louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06274931: Analysis of the Pulmonary Microbiome
Official title: Analysis of the Pulmonary Microbiome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Microbial Colonization
Microbial Disease
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of three groups: one ICU-patients with a diagnosis acute respiratory failure, another group of non - ICU patients, and finally, a control group of individuals without pulmonary involvement.

Brief summary: The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia.

Detailed description: The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia with severe acute respiratory failure, requiring admission to the Intensive Care Unit, and to compare it with that of patients diagnosed with pneumonia but who do not develop severe acute respiratory failure and subsequent admission to the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* Patients with acute respiratory failure
* Patients with suspect of pneumonia

Exclusion Criteria:

* pregnancy
* age \< 18 years

Primary outcomes:
measure: Assessment of Lung Microbiome in Acute Respiratory Failure
timeFrame: The study will be conducted over a period of two months, during which data collection, bronchoscopic examinations, and analysis of the lung microbiome will be carried out.
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Hosp[ital
Study officials:
affiliation: Magna Graecia University
name: Andrea Bruni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876731: Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases (IMMETAOS)
Official title: Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Bone Metastasis
Lead sponsor: Institut Jean-Godinot
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 13
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: Prospective, monocentric, comparative, non randomised

Primary objective :

- to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the conventional block and diffusion sequence in the search for bone metastases

Secondary objectives :

* compare accuracy of MRI diffusion and conventional MRI
* explore the evolution of the results of the different types of imaging over time or under treatment for patients with repeated examinations at 6 months

Detailed description: Prospective, monocentric, comparative, non randomised.

Organization of NaF PET-CT and MRI on the same day or within a 10 days period.

At 6 months :

* repeat both exams systematically if one of the initial tests showed a suspicious or doubtful abnormality
* final diagnosis by a committee of practitioners using the whole patient's file

Scheduled Project inclusion duration of 36 months (possible adaptation of duration in order to obtain the number of required patients)

Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 years
* Osteophilic cancer (breast, prostate, lung, kidney, thyroid) proved by pathological material, with a high probability of bone metastases
* With an indication to a bone examination: systematic search for metastasis for the staging or due to clinical or laboratory suspicion of bone metastasis
* Registered in a social security health scheme
* Written informed consent obtained

Exclusion Criteria:

* Classical contra-indications for PET CT (suspected pregnancy) or MRI (pacemaker, ferromagnetic material); for patients with a possibility of pregnancy (women of childbearing age without contraception and second part of the menstrual cycle, or the slightest suspicion), verification of the absence of pregnancy will be made by the beta HCG dosage before injection of radioactive tracer
* Uncontrollable claustrophobia with treatment anxiolytic
* Antitumor treatment started between the two imaging tests
* Imaging or treatment needed in emergency, if both tests are not performable in time required for the care
* Inaugural neurological complication
* Patient unable to undergo biomedical research (under guardianship or deprived of liberty)

Primary outcomes:
measure: Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
timeFrame: Up to 38 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Jean-Godinot
name: Yacine MERROUCHE
role: STUDY_DIRECTOR
References:
Clinical trial NCT04614831: A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis
Official title: Psoriasis and Beyond: A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis, Psoriatic Arthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 4978
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adults with self-reported Psoriasis and/or Psoriatic Arthritis. Screening questions will be used to determine the eligibility for each respondent to the survey.

Brief summary: The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with Psoriasis and Psoriatic Arthritis.

Detailed description: This is a cross-sectional, quantitative online survey of patients with psoriasis with or without concomitant psoriatic arthritis. Following assessment of participant eligibility via a 5-minute online screener, the 25-minute internet-based survey will be conducted without any follow-up.

Eligibility criteria: Inclusion Criteria:

1. Patients who self-report to have been diagnosed with Psoriasis or Psoriasis and Psoriatic Arthritis before or at the time of data collection
2. Patients 18 years of age or older at the time of data collection
3. Patients who did not participate in surveys regarding Psoriasis or Psoriatic Arthritis in the last 4 weeks
4. Body Surface Area (BSA) of \>5 to \<10, with psoriasis affecting sensitive and/or prominent body parts: face, palms, hands, fingers, genitals, soles of feet or nails or a BSA of 10 and above, when psoriasis was at its worst

Primary outcomes:
measure: A web-based survey will be answered by the participants. Data collected for the analysis of the primary objective include validated patient-reported outcomes (such as DLQI), as well as responses to non-validated questions.
timeFrame: 1 Day of survey
Secondary outcomes:
measure: A web-based survey will be answered by the participants. The data collected for the analysis of the secondary objectives include validated tools (such as PAM-13), as well as responses to non-validated questions.
timeFrame: 1 Day of Survey
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigational Site
Study officials:
References:
Clinical trial NCT05234931: Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair
Official title: Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Anal Sphincteric Injury,Immediate vs Delayed Repair
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sample size was calculated using epidemiological information statistical package version7 Based on paramaters for cross sectional study

Brief summary: comparison between immediate and delayed repair regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit

* Objective 1: to assess the operative time and surgical field of both choices.
* Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications

Detailed description: Many different secondary procedures have been described in an attempt to restore continence. These may be classified into indirect methods, where the divided sphincter is left unrepaired, and direct methods to repair the sphincter itself. Indirect techniques include construction of circum anal slings of striated muscle or fascia external sphincter reefing procedures" and the use of striated muscle grafts. Direct methods involve identification, mobilization, and suture of the ends of the divided sphincter. Thearliest 'attempts employed an end-to-end

Eligibility criteria: Inclusion Criteria:

1. both sex
2. - Traumatic Patients Who Presented by anal Sphincteric Injury
3. accept to participate in the study

Exclusion Criteria:

1. Patient who arrest immediately when arrived trauma unit
2. Obstetric Patients Who Presented by anal Sphincteric Injury

Primary outcomes:
measure: comparison between immediate and delayed repair
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Koscinski T, Marti MC. [Treatment of fecal incontinence by overlapping sphincteroplasty]. Wiad Lek. 1997;50 Suppl 1 Pt 1:151-4. Polish.
citation: Barisic G, Krivokapic Z, Markovic V, Popovic M, Saranovic D, Marsavelska A. The role of overlapping sphincteroplasty in traumatic fecal incontinence. Acta Chir Iugosl. 2000;47(4 Suppl 1):37-41.
citation: KRAATZ H. [PLASTIC SURGERY OF THE SPHINCTER FOR THE CONTROL OF INCONTINENCE]. Acta Chir Acad Sci Hung. 1964;5:219-23. No abstract available. German.
Clinical trial NCT04484831: A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
Official title: An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Overweight
Keywords: acceptance-based therapy
adolescents
weight
weight loss
obesity
overweight
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: StayWell
name: National Heart, Lung, and Blood Institute (NHLBI)
name: WellCare Health Plans, Inc.
First posted: 2020-07-24
Enrollment: 43
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
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 the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.

Detailed description: Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.

The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.

Post-treatment assessments will occur.

Eligibility criteria: Inclusion Criteria:

* Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts

Exclusion Criteria:

* Known pregnancy or plans to become pregnant in the next 2 years
* Plans to move out of the area in the next year
* Autism, any intellectual disability (e.g., down syndrome)
* Any condition prohibiting physical activity
* A diagnosis of cardiovascular disease or diabetes
* Have active cancer or cancer requiring treatment in the past 2 years
* Have active or chronic infections (e.g., HIV or TB)
* Have active kidney disease or lung disease
* An eating disorder or substance abuse disorder
* Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition
* Weight loss greater than or equal to 5% in the previous 6 months
* If they do not follow the study plan

Primary outcomes:
measure: BMI Change, 95th BMI Percentile (%)
timeFrame: Baseline; Month 6
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline; Month 6
measure: Change in Depression Using the Valid Beck Depression Inventory-II
timeFrame: Baseline; Month 6
measure: Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
timeFrame: Baseline; Month 6
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michelle I Cardel, PhD, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05428930: Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines
Official title: A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glabellar Lines
Lead sponsor: CKD Bio Corporation
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active-controlled
Primary purpose: TREATMENT

Brief summary: A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501B in Glabellar lines.


Eligibility criteria: Inclusion Criteria:

* Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)

Exclusion Criteria:

* Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
* History of facial nerve paralysis or ptosis
* Significant facial asymmetry
* Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
* Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
* Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: [Time Frame: up to week 12]
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: beomjoon Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04473248: Spartan COVID-19 System: Evaluation of Clinical Sample Collection
Official title: Evaluation of Clinical Sample Collection Project: Spartan COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Spartan Bioscience Inc.
Sponsor class: INDUSTRY
Collaborators: name: Humber River Hospital
name: The Ottawa Hospital
First posted: 2020-07-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.

Detailed description: Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.

The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.

Eligibility criteria: Inclusion Criteria:

* must have tested positive for COVID-19 via the existing nucleic acid testing method.

Exclusion Criteria:

-

Primary outcomes:
measure: Asses the % agreement between predicate results and Spartan COVID-19 results.
timeFrame: Through study completion; anticipated to be less than 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: Humber River Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Univeristy of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Spartan Bioscience Inc.
name: Tara Linseman, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02386930: Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Cognitive behavior therapy
Lifestyle modification
HbA1c
Carbohydrates
Lead sponsor: Rashid Centre for Diabetes and Research
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.


Eligibility criteria: Inclusion Criteria:

Females or males. Type 2 diabetes. BMI (kg/ m²) ≥ 25. Age 18-60 years old. HbA1c \> 7%.

Exclusion Criteria:

major physical activity disability that restricts participation in moderate physical activity.

serious heart condition like heart failure, heart attack, stroke within the last 3 months.

participating in a weight management or lifestyle program. presence of proliferative retinopathy or kidney failure.

Primary outcomes:
measure: HbA1c%
timeFrame: 6 months
Secondary outcomes:
measure: Weight
timeFrame: 6 months
measure: Body composition analysis
timeFrame: 6 months
measure: Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)
timeFrame: 6 months
measure: Blood presssure (systolic and diastolic)
timeFrame: 6 months
measure: carbohydrates intake in grams
timeFrame: 6 months
measure: physical exercise in minutes per day
timeFrame: 6 months
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Rashid Centre for Diabetes and Research
Study officials:
References:
Clinical trial NCT02120430: Promoting Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times
Official title: Promoting Effective Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Health Knowledge, Attitudes, Practice
Keywords: Early childhood
Audiovisual materials
Parent-child interaction
Parenting programs
Timing
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is an increasing need for parenting programs aimed at promoting parent-child interaction. A variety of interventions have been proposed. The use of audiovisual materials for parents has been shown to be effective but limited information is available on the optimal timing for its use, particularly for new parents during the first year of life of their children.

Based on the hypothesis that the effectiveness of information provided to first-time parents in modifying their knowledge, attitudes and intentions regarding rearing practices may depend on when the information is delivered, we designed an open randomized controlled trial to compare the effectiveness of administering a video at two different times, i.e. at one and seven months of age of the child.

The video addressed four specific activities related to early child development: reading aloud to the baby, early exposure to music, promotion of early socialization for parents and for children.


Eligibility criteria: Inclusion Criteria:

* first parenting experience
* local residence
* no major health or psychosocial problems in parents and in the newborn
* no delay in discharge from the maternity ward
* adequate knowledge of Italian

Exclusion Criteria:

* None

Primary outcomes:
measure: Parental knowledge, attitudes and intentions
timeFrame: 15 days after being exposed to the intervention
Secondary outcomes:
measure: Feelings elicited
timeFrame: 15 days after being exposed to the intervention
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Giorgio Tamburlini, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Roia A, Paviotti E, Ferluga V, Montico M, Monasta L, Ronfani L, Tamburlini G. Promoting effective child development practices in the first year of life: does timing make a difference? BMC Pediatr. 2014 Sep 5;14:222. doi: 10.1186/1471-2431-14-222.
Clinical trial NCT02739230: Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis: Joint Replacement Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-04-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and eliminate risks associated with catheters is the use of Exparel injection into the joint at the time of surgery.


Eligibility criteria: Inclusion Criteria:

1. Adults scheduled to undergo primary total knee replacement
2. Willing and able to provide informed consent

Primary outcomes:
measure: Total Morphine and morphine equivalent consumption
timeFrame: 96 hours post-op
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: