louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03050840: Gamification and Energetic Behavior Changes
Official title: Gamification and Energetic Behavior Changes in Adolescent-Parent Dyads With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2017-02-13
Enrollment: 76
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity \[Body mass index (BMI kg/m2 ≥ 95th percentile)\] affects 1 in 5 adolescents in the United States, with 13 million suffering from severe obesity (BMI ≥ 120% \> 95th percentile or ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and physical activity, but change in these behaviors requires self-monitoring and support, and weight loss is not always successful.

Parent involvement and parent weight-loss can help their children to lose weight and successfully change their behavior. Guidance from pediatricians can also help to facilitate weight loss among obese adolescents. That said, treatment of obesity through behavior change within the time constraints of a Pediatric practice visit is limited by treatment adherence and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep adolescents with severe obesity engaged in therapy outside of standard practice is a critical need.

The effects of monetary incentives through games (gamification), and a comprehensive remote digital monitoring system on sleep, physical activity, and dietary intake, has been successful in adults, but has not been tested in adolescents with obesity.


Eligibility criteria: Inclusion Criteria:

* Child Subjects age 10 - 16
* Obese as defined by body mass index (BMI)
* Computer access and data plan with text messaging
* SSB intake of 2 or more servings per day (1 serving=12oz)

Exclusion Criteria:

* Active substance abuse.
* Syndromic or secondary obesity.
* Any developmental disorder.
* Eating disorder (with the exception of binge eating disorder).
* Psychosis.
* Untreated depression.
* Use of medications (prescription or otherwise) known to effect body weight.
* Weight loss of more than 5% body weight in the past 3 months.
* History of bariatric surgery.

Primary outcomes:
measure: Difference in the total number of steps per day
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in the total number of sugar sweetened beverages consumed per day
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth Parks Prout, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06846840: Ketone Esters and Metabolism During Recovery from Endurance Exercise
Official title: Effect of Ketone Esters Ingested During Recovery on Metabolism and Subsequent Exercise Capacity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exercise
Metabolism
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance.

The aim of this study is to assess the effects of ketone esters ingested during recovery from exercise, on metabolism and subsequent exercise capacity.


Eligibility criteria: Inclusion Criteria:

* VO2max ≥ 45mL.kg-1.min-1
* Weekly aerobic training \> 3hours.
* 2years running experience.
* BMI \< 30kg/m2

Exclusion Criteria:

* \<18yrs or \>60yrs of age
* Habitual smoker within last 5 years.
* History of uncontrollable metabolic or respiratory disease.
* Currently taking medication, following a low carbohydrate or ketogenic diet, or consuming nutritional ketone supplements.
* History of Irritable Bowel Syndrome

Primary outcomes:
measure: Glucose concentrations
timeFrame: 240 minutes
Secondary outcomes:
measure: Non-oxidative fate of ingested sucrose
timeFrame: 240 minutes
measure: Exercise capacity
timeFrame: 240 minutes
Other outcomes:
measure: Blood beta-hydroxybutyrate concentrations
timeFrame: 240 minutes
measure: Urinary urea
timeFrame: 240 minutes
measure: Blood lactate concentrations
timeFrame: 240 minutes
measure: Plasma insulin concentrations
timeFrame: 240 minutes
measure: Blood pH
timeFrame: 240 minutes
measure: Blood bicarbonate
timeFrame: 240 minutes
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
References:
Clinical trial NCT06280040: Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
Official title: Longitudinal Follow-Up of Retinopathy and Opticopathy After Treatment With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveal Melanoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-02-28
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: Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study.

Brief summary: The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine.

Exclusion Criteria:

* unwillingness to participate in the study
* severe media opacity

Primary outcomes:
measure: Incidence and Severity of Retinopathy
timeFrame: 1 year
Secondary outcomes:
measure: Incidence and Severity of Opticopathy
timeFrame: 1 year
measure: Functional Outcome
timeFrame: 1 year
measure: Incidence and Severity of Retinopathy and Opticopathy in oximeter
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry, Medical University Vienna
Study officials:
affiliation: Department for Ophthalmology and Optometry, Medical University of Vienna
name: Reinhard Told, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04105140: Oxytocin Effects on the Prosocial Learning
Official title: Oxytocin Effects on the Prosocial Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: oxytocin
prosocial learning
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate whether intranasal oxytocin (24 IU) treatment can influence prosocial learning behavior in males.

Detailed description: In a double-blind, within-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on prosocial learning. Before the self-administration, participants need to finish several questionnaires including IRI, AAS, BASBIS, SPSRQ, SES, PTM, STAI, BDI, ASQ and PNAS. They would finish the PANAS again before the scanning.

Participants are informed that they perform the reward learning task either for themselves, another (unknown) person or no one (control). In the probabilistc reward learning task, associations with two stimuli with different reward probabilities are learned via monetary feedback (reward ￥1 or no reward ￥0). After the experiment, participants need to finish the PANAS.

Eligibility criteria: Inclusion Criteria:

* without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness

Primary outcomes:
measure: Neural processing during feedback based on prosocial learning assessed by fMRI scanner
timeFrame: 1 hour
Secondary outcomes:
measure: Behavioral learning performance measured by E-prime
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01701440: Efficacy Study for Magnetic Induction to Treat Wrinkles
Official title: Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrinkles and Rhytides
Lead sponsor: Rocky Mountain Biosystems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.


Eligibility criteria: The inclusion criteria for the study are:

* Male or female 21 to 65 years old,
* Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms \& buttocks as determined by the study investigator,
* For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
* Apparently healthy,
* Informed consent signed by the subject.

Exclusion Criteria:

The exclusion criteria for the study are:

* History of skin hypersensitivity,
* Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
* Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
* The current or recent use (within the past 12 months) of isotretinoin,
* Pregnancy,
* Infectious diseases (such as HIV) present,
* Are a tobacco smoker,
* Insulin dependent diabetic subjects,
* Oxygen dependent subjects,
* Subjects with severe chronic illness, scleroderma, or lupus,
* Subjects with open sores or scars in the treatment region, or
* Subjects with ischemia in the treatment region.

Primary outcomes:
measure: Improvement in cosmesis
timeFrame: 1 month
Secondary outcomes:
measure: Improvement in cosmesis
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Physicians Laser and Dermatolgy Institute of Chicago,LLC
state: Illinois
Study officials:
affiliation: Physicians Laser and Dermatology Institute of Chicago
name: Jerome Garden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02029040: Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis
Official title: A Randomized Trial of Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in The Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Bronchiolitis
Keywords: Bronchiolitis
Hypertonic saline
Emergency Department
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.


Eligibility criteria: Inclusion Criteria:

* Children 2-12 months of age presenting to Emergency Department
* Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
* Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist

Exclusion Criteria:

* Previous history of wheezing
* Known heart or lung disease
* Premature birth defined as birth before 37 weeks gestation
* Immunosuppression or immunodeficiency
* Treatment with corticosteroids in the previous 48 hours
* Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration
* Oxygen saturation \<85% on room air at the time of recruitment

Primary outcomes:
measure: Respiratory Assessment Change Score (RACS)
timeFrame: 5-15 minutes
Secondary outcomes:
measure: Rate of Hospitalizations
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center; Children's Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Mohamed Badawy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00177840: Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients
Official title: Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fatigue
Keywords: cancer-related fatigue
acupuncture
breast cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2005-09-15
Enrollment: 54
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.

Detailed description: Each participant will have a baseline visit before her radiation therapy begins to complete questionnaires. Participants will receive either true acupuncture or sham acupuncture twice per week for the six weeks of radiation therapy. She will have a short questionnaire at three weeks into her radiation, and she will complete questionnaires again at the end of her radiation and four weeks later.

Eligibility criteria: Inclusion Criteria:

* Localized breast cancer
* Average to above average fatigue
* Planning radiation therapy

Exclusion Criteria:

* History of acupuncture treatment
* Allergy to stainless steel
* Pacemaker
* Anticoagulant therapy
* Known bleeding disorder
* Metastatic breast cancer
* Seizure disorder

Primary outcomes:
measure: Cancer-related fatigue
timeFrame: 10 weeks
Secondary outcomes:
measure: Cancer-related fatigue distress
timeFrame: 10 weeks
measure: Quality of life
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Judith Balk, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06584240: A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Botulinum Toxin Type A (JHM03) in Adult Patients With Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Upper Limb Spasticity
Lead sponsor: JHM BioPharma (Tonghua) Co. , Ltd.
Sponsor class: NETWORK
First posted: 2024-09-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: JHM03 and Placebo
Primary purpose: TREATMENT

Brief summary: This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
* Body weight ≥50Kg
* Participants with stable post-stroke Spasticity (ULS) for at least 3 months
* Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor
* Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain)
* Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity

Exclusion Criteria:

* Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
* History of alcohol or drug abuse.
* Known allergy or hypersensitivity to any component of the study products.
* History of epilepsy
* Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C
* Any medical condition that may put the participant at increased risk for botulinum toxin type A use

Primary outcomes:
measure: The incidence rate of adverse events and severe adverse events
timeFrame: Within 12 weeks
measure: Change from baseline at week 4 for primary targeted muscle group on the MAS
timeFrame: Within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fudan University HuaShan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital , Fudan University
Study officials:
References:
Clinical trial NCT04766840: Donor-derived CAR-T Cells in the Treatment of AML Patients
Official title: A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: AML
Keywords: CAR-T
Immunotherapy
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.

Detailed description: This is a single-center, single-arm, open-label study. This study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and CAR-T cells manufacture. Donor-derived CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.

Eligibility criteria: Inclusion Criteria:

* Refractory or relapsed AML patients.
* Have found an appropriate matched donor for CAR-T cells manufacturing.
* Patients must have evaluable evidence of disease.
* Age ≥ 18 years; Expected survival is more than 3 months.
* ECOG score 0-2 points.
* Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up.
* Adequet liver, kidney, heart and lung function.

Exclusion Criteria:

* Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia.
* Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases.
* Prior use of any gene therapy product.
* History of epilepsy or other central nervous system diseases.
* Presence of concurrent active malignancy.
* Active hepatitis B or C virus, patients with HIV or syphilis infection.
* Currently participating in or having participated in other drug clinical trials during past 30 days.
* Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment.
* Other situations not suitable for the study judged by the investigator.

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: 28 days
Secondary outcomes:
measure: Objective response rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital (PKUPH)
Study officials:
affiliation: Peking University People's Hospital
name: Xiaojun Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426940: Anesthesia-Related Peroperative Critical Events
Official title: Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Frequency of Anesthesia-related Critical Events
Anesthesia-related Intraoperative Critical Events
Anesthesia-related Postoperative Critical Events
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 1904
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age, gender, ASA (the American Society of Anesthesiologists) risk, surgical clinic, anesthesia method (general/regional/local/sedation/local+sedation), anesthesia and surgery duration of the patients, and anesthesia-related CEs occurring within intraoperative and postoperative 1 h were recorded.

Brief summary: Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.


Eligibility criteria: Inclusion Criteria:

* All patients

Exclusion Criteria:

* intubated outside the operating room
* taken into operation from the intensive care unit (ICU).

Primary outcomes:
measure: Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
timeFrame: anesthesia-related intraoperative and within postoperative 1 hour critical events
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Gamze Küçükosman
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: gamze küçükosman
role: PRINCIPAL_INVESTIGATOR
References: