louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03063892: Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion
Official title: Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Fractures
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.


Eligibility criteria: Inclusion Criteria:

* Over the age of 60 years
* Hip fracture requiring surgical intervention
* Signs consent and agrees to participate

Exclusion Criteria:

* Under the age of 60
* Does not sign consent or refuses participation
* Known hypersensitivity to tranexamic acid
* Multiple acute fractures
* Creatinine clearance \<30
* History of seizures
* Active hormone therapy
* History of coagulation abnormality
* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
* Myocardial infarction (MI) and/or stents within the past year
* History of intracranial hemorrhage
* Acquired defective color vision
* Patients admitted directly to nursing units or surgery without stay in the Emergency Center
* Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital

Primary outcomes:
measure: proportion of patients requiring packed Red Blood Cell transfusion
timeFrame: 72 hours
Secondary outcomes:
measure: intraoperative blood loss
timeFrame: 24 hours
measure: postoperative anemia
timeFrame: 72 hours
Other outcomes:
Locations:
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
affiliation: ProMedica Toledo Hospital
name: Gregory M Georgiadis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03503292: Pharmacogenomics and Post-Operative Nausea and Vomiting
Official title: Using Pharmacogenomics (PGx) Results to Guide Post-operative Nausea and Vomiting (PONV) Treatment Practices: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea
Keywords: Pharmacogenetics
CYP2D6
Ondansetron
Granisetron
Bariatric surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.


Eligibility criteria: Inclusion Criteria

* A Mayo Clinic patient scheduled to undergo any bariatric surgical procedure, including Roux-en-Y gastric bypass, sleeve gastrectomy, or duodenal switch.
* Patient age 18 or above.
* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
* Patient is willing to engage in a medication adjustment as part of their clinical visit (when needed).

Exclusion Criteria

* Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
* Patients that deny access to their medical records for research purposes will not be included in this study. Also any patient who will be unable to have genetic testing at minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or granisetron.
* Any patient with prior genetic testing that is readily available in the medical record will be excluded from this study.
* Any patient that is pregnant

Primary outcomes:
measure: Episodes of Postoperative Nausea
timeFrame: 0-48 hours post bariatric surgery
measure: Episodes of Postoperative Vomiting
timeFrame: 0-48 hours post bariatric surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yvette N Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01119092: The Effects of Gentle Movements at the Ankle in Individuals With Diminished Range of Motion
Official title: The Effects of Talocrural Joint Mobilizations in Individuals With Diminished Dorsiflexion Range of Motion After Ankle Sprain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Ankle Sprain
Keywords: Ankle Sprain
Joint Mobilization
Manual Therapy
Range of Motion
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Athletic Training Association Research & Education Foundation
First posted: 2010-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the examine the effects of gentle movements applied to the ankle joint and stretching on self-reported function, ankle motion and stiffness in individuals who have suffered from an ankle sprain within the last year and have decreased ankle motion.

Detailed description: The purpose of this study is the examine the effects of a grade IV anterior to posterior joint mobilization and stretching on self-reported function, dorsiflexion range of motion, talar glide and stiffness in individuals who have suffered from an ankle sprain within the last year and have a 5° dorsiflexion range of motion deficit.

We will quantify range of motion with standard goniometric measures, stiffness with the use of an instrumented ankle arthrometer, talar glide with the use of the posterior talar glide test and self-reported function using the foot and ankle ability measure (FAAM) and FAAM-sport.

Eligibility criteria: Inclusion Criteria:

* History of a lateral ankle sprain within the last year
* Dorsiflexion range of motion deficit of 5°
* Return to full activity prior to participation in this study
* Individuals with dorsiflexion range of motion that is less than degrees of dorsiflexion.

Exclusion Criteria:

* A history of ankle surgery that involves intra-articular fixation
* Syndesmotic ankle sprain (to be ruled out based on the attending certified athletic trainers diagnosis)
* A history or signs of reflex sympathetic dystrophy
* Suffer from an acute injury in the lower extremity within the last 6 weeks
* Have received manual therapy for the ankle sprain prior to enrollment

Primary outcomes:
measure: Change in dorsiflexion range of motion
timeFrame: Baseline and 4 weeks
measure: Change in posterior talar glide
timeFrame: Baseline and 4 weeks
measure: Change in posterior talar translation
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in self reported function
timeFrame: Baseline and 4 weeks
measure: Change in ankle stiffness
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University to Virginia
name: Jay Hertel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869492: Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
Official title: A Double Blind Randomised Comparison of Nadifloxacin 1% Cream Alone and Nadifloxacine %1 Cream With Benzoyl Peroxide 5% Solution in the Treatment of Mild to Moderate Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne
Nadifloxacin
benzoyl peroxide
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
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 determine whether using of nadifloxacine 1% cream and benzoyl peroxide 5% solution together is more effective than using nadifloxacine alone in the treatment of mild to moderate facial acne.

Detailed description: Nadifloxacin; a new topical antibiotic for the treatment of acne has recently been marketed in our country. Only a few studies on its use and effectiviness could be found in the literature. Nadifloxacin may be an alternative to other topical antibiotics and benzoyl peroxide or its use along with benzoyl peroxide may be more effective and rational to prevent possible future resistance.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild to moderate facial acne vulgaris
* Must have at least 10 inflammatory and/or non-inflammatory and no more than 3 nodulocystic acne lesions

Exclusion Criteria:

* Nodulocystic acne lesions more than 3 and pure comedonal acne
* Additional truncal acne needs systemic therapy
* Usage of topical treatments for acne in last 2 weeks, systemic antibiotic in last 4 weeks, systemic isotretinoin in last 6 months
* Application of chemical peels and laser in last 4 weeks
* Usage of hormones in last 3 months
* Clinical signs of hyperandrogenism in females
* Pregrancy and lactation
* Hypersensitivity to interventions
* Additional facial skin diseases (eg. atopic and seborreic dermatitis)
* Photosensitive disorders and usage of drugs which can trigger Photosensitive conditions

Primary outcomes:
measure: Number of patients whom inflammatory lesions were decreased %50 or more
timeFrame: two months
Secondary outcomes:
measure: the number of patients whom were observed side effects
timeFrame: two months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University school of medicine
Study officials:
affiliation: Marmara University
name: Züleyha Yazıcı, doktor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03577392: Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.
Official title: Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Quality of Life
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Simcere Pharmaceutical Co., Ltd.
First posted: 2018-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
Primary purpose: TREATMENT

Brief summary: To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.
* There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）.
* Male or female , age 18～75
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The patients had to have a life expectancy of at least 3 months.
* A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.
* Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l；a creatinine value less than 130 lmol/l.
* Informed consent was obtained from all patients.

Exclusion Criteria:

* Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.
* a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.
* patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.

Primary outcomes:
measure: Progression free survival
timeFrame: 4 years
Secondary outcomes:
measure: local control
timeFrame: 4 years
measure: Overall survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People Hospital
name: Ke Xie, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06924892: Assessment of Music Experiences in Navigating Depression
Official title: Assessment of Music Experiences in Navigating Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Music Assessment
Music Therapy
Anxiety
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Carnegie Hall Weill Music Institute
name: Cooper Union College
name: Third Street Music Settlement
First posted: 2025-04-11
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Music therapy or no intervention provided for all consented participants
Primary purpose: TREATMENT

Brief summary: The study team sought to scientifically investigate strategic subsets of depressed individuals or people prone to or at-risk of depression through music experiences of individual, group, and blended supported contexts. Meetings with the study multi-disciplinary team, included member of the Carnegie Hall Weill Music Institute and University affiliates, where the study team gathered quantitative and qualitative data in individual and group forums, measuring disease process and levels of participation. Through tabulation of participatory options with standardized depression and resilience measurements, the study team studied how live music could alter depressive symptoms over time and/or change negative influencers of mood, shift quality of life, and lead toward possibly enhanced disease trajectory outcomes.


Eligibility criteria: Inclusion Criteria:

* Participants between the ages of 8-70 years with a clinical diagnosis of Major Depressive Disorder (MOD) who met the DSM-5 (2013) criteria for a Major Depressive Episode, and/or who identify themselves, or are identified by family, or referring clinicians as depressed, or are prone to depression
* Depressive episodes and/or showing symptoms of mild to moderate depression intensity
* Self-reported satisfactory bilateral hearing
* English or Spanish language fluency sufficient to complete the interviews and questionnaires

Exclusion Criteria:

* Axis I diagnosis, aside from MOD, considered the primary diagnosis
* Bipolar Disorder Type I or II,
* Axis II diagnosis such as antisocial or borderline.
* Arrhythmia,
* Pacemaker
* Prolapsed vertebral disc, and
* Recent back or neck injuries.

Primary outcomes:
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: end of study at 3 months
measure: The Beck Depression Inventory Second Edition (BDI-II) Score
timeFrame: end of study at 3 months
measure: Child Depression Inventory
timeFrame: end of study at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: NY
country: United States
facility: Mount Sinai Union Square
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Joanne Loewy, DA, LCAT, MT-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834092: Study of the Glycocalyx in Abdominal Aortic Aneurysm
Official title: Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurism
Surgery
Ischemic Reperfusion Injury
Keywords: Abdominal Aortic Aneurism
Endothelia
Glycocalyx
Reperfusion
Plasma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators want to measure the degradation of the endothelial glycocalyx before and after clamping the aorta, in patients operated for a abdominal aortic aneurism.

Detailed description: 50 patients is scheduled for enrollment. Blood samples will be up taken before surgery, 10 min after reperfusion, at the end of surgery and the following morning. In addition the investigators are placing a renal venous catheter where blood samples will be up taken as mentioned above for the analysis of endothelial markers together with markers for kidney damage.

The first 10 patient will act as part of a pilot study, where only measurement of the endothelial and renal failure markers will be performed.

Eligibility criteria: Inclusion Criteria:

* above 18 years

Exclusion Criteria:

* prior engagement in scientific study within the last 30 days.

Primary outcomes:
measure: Endothelial dysfunction
timeFrame: 24 hours
Secondary outcomes:
measure: Fluid balance
timeFrame: 24 hours
Other outcomes:
measure: Postoperative organ failure
timeFrame: 30 days
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
affiliation: Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.
name: Per I Johansson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05893992: fNIRS, Listening Effort, and Motivation
Official title: Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Toronto Metropolitan University
First posted: 2023-06-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to indicate what they heard using a closed-set response interface. Participants will complete 4 sessions: a training session, and a session for each condition. During each test session, participants will be instructed to listen to at least 100 sentences. Oxygenation, response times, and listening accuracy will be measured throughout.


Eligibility criteria: Inclusion Criteria:

* Adults (18-99) years
* Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
* Experienced hearing aid users
* Fluent in English

Exclusion Criteria:

* Minors (17 years or less)
* Hearing status that did not fall within inclusion criteria
* Vulnerable populations

Primary outcomes:
measure: Oxygenation using functional near infrared spectroscopy (fNIRS)
timeFrame: Up to 1 hour during 1 session (per condition - for a total of 3 hours)
measure: Response times
timeFrame: Up to 1 hour during 1 session (per condition - for a total of 3 hours)
measure: Listening accuracy
timeFrame: Up to 1 hour during 1 session (per condition - for a total of 3 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Sonova Innovation Centre Toronto
state: Ontario
Study officials:
affiliation: Sonova AG
name: Jinyu Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06931392: Expectations and Experiences With Virtual Reality Training Among ICU Physicians and Nurses
Official title: Expectations and Experiences With Virtual Reality Training Among ICU Physicians and Nurses
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Virtual Reality
Education
Intensive Care Unit ICU
Keywords: virtual reality
education
intensive care unit
training
European survey
physicians
nurses
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2025-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians and nurses working in ICU.

Brief summary: The goal of this observational study is to describe the expectations and experiences with virtual reality in physicians and nurses working in the European ICUs. The main questions it aims to answer are:

What emotions and worries does the expected training with virtual reality evoke? What are the potential factors causing negative emotions and fear from expected training? What is the institutional approach to the online training approach regarding participation in working hours and covering the costs? How does the experience of training using virtual reality spread among the population of ICU physicians and nurses? Participants will fill out an electronic survey.

Detailed description: The need for constant training envelopes every medical speciality. Anesthesiology and Intensive Care or Critical care are no exceptions. Virtual reality is a very modern and fast-growing field with huge potential for education and training. The investigators hypothesise that virtual reality and online education could improve healthcare professionals' education feasibility. The survey was developed based on a trial version carried out only in the Czech Republic on 120 participants without any comments about questions clarity. The questionnaire contains a descriptive part and an explorative part about expectations and experiences with virtual reality in training. The study will aim for European ICUs. After that, the responses will be interpreted using statistical methods that fit. The investigators aim to publish our findings in a journal in WoS.

Eligibility criteria: Inclusion Criteria:

* HCPs working in ICU.

Exclusion Criteria:

* HCPs not working in ICU.

Primary outcomes:
measure: What emotions and worries does the expected training with virtual reality evoke?
timeFrame: 6 months
measure: What are the potential factors causing negative emotions and fear from expected training?
timeFrame: 6 months
Secondary outcomes:
measure: What is the institutional approach to the online training approach regarding participation in working hours and covering the costs?
timeFrame: 6 months
measure: How is the experience of training using virtual reality spread among the population of ICU physicians and nurses?
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: