louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03665220: Effects of Two Home Ergonomics Programmes in Post-stroke Patients
Official title: Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Quality of Life
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 34
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 main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.

Detailed description: For post-stroke patients, rehabilitation must address different aspects. When the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. Physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. In this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group.

Eligibility criteria: Inclusion Criteria:

* stroke diagnosed 6-24 months previously
* aged over 18 years
* ability to speak and understand Portuguese.

Exclusion Criteria:

* severe cognitive deficit
* severe aphasia
* other associated neurological disease
* musculoskeletal pathology
* drug or alcohol abuse.

Primary outcomes:
measure: Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
timeFrame: Twelve weeks
measure: Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks
timeFrame: Twenty four weeks
Secondary outcomes:
measure: Change from the Older Americans Resources and Services (OARS) scale at 12 weeks
timeFrame: Twelve weeks
measure: Change from the Older Americans Resources and Services (OARS) scale at 24 weeks
timeFrame: Twenty four weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: José Manuel Pérez Mármol
Study officials:
affiliation: Department of Physiotherapy. Faculty of Health Sciences, University of Granada
name: José Manuel Pérez Mármol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425320: Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 0
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 will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Moderate acne on the face
* Willing to avoid swimming during the study
* Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study
* Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study

Exclusion Criteria:

* Severe cystic acne
* Use of topical or oral retinoids within 4 weeks
* Use of isotretinoin within 3 months
* Use of dapsone or adapalene within 3 months
* Anticipated need to engage in activities/exercise that would cause profuse sweating
* Donated blood or equivalent blood loss within 90 days

Primary outcomes:
measure: Plasma Levels of Dapsone
timeFrame: Day 1
measure: Plasma Levels of Dapsone
timeFrame: Day 14
measure: Plasma Levels of Adapalene
timeFrame: Day 1
measure: Plasma Levels of Adapalene
timeFrame: Day 14
Secondary outcomes:
measure: Local Dermal Tolerability Rating Using a 4-Point Scale
timeFrame: Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03075020: Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.
Official title: Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

Detailed description: To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

With transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Smoking
* Primary relatives with current or previous migraine

Primary outcomes:
measure: Headache scores, 12 hours
timeFrame: 12 hours
Secondary outcomes:
measure: Facial blood flow
timeFrame: [ Time Frame: 0-180 min ]
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
Clinical trial NCT03112720: Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache
Official title: A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postdural Puncture Headache
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: New Jersey Medical School
First posted: 2017-04-13
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

Detailed description: The sphenopalatine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalatine nerve block will help the patient with the headache.

Eligibility criteria: Inclusion Criteria:

* Males and females ages 13-92
* Subjects have medical diagnosis of PDPH and require treatment
* Subjects who signed consent/assent

Exclusion Criteria:

* \<13 years of age
* Pregnancy
* Subjects with heart failure
* Subjects already being treated with lidocaine patch or other vehicle for chronic pain
* Non-english speaking subjects
* Subjects with platelets \<100,000
* Subjects that are septic
* Subjects with an allergy to lidocaine
* Subjects with known nasal polyps
* Subjects with recent neurological event
* Subjects on anticoagulant therapy
* Subjects that received prior therapy with SPG block or EBP

Primary outcomes:
measure: Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy
timeFrame: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
measure: Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy.
timeFrame: At 30 minutes following either therapy.
measure: Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy.
timeFrame: At 60 minutes following either therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: New Jersey Pain Center
state: New Jersey
city: New Brunswick
country: United States
facility: RWJUH/Barnabus
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: William Grubb, DDS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03314220: The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers
Official title: The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Who Underwent Minor Surgery
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to accomplish the following objectives:

1. Develop a family-centered preoperative preparation program.
2. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.


Eligibility criteria: Inclusion Criteria:

* aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.

Exclusion Criteria:

* Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.

Primary outcomes:
measure: Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
timeFrame: before the operative day
measure: Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
timeFrame: the morning in the day of surgery
measure: Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
timeFrame: at induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04356820: The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
Official title: The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anxiety Acute
Keywords: acupressure,
nursing
music
gynecological examination
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 156
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.


Eligibility criteria: Inclusion Criteria:

* - not to be pregnant,
* no hearing problems
* Being between the ages of 19 and 65, Not having any psychiatric illness,
* No gynecological cancer, Not to have any deformity in her extremities

Exclusion Criteria:

-

Primary outcomes:
measure: questionnaire and scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Didem Simsek Kucukkelepce
Study officials:
References:
Clinical trial NCT00937820: Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism
Official title: YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: YM150
Bleeding
VTE
FXa inhibitor
Venous thromboembolism
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.


Eligibility criteria: Inclusion Criteria:

* Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
* Written informed consent obtained before screening

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an acute bacterial endocarditis
* Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
* Subject is receiving anticoagulants/antiplatelet agents
* Subject has a body weight less than 40 kg

Primary outcomes:
measure: Joint incidence of deep vein thromboembolism or pulmonary thromboembolism
timeFrame: 52 weeks
Secondary outcomes:
measure: Incidence of each thromboembolism
timeFrame: 52 weeks
measure: All cause mortality
timeFrame: 52 weeks
measure: Incidence of bleeding event
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03579420: Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program
Official title: Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare two different programs for lifestyle intervention in type 2 diabetes:

1. A brief group program, with three weekly sessions
2. A longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years.

The aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1c between 48 and 75 mmol/mol

Exclusion Criteria:

* Axis I Mental Disorders
* Heart failure (NYHA Class III or IV)
* Foot ulcers or lower limb amputations

Primary outcomes:
measure: HbA1c at 6 months
timeFrame: 6 months
measure: Treatment success at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Treatment success at 24 months
timeFrame: 24 months
measure: HbA1c at 24 months
timeFrame: 24 months
measure: MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores
timeFrame: 24 months
measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores
timeFrame: 24 months
measure: Well-being Enquiry in Diabetics (WED) questionnaire total score
timeFrame: 24 months
measure: Body Mass Index
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
measure: Body Mass Index
timeFrame: 24 months
measure: Waist circumference
timeFrame: 24 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Diabetologia AOU Careggi
Study officials:
References:
Clinical trial NCT05199220: Epidemiology of Injuries During Crossfit Practice
Official title: Epidemiology of Injuries During Crossfit Practice : a Prospective Cohort Study at Reunion Island
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sport Injury
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult who practices crosffit must be included in Reunion Island

Brief summary: This study aims to precisely describe epidemiology of injuries than occur during practice of crossfit. Each participant will complete questionnaires in order to identify injuries. The first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.


Eligibility criteria: Inclusion Criteria:

* person affiliated to a crossfit structure at Reunion Island at the beginning of the study
* personne who agrees to participate in the study

Exclusion Criteria:

* person under tutorship or curatorship,
* person whose the initial questionnaire initial is complete,
* person who can neither read nor write french.
* person planning to leave Reunion Island within 12 months after enrolment in the study

Primary outcomes:
measure: Location of injury by questionnaire
timeFrame: at month 3
measure: laterality of injury by questionnaire
timeFrame: at month 3
measure: mechanism of injury by questionnaire
timeFrame: at month 3
measure: circumstance of injury occurence by questionnaire
timeFrame: at month 3
measure: injury relapse or not
timeFrame: at month 3
measure: diagnosis of injury
timeFrame: at month 3
measure: record of exposure to injury
timeFrame: at month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Pierre
country: Réunion
facility: Crosffit Structure
Study officials:
References:
Clinical trial NCT06210620: Pro APP Prosthetic Outcome Registry
Official title: Prospective, Observational Registry to Collect Standard of Care Clinical Testing Data From Lower-limb Prosthesis Patients Via the PRO App.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation
Keywords: Registry
Lead sponsor: Össur Iceland ehf
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing lower limb prosthetic treatment with their prescribed devices, such as a new fitting, alignment, or replacement of a previous prosthesis.

Brief summary: A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.

Detailed description: This US national patient and outcome registry will provide demographic information on lower-limb prosthesis users and their real-world clinical outcomes. The intent is to collect data from multiple certified O\&P clinics that have access to use the digital data collection tool PRO App (https://www.ossur.com/en-us/professionals/PRO App). Any patient undergoing prosthetic treatment with their prescribed devices (such as a new fitting, alignment, or replacement of a previous prosthesis) at the investigational sites will be offered to provide data to the registry. Data collection will be a part of the standard of care and is entered by the participating prosthetists, physicians, physical therapists, or other designated staff during clinic/service visits. Data already entered into the PRO App system may also be collected into the registry if the participant consents. This registry will recruit patients who meet the inclusion criteria. Participation is fully voluntary. After the enrollment, all participants would be evaluated during follow-up visits as demanded by their standard of care.

Exploratory analyses may be implemented, utilizing the already collected data, to investigate specific populations and their outcomes depending on the enrollment of said population groups. As an example; data will be collected from the registry to stratify two demographically matching groups of prosthetic users using a powered knee and a non-powered knee.

Eligibility criteria: Inclusion Criteria:

Cognitive ability to understand all instructions and questionnaires in the study Willing and able to participate in the study and follow the protocol Individuals with lower limb loss, amputation or deficiency

Exclusion Criteria:

None

Primary outcomes:
measure: Provide data on patient characteristics
timeFrame: 10 years
Secondary outcomes:
measure: Provide data on device performance
timeFrame: 10 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Össur Americas
state: California
Study officials:
References: