louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00346411: Health Outcomes in Rheumatoid Arthritis
Official title: Health Outcomes in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
mood
adherence
medication
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-06-29
Enrollment: 164
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with rheumatoid arthritis and receiving treatment for this condition from a rheumatologist

Brief summary: This research is being done to help us learn about how different factors related to treatment affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient for one year as he or she receives usual treatment from his or her rheumatologist. Up to 360 adults with RA may join this study.


Eligibility criteria: Inclusion Criteria:

* Males and females age 19 or older
* Current active, adult-onset rheumatoid arthritis who meet American College of Rheumatology (ACR) criteria for RA and have: (ACR functional class I-III), defined as:
* 3 or more swollen or tender joints and
* Morning stiffness of 45min or longer
* OR judged by their rheumatologist to have active disease
* No evidence of other inflammatory diseases (e.g., Crohn's, IBS)
* Functional class I, II or III

Exclusion Criteria:

* Individuals with significant cardiovascular disease (CHF, stroke, MI)
* Unwilling to have medications monitored and/or comply with protocol
* Not fluent in English
* Planning to move from area within next year or change health insurance (which would preclude ongoing care by a Johns Hopkins rheumatologist)
* Enrolled in study evaluating efficacy of new or existing RA medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Susan Bartlett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Cynthia S Rand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05802511: Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
Official title: Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Neuropathic Pain
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012. The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.

The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.

Detailed description: The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* Men and women age 30 years or older
* Subject undergoing an Exablate procedure for their planned neuropathic treatment per local institution standard of care
* Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG)
* Patient has a score of 6 or higher on the Numeric Rating Scale (NRS)
* Subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes
* Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits

Exclusion Criteria:

* Subject diagnosed with a nociceptive chronic pain syndrome
* Subject does not agree to participate or is unlikely to participate for the entirety of the study
* Subject is currently participating in another clinical investigation with an active treatment arm

Primary outcomes:
measure: Pain Numerical Rating Score (NRS)
timeFrame: 72 h
measure: Pain Numerical Rating Score (NRS)
timeFrame: 1 month
measure: Pain Numerical Rating Score (NRS)
timeFrame: 3 months
measure: Pain Numerical Rating Score (NRS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi "Bonino-Pulejo"
Study officials:
References:
Clinical trial NCT04135911: A Prospective Study on The"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting"
Official title: A Prospective Study on The"Management of Hypertension in Young and Middle-aged Subjects in Enterprises Setting"
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hypertension
Blood Pressure
Lead sponsor: Shanghai Institute of Hypertension
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients measuring blood pressure at the workplace with normal high blood pressure or hypertensive patients.

Brief summary: In recent years, with the investment from government in the health management of the elderly, community management of hypertension in the elderly has made great progress in management rate and standardized management, but the management of young and middle-aged patients with hypertension is still blank.

Workplace pressure measurement may be more suitable for most of the young and middle-aged patients to find high blood pressure and monitor blood pressure changes in time.

However, there is not much research on workplace pressure measurement. Whether blood pressure measurement in the workplace can reduce the white coat effect, and how it relates to home blood pressure and ambulatory blood pressure is still unclear.


Eligibility criteria: Inclusion Criteria:

1. Male and female sex, aged 18-65 years
2. Three different daytime workplace blood pressure measurements meet the limits: systolic blood pressure ≥ 120 mmHg, or diastolic blood pressure ≥80 mmHg
3. Hypertensive patients who are taking antihypertensive drugs
4. Willing to provide information about disease history and lifestyle
5. Willing to receive follow-up for up to 2-3 years
6. Sign the informed consent

Exclusion Criteria:

1. Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months
2. Having a history of atrial fibrillation or frequent arrhythmia
3. Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors
4. The subject is participating in other clinical studies.

Primary outcomes:
measure: Diagnostic classification in hypertension
timeFrame: 2 years
Secondary outcomes:
measure: Change in different blood pressure measurement
timeFrame: 2 years
measure: The distribution of heart rate in young and middle-aged subjects
timeFrame: 2 years
measure: Progression of target organ damage
timeFrame: 2 years
measure: The development of with-coat hypertension
timeFrame: 2 years
measure: The proportion of masked hypertension in patients with normal high blood pressure
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03019211: Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly
Official title: Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Problems
Cognitive Impairment
Elderly
Postural Balance
Strength
Keywords: Physical Therapy Modalities
Accidental Fall
Elderly
Hydrotherapy
Nursing Home
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: Sanitas Mayores Les Corts
name: Residencial Augusta Park
First posted: 2017-01-12
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized old people. The secondary objectives are to study the applicability of the intervention in improving balance, function, gait mobility, muscle strength of the lower limbs and the perception of the intervention.

Detailed description: The participants will be randomized and divided into the hydrotherapy group or the control group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of duration. The study outcomes will be measured before the intervention and in 3 posterior phases to evaluate its effects in the short, medium and long terms.

Eligibility criteria: Inclusion Criteria:

* Be institutionalized in a care center
* Participate voluntarily and sign the informed consent
* Have a punctuation of 2 or more in The Downton Fall Risk Index

Exclusion Criteria:

* Suffer from a condition that can be affected or hinder exercise
* Acute disease unresolved in 10 days
* Not controlled hypertension
* Contagious skin disorder
* Urinary or faecal incontinence

Primary outcomes:
measure: Change from baseline Number of Falls at 3 months, 6 months and 9 months
timeFrame: 3 months, 6 months, 9 months
Secondary outcomes:
measure: Balance measured with Performance Oriented Mobility Assessment
timeFrame: 3 months, 6 months, 9 months
measure: Pain measured with Visual Analogue Scale
timeFrame: 3 months, 6 months, 9 months
measure: Mobility measured with Timed Up & Go Test
timeFrame: 3 months, 6 months, 9 months
measure: Daily living activities measured with Barthel Test
timeFrame: 3 months, 6 months, 9 months
measure: Muscle strength measured with Five Sit to Stand test and Handgrip Test
timeFrame: 3 months, 6 months, 9 months
measure: Intervention Perception measured with Qualitative interview
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Ramon Llull
Study officials:
affiliation: University Ramon Llull
name: Mercè Sitjà Rabert, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05981911: Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice
Official title: a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: drug eluting stent
Percutaneous Coronary Intervention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2023-08-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Xience-Skypoint™ stents.

Brief summary: The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 19 years old
2. Patients receiving Xience-Skypoint™ stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Patients with a mixture of other DESs
2. Terminal illness with life expectancy \<1 year
3. Patients with cardiogenic shock

Primary outcomes:
measure: the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: 12 months
Secondary outcomes:
measure: the event rate of all cause death
timeFrame: 5 years
measure: the event rate of cardiac death
timeFrame: 5 years
measure: the event rate of nonfatal myocardial infarction
timeFrame: 5 years
measure: the composite event rate of death, or nonfatal myocardial infarction (MI)
timeFrame: 5 years
measure: the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)
timeFrame: 5 years
measure: the event rate of Target- Vessel Revascularization (TVR)
timeFrame: 5 years
measure: the event rate of Target- lesion Revascularization (TLR)
timeFrame: 5 years
measure: the event rate of stent thrombosis
timeFrame: 5 years
measure: the event rate of stroke
timeFrame: 5 years
measure: the event rate of Procedural success
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Hospital
Study officials:
References:
Clinical trial NCT01686711: A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322
Official title: A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 207
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
* Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

* Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
* Others who are assessed to be ineligible for the study by the investigator or subinvestigator.

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hirosaki-shi
country: Japan
state: Aomori
city: Kisaratsu-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Kurume-shi
country: Japan
state: Fukuoka
city: Fukuyama-shi
country: Japan
state: Hiroshima
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Koga-shi
country: Japan
state: Ibaraki
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Miyazaki-shi
country: Japan
state: Miyazaki
city: Suita-shi
country: Japan
state: Osaka
city: Koshigaya-shi
country: Japan
state: Saitama
city: Otsu-shi
country: Japan
state: Shiga
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Ohta-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toyama-shi
country: Japan
state: Toyama
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05865093: Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
Official title: Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visual Impairment
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 700
Sex: ALL
Minimum age (years): 2
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children at risk for visual impairment due to brain lesion, brain malformation, genetic syndroms, Hypoxic Hischemic Encephalopathy, metabolic diseases or ocular pathologies, assessed at neonatal age and followed up to 36 months of age

Brief summary: The aim of the study is to assess visual function from neonatal age to 36 months of age in infants at risk of visual impairment due to brain lesion or ocular pathology


Eligibility criteria: Inclusion Criteria:

* Age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age
* Genetic syndroms
* Hypoxic Hischemic Encephalopathy
* Brain malformation
* Metabolic diseases
* Ocular pathologies

Exclusion Criteria:

* Patients at low risk of developing neurological outcomes
* Refusal of informed consent

Primary outcomes:
measure: Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
timeFrame: 5 years
Secondary outcomes:
measure: Correlation betwwen functional visual assessment score to MRI score
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
References:
Clinical trial NCT00861393: Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI)
Official title: The Impact of a Brief Cognitive Behavior Therapy Intervention Aimed at Improving Emotional Well-Being and Quality of Life for Individuals With Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances.

Detailed description: The goal of the current proposed research project is to investigate the potential efficacy of a group cognitive behavioural therapy (CBT) intervention aimed at improving emotional well-being, specifically mood, adjustment and quality of life (QOL), after Spinal Cord Injury(SCI). The intervention will be adapted to meet the unique needs of patients suffering from an SCI. The study objectives are:

(1) to evaluate the impact of a brief CBT intervention aimed at decreasing emotional distress and improving quality of life; (2) to evaluate the sustainability of CBT therapeutic gains over time; (3) to conduct sub group analyses in order to better determine why some patients may improve post CBT, while others may not.

Eligibility criteria: Inclusion Criteria:

* between ages 18-65
* diagnosed with spinal cord injury
* currently endorsing significant distress as measured
* able to provide informed consent
* if taking psychoactive meds, on a stable dosage
* are not currently enrolled in any other psychological treatment program
* speak basic english with no diagnosis of communication disorder

Exclusion Criteria:

* they endorse current suicidal ideation
* have a Neurodegenerative disorder such as Multiple Sclerosis

Primary outcomes:
measure: Symptom checklist -90-R (SCL-90-R) Depression Anxiety Stress Scales (DASS-21) Personality Assessment Inventory (PAI) PAI measure a broad range of psychological symptoms and personality characteristics.
timeFrame: one year
Secondary outcomes:
measure: The Ways of Coping Scale- Revised (WOC-R) Community Integration Questionnaire (CIQ) Satisfaction with Life Scale (SWLS) Life satisfaction Checklist (LiSat-11) Stage of change Scales (SOC)
timeFrame: one year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute (Lyndhurst Center)
state: Ontario
Study officials:
References: