louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01358604: Biomarkers in Samples From Young Patients With Neuroblastoma
Official title: ROR1 as a Novel Target for Neuroblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Keywords: localized resectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-23
Enrollment: 20
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with neuroblastoma.

Brief summary: RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study studies biomarkers in samples from young patients with neuroblastoma.

Detailed description: OBJECTIVES:

Primary

* To analyze the expression of ROR1 on the surface of primary neuroblastoma cells.
* To investigate the therapeutic potential of anti-ROR1 monoclonal antibodies (mAbs), bispecific antibodies, and immunotoxins in in vitro and in vivo models of neuroblastoma.

OUTLINE: Archived bone marrow and tumor tissue samples are analyzed for ROR1 expression by flow cytometry, western blotting, qPCR, and IHC.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with neuroblastoma

  * With or without N-myc amplification
* Primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees C
* Bone marrow samples from high-risk patients as peripheral blood mononuclear cells (PBMC) that have been cryopreserved with DMSO as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NCI - Experimental Transplantation and Immunology Branch
name: David Hema, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00276172: Open-Label Natalizumab Safety Extension Study
Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 1615
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: The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.


Eligibility criteria: Inclusion Criteria:

* Must give written informed consent.
* Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

Exclusion Criteria:

* History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* A clinically significant infectious illness within 30 days prior to study entry.

Primary outcomes:
measure: The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
timeFrame: Month 24
Secondary outcomes:
measure: EDSS scores and assessments of relapse.
timeFrame: Month 24
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in
state: Massachusetts
Study officials:
affiliation: Biogen
name: Michael Panzara, MD, MPH
role: STUDY_DIRECTOR
affiliation: Unity Health Toronto
name: Paul O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biogen Idec. Contact for more details
name: Eve Versage
role: STUDY_CHAIR
References:
Clinical trial NCT05646472: ICT-supported Multidimensional Approach for Frailty Screening in Community-dwelling Individuals Aged ≥ 65 Years
Official title: Approccio Multidimensionale Supportato Dalle ICT Per lo Screening Della fragilità Nei Soggetti di età ≥ 65 Anni Che Vivono in comunità - SUNFRAIL+
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frail Elderly Syndrome
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 700
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample

Brief summary: SUNFRAIL+ is a prospective observational cohort study aimed to carry out a multidimensional assessment of community-dwelling older adults, through an IT platform, which allows to connect the items of the SUNFRAIL frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. It is a multicentric study. Seven centres will administer SUNFRAIL questionnaire to 100 older adults each and, according to the specific "alerts" triggered by the answers provided, older adults will be subjected to one or more validated in-depth tests in order to perform further diagnostic or dimensional evaluations.


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years;
* Living at home;
* accessing participating centres for social and healthcare services other than those covered by this study;
* ability to sign the informed consent

Exclusion Criteria:

* Age \<65 years;
* Residents in care facilities (hospital, nursing home);
* have overt frailty or disability; are already enrolled in home care; are unable to understand the study aims and sign the informed consent

Primary outcomes:
measure: Improved quality of life
timeFrame: Month 14
measure: Appropriateness of care
timeFrame: Month 14
measure: Level of satisfaction of the health professionals
timeFrame: Month 14
Secondary outcomes:
Other outcomes:
Locations:
city: Busto Arsizio
country: Italy
facility: Azienda Socio Sanitaria Territoriale della Valle Olona
city: Cuneo
country: Italy
facility: Azienda Sanitaria Locale Cuneo 1
city: Genova
country: Italy
facility: Azienda Sociosanitaria Ligure n. 4
city: Lucca
country: Italy
facility: Azienda Unità Sanitaria Locale Nord-Ovest
city: Napoli
country: Italy
facility: Azeidna Ospedaliera Universitaria Federico II
city: Reggio Calabria
country: Italy
facility: Cooperativa Sociale "Res Omnia"
city: Roma
country: Italy
facility: Dipartimento di Biomedicina e Prevenzione dell'Università degli Studi di Roma Tor Vergata
city: Trento
country: Italy
facility: Azienda Provinciale Socio-Sanitaria Trento
Study officials:
References:
Clinical trial NCT01062672: Functional Neuroimaging of Cortical Plasticity in the Human Visual System
Official title: Functional Neuroimaging of Cortical Plasticity in the Human Visual System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Blindness
Vision
Keywords: plasticity
reorganization
cortical
fMRI
rehabilitation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2010-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lesions of the visual pathway (cortical or retinal)

Brief summary: The study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury will be studied and compared to appropriate controls. Functional magnetic resonance imaging methods are used to monitor cortical topography in time. The main aims of the study are to determine: 1) what are the patterns of cortical reorganization that are seen spontaneously after injury, and 2) whether rehabilitative training can promote adaptive reorganization enhancing recovery.


Eligibility criteria: Inclusion Criteria:

* Stable lesion of the visual pathways resulting in a visual field scotoma.

Exclusion Criteria:

* Inability to undergo magnetic resonance imaging,
* Inability to comply with basic instructions,
* Inability to perform the behavioral tasks required,
* Patients with chronic progressive neurological or psychiatric disorders,
* Patients that are pregnant, or breast feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Tuebingen
country: Germany
facility: Max Planck Institute for Biological Cybernetics
Study officials:
References:
Clinical trial NCT01018472: Probiotics in Infants With Cyanotic Congenital Heart Disease
Official title: Probiotics in Infants With Cyanotic Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyanotic Congenital Heart Disease
Keywords: cyanotic heart disease
congenital heart disease
intestinal microbiota
probiotics
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 12
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. It is unknown how congenital heart disease affects the development of bacterial colonization of the intestines. It is also unknown whether probiotics will change the bacteria in the intestine of infants with heart disease to become more like those of healthy infants without heart disease. This pilot trial is designed to address these two questions.

Detailed description: Infants with cyanotic congenital heart disease will be randomly assigned to receive either a placebo or probiotic Bifidobacterium infantis. Comparisons will be made between the infants receiving the placebo and healthy infants without heart disease and between the infants receiving the placebo and those receiving the probiotic.

Eligibility criteria: Inclusion Criteria:

* Cyanotic congenital heart disease
* Term infant
* Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

* Congenital anomalies of the intestinal tract

Primary outcomes:
measure: Fecal microbiota
timeFrame: Weekly for 4 weeks then monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Children's Hospital
state: California
Study officials:
affiliation: UC Davis School of Medicine
name: Mark A. Underwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06435572: Comparison of Open and Closed Aspiration in Newborns
Official title: Effect of Open and Closed Suction Systems on Newborn's Pain and Vital Signs in Neonatal Intensive Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn
Keywords: Closed system suctioning
Open system suctioning
Pain
Neonatal intensive care
Newborn
Suction
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will be considered as both an experimental and a control group.Two different aspiration methods will be applied in line with the patient's aspiration needs, and the effect of the methods will be evaluated on the same patient. In the study, open aspiration applied to the patient will be evaluated as control, and closed aspiration will be considered as the experimental group.
Primary purpose: TREATMENT

Brief summary: Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.

Detailed description: The aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. There is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.

Eligibility criteria: Inclusion Criteria:

* Newborns monitored with mechanical ventilation
* Newborn who need suctioning,
* Newborn who did not undergo painful procedures one hour before aspiration.
* Hemodynamically stable newborn;

Exclusion Criteria:

* Newborn with any facial/skull deformities
* Newborn with chromosomal/genetic abnormalities

Primary outcomes:
measure: Pain score
timeFrame: Pain will be evaluated before, during and 30 minutes after each suction procedure.
measure: Oxygen saturation
timeFrame: Oxygen saturation will be evaluated before, during and 30 minutes after each suction procedure
measure: Heart rate
timeFrame: Heart rate will be evaluated before, during and 30 minutes after each aspiration procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Buca
country: Turkey
facility: Aslı Alaca
state: İ̇zmi̇r- Turkey
Study officials:
References:
Clinical trial NCT04759872: Insulin and Muscle Fat Metabolism
Official title: Insulin and Muscle Fat Metabolism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight and Obesity
Insulin Resistance
Metabolic Disease
Mitochondrial Metabolism
Sedentary Lifestyle
Lead sponsor: Oregon State University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be asked to complete 1 screening visit to determine eligibility.

If participants remain eligible, they will be asked to complete 1 metabolic study visit.
Primary purpose: BASIC_SCIENCE

Brief summary: Our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. We will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and overweight/obese humans.


Eligibility criteria: Inclusion Criteria:

* Age 30-55 years
* Body mass index (BMI) 18-45 kg/m2
* Sedentary (\<1 hour of planned exercise per week)

Exclusion Criteria:

* Regular exercise (\>1 hour of planned exercise per week)
* Smoking, tobacco or nicotine use within the last 1-year
* Fasting glucose \>126mg/dL
* Hypertension (systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg)
* Chronic metabolic or cardiovascular health conditions
* Pregnant, nursing, irregular menses or post-menopausal
* Lidocaine allergy
* Certain medications
* Diminished capacity for consent

Primary outcomes:
measure: Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions
timeFrame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Secondary outcomes:
measure: Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions
timeFrame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Sean A Newsom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon State University
name: Matthew M Robinson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06696872: Enhancing Stability and Function in Adolescent
Official title: Proprioceptive Neuromuscular Facilitation Versus Core Training for Enhancing Stability and Function in Adolescent With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Adolescents
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the comparative effects of proprioceptive neuromuscular facilitation (PNF) stretching and core strength exercises on static balance in adolescents with patellofemoral pain syndrome (PFPS).


Eligibility criteria: Inclusion Criteria:

* Participants were between 16 and 18 years old.
* Patients had to have experienced anterior knee pain for at least 4 weeks, with the pain being exacerbated by at least two of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting (Chevidikunnan et al., 2016).
* Participants could not have undergone any surgical procedures on their lower limbs.
* Pain during the previous week needed to be greater than 30 mm on a 100 mm visual analogue scale (VAS) (Appendix I) (Rathleff et al., 2015).
* A spectrum of BMI was sought, with participants recruited to represent normal BMI percentile categories for both boys and girls. The normal BMI percentile categories for both boys and girls were defined as the 5th percentile to less than the 85th percentile (Appendix II) (King et al., 2012).

Exclusion Criteria:

* Adolescents with cruciate ligament injuries, meniscal injuries, collateral ligament injuries, and tenderness associated with any of these structures, any intra-articular injury, and tenderness over the iliotibial band, patellar tendon, pes anserine tendons, or evidence of joint effusion.

  * Adolescents with referred pain from the hip or lumbar region, or a known case of articular cartilage damage.

Primary outcomes:
measure: Visual analogue scale (VAS-100 mm) for pain
timeFrame: All adolescents were assessed before and after the 8-week intervention period
measure: Dynamic postural stability test and single leg test using the Biodex Balance System SD
timeFrame: All adolescents were assessed before and after the 8-week intervention period
Secondary outcomes:
measure: Self-administered Anterior Knee Pain Scale (AKPS) or Kujala Patellofemoral Score
timeFrame: All adolescents were assessed before and after the 8-week intervention period
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
affiliation: Delta University for Science and Technology
name: Amira H Mohammed, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00715572: Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
Official title: Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothyroidism
Keywords: hypothyroidism, treatment, thyroxine, triiodothyronine
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to analyze the features of monotherapy with L-T4 in comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.

Detailed description: We conducted a randomized controlled study with a crossover design in 36 premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones. All patients were divided into two groups: patients from Group A (n=20) were randomized to L-T4 in dose of 1,6 μg per kg, followed by combined L-T4 and L-T3; and 16 women from Group B received the combination of L-T4+L-T3 (the dose of L-T4 was reduced by 25 μg and replaced with 12,5 μg of L-T3), followed by monotherapy with L-T4. The treatment periods lasted for 6 months. Patients were examined at baseline and at the end of each treatment period.Blood samples were obtained to measure serum TSH, free T4, free T3, lipid profile, osteocalcin. Urine samples were collected to measure urinary deoxypyridinoline / creatinine ratio. 24-hour ECG-monitoring, osteodensitometry and psychological testing were also performed at baseline and at the end of each treatment period.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones

Exclusion Criteria:

* Peri- and postmenopause
* Pregnancy
* Major comorbidity
* Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.

Primary outcomes:
measure: biochemical parameters
timeFrame: the end of each period of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Moscow Medical Academy, Department of Endocrinology
name: Valentin V Fadeyev
role: PRINCIPAL_INVESTIGATOR
References: