for patients with depression. The study will also test the effect of the care process changes on changes in depression symptoms, healthcare costs, and work productivity.

Eligibility criteria: Inclusion Criteria:

* major depression
* Patient Health Questionaire (PHQ-9) \> 9
* primary care management of depression

Exclusion Criteria:

* comorbid psychiatric conditions

Primary outcomes:
measure: Rates of best care processes
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Improvement in depression symptoms, work productivity and total healthcare costs
timeFrame: baseline, 3 months, 6 months, 1 year
Other outcomes:
Locations:
Study officials:
affiliation: HealthPartners Institute
name: Leif I Solberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578603: Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
Official title: Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Plaque
Saliva Altered
Gingivitis
Keywords: prevention & control
Xylitol
casein phosphopeptide amorphous calcium phosphate complex
Streptococcus mutans
saliva
dental plaque
gingivitis
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 130
Sex: ALL
Minimum age (years): 16
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.

Detailed description: The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.

To this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.

After a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.

Eligibility criteria: Inclusion Criteria:

* systemically healthy
* dental student

Exclusion Criteria:

* less than 26 teeth in mouth
* use of orthodontic appliances
* use of antibiotics the last 3 months

Primary outcomes:
measure: Turesky index
timeFrame: a month
Secondary outcomes:
measure: Gingival index
timeFrame: a month
measure: salivary pH
timeFrame: a month
measure: Streptococcus mutans
timeFrame: a month
measure: Ca levels
timeFrame: a month
measure: facultative microorganisms
timeFrame: a month
measure: Lactobacillus
timeFrame: a month
measure: phosphate levels
timeFrame: a month
measure: BOP index
timeFrame: a month
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Facultad de Odontología, Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Maria C Martínez-Pabón, MsC Microb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01981603: Transplant Navigator Dissemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Renal Failure Chronic Requiring Hemodialysis
Keywords: Navigators
Kidney Transplant
Hemodialysis
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 1926
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel.

Hypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* between the ages of 18-70
* receiving in center hemodialysis

Exclusion Criteria:

* less than 18 years of age
* older than 70 years of age

Primary outcomes:
measure: The proportion of patients who are wait listed or receive a kidney transplant.
timeFrame: approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Lutheran Hospital
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: