louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06285448: Feasibility of Lecanemab Registry and Clinical Outcome Measures
Official title: Feasibility of Lecanemab Registry and Clinical Outcome Measures
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alzheimer Disease
Keywords: lecanemab
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 20
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: PLWD who are eligible to receive Lecanemab at HealthPartners clinics as standard of care, referred by clinic staff and their care partners.

Brief summary: Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners.


Eligibility criteria: Inclusion Criteria:

* PLWD who are eligible to receive Lecanemab infusion at our clinics.
* Care Partner who provides care for the PLWD who are eligible to receive Lecanemab infusion at our clinics.
* Age \>=18 years for PLWD and their care partners
* Provides informed consent prior to participation.

Exclusion Criteria:

* Unable to read and speak English

Primary outcomes:
measure: Feasibility of enrollment
timeFrame: 2 years
measure: Feasibility of completing visits
timeFrame: 3 months
measure: Qualitative experience at 3 months
timeFrame: 3 months
measure: Qualitative experience at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Bhavani Kashyap, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02415530: Early Family Based Intervention in Preterm Infants
Official title: Early Family-Based Intervention for Developmental Enforcement of Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Low Birth Weight Infants
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: CHA University
First posted: 2015-04-14
Enrollment: 150
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.


Eligibility criteria: Inclusion Criteria:

* preterm infants \< 32 weeks of gestation or 1,500 gm of birth weight
* normal term infants

Exclusion Criteria:

* major congenital anomaly
* neuromuscular disease
* chromosomal anomaly
* triplets or more multiplets

Primary outcomes:
measure: Bayley Scales of Infant and Toddler Development III, mental developmental index
timeFrame: Corrected age 10 months
Secondary outcomes:
measure: Bayley Scales of Infant and Toddler Development III, psychomotor developmental index
timeFrame: Corrected age 10 month
measure: CES-D-depression screening tool
timeFrame: Corrected age 2 month & 6 month
measure: Maternal attachment
timeFrame: Corrected age 2 month & 6 month
measure: Temperament scale
timeFrame: Corrected age 8 month
measure: Wechsler Intelligence Scale
timeFrame: 8 years of age
measure: Conners ADHD/DSM-IV Scales
timeFrame: 8 years of age
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoun National University Hospital
name: Ee-kyung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887430: Foot Reflexology Therapy and Non-specific Low Back Pain
Official title: The Effect of Foot Reflexology Therapy on Pain Intensity and Health-related Quality of Life in People With Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Low Back Pain
Keywords: foot reflexology
pain intensity
health-related quality of life
Lead sponsor: Universiti Sultan Zainal Abidin
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines.

Detailed description: Low back pain is a common health complaint in most societies. Many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. However, low back pain continues as a societal enigma. The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the Malaysian low back pain management guidelines. Analysis of health-related quality of life will also be carried out.

Eligibility criteria: Inclusion Criteria:

* Have been medically diagnosed with a non-specific low back pain.
* Have not received treatment for low back pain within the previous 2 weeks.
* Are at least 18 years old.
* Have both feet and all toes intact and free from wounds.
* Have not undergone any other complementary and alternative therapies during the study.

Exclusion Criteria:

* Have severe coexistent disease and serious pathology or systemic illness.
* Have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome).
* Have plantar fasciitis.
* Lack the ability to read and write Malaysia language.
* Had plans to move out of the area.

Primary outcomes:
measure: mean time in days to the recovery of pain
timeFrame: 5 months
Secondary outcomes:
measure: demographic information
timeFrame: 3 month
measure: side effects of treatment
timeFrame: 5 month
measure: health-related quality of life
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00695630: Flumazenil Reversal of Oral Triazolam
Official title: Flumazenil Rescue Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dental Anxiety
Keywords: conscious sedation
dental anxiety/drug therapy
behavior/drug effects
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).


Eligibility criteria: Inclusion Criteria:

* ASA I

Exclusion Criteria:

* Use of benzodiazepines, anxiolytics or any other medications that would interact with either triazolam's or flumazenil's metabolism or clinical effect (including herbals) within four weeks of the study
* Body mass index (BMI) no less than 15 kg/m2 and no greater than 30 kg/m2
* Pregnancy or not currently using pharmacologic methods of birth control
* Allergy or sensitivity to benzodiazepines
* History of a seizure disorder; AND
* Chronic tobacco use.

Primary outcomes:
measure: Observer Assessment of Alertness/Sedation
timeFrame: 360 minutes
Secondary outcomes:
measure: BIS
timeFrame: 360 minutes
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Dental Fears Research Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Peter M Milgrom, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson DL, Milgrom P, Heacox GA, Kharasch ED. Pharmacokinetics and clinical effects of multidose sublingual triazolam in healthy volunteers. J Clin Psychopharmacol. 2006 Feb;26(1):4-8. doi: 10.1097/01.jcp.0000186742.07148.da.
Clinical trial NCT03109730: Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
Official title: A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

Detailed description: The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 65 years of age
* Chronic HBV infection
* Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion Criteria:

* Seropositive for HIV, HCV, or HDV antibody at Screen
* Previous treatment with any investigational HBV antiviral treatments within the last 6 months
* Other known cause of liver disease, including NASH
* Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention

Primary outcomes:
measure: Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
timeFrame: Up to 57 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash University
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
city: Chuncheon
country: Korea, Republic of
facility: Hallym University
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
References:
Clinical trial NCT01283230: Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography
Official title: Prospective Cohort Study for Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography in Patients With Chronic Liver Disease and Healthy Liver/Kidney Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Liver Disease
Keywords: ARFI imaging
normal values
chronic liver disease
liver donors
kidney donors
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Severance Hospital
First posted: 2011-01-25
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease, Healthy liver and kidney donors

Brief summary: This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic radiation force impulse elastography in patients with chronic liver disease and healthy liver/kidney donors.

Detailed description: A recent new method for liver fibrosis assessment based on similar technology to transient elastography is acoustic radiation force impulse (ARFI) imaging. ARFI has the advantages which can be conducted in parallel ways of measuring points in the patients with chronic liver disease when they underwent routine ultrasound examination. Thus, the aim of this study was to identify the normal range of ARFI velocity and assess the best cut-off value by recruiting healthy living liver and kidney donors.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years
* chronic liver disease (hepatitis B, hepatitis C, liver cirrhosis) patients who are planned to liver biopsy
* Healthy liver and kidney donors
* The patients who is willing and able to provide written informed consent to participate in this study

Exclusion Criteria:

* Decompensated liver cirrhosis
* Patients with liver congestion due to heart dysfunction
* Patients who previously take antiviral agent and antifibrotic agent
* Healthy liver and kidney donors with any laboratory abnormalities regarding liver condition (Platelet count \< 150 x 103/ul, Fasting glucose \> 110 mg/dl, AST \> 40 IU/L, ALT\> 40 IU/L, Albumin \< 3.3 g/dl, Total bilirubin \> 1.2 mg/dl, GGT\> 54 IU/L, ALP \> 115 IU/L , Ferritin \> 322 ng/ml)
* A history of any other medical disease or condition that would make the patients unsuitable for this study

Primary outcomes:
measure: Evaluation of ARFI velocity in healthy donors and patients with chronic liver disease
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Department of Internal Medicine, Yonsei University College of Medicine
name: Kwang-Hyub Han, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Yonsei University College of Medicine
name: Seung Up Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06738030: Transcranial Stimulation Combined With Auditory Training
Official title: Transcranial Stimulation Combined With Auditory Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Difficulties Understanding Speech in Noise
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-12-17
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to active transcranial stimulation or sham stimulation groups.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if non-invasive brain stimulation (called transcranial stimulation) can enhance the benefits from auditory training in people who struggle to understand one talker when many people are talking at the same time. The main questions it aims to answer are:

* Does transcranial stimulation improve speech-on-speech understanding in people who struggle with this task?
* Does transcranial stimulation enhance the benefits of a commercially available auditory training program?

Researchers will compare transcranial stimulation to sham stimulation (no stimulation is applied during the listening task).

Participants will:

* Receive login information to an online auditory training program to complete at home over 2 weeks
* Visit the laboratory 4 times to receive transcranial stimulation while listening to speech-on-speech: once before at-home training, two times during the at-home training period, and once after at-home training has ended


Eligibility criteria: Inclusion Criteria:

* 50 years of age or older
* Audiometric thresholds that do not exceed 90 dB HL at any frequency from 250-6000 Hz
* Able to provide informed consent and understand experimental instructions
* Able to read print on a computer screen
* Difficulty with speech-on-speech understanding
* Access to computer or mobile phone with access to internet that can play sound (for the at-home training)

Exclusion Criteria:

* Non-native speakers of English
* History of skull fracture, scalp tissue damage, metallic implants around the head, seizures, neurological disorders, or traumatic brain injury, current or suspected pregnancy

Primary outcomes:
measure: Speech-on-speech intelligibility percent correct
timeFrame: From enrollment to the end of participation at 6 weeks
measure: Pupillometry measured listening effort
timeFrame: From enrollment to the end of participation at 6 weeks
measure: QuickSIN SNR Loss
timeFrame: Days 1, 6, and 14 of the two-week auditory training
measure: Hearing Handicap Inventory
timeFrame: Days 1 and 14 of the two-week auditory training program
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Communication Neuroscience Research Lab at Boston University
state: Massachusetts
Study officials:
References:
Clinical trial NCT00966030: Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)
Official title: An Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate Vs. a Single Dose of the Reference MK0974 Liquid Filled Capsule in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria:

* Subject has history of stroke, chronic seizures, or any major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has uncontrolled high blood pressure
* Subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results

Primary outcomes:
measure: Area under the curve (AUC(0 to infinity)) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation
timeFrame: Through 48 Hours Post Dose
measure: Peak plasma concentration (Cmax) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation
timeFrame: Through 48 Hours Post Dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: