louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05395949: A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
Official title: A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Diseases
Mastitis Granulomatous
Psychiatric Disorder
Keywords: granulomatous lobular mastitis ；Psychiatric Disorder；Steroid
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 50
Sex: FEMALE
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: Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older with granulomatous lobular mastitis
* Patients with Psychiatric Disorders;
* Patients volunteered to participate in the study after informed consent.

Exclusion Criteria:

* Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
* Patients in acute exacerbation of mental illness

Primary outcomes:
measure: Recurrence rate
timeFrame: Up to 1 years
measure: Breast appearance and cosmetic effect score
timeFrame: Up to 1 years
Secondary outcomes:
measure: recovery time
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Gaosong Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03347149: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (USA)
Official title: Nurses' Customization of Physiologic Monitor Alarms: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Alarms
Keywords: Alarms
Alarm Fatigue
Alarm Nuisance
Alarm Reduction
Patient Monitoring
Intensive Care
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2017-11-20
Enrollment: 1336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Routinely monitored intensive care patients

Brief summary: This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post- implementation of an "Alarm Advisor software".

Detailed description: In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded.

In an interim period an Alarm Advisor software will be introduced to the unit. In a second phase (post-implementation) the same set of alarm data will be recorded.

The "Alarm Advisor" Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits).

The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Eligibility criteria: Inclusion Criteria:

- Patients admitted to the intensive care units during the study periods

Exclusion Criteria:

- none

Primary outcomes:
measure: Number of Alarms
timeFrame: 2 month per phase with 2 month washout (6 month overall)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Marjorie Funk, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01190306: Safety Study of the VEGA UV-A System to Treat Keratoconus
Official title: Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Keratoconus
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 127
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.


Eligibility criteria: Inclusion Criteria:

* 12 years of age or older
* Having a diagnosis of keratoconus
* Presence of central or inferior steepening
* Topography consistent with keratoconus
* Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
* Contact lens wearers only:Removal of contact lenses for the required period of time
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
* Corneal pachymetry ≤ 400 microns
* Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
* A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
* A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
* Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.

Primary outcomes:
measure: Change in Corneal Curvature.
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Bloomington
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: New York
country: United States
facility: Pamel Vision & Laser Group
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Columbus
country: United States
facility: OSU Department of Ophthalmoloty
state: Ohio
city: Columbus
country: United States
facility: Revision Advanced Laser Eye Center
state: Ohio
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
city: Houston
country: United States
facility: Slade & Baker Vision Center
state: Texas
Study officials:
References:
Clinical trial NCT00736606: A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
Official title: A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD9056 (Steady State) and Simvastatin (Single Dose) When Co-Administered in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: simvastatin
AZD5672
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Male or female healthy subjects. Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy.
* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study periods
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment periods
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Charnwood, UK
name: Rod Hepburn
role: STUDY_DIRECTOR
affiliation: PAREXEL Clinical Pharmacology Research Unit
name: Maura Fallon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06799806: The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil
Official title: The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchial Fibroscopy
Keywords: virtual reality headset
anxiety
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-center, prospective, interventional study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination.

Investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile.

A great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. The innovative aspect is to target the patient's waiting time for the examination. Waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients with no age or gender restrictions, seen on an outpatient basis at Le Mans Hospital.
* In whom bronchial fibroscopy is indicated.
* Person affiliated with or benefiting from a social security .
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
* Patient able and willing to answer questionnaires

Exclusion Criteria:

* Patient refusing to participate in research
* Patient who has already undergone bronchoscopy in vigil
* Patient premedicated for bronchial fibroscopy (anxiolytic, etc.)
* Patients with a history of epilepsy or psychiatric pathology
* Patient with vertigo
* Patient uncooperative, demented or unable to tolerate headgear.
* patient under guardianship or curatorship
* Patients suffering from blindness or deafness
* Patient with known significant intolerance to screens and/or virtual reality devices
* Pregnant, nursing or parturient women
* Unscheduled patients: emergencies, etc.
* Hospitalized patients

Primary outcomes:
measure: Anxiety assessment
timeFrame: Immediately after intervention
Secondary outcomes:
measure: Assessment of bronchoscopy realisation and sample collection
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: Centre Hospitalier le Mans
name: Christine PETIT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06789406: PMCF Study of the Axonics SNM System Model 5101 (R20)
Official title: Post-Market Clinical Follow-up Study of the Axonics SNM System Model 5101 (R20)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Urge Incontinence (UUI)
Urinary Frequency (UF)
Overactive Bladder (OAB)
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.

Detailed description: This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments

Exclusion Criteria:

1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test

Primary outcomes:
measure: Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
timeFrame: 3 months
measure: Adverse event reporting (Safety)
timeFrame: 3 months
Secondary outcomes:
measure: Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
timeFrame: 12 months
measure: Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University College London Hospitals
name: Mrs. Mahreen Pakzad, MBBS BSc MRCS FRCS (Urol) MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143206: Modifying Exercise for the COPD Patient
Official title: Modifying Exercise for the COPD Patient With Arthritic Limitations to Improve Compliance in a Pulmonary Rehab Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Arthritis
Pain
Keywords: Chronic Obstructive Pulmonary Disease
Pain
Arthritis
Dyspnea
Exercise
Aerobic
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of 25 COPD patients (total N = 50) with osteoarthritis undergoing an exercise plan in a pulmonary rehab program.

Brief summary: This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the Nustep elliptical. The main outcome of participation will be measured by the number of exercise sessions the patient is able to complete during their pulmonary rehabilitation program. In addition, distance walked in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both groups. It is believed that the new machine will provide better overall outcomes compared to the traditional machine.

Detailed description: A Prospective cohort study of 25 COPD patients with osteoarthritis undergoing an exercise plan in a pulmonary rehab program. Patient pain level, clinical outcomes, and ultimately, quality of life outcomes will be assessed in order to assess whether future compliance for COPD arthritic patients will occur in an exercise rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* COPD Patient
* Osteoarthritic limitations in upper or lower extremities, or spine
* Forced Expiratory Volume (FEV)1 less than 70%
* Forced Expiratory Volume/Forced Vital Capacity (FEV/FVC) ratio less than 70%

Exclusion Criteria:

* Patients with rheumatoid arthritis

Primary outcomes:
measure: Number of Exercise Sessions Attended
timeFrame: 2 years
Secondary outcomes:
measure: Distance Walked
timeFrame: 6 minutes
Other outcomes:
measure: Dyspnea Score
timeFrame: Two years
measure: Rate of Perceived Exertion
timeFrame: 30 minutes
measure: Pain Index Score
timeFrame: 30 minutes
measure: Dartmouth Quality of Life Index
timeFrame: 1 year
Locations:
city: Cincinnati
country: United States
facility: TriHealth Fitness and Health Pavilion
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Craig Eisentrout, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05000606: A Home Visit Program and Perceived Care Burden
Official title: The Effect of a Home Visit Program for Caregivers of Asthmatic Patients on Perceived Care Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burden
Keywords: asthma
burden
caregiver
education
home visit
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group.

Detailed description: The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group. A total of five home visits over three months were performed. Data were collected by a personal information form, and the Zarit Caregiver Burden Scale (ZCBS).

Eligibility criteria: Inclusion Criteria:

* giving care to a patient who was poorly controlled or uncontrolled asthma
* giving care to a patient who used an inhaler
* age 18 or over
* volunteering to participate to the study

Exclusion Criteria:

* having a disease with a neuro-psychiatric diagnosis
* having vision and hearing problems

Primary outcomes:
measure: Zarit Caregiver Burden Scale
timeFrame: Baseline
measure: Zarit Caregiver Burden Scale
timeFrame: Change from Baseline Perceived Care Burden Scores at 1 month
measure: Zarit Caregiver Burden Scale
timeFrame: Change from 1 month Perceived Care Burden Scores at 3rd months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00485706: Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Official title: Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease
Hypercalcemia
Keywords: dialysis
vascular calcification
bone mineralism
arterial stiffness
bone metabolism
chronic kidney disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2007-06-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Renal patients have an increased risk for cardiovascular complications. There is also increased vascular calcification and bone metabolism is similarly abnormal in patients with chronic kidney disease.

In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering capacity in dialysis patients can be a mechanism for vascular calcifications.

Detailed description: Study hypothesis.

Patient with a higher ∆ Calcium (Calcium post - Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller ∆ Calcium.

This may result in higher extraosseous calcification and higher pulse wave velocity

∆ PTH/∆ Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid "health"

Eligibility criteria: Inclusion Criteria:

* maintenance hemodialysis patients

Exclusion Criteria:

* dialysis \<3 months
* aortobifemoral graft
* calcium level predialysis \>10.5 mg/dl

Primary outcomes:
measure: correlation between calcium increase and pulse wave velocity
measure: correlation between calcium change and pth change
Secondary outcomes:
measure: correlation between calcium increase and vascular calcifications
measure: correlation between calcium change and bone markers
Other outcomes:
Locations:
city: LEuven
country: Belgium
facility: UZ Gasthuisberg
Study officials:
affiliation: UZ Gasthuisberg
name: kathleen Claes, MD
role: PRINCIPAL_INVESTIGATOR
References: