louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06474767: Using Parent Engagement to Improve the Wellbeing of Black Premature Infants With Lung Disease
Official title: Addressing Racial Disparities in Chronic Lung Disease for Preterm Infants Through Parent Engagement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Lung Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot study is to test the feasibility and acceptability of a collaborative goal setting intervention to improve parent engagement of Black preterm infants with chronic lung disease in primary care. Preliminary impact on child and parent outcomes will also be explored.

The main questions it aims to answer are: 1) Will parents complete a pre-visit questionnaire that asks about goals for the child? 2) Does use of the pre-visit questionnaire help parents to achieve self-identified goals?

Participants will fill out a pre-visit questionnaire prior to the child's well visit. The participants will then complete two surveys after the visit (1 week and 2 months after).


Eligibility criteria: Inclusion Criteria:

* Parent/legal guardian of child born prior to 37 weeks gestational age
* Parent/legal guardian of child with diagnosis of chronic lung disease or bronchopulmonary dysplasia, as defined by the child's clinical team at the time of hospital discharge
* Parent/legal guardian of child who identifies that child's race as Black
* English speaking

Exclusion Criteria:

* Parent/legal guardian of child enrolled in palliative care or hospice services at time of hospital discharge
* Parent/legal guardian of child older than 12 months chronological age

Primary outcomes:
measure: Feasibility as measured by number of interventions completed
timeFrame: Day 0
measure: Feasibility as measured by the time it takes participant to complete intervention
timeFrame: Day 0
measure: Feasibility as measured by the number of goals submitted by each participant
timeFrame: Day 0
measure: Acceptability of the intervention as assessed by the Acceptability of Intervention Measure (AIM) scale
timeFrame: Day 7 post-intervention
Secondary outcomes:
measure: Goal attainment as assessed by number of goals submitted
timeFrame: Day 60 post-intervention
measure: Participation activation as measured by Parent Patient Activation Measure 10
timeFrame: Day 60 post-intervention
measure: Participant's child's respiratory symptoms as measured by self-report
timeFrame: Day 60 post-intervention
measure: Participant's child's use of the emergency department for breathing symptoms as measured by self-report
timeFrame: Day 60 post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Brandon M Smith, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036567: Evaluation of Pain Measurement Device
Official title: Longitudinal Observational Pilot Study to Assess the Capabilities of an Experimental Device to Objectively Measure Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women of all ethnicities will be included.

Brief summary: This longitudinal observational study will attempt to objectively measure pain with an experimental, non-invasive device. Patients and volunteers will receive a baseline screening with psychophysical tests and questionnaires. Investigators will apply the device to measure pain during routine clinical care and correlate patients pain ratings and analgesia requirements to that measured by the device. A more standardized approach with experimental pain stimuli will be pursued in human volunteer studies.


Eligibility criteria: Inclusion Criteria:

* age 18-100 years

Exclusion Criteria:

* inability to sign consent

Primary outcomes:
measure: correlation between pain as measured by the device and reported pain and clinical events, respectively
timeFrame: average 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Department of Anesthesia, Pain and Perioperative Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alexander Z Tzabazis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847067: Chronic Post Breast Surgery Pain
Official title: A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of central sensitization can be prevented by blocking sensory input to the CNS during surgery and the immediate post-operative period.


Eligibility criteria: Inclusion Criteria:

1. Female patient who are ≥ 18 and ≤ 80 years of age.
2. Patient with diagnosis of breast cancer.
3. Patient scheduled for modified radical mastectomy or lumpectomy with axillary node dissection
4. Patient scheduled for one of the above listed surgeries with or without sentinel, partial, or complete axillary lymph node dissection
5. Patients scheduled for one of the aforementioned surgeries with or without immediate or delayed reconstruction.

Exclusion Criteria:

1. Pre-existing peripheral neuropathy
2. Pre-existing chronic pain
3. Bilateral procedure
4. Previous breast surgery, except biopsy
5. Inability to read, write or speak English.
6. Allergy to amide local anesthetics
7. Contraindications to paravertebral nerve block including, but not limited to severe scoliosis of the spine, skin lesion overlying the block area, abnormal coagulation studies (some of these may not be known until after informed consent is obtained)
8. Pregnancy
9. Emergency surgery
10. Previous recipients of peripheral nerve block.
11. Medical professional whose experience includes caring for patients who have had peripheral nerve blocks.

Primary outcomes:
measure: To obtain practical experience and information with which to develop a larger, more definitive study, particularly with regard to distributions of VAS responses at 3 months, patient compliance, and achievable accrual rate.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Beth Ladlie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06141967: Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment
Official title: Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea Syndromes
Metabolic Syndrome
Diabetes
Obese
Keywords: Sleep Apnea Syndromes
Diabetes
Withings Sleep analyzer
Epworth
Berlin
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.

Detailed description: There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.

Eligibility criteria: Inclusion Criteria:

* Adult patients over 18 years old
* Diabetes Mellitus (Type 1 or 2), or obesity (BMI\>30kg/m²) or metabolic syndrome
* Hospitalized for at least one night in the Endocrinology department
* Affiliated or entitled to a social security scheme
* Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study

Exclusion Criteria:

* Known and/or treated OSAS-type respiratory pathology
* No signature of the informed consent form
* Minor or adult patients under guardianship or curatorship

Primary outcomes:
measure: patients real positive for each screening technique
timeFrame: Day 2
Secondary outcomes:
measure: Number of tests
timeFrame: Day 2
measure: Patient's experience with the use of Withings Sleep Analyzer
timeFrame: Day 2
measure: Nurse's satisfaction with the use of Withings Sleep Analyzer
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Natacha GERMAIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02501967: Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II
Official title: Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Keywords: multiple chronic conditions
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VA Connecticut Healthcare System
First posted: 2015-07-17
Enrollment: 128
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (CDSS) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy.


Eligibility criteria: Inclusion Criteria:

* Veterans age 65 years and older.
* Patients should be diagnosed with diabetes and hypertension and be prescribed five or more medications.
* Patients receiving primary care at the West Haven campus of VA Connecticut Healthcare System.

Exclusion Criteria:

* Unable to manage own medications because of cognitive impairment.
* Medications prescribed by physician outside of the VA.
* Severe vision or hearing impairment.

Primary outcomes:
measure: Patient Assessment of Care for Chronic Conditions (PACIC)
timeFrame: Immediately following the primary care visit at which the patient is enrolled in the study
Secondary outcomes:
measure: Number of changes made to the medication regimen
timeFrame: 3 Month Follow Up
measure: Coding of audiotapes of primary care visit
timeFrame: The primary care visit at which the patient is enrolled in the study
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare
state: Connecticut
Study officials:
affiliation: Yale University
name: Terri R Fried, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00356967: Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
Official title: An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Keywords: smoking
cessation
tobacco
smoking cessation
tobacco use cessation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 602
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 primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.


Eligibility criteria: Inclusion Criteria:

* Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months

Exclusion Criteria:

* Insufficient level of motivation
* Another participant in the household
* Patients with current psychotic disorder or major depressive disorder

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
measure: exhaled carbon monoxide testing
measure: and plasma cotinine measurements
Secondary outcomes:
measure: questionnaire of smoking urge
measure: Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Lysaker
country: Norway
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06503640: Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease (ANOCA-CMD)
Official title: Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angina Patients With Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction
Index of Microvascular Resistance
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients present of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80

Brief summary: The goal of this observational study is to explore the incidence and effect on prognosis of coronary microvascular dysfunction in patients present of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80.


Eligibility criteria: Inclusion Criteria:

* presence of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80

Exclusion Criteria:

1. acute myocardial infarction
2. significant valvular heart disease
3. advanced chronic kidney disease
4. patients with significant epicardial coronary artery stenosis (\>70% in major vessels by diagnostic coronary angiography) needing percutaneous coronary intervention
5. patients unable to provide written informed consent

Primary outcomes:
measure: MACE in 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03421067: Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.
Official title: Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse: A NSQIP Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 3458
Sex: FEMALE
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: patients who underwent hysterectomy for pelvic organ prolapse between 2015 and 2017, and whose cases are reported within ACS NSQIP®.

Brief summary: This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently recommended best practice of supporting the vaginal apex at time of hysterectomy for pelvic organ prolapse (POP).

Detailed description: The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%.

Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood.

In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for POP, and further that any woman having a hysterectomy for POP should undergo a concurrent apical suspension procedure as a standard of care.

The purpose of this study is to determine the proportion of patients undergoing hysterectomy for the indication of POP having concurrent apical suspension among the population whose cases are reported within the NSQIP database, and who underwent hysterectomy between 2015 and 2017.

Eligibility criteria: Inclusion Criteria:

* Underwent hysterectomy for pelvic organ prolapse, between 2015 and 2017

Exclusion Criteria:

* Age \< 18 years old
* Pelvic Organ Prolapse was not recorded in their postoperative diagnoses

Primary outcomes:
measure: proportion of patients having concurrent apical suspension performed
timeFrame: procedure (at time of hysterectomy for pelvic organ prolapse)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth - Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Catrina Crisp, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06177340: Nanoscope System During Sacrospinofixation
Official title: Visualization by the Nanoscope System During Sacrospinofixation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sacrospinofixation
Keywords: Nanoscope system
sacrospinofixation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns patients who underwent anterior and/or posterior sacrospinofixation surgery to correct a prolapse and for whom the Nanoscope system was used.

Brief summary: Sacrospinofixation is one of the reference techniques for the treatment of vaginal prolapse. It consists of fixing a non-absorbable thread on the sacrosciatic ligament unilaterally or bilaterally to correct a urogenital prolapse.

The technical difficulty is linked to the fact that the approach to the sacrosciatic ligament is palpatory without visual control. However, if the thread is not well fixed in the ligament, there is a risk of this suture coming loose and therefore of recurrence of the prolapse. On the other hand, due to the vascular and nervous proximity (pudendal nerve), vascular complications such as hemorrhage and/or hematoma have been described by vascular lesion during the passage of the needle through this ligament. Nervous complications due to pinning of the pudendal nerve or its nerve branches have also been described, which can cause after-effects of pain or even chronic dyspareunia.

Clearly and precisely visualizing the sacrosciatic ligament and the vascular and nervous structures with a microcamera could make it possible to better correct the prolapse and limit recurrences, but also to avoid these serious and disabling complications.

The Nanoscope system, which can be used in routine practice as part of sacrospinofixation, could make it possible to obtain visibility of tissues under vision control. Thus the precise visualization of the sacrospinous ligament would allow an easier approach and therefore more precise surgical procedures.


Eligibility criteria: Inclusion Criteria:

* women over 18
* patient who benefited from anterior and/or posterior sacrospinofixation using the nanoscope system
* person having expressed his non-opposition

Exclusion Criteria:

* inability to understand the information given
* person deprived of liberty
* person under guardianship

Primary outcomes:
measure: visualization of the sacrospinous ligament
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References: