louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03810248: Association Between Obstructive Sleep Apnea and Bruxism
Official title: Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bruxism, Sleep
Obstructive Sleep Apnea
Keywords: sleep bruxism
polisomnography
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 640
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who have undergone polysomnography at the Instituto do Sono de Pelotas (ISP) between March 2012 and July 2018, who meet inclusion criteria.

Brief summary: The objective of this retrospective observational study will be to investigate the between the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed through polysomnography (PSG).

Detailed description: The SB and OSAS are sleep disorders with great importance for dentistry. The OSAS is characterized by partial or total obstruction of the upper airways. SB is defined as a repetitive activity of the mandibular musculature characterized by the tightening or grinding of the teeth and/or by the retrusion or propulsion of the mandible. This study retrospective observational will be evaluation to investigate the association between OSAS and SB. Data from PSG and medical records (n=640) will be collected from January 2012 to July 2018 at "Instituto do Sono de Pelotas (ISP)".

Eligibility criteria: Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who was undergone PSG at the "Instituto do Sono de Pelotas (ISP)";
* Have completed all the respective PSG reports.

Exclusion Criteria:

•Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.

Primary outcomes:
measure: Tabulation of polysomnographic report related to sleep efficiency
timeFrame: The deadline is until May 2020 to have all data collected
measure: Tabulation of polysomnographic report related to sleep bruxism
timeFrame: The deadline is until May 2020 to have all data collected
measure: Tabulation of polysomnographic report related to obstructive sleep apnea syndrome (SAOS)
timeFrame: The deadline is until May 2020 to have all data collected
Secondary outcomes:
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Noéli Boscato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05075148: Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment
Official title: Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Cysts
Keywords: Radiology, Interventional
Epidemiology
Vascualr embolisation
Percutaneous alcoholization
Aneurysmal bone cyst
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aneurysmal bone cyst

Brief summary: This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)


Eligibility criteria: Inclusion criteria:

* Male of female
* Aging from 0 to 30 years
* With typical aneurysmal bone cyst at initial imaging
* At least one interventional radiology procedure performed

Exclusion criteria:

* No initial surgery
* Patient refuses to participate

Primary outcomes:
measure: Difference of size lesion after treatement
timeFrame: day 1
Secondary outcomes:
measure: Number of pain
timeFrame: day 1
measure: number of deficience
timeFrame: day 1
measure: number of complication
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Catherine CYTEVAL, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03652857: Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
Official title: the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non Small Cell Lung Cancer
Keywords: Apatinib plus Vinorelbine
NSCLC
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 30
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: The purpose of this study is to assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer

Detailed description: This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.

Eligibility criteria: Inclusion Criteria:

* 18，Pathologically proven non small cell lung cancer

  * Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
  * Squamous cell carcinoma，no gene detection
  * Progress after second line
  * PS score \>2

Exclusion Criteria:

* Patients received apatinib or Vinorelbine treatment before
* EGFR, ALK or ROS1 mutation
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women

Primary outcomes:
measure: ORR
timeFrame: Approximately 1 years
Secondary outcomes:
measure: PFS
timeFrame: Approximately 1 years
measure: OS
timeFrame: Approximately 1 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Nong Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang X, Xiong Y, Xia Q, Wu F, Liu L, Zhou Y, Zeng L, Zhou C, Xia C, Jiang W, Liao D, Xiao L, Liu L, Yang H, Guan R, Li K, Wang J, Lei G, Zhang Y, Yang N. Efficacy and Safety of Apatinib Plus Vinorelbine in Patients With Wild-Type Advanced Non-Small Cell Lung Cancer After Second-Line Treatment Failure: A Nonrandomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201226. doi: 10.1001/jamanetworkopen.2020.1226.
Clinical trial NCT03700957: The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
Official title: A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotizing Enterocolitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.

Detailed description: The efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in preterm neonates will be evalutaed through measuring its immune-modulatory effect on proinflammatory cytokines.

Eligibility criteria: Inclusion Criteria:

* Preterm neonates having a gestational age equal or less than 34 weeks at birth.
* Weight (less than or equal 1.500 KG)
* Clinically stable to begin enteral feeding

Exclusion Criteria:

* Persistent bleeding at any level.
* Receiving medication to avoid coagulation.
* Persistent vomiting.
* Gastrointestinal malformations.
* Mother taking Omega-3 supplements and planning to breastfeed.

Primary outcomes:
measure: Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Future University in Egypt
name: Dina Abou El Fadl, Msc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shulhan J, Dicken B, Hartling L, Larsen BM. Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products. Adv Nutr. 2017 Jan 17;8(1):80-91. doi: 10.3945/an.116.013193. Print 2017 Jan.
citation: Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. Daily Enteral DHA Supplementation Alleviates Deficiency in Premature Infants. Lipids. 2016 Apr;51(4):423-33. doi: 10.1007/s11745-016-4130-4. Epub 2016 Feb 4.
citation: Abou El Fadl DK, Ahmed MA, Aly YA, Darweesh EAG, Sabri NA. Impact of Docosahexaenoic acid supplementation on proinflammatory cytokines release and the development of Necrotizing enterocolitis in preterm Neonates: A randomized controlled study. Saudi Pharm J. 2021 Nov;29(11):1314-1322. doi: 10.1016/j.jsps.2021.09.012. Epub 2021 Sep 25.
Clinical trial NCT01288157: A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects
Official title: A Randomized, Open-label Study to Evaluate the Pharmacokinetics of a Single Subcutaneous Administration of 50 mg or 100 mg Golimumab in a Pre-filled Syringe Formulation to Healthy Male Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Chinese Males
Keywords: healthy
adult
Chinese
male
Simponi
CNTO 148
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.

Detailed description: This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 50 mg or 100 mg golimumab as a subcutaneous injection.

Eligibility criteria: Inclusion Criteria:

* Have no clinically relevant abnormalities
* non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.

Exclusion Criteria:

* Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any underlying physical or psychological medical condition
* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.

Primary outcomes:
measure: Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects
timeFrame: Day 71 (Week 11)
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Day 71
measure: Immunogenicity of golimumab, as measured by antibodies to golimumab
timeFrame: Day 71
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01601457: Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
Official title: A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Trauma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.


Eligibility criteria: Inclusion Criteria:

* Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction
* Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume

Exclusion Criteria:

* A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
* Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries
* Body weight exceeding 135 kg
* Cardiac arrest following trauma and prior to surgery
* Known congenital bleeding disorders
* Known pregnancy or positive pregnancy test at enrolment

Primary outcomes:
measure: Total volume of perioperative blood loss
Secondary outcomes:
measure: Volumes of intraoperative and postoperative blood loss
measure: Volume of blood transfused during the perioperative period
measure: Vital signs
measure: Adverse events
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2005 May;94(5):586-91. doi: 10.1093/bja/aei102. Epub 2005 Feb 25.
citation: Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
Clinical trial NCT00298857: A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
Official title: An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy
Obesity
Pharmacokinetics
Keywords: Healthy
Obesity
Pharmacokinetics
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2006-03-03
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

Detailed description: Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Eligibility criteria: Inclusion Criteria:

* Male or Female age 21-60 years
* Normal healthy volunteers as per interview at screening
* Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

* Inability to take oral medications
* pregnant or lactating females
* known hypersensitivity to valproic acid
* BMI less than 18.5 kg/m\^2
* BMI between 25 and 29.9 kg/m\^2, inclusive
* Taking any drug or dietary supplement within one week prior to study period
* Consumption of food 6 hours prior to study drug ingestion
* Know family history or history of urea cycle disorders
* Past history of pancreatitis
* Past history of liver disease

Primary outcomes:
measure: Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid.
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: North Shore - Long Island Jewish Medical Center
name: Alan Ettinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03050957: Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging
Official title: Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Deglutition Disorders
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 38
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oropharyngeal dysphagia (OD) is the most frequent digestive disorder in older people (\>70 years) and has been recently recognized as a geriatric syndrome. The main features of OD are: a high prevalence and severe complications either related with the decreased swallowing efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50% prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50% of mortality rate. However, there is no specific pharmacologic treatment for OD in older patients yet. Treatments are now evolving from compensation to active treatments aiming to restore the swallowing dysfunction and some groups have been looking for new therapeutic strategies. The main goal of this study is to evaluate the effect of administering menthol in bolus on the swallowing response in elderly and neurogenic patients with OD. In addition, this study will also assess the side effects of this pharmacological strategy.


Eligibility criteria: Inclusion Criteria:

* patients with suspicion of OD associated with aging (\>70 years), neurodegenerative diseases or stroke.

Exclusion Criteria:

* Patients with suspicion that they will not be able to compliment the protocol, patients participating or have participated in a clinical study the last 4 weeks and patients with alcoholic or drugs dependence

Primary outcomes:
measure: Laryngeal vestibule closure time
timeFrame: Laryngeal vestibule closure time is assessed during the videofluoroscopic assessment. Laryngeal vestibule closure time can occur between 100 milliseconds from the GPJ opening up to 1000 milliseconds.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06583148: A Smoke-Free Home Intervention in Tribal Communities
Official title: Assessing the Effectiveness of a Smoke-Free Home Program in Tribal Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco-Related Carcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2024-09-03
Enrollment: 575
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: This clinical trial evaluates a smoke-free home intervention for reducing exposure to secondhand smoke from commercial tobacco in homes of participants who live in rural tribal communities. Smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural tribal communities. Smoke-free policies, including those that target homes, can reduce exposure to secondhand smoke and support smoking cessation. Rural and racial/ethnic inequities intersect to increase tobacco-related harms among Indigenous populations. A smoke-free home program may improve the health of the household as well as impact smoking behavior among the family unit by reducing secondhand smoke exposure.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the effectiveness of a smoke-free homes intervention for tribal communities.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2.

GROUP II: Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.

After completion of study intervention, participants are followed up at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Self-report as being a smoker or living with a smoker
* Indicate that they do not reside in a smoke-free home
* Identify as living in an American Indian household

Exclusion Criteria:

* Children under the age of 18 will not be included

Primary outcomes:
measure: Self-Reported Smoke-Free Home
timeFrame: At 3 and 6 months
Secondary outcomes:
measure: Smoke-Free Vehicles Assessed Via Telephone Interview
timeFrame: At 3 and 6 months
measure: Secondhand Smoke (SHS) Exposure In The Home Assessed via Telephone Interview
timeFrame: At 3 and 6 months
measure: Number of Cigarettes Smoked In the Home
timeFrame: At 3 and 6 months
measure: Public Support for Smoke-Free Tribal Housing Assessed Via Telephone Interview
timeFrame: At 3 and 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Michelle Kegler, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: