louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04528966: Effects of WBV in Children With Hemiparetic CP
Official title: Short and Long-Term Effects of Whole Body Vibration on Spasticity and Motor Performance in Children With Hemiparetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Whole Body Vibration
Spastic Hemiplegia
Motor Performance
Keywords: Cerebral Palsy
Spasticity
Motor Performance
Whole-Body Vibration
Conventional Physical Therapy
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate short and long-term effects of Whole Body Vibration therapy on spasticity and motor performance in children with hemiparetic cerebral palsy in addition to conventional physiotherapy.

Twenty-six patients undergoing conventional physiotherapy in a private rehabilitation center were included in the study. Patients were randomized to treatment and control groups. Study was completed with a total of 22 cases (11 for each group). At the beginning of the study, cases were evaluated with Gross Motor Function Measure-88, LEGSys Spatio-Temporal Gait Analyzer, SportKAT550tm Portable Computerized Kinesthetic Balance Device and Modified Ashworth Scale. Cases in the treatment group were treated with Compex-Winplate for 8 weeks, 3 times a week, 15 minutes a day in one session. All cases were reevaluated immediately after the treatment and 12 weeks after the treatment.


Eligibility criteria: Inclusion Criteria:

* patients with hemiparetic CP
* patients were followed-up and treated by a special rehabilitation center
* aged between 6-18 years
* patients could walk independently without using assistive devices

Exclusion Criteria:

* any other neurological diseases
* cooperation problems
* visual or auditory disability

Primary outcomes:
measure: Gross Motor Functions assessed by Gross Motor Function Measure-88
timeFrame: 1 year
measure: Gait Parameters Assessed Using Modified Timed Up and Go Test by LegSys Spatio-Temporal Gait Analysis System
timeFrame: 1 year
measure: Balance Skills Assessed by SportKAT 550
timeFrame: 1 year
measure: Spasticity Assessed by Modified Ashworth Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Research Assistant
name: Fatih Tekin, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05602766: Ngenla Subcutaneous Injection Special Investigation
Official title: Ngenla® Subcutaneous Injection Special Investigation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Growth Hormone Deficiency Without Epiphyseal Closure
Keywords: Growth hormone deficiency (GHD)
Recombinant human growth hormone (hGH)
once-weekly injection
Somatrogon
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 1
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with GHD without epiphyseal closure who received NGENLA

Brief summary: The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.

Registration criteria of this study are the patients who:

* Have GHD without epiphyseal closure and receiving Ngenla for the first time.
* Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.

All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.

Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.

Detailed description: This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.

Eligibility criteria: Patients who satisfy all of the registration criteria are subject to this study.

Registration criteria

1. Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
2. Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.

Primary outcomes:
measure: The number of patients reporting Adverse Events (AEs)
timeFrame: up to 5 years
measure: Incidence of Glucose metabolism disorders per exposure period
timeFrame: up to 5 years
measure: Incidence of Neoplasm per exposure period
timeFrame: up to 5 years
measure: Annual growth rate (cm/year)
timeFrame: up to 5 years
measure: Growth rate standard deviation score (SDS) for chronological age
timeFrame: up to 5 years
measure: Change in height SDS for chronological age and time-course of height SDS for chronological age
timeFrame: up to 5 years
measure: Proportion of reported Adverse Events
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06923566: Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations
Official title: Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations, A Prospective Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Targeted Muscle Reinervation
Digital Amputation
Neuroma
Keywords: Targeted muscle reinnervation
neuroma
amputation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neuromas are a common complication after digital and hand amputations, resulting in significant pain, discomfort, and functional impairment. Various management methods are available, including surgical excision, nerve blocks, and nerve stump protectors, but these treatments may have limited success rates and potential complications. Targeted muscle reinnervation (TMR) is a promising technique that involves surgically rerouting a severed nerve into a nearby muscle, which can prevent the formation of neuromas and provide improved muscle function


Eligibility criteria: Inclusion Criteria:

* Arabic or English speaking individuals
* An upper limb amputation distal to the wrist crease
* A symptomatic neuroma within the hand or digits: defined as patient-reported localized pain consistent with a clinical exam of a neuroma pain.There must be a supporting Tinel's sign on physical exam.

Exclusion Criteria:

* Cognitive impairment for better assessment of patient reported outcomes and filling questionnaires and signing consents

Primary outcomes:
measure: Neuroma incidence
timeFrame: through study completion, an average of 1 year
measure: Neuroma recurrence
timeFrame: through study completion, an average of 1 year
measure: Pain intensity
timeFrame: will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
measure: Pain medication usage type
timeFrame: Followed up at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
measure: Pain medication usage frequency
timeFrame: Followed up at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
measure: Pain character
timeFrame: will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
measure: Pain character
timeFrame: will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
Secondary outcomes:
measure: operative time
timeFrame: intraoperative
measure: Rate of infection
timeFrame: up to 30 days postoperative
Other outcomes:
Locations:
city: Al Abbasiyah
country: Egypt
facility: Ain Shams University Faculty of medicine
state: Cairo
Study officials:
affiliation: Ain Shams University
name: Ayman Ibrahim Fathy Aly Howeidy, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06931366: Posterior Column Fractures of Tibial Plateau
Official title: Outcomes of Internal Fixation of Tibial Plateau Fractures Involving Posterior Column According to Three Column Concept: Prospective Case Series
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tibial Plateau Fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any public patient with posterior column tibial plateau fracture

Brief summary: The goal of this observational study is to learn about the long-term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept. The main question it aims to answer is:

Does the internal fixation of posterior column fractures of tibial plateau according to three column concept has a good radiological and clinical outcomes in follow up for 1 year? Participants already having internal fixation for their posterior column fractures will do X ray in their follow up visit and answer survey questions about their joint pain, ROM for 1 year.

Detailed description: The goal of this observational study is to measure the radiological and clinical long term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept by using Rasmussen score

Eligibility criteria: Inclusion Criteria:

* Skeletally mature patients (18 - 60 years old).
* Tibial plateau fracture with posterior column involvement classified by X-ray and CT scan
* Fractures within 3 weeks of trauma

Exclusion Criteria:

* Open fracture grade 3 Gustilo Anderson Classification but not managed by internal fixation within 3 weeks of trauma
* Paediatric fractures.
* Pathological fractures

Primary outcomes:
measure: Anatomical reduction of articular surface of tibial plateau by Rasmussen score
timeFrame: From the enrollment to the end of treatment of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university trauma hospital
Study officials:
affiliation: Department of Orthopedic Surgery and Traumatology, Assiut University
name: Ali F Abdelrahem, lecturer
role: STUDY_DIRECTOR
affiliation: Department of Orthopedic Surgery and Traumatology, Assiut University
name: Aly M Mohamed, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01748266: Microcirculation of the Thenar Eminence
Official title: Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Cardiac Surgery
Keywords: StO2
microcirculation
NIRS
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB

Brief summary: Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.

Detailed description: 40 patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB were included in this prospective observational study. Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. Organ dysfunction was assessed with the SOFA score.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* scheduled for an elective cardiac surgery at high risk of post operative systemic inflammatory response syndrome

Exclusion Criteria:

* BMI\>35

Primary outcomes:
measure: microcirculatory reactivity
timeFrame: 10 minutes before anesthésia induction
Secondary outcomes:
measure: microcirculatory reactivity
timeFrame: during CPB (30 minutes after the start), and 2, 6, 12, 24 and 48 hours after the end of the CPB
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jerome MOREL, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04678466: Flotetuzumab Expanded Access Program
Official title: An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Acute Myeloid Leukemia
AML
AML, Adult Recurrent
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
First posted: 2020-12-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.

Detailed description: MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.

Eligibility criteria: Inclusion Criteria:

* Weight of at least 17 kilograms
* CD123-positive hematologic malignancy
* Adequate organ reserve
* Provider and site are trained on study protocol using flotetuzumab

Exclusion Criteria:

* AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
* Primary induction failure
* Early relapse (less than 6 months after first complete remission )
* Three prior lines of therapy, including maximum of 1 prior salvage attempts

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MacroGenics
name: Ashley Ward, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02692066: Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.
Official title: Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Varicella
Transplants
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with liver disease and healthy controls who have not received varicella vaccination and who have no history of varicella or zoster

Brief summary: Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. This four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. However, these recommendations are not evidence based.

This is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.

Investigators will evaluate:

1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
2. the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.


Eligibility criteria: Inclusion Criteria:

* 6 months to 21 years
* no history of varicella, zoster or prior varicella vaccination

Exclusion Criteria:

* acute liver failure
* liver transplant anticipated within 28 days
* prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination
* fever
* pregnancy
* immunocompromised status
* receiving immunosuppressive meds

Primary outcomes:
measure: clearance of viral DNA
timeFrame: 4 weeks
measure: humoral response
timeFrame: 4 weeks
measure: cell mediated response
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Amy Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03362866: Epidemiology of Hepatitis B, C and Delta in Reunion Island
Official title: Epidemiology of Hepatitis B, C and Delta in Reunion Island
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Hepatitis C
Hepatitis D
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 2000
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: Hepatitis B, C, D patients in Reunion Island

Brief summary: Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized. Despite this, in its foreword, the Dhumeaux report on "Management of people infected with hepatitis B or hepatitis C viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories. The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France. This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.


Eligibility criteria: Inclusion Criteria:

Major patient

* with confirmed HBsAg and / or anti HCV positive Ab
* residing in Reunion Island
* followed in one of the participating centers

Exclusion Criteria:

• Patient carrying isolated anti HBc antibodies

Primary outcomes:
measure: Number of patients with hepatitis B, C and Δ in Reunion
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03236766: Engaging Pacific Islander Perspectives on Mental Illness and Mental Health Services
Official title: Engaging Pacific Islander Perspectives on Mental Illness and Mental Health Services
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Disorder
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will enroll 100 Samoan and 100 Marshallese adults to discuss mental health, mental disorders, and approaches for engaging Pacific Islander adults with mental illness into mental health services.

Detailed description: Despite enduring high mental health burden, Pacific Islanders have received minimal research or clinical attention in the US. Due to our poor understanding of the issues surrounding Pacific Islander mental health, engaging Pacific Islanders in mental health services has been very difficult.

This study draws from the Cultural Determinants of Help-Seeking Model to address this research and clinical gap by conducting focus groups and citizens' panels to obtain public input from 50 Samoans in LAC and 50 Marshallese in Arkansas on their unique mental health perspectives, needs, barriers and facilitators to services, and strategies to overcome these barriers. The citizens' panels will bring together lay public members, present multiple viewpoints about various mental health issues, and have members deliberate and reach a collective decision on these issues. All group materials will be translated into English, Samoan, and Marshallese, and interpreters will be present during the sessions. The groups will be audio-recorded, transcribed verbatim, and analyzed by the Research Team for themes. Numerical data will also be collected about levels of public awareness about mental illness, mental health stigma, acculturation, and underutilization of mental health services from 100 Samoan and 100 Marshallese community members to better understand these possible service barriers.

Analyzed data will be used to develop a set of intervention components that are likely to increase service engagement among both Samoans and Marshallese. These components will provide the foundation for a universal service engagement intervention for Pacific Islanders that will be developed and tested in future research.

Eligibility criteria: Inclusion Criteria:

* Samoan or Marshallese heritage; living in Los Angeles County or Northwest Arkansas; age 18 years or older; English, Samoan, or Marshallese oral and reading fluency

Exclusion Criteria:

* Not of Samoan or Marshallese heritage; living outside the catchment areas; younger than 18 years; not fluent in English, Samoan, or Marshallese

Primary outcomes:
measure: Number of participants participating in study
timeFrame: Up to 20 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04994366: Increasing Patient Experience Survey Responses
Official title: Increasing Patient Experience Survey Responses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 929
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have been discharged from the designated hospital units during the study period

Brief summary: This project aims to evaluate the effect of thank you cards on patient experience survey response rate.


Eligibility criteria: Inclusion Criteria:

* All patients who have been discharged from the designated hospital units during the study period

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Survey response rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leora Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: