louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01817179: Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
Official title: Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: hemiplegia, cerebral palsy, neuroprosthesis, children
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.

The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hemiplegic Cerebral Palsy
* Gross Motor Function Classification System (GMFCS) I or II
* Age 6-17 years inclusive
* Demonstrate foot drop during gait without wearing ankle foot orthosis
* Tolerance to neuroprosthesis stimulation
* Physician referral to participate in intervention
* Passive dorsiflexion to at least neutral with knee extended
* Available to travel to and from study visits
* Ability to follow instructions and cooperate with study protocol
* Caregiver reads and understands English

  * Exclusion criteria:
* Any metal implants containing electrical circuitry
* Continuous regular use of neuroprosthesis stimulation previous to study enrollment
* Previous orthopaedic procedure involving tibialis anterior muscle at any time
* Previous orthopaedic procedure to affected limb in the last year
* Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study
* Any condition that PI feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)

Primary outcomes:
measure: peak ankle dorsiflexion range during swing phase in gait
timeFrame: will be assessed at baseline and 3 months after continous use of neuroprosthesis
Secondary outcomes:
measure: gait efficiency
timeFrame: after 3 months of neuroprosthesis use
Other outcomes:
measure: functional skills
timeFrame: at baseline and 3 months after neuroprosthesis use
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Amy F Bailes, PT, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637779: A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain
Official title: A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mothers of Newborn Infants
Keywords: randomized controlled trial
parent education
pain management
infant
immunization
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2012-07-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

Detailed description: Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

Eligibility criteria: Inclusion Criteria:

* new mothers with health full-term infants
* 5 minute Apgar 7 or more

Exclusion Criteria:

* non-english speaking mothers
* mothers with psychiatric conditions
* infants admitted to intensive care unit

Primary outcomes:
measure: knowledge
timeFrame: 10 minutes after intervention (educational material)
Secondary outcomes:
measure: utilization of pain relieving interventions
timeFrame: 2 months after intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05611879: Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Official title: Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC, Stage III
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.


Eligibility criteria: Inclusion Criteria:

* Written informed consent provided.
* Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
* ECOG score is 0 or 1.
* Adequate hematological function, liver function and renal function.

Exclusion Criteria:

* Previously received systemic anti-tumor therapy for non-small cell lung cancer.
* history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
* History or active pulmonary tuberculosis.
* Active infections that require systemic treatment.
* History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
* Untreated active Hepatitis B.
* Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
* Grade 3 or above peripheral neuropathy.
* Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
* Underlying severe or uncontrolled disease.
* Malignant tumors other than NSCLC within 5 years.
* Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.

Primary outcomes:
measure: Resectability rate
timeFrame: At time of surgery
Secondary outcomes:
measure: Major pathological response rate (MPR)
timeFrame: At time of surgery
measure: Pathology complete response rate(pCR)
timeFrame: At time of surgery
measure: R0 Resection rate
timeFrame: At time of surgery
measure: Perioperative G3-4 Adverse Events (AEs)
timeFrame: Up to 1 month post surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: Donghong Chen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05893979: Myopia Control Spectacle Lens Cessation Study
Official title: Myopia Control Spectacle Lens Use Cessation Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Myopia Progression
Juvenile Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 90
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.

To quantify axial length progression following cessation of use of specific spectacle lenses.


Eligibility criteria: Inclusion Criteria:

* Previously a successfully completed participant in the CYPRESS Extension study;
* Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
* Willingness to participate in the trial for up to 12 months without contact lens wear;
* The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

* Known allergy to proparacaine, tetracaine, or tropicamide.

Primary outcomes:
measure: Cycloplegic Spherical Equivalent Refraction (cSER)
timeFrame: 12 months
Secondary outcomes:
measure: Cycloplegic Spherical Equivalent Refraction (cSER)
timeFrame: 6 months
measure: Axial Length (AL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Longwood
country: United States
facility: Omega Vision Center PA
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Raytown
country: United States
facility: Advanced Eyecare PC
state: Missouri
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Houston
country: United States
facility: Vision Optique
state: Texas
city: Salt Lake City
country: United States
facility: William J Bogus, OD, FAAO
state: Utah
Study officials:
References:
Clinical trial NCT00504179: The Effect of Osteopathic Manipulative Treatment on Recovery of Coronary Bypass Patients
Official title: The Effect of Osteopathic Manipulative Treatment on Post-Operative Medical and Functional Recovery of Coronary Artery Bypass Graft Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: coronary artery bypass graft
osteopathic manipulative treatment
cardiovascular disease
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to determine the effect on recovery after surgery of patients who received a standardized daily protocol of osteopathic manipulative treatment.Patients undergoing elective coronary artery bypass surgery were voluntarily enrolled in the study and assigned to one of three groups.One group received a standardized daily treatment protocol along with conventional care, another received daily similar placebo treatment with conventional care, and a final group received only conventional post surgical care.The research hypothesis was that daily treatment with osteopathic manipulative treatment would reduce hospital stay and hasten recovery from surgery.Persons in the treatment group had earlier discharge, and faster recovery of bowel function and basic mobility.

Detailed description: Fifty-three persons were voluntarily enrolled into this randomized, double-blinded placebo controlled trial to examine the effects of osteopathic manipulative treatment (OMT) on the post operative recovery of persons undergoing elective coronary artery bypass graft (CABG) surgery. Participants were assigned randomly to one of three cohorts: one with only conventiobnal treatment, one with a daily standardized protocol of OMT and a third with a daily time matched placebo OMT protocol.All patients received standard state of the art care consistent with national standards of post CABG care. The study showed favorable trends in terms of hospital length of stay , return of bowel function, and mobility.

Eligibility criteria: Inclusion Criteria:

* Adults undergoing elective coronary artery bypass graft surgery who were patients of the same surgeon

Exclusion Criteria:

* prior coronary artery bypass graft procedure
* unstable psychiatric illness
* chronic pain
* open chest phenomenon
* unforeseen peri or postoperative complications

Primary outcomes:
measure: Recovery of mobility, bowel function, and reduced length of hospital stay.
Secondary outcomes:
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Ingham Regional Medical Center
state: Michigan
Study officials:
affiliation: Michigan State University
name: Michael Wieting
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723879: Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)
Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C, Chronic
Hepacivirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature.

Brief summary: Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C naive to treatment

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.
timeFrame: NA (i.e. the study was terminated)
measure: Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.
timeFrame: NA (i.e. the study was terminated)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05960279: Microwave Imaging in NeuroTrauma
Official title: Microwave Imaging in NeuroTrauma (MINT) - a Feasibility Study Investigating Whether Microwave-based Scanning Technology Can Detect an Intra-cranial Bleed in Adult Head Injury Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Craniocerebral Trauma
Keywords: Head injury
Traumatic brain injury
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Air Ambulance Charity Kent, Surrey, Sussex
name: St George's University Hospitals NHS Foundation Trust
name: Medfield Diagnostics AB
First posted: 2023-07-25
Enrollment: 500
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: Head injury patients presenting to the emergency department

Brief summary: The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head.

The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. In clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. It was believed that this device had wider applications in trauma care.

The MD100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. The device is supported by software that determines the presence of a bleed.

This study will be set in the emergency department of major trauma centres. Patients that have sustained a head injury will be considered for enrollment into the study. Following a head CT scan, patients will be scanned by the MD100. The trial will run in two phases.

In phase one: the findings from the patient's head CT scan will be used to trial the device and teach the software what it is scanning. In phase two: The MD100 will be tested to see whether it can concur with the findings of the patient's CT scan, this will be used to determine the accuracy and reliability of the device.


Eligibility criteria: Inclusion Criteria:

* Patients 18 and over.
* Blunt head trauma
* The patient has had a CT head scan

Exclusion Criteria:

* Patients with head injuries penetrating the skull
* Patients with radiologically confirmed cervical spine fracture
* Patients with radiologically confirmed depressed skull fracture and/or dislocation
* Patients with implanted metal in or around their skull (including titanium places and surgical staples)
* Confirmed pregnancy
* Per the investigator's judgement, any condition or symptoms preventing the patient from entering the trial.

Primary outcomes:
measure: Accuracy of the MD100
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS FT
city: London
country: United Kingdom
facility: St George's Hospital NHS FT
Study officials:
affiliation: King's College Hospital NHS Trust
name: Malcom Tunnicliff, MBBS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03681379: Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units
Official title: Pharmacokinetics of Levosimendan, OR1855 and OR1896 in Neonates and Children With or Without Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Keywords: Levosimendan
pharmacokinetics
children
acute heart failure
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 27
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children admitted in pediatric intensive care units for acute heart failure

Brief summary: To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)

Detailed description: Levosimendan is a calcium sensitiver wih inotropic effects. It's use in the context of acute or chronic heart failure in children has yet to be defined. Due to physical proprieties of levosimendan and metabolites, we hypothesized that concomitant use of extracorporeal devices such as ECMO will cause major pharmacokinetic variations. Furthermore, pharmacokinetics of levosimendan in children with multiple organ failure has to be specify.

Eligibility criteria: Inclusion Criteria:

* All children admitted in pediatric intensive care units with planned infusion of 0.2 mcg/kg/min of levosimendan over 24h in context of routine care
* Arterial line or central venous catheter inserted for blood sampling procedures in context of routine care.

Exclusion Criteria:

* Absence of clear parental status or information

Primary outcomes:
measure: First parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Area under the plasma concentration versus time curve (AUC) )
timeFrame: At the end of the study, after 2 years.
measure: second parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (distribution volume)
timeFrame: At the end of the study, after 2 years.
measure: third parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (half-life time)
timeFrame: At the end of the study, after 2 years.
measure: fourth parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Peak Plasma Concentration (Cmax))
timeFrame: At the end of the study, after 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
citation: Kivikko M, Antila S, Eha J, Lehtonen L, Pentikainen PJ. Pharmacokinetics of levosimendan and its metabolites during and after a 24-hour continuous infusion in patients with severe heart failure. Int J Clin Pharmacol Ther. 2002 Oct;40(10):465-71. doi: 10.5414/cpp40465.
Clinical trial NCT06646679: Intelligent Segmentation Algorithm of Ultrasonic Image
Official title: Intelligent Segmentation Algorithm of Ultrasonic Image
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Segmentation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing an ultrasound scan, including volunteers.

Brief summary: This project aims to enhance the performance of ultrasonic image analysis by optimizing and refining neural network algorithms, while also collecting and constructing extensive datasets relevant to ultrasonic imagery. The algorithm will be trained and evaluated in a data-driven manner, with test results facilitating accurate segmentation of regional block images and identification of characteristic ultrasonic anatomy. This approach will significantly advance the study and development of ultrasonic technology.

Detailed description: 1. Algorithm development: Develop high-performance intelligent ultrasonic image recognition and segmentation algorithms;
2. Data set: Establish ultrasound image data set, which is convenient for researchers to develop and verify algorithms;
3. Apply for patents, publish academic papers, promote and popularize technology.

Eligibility criteria: Inclusion Criteria:

* None.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Ultrasonic image
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tianzhu Liu
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Mei Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
References: