louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03116789: Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
Official title: Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Kuo General Hospital
First posted: 2017-04-17
Enrollment: 43
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel, open lable Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

Detailed description: To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.

Eligibility criteria: Inclusion Criteria:

* Informed Consent Form.
* Subjects with bacterial vaginosis and Nugent score as 4-10
* Subjects in age of 20-55 years old
* Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
* Forbidden sexual behavior was required 72 hours before all visits

Exclusion Criteria:

* Subjects are pregnant, lactating or planning to become pregnant.
* Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.)
* Bleeding from genital tract of unknown aetiology.
* Congenital and acquired immunodeficiencies.
* Diabetes
* Mental illness
* Malignant tumor
* Application of NuvaRing hormonal contraceptive vaginal ring
* Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom
* Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period.
* Mycotic vaginitis
* Antibiotic(unless indicated by PI) and steroids therapy during this trial.
* Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1.
* Participation in another clinical study.

Primary outcomes:
measure: Nugent Score
timeFrame: 4 weeks
Secondary outcomes:
measure: Vaginal pH
timeFrame: 4 weeks
measure: Vaginal secretions microflora
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: KUO general hospital
Study officials:
affiliation: Kuo General Hospital
name: Ta-Chin Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00843089: Secondary Prevention After Coronary Bypass Surgery
Official title: Secondary Prevention After Coronary Bypass Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
CABG
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite immediate symptomatic success after coronary bypass surgery in patients with coronary artery disease, this effect is not sustained over time since risk factors for coronary artery disease are still in place. The role of secondary prevention becomes increasingly important as it can potentially decrease or eliminate the need for another intervention in these high risk subjects. This project seeks to evaluate the effect of emphasizing secondary prevention measures in this patient population during hospital admission and through six months post-discharge.


Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 18 who will undergo a CABG procedure and who have given written informed consent

Exclusion Criteria:

* Subjects under the age of 18 or who are unable to give consent on their own behald

Primary outcomes:
measure: compliance with medications and lifestyle changes
timeFrame: Month 1, 3, 6 and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05941689: Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System
Official title: Research on the Auxiliary Diagnosis and Treatment System of Digestive Endoscopy Based on Artificial Intelligence: An Efficacy Study of Artificial Intelligence-assisted Colonic Polyp Detection System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma Colon
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 1906
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.


Eligibility criteria: Inclusion Criteria:Patients who need to undergo colonoscopy. -

Exclusion Criteria:Patients with CRC, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded.

-

Primary outcomes:
measure: adenoma detection rate
timeFrame: up to 2months
measure: withdrawal time compliance rate
timeFrame: up to 2months
Secondary outcomes:
measure: polyp detection rate
timeFrame: up to 2 months
measure: adenoma per colonoscopy
timeFrame: up to 2 months
measure: polyp per colonoscopy
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Xiaowei Liu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06150989: Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring
Official title: A Biobehavioral Approach to Understand the Multilevel Determinants of Cardiovascular Health in Black Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Heart Disease Risk Factors
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-11-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study is non-pregnant Black women between the ages of 18 to 49.

Brief summary: This pilot study uses a state-of-the-science combination of remote behavioral monitoring, real-time experience sampling, in-lab physiological assessments, and extraction of neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e., racial discrimination, affective states, stress) on health behaviors (i.e., physical activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2) Test the association between daily behaviors and impairments in biomarkers associated with vascular function/health (i.e., augmented systemic inflammation and oxidative stress, impaired peripheral/cerebral vascular function, increased large artery stiffness), as well as the impact of daily experience on the relationship between behaviors and vascular function; and (3) Explore the influence of neighborhood-level characteristics (i.e., social environment factors: i.e., neighborhood income and poverty, racial composition; and built environment context, such as park density and walkability) on daily experience and health behaviors.


Eligibility criteria: Inclusion Criteria:

* born and identified as female;
* between 18-49 years old;
* self-identify as Black or African American;
* not currently pregnant;
* ownership of a smartphone with Internet access;
* able to speak and read English

Exclusion Criteria:

* diagnosed hypertension, cardiovascular, respiratory, metabolic, and/or neurological disorders;
* functional limitations or health issues that preclude physical activity;
* currently taking medications for thyroid function or psychological conditions such as depression, anxiety, and mood disorders;
* current use of oral or inhalant corticosteroids for asthma;
* have regularly smoked within the last 2 years.

Primary outcomes:
measure: Macrovascular function
timeFrame: Day 1
measure: Arterial Stiffness
timeFrame: Day 1
measure: Blood Flow Measurements (Large Blood Vessels)
timeFrame: Day 1
measure: Blood Flow Measurements (Cerebral Blood Vessels)
timeFrame: Day 1
Secondary outcomes:
measure: Physical activity
timeFrame: Day 2 to Day 11
Other outcomes:
Locations:
city: Arlington
country: United States
facility: The University of Texas at Arlington
state: Texas
Study officials:
References:
Clinical trial NCT03346889: Vestibular Outcomes in Vestibular Schwannoma
Official title: Vertigo Symptoms, Balance and Vestibular Function in Patients With Vestibular Schwannoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vestibular Schwannoma
Keywords: vestibular evoked myogenic potentials
head impulse testing
quality of life
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Norway with newly diagnosed vestibular schwannoma (VS) are referred to Haukeland University Hospital for evaluation. The size of the study population therefore depends on the incidence of VS in Norway and the inclusion period. The incidence of VS in Norway is approximately 150 per year in a population of 5.2 million.

Brief summary: Previous studies have shown that vertigo is the symptoms that mostly affect quality of life in patients with vestibular schwannoma. There is still limited knowledge as to why some patients with this disorder develop vertigo, while others with the same diagnosis do not. The purpose of this study is to measure symptom-related quality of life and to relate this to objective disease characteristics at baseline.

Detailed description: This is a longitudinal observational study with data collected at baseline and after treatment.

Variables collected at baseline include age, sex, tumor size, location, type (cystic/solid), tumor side, symptom variables including Dizziness Handicap Inventory, Vertigo Symptom Scale Short Form, Haukeland Dizziness Questionnaire, Visual analog scale, Hospital Anxiety and Depression Scale, RAND-12, dynamic posturography, video-based head impulse test, bithermal caloric tests, ocular and cervical vestibular evoked myogenic potentials.

Follow-up data after 1 year are the same patient-reported outcomes as at baseline.

Eligibility criteria: Inclusion Criteria:

* Patients living i Norway referred to Haukeland University Hospital due to newly diagnosed, untreated vestibular schwannoma

Exclusion Criteria:

* Inability to undergo test protocol due to physical or language barriers

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline and 1-year follow-up
Secondary outcomes:
measure: Vertigo Symptom Scale Short Form
timeFrame: Baseline and 1-year follow-up
measure: Haukeland Dizziness Questionnaire (HDQ-10)
timeFrame: Baseline and 1-year follow-up
measure: Vertigo Visual Analog Scale
timeFrame: Baseline and 1-year follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 1-year follow-up
measure: RAND-12
timeFrame: Baseline and 1-year follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Haukeland University Hospital
name: Frederik K Goplen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426489: Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
Official title: Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Weinberg Medical Physics LLC
Sponsor class: INDUSTRY
Collaborators: name: University of California, Irvine
First posted: 2015-04-27
Enrollment: 1
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.

Detailed description: 70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.

Eligibility criteria: Inclusion Criteria:

* Female over 21 years of age;
* with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
* and in good health (other than having breast lesions);
* and can lie still in a prone position for 30 minutes in an MRI scanner.

Exclusion Criteria:

* Pregnancy;
* unwilling to give informed consent;
* have implanted prosthetic heart valve,
* pacemaker,
* neurostimulator,
* surgical clips or other metallic implants;
* have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
* are claustrophobic;
* have been allergic to contrast agents;
* are diabetic;
* or have a history of kidney disease.

Primary outcomes:
measure: Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Weinberg Medical Physics LLC
name: Irving Weinberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405789: The Effect of Yoga on Mindfulness and Perceived Stress
Official title: The Effect of Yoga on Mindfulness and Perceived Stress Level in Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: yoga
mindfulness
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A randomized controlled design with intervention and control groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students. A randomized controlled study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The required institutional permission and ethics committee approval was received. The study participants were 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week. The control group did not practice yoga.

Detailed description: This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students in a parallel-group pretest-posttest randomized controlled study design. The required institutional permission and ethics committee approval was received.

The study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The study consisted of 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week face to face. The control group did not practice yoga. The data were collected using "Personnel data form", "Mindful Attention Awareness Scale", "Perceived Stress Scale". The data were collected from the students using the online survey. For data analysis, descriptive statistics, paired sample t test, independent t, Pearson chi-square test were used. At the end of the study, the same yoga session was held with the students in the control group.

Eligibility criteria: Inclusion Criteria:

* being a first-year class nursing student
* older than 18 ages
* volunteering to participate
* giving consent

Exclusion Criteria:

* with a disability to practice yoga, hearing, and visual impairment
* unwillingness to continue participating in the study and school absenteeism

Primary outcomes:
measure: Mindful Attention Awareness Scale
timeFrame: 15 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Democracy University
state: Ege Bölgesi
Study officials:
affiliation: İzmir Democracy University
name: özüm erkin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05942989: The Effect of Reiki on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life
Official title: The Effect of Reiki Applied to Pregnant Women in the Last Trimester on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstetric Complication
Keywords: reiki
breastfeeding
self-efficiency
quality of life
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women.

Detailed description: Reiki, one of the complementary and alternative therapy (CAM) methods; It means "universal life energy" and is natural healing energy (Müller \& Günther, 2006). This healing method is a way of treating others physically and spiritually (Vitale\&O'Connor, 2006; Yücel, 2007). Reiki focuses on energy chakras and bio-psycho-spiritual healing. Reiki enables vital signs (blood pressure, pulse rate, respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep, reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces the use of painkillers and increases coping skills. (Anderson \& Ameling, 2001; Kelley \& William, 2009; Lee et al., 2003; Pocotte \& Salvador, 2008; Vitale, 2006).

Nurses are responsible for increasing the general health level of the mother by detecting and treating the existing diseases in the pregnant, providing timely diagnosis and treatment of potential problems that may arise, monitoring and evaluating the development of the mother and the fetus during pregnancy, giving care to the mother during pregnancy, general body care, nutrition, activity, family planning, It is responsible for providing information on signs of danger, care of the newborn and other issues that the mother may need, preparing the mother for birth physiologically and psychologically, thus increasing the quality of life of the mother (Taşkın, 2016).

Eligibility criteria: Inclusion Criteria:

First pregnancy In 28th and above gestational week Able to read and write Open to communication

Exclusion Criteria:

Having psychiatric history Diagnosed with risky pregnancy Having congenital anomaly in the baby in the postpartum period Having the childbirth preparation classes Receiving energy therapies before and having reiki training certificate

Primary outcomes:
measure: Effect of reiki
timeFrame: starting from 28th gestational week until postpartum 6th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: