louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02470962: Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy
Official title: Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne / Becker Muscular Dystrophy
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 59
Sex: MALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
* Control group for CMR: children without heart disease

Brief summary: This study evaluates the function of the heart in young patients with muscular dystrophy type Duchenne or Becker. Participants have their hearts examined at regular intervals by ultrasound (echocardiography) and cardiac magnetic resonance imaging.

Detailed description: Muscular dystrophy leads to progressive loss of function in all muscles during childhood and adolescence, including the heart. The usual method to evaluate the heart is echocardiography, emphasizing few parameters. Cardiac magnetic resonance imaging is not as widely available as echocardiography, but early changes can be detected before they become visible on echocardiography. In this study, the investigators compare the methods of measuring heart function in order to find the best measurements for follow up and to see how fast the degenerative changes occur in the hearts of patients with muscular dystrophy.

Eligibility criteria: Inclusion Criteria:

* Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
* Informed consent

Exclusion Criteria:

* Other clinically significant concomitant disease states (e.g., renal failure)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or his/her parents or legal caregivers,
* Inability to lie still for the duration of the imaging procedures (approximately 45 minutes each for echocardiography and CMR)
* MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 3 years per patient
Secondary outcomes:
measure: Quantification of fibrosis by LGE/T1 mapping
timeFrame: 3 years per patient
measure: NT-proBNP
timeFrame: 3 years per patient
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Children's Hospital
state: ZH
Study officials:
affiliation: Children's Hospital Zürich, Switzerland
name: Barbara EU Burkhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00675662: Trim Tots Pre-school Obesity Prevention Programme
Official title: TrimTots Pre-school Obesity Prevention Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Obesity
overweight
BMI
ifestyle
diet
nutrition
physical activity
pre-school
toddlers
children
Prevention of overweight and obesity in pre-school children
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 173
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.


Eligibility criteria: Inclusion Criteria:

* Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.

Primary outcomes:
measure: Body Mass index
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular (CV) disease risk factors
timeFrame: 12 months
measure: Physical activity (accelerometry)
timeFrame: 12 months
measure: Motor co-ordination (ABC battery).
timeFrame: 12 months
measure: Motor co-ordination (ABC battery). Behaviour (general and dietary).
timeFrame: 12 months
measure: CV fitness (heart rate variability).
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Child Health, 30 Guilford Street
Study officials:
affiliation: Institute of Child Health
name: Julie Lanigan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Summerbell CD, Waters E, Edmunds LD, Kelly S, Brown T, Campbell KJ. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001871. doi: 10.1002/14651858.CD001871.pub2.
citation: Flynn MA, McNeil DA, Maloff B, Mutasingwa D, Wu M, Ford C, Tough SC. Reducing obesity and related chronic disease risk in children and youth: a synthesis of evidence with 'best practice' recommendations. Obes Rev. 2006 Feb;7 Suppl 1:7-66. doi: 10.1111/j.1467-789X.2006.00242.x.
Clinical trial NCT01116362: Comparing Primary With Secondary Repair of Based on Electrodiagnostic Assessment and Clinical Examination
Official title: Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Nerve Injury
Keywords: ulna
median
repair
primary
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.

Detailed description: Treatment of injuries to major nerve trunks in the hand and upper extremity remains a major and challenging reconstructive problem. Our goal was to compare primary versus secondary repair of median and\\or ulnar nerve by electrodiagnostic assessment and clinical examination.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria:

* crush injuries

Primary outcomes:
measure: motor function
timeFrame: at 18 months post-operatively
Secondary outcomes:
measure: sensory recovery
timeFrame: at 18 months post-operatively
measure: nerve conduction velocity
timeFrame: at 18 months post-operatively
measure: electromyography
timeFrame: at 18 months post-operatively
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01720862: Migraine and Body Composition
Official title: Migraine and Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine With and Without Aura
Chronic Migraine
Healthy Controls
Keywords: migraine
episodic migraine
chronic migraine
obesity
non-obese
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal Caucasian women ages 18-55 years with or without migraine.

Brief summary: This research is being done to look at the association between migraine and obesity.

Detailed description: Research into the role of inflammatory markers and other obesity related proteins and chemicals may help us understand migraine and lead to new treatment.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women (18-55 years)
* Normal weight (BMI = 18.5 - 24.9) or obese (BMI ≥ 30)
* Diagnosis of episodic or chronic migraine or pain free control

Exclusion Criteria:

* Evidence of pain disorder other than migraine (e.g. irritable bowel syndrome)
* Chronic conditions known to alter risk or pattern of migraine (e.g. hypothyroidism)
* Illnesses that may affect adipokine levels (e.g. diabetes)
* Clinically relevant abnormal glucose/cholesterol levels
* Pregnant women
* Potential participants who are unable to undergo MRI based on standard screening questionnaire (those with brain aneurysm or surgical clips, certain types of artificial heart valves, heart defibrillator or pacemaker, cochlear implants, eye implants, blood vessel coil, recently placed artificial joints, certain types of vascular stents, history of bullets, pellets, BBs, history of any implanted metal or device or who have worked with sheet metal in the past)

Primary outcomes:
measure: association between migraine and obesity - evaluate serum adipokine levels
timeFrame: 5 years
Secondary outcomes:
measure: association between migraine and obesity -evaluate subcutaneous adipose tissue (SAT) and its ratio to visceral adipose tissue (VAT)
timeFrame: five years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Bayview Headache Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Barbara L Peterlin, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03002662: Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopy
Colonoscopy
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are cases of distant referral to the gastroenterology surgeon's polyclinic and indications for colonoscopy.

Brief summary: During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define.


Eligibility criteria: Inclusion Criteria:

1. Above 18

Exclusion Criteria:

1. Bad bowel preparation
2. Failure of cecum intubation
3. Inflammatory bowel disease
4. Colectomy story

Primary outcomes:
measure: Body mass index (kg/m2)
timeFrame: 12/01/2016- 05/01/2017
measure: waist circumference (centimeter)
timeFrame: 12/01/2016- 05/01/2017
measure: waist / hip ratio
timeFrame: 12/01/2016- 05/01/2017
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Eagle Run High Special Education and Research Hospital
Study officials:
References:
Clinical trial NCT00228462: Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Official title: A 1-year, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo (Abbreviated)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 197
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: This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.


Eligibility criteria: Inclusion Criteria:

* Stable schizophrenic patients who have provided written informed consent
* Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine).

Exclusion Criteria:

* Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate,
* Expected non-compliance to treatment
* Known diabetes mellitus,
* Contraindications,
* Intolerance or non-responsiveness to Seroquel or other safety issues.

Primary outcomes:
measure: The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
Secondary outcomes:
measure: To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Investigative Site
city: Radnevo
country: Bulgaria
facility: Investigative Site
city: Sofia
country: Bulgaria
facility: Investigative Site
city: Bydgoszcz
country: Poland
facility: Investigative Site
city: Tuszyn
country: Poland
facility: Investigative Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00427362: A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)
Official title: A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who have had an unsatisfactory response or intolerance to prior or ongoing DMARDs


Eligibility criteria: Inclusion Criteria:

* Active psoriatic arthritis defined by \>= 3 tender or painful joints and \>= 3 swollen joints despite standard psoriatic arthritis therapy
* Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate)

Exclusion Criteria:

* Has a history of cancer or other than certain skin or cervical cancers
* Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc.
* Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk
* History of active tuberculosis, history of histoplasmosis or listeriosis
* Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment

Primary outcomes:
measure: ACR20 response
timeFrame: Week 12
Secondary outcomes:
measure: ACR50
timeFrame: Week 12
measure: ACR70
timeFrame: Week 12
measure: PsARC
timeFrame: Week 12
measure: DAS28
timeFrame: Week 12
measure: PASI50/75
timeFrame: Week 12
measure: HAQ-DI
timeFrame: Week 12
measure: PsAQoL
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Benoit Guerette, PhD
role: STUDY_DIRECTOR
References:
citation: Gladman DD; ACCLAIM Study Investigators; Sampalis JS, Illouz O, Guerette B. Responses to adalimumab in patients with active psoriatic arthritis who have not adequately responded to prior therapy: effectiveness and safety results from an open-label study. J Rheumatol. 2010 Sep;37(9):1898-906. doi: 10.3899/jrheum.100069. Epub 2010 Jul 1.
Clinical trial NCT02350062: Comparison of Two Neuromuscular Monitors
Official title: Comparison of Two Neuromuscular Monitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Monitoring
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Brief summary: Different neuromuscular monitors may be available in the same care structure. Two different monitors are available in the investigators' institution in the operative room and the recovery room. However, these two monitors have not been compared and may not be interchangeable. Starting the monitoring with one device and continuing with another device may be inaccurate and may lead to inadequate medical decisions. The investigators therefore conducted this observational study to compare the two devices available in our institution.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Exclusion Criteria:

* Pregnancy or feeding
* Any pathology or medication that may impair neuromuscular conduction or muscular response of the ulnar nerve stimulation
* American Society of Anesthesiology \[4\] physical status
* Allergy or contraindication of neuromuscular blocking agents

Primary outcomes:
measure: Time to recover T4/T1 > 90%
timeFrame: Time between muscle relaxant injection and: intubation; recovery of 4 responses on the train of four (TOF); recovery of T4/T1 >40%; recovery of T4/T1>90% average 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Georges Daccache, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747162: Muscle Oxygenation and Skin Pigmentation
Official title: Correlation Between Muscle Oxygenation and Skin Pigmentation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Muscle Oxygenation
Skin Pigmentation
Keywords: Compartment Syndrome
Muscle Oxygenation
Skin Pigmentation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean arterial pressure (MAP) at time of measurements. Additional information including diseases such as diabetes and vascular disorders will be recorded. Social demographics including alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could also contribute to cardiovascular diseases. The skin pigmentation of each subject will be recorded. Two different methods will be used for this measurement. Each patient will be graded on a six point scale as described by Young (Young, 1997). Additionally, each subject will have their skin measured using a reflectance colorimeter. The colorimeter, DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of light reflected off the skin. By measuring the light reflectance, the skin pigmentation can be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual wavelength near infrared spectrometer. Using the different absorption characteristics of deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI) will be used for all measurements.


Eligibility criteria: Inclusion Criteria:

* Male or Female between the ages of 18 and 75 years old
* Subjects that have no lower extremity injuries.
* Subject who are classified as being either light or dark skin pigmentation.
* Subjects willing to participate in the study.

Exclusion Criteria:

* Patients with previous injury to either lower extremity
* Patients with previously diagnosed vascular disease or insufficiency
* Patients with pulmonary insufficiency or severe pulmonary injury
* Patients not willing to consent to participate

Primary outcomes:
measure: Measure from The INVOS cerebral oximeter and DermaSpectrometer
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Healthcare System
state: Georgia
Study officials:
affiliation: Emory University, Department of Orthopaedics
name: Thomas J. Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745962: Thin EBUS Pilot Study
Official title: Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung; Node
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Olympus Medical Systems Corp., Tokyo, Japan.
First posted: 2021-02-09
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients who are scheduled for standard of care assessment of central pulmonary nodules.

Brief summary: This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide informed consent.
2. \>21 years of age or older.
3. Target lesion(s) within the middle third of the lung, which will be determined radiographically prior to scheduling the procedure by the bronchoscopist or radiologist, or by being located at least 2 airway generations from the main carina as seen radiographically.
4. Target lesion(s) location documented on CT scan report.
5. Indicated for bronchosocpy.
6. Bronchoscopic procedure scheduled within 30 days of the CT scan report.

Exclusion Criteria:

1. Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
2. Currently on anticoagulation medications with INR \>1.5.
3. Currently using DOAC and does not suspend use at least 7 days prior to the index procedure
4. Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.

Primary outcomes:
measure: Ability to visualize lung nodule
timeFrame: Throughout the procedure (approximately 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: The Medical University of South Carolina
name: Nicholas J Pastis, MD
role: PRINCIPAL_INVESTIGATOR
References: