louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04909710: Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
Official title: Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: digital
mobile
autism
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use parallel assignment to compare the device feasibility across children with autism and neurotypical children, who will serve as controls.
Primary purpose: OTHER

Brief summary: The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).


Eligibility criteria: Inclusion Criteria:

1. Parent or primary caregiver over 18 of a child with autism, we will enrich for children between the ages of 2 and 8 years old.
2. Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.

Exclusion Criteria:

(1) Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.

Primary outcomes:
measure: Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver
timeFrame: Baseline (Week 0), Week 12
measure: Mobile Application Usage-Total games started.
timeFrame: Week 12
Secondary outcomes:
measure: Change in parent reported social responsiveness from week 0 to week 12
timeFrame: Baseline (Week 0), Week 12
measure: Change in mobile autism risk assessment score from week 0 to week 12
timeFrame: Baseline (Week 0), Week 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Associate Professor
name: Dennis P Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531010: Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns
Official title: Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Failure
Keywords: Neonate
Premature
Pressure limited ventilation
Volume ventilation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 40
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. This study aims to compare pressure-limited to VTV in preterm infants.

Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning criteria compared to pressure-limited ventilation

Primary outcome: Time taken to achieve pre-specified weaning criteria.

Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within the first 24 hours of life and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV, required peak pressures of more than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by intention-to-treat.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated
* \<34 weeks gestation
* Within first 24 hours of life

Exclusion Criteria:

* Congenital diaphragmatic hernia
* Congenital heart disease
* Oesophageal atresia

Primary outcomes:
measure: Time to achieve weaning criteria
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02379910: A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis
Official title: AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: AnaMar AB
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2015-03-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.


Eligibility criteria: Inclusion Criteria:

* Males and/or females of any ethnic origin between 18 and 65 years of age
* Body mass index between 18.0 and 35.0 kg/m2
* Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4)
* AD lesions amenable to cutaneous treatment located on the trunk and/or limbs

Exclusion Criteria:

* Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas
* Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing
* Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing
* Treatment with systemic antihistamines within 24 hours of the first dose administration
* Treatment with SSRIs within 2 weeks of the first dose administration
* Subjects who have received phototherapy within 4 weeks prior to dosing

Primary outcomes:
measure: Adverse Events
timeFrame: Day 1-15
measure: Local Tolerability: Change in Erythema (Likert scale 0-4)
timeFrame: Day 1-15
measure: Local Tolerability: Change in Oedema (Likert scale 0-3)
timeFrame: Day 1-15
measure: Local Tolerability: Change in Burning (Likert scale 0-3)
timeFrame: Day 1-15
measure: Local Tolerability: Change in Prutitus (VAS)
timeFrame: Day 1-15
measure: Vital Signs
timeFrame: Day 1-15
measure: Vital Signs
timeFrame: Day 1-15
measure: Vital Signs
timeFrame: Day 1-15
measure: ECG
timeFrame: Day 1-15
measure: Physical Examination
timeFrame: Day 1-15
Secondary outcomes:
measure: Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F
timeFrame: Profil Day 1-15
measure: Pruritus on a Visual Analog Scale
timeFrame: Day 1-15
measure: Erythema on a Likert scale
timeFrame: Day 1-15
measure: Modified Eczema Area and Severity Index (mEASI)
timeFrame: Day 1-15
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance CRU
city: Liverpool
country: United Kingdom
facility: CRLCRU Royal Liverpool University Hospital
Study officials:
affiliation: Covance CRU
name: Jim Bush
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05819710: A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects
Official title: A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 43
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
2. Subjects with a body Mass Index (BMI) from 18.5 to less than 25.0 and a body weight of 40.0 kg or over at the screening test
3. Subjects who are judged by the principal investigators or subinvestigators as an eligible for the clinical trial participation based on the results of tests conducted in the screening, VISIT 1 and prior to the administration of the investigational drug.

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. Subjects who have any unsuitable medical histories for participation in this clinical trial, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
3. Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.

Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: RMS of COP in eye-open condition
timeFrame: 8 hour postdose
Secondary outcomes:
measure: RMS of COP in eye-closed condition
timeFrame: 8 hour postdose
measure: Trajectory of COP in eye-open condition
timeFrame: 8 hour postdose
measure: Trajectory of COP in eye-closed condition
timeFrame: 8 hour postdose
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02708810: RAD 1501: a Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Official title: RAD 1501: a Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: radiosurgery (RS)
trigeminal neuralgia (TGN)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

Detailed description: To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).

Eligibility criteria: Inclusion Criteria:

* Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
* Patients must have an ECOG status of 0, 1, or 2
* Patients must be at least 18 years of age
* Life expectancy must be greater than 12 months
* MRI of brain within prior 12 months to confirm lack of other causes of facial pain
* All patients must be given written informed consent

Exclusion Criteria:

* Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
* Patients with atypical trigeminal neuralgia or headache pain syndromes
* Patients with pain associated with multiple sclerosis or base of skull tumor
* Patients with medical contra-indications to MR imaging (e.g. pacemaker)

Primary outcomes:
measure: Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
timeFrame: 3 Month Follow-Up Visit
measure: The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.
timeFrame: 1 Year
Secondary outcomes:
measure: Number of Participants with treatment-related adverse events
timeFrame: 1 Year
measure: Mean of Quality of Life Scores as measured by SF-36 Questionnaire
timeFrame: 1 Year
measure: Patient Satisfaction Scores
timeFrame: 3 Month Follow-Up Visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hazelrig-Salter Radiation Oncology Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: John Fiveash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06995612: SMART-CPT for PTSD/Concussion Implementation
Official title: SMART-CPT for PTSD and History of Concussion: A Pragmatic Implementation Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PTSD
Concussion, Mild
Lead sponsor: San Diego Veterans Healthcare System
Sponsor class: FED
First posted: 2025-05-29
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT).


Eligibility criteria: Inclusion Criteria:

* PTSD diagnosis;
* mild TBI sustained greater than three months prior to enrollment;
* cognitive complaints;
* not medicated or stable on prescribed psychiatric medication for at least 6 weeks prior to study enrollment with no anticipated/pending medication changes;
* English literacy.

Exclusion Criteria:

* mTBI sustained less than 3 months previously;
* history of moderate, severe, or penetrating TBI;
* history of other significant neurological condition unrelated to TBI;
* severe psychiatric disturbance expected to interfere with successful completion of the study;
* current severe alcohol or other substance use disorder;
* suicidal intent or attempt within the previous month;
* current homicidal ideation;
* impaired decision making capacity;
* prior completion of five or more sessions of CPT or cognitive rehabilitation; -concurrent participation in other intervention studies for PTSD or TBI;
* life threatening or unstable medical illness;
* inability to read;
* dementia

Primary outcomes:
measure: PTSD Checklist (PCL5)
timeFrame: weekly through treatment completion, an average of 3 months
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: weekly through treatment completion, an average of 3 months
measure: The Patient Global Impression of Change (PGIC)
timeFrame: at treatment completion, an average of three months
measure: Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: at 3 primary assessment timepoints, week 0, week 12, week 24
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: at 3 primary assessment timepoints; week 0, week 12, week 24
measure: Traumatic Brain Injury Quality of Life Scale (TBI-QOL)
timeFrame: at 3 primary assessment timepoints; week 0, week 12, week 24
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego
state: California
Study officials:
References:
Clinical trial NCT00399412: ECG Signal Collection From Long QT Syndrome, Wide QRS Complexes, Heart Failure, and Cardiac Resynchronization Patients
Official title: Further Research on Human Feasibility of a Subcutaneous Implantable Defibrillator (S-ICD)- ECG Signal Collections From Various Patient Groups Whilst Attending Outpatient Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long QT Syndrome
Wide QRS Complexes
Heart Failure
Cardiac Resynchronisation
Keywords: S-ICD
ICD
ECG signals
Resting
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 86
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 long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS.

Brief summary: The purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS during a routine outpatient assessment. The ECGs collected will be used as test signals by the sponsor for the development of a subcutaneous implantable defibrillator

Detailed description: The objective of this study is to record standard ECG signals is each of the 4 patient populations together with signals from 4 non-standard surface positions when these patients attend the outpatient department for follow-up. The non-standard electrode positions mimic the positions of the subcutaneous electrodes of the subcutaneous implantable defibrillator (S-ICD) system in development by Cameron Health.

The collection of these signals will allow bench testing of the algorithms proposed for the S-ICD system. Additionally, it will allow a comparison of the response of different defibrillators to these same signals to asses how each would treat a particular rhythm.

Eligibility criteria: Inclusion Criteria:

* Patients attending the outpatient for routine follow-up for their cardiac disease or to have an implanted device follow-up

Exclusion Criteria:

* Patients unable or unwilling to provide informed consent
* Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Trust
state: Cambridge
Study officials:
affiliation: Papworth Hospital NHS Trust
name: Andrew A Grace, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191412: A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
Official title: Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy.
* Patient must have measurable disease
* Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy
* Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment.
* Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms.

Exclusion Criteria:

* Patients who have had prior therapy with Pemetrexed.
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
* Patients who have received radiation to more than 25% of marrow

Primary outcomes:
measure: Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
Secondary outcomes:
measure: Toxicity measured by CTCAE grading
measure: Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
measure: Duration of stable disease: Enrollment to PD or death of any cause
measure: Time to treatment failure: Enroll. to PD, death of any cause, early discontinuation of treatment for any reason other than adequate response or start of new therapy
measure: Progression-free survival: Enroll. to PD or death of any cause
measure: Overall survival: Enroll. to death of any cause
Other outcomes:
Locations:
city: Denver
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Colorado
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT) - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03843112: Modulating the Vaginal Microbiome After Implantation Failure
Official title: Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Implantation Failure
Infertility, Female
Vaginal Flora Imbalance
Keywords: Infertility, female
Vaginal microbiome
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: ARTPred
name: Bifodan A/S
First posted: 2019-02-15
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised placebo controlled, double blinded study
Primary purpose: TREATMENT

Brief summary: Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal supplements.


Eligibility criteria: Inclusion Criteria:

* unfavorable vaginal microbiome using ARTPreds test
* non-smoker

Exclusion Criteria:

* use of oral antibiotics oral probiotics between diagnosis and inclusion in the study
* pregnancy at inclusion
* allergy towards study drugs

Primary outcomes:
measure: Change in vaginal microbiome after intervention
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Fertilitetsklinikken, Region Sjælland
Study officials:
References: