louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00500916: Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
Official title: Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Airway
Ventilation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2007-07-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.


Eligibility criteria: Inclusion Criteria:

* Female patient
* 19-70 yr
* Body mass index \<35 kg/m2
* Difficult airway

Exclusion Criteria:

* \< 19 yr
* Body mass index \>35 kg/m2
* Risk of aspiration

Primary outcomes:
measure: Insertion success rate
timeFrame: 5 min
Secondary outcomes:
measure: Time to successful insertion
timeFrame: 5 min
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Anesthesia and Intensive Care
Study officials:
affiliation: Dept of Anesthesia and Intensive Care
name: Christian Keller, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eschertzhuber S, Brimacombe J, Hohlrieder M, Stadlbauer KH, Keller C. Gum elastic bougie-guided insertion of the ProSeal laryngeal mask airway is superior to the digital and introducer tool techniques in patients with simulated difficult laryngoscopy using a rigid neck collar. Anesth Analg. 2008 Oct;107(4):1253-6. doi: 10.1213/ane.0b013e31817f0def.
Clinical trial NCT03663816: Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
Official title: Villency - Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: shoe insert
orthotics
sway
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Villency Design Group, LLC
First posted: 2018-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy.

Detailed description: This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy. Healthy participants will wear this insole device in their own athletic/tennis shoes over the course of one week. There are two key purposes of this study: 1. To determine how using this insole device for 1 week may effect a healthy individual's balance and postural sway while standing; and 2. To determine how using this insole device for 1 week may effect how an individual walks (gait), how hard they hit the ground as they walk, and foot pressure patterns with each step. Each individual's balance, postural sway, and walking gait (how you walk) will be analyzed before and after wearing the shoe insole device for the one-week time period.

Eligibility criteria: Inclusion Criteria:

● Willing to maintain current level of physical activity during the study period of a week (no increase or decrease of activity level).

Exclusion Criteria:

* Moderate or severe obesity (body mass index \>35kg/m2)
* Known diagnosis of cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that impacts normal walking ability
* Any current ankle, knee, hip or low back pain
* Currently using any knee or ankle brace on a regular basis for joint pains
* Severe back pain, prior spinal fusion or spinal deformity that would affect gait
* Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer
* Any major orthopedic injury within the prior 12 months

Primary outcomes:
measure: Center of Mass Displacement (Sway) During Standing
timeFrame: At 1 week of acclimation
measure: Center of Variability Displacement During Standing
timeFrame: At 1 week of acclimation
measure: Center of Peak Speed of Displacement.
timeFrame: At 1 week of acclimation
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Heather Vincent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608516: Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque
Official title: Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Inflammation
Atheromatous Plaques
Carotid Artery Diseases
Keywords: PET/CT
68Ga-NODAGA-RGD
18F-FDG
MRI
US ultrasound
inflammatory atheromatous plaque
endarterectomy
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Swiss Heart Foundation
First posted: 2012-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.

Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.

Detailed description: Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation.

All imaging results and histopathology results will be pooled and compared.

Eligibility criteria: Inclusion Criteria:

* age \<= 85 years
* Karnofsky \>= 80%
* patient with indication ofr carotid endarterectomy
* signed consent form

Exclusion Criteria:

* indication for surgery other than endarterectomy \<14 days
* contraindication to surgery
* contraindication to MRI
* contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR\<30ml/min/1.73m2)
* pregnancy, breastfeeding
* lack of discernment

Primary outcomes:
measure: Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
timeFrame: Within1 month of endarterectomy
Secondary outcomes:
measure: Comparison of AUC of the imaging methods
timeFrame: Within1 month of endarterectomy
measure: Analysis of histopathological sample of endarterectomy
timeFrame: Within1 month of endarterectomy
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Lausanne University Hospitals
name: John O. Prior, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnesin S, Mitsakis P, Cicone F, Deshayes E, Dunet V, Gallino AF, Kosinski M, Baechler S, Buchegger F, Viertl D, Prior JO. First in-human radiation dosimetry of 68Ga-NODAGA-RGDyK. EJNMMI Res. 2017 Dec;7(1):43. doi: 10.1186/s13550-017-0288-x. Epub 2017 May 18.
Clinical trial NCT01399216: Effects of a Supplement Containing Fucoidan on Basal Body Temperature
Official title: Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Basal Body Temperature
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Three Peace Co., Ltd., Japan
First posted: 2011-07-21
Enrollment: 19
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in subjects with low basal body temperature.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with basal body temperature \< 36.0 ºC
* Healthy as based on medical history and physical examination
* Willing not to donate blood during the study
* Informed consent signed

Exclusion Criteria:

* Renal or hepatic dysfunction
* Heart disease
* Participation in any clinical trial within 90 days of the commencement of the trial
* Subjects who are taking medicines or functional food that may affect basal body temperature

Primary outcomes:
measure: Basal body temperature
timeFrame: up to 20 weeks
Secondary outcomes:
measure: Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)
timeFrame: Weeks 0, 8, 12, and 20
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06523816: Dermoscopy and Histopathology in Non-melanocytic Skin Tumors
Official title: Correlation Between Dermoscopy and Histopathology in Non-melanocytic Skin Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-melanoma Skin Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from those attending the outpatient clinic of department of Dermatology , Assiut University Hospitals.

Brief summary: The main aim of the study is to investigate the relation between dermoscopic findings in pre-operative diagnosis of non-melanocytic skin tumors and post-operative histopathology findings .


Eligibility criteria: Inclusion Criteria:

* All patients with NMST clinically of both genders in all ages with positive dermoscopic findings and definite histopathologic diagnosis of NMST

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: sensitivity of dermoscopy to detect NMSTs
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00463216: A Coordinated Return to Work Program
Official title: A Coordinated Return to Work Program for Workers on Long-term Sickness Absence Due to Musculoskeletal Disorders: a Prospective Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: back, neck, pain, sick leave
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 120
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: DIAGNOSTIC

Brief summary: The aim of the study is to investigate the possibility that a diagnostic evaluation by a multidisciplinary team reduces the length of sick leave.

Detailed description: Workers on sick leave due to back, neck or shoulder pain are randomized into 2 groups. Individuals in the intervention group are offered an extra multidisciplinary diagnostic evaluation. The multidisciplinary team consists of an occupational physician, a physiotherapist, a chiropractor, a psychologist and a social worker. The result is a coordinated evaluation of the individuals problems with suggestions as to further actions. The focus is on evaluating, if and when the individual can return to work. No treatment is given.

Verbatim exemption from the local medical ethics board:

"February 19, 2004 Journal no. VF 20040030 JK/csf Re: research project: A Coordinated Return to Work Program (KIA) The The Medical Ethics Committee of Vejle and Funen Counties has reviewed this research project at its meeting on February 9, 2004.

The entire committee decided that this project is an HTA (Health Technology Assessment) study and not a biomedical research project.

Therefore the committee decided that the project is not within the committee's legal competence areas, and is exempt from approval by a medical ethics committee before being carried out.

The committee has no further comments to this case. on behalf of the committee Sincerely Erik Laier Jette Krarup

__________________________________________________________________________________________________________________________________________________

Odense University Hospital direct telephone: +45 6541 3425 Kløvervaenget 10, 2.sal e-mail: Vejle-fynkomiteen@ouh.fyns-amt.dk 5000 Odense C fax: +45 6619 4392 Denmark"

Eligibility criteria: Inclusion Criteria:

* On sick leave due to back,
* Shoulder or neck pain

Exclusion Criteria:

* Pregnant,
* Other causes of sick leave

Primary outcomes:
measure: Number of hours on sick leave in the 1 year study period
Secondary outcomes:
measure: Sick leave related costs
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Dept Occup Environ Med, Vejle Hospital
Study officials:
affiliation: Vejle County, Vejle, Denmark
name: Jorgen Kilsgaard, chiropract
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398916: Music Listening to Reduce Pain and Anxiety During LEEP
Official title: Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. However, it could be associated with significant pain and anxiety.

The aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.


Eligibility criteria: Inclusion Criteria:

* Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix

Exclusion Criteria:

* Allergy to local anesthetic agent (lidocaine)
* Pregnancy
* Previous major surgical procedures on cervix (conization, LEEP, laser therapy, cryotherapy) or uterus
* Using cardiac pacemaker or history of cardiac arrhythmia
* Neurological disorder affecting perception of pain
* History of lower urinary tract cancer
* Coagulation defects
* History of drug dependence
* Lower genital tract infection
* Apparent invasive cancer of the cervix
* Hearing difficulty

Primary outcomes:
measure: Procedure-related pain, as measured by Visual Analog Scale
timeFrame: During the procedure
Secondary outcomes:
measure: Procedure-related anxiety, as measured by Visual Analog Scale
timeFrame: During the procedure
measure: Procedure-related satisfaction, as measured by Visual Analog Scale
timeFrame: During the procedure
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Kittipat Charoenkwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000216: Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts - 1
Official title: Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Depression
measure: Withdrawal symptoms
measure: Opioid and cocaine use
measure: Social and psychological functioning
measure: AIDS risk behavior
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Residential Services Division
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schottenfeld RS, Pakes JR, Oliveto A, Ziedonis D, Kosten TR. Buprenorphine vs methadone maintenance treatment for concurrent opioid dependence and cocaine abuse. Arch Gen Psychiatry. 1997 Aug;54(8):713-20. doi: 10.1001/archpsyc.1997.01830200041006.
Clinical trial NCT00399516: Effect of Pulse Width With Spinal Cord Stimulation
Official title: The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Chronic Pain
Back Pain
Keywords: Pain
Neurostimulation
Back pain
Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.

Detailed description: This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.

Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.

Eligibility criteria: Inclusion Criteria:

* Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
* Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
* Be 18 years of age or older.
* Be willing and able to comply with all study related procedures and visits.
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
* Have any other chronic pain condition likely to confound evaluation of study endpoints.

Primary outcomes:
measure: Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
timeFrame: Within 6 months post-implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Comprehensive Pain Management and Rehabilitation
state: Alabama
Study officials:
affiliation: Comprehensive Pain and Rehabilitation
name: Thomas Yearwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543816: MK0767 Added to Insulin Therapy in Patients With Type 2 Diabetes (0767-030)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look to see if MK0767 works better than placebo in controlling blood sugar in patients with Type 2 Diabetes who are taking insulin but do not have adequate control of their blood sugar.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes with inadequate glycemic control
* Patient is on stable insulin therapy alone or with one oral antidiabetic agent
* Male or non-pregnant female 21 years or older
* Total daily dose of insulin must be less than or equal to 30 but not greater than or equal to 200 units/day

Exclusion Criteria:

* Have a history of type 1 diabetes mellitus
* History of ketoacidosis who are being treated with insulin
* Are taking 2 or more antidiabetic agents in combination with insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: