louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02916394: In Vivo IGF-1R Molecular Imaging Using [68Ga]- Labelling Anti-IGF-1R Affibody Molecule
Official title: Targeted Molecular Imaging of [68Ga]- Labelling Anti-IGF-1R Affibody Molecule in IGF-1R Overexpression Cancer Patients （Such as Colon Cancer、NSCLC and Gliomas）and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molecular Imaging
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators developed \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting IGF-1R expression status.

Detailed description: The goals of investigators are to evaluate the use of \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule as a novel PET/CT radiotracer to monitor IGF-1R expression status. The investigators want to evaluate the use of \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule in IGF-1R expression cancer imaging in adult cancer patients （colon cancer 、NSCLC、gliomas cancer patients）with different IGF-1R expression status.

Eligibility criteria: Inclusion Criteria:

1. Colon cancer, NSCLC and gliomas patients with pathological and gene detection results and did not receive any treatment
2. More than 18 years old
3. A life expectancy of at least 12 weeks
4. Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
5. Written informed consent

Exclusion Criteria:

1. Could not get pathological and gene detection results
2. Pregnancy
3. do not want to write informed consent。

Primary outcomes:
measure: tumor SUV value of 68Ga-NODAGA-ZIGF-1R:4:40 PET/CT Imaging
timeFrame: after scanning(at time of imaging)
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Fourth Hospital of Harbin Medical University
name: Baozhong Shen
role: STUDY_CHAIR
References:
Clinical trial NCT02458794: Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM
Official title: A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Morbidity
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Krankenhaus Bozen
First posted: 2015-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.


Eligibility criteria: Inclusion Criteria:

* ASA 1 or 2
* Age 19-65 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35

Primary outcomes:
measure: oropharyngeal seal pressure
timeFrame: 5 minutes
Secondary outcomes:
measure: anatomic position
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Bozen
country: Italy
facility: Zentralkrankenhaus Bozen
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Christian Keller, MD MSc
role: STUDY_CHAIR
References:
Clinical trial NCT06826794: VentilO Prospective Study
Official title: Frequency of Respiratory Acidosis in the Intensive Care Unit After Postoperative Cardiac Surgery. Impact of Using VentilO Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mechanical Ventilation Complication
Respiratory Acidosis
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.


Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 years old)
* Intubated patients admitted to intensive care immediately post-operatively after cardiac surgery (all cardiac surgery combined)
* Ventilation in controlled mode (Assist Control or SIMV)

Exclusion Criteria:

* Absence of anthropometric data (height and weight) of patients available in the patient file
* Respiratory cycles mainly spontaneous on arrival
* Patient extubated on arrival in intensive care

Primary outcomes:
measure: Respiratory acidosis
timeFrame: 20 minutes after initiation of mechanical ventilation
Secondary outcomes:
measure: Acid-base disorders on arrival in intensive care
timeFrame: 5 minutes after initiation of mechanical ventilation
Other outcomes:
measure: Number of participants with hemodynamic shock - hypotension
timeFrame: Up to extubation
measure: Number of participants with a barotrauma
timeFrame: Up to extubation
measure: Mortality
timeFrame: Up to intensive care unit discharge
measure: Intensive care unit lenght of stay
timeFrame: Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge
measure: Number of participants with an acute kidney injury
timeFrame: Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge
Locations:
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Study officials:
References:
Clinical trial NCT02105194: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness
Official title: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cerebral Decompression Illness, All Phases
Keywords: cerebral decompression illness
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Harch Hyperbaric Research Foundation
First posted: 2014-04-07
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients.

Detailed description: SPECT brain imaging has been shown to be the most sensitive imaging modality for cerebral decompression illness. This study is a retrospective review of the PI's experience using SPECT brain imaging in the diagnosis and treatment of all phases of cerebral decompression illness over the past two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical condition and cognitive testing. Chart review of symptoms, and physical exam findings will be compared before and after treatment to SPECT brain imaging radiological readings to assess concordance.

Eligibility criteria: Inclusion Criteria:

* All patients in the P.I.'s practice who underwent hyperbaric oxygen therapy for cerebral decompression illness in the previous two decades who also underwent SPECT brain blood flow imaging early in the course of treatment and following completion of hyperbaric oxygen therapy.

Exclusion Criteria:

* none

Primary outcomes:
measure: SPECT brain imaging
timeFrame: Within one month after completion of hyperbaric oxygen therapy
Secondary outcomes:
measure: Symptoms of cerebral decompression illness
timeFrame: Within one month after hyperbaric oxygen therapy
measure: Abnormal physical exam findings
timeFrame: Within one month after hyperbaric oxygen therapy
Other outcomes:
Locations:
city: Marrero
country: United States
facility: Family Physicians Center
state: Louisiana
Study officials:
affiliation: LSU School of Medicine
name: Paul G Harch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06803394: Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
Official title: Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Age-related Hearing Impairment
Personal Communication
Hearing Impairment
Hearing Loss
Community-dwelling Seniors
Korean
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-01-31
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.


Eligibility criteria: PARTICIPANT CRITERIA Participant inclusion criteria

* Self-identified as first-generation KA in the target region
* Age 60 years or older
* Has a communication partner who lives in the same household or has at least weekly interactions
* Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) \>25 decibel (dB) hearing loss (HL) in better ear
* Hearing handicap as measured by HHIE-S score \>=8 Participant exclusion criteria
* Current use of hearing aid
* Medical contraindications to use amplification device (e.g., draining ear)
* Plan to move from the area within 6 months
* Active treatment for a terminal illness or in hospice

COMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria

* Age 18 years or older
* Able to read and speak Korean
* Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria
* Plan to move from the area within 6 months
* Active treatment for a terminal illness or in hospice

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly (HHIE-S) score
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Secondary outcomes:
measure: Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
measure: Relationship Quality as assessed by the Mutuality Scale
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hae-Ra Han, PhD,RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050894: Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients
Official title: A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with evidence of osteoarthritis.

Brief summary: This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* radiographic evidence of osteoarthritis
* signed informed consent

Exclusion Criteria:

* Pregnancy
* \< 18 years of age
* blood clotting disorder or active hematologic cancer
* undergoing chemotherapy
* history of rheumatoid arthritis
* septic joint or fracture
* active infection or history of chronic infection
* use of cytokine blocking drugs with the last 6 months
* intra-articular steroid or hyaluronic acid (HA) injection within last 6 months

Primary outcomes:
measure: Measure anti-inflammatory cytokines
timeFrame: immediately after processing
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Lexington
country: United States
facility: Orthopaedic Surgery, Kentucky Clinic
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University Sports Medicine Center
state: Ohio
Study officials:
References:
Clinical trial NCT01713894: Decision Aid - Extreme Prematurity
Official title: Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity; Decision Support
Keywords: Counseling
Limits of viability
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Virtua Health
name: University of Michigan
name: Endeavor Health
First posted: 2012-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?


Eligibility criteria: Inclusion Criteria:

* physicians who counsel women at the limits of viability
* women who are receiving counseling at the limits of viability

Exclusion Criteria:

* Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.

Primary outcomes:
measure: Decisional conflict
timeFrame: within 1 week after consult
Secondary outcomes:
measure: Knowledge
timeFrame: within 1 week after consult
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Systems
name: Ursula Guillen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillen U, Mackley A, Laventhal N, Kukora S, Christ L, Derrick M, Batza J, Ghavam S, Kirpalani H. Evaluating the Use of a Decision Aid for Parents Facing Extremely Premature Delivery: A Randomized Trial. J Pediatr. 2019 Jun;209:52-60.e1. doi: 10.1016/j.jpeds.2019.02.023. Epub 2019 Apr 2.
Clinical trial NCT02850094: The BWH Wellness Project
Official title: The Brigham and Women's Hospital Wellness Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical activity
Exercise
Financial Incentives
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 292
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose a 24 week program to provide proof-of-principle evidence that financial incentives stimulate Brigham and Women's Hospital (BWH) employees to be more physically active.

Detailed description: Participants wear a Fitbit Flex accelerometer for at least six months. During the first two weeks, they are paid simply for wearing the Fitbit. After that, they are regularly paid for either meeting CDC guidelines for moderate physical activity (PA) or increasing their PA by at least 10% from the preceding week. Moderate PA is defined as walking for at least 100 steps per minute for at least 10 minutes at a time. One minute of vigorous PA, over 175 steps/minute, counts as two minutes of moderate PA.

In addition to weekly bonuses, there are also bonuses for achieving all goals in 1 month, 3 month, and 6 month intervals. In cases where all three team members received a bonus, their bonuses are doubled. Individuals also fill out weekly questionnaires about their work attendance, as well as longer questionnaires at baseline, three months, and six months.

Eligibility criteria: Inclusion Criteria:

* Brigham and Women's Hospital employee
* Reported less than 30 minutes of exercise per week
* Use a computer daily at work or home
* Willing to wear a pedometer, undergo health screening, and complete occasional questionnaires

Exclusion Criteria:

* Occupation: Physician, nurse or other clinician
* Self-reported pregnancy at baseline

Primary outcomes:
measure: Physical Activity
timeFrame: 6 Months
Secondary outcomes:
measure: Individuals Meeting CDC Guidelines
timeFrame: 6 Months
measure: Fitbit Adherence
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
References:
citation: Meints SM, Yang HY, Collins JE, Katz JN, Losina E. Race Differences in Physical Activity Uptake Within a Workplace Wellness Program: A Comparison of Black and White Employees. Am J Health Promot. 2019 Jul;33(6):886-893. doi: 10.1177/0890117119833341. Epub 2019 Feb 26.
citation: Losina E, Smith SR, Usiskin IM, Klara KM, Michl GL, Deshpande BR, Yang HY, Smith KC, Collins JE, Katz JN. Implementation of a workplace intervention using financial rewards to promote adherence to physical activity guidelines: a feasibility study. BMC Public Health. 2017 Dec 1;17(1):921. doi: 10.1186/s12889-017-4931-2.
citation: Smith KC, Michl GL, Katz JN, Losina E. Meteorologic and Geographic Barriers to Physical Activity in a Workplace Wellness Program. J Phys Act Health. 2018 Feb 1;15(2):108-116. doi: 10.1123/jpah.2016-0731. Epub 2017 Nov 25.
Clinical trial NCT00068094: The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
Official title: The Effect of a Probiotic on Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Fatty Liver
Hepatic Steatosis
Diabetes Mellitus
Liver Diseases
Keywords: Probiotics
Bacteria
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-09-09
Enrollment: 30
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: The purpose of this study is to determine whether probiotics, bacteria that may improve liver health, can effectively treat a chronic condition in diabetics that increases fat in the liver.

Detailed description: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is also common in diabetics; unfortunately, research on NAFLD has been limited. Safe, inexpensive, and well-tolerated treatments for NAFLD are needed. Recent studies indicate that probiotics help to improve fat breakdown in mice. This study will evaluate the efficacy of probiotic therapy to reduce fat accumulation in the livers of people with NAFLD and diabetes.

Participants in this study will be randomly assigned to receive either a probiotic-containing mixture or placebo once daily for 6 months. Blood tests, and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

Eligibility criteria: Inclusion Criteria:

* Nonalcoholic fatty liver disease

Exclusion Criteria:

* Any cause of liver disease other than hepatic steatosis
* Diabetes
* Known or suspected cirrhosis
* Inability or unwillingness to undergo magnetic resonance procedures
* Requirement of long-term antibiotic therapy
* Pregnancy, breast-feeding, or plans to become pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steve Solga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solga SF, Diehl AM. Non-alcoholic fatty liver disease: lumen-liver interactions and possible role for probiotics. J Hepatol. 2003 May;38(5):681-7. doi: 10.1016/s0168-8278(03)00097-7. No abstract available.
citation: Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50. doi: 10.1053/jhep.2003.50048.