louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05520996: Impact of Ostracism on Prospective Memory in ADHD Children With or Without Emotional Dysregulation
Official title: Impact of Ostracism on Prospective Memory in ADHD Children With or Without Emotional Dysregulation/ Impact de l'Ostracisme Sur la mémoire Prospective Chez Des Enfants Atteint de TDA/H Avec ou Sans dysrégulation émotionnelle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assess the effect of exposure to a situation of social exclusion or ostracism on the prospective memory of children with ADHD


Eligibility criteria: Inclusion Criteria:

* Child with attention deficit disorder with or without hyperactivity (ADHD) according to the following criteria: score greater than 27 on the ADHD-RS scale or score greater than 65 on the Conners scale, and after clinical staff discussion
* Social security
* non opposition of parents and children to the study

Exclusion Criteria:

* Subject presenting elements in favor of a depressive disorder according to a clinical evaluation and on an evaluation by the CBCL scale
* Minor and/or parents who do not understand French
* Person under legal protection, adult guardianship or curatorship.

Primary outcomes:
measure: difference between prospective memory tests performed before and after cyberball task
timeFrame: At inlcusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU - Rouen
Study officials:
References:
Clinical trial NCT06333496: Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans
Official title: Effect of a Glucagon Like Peptide 1 (GLP1) Booster on Blood Glucose, HbA1c, Insulin, and GLP1 Levels, Body Weight and Body Fat in Overweight Adult Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sugar; High
Overweight and Obesity
Fat Burn
Obesity
Heart Health Markers
Lead sponsor: Alpine Biotech LLC
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.

PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.

SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.


Eligibility criteria: Inclusion Criteria:

* Volunteers must be over the age of 18.
* Volunteers cannot be smokers.
* Volunteers cannot be currently taking a dietary supplement or prescription for weight loss.
* Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study.
* Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study.
* Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9

Exclusion Criteria:

* Female volunteers who are pregnant or planning to become pregnant within the next three months.
* Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).

Primary outcomes:
measure: blood glucose level
timeFrame: 12 week
measure: blood HbA1c level
timeFrame: 12 week
measure: blood insulin level
timeFrame: 12 week
measure: blood GLP1 level
timeFrame: 12 week
measure: blood cholesterol level
timeFrame: 12 week
measure: body weight
timeFrame: 12 week
measure: body fat mass
timeFrame: 12 week
measure: body lean mass
timeFrame: 12 week
measure: body mass index
timeFrame: 12 week
measure: body fat index
timeFrame: 12 week
measure: waist hip ratio
timeFrame: 12 week
Secondary outcomes:
measure: Satiety score
timeFrame: 12 week
measure: Resting metabolic rate
timeFrame: 12 week
measure: Blood pressure
timeFrame: 12 week
measure: Heart rate
timeFrame: 12 week
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Alpine Bio
state: Utah
Study officials:
affiliation: Alpine Biotech LLC
name: Lawry Han, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385096: Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT
Official title: Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Autologous Hematopoietic Stem Cell Transplantation
Conditioning
Multiple Myeloma
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou First People's Hospital
name: Zhujiang Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2017-12-28
Enrollment: 122
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16 myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Multiple Myeloma patients
* Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision

Primary outcomes:
measure: OS
timeFrame: 3 year
Secondary outcomes:
measure: relapse rate relapse rate
timeFrame: 3 year
measure: DFS
timeFrame: 3 year
measure: TRM
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT01219296: Retrospective Database Studies
Official title: Retrospective Database Studies From Reproductive Endocrinology Practice Looking at Relationships Between Demographics, Stimulation Protocols and Outcomes, Retrieval and Transfer Outcomes, Number and Quality of Oocytes and Embryos Retrieved and Transferred, Pregnancy Rates and Pregnancy Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Patients Undergoing Infertility Treatment
Keywords: infertility
IVF
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing infertility treatment in our practice.

Brief summary: Data collection and comparison of relationships between patient demographics, stimulation protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.

Detailed description: No patient treatment is associated with the study.

Eligibility criteria: Inclusion Criteria:

none

Exclusion Criteria:

none

Primary outcomes:
measure: Improving Rates while Decreasing Adverse Outcomes
timeFrame: duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05627596: Free Samples for Health
Official title: Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Cigarette Smoking
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Massachusetts General Hospital
name: Northwestern University
name: HealthPartners Institute
name: University of Alabama at Birmingham
name: Kaiser Permanente
name: University of Rochester
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-11-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a gift of equal value (an electric toothbrush).


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* smokes at least 1 combustible cigarette per day on at least 25 days of the month

Exclusion Criteria:

* does not own a smartphone with internet access
* myocardial infarction or stroke in the past 3 months
* pregnant or breastfeeding
* use of tobacco cessation medication in the past week

Primary outcomes:
measure: 7-day biochemically confirmed point prevalence abstinence
timeFrame: 6 months post baseline
Secondary outcomes:
measure: 7-day self-reported point prevalence abstinence
timeFrame: 1 month post baseline
measure: 7-day self-reported point prevalence abstinence
timeFrame: 1 month post baseline
measure: 24-hour intentional quit attempts
timeFrame: 6 months post baseline
measure: Smoking heaviness
timeFrame: 6 months post baseline
measure: Nicotine replacement therapy utilization
timeFrame: 6 months post baseline
measure: Perceived nicotine replacement therapy safety
timeFrame: 6 months post baseline
measure: Perceived nicotine replacement therapy efficacy
timeFrame: 6 months post baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare/University of Minnesota Medical School
name: Sandra Japuntich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032096: The Physiological Response to Routine Head and Neck Cancer Surgery
Official title: The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cancer involving the head and neck region of the body.

Brief summary: The main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of Head and Neck cancer

Detailed description: This project is in keeping with the strategy of the anaesthetic and intensive care departments to push towards greater understanding of the immune, metabolic and inflammatory changes associated with surgery and how these may be modified through use of different anaesthetic and intensive care techniques. Through increased understanding of the stress, inflammatory and immune responses to surgery we may be able to modulate peri-operative care to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence micrometastatic spread at the time of surgery in future studies.

Eligibility criteria: Inclusion Criteria:

* Elective unilateral neck dissections (Levels I-V) and/or Hemithyroidectomy surgery.
* Royal Marsden Hospital patients with head and neck cancer - all histological sub-types.
* Capable of providing informed consent
* Age \>17
* American Society of Anaesthesiologists Classification I-III.

Exclusion Criteria:

* Past history of ipsilateral neck dissection.
* Bilateral neck dissection
* A recent course of systemic steroids (\< 3 months)
* Pregnancy
* Involvement in drug trials
* On following medications: Interleukins, Interferons, Immunosuppressants and long term opiates
* Recent Synacthen Test (within 48 hours)
* Emergency surgery
* American Society of Anaesthesiologists Classification IV-V.

Primary outcomes:
measure: The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.
Secondary outcomes:
measure: The area under the curve for insulin concentration.
measure: Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
measure: Description of other blood parameters related to stress response.
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dr Craig Carr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882596: Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to "Low-risk" Breast Cancer Patients
Official title: A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Contura
Cancer
Accelerated
Partial
Breast
Irradiation
Lead sponsor: Cancer Center of Irvine
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.

Detailed description: The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.

Eligibility criteria: Inclusion Criteria:

* Able and willing to sign informed consent
* Age 50 or older at diagnosis
* Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
* Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
* On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
* For patients with invasive breast cancer, an axillary staging procedure must be performed \[either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative\]
* The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter
* Estrogen receptor positive tumor

Exclusion Criteria:

* Age \< 50 at diagnosis (regardless of histology)
* Pregnant or breast-feeding
* Active collagen vascular disease
* Paget's disease of the breast
* Prior history of DCIS or invasive breast cancer
* Prior breast or thoracic radiation therapy for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive
* Positive axillary node(s)
* T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage of T3 or T4
* Estrogen receptor negative tumor

Primary outcomes:
measure: Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
timeFrame: 19 months
Secondary outcomes:
measure: Toxicity rates
timeFrame: 79 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Cancer Center of Irvine
state: California
Study officials:
affiliation: Cancer Center of Irvine
name: Kenneth M Tokita, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Center of Irvine
name: Richard B Wilder, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00376896: Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
Official title: A Phase IIa Experimental Medicine Study Assessing Alterations in Regional Cerebral Blood Flow by Functional Magnetic Resonance Imaging (fMRI) in Female IBS Patients and Healthy Controls Following Single Doses of GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Colon
Irritable Bowel Syndrome (IBS)
Keywords: IBS fMRI
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a three-period crossover study to compare GW876008 and placebo to see if GW876008 will normalise blood flow responses after different emotional stimuli.


Eligibility criteria: Inclusion Criteria:

* The subject should not have been taking and medication for the treatment of IBS for 1 month prior to the study
* Negative serum pregnancy tests (serum a-HCG negative) at Screening (Visit 1), and negative urine pregnancy tests at Visits 1, 2, 3 prior to study medication dose.
* Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).
* Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG at screen).

Exclusion Criteria:

* Subjects who are pregnant or nursing.
* Current evidence, or history of (at any time in the past) of a biochemical or structural abnormality of the digestive tract. including (but not limited to): inflammatory bowel disease (Crohn's disease or ulcerative colitis); functional dyspepsia; lactose intolerance, not on a stable diet; Celiac Disease
* Subjects who are taking NSAIDs on a regular basis or within 48 hours of a study day.
* The subject has a positive pre-study urine drug/alcohol screen.
* A positive pre-study HIV 1 / 2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study.

Primary outcomes:
measure: Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
timeFrame: throughout the study
Secondary outcomes:
measure: Questionnaires to assess IBS symptoms and anxiety
timeFrame: throughout the study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03867396: Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Official title: Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: Cochlear Implant
Hearing Loss
Hearing Aids
Hearing Tests
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
Primary purpose: TREATMENT

Brief summary: Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.

This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.


Eligibility criteria: Inclusion Criteria\*:

* An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
* Low frequency Pure Tone Audiometry (PTA)

Exclusion Criteria\*:

* Non-English speakers

  * Additional Inclusion and Exclusion criteria apply

Primary outcomes:
measure: Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
timeFrame: 12 minutes
measure: CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
timeFrame: 12 minutes
measure: CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
timeFrame: 12 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Melinda Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: