louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01707173: Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
Official title: Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: African American Infant Sleep Beliefs and Practices
Keywords: SIDS
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-10-16
Enrollment: 735
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a research study of African American parents/caregivers of newborns. The purpose of this research study is to learn what type of educational materials about infant safety and safe infant sleep are most effective and acceptable to parents and caregivers. The investigators will compare the responses of parents who receive enhanced materials to the responses of parents who receive the ordinary materials that are currently in use.

Detailed description: The goal of the proposed research is to determine whether a tailored multi-media mailed intervention is superior to standard non-tailored print brochures along with a generic DVD in increasing the prevalence of African American infant supine sleep during the first six months of life.

Eligibility criteria: Inclusion Criteria:-

- Self-identified AA adult parents and primary caregivers (≥ 18 years of age) of newborns ≤ four weeks old at the time of the infant's first office visit to the pediatrician.

Exclusion Criteria:

* Foster parents and temporary guardians:
* Prior study participants:
* Parents without a reliable phone number:
* Parents without ready access to a DVD player: an ownership of a DVD player,

Primary outcomes:
measure: Infant's usual sleep position per parental report
timeFrame: Change in position from study entry to infant ages 3 months and to six months; change in position from infant ages 3 months to 6 months
measure: Infants position for last night's sleep per parental report
timeFrame: Change in position from study entry to infant ages 3 months and six months; change in position from infant age 3 months to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Child Health Evaluation and Research Unit, University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kathryn L Moseley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05315973: Personalized Fingertip Glucose Measurement With a Touch Sensor
Official title: Personalized Fingertip Glucose Measurement With a Touch Sensor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 0
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: DIAGNOSTIC

Brief summary: Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which causes discomfort or inconvenience eventually lead to decreased willingness to perform such needle-based check-ups that are vital to DM management. While technology has evolved, currently there is no glucose monitoring device that is needle-free. The investigators are studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's fingertip. As it has not yet been tested in individuals with DM, the team will examine its accuracy and acceptability in these patients. Results from this clinical trial could serve as the basis for further development of a non-invasive glucose sensor.


Eligibility criteria: Inclusion Criteria:

* An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or etiology of diabetes
* Having a hemoglobin A1c \< 9.0%, and taking medication for diabetes. Individuals will bring their own lab report.
* Ability to provide informed consent for participation.

Exclusion Criteria:

* Individuals without diabetes
* Uncontrolled medical conditions, including diabetes with a hemoglobin A1c \> 9.0%, hypertension, heart, kidney, or liver failure.
* Those who cannot speak or read English. Participation will be limited to those who read and speak English, as this is a pilot study of a small number of participants, that will very unlikely offer the prospect of direct benefit from participating.
* Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.

Primary outcomes:
measure: Accuracy: glucose readings in mg/dL
timeFrame: 1 day
Secondary outcomes:
measure: Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Edward C Chao, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04593173: Diabetic Cardiomyopathy
Official title: Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Cardiomyopathies
Keywords: Diabetes
Cardiomyopathy
Diabetic Cardiomyopathies
Type 2 diabetes
Echocardiography
Left ventricle
strain 2D and 3D
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic and hypertensive patients, treated in the Internal Medicine and Diabetology Services of Strasbourg University Hospitals, between 04/15/2015 to 04/30/2019.

Brief summary: Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (\> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* Type 2 diabetic and hypertensive subjects, cardiac asymptomatic, without myocardial ischemia documented by Dobutamine stress ultrasound (ESD), having at least 1 additional CV risk factor among: dyslipidemia, active or stopped smoking for less than 3 years, family history (1st degree relationship) of major CV accident before age 60, obliterating arteriopathy of the lower limbs and / or carotid atheroma, or proteinuria.
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed his opposition to participating in the study
* Valvular heart disease (moderate to severe valve disease), hypertrophic or dilated (MVGi\> 95 g / m2 in women and MVGi\> 115 g / m2 in men), chronic pulmonary;
* History of cardiotoxic chemotherapy;
* Subject under legal protection, under guardianship or under guardianship.

Primary outcomes:
measure: Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients
timeFrame: The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Physiologie et d'Explorations Fonctionnelles
state: Starsbourg
Study officials:
References:
Clinical trial NCT03493373: Effect of Nervous System Mobilization on Older Adults' Postural Control
Official title: Effect of Nervous System Mobilization on Older Adults' Postural Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.

Detailed description: It is anticipated that 26 institutionalized older adults will be randomly allocated to receive either exercise and neural mobilization (n=13) or exercise only (n=13).

Data on pain intensity (a vertical numeric rating scale) and location (body chart), depression (Geriatric Depression Scale), balance, hand grip strength, timed up and go and gait velocity will be collected at baseline, end of treatment and at 3 months follow up.

Statistical analysis will be performed using a mixed-methods ANOVA.

Eligibility criteria: Inclusion Criteria:

* be 65 years of age or older;
* to have independent gait with or without technical aid;
* have indication of the institution's doctor for participation in the study

Exclusion Criteria:

* inability to understand study aims.

Primary outcomes:
measure: Gait velocity
timeFrame: Baseline
measure: Gait velocity
timeFrame: 9 weeks
measure: Gait velocity
timeFrame: 3 months
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: 9 weeks
measure: Pain intensity
timeFrame: 3 months
measure: Pain location
timeFrame: Baseline
measure: Pain location
timeFrame: 9 weeks
measure: Pain location
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: 9 weeks
measure: Depressive symptoms
timeFrame: 3 months
measure: Balance
timeFrame: Baseline
measure: Balance
timeFrame: 9 weeks
measure: Balance
timeFrame: 3 months
measure: Timed up and go test
timeFrame: Baseline
measure: Timed up and go test
timeFrame: 9 weeks
measure: Timed up and go test
timeFrame: 3 months
Other outcomes:
Locations:
city: Guarda
country: Portugal
facility: Lar Santa Catarina do Reboleiro
city: Guarda
country: Portugal
facility: Lar da Santa Cruz da Beselga
Study officials:
References:
Clinical trial NCT00268073: Incidence of Neo-Aortic Insufficiency
Official title: Comparison of the Incidence of Neo-Aortic Insufficiency After Classic Norwood I and Norwood I-Sano Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: Pediatric
cardiac
neo-aortic insufficience
Norwood standard Stage I procedure
Norwood Sano procedure
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. These patients will be compared with an equal number of consecutive cases treated by classic Norwood stage I operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.

Detailed description: Neoaortic valve insufficiency after Norwood type palliation of single ventricle patients has not been well studied. Patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. Re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. The introduction of the Sano modification of the Norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. It is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard Norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage II of the Norwood procedure (Glenn stage).

Eligibility criteria: Inclusion Criteria:

* patients undergone Norwood-Sano at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
* equal number of consecutive patients undergone Norwood classic stage I at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004

Exclusion Criteria:

* those who do not meet the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Kirk R Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968473: Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.
Official title: An Evaluation of Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation (NMES), When Applied to Parkinson's Disease Patients for Both Sensory and Motor Activation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Freezing of Gait
Neuromuscular Electrical Stimulation
Comfort
Pain tolerance
Pain
Sensory threshold
Motor threshold
Pain threshold
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population.

Detailed description: The comfort and tolerance of Parkinson Disease (PD) patients to surface neuro muscular electrical stimulation (NMES) will be investigated.

Six muscle sites will be tested sensory, motor and pain thresholds recorded. Furthermore pain tolerance will be recorded as the level at which the stimulus is unbearable.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of idiopathic PD (UK, PD Brain Bank Criteria)
* A Hoehn and Yahr stage of 2 - 4
* Exhibiting Freezing of Gait or another gait abnormalityin the ON or OFF state.
* An ability to mobilise independently for the purpose of research when in the 'off' state
* An ability to walk unaided for 10 meters.

Exclusion Criteria:

* A serious cognitive impairment (MMSE\<24)
* Pregnant or currently involved in another clinical trial.
* Uncontrolled heart problems
* Pacemakers
* On opioid or neuropathic pain medication

Primary outcomes:
measure: Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University Hospital Galway
Study officials:
affiliation: Electrical & Electronic Engineering NUI Galway
name: Gearoid O'Laighin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316973: A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants
Official title: A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Use Disorders
Methamphetamine Abuse
Methamphetamine Intoxication
Lead sponsor: Clear Scientific, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.


Eligibility criteria: Major Inclusion Criteria:

1. Healthy male and/or female participants aged 18 to 55 years, inclusive.
2. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg.
3. Females must be of nonchildbearing potential.

Major Exclusion Criteria:

1. Estimated glomerular filtration rate \<90 mL/min/1.73 m2
2. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG
3. Current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration.
4. History of alcohol abuse or excessive intake of alcohol

Primary outcomes:
measure: Number of participants with treatment-related adverse events (AEs) assessed by physical examinations
timeFrame: 3 days plus 8 day follow-up
measure: Number of participants with treatment-related adverse events (AEs) assessed by vital signs
timeFrame: 3 days plus 8 day follow-up
measure: Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs)
timeFrame: 3 days plus 8 day follow-up
measure: Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters
timeFrame: 3 days plus 8 day follow-up
Secondary outcomes:
measure: Time course of CS-1103 blood and urine concentrations
timeFrame: 48 hours
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Dr. Vince Clinical Research
state: Kansas
Study officials:
References:
Clinical trial NCT05689073: A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination
Official title: A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Hesitancy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to contribute to the growing body of evidence on the efficacy of digital health interventions. By rigorously evaluating the impact of the AI system on vaccine knowledge and acceptance, the study aims to inform future health communication strategies and policies. It stands as a potential model for integrating AI into public health initiatives, showcasing how technology can be harnessed to improve health outcomes on a large scale.


Eligibility criteria: Inclusion Criteria

* Individuals aged 18 or above
* Owning a smartphone/tablet capable of using the study app
* Willing to provide informed consent.

Exclusion Criteria

* Individuals with ocular or hearing disorders that preclude the use of mobile phones or reading.
* Individuals with mental disorders that preclude the use of mobile phones or reading.

Primary outcomes:
measure: Acceptance of vaccines
timeFrame: Day 14
Secondary outcomes:
measure: Hesitancy of vaccination
timeFrame: Day 14
Other outcomes:
measure: Feelings of coercion
timeFrame: Day 14
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04416373: COVID-19 and Pregnancy Outcomes
Official title: COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Pregnancy Complications
Vertical Transmission of Infectious Disease
Breastfeeding
Neonatal Infection
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women infected with Sars-Cov-2 from 6 to 41 weeks.

Brief summary: This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Detailed description: This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study.

Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.

Eligibility criteria: Inclusion Criteria: Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities.

Exclusion Criteria: RT PCR SARS-CoV-2 negative.

-

Primary outcomes:
measure: SARS-CoV-2 Neonatal Infection
timeFrame: 7 days
Secondary outcomes:
measure: Perinatal mortality
timeFrame: 35 weeks
measure: ICU maternal admission
timeFrame: 35 weeks
measure: 5 minute Apgar Score < 7
timeFrame: 1 day
measure: Preterm labour
timeFrame: 35 weeks
measure: PPROM
timeFrame: 35 weeks
measure: Miscarriage
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Nova Medical School - UNL
Study officials:
References:
Clinical trial NCT05982873: Expanded Access to Telisotuzumab Adizutecan
Official title: Expanded Access to Telisotuzumab Adizutecan
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non-Small Cell Lung Cancer
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to telisotuzumab adizutecan prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

- The participant must not be eligible for an telisotuzumab adizutecan clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: