louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01665872: New Haven MOMS Partnership
Official title: New Haven Mental Health Outreach for MotherS (MOMS) Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stress
Keywords: Mothers
Depression
Stress
Trauma
Public Housing
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Office of Research on Women's Health (ORWH)
First posted: 2012-08-15
Enrollment: 154
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase II of the MOMS Partnership aims to:

1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
2. provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.

Detailed description: The purpose of this project is to expand and enhance the New Haven Mental health Outreach for Mothers (MOMs) Coalition beyond pregnancy and depression to include a broader definition of mental illness (depressive, anxiety, and substance use disorders), and a larger target population (low-income, racially and ethnically diverse, pregnant and parenting women) in the City of New Haven. Through this expansion, the Coalition will bring together the community of women, their families and advocates, healthcare providers, policy and agency leaders, and academics, to inform the development and conduct of public health approaches around the mental health of low-income, racially and ethnically diverse, pregnant and parenting women. The specific goals of this Phase I proposal are:

1. To conduct a community-led needs assessment on the mental health of low-income, ethnically and racially diverse pregnant and parenting women in the City of New Haven.
2. To provide randomized intervention services to improve signs/symptoms of depression/stress/trauma among mothers living in public housing in New Haven, CT

Eligibility criteria: Inclusion Criteria:

* CES-D score \>=16
* Child under the age of 18 (participant must be a mother)
* Resident of public housing authority complex in New Haven, CT or an affiliated Section 8 recipient

Exclusion Criteria:

* Positive for psychosis
* Active suicidal ideation
* Non-English or Spanish speakers
* Unable to provide informed consent
* Unwilling to accept randomization
* Moving within the intervention \& follow-up period

Primary outcomes:
measure: Total Outpatient Mental Health or Substance Abuse Visits
timeFrame: 1 year
measure: Depressive and Anxiety Symptoms (CES-D)
timeFrame: approximately 1 year
measure: Parenting Stress
timeFrame: 1 year
measure: Gainful Employment
timeFrame: 1 year
measure: Implementation Cost
timeFrame: 1 series
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Megan V Smith, MPH, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223872: Childhood Cancer Survivors' Knowledge of Diagnosis,Treatment and Risk of Late Effects: Specialized Survivorship Clinic
Official title: Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 188
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty new cancer patients in the REACH for Survivorship clinic, fifty returning cancer patients in the REACH for Survivorship clinic, and one hundred routine care cancer patients are expected to enroll in this study.

Brief summary: This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care.


Eligibility criteria: Inclusion Criteria:

* Treatment for primary malignancy per risk-adapted protocol
* Age ≤ 21 years at time of diagnosis
* Currently alive without evidence of disease
* Off therapy for no more than 15 years

Exclusion Criteria:

-Patients who have received a bone marrow transplant

Primary outcomes:
measure: Knowledge gained by attending a multispecialty Survivorship Clinic which will be measured by comparison of self report with medical record data in both cross-sectional and longitudinal approach.
timeFrame: 12 months
Secondary outcomes:
measure: Characterizing how the initial consultation in a specialized clinic impacts childhood cancer survivors' knowledge of their cancer diagnosis, treatment, and risk of late effects by comparing patient's understanding among 3 sampled timepoints.
timeFrame: pre-clinic and a post-clinic interviews at 1 and 3 months.
measure: An analysis of differences in relative levels of recommended screening for late effects that childhood cancer survivors have received based on the type of their long-term follow-up care comparing medical records against Survivorship Care Plan.
timeFrame: 12 months
measure: A qualitative evaluation of program feedback will serve to improve the care provided in the REACH for Survivorship clinic
timeFrame: 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01193972: Decision Aid Development for Smokers
Official title: Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Elective Surgery
Keywords: Smoking cessation
Smoking
Tobacco
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A decision aid tool will be developed using participatory research approach. The decision aid will be targeted to cigarette smokers scheduled for elective surgery.


Eligibility criteria: Inclusion:

* Current cigarette smoker having elective surgery at Mayo Clinic Rochester and is scheduled to be seen at Preoperative Evaluation Center.

Primary outcomes:
measure: Score on Decisional Conflict Scale and COMRADE Scale
timeFrame: Perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636272: Longitudinal Surveillance Registry
Official title: Longitudinal Surveillance Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Sudden Cardiac Death
Keywords: ICD
CRT-D
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 2500
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: Patient who are or will be implanted with a LATITUDE-enabled pulse generator (ICD or CRT-D).

Brief summary: Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs).

Detailed description: The LSR is an active, prospective, non-randomized, multi-center registry of patients implanted with BSC commercially available LATITUDE-enabled products. The primary purpose of the LSR is to evaluate and report on the long-term reliability and clinical performance of BSC's commercially available PGs and leads using the LATITUDE Patient Management system to augment information collected from in-clinic visits. The LSR is designed to enroll patients implanted with BSC LATITUDE-enabled (wireless or wanded) commercially available PGs (lead systems may include other manufacturers' leads).

The primary objective of the LSR is to prospectively evaluate market-released PGs and leads to verify long-term system performance. The secondary objectives of the LSR include:

I. To compare PG- and lead-related reliability data collected via LATITUDE with PG- and lead-related reliability data collected at in-clinic visits II. To compare this active surveillance of BSC PG and lead reliability data to the current passive surveillance system III. To enhance understanding of feature performance, patient management and clinical outcomes

Eligibility criteria: Inclusion Criteria:

* Patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available BSC PG (lead systems may include other manufacturers' leads) that can be followed on the LATITUDE Patient Management system
* Patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician)
* Patient who confirms that s/he has a telephone line compatible with the LATITUDE Patient Management system Communicator
* Patient or appropriate legal representative who is willing and capable of providing authorization for participation in the LSR

Exclusion Criteria:

* Patient who cannot be followed on the LATITUDE Patient Management system
* Patient who is unable or unwilling to comply with the protocol requirements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Scientific Corporation
name: Boston Scientific
role: STUDY_DIRECTOR
References:
Clinical trial NCT00400972: Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Nasal Intubation
Official title: Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Nasal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Intubation
Keywords: GlideScope
videolaryngoscopy
intubation
nasal
nasotracheal
laryngoscopy
anesthesia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2006-11-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether nasal intubation assisted by GlideScope videolaryngoscopy is faster, easier, and less traumatic than nasal intubation with conventional direct laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* any patient who is at least 18 years old
* patient requires nasal intubation for surgical indications
* operator has performed at least 10 prior GlideScope intubations (oral or nasal)

Exclusion Criteria:

* cervical spine abnormalities
* known difficult airway
* requires rapid sequence induction
* any other patient in whom the attending anesthesiologist believes usage of the GlideScope is contraindicated

Primary outcomes:
measure: time to intubation
Secondary outcomes:
measure: ease of intubation (VAS)
measure: incidence of trauma
measure: number of failures
measure: severity of patient sore throat on post-operative day 1
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Philip M Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04174872: Epidural Anesthesia for Gynecological Surgeries
Official title: A Comparative Study Between Dexmedetomidine and Midazolam as Adjuvant to Bupivacaine During Epidural Anesthesia For Elective Gynecological Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epidural Analgesics for Comparison
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in present times. Gynecological surgeries are often associated with severe pain requiring a well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to decrease stay time in the hospital/post-anesthesia care unit (PACU) enabling patients to return to their normal activities quicker. Dexmedetomidine has been approved by Food and Drug Administration (FDA) as a short-term sedative for mechanically ventilated intensive care unit (ICU) patients as it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. Epidural administration of preservative free midazolam induces antinociceptive effects in humans, when midazolam is added it acts through gamma amino-butyric acid (GABA) receptors and enhances the affinity of GABA receptors. Midazolam is involved in the release of endogenous opioids acting on spinal delta receptors so antinociceptive effects of morphine like substances are potentiated when epidural midazolam is added. Studies have revealed that use of epidural midazolam provides effective analgesia in adults. So, the present study will evaluate the additive analgesic effects of epidural midazolam in combination with bupivacaine in elective gynecologic surgeries and compare the results with the use of bupivacaine with dexmedetomidine and observe the quality of epidural anesthesia with occurrence of side effects.


Eligibility criteria: Inclusion Criteria:

* Female patients of ASA I-II.
* Aged 18-55 years undergoing elective gynecological surgeries

Exclusion Criteria:

* Patient refusal.
* Patients with history of diabetes mellitus, cardiac disease, hypertension, chronic obstructive respiratory disease, coagulation abnormalities, spinal deformities, patients allergic to amide type of local anesthetics, localized skin sepsis, neurological disease, hepatic and renal diseases, peripheral neuropathy and psychiatric diseases.

Primary outcomes:
measure: Onset of sensory blockade
timeFrame: Eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia, Surgical ICU, and Pain Management
Study officials:
References:
Clinical trial NCT00742872: Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome
Official title: A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Constipation-Predominant Irritable Bowel Syndrome
Keywords: Mosapride
Irritable Bowel Syndrome
Constipation
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).


Eligibility criteria: Inclusion Criteria:

* Rome III Criteria for IBS:

Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:

* Relieved by defecation
* Onset associated with a change in stool frequency
* Onset associated with a change in stool form or appearance

In addition, patients have to experience at least two of the following symptoms for at least 25% of the time \[11\]:

* Altered stool frequency (\< 3 bowel movements per week)
* Altered stool form (lumpy/hard i.e. Bristol type I-III \[see appendix 1\])
* Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
* Passage of mucus, bloating, or a feeling of abdominal distension

Exclusion Criteria:

* Previous allergy to mosapride
* Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
* Age \< 18 years
* History of bloody stools or melena
* Diarrhea (\>3 bowel movements per day)
* Constitutional symptoms (fever, weight loss)
* Severe constipation (\< 1 bm/week)
* Pregnancy or lactation
* Patients with history of cardiac arrhythmias
* QT prolongation on baseline ECG
* Chronic laxative use and dependence
* Patients with previous history of congenital heart disease
* Patients with previous history of hypokalemia or hyperkalemia
* Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.

Primary outcomes:
measure: Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
timeFrame: Within the first 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Ala' I. Sharara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American University of Beirut Medical Center
name: Nabil M. Mansour, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02509572: Improvement of STI Detection in Adolescent Emergency Department Patients
Official title: Improvement of STI Detection in Adolescent Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 720
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs.

Detailed description: The investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ED) through the use of an audio-computer assisted self-interview (ACASI). This information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (STI) screening in the ED for adolescents. This randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased STI screening for patients who report high risk sexual activity. Secondary outcomes include evaluation of whether the clinical decision support results in increased STI detection, and identifying factors associated with adapting the clinical decision support.

Eligibility criteria: Inclusion Criteria:

* Aged 14-19 presenting to the emergency department.

Exclusion Criteria:

* history of developmental delay,
* medical instability,
* altered mental status,
* unable to understand English

Primary outcomes:
measure: Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
timeFrame: an expected average of 4-6 hours.
Secondary outcomes:
measure: The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
timeFrame: Baseline
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: CNMC
name: Monika Goyal, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goyal MK, Fein JA, Badolato GM, Shea JA, Trent ME, Teach SJ, Zaoutis TE, Chamberlain JM. A Computerized Sexual Health Survey Improves Testing for Sexually Transmitted Infection in a Pediatric Emergency Department. J Pediatr. 2017 Apr;183:147-152.e1. doi: 10.1016/j.jpeds.2016.12.045. Epub 2017 Jan 10.
Clinical trial NCT06691672: Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations. The CANSCAN Trial.
Official title: Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility Assessment of the VxWave Device for Vascular Access Imaging
Lead sponsor: Vexev Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: USRC Kidney Research
First posted: 2024-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.


Eligibility criteria: Inclusion Criteria:

1. Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD.
2. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
3. Greater than or equal to 21 years of age at the time of written informed consent.

Exclusion Criteria:

1. Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury).
2. Patient has evidence of open or incompletely healed wounds on both arms. Patients with open or incompletely healed wounds on a single arm are not excluded - if the ipsilateral arm is not able to be scanned - contralateral arm may be scanned.
3. Any acute or chronic condition that would limit the ability of the patient to participate in the study - in the opinion of the principal investigator.
4. Previous vascular/vascular access surgery on both upper limbs. Patients with previous vascular/vascular access surgery on a single arm are not excluded- contralateral arm may be scanned.

   -

Primary outcomes:
measure: Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability
timeFrame: From enrollment to the end of viable assessment window at 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: USRC E Houston Street
state: Texas
Study officials:
References: