louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03502590: IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks
Official title: Effectiveness of Airway Control Using the IGEL Laryngeal Mask Airway Device in Patients With Previous Radiotherapy to the Neck
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryngeal Masks
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2018-04-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is known that patients with head and neck cancer who have had radiation therapy to the structures of the neck are at a greater risk of difficult mask ventilation and tracheal intubation than the majority of patients undergoing general anaesthesia.

Failure to maintain oxygenation can lead to catastrophic consequences for any patient undergoing general anaesthesia, such as severe hypoxic brain injury and death.

As such, the current guidelines from the Difficult Airway Society promote the use of a second generation laryngeal mask airway to maintain oxygenation in the event of failed mask ventilation or tracheal intubation, a rescue technique that has in most patient groups a very high chance of success. Unfortunately these guidelines are by necessity generic guidance and do not take into account the clinical performance of these devices in specific patient groups. While there is evidence of the effectiveness of the IGEL device as the primary method of airway maintenance in many studies there are none that describe its clinical performance in a group of patients in whom the rate of failed mask ventilation and tracheal intubation are significantly higher than the general population of patients. It is therefore of great interest to have an idea of the likelihood of success of rescue ventilation with this device in a group of high risk patients.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Attending for an elective procedure requiring general anaesthesia
* Prior radiotherapy to the neck

Exclusion Criteria:

* General anaesthesia is not the primary airway plan
* Previously known difficult intubation
* Patient refusal

Primary outcomes:
measure: Successful insertion of the device and ventilation of the patient
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Livingston
country: United Kingdom
facility: St Johns Hospital
Study officials:
References:
Clinical trial NCT03902990: The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease
Official title: Effects of Dual Task Training And Treadmill Training on Physical and Cognitive Functions in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: dual task, treadmill, cognitive rehabilitation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective, randomized, controlled, double-blinded study the patients were randomized to three groups as; dual-task group, single-task group and control group. All of the patients were scheduled on standard exercise programme. The patients in dual-task group received treadmill training with cognitive tasks and the patients in single-task group received treadmill training alone in addition to standard exercise programme. The training was scheduled as 30 minute sessions under supervision of a specialist, three times in a week for four weeks.
Primary purpose: TREATMENT

Brief summary: The ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.


Eligibility criteria: Inclusion Criteria:

The patients with Idiopathic Parkinson Disease on medication who has

* Hoehn-Yahr 1-3
* Mini Mental Test score 20 and above
* Functional Ambulation Category 2 and above
* No changes in medication in last 3 months
* No rehabilitation programme in last 3 months

Exclusion Criteria:

* Diagnosis of Parkinsonism other than Idiopathic Parkinson Disease
* Global aphasia
* Severe cognitive dysfunction
* Other neurologic/orthopedic diseases
* Limiting cardiovascular or pulmonary disease
* Visual impairment
* Hearing loss

Primary outcomes:
measure: 10MWT
timeFrame: 12 weeks
measure: 10MWT with cognitive tasks
timeFrame: 12 weeks
measure: MoCA
timeFrame: 12 weeks
measure: TUG
timeFrame: 12 weeks
Secondary outcomes:
measure: PDQ-39
timeFrame: 12 weeks
measure: FES-I
timeFrame: 12 weeks
measure: Stroop Test
timeFrame: 12 weeks
measure: FOGQ
timeFrame: 12 weeks
measure: Falls Diary
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
state: Fatih
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
name: Ayse Yaliman, Prof
role: STUDY_DIRECTOR
affiliation: Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
name: Ekin Ilke Sen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03124290: The Effect of Attention Distractor on the Quality of Chest Compression
Official title: The Effect of Attention Distractor During Cardiopulmonary Resuscitation on the Quality of Chest Compression: Randomized Crossover Trial With Simulated Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation, Simulation Training
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators plan to investigate the effect of attention distractor on the quality of chest compression during cardiopulmonary resuscitation. For this, a simulated study with Manikin is performed and the paced auditory serial addition test (PASAT) is used for distracting performer's attention.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers who completed basic life support course among medical personnel (doctors, nurses, paramedics) working in a university hospital

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: adequate compression rate
timeFrame: two minutes
Secondary outcomes:
measure: adequate compression depth
timeFrame: two minutes
measure: adequate chest recoil
timeFrame: two minutes
measure: mean compression rate
timeFrame: two minutes
measure: mean compression depth
timeFrame: two minutes
measure: Subjective difficulty
timeFrame: Two minutes
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
Study officials:
affiliation: Inje University Ilsan Paik Hospital
name: Joon Min Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee K, Kim MJ, Park J, Park JM, Kim KH, Shin DW, Kim H, Jeon W, Kim H. The effect of distraction by dual work on a CPR practitioner's efficiency in chest compression: A randomized controlled simulation study. Medicine (Baltimore). 2017 Oct;96(43):e8268. doi: 10.1097/MD.0000000000008268.
Clinical trial NCT00685490: Vitrectomy for Branch Retinal Vein Occlusion
Official title: Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitrectomy
Keywords: branch retinal vein occlusion
internal limiting membrane
macular edema
vitrectomy
Lead sponsor: Shinjo Ophthalmologic Institute
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70 consecutive patients who underwent PPV, with and without OLM peeling, for persistent macular edema associted with BRVO

Brief summary: To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (BRVO).

Results suggest the following hypothesis:

* PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent macular edema due to BRVO
* Effectiveness is maintained long term
* ILM peeling does not significantly affect postoperative best corrected visual acuity (BCVA)


Eligibility criteria: Inclusion Criteria:

* duration of symptoms lasting 27 weeks

Exclusion Criteria:

* vitreous hemorrhage
* severe cataract
* biomicroscopic vitreomacular traction and epiretinal membrane
* previous vitreoretinal surgery
* other ocular diseases that could contribute to visual loss.
* patients with macular branch vein occlusion
* patients with a history of previous grid laser photocoagulation

Primary outcomes:
measure: Reporting of the long term outcomes of PPV, with and without ILM peeling, in eyes with persistent macular edema secondary to BRVO
timeFrame: 11 years
Secondary outcomes:
measure: Elevate the effectiveness of ILM peeling
timeFrame: 11 years
Other outcomes:
Locations:
city: Miyazaki
country: Japan
facility: Shinjo Ophthalmologic Institute
Study officials:
affiliation: Shinjo Ophthalmologic Institute
name: Kazuyuki Kumagai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03912090: Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.
Official title: Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Keywords: pediatric
fentanyl
intranasal
emergency
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 83
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Pediatric patients of the emergency pediatric department of Mercy hospital
* Coming for acute severe pain : EVA or FLACC scale \>=6 for less than 6 hours
* Age more than 12months
* Weight 10kg to 68kg
* Veinous access difficult to obtain
* No contra-indication for fentanyl use
* No contra-indication for intranasal administration

Brief summary: The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.


Eligibility criteria: Inclusion Criteria:

* All patients who received fentanyl intranasal between june 2017 and august 2018

Exclusion Criteria:

* Lack of surveillance data in the medical record of the patient

Primary outcomes:
measure: Pain scale evolution
timeFrame: Day 1
Secondary outcomes:
measure: Respiratory frequency
timeFrame: Day 1
measure: Cardiac frequency
timeFrame: Day 1
measure: Glasgow Coma scale
timeFrame: Day 1
measure: Oxygen saturation
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References:
Clinical trial NCT01716390: Lipid-lowering Effect of Plant Stanol Drink
Official title: The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of investigational products on serum LDL cholesterol.


Eligibility criteria: Inclusion Criteria:

* healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults
* signed written informed consent

Exclusion Criteria:

* participation in a clinical study within 30 days prior to screening visit and throughout the study
* severe obesity
* consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study
* consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2

Primary outcomes:
measure: Change in serum LDL cholesterol
timeFrame: 0 vs 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Good Food Practice
Study officials:
affiliation: Good Food Practice, Uppsala, Sweden
name: Johan Olsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hallikainen M, Olsson J, Gylling H. Low-Fat Nondairy Minidrink Containing Plant Stanol Ester Effectively Reduces LDL Cholesterol in Subjects with Mild to Moderate Hypercholesterolemia as Part of a Western Diet. Cholesterol. 2013;2013:192325. doi: 10.1155/2013/192325. Epub 2013 Sep 16.
Clinical trial NCT03665090: Shanghai Cohort Study of Diabetic Eye Disease
Official title: A Three-year Community-based Study in Diabetes: The Shanghai Cohort Study of Diabetic Eye Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema of Both Eyes (Diagnosis)
Diabetic Retinopathy Visually Threatening
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 8000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the enrolled participants got a yearly examination of diabetic eye disease for three years. Considering that the prevalence of DR gradually increases with age, the target population included adults with diabetes aged 35 years and above under archives management, residing in Shanghai. And the study participants were expected to be freely mobile, clear-thinking, and capable of cooperating to complete the ophthalmic examinations.

Brief summary: To describe the design, methodology and baseline characteristics of the Shanghai Cohort study of Diabetic Eye disease (SCODE) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.

Detailed description: The Shanghai Cohort study of Diabetic Eye disease (SCODE) was a three-year community-based study to carry out a regular ocular health screening and epidemiological analysis for diabetic eye disease in the approximately 8,000 middle-aged and elderly people with diabetes in Shanghai. Through this study, we hope to understand the prevalence, epidemic trend and the features of risk factors distribution on diabetic eye disease, especially on DR.

Meanwhile, our aims also included estimating the ocular fundus changes and visual impairment associated with different grade of DR. Furthermore, the aim of the present study was to investigate the association between serum and urine biochemical parameters and DR.

Eligibility criteria: Inclusion Criteria:

* Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai.

Exclusion Criteria:

* All the study participants have difficulties of mobility or communication.

Primary outcomes:
measure: Prevalence and incidence rate of diabetic eye disease
timeFrame: December 31, 2018
Secondary outcomes:
measure: Grading of DR
timeFrame: December 31, 2018
measure: Retinal and choroidal thickness
timeFrame: December 31, 2018
measure: Retinal blood flow
timeFrame: December 31, 2018
measure: Blood biochemistry indexes
timeFrame: December 31, 2018
measure: Urine biochemistry indexes
timeFrame: December 31, 2018
measure: Visual impairment
timeFrame: December 31, 2018
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01906190: Persistence of Immune Response After Vaccination With Influenza Vaccine
Official title: Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Immunisation Reaction
Keywords: influenza vaccine
immune response
persistence
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2013-07-24
Enrollment: 207
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.

Detailed description: Subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza vaccine.The persistence phase starts 24 months after the primary vaccination and blood samples will be taken at 6, 12, 18 and 24 months after primary vaccination. Subjects whose antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster dose of influenza vaccine.

Eligibility criteria: Inclusion Criteria:

* aged 12-60 years old
* male or non-pregnant female
* volunteers received 2010 seasonal influenza vaccine
* clinically healthy as determined by: medical history inquiring and physical examination
* provide written informed consents before joining the trial

Exclusion Criteria:

* without history of 2010 seasonal influenza vaccine administration,
* allergic to any ingredient of vaccine,
* autoimmune disease or immunodeficiency,
* severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain,
* severe acute and chronic diseases
* axillary temperature over 37.0℃ at the time of vaccination.

Primary outcomes:
measure: change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months
timeFrame: 6，12，18，24 months after the primary vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tuoketuo County
country: China
facility: Tuoketuo Centers for Disease Control & Prevention
state: Inner Mongolia
Study officials:
affiliation: Beijing Centers for Disease Control and Prevention
name: jiang wu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076890: Hemp 15 mg & 50 mg Capsule Absorption
Official title: Hemp 15 mg & 50 mg Capsule Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption; Chemicals
Lead sponsor: Gaia Herbs Inc.
Sponsor class: INDUSTRY
Collaborators: name: Appalachian College of Pharmacy
First posted: 2021-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract at two concentrations over a 4-hour timeline.

Detailed description: This study is designed to determine the time to maximum plasma concentration of CBD and CBD-A after an oral dose of standardized full spectrum hemp extract over a 4-hour timeline. This study is designed to include two arms. Each arm will be delivered a different concentration of standardized full spectrum hemp extract, either 15 mg or 50 mg. Throughout the course of the study all participants will be asked to provide four (4) plasma samples, 10 randomly selected participants will be asked to provide five (5) plasma samples. Samples will then be evaluated using a validated LC-MS/MS method to develop a blood concentration time curve in order to determine time to reach maximum blood concentration. This trial is double-blinded with two arms enrolling only healthy individuals. The participants randomized for a fifth blood draw will be randomly selected from these two arms.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Ages 18 - 65.
4. In good general health as evidenced by medical history as indicated by oral confirmation of study participant.
5. Ability and willingness to suspend the use of any other herbal dietary supplements for 48 hours prior the first clinical visit associated with this study.
6. Ability and willingness to abstain from alcohol use for 12 hours prior to the first clinical visit.
7. Cannabis and CBD naïve for 60 days or more prior to enrolling in the study.
8. Ability and willingness to abstain from food for 6 hours prior to the first clinical visit.

Exclusion Criteria:

1. Current use of regular medication for a chronic condition.
2. Current pregnancy or lactation.
3. Plans to become pregnant during the intended duration of the study.
4. Known allergic reactions to hemp flower.
5. Known severe food allergies.

Primary outcomes:
measure: Time to maximum plasma concentration
timeFrame: Over 4 hours
Secondary outcomes:
measure: Detectable THC
timeFrame: Over 4 hours
Other outcomes:
measure: Present in measurable amount over time
timeFrame: 7 - 10 days
Locations:
city: Oakwood
country: United States
facility: Appalachian College of Pharmacy
state: Virginia
Study officials:
References: