louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00989209: Myofunctional Therapy in Facial Palsy
Official title: Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Paralysis
Keywords: facial paralysis
asymmetry
myofunctional therapy
botulinum toxin
facial evaluation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2009-10-05
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 62
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.

Detailed description: Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.

Eligibility criteria: Inclusion Criteria:

* facial paralysis with more than 2 years elapsed since the onset of symptoms
* surgically treated for reanimation at least 12 months before
* static and/or dynamic facial asymmetry causing aesthetic concern

Exclusion Criteria:

* spastic paralysis
* serious systemic or neuromuscular diseases
* cognition impairment
* pregnant women

Primary outcomes:
measure: Clinical score
timeFrame: 2 months
Secondary outcomes:
measure: Facial Disability Index (self-report instrument)
timeFrame: 2 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Alessandra G Salles
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo General Hospital
name: Marcus C Ferreira
role: STUDY_CHAIR
affiliation: University of Sao Paulo General Hospital
name: Paula N Toledo
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo General Hospital
name: Claudia F Andrade
role: STUDY_DIRECTOR
References:
citation: Salles AG, Toledo PN, Ferreira MC. Botulinum toxin injection in long-standing facial paralysis patients: improvement of facial symmetry observed up to 6 months. Aesthetic Plast Surg. 2009 Jul;33(4):582-90. doi: 10.1007/s00266-009-9337-9. Epub 2009 Mar 28.
Clinical trial NCT01554709: Safety and Performance Study of the CardioGard Cannula
Official title: A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aortic Valve Replacement
Keywords: bypass
cannula
Lead sponsor: CardioGard Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 71
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.


Eligibility criteria: Inclusion Criteria:

* AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
* Non pregnant female

Exclusion Criteria:

* Contraindication for open heart surgery under bypass machine
* Emergency Operation

Primary outcomes:
measure: DWI- Diffusion Weighted Imaging
timeFrame: The outcome measure is assessed in average a week after the surgery
Secondary outcomes:
measure: TCD- Transcranial Doppler
timeFrame: The Outcome measure is assessed during the surgery
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Leipzig
country: Germany
facility: Heart Center Leipzig, University of Leipzig
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Bern
country: Switzerland
facility: Insel Hospital
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Rambam Health Care Campus
name: Gil Bolotin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03182309: Registry for Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome in China
Official title: The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Sleep Apnea Syndromes
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 3502
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive COPD patients in 10 participating centers in China

Brief summary: COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases. It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very high. COPD and sleep apnea may have pathological or genetics interactions so that patients having both disorders tend to have worse outcomes than either condition alone. Data reflecting the prevalence, disease course and outcome of overlap syndrome is very limited in China. Therefore, the aim of the study is to describe the prevalence, treatment and outcome in Chinese patients and exploring the underlying interaction mechanism.


Eligibility criteria: Inclusion Criteria:

* COPD patients with informed consent

Exclusion Criteria:

* pregnant patients, patients with serious respiratory diseases other than COPD, patients with limited life expectancy, patients that can't coordinate well

Primary outcomes:
measure: COPD acute exacerbation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References:
citation: Zhao Z, Zhang D, Sun H, Chang D, Lv X, Lin J, Liu J, Wu X, Hu K, Guo X, Tong Z. Anxiety and depression in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Sleep Breath. 2022 Dec;26(4):1603-1611. doi: 10.1007/s11325-021-02500-2. Epub 2021 Nov 16.
citation: Zhu J, Zhao Z, Wu B, Shi Z, Nie Q, Fu Z, Zeng Z, Hu W, Dong M, Xiong M, Hu K. Effect of Body Mass Index on Lung Function in Chinese Patients with Chronic Obstructive Pulmonary Disease: A Multicenter Cross-Sectional Study. Int J Chron Obstruct Pulmon Dis. 2020 Oct 13;15:2477-2486. doi: 10.2147/COPD.S265676. eCollection 2020.
citation: Hu W, Dong M, Xiong M, Zhao D, Zhao Y, Wang M, Wang T, Liu Z, Lu L, Hu K. Clinical Courses and Outcomes of Patients with Chronic Obstructive Pulmonary Disease During the COVID-19 Epidemic in Hubei, China. Int J Chron Obstruct Pulmon Dis. 2020 Sep 23;15:2237-2248. doi: 10.2147/COPD.S265004. eCollection 2020.
citation: Zhu J, Zhao Z, Nie Q, Wang Y, Fu Z, Guo X, Hu K. Effect of lung function on the apnea-hypopnea index in patients with overlap syndrome: a multicenter cross-sectional study. Sleep Breath. 2020 Sep;24(3):1059-1066. doi: 10.1007/s11325-019-01961-w. Epub 2019 Nov 25.
Clinical trial NCT01010009: The Cognitive and Cerebral Blood Flow Effects of Resveratrol
Official title: Effects of Resveratrol on Cerebral Blood Flow Parameters and Cognitive Performance in Humans: a Double-blind, Placebo-controlled, Crossover Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive and Cerebral Blood Flow Effects of Resveratrol
Keywords: resveratrol
cerebral blood flow
NIRS
cognitive performance
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. The aim of this investigation was to determine if the consumption of resveratrol could modulate cerebral blood flow and if this in turn could influence cognitive performance by increasing access to blood borne metabolic fuel. Results showed that compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total haemoglobin were significantly higher in the frontal cortex of young, healthy participants during cognitive task completion. Cognitive performance was not effected.


Eligibility criteria: Inclusion Criteria:

* Male/female,
* Healthy
* Age 18-35 years old
* Non smoker
* Proficient in English
* Not taking any herbal or prescription medications
* Not pregnant
* Does not drink more than 6 cups of coffee per day

Exclusion Criteria:

* Suffered a head injury, neurological disorder or neuro-developmental disorder
* Food allergies/intolerances

Primary outcomes:
measure: Modulation of Levels of Total Haemoglobin
timeFrame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
measure: Modulation of Deoxygenated Levels of Haemoglobin
timeFrame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
Secondary outcomes:
measure: Number of Participants With Significant Modulation of Cognitive Performance
timeFrame: 46-81 mins post dose
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: Crystal Haskell
role: STUDY_DIRECTOR
References:
Clinical trial NCT03400709: Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
Official title: Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cisplatin Adverse Reaction
Hearing Loss Ototoxic
Keywords: Cisplatin
Ototoxicity
N-acetylcisteine
Lead sponsor: Hospital San Juan de Dios, Santiago
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.


Eligibility criteria: Inclusion Criteria:

* Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.

Exclusion Criteria:

* Conductive Hearing Loss
* SNHL with \>= 40db PTA

Primary outcomes:
measure: Hearing threshold
timeFrame: Baseline.
measure: Hearing threshold
timeFrame: up to 4th week of chemoradiotherapy
measure: Hearing threshold
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Daniel Munoz
state: Metropolitana
Study officials:
References:
Clinical trial NCT02749409: Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
Official title: Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parecoxib
Rib Fractures
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 17
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: Patients diagnosed traumatic rib fracture and need admission will be included. Patients will be divided two groups.The experimental group will be given parecoxib after visiting emergency department. The control group will be given Narcotic agent such as morphine for pain control. The outcome such as numerical rating scale (NRS) and hospital length of stay will be recorded.

Detailed description: 3.1 Inclusion/exclusion criteria Patients who are diagnosed ribs fracture and need admission. Exclusion criteria included heart failure, Coronary artery disease (CAD) history. Traumatic cardiac injury and cardiac tamponade will be excluded, too.

3.2 Group design Patients will be divided two groups, and the experimental group will be given parecoxib after visiting emergency department. And they will be kept given after admission by intravenous method every 12 hours for 4 days. The control group will be given Narcotic agent such as morphine for pain control. The daily dose will be recorded. Finally the end outcome will be recorded.

3.3 Data collection The data of patient's medical history and laboratory results will be recorded on pre-designed case report forms (CRFs) by study nurses. In all patients, age, gender, diagnosis, co-morbidities, length of hospital and intensive care unit (ICU) stay, Injury Severity Score (ISS) score, numerical rating scale (NRS) and outcomes, will be recorded. In addition, all microorganisms isolated and antibiotic substances applied will be documented.

Eligibility criteria: Inclusion Criteria:

1. Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures
2. Age ≧18 y/o

Exclusion Criteria:

1. Patients who have history of heart failure, CAD history.
2. Traumatic cardiac injury and cardiac tamponade
3. History of allergy effect for Cyclooxygenase 2 (COX2) inhibitor or NSAID

Primary outcomes:
measure: all cause mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06332209: Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Official title: Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: trauma focused cognitive behavioral therapy
telehealth
community implementation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

Detailed description: The current study will use a randomized controlled trial to examine telehealth delivery of Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) for youth with trauma symptoms receiving care in community based clinics in Puerto Rico. First, the effectiveness of Tele-TF-CBT in improving trauma symptoms will be examined compared with clinic-based TF-CBT. Next, the feasibility, acceptability, and engagement outcomes of Tele-TF-CBT will be examined in this population. Lastly, implementation factors will be explored.

Eligibility criteria: Inclusion Criteria:

* 7-18 years old
* experienced at least one traumatic event
* present with clinically significant levels of post-traumatic stress symptoms

Exclusion Criteria:

* significant suicidal ideation
* substance use disorder
* active psychotic symptoms
* pervasive developmental delays,
* currently living with or in close contact with the perpetrator of their abuse

Primary outcomes:
measure: Traumatic Stress Symptoms
timeFrame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)
measure: Traumatic Stress Symptoms
timeFrame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)
Secondary outcomes:
measure: Anxiety and Depression Symptoms
timeFrame: baseline, post-treatment, 3-month follow-up
measure: Anxiety and Depression Symptoms
timeFrame: baseline, post-treatment (2-weeks of completing treatment), 3-month follow-up (within 3 months of post-treatment assessment)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT00308009: Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After
Official title: Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Urinary Stress Incontinence
Keywords: Pelvic Organ Prolapse
Urinary stress incontinence
Surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 194
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

Detailed description: All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.

Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Eligibility criteria: Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -

Exclusion Criteria: Not agreed to participate in randomization

-

Primary outcomes:
measure: Any or no leakage of urine when coughing
timeFrame: 1 year
Secondary outcomes:
measure: The cure of urinary stress incontinence (USI) by only prolapse surgery
timeFrame: 1 year
measure: Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Michael Abdelnoor Phd, Department of epidemiology (same hospital)
name: Ellen Borstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01722409: A Better Choice for Patients Undergoing Endovascular Coil Embolization
Official title: Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intracranial Aneurysms
Keywords: dexmedetomidine, endovascular coil embolization
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 64
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 investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.


Eligibility criteria: Inclusion Criteria:18-65 years old ASA I or ASA II patients undergoing ECE treatment for intracranial aneurysms were included.

Exclusion Criteria:Patients were excluded based on the following parameters: older than 65 yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.

Primary outcomes:
measure: Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
timeFrame: At the end of the operation and 24 hours later
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Wen-fei Tan
state: Liaoning
Study officials:
affiliation: Dept. of Anesthesiology, the First Hospital of CMU
name: Hong Ma, M.D.,PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT01387009: Acquisition of Normative Data for Musculoskeletal Ultrasound in Children
Official title: Acquisition of Normative Data for Musculoskeletal Ultrasound in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normative Data Study of Joints of Healthy Children
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2011-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children will be recruited via invitation by investigators

Brief summary: The primary objective is to establish normative data for Canadian children for the shoulder, elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons surrounding the joint.

Detailed description: The respective joints will be assessed through ultrasonography and data will be collected and analyzed

Eligibility criteria: Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Do not suffer from any condition that might have an effect on their joints.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Johannes Roth
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Johannes Roth
role: PRINCIPAL_INVESTIGATOR
References: