louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06793644: Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients
Official title: Prospective Observational Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients: Early Comparison With a Novel Imaging Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fractures, Bone
Trauma Injury
Keywords: Immunofluorescence
Orthopaedic Trauma
Infection
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2025-01-27
Enrollment: 10
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: Patients 18 years of age or older who present with an open fracture or fracture related infection.

Brief summary: The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older.
* Open extremity fracture, planning for management with external fixation, internal fixation or joint fusion.
* Fracture Related Infection, planning for management with debridement and possible removal of hardware.
* Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
* Provision of informed consent.

Exclusion Criteria:

* Inability of patient to provide informed consent
* Fracture of the hand.
* Iodine allergy.
* Burns at the fracture site.

Primary outcomes:
measure: Number of participants who undergo an unplanned fracture-related reoperation
timeFrame: 12 Months
measure: Number of participants who experience a post-procedure surgical site infection
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ida L Gitajn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02259244: Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients
Official title: Effect of the Mediterranean Diet and Hypolipemic Reduction Diet in Combination With Exercise in Obese Croatian Population- 1-year Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: University Hospital Dubrava
First posted: 2014-10-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 kg/m2

Exclusion Criteria:

* newly diagnosed diabetes, hypertension or cardiovascular disease
* change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study
* insulin therapy
* alcohol consumption \>500 g of alcohol/week in the last year
* pregnancy or breast feeding
* use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)

Primary outcomes:
measure: Oxidative stress
timeFrame: The outcome measure is studied at baseline, 1 and 12 months
Secondary outcomes:
measure: Body weight (kg)
timeFrame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Waist circumference (cm)
timeFrame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Fasting glycemia
timeFrame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Lipid profile (HLD, LDL, TC,)
timeFrame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Urate
timeFrame: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
measure: Blood pressure (mmHg)
timeFrame: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
measure: Physical activity level
timeFrame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
measure: Quality of life
timeFrame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
measure: Dietary intakes
timeFrame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03530644: Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
Official title: Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Keywords: Non-invasive glucose monitoring
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2018-05-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device.

Detailed description: Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered.

Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples will be collected.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic type 1 patients
* Insulin pump users
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female participants: Breastfeeding
* Subjects not able to understand and read Danish
* In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Rejection by optical screenings
* Subjects not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Known allergy to medical grade alcohol
* Known allergy to adhesives
* Systemic or topical administration of glucocorticoids for the past 7 days
* Subjects undergoing dialysis treatment
* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff
* Subjects currently enrolled in another study

Primary outcomes:
measure: Generation and validation of prediction models
timeFrame: 4 months
measure: Performance evaluation
timeFrame: 4 months
Secondary outcomes:
measure: Safety by paucity of adverse events
timeFrame: 4 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Steno Diabetes Center Odense
Study officials:
affiliation: Steno Diabetes Center Odense, Denmark
name: Jan Erik Henriksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Odense, Denmark
name: Vibe Vestergaard, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03114644: Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
Official title: Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Infant
Mother-Baby Synchrony
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby.

Detailed description: Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby. In this study, the investigator proposes to focus on premature births (before 37 years) because prematurity disrupts the synchronization of these mother-baby communication. For several years, reading of stories and nursery rhymes has been used by the liaison child psychiatry team in the neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The study is innovative because it simultaneously explores several fields: physiological, neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the feasibility of this exploration in the three protagonists of the interaction: mother, preterm baby and reader.

Eligibility criteria: Inclusion Criteria:

* A premature birth between 27 and 37 SA
* At the time of the transfers, the latter must be hospitalized in intensive care and extubated

Exclusion Criteria:

For the baby:

* an unstable medical condition
* Serious somatic complications
* genetic or neurological diseases
* a twin.

For the mother:

* an impossibility to understand and speak the French language
* a mental or cognitive pathology
* an addiction to alcohol or other psychoactive substances
* persons under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision

Primary outcomes:
measure: Analysis of cardio-respiratory synchronies and vagal tone
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT02186444: Navigator Guided e-Psychoeducational Intervention
Official title: Navigator Guided e-Psychoeducational Intervention for Prostate Cancer Patients and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: newly diagnosed prostate cancer
prostate
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-07-10
Enrollment: 391
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from Moffitt Cancer Center Genitourinary Clinic, University of South Florida Genitourinary Clinic, or community-based urologists and primary care providers.

Brief summary: The purpose of this study is to evaluate the impact of providing newly diagnosed prostate cancer patients and their caregivers with an interactive mobile tablet technology-based application delivered by a community navigator versus providing National Cancer Institute (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared decision making practices (decision making involvement).


Eligibility criteria: Inclusion Criteria:

* Men newly diagnosed (within 6 months) with biopsy confirmed case of prostate cancer
* 40 - 80 years of age
* Able to speak and read English
* Live within 120 miles of a healthcare treatment facility
* Have no documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation
* Be able to complete telephone interviews
* Have not completed the first course of treatment
* Have a family member/caregiver willing to participate
* Capable of providing written consent for study participation. Men diagnosed with early stage, locally advanced or metastatic disease or men who are on active surveillance will be eligible to participate in this study.
* Caregiver must be aged 18 or older
* Caregiver must be identified by patient as their caregiver (i.e., provider of emotional and/or physical care)
* Caregiver must have not been diagnosed with cancer in the previous year or be receiving cancer treatment

Primary outcomes:
measure: Final Survey Results per Study Arm
timeFrame: 6 months post baseline survey
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: B. Lee Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861444: An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)
Official title: National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis D, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B, and then those who are positive for anti-HDV Ab and treated with Pegasys

Brief summary: This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.


Eligibility criteria: Inclusion Criteria:

For epidemiological part of the study:

* Adult patients \>/= 18 years of age
* Positive HBsAg for at least 6 months

For the non-interventional section of the study

* Adult patients, \>/= 18 years of age
* Positive HBsAg for at least 6 months
* Positive anti-delta and positive HDV RNA by PCR
* Elevated serum ALT \>/= 2x ULN

Exclusion Criteria:

Patients with any of the following will not be eligible for treatment with Pegasys:

* History of neurological disease
* History of severe psychiatric disease
* Decompensated diabetes
* History of immunologically mediated disease
* History of severe cardiac disease
* History or other evidence of severe chronic pulmonary disease
* Inadequate hematologic function

Primary outcomes:
measure: Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection
timeFrame: approximately 3.5 years
measure: Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment
timeFrame: approximately 3.5 years
Secondary outcomes:
measure: Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D
timeFrame: approximately 3.5 years
measure: Proportion of chronic hepatitis D patients with liver cirrhosis
timeFrame: approximately 3.5 years
Other outcomes:
Locations:
city: Bucharest
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04986644: Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers
Official title: Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses: Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error - Myopia Bilateral
Lead sponsor: Vision Service Plan
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over with 1 week of lens wear with each contact lens type.
Primary purpose: TREATMENT

Brief summary: The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.

Detailed description: This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.

The primary outcome variable for this study is overall subjective comfort.

Eligibility criteria: Inclusion Criteria:

* Currently wearing hydrogel, spherical DD contact lenses at least 5 days/week
* Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
* No ocular or systemic disease that contra-indicates soft contact lens wear

Exclusion Criteria:

* Currently wearing silicone hydrogel DD contact lenses
* Currently wearing 1-DAY ACUVUE® MOIST (comparator) contact lenses
* Currently using rewetting drops with habitual contact lenses
* Vision not correctable to 20/30
* Participating in another clinical trial

Primary outcomes:
measure: Overall subjective comfort
timeFrame: 1 week after contact lens wear
measure: Overall subjective comfort
timeFrame: 2 weeks after contact lens wear
Secondary outcomes:
measure: End of day subjective comfort
timeFrame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
measure: Subjective vision
timeFrame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
measure: Overall subjective lens preference
timeFrame: Visit 3 - After approximately 2 weeks of contact lens wear
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Ross Eyecare
state: Georgia
city: Westerville
country: United States
facility: Professional VisionCare
state: Ohio
Study officials:
References:
Clinical trial NCT01242644: Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
Official title: Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.

Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.

Detailed description: Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.

Eligibility criteria: Inclusion Criteria: All subjects who underwent:

* knee arthroscopy + synovectomy
* knee arthroscopy + partial or complete meniscectomy
* knee arthroscopy + chondroplasty
* knee arthroscopy + microfracture
* knee arthroscopy + autologous osteoarticular transplantation

Exclusion Criteria:

* A surgical procedure that required an incision other then an arthroscopic portal
* A surgical procedure within the same joint within ninety days
* A acute or chronic knee infection
* Any diagnosis of complex regional pain syndrome
* A known allergy to one of the study drugs
* A documented history of narcotic use
* A score of less than two standard deviation on the SF-12 mental component
* Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
* Under the age of eighteen years

Primary outcomes:
measure: Pain Score 8 Hours Post-operativley
timeFrame: 8 hours post surgery
measure: Pain Scale
timeFrame: 24 hours post surgery
measure: Pain Scale
timeFrame: 48 hours post-surgery
measure: Pain Scale
timeFrame: 72 hours post surgery
Secondary outcomes:
measure: Number of Narcotic Pills and Morphine Sulfate Used
timeFrame: In recovery room
measure: Number of Narcotic Pills and Morphine Sulfate Used
timeFrame: Post surgery day 1
measure: Number of Narcotic Pills and Morphine Sulfate Used
timeFrame: Post surgery day 2
measure: Number of Narcotic Pills and Morphine Sulfate Used
timeFrame: Post surgery day 3
Other outcomes:
Locations:
Study officials:
affiliation: University of South Alabama
name: Albert W Pearsall, MD
role: PRINCIPAL_INVESTIGATOR
References: