louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04667507: Pharmacokinetics of Aqueous Dexamethasone
Official title: The Pharmacokinetics of Aqueous Dexamethasone and the Inflammatory Cytokine Response After Treatment with a Dexamethasone Intracanalicular Insert - the CYTODEX Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacokinetics
Aqueous Dexamethasone
Inflammatory Cytokine Response
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 102
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.


Eligibility criteria: Inclusion Criteria:

* Male of female, aged 55 or older
* Scheduled to undergo phacoemulsification with the intraocular lens (IOL) implantation for the treatment of cataract
* Willing to comply with study instructions, agree to make study appointments, and complete the course of the study
* Must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate

Exclusion Criteria:

* Known allergy or contraindication to the test article or its components
* Presence of any ocular abnormality or significant illness that, in the investigator's opinion, could affect the subject's health
* History of any illness that could be expected to interfere with the study
* Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or study
* May not be currently using topical or systemic steroids or NSAIDs during the course of the study or within 4 weeks prior to enrolling in the study other than Dextenza and Omidria
* Subject has active corneal, conjunctival, or canalicular infections, including:
* Epithelial herpes simplex keratitis (dendritic keratitis)
* Vaccini
* Varicella
* Mycobacterial infections
* Fungal diseases of the eye
* Dacryocystitis

Primary outcomes:
measure: Pharmacokinetics in Aqueous Humor Samples
timeFrame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
measure: Pharmacokinetics in Aqueous Humor Samples
timeFrame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Secondary outcomes:
measure: Correlation between dexamethasone levels and inflammatory cytokines
timeFrame: 1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision Institute
name: Frank A Bucci, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04168307: Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.
Official title: Conventional Physiotherapy Versus Use of a New Ankle Trainer Device After Weber b Ankle Fracture Operation. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture - Lateral Malleolus
Post-Op Complication
Keywords: ankle fracture
rehabilitation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures

Detailed description: Patients that are operated for weber b ankle fractures will after the surgery be randomized into two different post operative rehabilitation protocols. One group will receive conventional physiotherapy with stretching of the ankle with a non-elastic band, while the other group will use a new spring-loaded ankle trainer. The rehabilitation will continue for 3 weeks. Patients will be evaluated with the Olerud Molander ankle score and visual analog scale for pain at 3, 6, 12 and 52 weeks follow-up. Length of hospitalization and all adverse events will be registered. Ankle range of motion will be registered at 6, 12 and 52 weeks

Eligibility criteria: Inclusion Criteria:

* Weber b ankle fracture. Exercise stable osteosynthesis. Good compliance

Exclusion Criteria:

* Previous trauma to the tibia or fibula. Previous ankle or foot surgery. Sympthomatic arthritis or generalized joint disease

Primary outcomes:
measure: Olerud Molander ankle score (OMAS)
timeFrame: 52 weeks after surgery
Secondary outcomes:
measure: Visual analog scale for pain (VAS)
timeFrame: 52 weeks
measure: Ankle range of motion
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Marius Molund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152307: Measuring Quality of Decisions About Treatment of Depression
Official title: Measuring Quality of Decisions About Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Depressive disorder
Decision Making
Decision Aids
Decision Quality Instrument
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
name: Massachusetts General Hospital
First posted: 2010-06-29
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.


Eligibility criteria: Inclusion Criteria:

* Aged 18+
* In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

Exclusion Criteria:

* none

Primary outcomes:
measure: Depression Knowledge
timeFrame: 2 weeks, on average
Secondary outcomes:
measure: Value Concordance
timeFrame: 2 weeks, on average
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Survey Research - University of Massachusetts Boston
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Boston
name: Patricia M Gallagher, PhD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brodney S, Valentine KD, Sepucha K. Psychometric evaluation of a decision quality instrument for medication decisions for treatment of depression symptoms. BMC Med Inform Decis Mak. 2021 Aug 27;21(1):252. doi: 10.1186/s12911-021-01611-w.
Clinical trial NCT04498507: Psychosocial Outcomes in Families of COVID-19 ICU Patients
Official title: Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Family
Psychological Stress
Covid19
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 39
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: this study includes the family members of patients who were admitted in ICU for sever COVID-19 during the first part of the pandemic when visits in ICU were not allowed

Brief summary: During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. The aim of the study is to study the psychosocial outcomes of families of patients who were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for any differences in outcomes whether families benefited from video-conferences with the medical team and their relatives or not during the ICU stay.


Eligibility criteria: Inclusion Criteria:

* the referent family member of any patient admitted in ICU for COVID-19 during the first part of the pandemic

Exclusion Criteria:

* cognitive disorders
* not French-speaking
* refusal to participate

Primary outcomes:
measure: occurence of anxiety and depression
timeFrame: one month after ICU discharge
measure: occurence of anxiety and depression
timeFrame: three months after ICU discharge
measure: occurence of acute stress
timeFrame: one month after ICU discharge
measure: occurence of post-traumatic stress disorder
timeFrame: three months after ICU discharge
measure: quality of life
timeFrame: one month after ICU discharge
measure: quality of life
timeFrame: three months after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
References:
Clinical trial NCT04884607: Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
Official title: Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Cardiovascular Diseases
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: * Purpose of the study This study aimed to investigate electrocardiogram measurement and subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes among healthy adult participants
* Study design Prospective, single-center, interventional, single-arm design
* Study participants A total of 12 healthy adult participants without cardiovascular diseases will be recruited.
* Study methods

  1. Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
  2. Evaluation of electrocardiogram measurement from external auditory canal electrodes Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared.
  3. Evaluation of low-level autonomic nerve stimulation using external auditory canal Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.


Eligibility criteria: Inclusion Criteria:

* Healthy adults without cardiovascular diseases
* Aged 20 years or more with Informed consent

Exclusion Criteria:

* Patients with autonomic disorder, cardiovascular drug prescriptions, cardiovascular diseases, diabetes, or with cardiac implantable electronic devices
* Patients with abnormalities at both external auditory canals and ears

Primary outcomes:
measure: Heart rate variability
timeFrame: Through study completion, an average of within 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seil Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06859307: Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
Official title: Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adhesive Peritoneal Band
Keywords: adhesions
corticosteroids
fresh frozen plasma
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-03-05
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Most of them (73% - 90%) can be managed conservatively.Despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. Because of the nature of the disease recurrence has been estimated to be 30%.Many attempts to prevent formation of postoperative adhesions have been tried. In this trial, we will study the effect of corticosteroids and FFP in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.


Eligibility criteria: Inclusion Criteria:

* Patients with attacks of adhesive intestinal obstruction

Exclusion Criteria:

* Associated abdominal malignancy, patients with adhesive IO who respond to conservative treatment.

Primary outcomes:
measure: intestinal obstruction
timeFrame: from 1 day to 2 years post operative
measure: bowel injury
timeFrame: from 1 day to 2 years post operative
measure: wound infection
timeFrame: from 1 day to 2 weeks post-operative
Secondary outcomes:
measure: age
timeFrame: from 2 to 3 days before surgery
measure: sex
timeFrame: from 2 to 3 days before surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharqia
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
References:
Clinical trial NCT06473688: The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)
Official title: The DEXTER-assisted Non-emergent and Acute Cholecystectomy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy
Lead sponsor: Distalmotion SA
Sponsor class: INDUSTRY
Collaborators: name: confinis AG
First posted: 2024-06-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing a cholecystectomy.

Brief summary: This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Aged \> 18 years
* Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion Criteria:

* Morbidly obese patients (BMI \> 40)
* Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
* Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
* Bleeding diathesis
* Pregnancy
* Patients with pacemakers or internal defibrillators
* Any planned concomitant procedures
* Patient deprived of liberty by administrative or judicial decision
* Participation in another interventional clinical trial

Primary outcomes:
measure: primary safety endpoint
timeFrame: up to 30 days
measure: primary performance endpoint
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Saintes
country: France
facility: Groupe Hospitalier Saintes - Saint-Jean-d'Angély
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich
country: Switzerland
facility: Klinik Hirslanden Zürich
Study officials:
References:
Clinical trial NCT02559388: Montelukast for Treatment of Uremic Pruritus
Official title: Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.

Detailed description: Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.

Eligibility criteria: Inclusion Criteria:

* hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly
* presence of uremic pruritus
* patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities
* patients should took a course of antipruritic treatment with no proper response

Exclusion Criteria:

* presence of pruritus less than three months
* kt/V less than 1.2
* presence of pruritus due to other cause other than uremic state
* presence of other pruritic diseases; malignancies; cholestasis; hepatitis B and C infection
* treatment with corticosteroid
* presence of anemia with hemoglobin less than 10

Primary outcomes:
measure: Change from Baseline in Detailed score proposed by Duo for pruritus
timeFrame: Change from Baseline in Detailed score at 1months
Secondary outcomes:
measure: Highly sensitive CRP (hs-CRP)
timeFrame: Change from Baseline in serum value at 1months
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Mohammad Mehdi Sagheb, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT04501588: Parent Telehealth Intervention for Children With Autism
Official title: Parent Language Intervention for Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Autism
Keywords: autism
parent intervention
parent coaching
early intervention
parent-mediated intervention
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.
Primary purpose: TREATMENT

Brief summary: As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.


Eligibility criteria: Inclusion Criteria:

Child inclusion criteria include:

* diagnosis of ASD or showing signs of ASD based on autism screening
* chronological age of less than 48 months
* a parent who is willing to learn intervention strategies
* English as the primary language spoken in the home

Parent inclusion criteria include:

- Biological Mother

Exclusion Criteria:

* Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study.
* Fathers or caregivers other than the child's Mother will be excluded from the study.

Primary outcomes:
measure: Parent Use of Language Support Strategies (Mother-child interaction)
timeFrame: Two months after the start of the study
Secondary outcomes:
measure: MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
timeFrame: Two months after the start of the study
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.
Clinical trial NCT00592488: Acetyl-L-Carnitine in the Treatment of Septic Shock
Official title: Prospective, Randomized, Placebo-controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-carnitine in the Treatment of Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Septic Shock
Keywords: Septic shock
Acetyl-L-carnitine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

Detailed description: This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Eligibility criteria: Inclusion Criteria:

* documented or presumed infection
* shock requiring vasopressors

Exclusion Criteria:

* dialysis
* hepatic failure
* seizures

Primary outcomes:
measure: Mean Arterial Blood Pressure
timeFrame: 18 hours
Secondary outcomes:
measure: Vasopressor Dose
timeFrame: 6-24 hours
measure: Serum Lactate
timeFrame: 12-36 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Todd W. Rice, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: