louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04928404: Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients
Official title: Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: tongue base
tongue base suspension
barbed suture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events.

One of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea.

DeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.


Eligibility criteria: Inclusion Criteria:

* BMI of patients less than 35 kg/m2.
* Patients who have symptoms and signs of OSA.
* Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15).
* Friedman tongue position III or IV.
* Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
* The presence of retrolingual collapse confirmed preoperatively with flexible fiberoptic endoscope during Muller maneuver.
* Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm.

Exclusion Criteria:

* Failure to attend postoperative follow-up polysomnography within 6 months of surgery.
* Previous surgery to the base of the tongue or other surgical treatment of OSAHS.
* A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery.
* Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.
* Huge lymphoid tissue of the tongue and/or lingual tonsil.

Primary outcomes:
measure: changes in obstructive sleep apnea
timeFrame: 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT05159804: Association Between Carotid Plaque Length and Cardiovascular Events
Official title: Association Between Carotid Plaque Length and Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Arteriosclerosis
Keywords: Carotid Artery Ultrasound
Carotid Plaque
Coronary Artery Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Putuo Hospital, Shanghai University of Traditional Chinese Medicine
name: 904th Hospital of the Joint Logistics Support Force of the PLA
name: Gongli Hospital
name: Yueyang Hospital, Shanghai University of Traditional Chinese medicine
First posted: 2021-12-16
Enrollment: 3637
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized for coronary angiography and underwent carotid ultrasonography simultaneously

Brief summary: This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 3637 patients with coronary atherosclerosis who were confirmed by coronary angiography from January 2017 through December 2018.

Detailed description: Patients with coronary atherosclerosis who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was simultaneously performed, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.

Eligibility criteria: Inclusion Criteria:

* Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.

Exclusion Criteria:

* Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 3 years
Secondary outcomes:
measure: Incident cardiovascular events
timeFrame: 3 years
Other outcomes:
Locations:
city: Wuxi
country: China
facility: No. 904 Hospital of the PLA Joint Logistics Support Force
state: Jiangsu
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Gongli Hospital
state: Shanghai
city: Shanghai
country: China
facility: Putuo Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Pan Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Putuo Hospital
name: Jian Na, MD
role: STUDY_DIRECTOR
affiliation: 904th Hospital of the Joint Logistics Support Force of the PLA
name: Liang Chen, MD
role: STUDY_DIRECTOR
affiliation: Gongli Hospital
name: Wei Zhang, MD
role: STUDY_DIRECTOR
affiliation: Yueyang Hospital
name: Yawei Yang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04077801: Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain: An Observational Case-control Study
Official title: Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain: An Observational Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Pain
Keywords: Pelvic girdle Pain, lumbopelvic angles, pelvic parameters, and temporomandibular joint disorders.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 75 women will participate in this study, The selected cases divide into a study group(A) included 44 women who have CPP and group (B) included 31 women of the participants were normal and considered the control group. They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre.

All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study (

Brief summary: Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.

Detailed description: Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.

Eligibility criteria: Inclusion Criteria:

- The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs

Exclusion Criteria:

* Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality. Major jaw abnormality. Any jaw orthotics or prosthesis. Missing teeth.

Primary outcomes:
measure: body mass index
timeFrame: 3 months
measure: Pelvic tilt in degrees:
timeFrame: 3 months
measure: jaw movement
timeFrame: 3 months
measure: Spinal curves Measurement
timeFrame: 3 months
measure: Satisfaction assessed by the VAS
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Rovan Elbesh
Study officials:
References:
Clinical trial NCT01559701: Long-term Safety of PF-00345439 (Oxycodone)
Official title: A Long-Term, Open-Label, Safety Study Of PTI-821 In Patients With Moderate To Severe Chronic Low Back Pain Or With Moderate To Severe Chronic Pain Due To Osteoarthritis Of The Hip Or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Safety
PF-00345439
Remoxy
PTI-821
Lead sponsor: PainT
Sponsor class: UNKNOWN
First posted: 2012-03-21
Enrollment: 823
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis

Detailed description: This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of analgesia, and the global assessment of study medication.

Eligibility criteria: Inclusion Criteria:

* Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while regularly taking one or more of the following types of oral analgesic medication(s) prior to the Baseline Visit.
* Patient agrees to refrain from taking any opioid medications other than study drug during the study period. Patients must agree to report all non-opioid analgesic medications taken.
* Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or IUD). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at the Baseline Visit.

Exclusion Criteria:

* Patient has a positive urine drug screen at the Baseline Visit.
* Patient currently is on an opioid regimen with a daily opioid dose equivalent of oxycodone \> 160 mg.
* Patient has major surgery planned during the proposed study period.

Primary outcomes:
measure: Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 12 months
Secondary outcomes:
measure: Percent change from baseline Pain Intensity Scale
timeFrame: baseline 1, 3, 6, 9 and 12 months
measure: Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor.
timeFrame: 1, 3, 6, 9 and 12 months
measure: Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor.
timeFrame: 1, 3, 6, 9 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00136201: Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections
Official title: A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Abscess
Keywords: Peritonitis
Community-Acquired Infections
Cross Infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 200
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: The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. \<br /\>


Eligibility criteria: Inclusion Criteria:

· Hospitalized male or female subjects over 18 years of age

Exclusion Criteria:

· Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.

Primary outcomes:
measure: Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
Secondary outcomes:
measure: Microbiological response at the subject and pathogen level and evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and minimal inhibitory concentration (MIC) values and susceptibility data by isolate
Other outcomes:
Locations:
city: Guoxuexiang
country: China
state: Chengdu
city: Shengyang
country: China
state: Liaoning
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Wuhan
country: China
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For China, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Z, Wu J, Zhang Y, Wei J, Leng X, Bi J, Li R, Yan L, Quan Z, Chen X, Yu Y, Wu Z, Liu D, Ma X, Maroko R, Cooper A. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial. BMC Infect Dis. 2010 Jul 21;10:217. doi: 10.1186/1471-2334-10-217.
citation: Fomin P, Koalov S, Cooper A, Babinchak T, Dartois N, De Vane N, Castaing N, Tellado J; 301 And 306 Study Groups. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. J Chemother. 2008 Oct;20 Suppl 1:12-9. doi: 10.1179/joc.2008.20.Supplement-1.12.
Clinical trial NCT03407001: Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis
Official title: Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cirrhosis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.

SECONDARY OBJECTIVES:

I. Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).

OUTLINE:

Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason intravenously (IV) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.

Eligibility criteria: Inclusion Criteria:

* Able and willing to provide written informed consent
* Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI

Exclusion Criteria:

* History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
* Pregnant patients-excluded by history
* Pediatric patients, as pediatric cirrhosis is uncommon

Primary outcomes:
measure: Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound
timeFrame: Up to 3 years
Secondary outcomes:
measure: Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ott Le
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02627001: Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial
Official title: Comparison of Air Leak During Ventilation With Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask in a Cadaver Model: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Apnea
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2015-12-10
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat medics.

Detailed description: This study comprised a randomized crossover trial of adult United States Army combat medic volunteers participating in a cadaver laboratory as part of their training. The study took place in Bulverde, TX. Participants were randomized to perform cadaver ventilation first using either the novel Nu-MaskR intraoral device or conventional bag valve mask. A one handed seal technique was used to simulate single operator ventilation. Participants were responsible for mask placement while a ventilator delivered 10 breaths each with a standardized tidal volume of 750 ml. After a 5-minute washout period, they performed ventilation using the alternative device. The primary outcome measure was air leak as calculated by subtracting tidal volume received from tidal volume delivered as measured by the ventilator.

Eligibility criteria: Inclusion Criteria:

* United States Army Combat Medics

Exclusion Criteria:

* Injuries precluding performance of bag valve mask ventilation

Primary outcomes:
measure: Received Minute Volume (Liters) as Measured by Wright Respirometer
timeFrame: 1 Minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00623701: Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
Official title: A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Rhinitis
Conjunctivitis
Keywords: sublingual grass pollen preparation
IgE-mediated Allergic Disease attributed to grass pollen
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety from a high-dosed sublingual grass pollen preparation


Eligibility criteria: Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to grass pollen
* Positive SPT
* Positive EAST
* Positive provocation Test

Exclusion Criteria:

* Serious chronic disease
* other perennial allergies

Primary outcomes:
measure: Symptom and Medication Score
timeFrame: Grass pollen season 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Prof. Kristian Reich, MD
Study officials:
affiliation: not affiliated
name: Kristian Reich, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469001: Evaluation of NT PRO BNP Guided Therapy on Hospitalization Rate and Mortality in Patients With Chronic HF NYHA II-IY
Official title: Phase 1 Study of Using BNP as Guided Parameter in Treatment HF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: Hospitalization and death from exacerbation CHF.
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic heart failure. Half of the patients were treated by common medical practice for patients with heart failure. The other half were treated according to BNP values and common medical practice.

Brief summary: To use continuous measurement of NT Pro BNP level as guide in therapy patients with CHF.

Detailed description: Group of 100 patients with CHF, NYHA II-IY will be followed for 1 years in outpatient clinic of our hospital for hospitalization, death, 6 min walking protocol, number of decompensation as a primary end point. 50 patients will be treated according usual practice in outpatient clinics and in 50 patients will be additionally used level of NT Pro BNP as additional parameter.If level NT Pro BNP will be goes down will not be changes in treatment regiment. If level of NT Pro BNP will be increased treatment will be intensified.At the end of 1 year follow up we will compare the result of two strategies.

Eligibility criteria: Inclusion Criteria:

* Patient older 18 y.old with CHF NYHA II-IY.

Exclusion Criteria:

* All conditions with life expectancy less than 2 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Michael Shochat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: