louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04512859: Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Official title: Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Cerebral Vasospasm
Keywords: Stellate Ganglion Block
Subarachnoid Hemorrhage
Cerebral Vasospasm
Transcranial Doppler Ultrasonography
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 160
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: PREVENTION

Brief summary: To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).


Eligibility criteria: Inclusion Criteria:

* 1.Emergency patients with subarachnoid hemorrhage caused by ruptured aneurysm, aged 18-65 years; 2. ASA : II-IV grade, Hunt-Hess : I-III grade 3. For the first case, the operation time is within 24 hours. 4.After signing informed consent, underwent interventional intravascular embolization

Exclusion Criteria:

* 1. Patients with severe bleeding disorders; 2. Patients with trauma and local infection risk in the nerve block area; 3. Patients with previous aneurysm surgery and unruptured aneurysm; 4. Aneurysm located in middle cerebral artery; 5. Patients with unconsciousness cannot cooperate with the block operation; 6. Those with a history of mental illness and epilepsy; 7. Those who have a history of severe cardiovascular and cerebrovascular diseases and severe organ diseases;

Primary outcomes:
measure: The incidence of cerebral vasospasm
timeFrame: Change from baseline at 5day,after subarachnoid hemorrhage
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00312559: The Therapeutics Effects of Yoga in Individuals With Parkinson's Disease
Official title: The Therapeutic Effects of Yoga in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2006-04-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease

Detailed description: This pilot study is a randomized controlled study of 20-30 individuals with Parkinson's disease will have a control group with no training and a research group with yoga training. The control group will have the opportunity to attend yoga training of the same intensity after the study is completed. The effects of yoga will not be on the control group. Data on physical function will be derived from assessments including strength, balance, flexibility, ROM. gait, posture and functional analysis performed in the Georgia Holland Cardiopulmonary and Neuromuscular Research Lab. Questionnaires related to quality of life, depression and falls will determine psychological impact or yoga training. Vital signs, pulmonary function tests and blood draws will be done in the General Clinical research Center (GCRC) and protein analysis will be done in the diabetes research lab.

Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease
* Stage 1-3 Hoehn \& Yahr

Exclusion Criteria:

* Decline in immune function
* 6 month joint surgery
* spinal fusions
* decline in mental status measured by Folstein Mini Mental Status Exam

Primary outcomes:
measure: Pulmonary function test, serum protein levels BP, HR, RR, strength testing using microFET, flexibility and range of motion testing using goniometer, balance/posture gait optitrk system, Berg balance scale
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale
measure: Hoehn & Yahr Classification Scale
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Yvonne Searls, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745159: Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
Official title: Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate/Severe Atopic Dermatitis
Keywords: tacrolimus
Protopic
pediatric
atopic dermatitis
China
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 125
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.

Detailed description: This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as AD according to Williams diagnostic criteria.
2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
3. At least approximately 10 % of body area
4. Patient is able to reach the centre within 3 days in case of a disease exacerbation.
5. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well

Primary outcomes:
measure: Time to first DE (disease exacerbation)
timeFrame: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
Secondary outcomes:
measure: Number of DEs during the DCP
timeFrame: 6 months of DCP (Disease Control Period)
measure: Eczema Area and Severity Index (EASI)
timeFrame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
measure: Investigator's Global Assessment (IGA)
timeFrame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
measure: Duration of DE during DCP
timeFrame: 6 months of DCP (Disease Control Period)
measure: The overall efficacy during OLP
timeFrame: After 2 to 6 weeks of OLP (Open Label Period)
measure: Quantity of tacrolimus ointment used
timeFrame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
measure: Incidence of adverse events
timeFrame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Other outcomes:
Locations:
city: Beijing
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03883659: Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Official title: Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Keywords: frozen shoulder
smartphone
home exercise program
range of motion
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts.

Detailed description: This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts. The outcome measure including shoulder range of motion, pain condition, home exercise adherence and satisfaction of smartphone program

Eligibility criteria: Inclusion Criteria:

* gradual shoulder pain and stiffness at least 4 months
* loss of active and passive shoulder mobility, shoulder external rotation \<45 degree
* ability to use the smartphone

Exclusion Criteria:

* normal shoulder mobility
* diagnostic shoulder osteoarthritis
* nerve pain
* injection of corticosteroids in 3 months

Primary outcomes:
measure: home exercise adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: shoulder range of motion
timeFrame: baseline, 4 weeks
measure: Visual analog scale (VAS)
timeFrame: baseline, 4 weeks
measure: System usability scale (SUS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Neihu District
city: Taipei
country: Taiwan
facility: Yang Ming university
Study officials:
affiliation: Principal Investigator
name: Wen-Hsu Sung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06013059: A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement
Official title: A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disc Disorder
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.


Eligibility criteria: Inclusion Criteria:

* Patients with TMJ internal derangement Wilkes III

Exclusion Criteria:

1. Medically unfit patients.
2. Patients with TMDs secondary to malocclusion.
3. Psychological instability.
4. Patients operated before for other TMJ problems.

Primary outcomes:
measure: Mouth opening measurement
timeFrame: 1, 3 and 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: Mohamed Fayad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839759: Hearing Aid Education and Adaptation System
Official title: Interactive Technology for Hearing Aid Education and Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing loss
Presbycusis
Aging
Teleaudiology
Lead sponsor: Healthcare Technologies and Methods, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-07-21
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.

Detailed description: HTM will develop the "TELLYHealth (tm) system" that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.

Eligibility criteria: Inclusion Criteria:

* Speaks and reads English fluently
* Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss
* Will be fitted with one or two hearing aids at the time of enrollment
* Owns a standard TV
* Has Internet access at home
* Has sufficient corrected vision to watch videos and read text on the TV and mobile device
* No signs of dementia

Exclusion Criteria:

* Lives with person who has enrolled in the study

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Communication Scale for Older Adults (CSOA)
timeFrame: 8-12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Clear Sound Audiology
state: Florida
city: Rockville
country: United States
facility: Potomac Audiology
state: Maryland
Study officials:
affiliation: Healthcare Technologies and Methods, LLC
name: Alan M Letzt, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02217059: Emergency Department Home Blood Pressure Monitoring and BpTRU Study
Official title: Congruence of Emergency Department Attendings' Predictions of Hypertension With Results of Home Blood Pressure Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Emergency Medical Services
Emergency Care
Hypertension
BpTRU
Blood pressure
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency Department

Brief summary: The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.

Detailed description: Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring \& evaluate reliability of ED measured elevated blood pressure compared to the BpTRU

Eligibility criteria: Inclusion Criteria:

* One elevated blood pressure greater than 120 systolic and/or 80 diastolic
* BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED

Exclusion Criteria:

* Prior history of hypertension
* Currently on antihypertensives or receiving prescription on discharge
* Pregnancy
* History of atrial fibrillation
* Dialysis patient
* Nursing home or rehabilitation center resident
* Admitted
* Moving out of the area in next 30 days
* Substance abuse
* Prisoner
* Presenting for psychiatric complaint requiring constant observation
* Inability to give informed consent (intoxicated, altered, non-English speaking)
* Presenting with symptoms of hypertensive emergency
* Inability to demonstrate adequate use of the home blood pressure device in the ED
* Arm circumference less than 9 inches or greater than 17 inches

Primary outcomes:
measure: The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.
timeFrame: 18 months
Secondary outcomes:
measure: The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up
timeFrame: 18 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT03003559: HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation
Official title: Comparison of High Flow Nasal Cannula vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Keywords: COPD Exacerbation
High Flow Oxygen
Nasal Cannula
mild
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Detailed description: For AECOPD patients, most of patients don't need respiratory support, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Eligibility criteria: Inclusion Criteria:

* AECOPD; pH≥7.35, PaCO2\>45 mmHg

Exclusion Criteria:

* Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

Primary outcomes:
measure: endotracheal intubation demand rate
timeFrame: 90days
Secondary outcomes:
measure: actual endotracheal intubation rate
timeFrame: 90days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Qingyuan Zhan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xia J, Gu S, Lei W, Zhang J, Wei H, Liu C, Zhang H, Lu R, Zhang L, Jiang M, Hu C, Cheng Z, Wei C, Chen Y, Lu F, Chen M, Bi H, Liu H, Yan C, Teng H, Yang Y, Liang C, Ge Y, Hou P, Liu J, Gao W, Zhang Y, Feng Y, Tao C, Huang X, Pan P, Luo H, Yun C, Zhan Q. High-flow nasal cannula versus conventional oxygen therapy in acute COPD exacerbation with mild hypercapnia: a multicenter randomized controlled trial. Crit Care. 2022 Apr 15;26(1):109. doi: 10.1186/s13054-022-03973-7.
Clinical trial NCT02233959: Palatability of a Novel Oral Formulation of Prednsione
Official title: Palatability of a Novel Oral Formulation of Prednsione
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palatability
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Orbis
First posted: 2014-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32 years of age comprised of a convenience sample who meet study eligibility criteria.

Brief summary: Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.


Eligibility criteria: Inclusion Criteria:

* age 18 to 32 years, male and female who are healthy at the time of study
* can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
* demonstrate ability to complete study questionnaire

Exclusion Criteria:

* history of smoking or using any tobacco products
* previous history of taste disturbance
* any condition or dietary habit known to interfere with the sense of smell and taste
* any structural or functional abnormality of the upper gastrointestinal tract
* ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
* history of any significant illness within the two weeks prior to study
* history of autonomic dysfunction, bronchospastic disease or atopic allergy
* known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
* any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
* brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
* inability to speak and/or read English at a grade 10 level

Primary outcomes:
measure: Palatability of a new oral formulation of prednisone
timeFrame: Immediately
Secondary outcomes:
measure: Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP).
timeFrame: Immediately
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Gregory L Kearns, Pharm D. PhD
role: PRINCIPAL_INVESTIGATOR
References: