louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01606969: Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution
Official title: Randomized Controlled Trial to Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution for the Effect on Hemodynamic Response Due to Scalp Infiltration in Patients Undergoing Craniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniotomy
Keywords: Dexmedetomidine
epinephrine
lidocaine
scalp infiltration
craniotomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Scalp infiltration with Epinephrine- containing lidocaine solution is common method for craniotomy but it may result in transient but significant hypotension in patients undergoing neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during scalp incision in craniotomy.

The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Aged between 20 and 70 year
* general anesthesia for craniotomy

Exclusion Criteria:

* Congestive heart failure, coronary artery occlusive disease
* Bradycardia \< 50 BPM, 2nd degree \< AV block
* Poorly controlled hypertension
* ß blocker medication
* Coagulopathy
* Pregnancy, nursing

Primary outcomes:
measure: Mean arterial pressure
timeFrame: before and after scalp injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT01411969: Impact of External Nasal Dilator on the Rhinogram
Official title: Acoustic Rhinometry: Impact of External Nasal Dilator on the Two First Notches of the Rhinogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Obstruction
Keywords: external nasal dilator strip
nasal valve
acoustic rhinometry
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 32 nasal cavities of 16 normal adult Caucasian individuals

Brief summary: The aim of this study is to present new data for a better understanding of the anatomic correlation of these two notches.

This study included 32 nasal cavities (16 individuals) with external nasal dilator strip (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray);

Detailed description: Acoustic rhinometry is more accurate in the anterior portion of the nasal cavities, from the nostril to the nasal valve (NV), the most important site of nasal obstruction. Literature presents different opinions regarding the anatomical correlation of the two notches at the beginning of the rhinogram curve in normal adult Caucasian individuals.

This prospective study included 32 nasal cavities under the following conditions: 1st - basal condition; 2nd - with external nasal dilator strip (ENDS) (Breath Right®); 3rd - after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray); 4th - after decongestion with ENDS.

Eligibility criteria: Inclusion Criteria:

* Adult, Caucasian

Exclusion Criteria:

* Allergies, sinusitis, nasal polyps, external nasal deformities congenital or acquired, obstructive nasal deviation and regular use of any drug.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Joao F Mello-Jr, Ph.D
role: STUDY_DIRECTOR
References:
citation: Seren E. The effect of an adhesive external nasal dilator strip on the inspiratory nasal airflow. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):e29-31. doi: 10.2500/ajra.2010.24.3426.
citation: Nigro CE, Mion O, Mello JF Jr, Voegels RL, Roithmann R. Acoustic rhinometry: impact of external nasal dilator on the two first notches of the rhinogram. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e247-50. doi: 10.2500/ajra.2011.25.3708.
Clinical trial NCT01791569: Pulse Oximetry- Evaluating Sensor Off- PCBA-1
Official title: Sensor Off Studies Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, Well Perfused subjects

Brief summary: To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications when the sensor is removed from the finger.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 or older (inclusive).
2. Subject is able to participate for the duration of the study
3. Subject is willing to sign an informed consent

Exclusion Criteria:

1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
2. Physiologic abnormalities that prevent proper application of a medical sensor and electrode
3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

Primary outcomes:
measure: Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.
timeFrame: 1-2 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Covidien
state: Colorado
Study officials:
References:
Clinical trial NCT05740969: Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
Official title: Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Actinic Keratoses
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to investigate the effect of 5-fluorouracil, imiquimod, and melatonin for actinic keratosis on immunological gene, and protein expressions profiles. Secondarily, the aim is to assess the effect of the treatment on the histopathology of actinic keratoses.


Eligibility criteria: Inclusion Criteria:

* Participants should have a clinical diagnosis of actinic keratosis
* Participants should be 18 years old or above
* Participants must sign an informed consent

Exclusion Criteria:

* Known allergic reaction to either 5-fluorouracil , imiquimod, or melatonin
* Immunomodulating treatment
* Predictable poor compliance (due to i.e. dementia, substance abuse, psychiatric disease, life-threatening disease or language barriers)
* Pregnant or breastfeeding
* Females not in menopause (defined as no menstruation during the last 12 months) should use a secure birth control (intrauterine devices, hormonal contraceptives including - oral pills, patches, vaginal rings and injections) during the entire period of the trial

Primary outcomes:
measure: Gene and protein expression profiles
timeFrame: 10 days of treatment
Secondary outcomes:
measure: histopathological assessment of actinic keratoses
timeFrame: 10 days of treatment
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
state: Region Sjælland
Study officials:
affiliation: Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial
name: Ismail A. Gögenur, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02622269: Patient-driven Compression in Urography
Official title: Patient-driven Compression in Urography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Keywords: Urography
Radiation dosage
image enhancement
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.

Evaluation of radiation dose, image quality and patients' experiences

Detailed description: Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.

Two compression devices are investigated in each patient, in randomized order.

Aims of the study:

1. Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.
2. Evaluate image quality with the two devices.
3. Describe patients' experiences from using the two devices.

Eligibility criteria: Inclusion Criteria:

* Outpatients with a request for a urographic study

Exclusion Criteria:

* Emergency studies,
* cannot participate actively with compression,
* contraindications to compression of the abdomen,
* pregnancy,
* inability to understand the language of the questionnaire

Primary outcomes:
measure: Radiation dose measured as Dose-area product
timeFrame: Immediately
Secondary outcomes:
measure: Image quality measured with Visual Grading
timeFrame: Immediately
measure: Patient experience (questionnaire)
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Radiology
Study officials:
affiliation: Örebro University, Sweden
name: Håkan Geijer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06437769: The Effect of Reiki on Cesarean During Hospitalization
Official title: The Effect of Reiki Applied to Women Who Have Been Hospitalized by Cesarean During the Hospitalization Process on Anxiety, Depression, Comfort and Breastfeeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the effect of reiki applied to women who have been hospitalized by cesarean during the hospitalization process on anxiety, depression, comfort and breastfeeding

Method: The study will be completed in a randomized controlled manner with a total of 70 women, 35 in the experimental group and 35 in the control group. Women in the experimental group Reiki therapy will be applied to the participants for 30 minutes while they lie down with their eyes closed. Research data will be collected with the Comfort Scale, Hospital anxiety and depression scale and bristol breastfeeding points and will be recorded

Detailed description: Design and Settings: This randomized controlled experimental study will conducted in the post operative room of the, Turkey between the dates of June 2024 and October 2024

Eligibility criteria: Inclusion Criteria:

* volunteering
* be over 18 years old
* Not having a diagnosed psychiatric disease
* no communication problems
* No drug sensitivity or allergy
* women who have had a cesarean section

Exclusion Criteria:

* Having a diagnosed psychiatric illness
* no communication problems
* Being under 18 years of age
* not volunteering to participate in the research
* drug sensitivity and allergy
* women who gave birth normally

Primary outcomes:
measure: anxiety and depression
timeFrame: immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
affiliation: Ondokuz Mayıs University
name: Sümeyye BAL, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03564769: Evaluation Study of SPOTme® Skin Cancer Screenings
Official title: Evaluation Study of SPOTme® Skin Cancer Screenings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: screening
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: American Academy of Dermatology (AAD)
First posted: 2018-06-21
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Detailed description: Despite tremendous growth in both the interest and volume of skin cancer screenings at the national level, the actual utility and impact of the AAD SPOT me™ skin cancer screening programs have not been fully evaluated. This study will address this knowledge gap. Early detection is vital in the fight against skin cancer, the most common cancer in the United States. While the effects of skin cancer can be devastating, this disease is highly treatable when detected early.

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Eligibility criteria: Inclusion Criteria:

* Participated in the American Academy of Dermatology national screening program in 2016 or 2017
* Have a presumptive diagnosis (screening, non-confirmed) of melanoma
* Have provided the AAD with permission to be re-contacted
* Have provided the AAD with an email address
* Aged 18 years or older
* Able to read English

Exclusion Criteria:

* None

Primary outcomes:
measure: Completion of a physician skin examination
timeFrame: Baseline
Secondary outcomes:
measure: Completion of a physician skin examination
timeFrame: 6 months
measure: Patient thorough skin self-examination (TSSE)
timeFrame: 6 months
measure: Patient attitude towards sun protection
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard TH Chan School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard TH Chan School of Public Health
name: Alan Geller, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201069: My Health Coach Study
Official title: My Health Coach Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: nutrition
physical activity
sleep
weight loss
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The "My Health Coach Study" seeks to determine if health coaching by a medical assistant can help patients have better sleep, a better diet, be more physically active or lose weight, according to the recommendation of their health care provider.

Detailed description: The aim of the study is to determine whether medical assistants (MAs) can assist primary care providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or increased physical activity in their patients. The hypothesis driving this research is that health coaching can be done by existing medical support staff to facilitate healthy lifestyles in a primary care setting. Coaching can maximize the health of the patient population in a cost-effective way if the coaching service is integrated into primary care clinics with minimal capital investment at the outset. A major focus will be on behaviors associated with weight management since this is the most common health issue in the U.S. today. This method, if successful, should be easily adaptable to other health behaviors and in most any medical practice that seeks to improve the health of its patient base in a cost-effective way.

In order to achieve a change in health behaviors, and especially weight loss, regular follow-up contacts are needed. Previous research has shown health coaching to be effective, but this has utilized programs that "add on" to the existing clinic structure. This type of coaching model is difficult to sustain. Utilizing existing staff for health coaching is a method we propose to more fully integrate this service into primary care clinics.

Eligibility criteria: Inclusion Criteria:

* adults age 21 and over
* referred by primary care physician for health coaching
* have telephone for follow-up
* English speaking

Exclusion Criteria:

* pregnant or trying to become pregnant

Primary outcomes:
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: Diet quality
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Sleep
timeFrame: 12 weeks
Other outcomes:
measure: Quality of Life
timeFrame: 12 weeks
Locations:
city: Ann Arbor
country: United States
facility: Briarwood Family Medicine
state: Michigan
Study officials:
References:
Clinical trial NCT00873769: Staccato Loxapine PK in Smokers and Nonsmokers
Official title: Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking, Cigarette
Keywords: Staccato Loxapine
pharmacokinetics
smokers
non-smokers
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.

Detailed description: Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.

Eligibility criteria: Inclusion Criteria:

* Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
* Smokers must have a history of smoking \> 15 cigarettes/day currently and for at least the last 2 years,
* Nonsmokers must have never smoked \> 5 cigarettes/day and not smoking at all for at least the last 2 years.

Exclusion Criteria:

* Any acute illness in the 5 days,
* Use of a bronchodilator for the treatment of wheezing within 12 months, OR
* Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.

Primary outcomes:
measure: Noncompartmental Pharmacokinetic parameters
timeFrame: 24 hours
Secondary outcomes:
measure: Vital signs
timeFrame: 24 hours
measure: Treatment emergent adverse events
timeFrame: 24 hours
measure: Sedation visual analog scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Indiana
Study officials:
affiliation: Covance Clincial Research Unit, Inc.
name: Randall R. Stoltz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV. Effect of smoking on the pharmacokinetics of inhaled loxapine. Ther Drug Monit. 2014 Oct;36(5):618-23. doi: 10.1097/FTD.0000000000000048.