louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02736292: Mindfulness Practice for Healthcare Professionals in Training
Official title: Mindfulness Practice for Healthcare Professionals in Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility, acceptability, accessibility, and preliminary effects within this population.


Eligibility criteria: Inclusion Criteria:

* Healthcare professional
* Healthcare professional in training

Exclusion Criteria:

* None

Primary outcomes:
measure: Experience of participants regarding feasibility and acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Burnout (MBI)
timeFrame: 8 weeks
measure: Perceived stress (PSS)
timeFrame: 8 weeks
measure: Depressive symptoms (PHQ9)
timeFrame: 8 weeks
measure: Mindfulness (FFMQ)
timeFrame: 8 weeks
measure: Anxiety (STAI)
timeFrame: 8 weeks
measure: Ruminations (RRS)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Patricia A Kinser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellen Braun S, Kinser P, Carrico CK, Dow A. Being Mindful: A Long-term Investigation of an Interdisciplinary Course in Mindfulness. Glob Adv Health Med. 2019 Jan 9;8:2164956118820064. doi: 10.1177/2164956118820064. eCollection 2019.
Clinical trial NCT01510392: CEI Van Outreach Screening Study
Official title: Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Macular Disease
Keratoconus
Keywords: Optical coherence tomography
Glaucoma
Macula
Keratoconus
Screening
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2012-01-16
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be performed enrolling participants from the Casey Eye Institute outreach van.

Brief summary: The primary goal of the trial is to show that optical coherence tomography (OCT) technology can be used to effectively screen for diseases of the eye including glaucoma, macular diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision. Keratoconus is a disease that affects the cornea (clear surface covering the colored part of the eye).

Detailed description: The identification of many eye diseases would significantly benefit from earlier detection than is available with typical eye exams. Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of tissue structure in real time. It is similar to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than sound waves.

Eligibility criteria: Inclusion Criteria:

* Participant undergoing a screening examination at the Casey Eye Institute Outreach Van.
* Participants must be between the ages of 18 and 89 years old.

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging

Primary outcomes:
measure: OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Casey Eye Institute Outreach Screening Van
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Michael Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228992: Ibuprofen Versus Placebo For Muscle Soreness
Official title: A DOUBLE-BLIND, REPEAT-DOSE, PARALLEL GROUP, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Soreness
Lead sponsor: Jean Brown Research
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.

Detailed description: This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. Healthy male or female subjects who have a history of occasional muscle soreness and are not currently exercising will be asked to volunteer for the study. All subjects will complete an informed consent process prior to study procedures.

The study duration is anticipated to be approximately 4 months. Each subject may be in the study for up to 45 days including screening, run-in, inpatient and outpatient dosing and assessments, follow-up visit and follow-up telephone contact.

Eligibility criteria: Subjects must meet the following criteria to be included in the study:

1. Male or female subjects aged 18-55 years;
2. In good general health;
3. Non-pregnant, non-lactating female subjects must be:

   1. physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or
   2. practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization.
4. History of experiencing muscle pain/soreness after moderately strenuous exercise;

Subjects are excluded from the study if any of the following criteria apply:

1. Currently participating in an exercise regimen.
2. Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;
3. History of rhabdomyolysis;
4. Have participated in an investigational study within the past 30 days of screening;
5. Are an employee or relative of an employee of the study site (directly involved with the study).

Primary outcomes:
measure: Model Sensitivity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References:
Clinical trial NCT06221592: Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses
Official title: Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 252
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.


Eligibility criteria: Inclusion Criteria:

1. Age: 6-14 years old;
2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Exclusion Criteria:

1. Diagnosed constant strabismus;
2. Diagnosed pathological myopia;
3. Other congenital eye diseases;
4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.

Primary outcomes:
measure: Axial length
timeFrame: 2 years
Secondary outcomes:
measure: Subjective refraction equivalent spherical
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Diseases Prevention &amp;Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University
state: Shanghai
Study officials:
References:
Clinical trial NCT03859492: Screening CEDM in Intermediate and High-Risk Patient Populations
Official title: Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 461
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are prospectively assigned to the CEDM /screening intervention which may lead to additional screening or biopsy based on the study schema.
Primary purpose: SCREENING

Brief summary: This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.


Eligibility criteria: Inclusion Criteria:

* Women aged 35 and had a negative routine mammogram within 6 months.
* Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).

Exclusion Criteria:

* Known breast cancer
* Previously had negative MBI or MRI within 12 months of study
* Pregnant or lactating
* Contraindication to intravenous iodinated contrast
* Unable to understand or sign informed consent
* Self-reported signs or symptoms of breast cancer

Primary outcomes:
measure: Breast Cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Bhavika Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02820792: Non-Crossover Study of the LMA Protector Versus Ambu AuraGain
Official title: A Randomized Non-Crossover Study of the LMA ProtectorTM Versus Ambu Aura GainTM in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The LMA ProtectorTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized study the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and the Ambu AuraGainTM in paralyzed, anesthetized patients.


Eligibility criteria: Inclusion Criteria:

* ASA 1 or 2
* Age 19-65 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35

Primary outcomes:
measure: oropharyngeal leak pressure
timeFrame: 5 min
Secondary outcomes:
measure: anatomic position
timeFrame: 5 min
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Christian Keller MD, M.Sc.
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Berthold Moser, MD MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03436992: Estrogen and Diabetes
Official title: Estrogen-Mediated Impairments of Vascular Health in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Estrogen, Diabetes
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-02-19
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.


Eligibility criteria: Inclusion Criteria:

* Both men and premenopausal
* Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
* All races
* Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Exclusion Criteria:

* Clinical diagnosis of hepatic, cardiovascular, or renal disease
* Uncontrolled Diabetes (HbA1c\>9%)
* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
* Proteinuria
* Uncontrolled Hypertension (\>140/90 mmHg on therapy)
* Hormonal use of birth control (past 3 months)
* Pregnancy
* Oligomenorrhea
* Direct vasoactive medications (i.e. nitrates)
* Anti-estrogens (i.e. SERMs)
* Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
* Undetectable Anti-Mullerian Hormone (AMH) following screening

Primary outcomes:
measure: FMD/Shear
timeFrame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: Augusta University
name: Ryan Harris, PhD, CES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01731392: Children Immune Functions(2)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Upper Respiratory Infections
Keywords: Diarrhea
Children
Lactobacilli
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 604
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the effect of milk-based formulas on infections and immune functions in healthy children.

Detailed description: Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.

The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.

Eligibility criteria: Inclusion Criteria:

* Parents written and signed informed consent for participation in the study.
* Healthy children aged 1 to 3 years that are no more breastfed.
* Go to a selected nursery and / or pediatrician.
* Parents must have a phone at home or a cellular phone to call the paediatrician.
* No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
* Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
* Children not being intensive consumers of regular yoghurts

Exclusion Criteria:

* Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
* Used antibiotics within the last 30 days prior to V1 (baseline visit).
* Congenital or chronic disease.
* Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
* Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

Primary outcomes:
measure: Days with diarrhea
timeFrame: during the 5 months of follow up
Secondary outcomes:
measure: Number of episodes of Upper Respiratory Infections
timeFrame: 5 months
measure: Duration of episodes of Upper Respiratory Infections
timeFrame: 5 months
measure: Severity of episodes of Upper Respiratory Infections
timeFrame: 5 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dept. Nutrition, Faculty of Medicine University of Indonesia
Study officials:
affiliation: Nutrition Department, Faculty of Medicine,
name: Saptawati Bardosono, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376892: Quality of Life and Exercise Capacity in COPD
Official title: The Effect of Exercise Capacity on Quality of Life in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Quality of Life
Exercise Capacity
Keywords: copd
quality of life
exercise capacity
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: COPD patients will be examined in 4 groups according to their walking distance. Patients walking under 150 meters will be determined as Group 1, those walking between 150-249 meters will be Group 2, those walking between 250-349 meters will be selected as Group 3, and patients with COPD who walk 350 and above will be determined as Group 4. The groups were compared in terms of quality of life, psychological symptoms and dyspnea.

Detailed description: Quality of life affects the mortality rate independently in patients with COPD. The treatment applied in COPD does not stop the decrease in lung function, nor does it prolong the survival time. Spirometric evaluations to determine the severity of the disease are not sufficient to explain the perception of patients and their adaptation to their diseases. Therefore, evaluating the quality of life has become an important measure of treatment in COPD patients. Quality of life measurements should be done to minimize the effect of the disease, to help patients better cope with the consequences of an incurable long-term condition, and to determine modifiable factors. Identifying modifiable factors; in personalized treatment adopted in airway diseases in recent years; it is important to be able to apply appropriate pharmacological and non-pharmacological treatments Our aim is to exercise capacity in COPD patients; firstly to investigate the effect on quality of life, then to determine the relationship between emergency admission and hospitalization, dyspnea, psychological symptoms.

Eligibility criteria: Inclusion Criteria:

* COPD patients completed all tests and qustionnaires

Exclusion Criteria:

-

Primary outcomes:
measure: Quality of life questionnaire
timeFrame: 20 minutes
Secondary outcomes:
measure: Dyspnea Severity
timeFrame: 5 minutes
measure: Respiratory Function
timeFrame: 20 minutes
measure: Anxiety Depression
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Hulya S, Ilknur N, Gulru P. Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease. Heart Lung. 2020 Nov-Dec;49(6):753-757. doi: 10.1016/j.hrtlng.2020.09.008. Epub 2020 Sep 23.
Clinical trial NCT01956292: Continuous Monitoring of Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage
Official title: Observational Study of Continous Monitoring of Arterial Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraparenchimal Cerebral Haemorrhage
Lead sponsor: Azienda Ospedaliera Sant'Anna
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to hospital for intraparenchimal cerebral haemorrhage

Brief summary: Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome


Eligibility criteria: Inclusion Criteria:

* hospitalization only for spontaneous intraparenchimal cerebral haemorrhage
* age over 18 years

Exclusion Criteria:

* cerebral haemorrhage secondary to other causes

Primary outcomes:
measure: evaluation of blood pressure varibility on clinical course in patients with cerebral haemorrhage
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Como
country: Italy
facility: AO Sant'Anna Hospital
Study officials:
References:
Clinical trial NCT02503189: A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye With Sjögren's Syndrome
Keywords: Dry eye syndromes
Corneal diseases
Conjunctival diseases
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome


Eligibility criteria: Inclusion Criteria:

* Dry eye patients with Sjögren's syndrome
* Corneal and conjunctival damage

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctal plugs or surgery for occlusion of the lacrimal puncta

Primary outcomes:
measure: Score of the corneal staining
timeFrame: 12 weeks
Secondary outcomes:
measure: Score of the conjunctival staining
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
Study officials:
References: