louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04049981: Investigation of Mechanisms of Action in Superpower Glass
Official title: Examining Mechanisms of Action in Superpower Glass Behavioral Intervention for Children With Autism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Autism Spectrum Disorder
Autism
Keywords: digital
autism
mobile health
ASD
mobile therapy
Google Glass
wearable computing
technology
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Randomization
Primary purpose: OTHER

Brief summary: The following study aims to understand the mechanism of action at work in a novel artificial intelligence (AI) tool that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This study will examine 2 versions of software on the Google Glass based wearable intervention system. Participants will receive 1 of 2 versions of the software and use the device at home for 4 weeks. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that both mechanisms under investigation will contribute to social gains in children over the 4 week period of use.


Eligibility criteria: Inclusion Criteria:

* Parent of a child with a professional diagnosis of autism who is at least 18 years old.
* Child with autism is 4-8 years old
* Parent/Guardian is able to drive to Stanford University for 2 in lab appointments.(Lives within driving distance of Stanford University).

Exclusion Criteria:

* Parent/Guardian unable to speak and read in English.
* Child with autism receives Social Communication Questionnaire score\>15

Primary outcomes:
measure: Change in socialization subscale scores of the Vineland Adaptive Behavior Scales,3rd Edition (VABS-III) from baseline to week 4.
timeFrame: Baseline (Week 0), Week 4
measure: Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 4
timeFrame: Baseline (Week 0), Week 4
Secondary outcomes:
measure: Changes in Parent Self Agency Measure scores from Baseline to Week 4
timeFrame: Baseline (Week 0), Week 4
measure: Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 4
timeFrame: Baseline (Week 0), Week 4
Other outcomes:
measure: Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ) score at baseline
timeFrame: Baseline (Week 0)
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Dennis P Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843881: The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
Official title: The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Gastric Bypass
bariatric surgery
carbohydrate metabolism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2013-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can affect insulin secretion after meals. The hypothesis of this study is the Disposition Index is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by glucagon-like peptide-1 (GLP-1) receptor blockade.


Eligibility criteria: Inclusion Criteria Roux-en-Y Gastric Bypass (RYGB)Subjects:

* Subjects who have undergone RYGB

Inclusion Criteria Healthy Subjects:

* Must match RYGB subjects in age, weight, and gender
* Subjects will be without active systemic illness

Exclusion Criteria all Subjects:

* Subjects \<20 years old and \>70 years old
* For Female Subjects: positive pregnancy text at the time of enrollment or study
* Subjects with functional or organic bowel symptoms.

Primary outcomes:
measure: Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)
timeFrame: Day 1, Day 2 (approximately 2 weeks after day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03311581: The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
Official title: The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease
Hemodialysis Complication
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.

Detailed description: The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will receive general anesthesia and brachial plexus block. Patients will be randomly allocated into two groups. Study and control group received propofol target-controlled infusion (TCI) and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2, analgesics dosage, pain intensity and perioperative adverse events.

Eligibility criteria: Inclusion Criteria:

* Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery

Exclusion Criteria:

* one of below systemic diseases; chronic pulmonary, cardiac diseases(such as COPD, asthma, acute myoischemia), hepatic co-mobility(such as liver cirrhosis), morbid obesity, alcoholism, allergy to propofol and inhaled anesthetics, the women who are pregnant or breastfeeding

Primary outcomes:
measure: Change in blood pressure
timeFrame: The blood pressure change between baseline, post-induction 3mins, operation start, post-operation 10 mins,post-operation 30 mins,post-operation 1 hour,post-operation 2 hours, end of surgery, recovery room, up to 4 hours
Secondary outcomes:
measure: analgesics dosage
timeFrame: The amount of analgesics dosage use at recovery room,an average of 4 hours
measure: Change in pain intensity
timeFrame: The pain intensity change at recovery room, post-operation day 1, post-operation day 2
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT06830681: CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula
Official title: A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cow Milk Protein Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 460
Sex: ALL
Minimum age (years): 4
Maximum age (years): 22
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula


Eligibility criteria: Inclusion Criteria:

1. Full term infant (gestational age ≥37 weeks and ≤42 weeks).
2. Birth weight ≥2500 g and ≤4500 g.
3. Infant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks).
4. Not breastfed at time of Screening Visit.
5. History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.

Exclusion Criteria:

1. Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
2. Demonstrated chronic malabsorption not due to CMPA.
3. History of anaphylaxis to CMP.
4. Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
5. Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
6. History of any immunotherapy for CMPA.
7. Past or current disease or disorder which, in the opinion of the Investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.

Primary outcomes:
measure: Growth
timeFrame: 16 weeks
Secondary outcomes:
measure: Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 52 weeks
measure: Tolerability
timeFrame: 52 weeks
measure: Growth
timeFrame: 52 weeks
measure: Stool frequency and characteristics
timeFrame: 52 weeks
measure: Quality of life
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Grupo Pediátrico Uncibay
Study officials:
References:
Clinical trial NCT03970681: Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage
Official title: Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroma, Acoustic
Keywords: Acoustic neuroma
Vestibular schwannoma
Spontaneous shrinkage
Neoplasm regression
Volume quantification
Tridimensional measurements
Volumetric measurements
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018

Brief summary: To evaluate the regression characteristics of this Acoustic Neuroma population using volumetric data To study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018
* Subject who has agreed to the use of his data for the purpose of this research
* Subject presenting an untreated neuroma

Exclusion Criteria:

* Subject having expressed his opposition to participating in the study
* Subject followed for neuroma of other cranial pairs,
* Subject followed in the context of type II neurofibromatosis
* Subject with a treated neuroma (radiotherapy or surgery)

Primary outcomes:
measure: Measurement of tumoral volume using tridimensional reconstruction on MRI, and kinetics of decay
timeFrame: Files analyzed from January 01, 2013 to June 30, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Orl Et de Chirurgie Cervico-Faciale
Study officials:
References:
Clinical trial NCT04984681: Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Supplement
Official title: Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Administrative Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Mild Cognitive Impairment
Keywords: HIV
Cisgender women
African American or Black
Mindfulness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In our Supplement Aim we will conduct a two-arm randomized pilot test of the adapted intervention compared to a usual care control group among 30 African American/Black women with HIV (15/arm) to assess the feasibility and acceptability of the mindfulness-based stress reduction among women with HIV with mild cognitive impairment. Feasibility will be assessed by our ability to (1) recruit, randomize, and retain participants and (2) deliver the intervention per the manual, as well as (3) participants adherence to home practices and assignments. Acceptability will be assessed via qualitative data (focus group input regarding participants' satisfaction with the intervention and intent to continue using the practices), as well quantitative data (satisfaction survey).


Eligibility criteria: Inclusion Criteria:

* Cisgender females
* HIV seropositive
* 18 years of age or older
* English speaking
* An active patient at the local HIV ambulatory clinic in Alabama.
* No history of neurological (including dementia diagnosis)
* No history of severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders

Exclusion Criteria:

* Non-English speaking
* Appear temporarily impaired (e.g., intoxicated)
* Not willing to or legally unable to provide informed consent.

Primary outcomes:
measure: Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment
timeFrame: Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Nursing
state: Alabama
Study officials:
References:
Clinical trial NCT01451710: The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
Official title: The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgA Nephropathy
Keywords: enough steroids
MCD
efficacy
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center,prospective,no-controlled clinical trial

Detailed description: 1. The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
2. The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

Eligibility criteria: Inclusion Criteria:

* Female or male patients aged between 18 to 65 years
* Renal biopsy was used to diagnose IgA nephropathy
* Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

Exclusion Criteria:

* Patients with serum creatinine ≥ 3 mg/dl or eGFR \< 30ml/min per 1.73 m2
* urine RBC \> 1 million/ml
* Patients who have received treatment of enough steroids for more than 12 weeks
* patients with secondary IgA
* Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
* Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2

Primary outcomes:
measure: 24h urinary protein excretion
timeFrame: 3 months
Secondary outcomes:
measure: remission rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
name: Zhihong Liu, MD
role: STUDY_DIRECTOR
References:
citation: Wang J, Juan C, Huang Q, Zeng C, Liu Z. Corticosteroid therapy in IgA nephropathy with minimal change-like lesions: a single-centre cohort study. Nephrol Dial Transplant. 2013 Sep;28(9):2339-45. doi: 10.1093/ndt/gft211. Epub 2013 Jun 19.
Clinical trial NCT01216410: Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
Official title: The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery
Keywords: Nausea
Vomiting
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
First posted: 2010-10-07
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.


Eligibility criteria: Inclusion Criteria:

* English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
* Scheduled or unscheduled cesarean delivery under spinal anesthesia
* Height: 5 feet-5 feet 11 in.

Exclusion Criteria:

* Laboring women needing an emergency cesarean delivery

  * Subjects less than 18 years of age
  * Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
  * Allergy to ondansetron, or metoclopramide
  * Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)\>160mmHg, diastolic blood pressure (DBP)\>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
  * Severe Cardiac disease in pregnancy with marked functional limitations
  * Diabetes type I
  * Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
  * Morbid obesity (body mass index (BMI)\>45)
  * Inclusion in another anesthetic study involving drug administration

Primary outcomes:
measure: Intraoperative Nausea and Vomiting
timeFrame: Intraoperatively
Secondary outcomes:
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 0-2h, 2-6h, 6-24h
measure: Pruritus
timeFrame: 0-24 hrs
measure: Satisfaction
timeFrame: 24 h
measure: Maternal Hemodynamics
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.
Clinical trial NCT06923410: Clinical Intelligent Management System - Multilingual Exploration
Official title: Multilingual Exploration of the Clinical Intelligent Management System Based on a Multimodal Foundation Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Care Diseases
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to explore the diagnostic and therapeutic performance of a multimodal foundation model-based clinical intelligent management system in simulated outpatient scenarios. Specifically, it will compare the system's AI agent with general practitioners from different linguistic and cultural backgrounds worldwide, as well as various dialect and minority language regions in China.

The study will be conducted across multiple centers in diverse regions to comprehensively evaluate the system's adaptability. Using a prospective, single-blind design, each center will recruit primary care physicians.

Standardized simulated patients across all centers will be trained based on the same set of standardized cases and then will consult with four real physicians and the AI agent, ensuring consistency.

By comparing diagnostic and treatment quality, patient satisfaction, and clinical outcomes, this study aims to explore the system's effectiveness in enhancing primary care and patient management across different regions and linguistic environments.


Eligibility criteria: Inclusion criteria for primary care physicians:

* Fluent in the local languages spoken at each center.
* With the general practice medical qualifications.
* Agree to participate in the study and sign the informed consent form.

Inclusion criteria for simulated patient volunteers:

* Age ≥ 18 years.
* Fluent in the local languages spoken at each center.
* Able to use electronic devices with intelligent systems.
* Able to accurately express symptoms and participate throughout the process.
* Agree to participate in the study and sign the informed consent form.

Exclision criteria: N/A

Primary outcomes:
measure: Comprehensive Assessment of physician's clinical abilities
timeFrame: Immediately after the simulated consultation
Secondary outcomes:
measure: System's Usability
timeFrame: Immediately after the simulated consultation with AI system
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tiantongyuan North Community Healthcare Center
state: Beijing
Study officials:
References: