louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05635188: Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection
Official title: Impact of Surgical Technique (Laparoscopic, Open or Trephine) on Post-operative Complications in Urgency Ostomy Confection - a Single Center Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colostomy Stoma
Colostomy Complication
Obstruction Bowel
Surgical Complication
Surgical Procedure, Unspecified
Keywords: colostomy
laparoscopy
ostomy
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent emergency surgery between 2008 and 2019 by the surgical team of the Cancer Institute of São Paulo State (Instituto do Câncer do Estado de São Paulo - ICESP)

Brief summary: This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).


Eligibility criteria: Inclusion Criteria:

* Patients who underwent emergency colostomy or ileostomy

Exclusion Criteria:

* Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection

Primary outcomes:
measure: Surgical complications
timeFrame: Between cohort enter (2008-2019) and study finish (2021)
Secondary outcomes:
measure: Postoperative length of hospital stay
timeFrame: Between cohort enter (2008-2019) and study finish (2021)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo - ICESP
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Gabriella Rosceli C Zerbetto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01255488: Research Abstract Usefulness in Clinical Decision-making
Official title: Family Nurse Practitioner Perception of Journal Abstract Usefulness in Clinical Decision-making: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Decision-making
Keywords: Search engine
Clinical decision-making
Research abstracts
Full-text manuscripts
Family Nurse Practitioners
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2010-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To better understand the extent to which family nurse practitioners (FNPs) might use research abstracts in shaping their clinical decision-making under simulated conditions. A secondary point is to examine if and how FNPs might use full-text manuscripts (associated with the abstracts) if made available to them.

Detailed description: The study will recruit the approximate 25 - 1st year and 25 - 2nd year family nurse practitioner students of the Graduate School of Nursing. After being presented an overview of the study and informed consent document, those electing to participate will draw a sealed envelope indicating whether they are assigned to group A (intervention group) or group B (control group). The participant will proceed to the associated room, be provided a brief clinical case (appropriate to their training), an iPad device with pre-loaded EBN-Search engine, and a questionnaire. The EBN-Search engine for the intervention group will include 9 research abstracts associated to the case. The EBN-Search for the control group will include both the research abstracts and full-text versions of the manuscripts. The participants will be provided 20 minutes to complete the questionnaire using the information available to them. The questionnaire will require the participant to indicate treatment plan, respond to questions regarding the usefulness of research abstracts, questions regarding the usefulness of full-text (control group only) and recommendations on improving EBN-Search.

Eligibility criteria: Inclusion Criteria:

* Matriculated family nurse practitioner graduate students of USUHS 2010/2011 academic year

Exclusion Criteria:

* None

Primary outcomes:
measure: Measure of perception of abstract usefulness in clinical decision-making
timeFrame: Immediate post-experiment
Secondary outcomes:
measure: Use of full-text manuscripts when available in simulated clinical encounter
timeFrame: During experiment
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Ronald W. Gimbel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718588: A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis
Official title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.


Eligibility criteria: Inclusion Criteria:

1. SAD Stage

   * RA diagnosed according to the ACR
   * For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization
   * Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period
2. MAD Stage (same as above with the addition of the following)

   * Failure of at least one biologic agent, defined as lack of or loss of response or intolerance
   * Active disease defined by swollen and tender count

Exclusion Criteria:

* Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
* Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
* History of treatment with any T cell-directed therapy

Primary outcomes:
measure: Safety and tolerability of MTRX1011A in both the SAD and MAD stages
timeFrame: Length of study
Secondary outcomes:
measure: Characterize the pharmacokinetic response of MTRX1011A
timeFrame: Length of study
measure: Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A
timeFrame: Length of study
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: John Davis, M.D., M.P.H.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01394588: Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery
Official title: A Prospective Observational Trial of Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Surgery
Keywords: Cardiac Surgery
Perioperative Glucose Control
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-07-14
Enrollment: 0
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: Competent adults scheduled for elective cardiac surgery.

Brief summary: This is an observational study of continuous glucose monitoring technology during cardiac surgery. The investigators would like to develop data for descriptive analysis of a comparison of continuous glucose monitoring with a gold standard under the conditions of cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Competent adults scheduled for elective cardiac surgery.

Exclusion Criteria:

* Inability to consent, emergency surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Robert Schonberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00598988: Acupuncture for Infectious Mononucleosis Trial
Official title: Acupuncture for Infectious Mononucleosis Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Infectious Mononucleosis
Keywords: infectious mononucleosis, mono, acupuncture
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 3
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate feasibility issues related to conducting an acupuncture study in a population of adolescents and young adults with infectious mononucleosis. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Detailed description: This study examines the feasibility of treating adolescents and young adults diagnosed with infectious mononucleosis with acupuncture. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Eligibility criteria: Inclusion Criteria:

* mono diagnosis confirmed by lab test
* 21 days or less between start of symptoms and diagnostic test
* presence of fatigue of at least 4/11 (by Chalder Fatigue Questionnaire)
* no other illnesses present
* meets residency requirement

Exclusion Criteria:

* insufficient communication in English
* unable to begin acupuncture within 21 days of diagnostic test
* acupuncture use currently or in the preceding 3 months
* currently under the care of a TCM practitioner
* unwilling to be randomized

Primary outcomes:
measure: Chalder Fatigue Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: MOS SF-36
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sunita Vohra, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04695678: Epidemiological Multicohort Study of Latent COVID-19 Infections
Official title: Epidemiological Multicohort Study of Latent COVID-19 Infections in Residents and Staff of Nursing Homes in the City of Solingen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 1462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All residents and staff in the nursing homes in Solingen who consent to participate in the study.

Brief summary: Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup.

Detailed description: Particular interest is being paid to old people's and nursing homes during the COVID-19 pandemic, as people at particular risk are to be found there. Therefore, the health department of the city of Solingen will carry out extensive testing of both staff and residents for COVID-19 in this sensitive area. The scientific institute Bethanien für Pneumologie e.V. would like to collect and evaluate the data and test results collected in the process in order to record the occurrence of infections in this area and to obtain information on possible routes of infection and the effectiveness of hygiene measures taken. The aims of the study are:

1. Prevalence of latent COVID-19 infections at one point in time among residents and staff of old people's and nursing homes in Solingen.
2. Prevalence of latent COVID-19 infections over a period of 6 months among staff of a single nursing home (=subgroup)
3. Analysis of transmission pathways of the virus in a nursing home
4. Analysis of the effectiveness of hygiene measures taken
5. Analysis of risk factors (previous illnesses, medication, etc.)

Eligibility criteria: Inclusion Criteria:

* informed consent of the test person or the legally authorised guardian

Exclusion Criteria:

* missing consent

Primary outcomes:
measure: Prevalence of latent COVID-19 infections at one point in time among residents and staff of all old people's and nursing homes in Solingen.
timeFrame: baseline
measure: Prevalence of latent COVID-19 infections over a follow-up period of 6 months among staff of one single nursing home
timeFrame: 6 months
Secondary outcomes:
measure: Analysis of risk factors (previous illnesses, medication...)
timeFrame: 6 months
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
state: Nordrhein-Westfalen
Study officials:
affiliation: Krankenhaus Bethanien Solingen
name: Winfried Randerath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760578: A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
Official title: A Phase 2A, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of Mitoglitazone™ in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Metabolic Solutions Development Company
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 if MSDC-0160 is effective in the treatment of Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 2 Diabetes naive or on metformin
* Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.

Exclusion Criteria:

* Use of diabetes medications other than metformin.
* History of heart failure or previous myocardial infarction.
* Blood pressure great than 160/100 mmHg.

Primary outcomes:
measure: Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test
timeFrame: 28 days
Secondary outcomes:
measure: Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test
timeFrame: After four weeks of active therapy
measure: Change From Baseline in FFAs
timeFrame: After 28 days of active therapy
measure: Change From Baseline in Triglycerides
timeFrame: 28 days
measure: Change From Baseline in HDL
timeFrame: 28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Miami Gardens
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Kalamazoo
country: United States
state: Michigan
city: Greenville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Renton
country: United States
state: Washington
Study officials:
affiliation: Metabolic Solutions Development Company
name: Jerry R Colca, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04774978: Real-time Continuous Cardiac Output Measurements
Official title: Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Output, Low
Keywords: Cardiac output
TTE
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
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 real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Detailed description: Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements

Study design: prospective, feasibility study

Study population: Adult Intensive Care patients ( \> 18 years)

Intervention (if applicable):

Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements.

Main study parameters/endpoints:

* Percentage of patients in which continuous cardiac output can be measured using TTE
* Correlation between continuous TTE and Flotrac measurements

Eligibility criteria: Inclusion Criteria:

* Adult Intensive Care patients ( \> 18 years)

Exclusion Criteria:

* Pregnancy
* Atrial fibrillation or other irregular heart rhythm

Primary outcomes:
measure: Patients in which the ProbeFix can be used continuously
timeFrame: 2 months
Secondary outcomes:
measure: Correlation between continuous TTE and Flotrac
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04286178: Exercise, Creatine and Coenzyme Q10 for Childhood Myositis
Official title: The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myositis, Juvenile
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 15
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be a double-blinded, placebo-controlled, randomized, multiple baseline design (MBD) where each subject will be randomly allocated a start time for the active supplements
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children with JDM are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JDM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.


Eligibility criteria: Inclusion Criteria:

* Ages 7 to 18 years
* Diagnosis of juvenile idiopathic inflammatory myopathy (JIIM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria: ≥90% probability, age of onset \<18 years
* Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
* Minimum height of 132.5cm (required to fit on the cycle ergometer)

Exclusion Criteria:

* Subjects with newly diagnosed JIIM within the previous 6 months
* Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
* Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR \<90 ml/min/1.73m\^2)
* Subjects currently taking anti-hypertensive drugs or blood thinners
* Subjects who are currently pregnant or planning to become pregnant within the study period

Primary outcomes:
measure: Change in muscle function
timeFrame: 6 months
Secondary outcomes:
measure: Change in muscle fatigue
timeFrame: 6 months
measure: Change in general fatigue
timeFrame: 6 months
measure: Change in quality of life
timeFrame: 6 months
measure: Change in physical function
timeFrame: 6 months
measure: Change in physical function
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Brian Feldman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761878: Evaluation of the PlasmaJet Neutral Argon Plasma System to Treat Skin Ageing
Official title: Evaluation of the PlasmaJet Neutral Argon Plasma System for Skin Regeneration and Comparison With the Rhytec Portrait PSR Plasma System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: Skin aging
Skin wrinkling
Lead sponsor: Plasma Surgical Inc
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 35
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: The purpose of this study is to determine the comparative effects of the PlasmaJet neutral argon plasma system and the Rhytec Portrait PRS nitrogen plasma system in the treatment of aging facial skin


Eligibility criteria: Inclusion Criteria:

* request for treatment to improve facial skin

Exclusion Criteria:

* pregnancy
* history of HIV infection
* autoimmune or connective tissue disorder

Primary outcomes:
measure: Assessment of skin appearance and condition by photography and digital image analysis
timeFrame: At intervals for up to 12 months
Secondary outcomes:
measure: Assessment of skin condition and dermal architecture by ultrasound imaging
timeFrame: At intervals for up to 12 months
measure: Assessment of skin elasticity by non-invasive means
timeFrame: At intervals for up to 12 months
measure: Assessment of pain during treatment
timeFrame: During treatment
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Denis F Branson MD
state: New York
Study officials:
affiliation: Denis F Branson MD
name: Denis F Branson, MD
role: PRINCIPAL_INVESTIGATOR
References: