louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04441307: Promoting Co-Parenting and Reducing Hazardous Drinking in New Families
Official title: Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Parent-Child Relations
Drinking, Alcohol
Adjustment
Keywords: Parenting
Couple Relationship
Alcohol and Health
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Rochester Institute of Technology
name: University at Buffalo
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-06-22
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In both arms, couples will experience a parenting program for expecting first time parents. In one arm, parents will receive an adapted Family Foundations program. In the other arm, parents will receive an empirically supported community parenting program.
Primary purpose: PREVENTION

Brief summary: This study aims to understand if a parenting program that helps couples learn to parent as a team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use, promotes parent and child health and well-being. Programs will be delivered prenatally and postnatally and will include both group classes and individualized sessions. A comprehensive assessment is administered during pregnancy and then at 6 and 12 months of child age. It is hypothesized that targeting intervention during the naturally motivating transition to parenthood may not only provide opportunities for long lasting behavioral change for parents, but also initiate a cascade of protective processes that ultimately reduce risk for negative emotional and behavioral outcomes for children.


Eligibility criteria: Inclusion Criteria:

* Pregnant couples who are cohabitating
* Parents are 18 years of age or older
* Health behavior such as moderate to heavy drinking
* English speaking

Exclusion Criteria:

* Plural pregnancy
* Illicit drug use other than cannabis for either parent

Primary outcomes:
measure: Couple Relationship/Co-parenting
timeFrame: 6 months of child age
measure: Parent Adjustment
timeFrame: 6 months of child age
measure: Parent Alcohol Use
timeFrame: 6 months of child age
Secondary outcomes:
measure: Parent-infant Interactions
timeFrame: 6 and 12 months of child age
measure: Infant Self-Regulation
timeFrame: 6 and 12 months of child age
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Henrietta
country: United States
facility: Rochester Institute of Technology
state: New York
Study officials:
affiliation: Penn State
name: Rina D Eiden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rochester Institute of Technology
name: Stephanie Godleski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971607: Sevoflurane In Acute Myocardial Infarction
Official title: Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Postconditioning
Sevoflurane
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 50
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: Ischemic postconditioning can reduce myocardial injury following myocardial infarction.

A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.

Detailed description: Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.

Eligibility criteria: Inclusion Criteria:

* First STEMI, presenting within 6 hours after the onset of chest pain
* Symptoms lasting \> 30 minutes
* Persistent ST-segment elevation \> 0.1 mV in 2 or more contiguous leads

Exclusion Criteria:

* Hypersensitivity to sevoflurane or other halogenated agents
* Malignant hyperthermia
* Cardiac arrest
* Cardiogenic shock
* Previous myocardial infarction or coronary bypass surgery
* Pre-infarction angina
* Heart failure (NYHA III/IV)
* Chronic inflammatory disease
* Severe renal impairment
* Hepatic dysfunction
* Use of Glyburide

Primary outcomes:
measure: Infarct size by area under the curve of cardiac markers.
timeFrame: 3 days
Secondary outcomes:
measure: Left ventricular function.
timeFrame: Six month
measure: ST segment elevation resolution
timeFrame: 90 minutes
measure: TIMI flow
timeFrame: 60 minutes
measure: Renal function
timeFrame: 48 hours
measure: CRP
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 1 hour
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sceinces Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Shahar Lavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavi S, Alemayehu M, McCarty D, Warrington J, Lavi R. One-year outcome of the sevoflurane in acute myocardial infarction randomized trial. Can J Anaesth. 2015 Dec;62(12):1279-86. doi: 10.1007/s12630-015-0456-2. Epub 2015 Aug 22.
Clinical trial NCT00900107: Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals
Official title: Time Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2009-05-12
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Only few data are available on the influence of strenuous exercise on the content of circulating progenitor cells and especially the timeframe of their release. The aim of the present study was to investigate the potential influence of 4 hours of cycling on the time-dependent release of progenitor cells.

Detailed description: 1. What is the response of hematopoietic and endothelial progenitor cells after a standardized prolonged endurance exercise?
2. What is the kinetic of cell mobilization during this standardized exercise?

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* cardiovascular disease

Primary outcomes:
measure: Endothelial progenitor cells (EPC) release on
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Leipzig, Heart Center
Study officials:
affiliation: Heart Center Leipzig
name: Gerhard C Schuler, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03220607: Uterocervical Angle in the Termination of Second Trimester Pregnancy
Official title: The Predictive Performance of Uterocervical Angle in the Termination of Second Trimester Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion, Second Trimester
Keywords: uterocervical angle, second trimester abortion
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant population undergoing medical induced second trimester abortion.

Brief summary: To evaluate the performance of uterocervical angle (UCA) in the prediction of second trimester terminations.

Detailed description: Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on nulliparous women who are taking misoprostol for the cervical preparation and aim to measure their UCA.

Eligibility criteria: Inclusion Criteria:

* Nulliparous singleton pregnancy
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of LEEP and cervical conization

Primary outcomes:
measure: uterocervical angle
timeFrame: once at the beginning of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Alev Atis, MD,ObGyn
role: STUDY_DIRECTOR
References:
Clinical trial NCT05469607: The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Official title: The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: Resectional surgery
Post operative prevention of Crohn's recurrence
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
Collaborators: name: Florey Institute of Neuroscience and Mental Health
name: University of Melbourne
name: The Bionics Institute of Australia
name: University of Queensland Diamantina Institute
First posted: 2022-07-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality.
* Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining bowel.
* Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine.
* Patients must have proven history of Crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria).

Exclusion Criteria:

* Patients with anastomosis which is endoscopically inaccessible by standard colonoscopy.
* Patients in whom there is persisting macroscopic abnormality post-surgical resection.
* Patients with Crohn's disease who have an end stoma (ileostomy or colostomy).
* Patients for whom endoscopy is not suitable due to co-morbidities or unwell clinical state
* Inability to give informed consent.
* Inability to obtain access to the anastomosis at colonoscopy.
* Suspected perforation of the gastrointestinal tract.
* Patients who are pregnant or breastfeeding.

Primary outcomes:
measure: Safety and efficacy based on endoscopic recurrence
timeFrame: 6 months post-operation
Secondary outcomes:
measure: Endoscopic recurrence
timeFrame: 18 months post-operation
measure: Clinical recurrence
timeFrame: 6 months and 18 months post-operation
measure: Surgical recurrence
timeFrame: 6 and 18 months post-operation
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: Austin Health, Melbourne
name: Peter De Cruz, MBBS PhD FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989807: Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis
Official title: Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cystic Fibrosis
Pseudomonas Aeruginosa
Keywords: CF
Cystic fibrosis
Pseudomonas aeruginosa
EAP
Expanded access
AZLI
Aztreonam lysine
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2009-10-06
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.


Eligibility criteria: Inclusion Criteria:

* ≥ 6 years of age
* Patient has CF as diagnosed by one of the following:
* Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test, or
* Two well characterized genetic mutations in the CFTR gene, or
* Abnormal nasal potential difference with accompanying symptoms characteristic of CF
* PA present in expectorated sputum or throat swab culture within 2 months prior to consent
* Patient must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure
* At high risk for disease progression as defined by one of the following patient populations:
* FEV1 ≤ 50 % predicted at the time of consent OR
* Completed participation in CP-AI-006 (through Visit 20). Patients who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol.

Exclusion Criteria:

* Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements
* Patients with hypersensitivity to any of the components of the drug product
* Currently enrolled in another clinical trial
* Pregnant or lactating females

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Adult CF Clinic
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre de Recherche du CHUM
state: Quebec
Study officials:
References:
Clinical trial NCT00013507: Effects of Functional Incidental Training in VA NHCU Residents
Official title: Effects of Functional Incidental Training in VA NHCU Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Keywords: Frail
FIT
transfer
continence
ambulation
balance
fall risk
strength,endurance
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This research on Functional Incidental Training ( FIT) primarily involves women residing in community nursing homes. It is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans.

Objectives of the project are as follows:

1) Test the effects of FIT on transfer ability, continence, ambulation/mobility, balance and fall risk, strength, and endurance; 2) Determine the characteristics of NHCU residents who respond to FIT; 3)Identify the most sensitive outcome measures related to FIT; and 4) Determine the labor costs of FIT relative to usual care.

Detailed description: This research on Functional Incidental Training ( FIT) primarily involves women in community nursing homes.

Objectives:

1. test the effects of FIT on functions such as transfer ability, continence, ambulation/mobility,balance and fall risk, strength, and endurance; 2. determine the characteristics of NHCU residents who respond to FIT; 3. identify the most sensitive outcome measures related to FIT; and 4. determine the labor costs of FIT relative to usual care.

. The intervention is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans in VA nursing home care units(NHCUs).The design is a multi-site cross-over design, to be carried out in five NHCUs (Atlanta, Durham, Salisbury, Augusta, Tuscaloosa) over about eight months in each site. About 24 residents will be recruited in each NHCU: 12 each will be randomized to initial intervention and control for 8 wks and evaluated; the controls will then receive the intervention and vice versa for another 8 wks with another evaluation. Patients are seen 4x a day for FIT activities, including walking/using wheel chair, prompted toileting, strengthening exercises. Outcome measures will be made in a blinded manner by Project Manager.

Eligibility criteria: Functionally impaired elderly

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: VAMC, Decatur
state: Georgia
Study officials:
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D., Asst. Director
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Victoria Mongiardo, Program Analyst
References:
Clinical trial NCT01262807: Reducing Range of Motion Deficits Post Radial Fracture
Official title: Reducing Range of Motion Deficits With In-cast Exercises: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Keywords: fracture
radius
adult
range of motion
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Pan Am Clinic
First posted: 2010-12-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This a randomized controlled study to test the hypothesis that patients who perform in-cast exercises will have superior range of motion immediately post-cast removal, without a concomitant increase in complication rate when compared with a control group who receives standard post cast care which does not include the intervention exercises.


Eligibility criteria: Inclusion Criteria:

* patient experienced distal radial fracture
* patient is over 18 years of age
* patient can follow instructions and comply with protocol
* fracture is managed non-operatively

Exclusion Criteria:

* bilateral wrist fractures
* previous fracture to the affected wrist
* previous range of motion limitations to the affected wrist
* involvement of other upper extremity structures (i.e. shoulder)

Primary outcomes:
measure: Change in range of motion
timeFrame: 6 weeks, 6 months, 1 year
Secondary outcomes:
measure: Complications
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jamie Dubberley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pan Am Clinic
name: Jeff Leiter, PhD
role: STUDY_CHAIR
affiliation: Winnipeg Health Sciences Centre
name: Kristy Wittmeier, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03476707: Association of Anemia With Hospital Costs in Elective Colorectal Surgery
Official title: Association of Anemia With Hospital Costs in Elective Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Surgical Blood Loss
Anemia
Colon Cancer
Economic Problems
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 851
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: All adults having elective colorectal surgery with national surgical quality improvement program data available

Brief summary: The objective is to measure the adjusted association between preoperative anemia and total hospital costs. We hypothesize that patients with anemia before surgery will have higher hospitalization costs than people without anemia.

Detailed description: This study will examine the association between preoperative anemia (hematocrit less than 0.39; low blood counts) and hospital total costs from elective colorectal surgery. Total costs will be defined as the combination of direct and indirect costs ascertained using standardized patient-level costing algorithms (i.e. the standard way that hospital measure their costs). Adjustment will be made for factors that are likely to influence both the presence of anemia and costs of care.

Eligibility criteria: Inclusion Criteria:

* Elective hospital admission
* having colorectal surgery

Exclusion Criteria:

* not enrolled in national surgical quality improvement program data collection

Primary outcomes:
measure: Total Hospital Costs
timeFrame: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
Secondary outcomes:
measure: Length of Stay
timeFrame: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
measure: Red Blood Cell Transfusion
timeFrame: Hospital admission to date of surgery, or 365 days after admission, whichever came first
Other outcomes:
Locations:
Study officials:
References:
citation: Feng S, Greenberg J, Moloo H, Thavorn K, McIsaac DI. Hospital cost associated with anemia in elective colorectal surgery: a historical cohort study. Can J Anaesth. 2019 Aug;66(8):877-885. doi: 10.1007/s12630-019-01379-8. Epub 2019 May 1.