louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02494622: Alternative Treatment of Giant Spinal Schwannomas
Official title: Alternatives to The Surgical Approach for Giant Spinal Schwannomas: A Clinic Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Neoplasms
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-07-10
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 76
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who underwent surgery for benign spinal schwannoma Sridhar Type III, IV and V (all tumors were larger than 2.5 cm).

Brief summary: Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of these cases differ from those of small schwannomas. The aim of this study was to review the diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of patients who underwent surgery.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with benign spinal schwannoma Sridhar Type III, IV and V

Exclusion Criteria:

* Malign spinal schwannoma
* Sridhar Type I and II

Primary outcomes:
measure: Effects of the alternative surgical techniques to the amount of the tumor mass which measured by Nurick Scale
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gulsah Karaoren
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Said Naderi, Proffesor
role: STUDY_CHAIR
References:
citation: Samii M, Alimohamadi M, Gerganov V. Surgical Treatment of Jugular Foramen Schwannoma: Surgical Treatment Based on a New Classification. Neurosurgery. 2015 Sep;77(3):424-32; discussion 432. doi: 10.1227/NEU.0000000000000831.
citation: Ohnishi Y, Iwatsuki K, Ohkawa T, Ninomiya K, Moriwaki T, Yoshimine T. Differences between Cervical Schwannomas of the Anterior and Posterior Nerve Roots in Relation to the Incidence of Postoperative Radicular Dysfunction. Asian Spine J. 2015 Apr;9(2):263-70. doi: 10.4184/asj.2015.9.2.263. Epub 2015 Apr 15.
Clinical trial NCT00497822: A Randomized Controlled Trial on the Effect of Exercise on Physical, Cognitive and Affective Function in Dementia Subjects
Official title: To Study the Effect of Exercise Training in Term of Aerobic Exercise for 3 Months, on the Physical, Cognitive and Affective Function in Dementia Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Dementia
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-07-09
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Studies have shown conflicting results of the effect of exercise on dementia patients.

The aim of this study is to examine the role of physical activity on the risk of cognitive impairment and dementia in older persons.

To promote the benefits of aerobic exercise on dementia patients and encourage exercise prescription in the management of dementia subjects.


Eligibility criteria: Inclusion Criteria:

* MMSE\<26
* Age \>60
* Community dwelling and ambulatory
* Have a caregiver that is willing to participate and escort patient to hospital for training and assessment

Exclusion Criteria:

* MMSE\<10
* live in old age home
* poor mobility, unable to attend exercise training
* no carer to bring patient to attend hospital training

Primary outcomes:
measure: Physical function measurement using SF-12
timeFrame: every 3 months for 1 year
measure: Affective function measurement by Cornell depression score
timeFrame: every 3 months for 1 year
measure: Cognitive function by MMSE and ADAS-cog
timeFrame: every 3 months for 1 year
Secondary outcomes:
measure: 6 minutes walk, functional reach, Berg balance scale
timeFrame: every 3 months for 1 year
measure: Carer stress scale
timeFrame: every 3 months for 1 year
measure: No. of fall/restricted activity days/time spend in exercise or walking
timeFrame: every 3 months for 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Kwong Wah Hospital
Study officials:
affiliation: Department of Medicine and Geriatrics, Kwong Wah Hospital
name: Doris KY Miu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04176822: Designing Animated Movie for Preoperative Period
Official title: The Effects of Designing an Educational Animated Movie About Preoperative Preparation on Fear and Post-Operative Pain in Children:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Fear
Surgery
Pain
Nursing Caries
Nurse's Role
Clinical Anxiety
Patient
Pediatric
Keywords: pediatric surgery
preoperative preparation
animation
fear
pain
nursing
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 132
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: There are 3 independent working groups.
Primary purpose: BASIC_SCIENCE

Brief summary: Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery.

Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.


Eligibility criteria: Inclusion Criteria:

* First surgery
* Daily surgery and uncomplicated surgery
* Agree to participate in the study
* Speaking Turkish

Exclusion Criteria:

* Refusal to participate in the study
* A genetic/congenital disease
* A chronic disease
* Second or more surgery
* Not speaking Turkish

Primary outcomes:
measure: Change of Children's Preoperative Fear
timeFrame: 15 minutes (2 measurements are made-before and after intervention)
measure: Change of Children's Postopeartive Pain
timeFrame: 15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT00421122: Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
Official title: A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chinese patients
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 315
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.


Eligibility criteria: Inclusion Criteria:

* Signed and dated inform consent
* Out-patient, clinical diagnosis of COPD
* Men or women at the age of 40 or over

Exclusion Criteria:

* A history of asthma
* Seasonal allergic rhinitis before 40 years of age
* Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder

Primary outcomes:
measure: Post-study medication FEV1
timeFrame: 1 hour after medication
Secondary outcomes:
measure: FVC
timeFrame: Pre dose and 1 hour post dose
measure: FEV1
timeFrame: Pre-dose and 15 minutes post dose
measure: SGRQ symptom scores
measure: COPD symptom scores
measure: morning and evening PEF
timeFrame: Assessed daily
measure: reliever medication use
measure: AE
measure: lab measures
measure: ECG
measure: physician examination
measure: vital signs
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Shenyang
country: China
facility: Research Site
state: Liaoling
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: AstraZeneca
name: Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, Yao W, Sun T, Zhao Z, Shen H, Shi Y, Lin J, Li Q. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012 Feb;28(2):257-65. doi: 10.1185/03007995.2011.636420. Epub 2012 Jan 20.
Clinical trial NCT01844622: Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying
Official title: Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive System Disease
Keywords: Digestive System Diseases Disease
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to treat patients with on-going slow stomach emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy

Detailed description: This is a study on the effectiveness of domperidone, which increases movement through the digestive system for relief of symptoms, in patients who have delayed gastric solid-phase emptying

Eligibility criteria: Inclusion Criteria:

* Persistent esophagitis
* Heartburn
* Nausea
* Vomiting
* Severe dyspepsia
* Severe chronic constipation

Exclusion Criteria:

* History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.

Primary outcomes:
measure: Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Division of Gastroenterology, Mt. Sinai Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai Medical Center, Division of Gastroenterology
state: Florida
Study officials:
affiliation: Mt. Sinai Medical Center
name: Jamie S. Barkin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02428322: Trial of Vitamin D3 Supplementation in Paediatric Asthma
Official title: Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (\<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.

Detailed description: Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.

Eligibility criteria: Inclusion Criteria:

* Previous clinical diagnosis of asthma
* Ability to perform pulmonary function tests
* Established on anti-asthmatic pharmacotherapy with no expected change

Exclusion Criteria:

* Use of medications that influence vitamin D metabolism or absorption
* Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease

Primary outcomes:
measure: Paediatic Asthma Control Test (P-ACT)
timeFrame: 15 weeks
Secondary outcomes:
measure: Global Initiative for Asthma Score
timeFrame: 15 weeks
measure: Pulmonary function
timeFrame: 15 weeks
measure: Height velocity
timeFrame: 15 weeks
measure: Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.
timeFrame: 15 weeks
measure: Mini paediatric asthma quality of life questionnaire
timeFrame: 15 weeks
measure: Asthma Diary
timeFrame: 15 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Children's Hospital, Dublin 24, Ireland
name: Basil Elnazir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02975622: Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial
Official title: Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial Comparing Jugular and Subclavian Approaches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheterization, Central Venous
Ultrasonography
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2016-11-29
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ultrasound (US)-guided central venous catheterization is now considered standard of care according to recent clinical evidence, at least considering jugular vein approach. Recent trials suggested that even US-guided subclavian approach could be more effective that landmark technique. However, studies comparing both sites employing US are still lacking.

We, therefore, designed a non-inferiority randomized controlled trial to compare these sites, both using US guidance, according to immediate complications following central venous catheterization.


Eligibility criteria: Inclusion Criteria:

* critically ill patients; central venous access indicated.

Exclusion Criteria:

* cardiac arrest; at least one side of each vein available for insertion; pacemaker insertion; pulmonary artery catheter insertion; non-corrected coagulopathy; thrombolytics in the past 24 hours.

Primary outcomes:
measure: Immediate complications
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
References:
Clinical trial NCT04230122: A Study of LY3478006 in Healthy Participants
Official title: A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3478006 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination
* Women not of childbearing potential
* Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at screening

Exclusion Criteria:

* Have clinically significant abnormal electrocardiogram (ECG) results
* Have persistent abnormal blood pressure or pulse rate, as determined by the investigator
* Have evidence of orthostatic hypotension, defined as a decrease in systolic or diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg) or ≥10 mmHg, respectively
* Have significant history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders
* Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy
* Have significant allergies to humanized monoclonal antibodies

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through study completion (up to 109 days)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006
timeFrame: Predose; Day 1 with end of infusion, 3, 6, 12 hours
measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006
timeFrame: Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04865822: Single Session Pain Education
Official title: Single Session Pain Education for Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 20
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: To pilot single session pain education classes aimed at improving outcomes and behaviors in patients with chronic pain.


Eligibility criteria: Inclusion Criteria:

* chronic pain patients, pain longer than 3 months
* ability to adhere to and complete study protocols

Exclusion Criteria:

* not fluent in English
* recent injury at the discretion of the researcher
* previous completion of pain education class at the discretion of the researcher
* current cancer diagnosis or other medical condition at the discretion of the researcher

Primary outcomes:
measure: Mean change in Tampa scale for kinesiophobia at three months
timeFrame: month 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06128122: Dextrose Concentration Decline Rate in Vivo
Official title: Dextrose Concentration Decline Rate in Vivo After Intraarticular Knee and Subcutaneous Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dextrose Concentration
Keywords: Dextrose
Hydrodissection
Proliferation
Lead sponsor: Dr. Dean Reeves Clinic
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 1
Sex: MALE
Minimum age (years): 69
Maximum age (years): 69
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dextrose curve production from a single individual
Primary purpose: BASIC_SCIENCE

Brief summary: Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies

Detailed description: Rationale: In vitro studies of the potential mechanism of action of therapeutic dextrose injection commonly place human or animal cells in a dextrose (glucose) culture medium for a prolonged period of time, typically 24 hours, and expose them to high dextrose levels, typically 1-25% (1000- 25,000mg%). High glucose levels in culture media can cause cell death. Given that cellular apoptosis/death has not been shown to occur after therapeutic dextrose injection in vivo by histologic analysis, we expect that elevated glucose levels drop rapidly in vivo. In this study 12.5% dextrose will be injected intraarticularly (in the knee) and dextrose 5% will be injected subcutaneously, and dextrose level measurements will be obtained at timed intervals after each in order to produce a curve depicting the pattern and speed of decrease in dextrose levels after in vivo injection. In vitro studies can then utilize this information to alter the pattern and speed of decrease of dextrose levels to mimic in vivo conditions, and in so doing provide more useful data on potential mechanisms of therapeutic dextrose injection in soft tissue and joints.

Eligibility criteria: Inclusion Criteria:

Able to be relatively immobile for intermittent measurement of dextrose levels

Exclusion Criteria:

Diabetic

Primary outcomes:
measure: Dextrose levels in synovial fluid
timeFrame: 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, and 6.0 hours
measure: Dextrose level in subcutaneous tissue (interstitial space) in upper arm or abdomen
timeFrame: Continuous glucose measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Shawnee Mission
country: United States
facility: Kenneth Dean Reeves
state: Kansas
Study officials:
affiliation: Dr. Dean Reeves Clinic
name: Kenneth D Reeves, M.D.
role: PRINCIPAL_INVESTIGATOR
References: