louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00814775: Comparison Between the Fastrach and CTrach Laryngeal Mask Airway
Official title: Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intubation
Keywords: Laryngeal mask
Difficult intubation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-12-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.

Detailed description: Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices.

Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.

Eligibility criteria: Inclusion Criteria:

1. Patients with an ASA score of 1-3.
2. Scheduled for elective surgical procedure
3. Age 18 and above
4. Patients with Mallampati airway classification scores III and IV

Exclusion Criteria:

1. Current pregnancy
2. Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures
3. Patients with obstructive sleep apnea or with a history of difficult ventilation
4. Mouth opening less than 3 cm.
5. Patients with indication for awake fiberoptic intubation or with a history of difficult intubation
6. Patients with cancer of the neck or the upper airway
7. Emergent surgery, patients requiring rapid sequence induction
8. Patients with severe gastroesophageal reflux
9. Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.

Primary outcomes:
measure: To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy
timeFrame: from start of intubation to successfully intubated
measure: To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Marco Maurtua, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01272375: This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Official title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.

Primary outcomes:
measure: Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793
timeFrame: 48 hours
measure: Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.
timeFrame: 48 hours
Secondary outcomes:
measure: Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793.
timeFrame: 48 hours
measure: Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793.
timeFrame: 48 hours
measure: Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma.
timeFrame: 48 hours
measure: Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01104675: Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
Official title: A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Cancer
Peritoneal Cancer
Keywords: ovarian
platinum resistant ovarian cancer
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.


Eligibility criteria: Inclusion Criteria:

* Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
* Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
* Greater than or equal to 18 years of age
* Have clinically acceptable laboratory screening results
* Have an ECOG performance status of 0 or 1
* Able to tolerate oral medications

Exclusion Criteria:

* Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
* Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
* Have active, acute, or chronic clinically significant infections or bleeding
* Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome

Primary outcomes:
measure: Progression free survival rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Boston
country: United States
facility: Dana Farber/Partners Cancer Care
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: CASI Pharmaceuticals, Inc.
name: William Gannon, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01098175: Peritoneal Cavity Conditioning During Open Surgery.
Official title: Peritoneal Cavity Conditioning During Open Surgery Decreases Postoperative Pain and Inflammation and Decreases Time to Restore Transit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laparotomy
Thoracotomy
Keywords: laparotomy
thoracotomy
peritoneal conditioning
humidification
temperature control
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Standard open surgery such as hysterectomy, cancer surgery, bowel resections, cardiac surgery

Brief summary: Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit faster.

Detailed description: Aim of the Trial :

RCT demonstrating that peritoneal cavity conditioning during open surgery will result in a less postoperative inflammation, less postoperative pain, and shorter time to flatus and transit.

Eligibility criteria: Inclusion criteria :

* patients will be stratified and randomised according to the type of surgery
* total laparoscopic hysterectomy,
* promontofixation
* cholecystectomy

Exclusion criteria :

* Any pre-existing condition increasing the risk of surgery such as age, pre-existing conditions as clotting disorders, heart or lung impairment etc.
* Not signed informed consent
* known allergic reaction to Sprayshield, Intercoat of hyalobarrier gel ® or - any bowel lesion requiring a single or double layer suture. (given that for none of the any anti-adhesion barriers safety has been proven following bowel lesions and suture)
* Any condition that might interfere with inflammatory parameters or pre-existing such as ,pregnancy, immunodeficiency, chronic inflammatory disease as Crohn's disease, chronic pain conditions as (peripheral neuropathy, pathology of the vertebral column and osteo-articular disease, any condition causing acute pain e.g. trauma.

Primary outcomes:
measure: Primary endpoint : decreased pain on day 1 and 2 after surgery
timeFrame: 0 to 7 days
Secondary outcomes:
measure: decrease in CRP and inflammatory parameters on day 1 and 2 or longer
timeFrame: day 1-4
measure: lower peritoneal fluid volume on day 2
timeFrame: day 2 after surgery
measure: Shorter time to resumption of transit: time to first flatus and time to first stool
timeFrame: day1 to 5
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
Study officials:
affiliation: UZ Gasthuisberg, KULeuven
name: philippe R Koninckx, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06832475: Comparing the Impact of Rubber Bands on Teeth Straightening with Clear Aligners Versus Traditional Braces: a Clinical Study
Official title: Effects of Class II Elastics During Treatment with Clear Aligners Vs Fixed Appliance: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
IMPA Angle
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial, blinded about the type of treatment
Primary purpose: TREATMENT

Brief summary: Aim: To analyze the inclination of lower incisors in patients with Class II malocclusion treated with elastics and clear aligners compared to a group wearing the same elastics and fixed appliance. A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years, was randomly divided in two groups: Clear aligner group (CA), Fixed appliance group (FA). The subjects were selected according to inclusion criteria: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no history of orthodontic treatment.

Detailed description: Trial design: Prospective two-arms parallel group randomized clinical trial with 1:1 allocation ratio.

Materials and Methods: A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years, was collected from the Department of Orthodontics at Policlinico "Tor Vergata" of Rome, and it was randomly divided in two groups: Clear aligner group (CA), Fixed appliance group (FA). The subjects were selected according to inclusion criteria: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no history of orthodontic treatment. Results: In the short term (T1-T0=18 months), the analysis of the results showed no statistically significant changes in all evaluated parameters. Therefore, there is no statistically significant change in the inclination of the lower incisors between the two groups.

Conclusions: The use of Class II elastics in CA group showed a better control of the lower incisors' inclination, compared to the FA group, even if the difference is not significant.

Trial registration: ClinicalTrials.gov (registration number: ..........)

Eligibility criteria: Inclusion Criteria:

* full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no or moderate crowding (0- 3 mm) no history of orthodontic treatment.

Exclusion Criteria:

* not completed permanent dentition, skeletal Class II or dental Class II more than 4 mm, crowding more than 3 mm, subjects already treated with iother orthodontic appliances.

Primary outcomes:
measure: Comparison between two different devices to solve class II dental malocclusion
timeFrame: From enrollment to the end of treatment at 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Tor Vergata
Study officials:
References:
Clinical trial NCT01765075: Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
Official title: Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Permanent Atrial Fibrillation
Keywords: Electrophysiological mapping
Multi-electrode catheter
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Permanent atrial fibrillation

Brief summary: The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
* Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation
* Able to meet study requirements for follow-up visit

Exclusion Criteria:

* Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves
* Active systemic infection or sepsis
* Echocardiographically confirmed presence of thrombus
* Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required
* Subjects who cannot be anticoagulated or infused with heparinized saline
* Heparin induced thrombocytopenia
* Hemodynamic instability or shock
* Atrial anatomy contradictory to catheter labeling or size indices
* EF \< 35%
* Subjects with an active heart failure decompensation

Primary outcomes:
measure: Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.
timeFrame: Acute - time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Na Homolce
city: London
country: United Kingdom
facility: Guys & St. Thomas' Hospital
Study officials:
affiliation: Guys & St. Thomas' Hospital
name: Jas Gill, MA MD FRCP FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Child N, Clayton RH, Roney CH, Laughner JI, Shuros A, Neuzil P, Petru J, Jackson T, Porter B, Bostock J, Niederer SA, Razavi RS, Rinaldi CA, Taggart P, Wright MJ, Gill J. Unraveling the Underlying Arrhythmia Mechanism in Persistent Atrial Fibrillation: Results From the STARLIGHT Study. Circ Arrhythm Electrophysiol. 2018 Jun;11(6):e005897. doi: 10.1161/CIRCEP.117.005897.
Clinical trial NCT03894475: Non-inferiority of Portable Versus Desktop Spirometry
Official title: Non-inferiority of Portable Versus Desktop Spirometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
COPD
Keywords: Asthma
COPD
Mobile Spirometry
Lead sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
Sponsor class: OTHER
Collaborators: name: Healthup Sp. z o.o.
First posted: 2019-03-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators compared the ventilation parameters for volume and flow obtained from standard spirometry procedures from patients presently monitored and treated for asthma or chronic obstructive pulmonary disease (COPD) using AioCare (HealthUp Sp. z o.o., Serial Number: MS082017005412, software version: MySpiroo app 1.1.14) as the tested device and Spirometer USB CPFS/D (MGC Diagnostics) as the reference, which required calibration prior to each session. Spirometry measurements were performed on sixty-two patients (forty-four females (58±17 years old) and eighteen males (52±19 years old)) at the Institute of Tuberculosis and Lung Disease in Warsaw, Poland. Participants were asked to perform correct spirometry examinations (which means at least three technically correct exhales and meeting repeatability criteria for FEV1 and FVC) on both measuring devices with a five-minute break between devices to prevent respiratory muscle fatigue. The highest value from all acceptable spirometry results was then used for analysis. All spirometry examinations followed ERS/ATS standards.


Eligibility criteria: Inclusion Criteria:

1. Age\>18.
2. Diagnosed asthma or COPD
3. Signed consent to participation in the research experiment.
4. Ability to comply with the spirometry protocol.

Exclusion Criteria:

1. Pregnant females (based on declaration; no pregnancy tests are planned before the test).
2. Recent myocardial infarction (\<30 days).
3. Known thoracic, aortic or cerebral aneurysm.
4. Recent stroke, eye surgery, thoracic/abdominal surgery.
5. Haemoptysis.
6. Recent pneumothorax.
7. Uncontrolled hypertension.
8. Pulmonary Embolism.
9. Angina.
10. Chest or abdominal pain of any etiology.
11. Oral or facial pain exacerbated by a mouthpiece.
12. Stress incontinence.
13. Dementia or state of confusion. 14, Acute Diarrhea

Primary outcomes:
measure: Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer
timeFrame: 6 months
measure: Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer
timeFrame: 6 months
measure: Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute for Tuberculosis and Lung Diseases
state: Mazowieckie
Study officials:
affiliation: National Institute for Tuberculosis and Lung Diseases, Poland
name: Piotr Boros, Prof. dr hab. n. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204175: Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality
Official title: A Randomised Control Trial of a Sanitation Operation and Management Intervention in Elementary Schools in the Philippines (Fit for School Plus)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Hygiene
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Deutsche Gesellshaft fur Internationale Zusammenarbeit (GIZ) GMBH
name: Academic Centre for Dentistry in Amsterdam
First posted: 2017-06-29
Enrollment: 8687
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess the impact of a school-based water, sanitation, and hygiene management intervention on toilet use and pupil handwashing in the Philippines.


Eligibility criteria: Inclusion Criteria:

* Attending study school on day of observation

Exclusion Criteria:

* No predefined exclusion criteria since individual-level data is not recorded.

Primary outcomes:
measure: Toilet Usability Index
timeFrame: 5 months after intervention delivery
Secondary outcomes:
measure: Soap Use Ratio
timeFrame: 5 months after intervention delivery
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: GIZ / Fit For School
Study officials:
References:
citation: Buxton H, Dimaisip-Nabuab J, Duijster D, Monse B, Benzian H, Dreibelbis R. The impact of an operation and management intervention on toilet usability in schools in the Philippines: a cluster randomised controlled trial. BMC Public Health. 2019 Dec 16;19(1):1680. doi: 10.1186/s12889-019-7833-7.