louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00244114: Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
Official title: In Vitro Evaluation Of Allergic Reactions In Hemophilia B Subjects Who Have Exhibited A Systemic Allergic Response After Exposure To BeneFIX (Nonacog Alfa; Recombinant Factor IX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Keywords: Hemophilia B
Allergic Reaction
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-25
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate subject sensitization to FIX.


Eligibility criteria: Inclusion Criteria:

Study Group:

* Written informed consent or assent, as applicable.
* Subjects with moderate to severe Hemophilia B (FIX:C \<5%), who have reported class II or class III allergic manifestations within 24 hours of a BeneFIX infusion.

Control Group:

* Written informed consent or assent, as applicable.
* Subjects with moderate to severe Hemophilia B (FIX:C \<5%)

Exclusion Criteria:

Study group:

* Subjects who had no reaction when rechallenged with BeneFIX, in the absence of prophylactic immunomodulating therapy.
* Subjects whose most recent allergic manifestations with BeneFIX occurred \>36 months prior to providing written informed consent for this study.
* Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
* Subjects with immune disorders.
* Subjects unable to comply with a minimum 5-day FIX washout requirement.

Control group:

* Subjects with documented evidence of prior allergic reaction to any FIX product.
* Subjects with documented evidence of prior or current FIX inhibitor (BU \>0.6).
* Subjects have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study blood draw.
* Subjects with immune disorder.
* Subjects unable to comply with a minimum 5-day FIX washout requirement.

Primary outcomes:
measure: Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
timeFrame: within 36 months after allergic reaction
Secondary outcomes:
measure: Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected
timeFrame: 15 days
measure: Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported.
timeFrame: 15 days following study blood draw
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06753214: Telemedicine Education for Caregivers and Asthma Control in Children
Official title: Effectiveness of Telemedicine-Based Education for Caregivers on Asthma Control in Children With Uncontrolled Asthma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uncontrolled Asthma
Telemedicine-Based Education
Keywords: Asthma
Pediatrics
Telemedicine
Uncontrolled asthma
Lead sponsor: Can Tho University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthma control in pediatric patients remains a critical issue for healthcare providers. Telemedicine has emerged as an effective solution for overcoming distance barriers in healthcare delivery. This study aims to utilize telemedicine-based education for caregivers to improve asthma control in children with uncontrolled asthma. By providing remote guidance and support, the study seeks to enhance caregivers' knowledge and management practices, ultimately leading to better asthma outcomes for pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Pediatric asthma patients diagnosed according to the GINA guidelines, classified as having uncontrolled asthma, are managed and followed up for at least 1 month at the pediatric asthma unit of the outpatient department.

Exclusion Criteria:

* Pediatric patients who do not cooperate or are unable to complete the Childhood Asthma Control Test questionnaire.
* Caregivers who cannot complete the questionnaires related to the assessment of asthma control and associated factors.
* Pediatric patients who have siblings participating in the study.
* Patients currently participating in another clinical study (excluding non-interventional studies or registries).

Primary outcomes:
measure: The improvement of asthma control
timeFrame: 1 month after enrollment
Secondary outcomes:
measure: The improvement of caregiver's knowledge regarding asthma control
timeFrame: 1 month after enrollment
measure: The improvement of caregiver's attitudes toward asthma management
timeFrame: 1 month after enrollment
measure: The improvement of proper inhaler technique usage
timeFrame: 1 month after enrollment
Other outcomes:
Locations:
city: Can Tho City
country: Vietnam
facility: Can Tho Children's Hospital
Study officials:
affiliation: Can Tho University of Medicine and Pharmacy
name: Nghia Quang Bui, MD, PhD
role: STUDY_CHAIR
affiliation: Can Tho University of Medicine and Pharmacy
name: Ly Cong Tran, MD, MSc
role: STUDY_DIRECTOR
affiliation: Can Tho University of Medicine and Pharmacy
name: Thang Hoang Le, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06471114: Evaluation of the Efficacy of Systemic Treatments for Alopecia (ESTAA)
Official title: Evaluation of the Efficacy of Systemic Treatments for Alopecia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alopecia Areata
Keywords: severe
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected from 5 university hospitals in the HUGO network (Brest, Rennes, Tours, Angers, Nantes).

Brief summary: The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours.


Eligibility criteria: Inclusion Criteria:

* Patient with severe alopecia
* Has received at least one systemic treatment for at least 3 months (among methotrexate, intravenous or oral corticosteroid therapy, Ciclosporin, UVA/UVB phototherapy)
* Patient affiliated to a social security scheme
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patients under legal protection (guardianship, curatorship, etc.)
* Refusal to participate
* Other cause of alopecia
* Follow-up less than 3 months
* Age under 18 years

Primary outcomes:
measure: Short-term efficacy and security of systemic treatments
timeFrame: From January 2010 to December 2020
Secondary outcomes:
measure: Long-term efficacy of systemic treatments
timeFrame: From January 2010 to December 2020
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT06424314: Exploration of Mechanisms for Weaning Failure
Official title: Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weaning Failure
Central Respiratory Depression
Diaphragm Injury
Phrenic Nerve Disorder
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing weaning from mechanical ventilation；Hemodynamic stability

Brief summary: This study is a prospective physiologic study. The primary study population will be adult invasive tracheal intubated patients with COPD, and investigators will collect relevant demographic data, vital signs, and baseline physiologic parameters of the patients prior to the spontaneous breathing test（SBT).

The participants will be divided into a successful withdrawal group and a failed withdrawal group according to the SBT outcome, and the changes in the above parameters during SBT will be compared between the two groups .

Detailed description: This observational study mainly include participants who had invasive mechanical ventilation for ≥48 h and are assessed to be ready for the SBT trial.The SBT approach is based on the low-level pressure support mode.

Prior to the SBT trial, baseline demographic and physiologic data of the participants will be collected, and the participants will be divided into two groups based on the results of the SBT trial: successful and unsuccessful, and the physiologic changes during the SBT trial will be compared between the two groups, respectively.

Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

* neuromuscular disease；Postoperative patients or patients with traumatic brain injury

Primary outcomes:
measure: weaning success
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT04830514: Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Official title: Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: muscle loss
protein
animal-based protein
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.

Detailed description: Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.

3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.

Eligibility criteria: Inclusion Criteria:

* BMI ≤ 35 kg/m2
* Capable of providing informed consent
* COVID-19 negative and/or asymptomatic

Exclusion Criteria:

* Subject who does not/will not eat animal protein sources.
* Body mass index \> 35.
* History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
* Use of insulin to control blood sugar level.
* Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
* Currently using prescription blood thinning medications.
* Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
* Unwilling to avoid using protein or amino-acid supplements during participation.

Primary outcomes:
measure: Whole Body Protein Turnover
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Arny A Ferrando, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02199314: Anesthesia and Motor Evoked Potential (MEP) Recruitment
Official title: The Effect of Anesthesia on the Recruitment of Motor Evoked Potentials Using an Increased Number of Pulses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: intra
operative
neurophysiologic
monitoring
transcranial
motor
evoked
potential
anesthesia
pulses
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Test the hypothesis to recruit larger motor responses to transcranial stimulation.

Detailed description: The study is designed to test the hypothesis that it is possible to recruit larger motor responses to transcranial stimulation by increasing the number of stimulating pulses under both baseline conditions and conditions of increased anesthetic suppression of the motor responses.

Eligibility criteria: Inclusion Criteria:

* Age 12 through 17 years
* Diagnosis of idiopathic scoliosis
* Scheduled for posterior spinal fusion with neurophysiological monitoring
* No known allergies to propofol or remifentanil
* No contraindication to total intravenous anesthesia
* No contraindications to the administration of volatile agents

Exclusion Criteria:

* Failure to consent or assent to study
* Diagnosis other than idiopathic scoliosis
* Poorly controlled seizures or the presence of a cochlear implant
* Patient history or family history of malignant hypothermia or mitochondrial myopathies

Primary outcomes:
measure: Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00365014: Progression of Hematopoietic Diseases in Shanghai, China
Official title: Analysis of Disease Progression for Aplastic Anemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia and Benzene Poisoning in Shanghai, China.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Keywords: aplastic anemia
myelodysplastic syndromes
cytopenias
acute myeloid leukemia
myelodysplastic/myeloproliferative diseases
benzene poisoning
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Fudan University
name: University of Cincinnati
name: ExxonMobil Biomedical Sciences, Inc.
name: British Petroleum P.L.C.
name: Chevron Corporation
name: ConocoPhillips
name: Exxon Mobil
name: Marathon Ashland
name: Shell Chemicals
First posted: 2006-08-16
Enrollment: 10757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with blood diseases

Brief summary: The purpose of this study is to identify and characterize blood diseases presenting at Shanghai hospitals and to compare them with respect to clinical presentation, phenotype, molecular characteristics, benzene or other exposures and genetic susceptibility.

Detailed description: The purpose of this study is to identify and characterize blood diseases presenting at Shanghai hospitals and to compare them with respect to clinical presentation, phenotype, molecular characteristics, benzene or other exposures and genetic susceptibility. The format for these studies is a set of clinical series superimposed on a case-control design that enables integration of detailed clinical and molecular characterizations of disease pathogenesis together with an evaluation of potential confounding and interacting factors within a structured statistical analysis of benzene exposure.

Eligibility criteria: Inclusion Criteria:

Men and women 18 years or older Diagnosis of hematologic abnormality

Exclusion Criteria:

Children Non hematologic diseases

Primary outcomes:
measure: blood diseases presenting at Shanghai hospitals
timeFrame: hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Joint Sino-US Clinical and Molecular Laboratory (JCML)
Study officials:
affiliation: University of Colorado at Denver and Health Sciences Ctr.
name: Richard D Irons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00289614: Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)
Official title: Patients With Renal Impairment and Diabetes Undergoing Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Diseases
Keywords: contrast induced nephropathy
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.


Eligibility criteria: Inclusion Criteria:

* Referred for contrast enhanced MDCT
* Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
* Diagnosed as having diabetes mellitus

Exclusion Criteria:

* Unstable renal function
* Unstable diabetes
* Concurrent administration of nephrotoxic drugs
* Undergoing dialysis

Primary outcomes:
measure: Increase in serum creatinine (SCr) at 48-72 hours post dose
Secondary outcomes:
measure: Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Kathleen S Bensel, CNMT
role: STUDY_DIRECTOR
References:
Clinical trial NCT06754514: Organ Retractor Device Study
Official title: Boehringer Laboratories Organ Retractor Device Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Retraction During Bariatric Surgery
Lead sponsor: Boehringer Labs LLC
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Identified by doctor

Brief summary: This study aims to assess the safety and efficacy of an organ retraction device. The study is low risk as it is only being used in patients already undergoing primary robotic bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* undergoing minimally invasive primary bariatric surgery

Exclusion Criteria:

* known liver disease

Primary outcomes:
measure: Ease of use and Feasibility
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
Study officials:
References:
Clinical trial NCT04682314: B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation
Official title: B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Malignancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years and older with hematological malignancies and subject to allogeneic HSCT

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematological malignancies. However, patients who have received this treatment have a persistent deficit in humoral immunity up to one year post-transplant. To date, the design of new therapeutic strategies to improve immune recovery in allo-HSCT patients is still hampered by the fact that post-transplant regenerative hematopoiesis has never been studied, and more generally by our currently limited knowledge on the development and function of human B lymphocytes. The main objective of our study is to study early B-cell progenitor reconstitution after allogeneic hematopoietic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

Patients :

* 18 years of age and older
* with hematological malignancies and subject to allogeneic HSCT
* with health insurance coverage (bénéficiaire ou ayant droit)
* having signed a written informed consent.

Inclusion criteria of donor

* 18 years of age and older
* with health insurance coverage (bénéficiaire ou ayant droit)
* having signed a specific written informed consent.

Exclusion criteria of recipient and donor

* Absence of written informed consent
* Patient or donor on AME
* Patient or donor on AME or under protection by law, tutorship or curatorship
* Pregnant women

Primary outcomes:
measure: B cells reconstitution
timeFrame: at day 100 days post-transplant
Secondary outcomes:
measure: B cells reconstitution
timeFrame: at 6 months post-transplant
measure: Perturbations in growth or differentiation of progenitor/precursor of B cells
timeFrame: at 100 days post transplant
measure: Perturbations in growth or differentiation of progenitor/precursor of B cells
timeFrame: at 6 months post-transplant
Other outcomes:
Locations:
Study officials:
References: