louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01538524: Analysis of Patient Seeking Second Opinion Who Are Undergoing Full Mouth Orthodontic Treatment
Official title: Analysis of Patient Seeking Second Opinion Who Undergoing Full Mouth Orthodontic Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malocclusion
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are not under full mouth fixed orthodontic treatment in National Taiwan University Hospital

Brief summary: Patient safety is a great concern for the whole society. Since the investigators have a leadership in the medical field in Taiwan, the investigators should be courageous to face the reality from the patients seeking second opinions undergoing orthodontic treatment.

Orthodontics just became a recognized specialty by the Department of Health in Taiwan in 2009. It is just a beginning to set up the training course criteria at the national level. It will be a good timing for us to look at the treatment quality when patients seeking second opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or a simple communication problem, depend on a good systemic analysis from the records and questionnaire collected in a timely fashion.

The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment and seeking second opinion to join this study. The investigators will thoroughly explain to patients before they agree to take records and fill in questionnaire. Then the investigators use these records to perform root cause analysis.

Our hypothesis is that the risk of adverse event (AE) is related to the training quality, communication skills, patient's understanding and compliance. From these results, the investigators shall be able to assess the risk of AE and make the education policy either at continued education level or special training courses towards a patient satisfied treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who are not under full mouth fixed orthodontic treatment in National Taiwan University Hospital

Exclusion Criteria:

* Patient who only had partial orthodontic treatment
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Pi-Huei Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01169324: Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders
Official title: Effect of DBS on Sleep Architecture in Patients With Movement Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Tremor
Dystonia
Keywords: Parkinson's disease
Tremor
Dystonia
DBS
Sleep
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.


Eligibility criteria: Inclusion Criteria:

* Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
* Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
* Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score \>5) at the subject's baseline pre-surgical evaluation.

Exclusion Criteria:

* Known narcolepsy
* Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
* Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 1 month
Secondary outcomes:
measure: Wake after sleep onset (WASO)
timeFrame: 1 month
measure: Total Sleep Time
timeFrame: 1 month
measure: Two timed motor tasks
timeFrame: 1 month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB Neurology
name: Amy W Amara, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01980524: The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes
Official title: HYPOglycemia Linked to Cardiac sTEatoSIS? - Identifying Mechanisms That Explain Adverse Cardiovascular Outcome Associated With Intensive Glucose Control in Patients With Diabetes (HYPOTESIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation.

Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* HbA1C \>6%

Exclusion Criteria:

* Insulin therapy (except: BOT=basal supported oral therapy)
* Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery
* Known intolerance against niacins
* Known contra-indications against magnetic resonance (MR-) examinations

Primary outcomes:
measure: MYCL
timeFrame: 180 minutes
Secondary outcomes:
measure: Ejection Fraction
timeFrame: 180 minutes
Other outcomes:
measure: Stroke Volume
timeFrame: 180 minutes
Locations:
city: Vienna
country: Austria
facility: Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Dept. of Internal Medicine III, Division of Endocrinology and Metabolism
name: Michael Krebs, Prof.MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822224: Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia
Official title: Use of MEOPA for Elderly With Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: acute pain
MEOPA
Dementia
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2009-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring.

MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers.

In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.


Eligibility criteria: Inclusion Criteria:

* dementia (Folstein scoring between 0 and 25)
* older than 75
* health necessitating of painful care for example eschar care

Exclusion Criteria:

* bullous emphysema
* pneumothorax

Primary outcomes:
measure: feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation
timeFrame: one time, at the first care with MEOPA
Secondary outcomes:
measure: satisfaction rate of patient
timeFrame: one time, at the first care with MEOPA
Other outcomes:
Locations:
city: Nice
country: France
facility: Gerontology department, Nice University Hospital
Study officials:
affiliation: Gerontology department, Nice University Hospital
name: Françoise CAPRIZ-RIBIERE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419924: Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Official title: Proof of Concept: A Commode Assist Device for Excessive Perineal Descent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation Aggravated
Pelvic Floor; Incompetency
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as "the Bottom's Up".

Detailed description: Efficacy and safety of a unique pelvic floor support device that fits into the Radiology defecography commode will be tested. Patients with refractory constipation due to known pelvic floor laxity and/or excessive perineal descent will be examined without, then with the device in place. Patients will complete questionnaires pertaining to device safety and efficacy before and after using the device. Radiographic images to document efficacy of support plus adequate emptying will be acquired during the study resulting in very low dose radiation exposure.

Eligibility criteria: 10 Males and female subjects greater that 18 years of age with aggravated constipation due to pelvic floor laxity of at least 4 cm and excessive perineal descent of at least 4 cm will be evaluated.

Patients with constipation but no excessive laxity or descent will not be evaluated. Patients must be willing to sign consent, undergo defecography with and without "The Bottom's Up" device.

Primary outcomes:
measure: Adverse Events
timeFrame: through study completion, approximately one day
Secondary outcomes:
measure: Sense of Staining
timeFrame: post-defecography test, approximately 1 day
measure: Ease of Evacuation
timeFrame: post-defecography test, approximately 1 day
measure: Completeness of Evacuation
timeFrame: post-defecography test, approximately 1 day
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Amy Foxx-Orenstein, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04187924: Effects of SIMEOX on Airway Clearance in Cystic Fibrosis
Official title: Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage.

This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis.

Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.


Eligibility criteria: Inclusion Criteria:

* Adults with cystic fibrosis
* Chronic bronchorrhea, able to expectorate by themselves
* Hospitalized

Exclusion Criteria:

* Regular use of SIMEOX,
* Difficulties in understanding instructions,
* Severe cardiac comorbidity.

Primary outcomes:
measure: Amount of sputum secretion
timeFrame: 30-min
measure: Mucus viscoelasticity
timeFrame: 30-min
measure: Subjective feeling of ease to expectorate
timeFrame: 3-min
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels Capital
Study officials:
References:
Clinical trial NCT06006624: Exparel vs Block for ACL Reconstruction
Official title: Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: ACL
Postoperative Pain
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.


Eligibility criteria: Inclusion Criteria:

* Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
* Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
* Age 18 and older
* English speaking
* Ability to complete surveys by phone or in person
* Ability to provide informed consent

Exclusion Criteria:

* Revision cases
* Multi-ligamentous knee injuries
* Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
* ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
* Allergies to study medications
* Non-English speakers
* Known alcohol or narcotic abuse history
* Existing contract with a pain specialist due to underlying preoperative pain syndrome
* Preoperative opioid use within the 3 months prior to surgery

Primary outcomes:
measure: Postoperative Pain
timeFrame: 14 days
measure: Postoperative opioid use
timeFrame: 14 days
measure: Postoperative Pain #2
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00300924: A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
Official title: A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Diamond Headache Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-03-10
Enrollment: 200
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 purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject has at least a 6 month history of migraine, with or without aura
* Subject can distinguish between migraine attacks and other types of headaches
* Subject of childbearing potential agrees to use adequate contraception

Exclusion Criteria:

* Subject typically has fewer than 1 or greater than 6 migraine attacks per month
* Subject typically has greater than 10 headache days per month
* Subject has evidence of ischemic heart disease
* Subject has uncontrolled high blood pressure
* Subject has a history, within 1 year, or current evidence of drug or alcohol abuse

\*This list is not all inclusive\*

Primary outcomes:
measure: To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
Secondary outcomes:
measure: 24 hour sustained pain relief
measure: Pain relief at 30, 45,60,90 minutes and 4 hours post dose
measure: Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
measure: 24 sustained pain freedom
measure: Associated symptoms of phonophobia, photophobia, nausea and vomiting
measure: Functional disability
measure: Use of rescue medication
measure: Self-reported adverse experiences
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SanFrancisco Headache Clinic
state: California
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Mount Vernon
country: United States
facility: Elkind Headache Center
state: New York
city: West Chester
country: United States
facility: ClinExcel
state: Ohio
Study officials:
affiliation: Diamond Headache Clinic
name: Merle Diamond, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03848624: CUHK Jockey Club HOPE 4 Care Programme - FES Bike
Official title: CUHK Jockey Club HOPE 4 Care Programme - Interactive FES Cycling System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
First posted: 2019-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community.

Our research team had developed the "Interactive FES Cycling System" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. The system can integrate both motor power and muscle power in order to facilitate an active rehabilitative exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
* Significant gait deficit (Functional Ambulatory Category, FAC\<4 \[person cannot walk independently\]).

Exclusion Criteria:

* Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
* Severe hip, knee or ankle contracture that would preclude passive range of motion of the leg (MAS\<3).

Primary outcomes:
measure: Fugl-Meyer Assessment for Lower-Extremity
timeFrame: Three months after the last training session
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: Three months after the last training session
measure: Timed 10-meter Walk Test
timeFrame: Three months after the last training session
measure: Berg Balance Scale
timeFrame: Three months after the last training session
measure: Modified Ashworth Scale
timeFrame: Three months after the last training session
measure: Functional Ambulation Category Test
timeFrame: Three months after the last training session
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Raymond Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References: