louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00956761: Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2009-2010, When Administered to Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Influenza
Keywords: Influenza vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2009-08-11
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a trial for annual registration of the updated seasonal influenza vaccine formulation.


Eligibility criteria: Key Inclusion Criteria:

* Subjects of 65 years of age or older
* Mentally competent
* Willing and able to give written informed consent prior to study entry
* Able to comply with all the study requirements
* In general good health

Key Exclusion Criteria:

* Any serious chronic or acute disease disease
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
* A proven hypersensitivity to any component of the study vaccine
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
* Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
* Within the past 12 months, participants had received more than one injection of influenza vaccine
* Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine

Primary outcomes:
measure: Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD
timeFrame: Day 21
measure: Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
timeFrame: day 21
measure: Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
timeFrame: day 21
measure: Number of Participants Who Reported Solicited Local and Systemic Reactions
timeFrame: 0-3 days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Lanciano
country: Italy
facility: Site 2: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
city: Pianiga
country: Italy
facility: Site 3: Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT01286961: The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
Official title: The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Timing of Bowel Preparation in Outpatient Colonoscopy
Keywords: Bowel preparation
Polyethylene glycols
Colonoscopy
Outpatient
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult outpatients who undergo colonoscopy

Brief summary: As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.

Detailed description: The aim of the present studies is to determine how the duration of the interval of the time of last preparation dose and the start of colonoscopy affects the quality of the bowel preparation and when the proper timing of the colonoscopy is after completion of last preparation regimen

Eligibility criteria: Inclusion Criteria:

* Adult outpatients(18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria:

* age under 18 years, pregnancy, breast feeding, prior history of surgical large bowel resection, severe renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4)), drug addiction or major psychiatric illness; allergy to PEG, refusal of consent to participate in the study.

Primary outcomes:
measure: Quality of bowel preparation according to Ottawa scale
timeFrame: 6 months
Secondary outcomes:
measure: Proper timing of colonoscopy
timeFrame: 6 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital
Study officials:
affiliation: Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
name: Tae Oh Kim, Ph.D.
role: STUDY_DIRECTOR
affiliation: Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
name: Eun Hee Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00864461: Frequency of Metabolic Syndrome in Down Syndrome Patients
Official title: Prevalence of Metabolic Syndrome in Down Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome X
Down Syndrome
Keywords: Down syndrome
Metabolic syndrome X
Insulin resistance
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Down syndrome

Exclusion Criteria:

* History of congenital cardiac defects requiring open-heart surgery
* History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention
* History of leukemia or other cancer
* History of hypothyroidism requiring thyroid hormone replacement

Primary outcomes:
measure: To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo.
timeFrame: One year
Secondary outcomes:
measure: Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods.
timeFrame: One year
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: School of Medicine, University of Guanajuato
state: Guanajuato
Study officials:
References:
Clinical trial NCT06468761: 2-year Mortality After COVID-19 in Nursing Home Residents
Official title: COVID-19 Infection and 2-year Mortality in Nursing Home Residents Who Survived the First Wave of the Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
Older Adults
Nursing home
Long-tem mortality
Lead sponsor: Bichat Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 315
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 315 residents of 3 nursibg omes, mean age 86 years old. 50% severe disability. 111 contracted COVID-19 and survived the first pandemic wave.

Brief summary: This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. The collected data also included age, sex, length of residence in the NH, disability status, legal guardianship status, nutritional status, need for texture-modified food, hospitalization or Emergency Department visits during lockdown and SARS-COV2 vaccination status during the follow-up. Non-adjusted and adjusted Cox models were used to analyse factors associated with 2-year post-1stCoPW mortality.


Eligibility criteria: Inclusion Criteria:

* Living in one of the Nursing Homes during the fiorst COVID-19 pandemic wave
* Having survived the first pandemic wave

Exclusion Criteria:

* Residents who died during the first pandemic wave
* Refusal for articipation to the study

Primary outcomes:
measure: All cause mortality
timeFrame: months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Geriatrics
Study officials:
References:
Clinical trial NCT05626361: Specialize Dysphagia Training and Knowledge/Competency of Nurses
Official title: Effect of Specialized Dysphagia Training on Knowledge and Competency of Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Dysphagia
Swallowing disorder
Dysphagia screening
Nurses role
Assessment
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 64
Sex: ALL
Minimum age (years): 23
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this research is to determine the effect of specialized dysphagia training on knowledge and competency of nurses.


Eligibility criteria: Inclusion Criteria:

* Nurses of both gender
* At least one year of experience
* Nurses working at Govt. hospital

Exclusion Criteria:

* Undergraduate nursed working as intern at hospital

Primary outcomes:
measure: Nurses Knowledge and competency regarding dysphagia scale
timeFrame: 1st day
measure: Nurses Knowledge and competency regarding dysphagia scale
timeFrame: 3 months
Secondary outcomes:
measure: The simulation Design scale
timeFrame: 1st day
measure: Educational practice questionnaire
timeFrame: 1st day
measure: Student satisfaction and self confidence in learning
timeFrame: 1st day
Other outcomes:
Locations:
city: Chakwal
country: Pakistan
facility: District Headquarters Hospital Chakwal
state: Punjab
Study officials:
affiliation: Riphah International University
name: Asghar Khan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Raffa Mubeen, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02087761: A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
Official title: A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Tract Infection
Bronchitis
Pneumonia
Keywords: ARIES Flu
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All comers

Brief summary: The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.

The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.

Detailed description: The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Eligibility criteria: Inclusion Criteria:

* The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing
* The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
* The specimen is a nasopharyngeal swab

Exclusion Criteria:

* The specimen is NOT a nasopharyngeal swab
* The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.

Primary outcomes:
measure: Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
timeFrame: Within the first year of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Lake Success
country: United States
facility: North Shore-LIJ Health System Laboratories
state: New York
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
Study officials:
affiliation: Luminex Corporation
name: David Himsworth
role: STUDY_DIRECTOR
References:
Clinical trial NCT01276561: Single Incision Versus Standard Laparoscopic Splenectomy
Official title: Single Incision Versus Standard Laparoscopic Splenectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hereditary Spherocytosis
Idiopathic Thrombocytopenic Purpura
Keywords: laparoscopy
splenectomy
single site
trial
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.

The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.

Detailed description: This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for splenectomy. We will offer enrollment to several institutions provided they reach institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 30 patients will give us a power of 0.8 with an α of 0.05. Thus operative time is the primary outcome variable by definition. This is recorded and reported in MINUTES.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Secondary outcome measures include days in the hospital (measured in days), doses of analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment form which will be filled out by the patient and/or parents at 6 weeks and 6 months. This is a validated quality of life survey with 39 questions and each has 4 categories from best to worst.

Eligibility criteria: Inclusion Criteria:

* Need for splenectomy

Exclusion Criteria:

* Splenomegaly

Primary outcomes:
measure: Operative time
timeFrame: 1 day
Secondary outcomes:
measure: operative complications
timeFrame: 1 day
measure: wound complications
timeFrame: 1 month
measure: cosmesis
timeFrame: 6 months
measure: length of stay
timeFrame: 1 week
measure: operative difficulty
timeFrame: 1 day
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06424561: The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery
Official title: The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Wounds
Keywords: VSD drainage surgery
systematic psychological intervention
chronic wounds
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study focuses on providing clinical care to patients undergoing VSD drainage surgery for chronic wounds, while also paying attention to the impact of negative emotions such as depression and anxiety, as well as quality of life and social support, on the patients' physical and mental well-being. It observes the influence of psychology on patients.

Detailed description: The chronic, difficult-to-heal wounds not recovering within the expected timeframe not only impact the quality of life for patients and hinder the recovery of the primary condition but also exacerbate their financial and psychological burdens, further affecting the quality of wound healing. The objective of this study is to employ psychological nursing interventions effectively combined with nursing techniques and communication strategies. By listening to patients' fears, anxieties, and tensions, it significantly alleviates their negative emotions, enhances compliance with medical advice, and predicts postoperative complications to mitigate them. Tailored and empathetic care, along with psychological counseling, is provided to expedite wound healing.

Eligibility criteria: Inclusion Criteria:

- A mentally healthy, communicative adult. Patients and their families are cooperative, understanding, and supportive of this study.

Adult patients undergoing VSD surgery for chronic wounds.

Exclusion Criteria:

- Patients who are unable to effectively cooperate with nursing questionnaires due to auditory or visual impairments, cognitive impairments, or low levels of cultural literacy.

Patients with poor compliance or those who harbor skepticism and hostility towards this research.

Primary outcomes:
measure: Self-rating anxiety scale (SAS)
timeFrame: After 4 weeks of intervention
measure: self-rating depression scale (SDS）
timeFrame: After 4 weeks of intervention
Secondary outcomes:
measure: Patient satisfaction with hospitalization
timeFrame: After 4 weeks of intervention
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT02263261: Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
Official title: Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastectomy
Breast Reconstruction
Keywords: dermal matrix
Lead sponsor: Musculoskeletal Transplant Foundation
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Use of a HADM and implant in post-mastectomy breast reconstruction.

Detailed description: This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
* Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
* Skin incision may be skin sparing, or nipple-areolar sparing
* Have signed written, informed consent
* Be at least 18 years of age

Exclusion Criteria:

* Patients undergoing autologous breast reconstruction
* Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
* Patients undergoing reconstruction after previously failed attempts at reconstruction
* Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
* There will be no exclusions based on race or ethnicity
* BMI \> 40
* Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.

Primary outcomes:
measure: Types and incidence of complications
timeFrame: 6 months post reconstruction
Secondary outcomes:
measure: Aesthetic Outcomes
timeFrame: 6 months post reconstruction
measure: Patient-Reported Outcomes
timeFrame: 6 months post reconstruction
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Liu Plastic surgery
state: California
city: San Jose
country: United States
facility: Liu Plastic Surgery
state: California
Study officials:
References:
Clinical trial NCT01905761: UMP Lifestyle Medicine Program
Official title: UMP Lifestyle Medicine Program
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Keywords: obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are adults with obesity (BMI \> 30) seen at our Lifestyle Medicine program in weight management at the University of Minnesota

Brief summary: To systematically follow patients seen at the University of Minnesota's Lifestyle Medicine Program for Weight Management.


Eligibility criteria: Inclusion Criteria:

* All patients seen who sign medical release form

Exclusion Criteria:

None

Primary outcomes:
measure: Body weight change
timeFrame: 3 - 60 months
Secondary outcomes:
measure: Body fat percentage
timeFrame: 3-60 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota's Smiley's clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Steven Stovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: