louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01692522: Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children
Official title: Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 80
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

Detailed description: After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation

Eligibility criteria: Inclusion Criteria:

* 0-16 years
* max 50kg
* ASA I-III

Exclusion Criteria:

* risk of aspiration
* known difficult airway
* congenital malformations respiratory tract

Primary outcomes:
measure: First attempt visualized blind intubation success rate
timeFrame: how many seconds needed
Secondary outcomes:
measure: Overall intubation success rate
timeFrame: how many seconds needed
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital
Study officials:
affiliation: University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
name: Robert Greif, MD MME FERC
role: STUDY_CHAIR
References:
citation: Kleine-Brueggeney M, Nicolet A, Nabecker S, Seiler S, Stucki F, Greif R, Theiler L. Blind intubation of anaesthetised children with supraglottic airway devices AmbuAura-i and Air-Q cannot be recommended: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):631-9. doi: 10.1097/EJA.0000000000000261.
Clinical trial NCT00266422: Neurological Outcome of VLBW Infants With Early Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 1. VLBW Infants
2. Hypotension
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-16
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: Comparison of short and long term neurological outcome of VLBW infants with and without early onset hypotension required intervention. The cohort includes all VLBW infants born in our institution between January 1997 and December 2000.


Eligibility criteria: Inclusion Criteria:

-VLBW infants born at the Sheba Medical Center between January 1997 and December 2000

Exclusion Criteria:

- none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Jacob Kuint, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03002922: Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)
Official title: Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise


Eligibility criteria: Inclusion Criteria:

Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be capable of understanding and providing written informed consent.

Subjects must sign a written confidentiality agreement including a photography release form.

Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.

Exclusion Criteria:

Subjects must not have received or used an Investigational New Drug within the last 30 days.

Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor. Subjects must not have a known physical or medical condition that would preclude vigorous exercise Subjects must not have a five-minute resting pulse rate greater than 80 bpm.

Primary outcomes:
measure: Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)
timeFrame: At baseline, and post exercise (30 minutes)
Secondary outcomes:
measure: Report of eye stinging assessed by questionnaire
timeFrame: Up to 30 minutes
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Hill Top Research
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04356222: Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Official title: Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Leptomeningeal Metastasis
Durvalumab
Keywords: Leptomeningeal Metastasis
Durvalumab
Intrathecal chemotherapy
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2020-04-22
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 observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis


Eligibility criteria: Inclusion Criteria:

1. Male and Female age 18 or more
2. Pathologically proven non-small cell lung cancer
3. MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid
4. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. KPS score \<60
2. History of autoimmune diseases
3. With severe hepatic and renal dysfunction
4. Has a history of (non-infectious) pneumonitis that required steroids

Primary outcomes:
measure: overall survival (OS)
timeFrame: 36 months
measure: Neurological Progression Free Survival(NPFS)
timeFrame: 36 months
measure: The incidence of adverse reactions
timeFrame: 36 months
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 36 months
measure: Objective response rate (ORR)
timeFrame: 36 months
measure: Neurological assessment
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Hui Bu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01442922: Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure
Official title: Intervertebral Disc Nucleus Augmentation With Allograft Meniscus With Minimally Invasive Surgical Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: L3-L4
L4-L5
L5-S1
Human Meniscus Allograft
Nucleus pulposus
Minimally invasive surgery
Degeneration of L3-L4 Intervertebral Disc
Degeneration of L4-L5 Intervertebral Disc
Degeneration of L5-S1 Intervertebral Disc
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative disk disease at L3-L4, L4-L5, or L5-S1 scheduled to undergo surgery for HMA implantation to replace the nucleus pulposus.

Brief summary: The primary purpose of the study is to establish the degree and duration of pain relief following minimally invasive surgery for a painful degenerative disc.

Detailed description: The investigators will study patient recovery (outcome measures) in patients who have had minimally invasive surgery for implantation of human meniscus allograft (HMA) to replace the nucleus pulposus of a degenerative intervertebral disc.

Eligibility criteria: Inclusion Criteria:

* diagnosis of degenerative disk disease at L3-L4, L4-L5, or L5-S1
* low back for no more that one year prior to enrollment

Exclusion Criteria:

* Osteoporosis
* Degenerative changes of vertebral endplates (obvious fractures, osteophytes)
* Modic Type II changes indicative of advanced bony degeneration
* Facet arthrosis (loss of facet joint cartilage, increased synovial fluid collection, or presence of osteophytes in inferior or superior plates)
* Discs classified with stage I or II degeneration
* Patients unable to have an MRI (pacemaker, claustrophobia, etc.)

Primary outcomes:
measure: Visual Analog Scale (VAS) documentation of the level of back pain. The (VAS) will describe the change in the level of back pain from the pre-op level.
timeFrame: Patients will complete the (VAS) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.
Secondary outcomes:
measure: The Oswestry Low Back Pain Disability Questionnaire (OLBPQ) function assessment The (OLBPQ) will describe the change in the level of function from the pre-op level.
timeFrame: Patients will complete the (OLBPQ) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics and Rehabilitation
name: Michael Mac Millan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00938522: Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention
Official title: PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Cilostazol loading
Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-07-14
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of cilostazol loading before planned PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective PCI
* Presence of coronary lesions amenable to stent

Exclusion Criteria:

* Cardiogenic shock
* Urgent PCI
* Hypersensitivity to aspirin, clopidogrel, or cilostazol
* LVEF \< 30% or congestive heart failure
* Bleeding diathesis
* leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3
* aspartate aminotransferase or alanine aminotransferase \> 3 times upper normal; serum creatinine \> 2.0 mg/dl
* noncardiac disease with a life expectancy \< 1 year
* inability to follow the protocol

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
timeFrame: at 3 months after PCI
Secondary outcomes:
measure: Late loss on quantitative coronary angiography
timeFrame: 9 months after index PCI
measure: % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS
timeFrame: 9 months after index PCI
measure: Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
timeFrame: 12 months after index PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695222: Cutaneous Squamous Cell Carcinoma Staging Study
Official title: Comparison of the Prognostic Capacity of Existing Staging Systems for Cutaneous Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at two tertiary Dermatology centers

Brief summary: Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer, and one of the most common cancers worldwide. The majority of CSCCs are easily removed by surgery and have excellent prognosis. However, a small subset has poor outcomes, including secondary spread in the body (metastasis) and death.

The investigators will look at existing CSCC in people from two UK dermatology centres. The investigators will then evaluate the accuracy of current staging systems in predicting risk of poor outcomes in people. The investigators hope that this project will improve the management of patients with CSCC by validating the predictive power of currently available histological staging classifications for cSCC. In the second stage of the study, The investigators will see whether better prediction tools can be found.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old with diagnosis of CSCC

Exclusion Criteria:

* Patients who decline for their data to be used for research purposes

Primary outcomes:
measure: Recurrence or metastasis
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: Dr Emilia Peleva
Study officials:
References:
Clinical trial NCT04221022: PHYSICAL ACTIVITY AS COPING STRATEGY FOR ACADEMIC STRESS AMONG UNDERGRADUATE FEMALE COLLEGIATE STUDENT
Official title: PHYSICAL ACTIVITY AS COPING STRATEGY FOR ACADEMIC STRESS AMONG UNDERGRADUATE FEMALE COLLEGIATE STUDENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity and Stress
Keywords: Physical Activity
academic stress
Light Physical activity
Moderate Physical Activity
Vigorous Physical Activity
Lead sponsor: Zohra Institute of Health Sciences
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical Inactivity is one of the major cause causing academic stress in students, so effectiveness of Light, moderate and vigorous physical activity as a baseline treatment were assessed through academic stress scale questionnaire, Cohen Perceived stress Scale and rapid assessment of physical activity (RAPA).

Detailed description: A total of 388 students participated in first phase of study and total 60 students with moderate academic stress were filtered. Among those only 37 were physically inactive from last one month by the assessment through RAPA (Rapid assessment of physical activity). ASS (Academic stress scale), Cohen Perceived stress Scale and RAPA questionnaires were used to collect data. Three equally distributed groups were given three different modes of physical activities i.e light, moderate \& vigorous.

Eligibility criteria: Inclusion Criteria:

* Undergraduate female students between 18-24 years.
* Students with moderate level of academic stress
* Students inactive from last one month

Exclusion Criteria:

* Students with any other type of stress
* Students with other psychological disorders
* Student with known systemic disease.
* Physically active from last one month were excluded.

Primary outcomes:
measure: Academic stress scale
timeFrame: upto 6 weeks
measure: Rapid Assessment Physical Activity scale
timeFrame: upto 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Syed Alamdar Hussain
state: KP
Study officials:
References:
Clinical trial NCT02421822: BMI Study for Children Ages 6-9 Years and Parents
Official title: BMI Study for Children Ages 6-9 Years and Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 487
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the Fitwits office tool and games with 6-9 year old children and their parents to: 1) assist parent-child dyad with correct BMI status identification and understanding; 2) address nutrition, portion size, and activity cues; and, 3) track BMI trajectory over 12-month period.

Detailed description: The investigators will study parents' perceptions of their child's BMI before and after the Fitwits intervention with a primary goal of improving parents' ability to identify their child's actual BMI status (underweight, healthy weight, overweight, or obese). Secondary goals are to measure changes in behaviors and BMI trajectories with repetitive use of the Fitwits office tool.

The study design is a longitudinal non-randomized intervention study with four time points (baseline, 3, 6, and 12 months). The investigators will recruit family medicine residents, fellows, and faculty at the investigators' three family health centers and enroll 150 parent/guardians and children aged 6-9 years at well child visits, regardless of initial BMI.

The investigators will use electronic health record-generated BMI percentages, the physician-led Fitwits Office Tool as the intervention, and self-reported surveys for the parent-child dyad. Surveys will record the BMI understanding -pre- and post-Fitwits intervention at each visit.

The investigators will compare the intervention to a control group residency-based family health center with usual care for child/parent dyads presenting at well child care and 12 months later. At this site the investigators will survey for correct parent identification of the child's BMI category.

Eligibility criteria: Inclusion Criteria:

* Ages 6-9 regardless of BMI status

Exclusion Criteria:

* non-English-speaking

Primary outcomes:
measure: Improved parent correct identification of child BMI category (surveys)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC St.Margaret Bloomfield/Garfield Family Health Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ann L McGaffey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914222: Comparing PA Compliance During and After Decompensation in HFP
Official title: Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congestive Heart Failure
Decompensated Heart Failure
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pulmonary Artery Compliance measurements will be obtained with the Respirix device in patients with congestive heart failure decompensation. Echocardiogram, weight measurements, and BNP will also be gathered as independent measures of decompensation in the clinic. Pulmonary Artery Compliance measurements will be made daily during the hospital stay. Patients can continue using the device at home for the next 3 weeks. Each patient will serve as their own control and relative changes from their baseline will be recorded for each parameter.


Eligibility criteria: Inclusion Criteria:

1. Patient must ≥ 18 years of age
2. Patient has been diagnosed with Congestive Heart Failure, class II-IV
3. Patient is currently being admitted for decompensation related to Congestive Heart Failure
4. Subject or subject's legally authorized representative is able to give informed consent before entering the study.

Exclusion Criteria:

1. Currently pregnant or breastfeeding
2. Clinical signs or symptoms of a respiratory infection
3. Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment
4. Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator
5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Primary outcomes:
measure: Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
timeFrame: Through study completion, up to 1 month depending on readmission
measure: Vasoactives resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
timeFrame: Through study completion, up to 1 month depending on readmission
measure: Fluid status based on weight changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
timeFrame: Through study completion, up to 1 month depending on readmission
measure: Clinical congestion measurement changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
timeFrame: Through study completion, up to 1 month depending on readmission
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
Study officials:
References: