louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04227392: Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
Official title: Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Laxity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.


Eligibility criteria: Inclusion Criteria:

* vaginal laxity score \>= 3
* negative pregnancy test within 2 months

Exclusion Criteria:

* genital anomaly
* pelvic prolapse stage \>= stage 3
* active genital infection
* vulvar pain or deformity
* disease related to sexual behavior
* current, chronic NSAIDs intake
* fever
* any acute illness
* cognitive disorder
* pacemaker insertion
* metal implants

Primary outcomes:
measure: change of vaginal laxity score from baseline
timeFrame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
Secondary outcomes:
measure: change of FSFI score from baseline
timeFrame: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
measure: change of FSDS score from baseline
timeFrame: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
measure: change of vaginal pressure from baseline
timeFrame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
Other outcomes:
Locations:
city: Seongnam Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyenggi DO
Study officials:
References:
Clinical trial NCT03097692: Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?
Official title: Variable Types of Preconditioning,is There a Different Impact Upon Multiorgan Function After Open Heart Surgery ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neutrophil Lymphocyte Ratio
Serum Createnine
Mechanical Ventilation
Keywords: cardiac preconditioning
open heart surgery
createnine
inflammation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group well be pretreated with cardiac preconditioning
Primary purpose: OTHER

Brief summary: An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation

Detailed description: Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in open heart surgery .

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* American Society of Anesthesiologists physical status II and III
* Patients scheduled for open heart surgery
* no active inflammatory process

Exclusion Criteria:Exclusion Criteria:

* Emergency surgery
* Clinically significant kidney or liver disease
* Patients allergic to local anesthetic
* Patients with prolonged cardiopulmonary bypass time (\>120 min)
* Patients required intra-aortic balloon pump
* Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration

Primary outcomes:
measure: change of Neutrophil lymphocyte ratio
timeFrame: during first two postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT05977192: Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination
Official title: Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Hesitancy
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2023-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Reside in a rural area
* No previous dose of a SARS-CoV-2 vaccine
* Speak English
* Able to provide informed consent

Exclusion Criteria:

* A cognitive or other disability that inhibits smart phone use
* Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician
* Enrollment in other COVID-19 research; pregnant or lactating

Primary outcomes:
measure: Changes in vaccine hesitancy and confidence
timeFrame: Baseline and follow-up (8 weeks)
measure: Changes in intention to receive the vaccine
timeFrame: Baseline and follow-up (8 weeks)
Secondary outcomes:
measure: Changes in expectations related to vaccines
timeFrame: Baseline and follow-up (8 weeks)
measure: Changes in self-efficacy
timeFrame: Baseline and follow-up (8 weeks)
measure: Changes in ambivalence
timeFrame: Baseline and follow-up (8 weeks)
measure: Changes in value-behavior discrepancy
timeFrame: Baseline and follow-up (8 weeks)
measure: Number of participants who receive the COVID-19 vaccine
timeFrame: Follow-up (8 weeks)
Other outcomes:
measure: Percentage of total of ecological momentary assessment messages opened/viewed
timeFrame: 8 weeks (from baseline to follow up)
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT06638892: Using PrEP, Doing It for Ourselves
Official title: Cluster Randomized Controlled Trial of Using PrEP, Doing it for Ourselves [UPDOs] Protective Styles: A Salon-based Intervention to Improve PrEP Uptake Among Black Cis-gender Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Prevention
PrEP
Keywords: Black Women
Community-based Research
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2024-10-15
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to test the effectiveness of the Using PrEP, Doing it for Ourselves (UPDOs) intervention is to improve pre-exposure prophylaxis (PrEP) uptake for Black women using the Motivational PrEP Cascade framework within a community engaged cluster-randomized controlled trial of intervention and control salon clusters. It is expected that compared to control, women in the UPDOs intervention will have higher PrEP uptake. Additionally, this study aims to examine the barriers and facilitators underlining PrEP decision-making among a subsample of Black women in both intervention and control groups using quantitative surveys and qualitative individual interviews. Lastly, the study aims to understand the facilitators influencing implementation of UPDOs for future scalability using quantitative surveys and qualitative interviews grounded in the CFIR (Consolidated Framework for Implementation Research) framework.


Eligibility criteria: Inclusion Criteria:

* Black
* Cisgender female
* Ages 18+

Exclusion Criteria:

* Under 18 years of age
* Does not identify as Black
* Not a cisgender female

Primary outcomes:
measure: Pre-exposure prophylaxis (PrEP) Contemplation Ladder total score
timeFrame: 12, 24, 32, and 52 weeks post-intervention
Secondary outcomes:
measure: Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 12 to 24 weeks
timeFrame: 12 to 24 weeks post-intervention
measure: Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 24 to 32 weeks
timeFrame: 24 to 32 weeks post-intervention
measure: Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 32 to 52 weeks
timeFrame: 32 to 52 weeks post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Schenita Randolph, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05552092: Optimal Depth for Esophageal Stethoscope
Official title: Optimal Depth for Esophageal Stethoscope for the Monitoring of Core Temperature
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgery
Keywords: Anatomic Landmarks
Body Temperature
Monitoring, Intraoperative
Lead sponsor: Chosun University Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the present study was to evaluate the optimal insertion depth of an esophageal stethoscope with a thermistor for core temperature monitoring.

Detailed description: Monitoring core temperature is crucial for maintaining normothermia during general anesthesia. During anesthesia, an esophageal stethoscope with a thermistor for monitoring esophageal temperature is frequently used.

There are several researches on the depth or position of the esophageal stethoscopes, but there is only limited information (known as about 40-45 cm or T8-T9).

The purpose of the present study was to evaluate the optimal insertion depth of an esophageal stethoscope with a thermistor for core temperature monitoring.

Eligibility criteria: Inclusion Criteria:

* The patients with ASA class 1-2 (20-65 years old) who are undergoing elective surgery with supine or lithotomy position, without position change scheduled to last more than 90 min.

Exclusion Criteria:

* anatomical abnormality with the upper airway
* risks of a difficult airway
* abnormal central anatomical structures such as airway, diaphragm, or spine on the chest X-ray
* history of disease or surgery on the stomach or esophagus
* risks of bleeding or coagulopathy on the preoperative laboratory results
* obese patients with BMI over 30
* contraindication to insertion of ES for the surgery
* who did not take a standing chest PA X-ray before surgery
* position change during the surgery
* open chest surgery

Primary outcomes:
measure: Desired insertion depth of ES thermistor
timeFrame: 1 day
Secondary outcomes:
measure: Correlation analysis
timeFrame: Through study completion, 1 year
measure: Optimal depth analysis
timeFrame: Through study completion, 1 year
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
Study officials:
affiliation: Chosun University Hospital
name: Ki Tae Jun, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Wang M, Singh A, Qureshi H, Leone A, Mascha EJ, Sessler DI. Optimal Depth for Nasopharyngeal Temperature Probe Positioning. Anesth Analg. 2016 May;122(5):1434-8. doi: 10.1213/ANE.0000000000001213.
Clinical trial NCT05900492: Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery
Official title: Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery and Assessment of Its Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section
Dehiscence
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.

Brief summary: To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.

Detailed description: It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital using Ultrasound:

Six months after the cesarean delivery, participants will be invited to the gynecologic outpatient clinic or department for ultrasound (US) examination to detect the presence of the niche.

Women without contraception will be examined during the follicular phase of the menstrual cycle to avoid an eventual early pregnancy. Otherwise, a random phase of the menstrual cycle will be accepted. Women who are pregnant at the time of US will be excluded. Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way, with trans-vaginal US performed first.

For the diagnosis of cesarean scar niche (defined as an anechoic defect in the anterior wall of the lower uterine segment, communicating with the endometrial cavity),we will use a predetermined definition of a defect at least 2.0 mm deep

Eligibility criteria: Inclusion Criteria:

1. Delivery by cesarean section.
2. More than 6 months after delivery.
3. Cesarean section by senior resident or assistant lecturer.

Exclusion Criteria:

1. Single layer technique in uterine closure.
2. Uterine anomaly.

Primary outcomes:
measure: the incidence of cesarean scar niche among cesarean deliveries
timeFrame: 6 months after delivery
Secondary outcomes:
measure: risk factors that affect the development of the niche.
timeFrame: within 1 month of delivery
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: sara M salem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884792: Effects of Standing on Glycemia in Prediabetic Adults
Official title: Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Keywords: prediabetes
physical inactivity
sedentary
standing
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2013-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.


Eligibility criteria: Inclusion Criteria:

* Fasting blood glucose \>100 mg/dl
* Employed full-time working at least 35 hours/week
* Able to safely begin a light physical activity program

Exclusion Criteria:

* Heart disease
* Renal disease
* Peripheral neuropathy
* Retinopathy
* PAD
* Lower limb amputation
* pregnancy
* active substance abuse
* current smoker
* psychiatric disorder
* severe visual impairment
* immune-compromised individuals,
* enrollment in a physical activity study
* use of insulin or an insulin pump

Primary outcomes:
measure: Blood sugar area under the curve
timeFrame: 2 hours
Secondary outcomes:
measure: Accelerometer counts
timeFrame: 4 hours and 2 5 day periods
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Department of Human Services
state: Minnesota
Study officials:
References:
Clinical trial NCT00786292: Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
Official title: Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2008-11-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.


Eligibility criteria: Inclusion Criteria:

* age 18 to 75 yrs
* 150 mmHg \< PaO2/FIO2 \< 300 mmHg
* mechanical ventilation with PSV or BIPAP
* less than 15 days of mechanical ventilation
* at least 20% of minute ventilation originated from spontaneous breathing

Exclusion Criteria:

* BMI \> 35
* esophageal disease
* neuromuscular disease
* instable thorax
* pneumothorax
* head trauma
* brain injury
* increased intracranial pressure
* agitation
* increased need for vasoactive drugs
* chronic lung disease
* acute coronary disease
* participation in another clinical trial within the last 4 weeks at enrollment

Interruption criteria:

* acute change of mental status
* SaO2 \< 92%
* pHa \< 7.30
* respiratory rate \> 30 or \< 6 /min
* dyspnea
* diaphragm/thorax antagonism
* diaphoresis
* abnormal use of respiratory muscles
* increase of the heart rate above 120% of baseline or absolute value \< 60 or \> 130 /min
* mean arterial pressure above 120% of baseline or absolute value \< 70 or \> 110 mmHg

Primary outcomes:
measure: Effect on the arterial oxygenation
Secondary outcomes:
measure: Effect on the work of breathing
measure: Effect on PaCO2
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Clinic Carl Gustav Carus, Technical University Dresden
Study officials:
affiliation: Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
name: Marcelo Gama de Abreu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spieth PM, Guldner A, Huhle R, Beda A, Bluth T, Schreiter D, Ragaller M, Gottschlich B, Kiss T, Jaber S, Pelosi P, Koch T, Gama de Abreu M. Short-term effects of noisy pressure support ventilation in patients with acute hypoxemic respiratory failure. Crit Care. 2013 Oct 31;17(5):R261. doi: 10.1186/cc13091.
Clinical trial NCT00918892: Assessment of Candidate Protein Expression in Breast Cancer Specimens
Official title: Assessment of Candidate Protein Expression in Human Breast Cancer Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer
triple-negative breast cancer
HER2-negative breast cancer
HER2-positive breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 460
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Brief summary: RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

Detailed description: OBJECTIVES:

* To determine if candidate genes display differential expression between normal and cancer breast tissues.

OUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Eligibility criteria: Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Tissue samples available
* Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:

  * Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
  * ER-positive/PR-positive/ HER2-positive by FISH
  * ER-negative/PR-negative/HER2-positive
  * ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Exclusion Criteria:

* There are no exclusion criteria in this protocol

Primary outcomes:
measure: Differential expression of candidate genes between normal and cancer breast tissues
timeFrame: non-applicable
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Stefanie Avril, MD
role: PRINCIPAL_INVESTIGATOR
References: