louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03773120: Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery
Official title: Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Papillary, Follicular
Keywords: superior laryngeal nerve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

Detailed description: The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.

Eligibility criteria: Inclusion Criteria:

* planned open thyroidectomy
* acceptable clinical laboratory tests
* understand clinical trials
* no significant past medical history

Exclusion Criteria:

* planned radical neck dissection
* hyperthyroidism history
* history of laryngeal nerve palsy
* laryngeal disease history
* uncontrolled hypertension or diabetes mellitus or heart disease
* anticoagulation or antiplatelet medication
* stroke history
* participated another clinical trials in 30days

Primary outcomes:
measure: Identification of EBSLN during thyroid surgery
timeFrame: up to postoperative 12 months
Secondary outcomes:
measure: Location of EBSLN
timeFrame: up to postoperative 12 months
measure: Vocal outcome
timeFrame: up to postoperative 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00868920: Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation
Official title: A Phase IV, Randomized, Double-Blind, Controlled Study of the Effects of Patient-Controlled Sedation vs. Anesthesiologist-Administered Sedation With Propofol and Remifentanil on Rate of Disordered Breathing in Subjects Undergoing Elective Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether patients controlling their own sedation during colonoscopy are less likely to need help breathing than when an anesthesiologist controls the medicine, and whether we can predict when the need for help will occur. The pump used in the study is approved for clinical use by the FDA, as are the medicines used in the pump.


Eligibility criteria: Inclusion Criteria:

1. Undergoing elective, outpatient colonoscopy
2. Age ≥ 18, \<90
3. Meet criteria for conscious sedation (HUP Policy 1-12-11, Appendix F), as determined by the attending gastroenterologist and confirmed by the anesthesiologist by review of history
4. Able to give informed consent

Exclusion Criteria:

1. Have a history of allergy or adverse reaction to propofol or remifentanil
2. Have a condition which would pose an elevated risk for administration of propofol, including primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
3. Female of child-bearing potential (under 50 without surgical sterilization)
4. Unable to understand the use of Patient Contolled Sedation

Primary outcomes:
measure: The primary outcome measure is the depth of sedation,
timeFrame: during colonoscopy procedure
Secondary outcomes:
measure: The secondary outcome measure is rate of respiratory depression
timeFrame: during colonoscopy procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Anesthesia
name: Jeff E Mandel, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mandel JE, Lichtenstein GR, Metz DC, Ginsberg GG, Kochman ML. A prospective, randomized, comparative trial evaluating respiratory depression during patient-controlled versus anesthesiologist-administered propofol-remifentanil sedation for elective colonoscopy. Gastrointest Endosc. 2010 Jul;72(1):112-7. doi: 10.1016/j.gie.2010.01.031. Epub 2010 May 20.
Clinical trial NCT00241020: Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Official title: Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Octreotide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* HCC diagnosis :
* histologically or cytologically proven HCC
* or association of the three following criteria:
* cirrhosis
* typical measurable mass (\> 3cm, by 2 methods)
* serum alpha-foetoprotein (AFP) ≥500 µg/L
* Cancer Liver Italian Program (CLIP) score : 0 to 3
* Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)

Exclusion Criteria:

* Glycemia \> 2.5 g/L or hypoglycemia
* Extra hepatic life-threatening disease
* Serum creatinin\> 120 µmol/L
* Prothrombin time \< 50 %
* Platelet count \< 50.000 /µL
* Symptomatic cholelithiasis
* Non-measurable tumor

Primary outcomes:
measure: Overall Survival
Secondary outcomes:
measure: Objective response
measure: Survival without progression
measure: Digestive bleeding
measure: Renal insufficiency
measure: Quality of life
measure: · Safety
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05192720: Andosan in Allergic and Asthma Patients
Official title: Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Allergic Rhinoconjunctivitis
Immune Tolerance
Keywords: ASIT
SLIT
Andosan
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: ImmunoPharma AS
First posted: 2022-01-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 25-30 patients in each arm receiving Andosan or placebo.
Primary purpose: OTHER

Brief summary: Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.

Detailed description: Asthma and allergy are increasing in Norway and Western countries. Treatment is still mostly symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as Andosan™, have been shown to protect against asthma and allergy in murine models by changing the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune system. Positive effects on allergy were also shown in a RCT on blood donors with selfreported allergy. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway.

The aim of this study is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking Andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (ASIT).

If the extract shows effect on these patients it support the hypotheses that Andosan helps against atopic diseases and facilitate the shift from Th-2 to Th-1 responses at a cellular level.

Eligibility criteria: Inclusion Criteria:

* Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy).
* Age above 18.
* Able to understand written and oral Norwegian

Exclusion Criteria:

- none other than not meeting the inclusion criteria

Primary outcomes:
measure: FEV1
timeFrame: 20 days
Secondary outcomes:
measure: Oscillometry
timeFrame: 20 days to four weeks
measure: Questionnaire ACT
timeFrame: four weeks
measure: Questionnaire RQLQ
timeFrame: four weeks
measure: Passive basophil cell activation in serum
timeFrame: four weeks
measure: Immunoglobulin E in serum
timeFrame: four weeks
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus university hospital
state: Viken
Study officials:
affiliation: University Hospital, Akershus
name: Faiza Mahmood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03446820: This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep
Official title: Sleep Quality and Microclimate Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 16
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Intervention model description: Participants will be randomly assigned to sleep in the residential module of the Well Living Lab. One week will be with standard sheets, followed by one week of hygro cotton sheets.
Primary purpose: OTHER

Brief summary: Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.

Detailed description: Participants will spend nights sleeping in the residential module of the Well Living Lab. Participants will cross over from normal sheets to hygro cotton sheets to assess impact of different sheet types on microclimate (e.g. temperature) and the impact on sleep quality.

Eligibility criteria: Inclusion Criteria. Premenopausal women Age 21-45

Exclusion Criteria History of sleep disorders

Primary outcomes:
measure: body temperature
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent A Bauer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06765382: Association of Vitamin D Intake, and Associated Factors with Low Back Pain: a Retrospective Cohort Study
Official title: Association of Vitamin D Intake, and Associated Factors with Low Back Pain: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D
Keywords: : Low back pain, Vitamin D, Pain, Disability, Oswestry low back disability questionnaire
Lead sponsor: Mutah University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients that were presented at our institute with chronic LBP and no associated comorbidities.

Brief summary: While there have been studies indicating a connection between insufficient levels of vitamin D and persistent low back pain (LBP), there is still a lack of definitive evidence. The primary objective of this study was to evaluate the correlation between vitamin D intake, and associated factors with chronic lower back pain.


Eligibility criteria: Inclusion Criteria:

* We included patients that were presented at our institute with chronic LBP and no associated comorbidities.

Exclusion Criteria:

-

Primary outcomes:
measure: Lower back pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ibn Haytham Hospital
Study officials:
References:
Clinical trial NCT04147520: Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising
Official title: Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Drinking
Alcohol; Harmful Use
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-11-01
Enrollment: 1475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. Members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class. A subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a Brief Motivational Interview. There is evidence that this sort of interview can reduce harmful alcohol use. The investigators expect that following the Brief Motivational Interview others in their friendship clusters will show reduced harm associated with alcohol use as well.


Eligibility criteria: Inclusion Criteria:

• Must be a member of the class of 2021 or 2021.5 at the site university

Exclusion Criteria:

• None

Primary outcomes:
measure: Alcohol use
timeFrame: At each follow up, measure average drinks per week in the past 30 days
measure: Average number of alcohol consequences in the past 30 days
timeFrame: At each follow up, measure count of alcohol consequences in the past 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Nancy Barnett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02922920: Effects of Tart Cherry Juice on the Body
Official title: Effects of Tart Cherry Juice on the Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Age-Related Cognitive Decline
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health.

Detailed description: Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry juice or placebo drink for 12 weeks. Blood and urine samples were collected at baseline and 12 weeks to assess biomarkers. Physical activity and 3-day diet records were also collected throughout the study.

Eligibility criteria: Inclusion Criteria:

• Age 65-80

Exclusion Criteria:

* Allergic to tart cherries
* Heavy smoker
* Taking medications that affect cognitive function
* History of neurological disorders
* History of traumatic brain injury
* History of stroke
* Clinical diagnosis of diabetes
* Clinical diagnosis of Alzheimer's Disease/Dementia
* GI disease
* Kidney disease
* Liver disease
* Cancer

Primary outcomes:
measure: Cognitive function
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: Baseline and 12 weeks
measure: Oxidative stress markers
timeFrame: Baseline and 12 weeks
measure: Inflammatory markers
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Sheau Ching Chai, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04204720: A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle
Official title: A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle During Caudal Epidural Block : a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis Lumbar
Disk Herniated Lumbar
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Caudal epidural injection (CEI) is effective for spinal pain. However, intravascular injection may occur during CEI, which can lead to hematoma, neurologic deficit and local anesthetics systemic toxicity. Whitacre type needle has been reported to be effective for reducing intravascular injection during transforaminal epidural injection. In this study, we compared the Chiba needle and Whitacre needle on incidence of intravascular injection during CEI.

Detailed description: A total of 164 caudal epidural injections were performed in patients with disc herniation or spinal stenosis on lumbosacral region. Patients were randomly allocated to Group Whitacre (n=82) and Group Chiba (n=82). Patients in Group Whitacre received caudal epidural injection using Whitacre type needle and those in Group Chiba received the procedure using Chiba type needle. Intravascular injection was assessed with blood aspiration and angiography during real-time fluoroscopy.

Eligibility criteria: Inclusion Criteria:

* patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis

Exclusion Criteria:

* allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection

Primary outcomes:
measure: incidence of intravascular injection
timeFrame: 5 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Younghoon Jeon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00996320: Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
Official title: Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Depression
Keywords: Internship and Residency
Medical Errors
Burnout, Professional
Burnout
Depression
Actigraphy
Personnel Staffing and Scheduling
Sleep Deprivation
Workload
Humans
Adult
Male
Female
Intensive Care Units
Prospective Studies
Crossover Studies
Work Schedule Tolerance
Disorders of Excessive Somnolence
Guideline Adherence
Internal Medicine Education
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Providence St. Vincent Department of Medicine
name: Providence Center for Outcomes Research and Education
First posted: 2009-10-16
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.

Detailed description: Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.

Eligibility criteria: Inclusion Criteria:

* Interns rotating at Providence St. Vincent Medical Center ICU

Exclusion Criteria:

* Diagnosis of narcolepsy

Primary outcomes:
measure: Multiple Sleep Latency Test
timeFrame: Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle
Secondary outcomes:
measure: Hours slept per night measured by actigraphy
timeFrame: Daily
measure: Pharmaceutical order error rate
timeFrame: Daily
measure: Burnout measured by Maslach Burnout Inventory
timeFrame: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation
measure: Beck Depression Inventory, Second Edition (BDI-II)
timeFrame: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation
measure: Hours worked per shift on the traditional and intervention schedules
timeFrame: Daily
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence St. Vincent Medical Center Intensive Care Unit
state: Oregon
Study officials:
affiliation: Providence St. Vincent Medical Center
name: Michelle L Schoepflin Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References: