louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04286581: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center
Official title: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if an I-gel laryngeal mask airway (LMA) has a higher oropharyngeal leak pressure compared to an Ambu Auragain in adult patients in an ambulatory surgery center.

Detailed description: Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.

Eligibility criteria: Inclusion Criteria:

- undergoing outpatient ambulatory surgery under general anesthesia that is amenable to using a laryngeal mask airway

Exclusion Criteria:

* non-English speaking patients
* patients with abnormal airway anatomy

Primary outcomes:
measure: Oropharyngeal Leak Pressure (OLP)
timeFrame: immediately after placement
Secondary outcomes:
measure: Time to Placement
timeFrame: time from opening mouth to successful placement (4 hours)
measure: Sore Throat
timeFrame: Pain right before discharge from pacu (8 hours)
measure: Sore Throat
timeFrame: 24 hours post-surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jacob Hutchins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03636581: Lifestyle Intervention Program in Overweight Medical Students
Official title: A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year. The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year. The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention. All final outcome measures will be performed at the end of the second year.


Eligibility criteria: Inclusion Criteria:

* Male and female NYITCOM students between the ages of 18-35
* BMI ≥ 25.0
* Body fat % \>19% for males; \>33% for women (will be determined by body composition scan)
* Own their own smartphone

Exclusion Criteria:

* People who have used weight loss smartphone applications in the past 6 month
* People who have used an activity tracker in past 6 months
* Anyone who answers yes to one or more questions on the PAR-Q screen
* Any contraindication to having a duel x-ray body scan performed based on the American College of Radiology's practice guidelines

Primary outcomes:
measure: Body fat percentage
timeFrame: 4 months
Secondary outcomes:
measure: Step Count
timeFrame: 4 months
measure: Resting Metabolic Rate
timeFrame: 4 months
measure: Total Cholesterol
timeFrame: 4 months
measure: High Density Lipoproteins
timeFrame: 4 months
measure: Low Density Lipoproteins
timeFrame: 4 months
measure: Triglycerides
timeFrame: 4 months
measure: Hemoglobin A1C
timeFrame: 4 months
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Joanne Donoghue
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370981: Exploratory Study of Pagoclone in Men With Premature Ejaculation.
Official title: A Four-arm, Randomized, Double-blind, Parallel, Placebo-controlled Exploratory Study of Pagoclone 0.15mg, 0.30mg, and 0.60mg in Men With Primary Premature Ejaculation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Ejaculation
Keywords: investigational drug
ejaculation
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

Detailed description: The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.

Eligibility criteria: Inclusion Criteria:

* A male regularly experiencing premature ejaculation
* 18 to 55 yrs old
* In a Stable relationship with one woman for at least 6 months

Primary outcomes:
measure: Intravaginal ejaculation latency time (IELT)
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama, PC
state: Alabama
city: San Diego
country: United States
facility: SD Uro-Research
state: California
city: Aurora
country: United States
facility: Urology Research Options
state: Colorado
city: Denver
country: United States
facility: Urology Associates, PC
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Fort Wayne
country: United States
facility: Northeast Indiana Research, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Davis Clinic, PC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island, PC
state: New York
city: Williamsville
country: United States
facility: Center for Urologic Research of WNY
state: New York
city: Charlotte
country: United States
facility: Metrolina Urology Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Edmond
country: United States
facility: Johnny B. Roy, MD Private Practice
state: Oklahoma
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
Study officials:
References:
Clinical trial NCT02296281: Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiation Pneumonitis
Lead sponsor: Beijing Continent Pharmaceutical Co, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Genomics, Inc.
name: GNI-EPS Pharmaceuticals, Inc. (GNI Group)
First posted: 2014-11-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years old (include 18 and 70 years), male or female
2. The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
3. General condition assessment, ECOG score of 0-1
4. Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
5. The expected survival at 6 months or more
6. Subject is able to eat solid food
7. The initial radical thoracic radiotherapy treatment
8. The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
9. The duration of radiation-induced lung injury in less than 1 month
10. Signed informed consent

Exclusion Criteria:

1. Radiation-induced lung injury has entered the chronic phase
2. A history of chronic bronchitis, emphysema, or a history of cor pulmonale
3. Lung resection surgery
4. Cancer progression
5. Pulmonary infection
6. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
7. With active peptic ulcer
8. Pregnant women and patients with mental disease
9. Those who participate in clinical trials of other drugs within 3 months
10. Investigator judge does not apply to participate in the trial

Primary outcomes:
measure: Changes in radiation-induced lung injury classification
timeFrame: 36 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05567081: Efficacy of Ultrasound-Guided PRP Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow
Official title: Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ulnar Neuropathy at Elbow
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was be performed on 60 patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography selected from Physical medicine, Rheumatology \& Rehabilitation Department, Faculty of Medicine, Tanta University.

Patients were be randomly divided into 2 groups:

Group I: will undergo a single ultrasound-guided deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve. PRP will be prepared by PRP method.

Group II: will undergo a single ultrasound-guided deep perineural injection with 1ml corticosteroid (triamcinolone acetonide, 40mg/mL) mixed with 1ml lidocaine hydrochloride.


Eligibility criteria: Inclusion Criteria:

* Patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography.

Exclusion Criteria:

1. Patients with severe ulnar neuropathy at elbow according to Gu's classification. 15
2. Brachial plexopathy, peripheral neuropathy, and cervical radiculopathy.
3. History of recent elbow trauma or operation.
4. Malignant neoplasm.
5. Pregnancy.
6. Bleeding Disorders.
7. Factors affecting nerve healing process e.g., tobacco use and systemic corticosteroid administration.
8. Contraindications for PRP injection:

   1. Significant renal or hepatic dysfunction.
   2. Critical thrombocytopenia.
   3. Hemodynamic instability.
   4. Septicemia.
   5. Local infection at the site of the procedure.
   6. Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks.
   7. Local injection at the suspected treatment site within the last month.
   8. Recent fever or illness.
   9. Hemoglobin level \<10 g/dL.
   10. Platelet dysfunction disorders.

Primary outcomes:
measure: Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
timeFrame: 1, and 3 months after injection
measure: Change in nerve conduction parameters of ulnar nerve at elbow after injection
timeFrame: 1 and 3 months after injection
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 month after injection
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
References:
Clinical trial NCT02821481: Beta-alanine and Elder Endurance
Official title: The Interactive Effects Of Beta-Alanine Supplementation and Resistance Training on Muscular Endurance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Endurance
Keywords: Neuromuscular
Supplementation
Elderly
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose for this study is to determine if beta-alanine supplementation combined with endurance-based resistance training can increase gains in muscular endurance to a greater extent than endurance-based resistance-training alone in older adults.


Eligibility criteria: Inclusion Criteria:

* 60-90 years of age
* Living independently (not residing in an assisted living facility)
* Through testing are found not to have sarcopenia
* Gait speed \> 1 m/s
* Skeletal Muscle Index \> 37% in men and \> 27.6 % in women
* Exclusion Criteria
* Responding with a "yes" to any question on the PAR-Q.
* Are currently pregnant, or plan to try and become pregnant during the study
* Functional impairments that could impede the person's ability to participate in a resistance training program
* Current or recent use of supplements (within the past 3 months for non-alanine containing supplements or one year for supplements containing beta-alanine). Individuals taking only basic multivitamins (without any herbal co-ingredients) may still be allowed to participate. These situations will be reviewed on a case-by-case basis.
* Are currently enrolled in a regular exercise program (more than once per week)
* Current or recent smoker
* Use of medication containing corticosteroids
* Mini-mental score of 21 or below
* Severe musculoskeletal impairment
* Uncontrolled chronic disease
* Major depression
* Severe vestibular problems

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Change in Performance of Daily Activities
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in Body Fat
timeFrame: baseline, 12 weeks
measure: Change in Muscular Endurance
timeFrame: baseline, 12 weeks
measure: Change in Muscular Strength
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Max Orovitz Laboratories
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph F. Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01769781: Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence
Official title: Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Keywords: endometriosis recurrence
pelvic pain
aromatase inhibitor
Lead sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor class: NETWORK
First posted: 2013-01-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Detailed description: Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Eligibility criteria: Inclusion Criteria:

* women affected by endometriosis showing recurrence of pain symptoms, previous surgery for endometriosis

Exclusion Criteria:

* presence of other systemic diseases

Primary outcomes:
measure: disease free time
timeFrame: 24 months
Secondary outcomes:
measure: time of pain disappearance
timeFrame: 24 months
Other outcomes:
measure: reduction of endometriosis lesions
timeFrame: 24 months
Locations:
city: Rome
country: Italy
facility: Cerm-Hungaria
Study officials:
affiliation: CERM-HUNGARIA
name: marco sbracia, md
role: STUDY_CHAIR
References:
Clinical trial NCT03294681: Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
Official title: Trans-impedance Matrix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-09-27
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Routine patients undergoing a standard cochlear implantation.

Brief summary: The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.


Eligibility criteria: Inclusion Criteria:

* Candidate for cochlear implantation with the CI532 or CI512 devices
* 18 years of age or older at the time of enrolment
* Normal cochlea anatomy, established via pre-operative Computer Tomography
* Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging
* Additional handicaps that would prevent participation in evaluations
* Pregnant and breast feeding women, prisoners, or anyone in custody
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure

Primary outcomes:
measure: Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over
timeFrame: at surgery, within one minute
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: HEARing CRC
city: Erlangen
country: Germany
facility: Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: Cochlear
name: Bart Volckaerts, PhD
role: STUDY_DIRECTOR
References:
citation: Hoppe U, Brademann G, Stover T, Ramos de Miguel A, Cowan R, Manrique M, Falcon-Gonzalez JC, Hey M, Baumann U, Huarte A, Liebscher T, Bennett C, English R, Neben N, Ramos Macias A. Evaluation of a Transimpedance Matrix Algorithm to Detect Anomalous Cochlear Implant Electrode Position. Audiol Neurootol. 2022;27(5):347-355. doi: 10.1159/000523784. Epub 2022 Mar 18.
Clinical trial NCT02018081: Pharmacokinetics of Levofloxacin in Intensive Care Unit
Official title: Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intensive Care Unit Syndrome
Community-acquired Pneumonia
Keywords: pharmacokinetic study : open, prospective, monocentric
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 52
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 aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio \> 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio \> 125. No therapeutic drug monitoring will be performed in this study.


Eligibility criteria: Inclusion Criteria:

* severe community-acquired pneumonia due to a strain sensible to levofloxacin
* Age \> 18 years
* Informed consent
* SAPS II (simplified acute physiological score) \> 20 Awaited duration of survival higher than 7 days

Exclusion Criteria:

* Historic of allergy to levofloxacin
* Resistant strain to levofloxacin
* Pregnancy
* Contra-indications of levofloxacin use, renal failure

Primary outcomes:
measure: Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
timeFrame: Levofloxacin concentration assessment at 8 different time points during 12h
Secondary outcomes:
measure: Efficiency (clinical,bacteriological, pharmacodynamic)
timeFrame: 12 hours
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Bernard GEORGES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: