louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03231891: Inherited CAncer REgistry
Official title: Inherited CAncer REgistry (ICARE) Initiative
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 10000
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: Individuals interested in participating in inherited cancer research studies.

Brief summary: The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals interested in participating in studies focused on inherited cancer predisposition the opportunity to enroll in a research registry. Efforts through the registry include, but are not limited to, contribution of data to observational studies, targeted gene-specific studies, and education and outreach efforts for both participants and recruiting healthcare providers. Participants are given the opportunity to learn about and participate in other efforts for which they may be eligible.

All participants and recruiting healthcare providers receive educational newsletters twice per year which contain research and clinical updates in the field of cancer genetics. Providers who recruit patients can also access monthly web-based genetics case conferences which focus on different topics each month and are generally attended by a guest expert who provides background information on the topic as well as comments on the case presentations.

Participation in ICARE involves completion of an informed consent form, baseline questionnaire, follow-up questionnaires every two years, and medical record/tumor releases, as applicable. There is no cost to participate and all correspondence can be facilitated through phone, email, or mail.

Enrollment can be completed either through a traditional paper-based consenting method (i.e. postal mail) or through the online enrollment option available on the ICARE website (InheritedCancer.net). If you are a patient interested in learning more or a provider interested in recruiting to ICARE, please visit our website where you may complete an online contact form requesting a study team member contact you.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Able and willing to provide informed consent

Primary outcomes:
measure: Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations.
timeFrame: Up to 100 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Tuya Pal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06513091: US National TOP Registry
Official title: US National OCS Lung Thoracic Organ Perfusion (TOP) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The US National TOP Registry will enroll all lung transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry, as well as patients transplanted using other preservation modalities for benchmarking clinical outcomes.

Brief summary: The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.


Eligibility criteria: All lung transplant recipients

Primary outcomes:
measure: One-year patient and graft survival
timeFrame: 1-year post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT03707691: Pitch Perception and Memory: Deficits and Training
Official title: Pitch Perception and Memory: Deficits and Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cochlear Implants
Keywords: Hearing
Cochlear Implants
Congenital Amusia
Pitch
Audio-visual interactions
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 960
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Pitch perception and memory are central in auditory cognition, in particular for sound source segregation and recognition, speech prosody and music processing. Here the investigator assess pitch perception and memory in hearing-impaired listeners wearing cochlear implant(s) and listeners with congenital amusia, both compared with control listeners. Behavioral, EEG, and MEG measures are collected in audio and audio-visual contexts to characterize pitch processing deficits, and test a pitch training program.


Eligibility criteria: Inclusion Criteria:

For adult participants:

* Aged between 18 and 90
* Absence of neurological and psychiatric disorders
* No major cognitive deficit, ability to understand and apply study instructions
* Motivation to participate efficiently in the study
* Written informed consent to participant in the study
* Affiliated to social security
* Control participants and participants with congenital amusia for Experiment 5: MRI/MEG compatibility

For underage participants:

* Subject aged 5 years and over
* Informed consent of parents or guardians for the participation of the child being studied
* No neurological or psychiatric history
* Without major cognitive impairment and ability to understand and apply setpoint.
* Subject affiliated to a social security scheme
* Motivation to participate effectively in the project

Exclusion Criteria:

For adult participants:

* Age below 18 or above 90
* Pregnant or breast-feeding woman

For underage participants:

- Pregnant or nursing minors

Primary outcomes:
measure: percentages of correct responses in listening tests
timeFrame: during procedure
measure: reaction times in listening tests
timeFrame: during procedure
measure: Event-Related Fields
timeFrame: during procedure
measure: Oscillations
timeFrame: during procedure
Secondary outcomes:
measure: percentages of correct responses
timeFrame: Day 0
measure: percentages of correct responses
timeFrame: Day 0
measure: reaction times
timeFrame: Day 0
measure: reaction times
timeFrame: Day 0
measure: Event-Related Fields
timeFrame: Day 0
measure: Oscillations
timeFrame: Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Lyon Neuroscience Research Center
Study officials:
affiliation: Hospices Civils de Lyon
name: Anne CACLIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05861791: Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Official title: Comparison of Patient-controlled Analgesia With Background Opioid Versus Non-opioid Infusion for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: a Randomized, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Lead sponsor: Chung-Ang University Gwangmyeong Hospital
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 98
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of PCA: (A) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (B) non-opioid group who receive ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug. All the patients will receive additional fentanyl citrate as bolus injection drug if they need more analgesics postoperatively.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* undergoing elective total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* history of stomack ulceration
* increased ICP
* bronchial asthma
* allergy on aspirin, NSAIDs, Nefopam
* drug user of antiplatelet or anticoagulant

Primary outcomes:
measure: postoperative pain score
timeFrame: 24 hours after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: ChungAng University Gwangmyeong Hospital
state: Gwangmyeon-si
Study officials:
affiliation: ChungAng University Gwangmyeon Hospital
name: Se-Hee Min
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02392091: Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients
Official title: Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acidosis, Renal Tubular
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 100
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: Critically ill patients from a medical ICU

Brief summary: The aim of this study was to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.

Detailed description: Hyperchloremic acidosis is frequent in critically ill patients. Renal tubular acidosis (RTA) may contribute to acidemia in the state of hyperchloremic acidosis, but the prevalence of RTA has never been studied in critically ill patients. Therefore, we aimed to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.

This prospective, observational trial was conducted in a medical ICU of a university hospital. 100 consecutive critically ill patients at the age ≥18, expected to stay in the ICU for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria were included.

Base excess subset calculation based on a physical-chemical approach on the first seven days after ICU admission was used to compare the effects of free water, chloride, albumin, and unmeasured anions on the standard base excess. Calculation of the urine osmolal gap (UOG) - as an approximate measure of the unmeasured urine cation ammonium - served as determinate between renal and extra-renal bicarbonate loss in the state of hyperchloremic acidosis.

Eligibility criteria: Inclusion Criteria:

* admitted to the medical ICU of the Div. of Gastroenterology \& Hepatology of the Medical University of vienna
* age ≥18
* expectancy to stay in the ICU ≥24hours
* clinical necessity for a urinary catheter

Exclusion Criteria:

* anuria

Primary outcomes:
measure: renal-tubular acidosis
timeFrame: up to 7 days after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Richard Brunner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunner R, Drolz A, Scherzer TM, Staufer K, Fuhrmann V, Zauner C, Holzinger U, Schneeweiss B. Renal tubular acidosis is highly prevalent in critically ill patients. Crit Care. 2015 Apr 6;19(1):148. doi: 10.1186/s13054-015-0890-0.
Clinical trial NCT05020691: NIV in Covid-19 Respiratory Failure
Official title: Non-invasive Ventilation in Covid-19 Respiratory Failure - Predicting Success: A Retrospective Observational Study to Determine Predictive Factors in the Success or Failure of Non-invasive Ventilation.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19 Pneumonia
Keywords: Covid-19
HACOR
Non-Invasive Ventilation
CPAP
Lead sponsor: National Heatlh Service Ayrshire and Arran
Sponsor class: OTHER_GOV
First posted: 2021-08-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with confirmed Covid-19 respiratory failure treated with facemask CPAP in a district general hospital

Brief summary: A retrospective, single centre observational study to validate use of the HACOR score (Duan et al, 2017) in determining efficacy of non-invasive ventilation in Covid-19 respiratory failure.

Detailed description: The investigators will retrospectively analyse medical records of patients with confirmed Covid-19 respiratory failure who received continuous positive airway pressure (CPAP) via facemask, as per clinician decision, in the High Dependency Unit (HDU) or Intensive Care Unit (ICU) of University Hospital Crosshouse between 1st March 2020 and 30th April 2021. By collecting baseline demographics and physiological data (including APACHE II and clinical frailty score) and calculating the HACOR score at initiation of CPAP, then at 1hr, 6hrs, 12hrs, 24hrs and 48hrs after initiating CPAP the investigators aim to validate use of the HACOR score in determining efficacy of NIV in Covid-19 respiratory failure. The investigators will also collect other variables (CRP and lymphocytes, lactate, mean arterial pressure, temperature) to determine if these factors have utility in predicting efficacy of NIV in Covid-19 respiratory failure.

Eligibility criteria: Inclusion Criteria:

1. Confirmed Covid-19 respiratory failure
2. NIV treatment instituted as per clinician decision
3. Admitted to HDU or ICU between 1/3/20 and 30/4/21

Exclusion Criteria:

1. Patients with immediate indication for invasive ventilation
2. Patients whose primary diagnosis was not Covid-19 respiratory failure, but received NIV in that time period

Primary outcomes:
measure: Escalation to Invasive Ventilation
timeFrame: Up to 6 months
measure: Death Due to Respiratory Failure
timeFrame: Up to 6 months
measure: Clinical Improvement
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kilmarnock
country: United Kingdom
facility: University Hospital Crosshouse
Study officials:
References:
citation: Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3.
Clinical trial NCT02436291: Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Official title: Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Onychomycosis
Lead sponsor: MB Mazor Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.

Detailed description: Each affected nail will be treated twice daily for 24-30 weeks. Efficacy will be evaluated by measuring the growth of healthy nail.

Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).
2. Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.
3. Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.

Exclusion Criteria:

1. lunula infected with onychomycosis.
2. Pregnant or breast feeding female.

Primary outcomes:
measure: Nail cure as measured by measured by length of healthy nail of at least 5 mm
timeFrame: 24-30 weeks
measure: Nail cure as measured by culture and smear
timeFrame: 24-30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Natanya
country: Israel
facility: Lev Yasmin Clinic
Study officials:
affiliation: Dermatology Clinic Natanya Israel
name: Avner Shemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449891: Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
Official title: Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: William E And Aenid R Weisgerber Foundation
First posted: 2007-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: please see inclusion and exclusion criteria

Brief summary: This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.

Detailed description: In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for study subjects:

* To be between ages 3 to 10 years
* Have been diagnosed with type 1 diabetes for at least 6 months; and
* Do not have plans to move out of the area within the next 36 months.

Inclusion Criteria for control subjects:

* To be between ages 3 to 10 years

Exclusion Criteria:

* No history of head trauma with any loss of consciousness,
* Cystic fibrosis,
* Prematurity (born less than 30 weeks of gestation),
* Significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age),
* Neurologic disease independent of diabetes (eg seizure disorder); or
* Medical contraindication to MRI procedure (eg metal appliances such as braces).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tandy Aye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aye T, Barnea-Goraly N, Ambler C, Hoang S, Schleifer K, Park Y, Drobny J, Wilson DM, Reiss AL, Buckingham BA. White matter structural differences in young children with type 1 diabetes: a diffusion tensor imaging study. Diabetes Care. 2012 Nov;35(11):2167-73. doi: 10.2337/dc12-0017. Epub 2012 Sep 10.
Clinical trial NCT04417491: Patient Expectations and Dry Needling
Official title: Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Needling
Expectance
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. This study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. Expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies (PSOE) questionnaire which was adapted to the cervical spine.


Eligibility criteria: Inclusion Criteria:

* Non-specific mechanical neck pain of at least 3 months of duration
* At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms

Exclusion Criteria:

* whiplash injury;
* previous cervical or thoracic surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone physical therapy in the previous 6 months;
* fear to needles

Primary outcomes:
measure: Changes in Neck Pain Intensity between baseline and follow-up periods
timeFrame: Baseline, immediately after and 1 week after intervention
Secondary outcomes:
measure: Changes in Pressure pain sensitivity between baseline and follow-up periods
timeFrame: Baseline, immediately after and 1 week after intervention
measure: Changes in patients self-perceived improvement between baseline and follow-up periods
timeFrame: Baseline and 1 week after intervention
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: César Fernández-de-las-Peñas
state: Rest Of The World
Study officials:
References:
citation: Gallego-Sendarrubias GM, Voogt L, Arias-Buria JL, Bialosky J, Fernandez-de-Las-Penas C. Can Patient Expectations Modulate the Short-Term Effects of Dry Needling on Sensitivity Outcomes in Patients with Mechanical Neck Pain? A Randomized Clinical Trial. Pain Med. 2022 May 4;23(5):965-976. doi: 10.1093/pm/pnab134.