louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05287620: Objective, Passive Assessment of LRRK2 Carriers
Official title: Objective, Passive Assessment of LRRK2 Carriers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Emerald Innovations
name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2022-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll LRRK2 G2019S carriers without self-reported or clinician-determined Parkinson's disease (PD) from the VALOR-PD study. VALOR-PD is an observational study following and characterizing a remote, nationwide cohort of LRRK2 G2019S carriers with (n = 59) and without PD (n = 218). Individuals who have a diagnosis of PD will not be eligible to participate, since we aim to explore the device's sensitivity in detecting early symptoms/signs of PD.

Brief summary: The goal of this project is to identify objective, sensitive, and convenient measures for assessing early signs of Parkinson's disease in an at-risk population at home. We will do so by using a wireless sensor and analyzing the radio signals that bounce off patients' bodies, while patients go about their normal life without needing to wear sensors, answer questionnaires, or actively perform any tests.


Eligibility criteria: Inclusion Criteria:

* At least 50 years of age
* Able and willing to provide informed consent
* English fluency
* U.S. resident
* LRRK2 G2019S gene carrier, determined by participation in VALOR-PD
* Mild parkinsonian signs, determined by modified Movement Disorder Society-Unifeid Parkinson's Disease Rating Scale (MDS-UPDRS) score from the most recent VALOR-PD visit
* Have WiFi in their residence
* Access to a smartphone or tablet

Exclusion Criteria:

* Inability to complete study activities, as determined by the study team
* Any medical or psychiatric condition that, in the study team's judgement, would preclude participation
* Self-reported or VALOR-PD investigator determined Parkinson's disease
* Any movement disorder (e.g. essential tremor)
* Currently taking neuroleptics or other drugs known to cause parkinsonism
* Pregnancy
* Non-ambulatory status
* More than one ambulatory pet in the household\*
* More than two individuals in the household (not including participant)\*

  * these criteria can be waived at the discretion of the investigators

Primary outcomes:
measure: Gait speed
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Ray Dorsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850420: A Study of IMC-1 In Patients With Fibromyalgia
Official title: A Double-Blinded, Randomized, Placebo-Controlled, Proof of Concept Phase 2a Study Exploring the Safety and Efficacy of IMC-1 for the Treatment of Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Chronic Pain
Myofascial Pain
Keywords: fibromyalgia
Myofascial
Lead sponsor: Innovative Med Concepts, LLC
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia
* English speaker

Exclusion Criteria:

* Rheumatologic diseases
* Bipolar disease, OCD, severe anxiety, schizophrenia
* Systemic infection, severe cardiac disease, chronic steroid usage
* chronic opioid usage

Primary outcomes:
measure: Change in pain from baseline
timeFrame: 16 weeks
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: 16 weeks
measure: Fibromyalgia Impact Questionnaire
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: IMC Study Site
state: Alabama
city: Sacramento
country: United States
facility: IMC Study Site
state: California
city: San Diego
country: United States
facility: IMC Study Site
state: California
city: Vista
country: United States
facility: IMC Study Site
state: California
city: Jacksonville
country: United States
facility: IMC Study Site
state: Florida
city: Tampa
country: United States
facility: IMC Study Site
state: Florida
city: Evansville
country: United States
facility: IMC Study Site
state: Indiana
city: Lafayette
country: United States
facility: IMC Study Site
state: Indiana
city: Ann Arbor
country: United States
facility: IMC Study Site
state: Michigan
city: Raleigh
country: United States
facility: IMC Study Site
state: North Carolina
city: Medford
country: United States
facility: IMC Study Site
state: Oregon
city: Salt Lake City
country: United States
facility: IMC Study Site
state: Utah
Study officials:
References:
Clinical trial NCT02889120: Assessment of Drug Prescription by Phone
Official title: Telemedicine Performed by General Practitioners in Medical Call Centres:Quality Assessment of Drug Prescription by Phone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Advice by Phone
Keywords: Drug advice by phone
Teleprescription
Medical call centre
Out of hours call
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
name: Central Hospital, Nancy, France
name: Centre Hospitalier Universitaire Dijon
First posted: 2016-09-05
Enrollment: 1263
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All phone calls, from september to october 2013, leading to a drug prescription by a general practitioner of four medical call centres were eligible.

Brief summary: Prescription of medicines by telephone in French medical call Centres is a part of the general practitioners activity.

This study aimed to described drug prescription by phone (MTP) performed in four medical call centers. The primary objective is to evaluate adherence to french practice guidelines for the drug prescription by phone (Haute Autorité de Santé, 2009) The secondary objective is to evaluate the risk/benefit ratio for drug prescription by phone.


Eligibility criteria: Inclusion Criteria:

* All phone calls, from september to october 2013, leading to a drug prescription by a general practitioner of four medical call centres..

Exclusion Criteria:

* Medical emergency
* Patient refusing or not able to provide consent.

Primary outcomes:
measure: Adherence to Practice Guidelines for the drug prescription by phone
timeFrame: 3 days
measure: Risk/benefit ratio for drug prescription by phone
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03354520: Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Official title: Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.


Eligibility criteria: Inclusion Criteria:

* Self-reported race/ethnicity as African American, African, Caribbean or black
* Accessible by phone
* No plans to move away within the year
* OSA diagnosis, consent, including permission to release medical data
* Physician-diagnosed medical conditions.

Exclusion Criteria:

* Progressive illnesses in which disability or death is expected within 1 year
* Impaired cognitive/ functional ability precluding participation
* Intention to move within the same year of enrollment
* Family member currently enrolled

Primary outcomes:
measure: Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score
timeFrame: 2 Months and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Girardin Jean-Louis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604120: Preoxygenation for Difficult Airway Management
Official title: PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: Preoxygenation
High flow nasal cannula
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 186
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: Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation

Detailed description: This study will be designed as followed: Patients will be randomized in 2 groups:

* Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation.
* Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of aged and over
* And anticipated difficult intubation
* And requiring a rapid sequence induction for laryngoscopic intubation
* Or requiring a fiberoptic intubation

Exclusion Criteria:

* BMI \> 35
* Pulse oxymetry \< 90% in ambient air
* Haemodynamic instability
* Pregnancy
* Protected adult
* Lack of consent
* Patient already enrolled in another randomized study looking forward improving preoxygenation quality.

Primary outcomes:
measure: Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.
timeFrame: 4 minutes
Secondary outcomes:
measure: Improvement of quality of preoxygenation
timeFrame: 4 minutes
measure: Reduction in side effects incidence related to intubation
timeFrame: 6 hours
measure: Morbi-mortality during surgery.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Mickael VOURC'H, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vourc'h M, Huard D, Feuillet F, Baud G, Guichoux A, Surbled M, Tissot M, Chiffoleau A, Guitton C, Jaber S, Asehnoune K. Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study. BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909.
Clinical trial NCT04850820: Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
Official title: Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amino Acids, Essential
Metabolism
Exercise
Keywords: Home-based resistance exercise
Protein synthesis
Net protein balance
Protein breakdown
Essential amino acids
Branched-chain amino acids
Protein metabolism
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Iovate Health Sciences International Inc
First posted: 2021-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).
Primary purpose: BASIC_SCIENCE

Brief summary: An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB.

However, no study has investigated how a supplement of all of the essential amino acids (EAA) affects NPB following resistance exercise in a free-living, home-based setting, particularly when compared to a supplement of branched-chain amino acids (BCAA).

Therefore, the purpose of this study is to determine the impact of a novel EAA supplement on anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based resistance exercise.


Eligibility criteria: Inclusion Criteria:

* Aged 18-35 years
* Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week

Exclusion Criteria:

* Body Mass Index: \>29.9kg/m\^2
* Inability to perform physical activity as determined by the Physical Activity Readiness Questionnaire
* Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)
* Regular tobacco use
* Illicit drug use (e.g., growth hormone, testosterone)
* Diagnosed medical condition under the care of a physician
* Inability to abstain from supplements (e.g., protein, creatine, HMB, BCAA, phosphatidic acid) at least three weeks before and during trials
* Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)

Primary outcomes:
measure: Whole-body net leucine balance (umol/kg)
timeFrame: 5 hours/trial (four trials total)
Secondary outcomes:
measure: Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio)
timeFrame: 5 hours/trial (four trials total)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel Moore
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05506020: Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy
Official title: Retrospective Study on the Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Living Donor Liver Transplantation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and injection time of ICG.

Detailed description: This was a retrospective cohort study. The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during LLLS on the occurrence of biliary complications in both donors and recipients. The optimal dose and injection time of ICG were also investigated. From October 2016 to May 2022, the clinical data of 85 donors who underwent LLLS and relevant recipients in the Department of General Surgery of Huashan Hospital were retrospectively analyzed. According to whether ICG fluorescence cholangiography was used, they were divided into a non-ICG group (n=46) and an ICG group (n=39). Biliary complications were observed and the optimal dose and injection time of ICG were explored.

Eligibility criteria: Inclusion Criteria:

1. From October 2016 to May 2022, donors and their corresponding recipients underwent laparoscopic donor liver acquisition surgery in the general surgery department of Huashan Hospital.
2. Donor age ≥ 18 years old, regardless of gender; The receptor is the corresponding receptor of the donor, and the age and sex of the receptor are unlimited.
3. The medical history is complete, which can meet the requirements of this study.
4. Volunteer to participate in this study.

Exclusion Criteria:

1. The medical history is incomplete, which cannot meet the requirements of this study.
2. The donor or recipient expressly refused to participate in this study.

Primary outcomes:
measure: Biliary complications
timeFrame: two months after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of general surgery, Huashan Hospital
name: Lunxiu Qin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03726320: Trial of Community Health Worker-led Decision Coaching
Official title: Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision Making for Prostate Cancer Screening Among Black Male Patients and Their Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-10-31
Enrollment: 162
Sex: MALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.


Eligibility criteria: Inclusion Criteria:

Patients:

* Black
* Male
* Attending FQHC for routine primary care appointment

Providers:

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria

Exclusion Criteria:

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria

Primary outcomes:
measure: Prostate Specific Antigen (PSA) Screening Rates
timeFrame: Up to Month 3
measure: Patient Knowledge Survey Score
timeFrame: Day 1
measure: Decision Quality Score
timeFrame: Day 1
measure: Percentage of Participants Who Make Informed Choice
timeFrame: Day 1
Secondary outcomes:
measure: Decision Self-Efficacy Scale Score
timeFrame: Day 1
measure: Doctor-Patient Communication Survey Score
timeFrame: Day 1
measure: Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score
timeFrame: Day 1
measure: Change in Decisional Conflict Scale Score
timeFrame: Day 1
measure: Satisfaction With Decision Scale Score
timeFrame: Day 1
measure: Decisional Regret Scale Survey
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Danil Makarov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makarov DV, Feuer Z, Ciprut S, Lopez NM, Fagerlin A, Shedlin M, Gold HT, Li H, Lynch G, Warren R, Ubel P, Ravenell JE. Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers. Trials. 2021 Feb 10;22(1):128. doi: 10.1186/s13063-021-05064-4.
Clinical trial NCT01308320: Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Official title: Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Neoplasm
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-03-04
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.


Eligibility criteria: Inclusion Criteria:

* the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
* ASA I-II.
* 20-59 years old.
* female only.

Exclusion Criteria:

* signs of difficult intubation.
* risks for perioperative pulmonary aspiration.
* history of chronic respiratory disease.
* recent upper respiratory track infection.
* previous and recent smoking history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.
citation: Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.