louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04426409: Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children
Official title: Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Intubation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which is reported as the most common side effect.

In order to reduce these side effects, heating of the tube and use of a tube lubricant immediately before intubation have been recommended in children. However, research on whether the dry state of the mucosa itself contributes to the development of epistaxis is limited. A study in adults reported that pretreatment of the ointment on the mucosa reduced the damage to the mucosa. However, its effect on the incidence of epistaxis in children has not been studied.

The purpose of this study is to investigate the effects of pretreatment of nasal ointment on epistaxis of nasotracheal intubation in children.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical statue I or II
* Patients scheduled to undergo surgery under nasotracheal intubation

Exclusion Criteria:

* expected difficult intubation based on history, physical examination, weight.
* bleeding tendency
* upper respiratory infection within the previous 14 days

Primary outcomes:
measure: incidence of epistaxis
timeFrame: immediate after intubation
measure: incidence of epistaxis
timeFrame: immediate after extubation
Secondary outcomes:
measure: severity of epistaxis
timeFrame: immediate after intubation
measure: severity of epistaxis
timeFrame: immediate after extubation
measure: Navigability
timeFrame: immediate after intubation
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeong-gi
Study officials:
References:
Clinical trial NCT02533609: Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
Official title: Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Bacterial Infection
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Deutschland GmbH
First posted: 2015-08-27
Enrollment: 30
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: Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation

Brief summary: Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate

1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
2. whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h


Eligibility criteria: Inclusion Criteria:

* Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
* Age \> 18 y

Exclusion Criteria:

* \< 18 y
* Pregnancy
* Contraindications against citrate-anticoagulation or continous renal replacement therapy

Primary outcomes:
measure: Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d)
timeFrame: up to three days
measure: Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD
timeFrame: up to three days
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Prof. Kindgen-Milles
Study officials:
affiliation: Department of Anesthesiology
name: Detlef Kindgen-Milles, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00564109: Are the Pancreatic Serum Proteins Pancreatic Stone Protein (PSP) and Pancreatitis-Associated Protein (PAP) Predictive for the Development of Sepsis? Retrospective Study in Trauma Patients With Soft Tissue Defects.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma Patients With Soft Tissue Defects
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma patients

Brief summary: Retrospective analysis of PSP- and PAP-serum levels in trauma patients with soft tissue defects and possible correlation with the incidence and onset of infection and sepsis.


Eligibility criteria: Inclusion criteria:

* Trauma patients submitted to the university hospital Zurich, aged 18-65 with soft tissue defects

Exclusion criteria:

* Patients with known immunocompromising illnesses, drug abuse or infectious diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT01902056: Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix
Official title: Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Efficacy
Keywords: allograft
acellular dermal matrix
Alloderm
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
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 compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.

Detailed description: Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.

Eligibility criteria: Inclusion Criteria: The inclusion criteria were;

1. one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
2. at least 18 years of age
3. must sign the informed consent -

Exclusion Criteria: The exclusion criteria included:

1. uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
2. previous head and neck radiation
3. oral bisphosphonates for \> 3 years or any IV bisphosphonates
4. smoking \> 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
5. requirement for prophylactic antibiotics
6. allergies to any medication or material used in the study, or that would adversely affect study procedures
7. chemotherapy in the previous 12 months
8. psychological problems that would interfere with treatment
9. patients unable or unwilling to sign the informed consent
10. pregnancy -

Primary outcomes:
measure: Soft tissue thickness.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic, School of Dentistry, University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139356: The Effect of Spontaneous Respiration on Pulse-oximetry Measurements
Official title: The Effect of Spontaneous Respiration on Pulse-oximetry Measurements and Analysis of Variability Mechanisms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Respiratory Disease
COPD
Interstitial Lung Disease
Keywords: pulseoxymetry
capnography
Dead space
cardiac output
lung recruitment
deep breaths
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical experimental trial of changes in pulse-oxymetry measurements with deep inspirations
Primary purpose: OTHER

Brief summary: This is a study designed to measure, characterize and describe changes on pulse-oxymetry values produced as a result of deep breaths in patients with stable chronic hypoxemic respiratory failure.

Detailed description: There is no standard way of measuring rest pulse-oxymetry in terms of depth of respiration. Rest pulse-oxymetry values are used in the clinical setting to make therapeutic decisions regarding the need of supplemental oxygen. The primary goal of this study is to measure the change of pulse-oxymetry values during an experimental protocol of 10 deep breaths during one minute in patients with chronic hypoxemia. 45 patients will be studied in this first phase. In a second phase, secondary goals will be to measure Vd/Vt vent, noninvasive cardiac output and CT densitometry during the same deep breaths protocol in a subset of 13 patients with the grater increase observed in the first phase of study.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air
* Ambulatory patients capable of performing 6 min walking test
* Patients older than 18 years old.

Exclusion Criteria:

* Patients with significant collagen disease causing Raynaud phenomenon.
* Patients with hypothermia lower than 35 degrees Celsius
* Patients with rest SpO2 values equal or lower than 80% on room air
* Patients unable to perform PFTs
* Patients unable to complete 6 min walking test without supp O2.
* Patients unable to perform experimental deep breaths on CT scan

Primary outcomes:
measure: Change in O2 saturation
timeFrame: Lenght of experimental protocol: 6 minutes.
Secondary outcomes:
measure: Vd/VT
timeFrame: Lenght of experimental protocol: 6 minutes.
measure: Cardiac output (CO)
timeFrame: Lenght of experimental protocol: 6 minutes.
measure: CT recruitment
timeFrame: Lenght of experimental protocol: 6 minutes.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Facultad de Medicina y Hospital Universitario UANL
state: Nuevo Leon
Study officials:
affiliation: Facultad de Medicina y Hospital Universitario UANL
name: Uriel Chavarria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02531256: An Investigation of a New Laryngeal Mask Airway LMA Protector
Official title: An Investigation of a New Laryngeal Mask Airway LMA Protector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: Laryngeal Mask Airway
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2015-08-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of LMA Protector

Detailed description: This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.

Eligibility criteria: Inclusion Criteria:

* planned elective surgery with indication for LMA use

Exclusion Criteria:

* body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm

Primary outcomes:
measure: Number of insertion attempts
timeFrame: 5 minutes
Secondary outcomes:
measure: Oropharyngeal Leak Pressure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sng BL, Ithnin FB, Mathur D, Lew E, Han NR, Sia AT. A preliminary assessment of the LMA protector in non-paralysed patients. BMC Anesthesiol. 2017 Feb 20;17(1):26. doi: 10.1186/s12871-017-0323-5.
Clinical trial NCT05942456: Soluble B7-H3 as a Biomarker for Osteosarcoma
Official title: An Exploratory Research of Soluble B7-H3 Expression in Peripheral Blood as a Biomarker to Monitor Therapeutic Effect of Systemic Treatment for Osteosarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biomarker
Progression
Osteosarcoma
Surveillance
Keywords: sB7-H3
osteosarcoma
biomarker
prognosis
clinical evaluation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.

Brief summary: Increasing data has indicated an association between increased soluble B7-H3 (sB7-H3) levels and unfavorable prognosis in patients with malignancies. However, the level of sB7-H3 and its clinical significance in osteosarcoma are not well known. In this present study, we investigated whether sB7-H3 levels in serum could be as a biomarker for osteosarcoma treatment.


Eligibility criteria: Inclusion Criteria:

* High Grade osteosarcoma verified with pathologic diagnosis.
* systemic treatment-naive before the first time Blood drawing.
* ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy.
* All radiographs are complete for clinical evaluation.

Exclusion Criteria:

* Patients who Can't tolerate blood drawing.
* Patients without complete medical records in PKUPH system.
* Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy.
* other conditions that investigators think are not suitable for this study.

Primary outcomes:
measure: correlation of quantity of Protein B7-H3 Expression with clinical evaluation
timeFrame: 6 months
Secondary outcomes:
measure: correlation of quantity of Protein B7-H3 Expression with histological responses
timeFrame: 6 months
measure: correlation of quantity of Protein B7-H3 Expression with event-free survival
timeFrame: 2 years
measure: correlation of quantity of Protein B7-H3 Expression with overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
citation: Wang L, Kang FB, Zhang GC, Wang J, Xie MF, Zhang YZ. Clinical significance of serum soluble B7-H3 in patients with osteosarcoma. Cancer Cell Int. 2018 Aug 13;18:115. doi: 10.1186/s12935-018-0614-z. eCollection 2018.
citation: Xie L, Chen C, Liang X, Xu J, Sun X, Sun K, Yang R, Tang X, Guo W. Expression and Clinical Significance of Various Checkpoint Molecules in Advanced Osteosarcoma: Possibilities for Novel Immunotherapy. Orthop Surg. 2023 Mar;15(3):829-838. doi: 10.1111/os.13620. Epub 2022 Dec 15.
Clinical trial NCT01203956: DeVilbiss AutoAdjust With SmartFlex Comparative Study
Official title: A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; "AutoAdjust With SmartFlex Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: AutoAdjust
SmartFlex
Apnea Hypopnea Index
Patient reported outcomes
Lead sponsor: DeVilbiss Healthcare LLC
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.


Eligibility criteria: Inclusion Criteria:

* Epworth Sleepiness Scale \>10
* Body Mass Index \> 26
* Apnea-hypopnea index (AHI) ≥15 (mod to severe range)
* AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure
* CPAP naïve patients
* Polysomnogram (PSG) within 3 months of enrollment
* Average oxygen saturation by pulse oximetry (SpO2) \> 90% during titration
* Sleep efficiency on titration night ≥ 78%

Exclusion Criteria:

* Diagnosis of mild obstructive sleep apnea (OSA)
* Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness
* Allergies to mask materials
* Difficulties with nasal breathing
* Evidence of another primary sleep disorder
* Evidence of arousing periodic limb movements during titration
* Contraindications as listed on product labeling.
* Pregnant
* Currently diagnosed with depression if symptomatic
* Predominately central sleep apnea
* Deemed medically unsuitable by investigator
* Evidence of any type of infection or treatment of an infectious condition during the period of research participation
* Full Face Mask during titration
* Have a bi-level requirement
* CPAP pressure \>15cmH2O
* Subjects with tracheotomy
* Uncontrolled hypertension
* Require supplemental oxygen
* Stimulants, major tranquillizers or antipsychotics.

Primary outcomes:
measure: Apnea-hypopnea Index (AHI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Key Measures That Will be Used to Evaluate the Intervention(s)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: Sleep Medicine Associates of Texas
name: Leon Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946556: Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Official title: Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex Type Two Infection
HIV Infections
Keywords: herpes simplex virus type 2
HIV
genital immunology
CD4+ T cell
valacyclovir
HIV seronegativity
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells and dendritic cells) in the cervical mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV acquisition rates. The reasons for this negative result are unclear. The investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and HIV target cells in the cervix. The study will take the form of a randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1) the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.


Eligibility criteria: Inclusion Criteria:

* Female
* HSV2 infected

Exclusion Criteria:

* HIV infected
* Pregnant
* Taking HSV2 therapy
* Current/recent (past 3 months) genital infection

Primary outcomes:
measure: Number of CD4+ T cells on a cervical cytobrush.
timeFrame: Monthly intervals for 5 months
Secondary outcomes:
measure: Number of immature dendritic cells on a cervical cytobrush
timeFrame: Monthly intervals for 5 months
measure: Proinflammatory cytokine/chemokine levels in cervicovaginal secretions
timeFrame: Monthly intervals for 5 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's Health In Women's Hands
state: Ontario
Study officials:
affiliation: University of Toronto
name: Rupert Kaul, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rebbapragada A, Wachihi C, Pettengell C, Sunderji S, Huibner S, Jaoko W, Ball B, Fowke K, Mazzulli T, Plummer FA, Kaul R. Negative mucosal synergy between Herpes simplex type 2 and HIV in the female genital tract. AIDS. 2007 Mar 12;21(5):589-98. doi: 10.1097/QAD.0b013e328012b896.
citation: Yi TJ, Shannon B, Chieza L, Su D, Saunders M, Tharao W, Huibner S, Remis R, Raboud J, Kaul R. Valacyclovir therapy does not reverse herpes-associated alterations in cervical immunology: a randomized, placebo-controlled crossover trial. J Infect Dis. 2014 Sep 1;210(5):708-12. doi: 10.1093/infdis/jiu163. Epub 2014 Mar 23.