louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03695822: Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
Official title: Far Eastern Memorial Hospital
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Overactive Bladder Syndrome
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.

Detailed description: Background/Purpose: Pharmacologic treatments for female overactive bladder syndrome (OAB) include antimuscarinics and beta-agonist. Similar efficacy has been reported between antimuscarinics and beta-agonist. Antimuscarinics has been found to be beneficial for patients with psychological distress. However, the impact of mirabegron on psychological distress in female OAB remains unknown. In addition, some animal studies found that beta-3 agonist can improve arterial blood flow, bladder ischemia and might improve bladder function; however, there is still lack of human study. Besides, c reactive protein was found to be elevated in female OAB. Nonetheless there is no study mentioning about the impact of mirabegron on c reactive protein. Thus, the aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.

Eligibility criteria: Inclusion Criteria:

* All OAB female patients
* \>20 years

Exclusion Criteria:

* Allergy to mirabegron, urinary tract infections

Primary outcomes:
measure: Brief symptom rating scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Bladder wall blood flow
timeFrame: 12 hours
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT02078622: Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients With COPD
Official title: A Prospective Randomized Controlled Trial to Evaluate the Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients Diagnosed With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Respiratory Therapist
Case Management
Education
Lead sponsor: StratiHealth
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 114
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with COPD

Brief summary: Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints

Utilize: Chronic Respiratory Disease Questionnaire (CRQ)

The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency room encounters, hospital admissions)

Detailed description: Evaluate subjects in an prospective randomized controlled trial in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in health outcomes and quality of life as primary endpoints, utilizing the Chronic Respiratory Disease Questionnaire (CRQ). The secondary endpoints will be rate of exacerbation's and health care utilization (emergency room encounters, hospital admissions).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Cognitive ability to retain education and training
* Resides in a stable residence or home, apartment
* Managed by primary care physician (family practice)

Exclusion Criteria:

* Lacks cognitive ability to retain education and training
* Not managed by primary care physician (family practice)
* No stable residence or is homeless

Primary outcomes:
measure: Quality of Life Using Chronic Respiratory Disease Questionnaire
timeFrame: Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: 1 year
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Isabel Pereira, Md
state: California
Study officials:
affiliation: StratiHealth
name: ISABEL PEREIRA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: StratiHealth
name: VERNON R PERTELLE, RRT
role: STUDY_DIRECTOR
References:
Clinical trial NCT05401422: Brimonidine in Rosacea
Official title: Efficacy and Safety of Combining Doxycycline With Pulsed Dye Laser Versus Topical Brimonidine 0.33% in the Treatment of Erythematotelangiectatic Rosacea: a Comparative Clinical and Dermoscopic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rosacea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rosacea is a chronic and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide.

Detailed description: In our study, we will compare the safety, efficacy, and adverse effects of low-dose oral doxycycline alone versus combined with pulsed dye laser or topical brimonidine in treating erythematotelangiectatic rosacea in an attempt to build a treatment strategy in a disease with complex pathogenesis.

Eligibility criteria: Inclusion Criteria:

* Patient with current erythematotelangiectatic rosacea

Exclusion Criteria:

- Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder.

4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.

Primary outcomes:
measure: Clinical erythema assessment scale
timeFrame: 3 months
Secondary outcomes:
measure: Thickness of capillaries by dermoscope
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05281822: The Stress Management Training Provided to Obese Women
Official title: Sivas Cumhuriyet University, Faculty of Health Sciences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Women
Stress
Training
Keywords: women
obesity
stress
stress management training
eating attitude
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: Obesity, which is an important public healthcare issue, can affect women's physical, mental, social health, stress level, and coping negatively.

Aim: The present study was conducted to determine the effects of stress management training provided to obese women on eating attitudes, stress, and coping with stress.

Detailed description: Methods: The sampling of the randomized controlled experimental study based on the pre-test and post-test model consisted of 70 women (experimental = 35; control = 35) with a Body Mass Index ≥30, who applied to a Community Healthcare Center Obesity Unit in primary care in Turkey. The data were collected by using Personal Information Form, Perceived Stress Scale, Stress Coping Styles Scale, Dutch Eating Behavior Questionnaire, and height-weight measurements.

Eligibility criteria: Inclusion Criteria:

* Women who lived in the city center,
* Body Mass Index ≥30,
* Having no perception and communication problems and being able to answer questions,
* Women who volunteered to participate in the study

Exclusion Criteria:

* Being a man
* Non-obese women and those with a body mass index below 30
* Those with communication problems
* Those who do not live in the city center

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 10 months
measure: Styles of Coping with Stress Inventory
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sukran Ertekin Pinar
Study officials:
affiliation: Cumhuriyet University
name: Sukran Ertekin Pinar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409822: Non-invasive Hemoglobin Monitoring in Cesarean Section
Official title: The Effectiveness of Intraoperative Non-invasive Hemoglobin Monitoring in Parturients With Placenta Previa Undergoing Cesarean Section: Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Previa
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 39
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean section with placenta previa and this will be compared with actual laboratory findings.

The investigators will investigate whether noninvasive hemoglobin monitoring can adequately reflect the massive bleeding that occurs within a short period of time and find out if it matches the actual laboratory findings.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* Elective Cesarean section
* Placenta previa

Exclusion Criteria:

* Decline of consent
* Peripheral vascular disease
* Cyanosis due to congenital heart disease
* Refusal of transfusion
* Mental retardation

Primary outcomes:
measure: The change of total hemoglobin
timeFrame: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
Secondary outcomes:
measure: The change of oxygen content
timeFrame: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
measure: The change of methemoglobin
timeFrame: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
measure: The change of carboxyhemoglobin
timeFrame: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
measure: The change of pleth variability index
timeFrame: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
measure: The change of perfusion index
timeFrame: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT05024422: Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline
Official title: Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation Suppressed
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some mothers may seek lactation suppression on personal, social, or medical grounds. To reduce congestion symptoms and shorten the duration of milk production lactation suppression can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems or liver disease. Vitamin B6 has also been studied for this indication with no significant side effects. All those studies conducted before 1980. There is no current literature on the subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication.

Purpose:

The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for lactation suppression.

method: A prospective randomized study in the maternity ward at Haemek medical center in Afula, Israel.

Postpartum women without contraindication to any one of the treatments, who are interested in a pharmaceutical induced lactation suppression will be divided into two randomized groups:

1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
2. Administration of Vitamin B6 (200 mg X 3 per day for a week)

All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.


Eligibility criteria: Inclusion Criteria:

1. Postpartum women who are interested in pharmacologic lactation suppression
2. Women over the age of 18

Exclusion Criteria:

1. Women with known sensitivity to vitamin B6 or Cabergoline
2. Women with hypertensive Disorders or contraindication to Cabergoline.

Primary outcomes:
measure: Lactation suppression
timeFrame: 7 days
measure: reduction of congestion
timeFrame: 14 days
measure: cessation of milk leakage
timeFrame: 14 days
measure: cessation of breast pain
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References:
Clinical trial NCT02336022: The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia
Official title: The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Complications
Keywords: general anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing general anesthesia for surgical procedures at Boston Children's Hospital.

Brief summary: Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* pediatric patients between the ages of 1 year and 17 years
* ASA status of 1-3
* scheduled to undergo a procedure with general anesthesia at Boston Children's Hospital

Exclusion Criteria:

* Patients undergoing an emergency procedure or a
* patients undergoing a procedure where the study monitor will interfere with the surgical procedure site or standard of care
* preexisting respiratory disease
* muscular disease affecting the respiratory system

Primary outcomes:
measure: Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.
timeFrame: intraoperative
measure: Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation.
timeFrame: intraoperative
measure: Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Viviane Nasr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03520322: A Study of a Mastoid Device in Subjects With Ménière's Disease
Official title: A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Meniere Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 7
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 purpose of this study is to investigate the efficacy of a mastoid treatment device in patients with active Ménière's disease that is not controlled by traditional medical management

Detailed description: This is a single center, randomized, placebo-controlled trial of mastoid oscillation for treatment of Ménière's disease. Eligible subjects will be randomized using a 1:1 allocation to either mastoid oscillation or placebo (oscillator device that provides the same sound but no vibration of the mastoid) received for 30 minutes at four weekly study visits, with efficacy determination via change in frequency and severity of Ménière's symptoms following the final study visit.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 and older
2. Clinical diagnosis of Ménière's disease, with classical symptoms:

i. Episodic spinning vertigo ii. Fluctuating unilateral low frequency sensorineural hearing loss iii. Tinnitus iv. Aural fullness c. Failure of traditional medical management of Ménière's disease symptoms d. English language skills sufficient to provide informed consent to the study

Exclusion Criteria:

1. Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
2. Bilateral Ménière's disease

Primary outcomes:
measure: Change in the Number of Monthly Vertigo Episodes
timeFrame: Baseline to 90 days
Secondary outcomes:
measure: Change in Average Pure Tone Threshold
timeFrame: Baseline to 90 days
measure: Change in Percentage of Words Recognized
timeFrame: Baseline to 90 days
measure: Change in Meniere's Functional Level
timeFrame: Baseline to 90 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: 2365 S. Clinton Ave
state: New York
Study officials:
References:
Clinical trial NCT02026622: Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
Official title: Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: major depressive disorder
cerebrovascular reactivity
emotional reactivity
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.


Eligibility criteria: Inclusion Criteria:

* Female between 18 and 55
* Informed consent form signed
* Affiliated to a medical insurance
* visual and hearing abilities suitable for exams
* for the depressive group (group D): major depressive disorder according to the DSM-IV criteria as evaluated by the MINI test and MADRS score ≥22
* for the depressive patients in remission's group (group R) : matched on age, at least 1 history of major depressive disorder in the last 10 years and solved for more than 6 months, and MADRS score \< 9
* for the control subjects (group T) : matched on age, no psychiatric history, MADRS score \< 9

Exclusion Criteria:

* psychotic disorder, bipolar disorder, addiction, suspected dementia (MMSE\<25)
* current betablockers or neuroleptics treatment
* any current organic unstable pathology
* history of serious cardiovascular disease (coronary syndrome, cardiac arrythmia, etc.)
* smoking \> 10 PY
* history of serious neurologic disease (stroke, cerebral tumour, serious cranial trauma, headache, ...)
* contra-indication to MRI
* uncorrected vision or audition troubles
* patient under juridic protection
* pregnancy, lactating or female without reliable contraception

Primary outcomes:
measure: amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity
timeFrame: one day
Secondary outcomes:
measure: MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)
timeFrame: one day
measure: ultrasound data of doppler as measure of cerebral pulstility
timeFrame: one day
measure: score of psychometric tests as measure of emotional state
timeFrame: one day
measure: spontaneous verbal production to emotional pictures and explicitative interviews
timeFrame: one day
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
References: