louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00905398: Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Official title: Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Acute Lymphoblastic Leukemia
Keywords: Leukemia
Lymphoblastic
Acute
Philadelphia
BCR-ABL
Nilotinib
Treatment
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment.

Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe.

The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Acute Lymphoblastic Leukemia (ALL)
* BCR-ABL positive positive by PCR (central Lab)
* No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2
* Must be able to swallow tablets
* Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase)

Exclusion Criteria:

* Heart disease
* Interval QTc Fridericia \> 480 msec
* Coumadin use
* Pregnancy
* PS = 4
* Previous medical history of etilism or/and pancreatic disease

Primary outcomes:
measure: Complete remission
timeFrame: Day + 21 and Day + 41
Secondary outcomes:
measure: Overall Survival
timeFrame: Three years
measure: Molecular remission
timeFrame: Every three months until three years
measure: Toxicity
timeFrame: Three times a week for the first 40 days than once weekly for the next 9 months than monthly for the next 2.1 years
Other outcomes:
Locations:
Study officials:
affiliation: Rio de Janeiro Federal University
name: Rony Schaffel, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rio de Janeiro Federal University
name: Nelson Spector, MD, PHD
role: STUDY_CHAIR
affiliation: São Paulo University (Ribeirão Preto)
name: Belinda Simões, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901198: Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers
Official title: A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Beijing Bio-Fortune Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.

Detailed description: This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.

Eligibility criteria: Inclusion Criteria:

* Must be healthy males or females between 18 to 45 years old, inclusive
* Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg

Exclusion Criteria:

* History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
* Female subjects who are pregnant or breastfeeding
* Any previous treatment with Human Albumin Interferon fusion protein

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of participants with adverse events after single dose
timeFrame: 4 weeks
Secondary outcomes:
measure: Plasma concentration of interferon after single dose
timeFrame: 4 weeks
measure: Plasma concentration of Neopterin after single dose
timeFrame: 4 weks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing YouAn Hospital
name: Ning Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398145: D-chiro-inositol and AUB
Official title: The Use of D-chiro-inositol in the Treatment of AUB
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Abnormal Uterine Bleeding
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with AUB will undergo 6-month treatment with D-chiro-inositol and will fill in questionnaires on AUB, with the evaluation of hormonal serum levels.


Eligibility criteria: Inclusion Criteria:

* AUB

Exclusion Criteria:

* Menopause
* Cancer diagnosis
* Atypical endometrial hyperplasia
* Uterine fibroids
* Heavy symptoms requiring pharmacological intervention
* Progestogens treatment in the six months before the study
* Inositol treatment in the six months before the study

Primary outcomes:
measure: AUB
timeFrame: 0, 3 and 6 months
Secondary outcomes:
measure: Serum level of Estradiol
timeFrame: 0, 3 and 6 months
measure: Serum level of Estrone
timeFrame: 0, 3 and 6 months
measure: Serum level of Testosterone
timeFrame: 0, 3 and 6 months
measure: Serum level of Androstenedione
timeFrame: 0, 3 and 6 months
measure: Serum level of Total cholesterol
timeFrame: 0, 3 and 6 months
measure: Serum level of High-Density Lipoprotein
timeFrame: 0, 3 and 6 months
measure: Serum level of Low-Density Lipoprotein
timeFrame: 0, 3 and 6 months
measure: Serum level of Triglyceride
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04876105: Treatment Preferences in Patients With Low Back Pain
Official title: Do Treatment Preferences Change According to the Duration of the Pain of the Patients With Low Back Pain?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
acute pain
subacute pain
chronic pain
treatment preference
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 155 individuals between the ages of 18-65 with complaints of low back pain, meeting the inclusion criteria and agreeing to participate in the study were included in the study.

Brief summary: Together with the guidance of health professionals try to obtain information from media, popular magazines and books and the internet regarding diseases and treatment methods in patients with low back pain with the development of technology. In parallel with this information which they obtained, they turn to different treatment methods. This study was carried on examining how pain duration affects treatment preferences in patients with low back pain.


Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 18-65 with complaints of low back pain and no communication problems were included in the study.

Exclusion Criteria:

* Individuals with any systemic, neurological and / or orthopedic disease diagnosed other than complaint of low back pain were excluded from the study.

Primary outcomes:
measure: Evaluation of treatment preferences
timeFrame: 5 minutes
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 1 minute
measure: Oswestry Disability Index
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT06268405: Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings
Official title: Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Positron Emission Mammography (PEM)
Liquid Biopsy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Radialis Inc.
name: The Princess Margaret Cancer Foundation
First posted: 2024-02-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this research study is to evaluate the performance of two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to assess whether findings from the combination or each individual test can assist radiologists in visualizing and characterizing beast abnormalities.

Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses a low dose of injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.

If PEM and/or Liquid Biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.


Eligibility criteria: Inclusion Criteria:

* Individuals who are older than 18 years of age
* Individuals who are planned to undergo an MRI-guided biopsy based on high- risk screening imaging detected lesions
* Individuals with the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* High-risk Individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or MRI
* Individuals who are pregnant or who think they may be pregnant
* Individuals who are breast-feeding
* Individuals with known allergies to F-18 FDG

Primary outcomes:
measure: Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Vivianne Freitas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06840405: Cortical Activation During Walking in Stroke
Official title: Cortical Activation During Forward and Backward Walking in Individuals With Chronic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Forward walking
Backward walking
Brain activity
Stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with chronic stroke

Brief summary: After stroke, damage to one cerebral hemisphere disrupts the normal balance of activity between the two hemispheres. The affected hemisphere typically exhibits reduced excitability, whereas the unaffected side may demonstrate increased excitability. This phenomenon, referred to as interhemispheric imbalance, further inhibits activity in the affected hemisphere, thereby restricting motor recovery. According to the interhemispheric competition model, enhancing excitability in the affected hemisphere and/or suppressing excitability in the unaffected hemisphere may contribute to the improvement of motor function in individuals with stroke. Furthermore, as motor function recovers, the balance of interhemispheric activation in motor-related cortical areas undergoes corresponding changes. Previous studies have shown that treadmill training enhances the excitability of the primary motor cortex in both hemispheres of stroke patients, as well as increases excitability across multiple cortical and subcortical regions in both hemispheres. However, it remains unclear whether treadmill training can normalize the interhemispheric imbalance in stroke patients. Additionally, the effects of forward and backward walking on the activity of motor-related brain regions in individuals with stroke are still unclear. Therefore, this cross-sectional study aims to investigate the changes in motor-related brain activity during forward walking and backward walking in individuals with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* ≥ 6 months after the diagnosis of stroke
* Independent walking over at least 7m with or without a walking aid
* Mini-mental state examination score ≥ 24

Exclusion Criteria:

* Had difficulty in backward walking
* Any neuromuscular disorders history
* With visual or auditory disorders
* Unstable cardiac status or uncontrolled hypertension
* Any musculoskeletal disorders that would affect walking ability

Primary outcomes:
measure: Brain activity
timeFrame: One-time measurement during a one-minute walking task at a single study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT04648605: Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization
Official title: Post-traumatic Stress Disorder Occurrence in Parents of Neonate and Children Hospitalized in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 87
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown.

It is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.


Eligibility criteria: Inclusion Criteria:

- All parents of children aged 0 to 18 who have been admitted in paediatric resuscitation unit.

Exclusion Criteria:

* Holders of parental authority who cannot answer the questionnaire because they do not speak French.
* Opposition of one of the two holders of parental authority
* Minor parental authority holders
* Holders of parental authority under safeguarding of justice or guardianship

Primary outcomes:
measure: Prevalence of post-traumatic stress disorder among parents of newborns, infants and children who have been hospitalized in a paediatric resuscitation unit.
timeFrame: Between one and 6 months after hospitalization.
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Sophie BREINIG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00467805: Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Light exposure
light spectrum
reproductive hormones
women
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.

Detailed description: Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be exposed for 45' to white-appearing or red LED light (sequential allocation). The white light has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10 lux. Blood and saliva samples were collected before, in the middle, and during the last minutes of the 45' exposure to be measured later for concentration of luteinizing hormone, follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and melatonin (the last one - in saliva) as well-studied indicators of the direct effect of light.

Eligibility criteria: Inclusion Criteria:

* age 18-45 y
* normal (21-35 days) menstrual cycle
* good and stable general health
* normal body weight index 18.5-29.9
* normal sleep-wake regimen
* living close to the laboratory (\<7' by walk)
* "good"cubital veins

Exclusion Criteria:

* difficulty to contact
* travel over several time zones during last month
* medications known to interfere with hormone release

Primary outcomes:
measure: Reproductive hormones concentration
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Institute of Internal Medicine SB RAMS
Study officials:
affiliation: Institute of Internal Medicine SB RAMS
name: Konstantin V Danilenko, MD
role: STUDY_CHAIR
affiliation: Institute of Internal Medicine SB RAMS
name: Oksana Y. Sergeeva, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02281305: Post-MI PET Scan Imaging of Inflammation
Official title: Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: G.Gennimatas General Hospital
Sponsor class: OTHER
Collaborators: name: Academy of Athens
First posted: 2014-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.


Eligibility criteria: Inclusion Criteria:

* The study will enroll patients 18 years old or older
* Who presented to the hospital within twelve (12) hours of the onset of chest pain -Who had ST segment elevation \> 1 mm in two contiguous limb leads or ST segment elevation \> 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.

Exclusion Criteria:

* Excluded patients:

  * with age \> 80 years old
  * with active inflammatory diseases, infectious diseases or known malignancy
  * under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
  * with known hypersensitivity-allergy to colchicine
  * under chronic treatment with colchicine
  * with severe renal failure (eGFR \< 30 ml/min/1.73 m2)
  * with hepatic failure (Child - Pugh class B or C)
  * presented with cardiac arrest
  * presented with ventricular fibrillation
  * presented with cardiogenic shock
  * with stent thrombosis
  * with angina within 48 hours before infarction
  * with previous myocardial infarction in the affected territory
  * with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)

Primary outcomes:
measure: Degree of inflammation of the involved myocardium as assessed by the PET scan
timeFrame: 5 days post-MI
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens General Hospital "G. Gennimatas"
state: Attika
Study officials:
affiliation: Biomedical Research Foundation of Academy of Athens
name: Constantinos Anagnostopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Athens General Hospital "G. Gennimatas"
name: Christos Angelidis, MD
role: PRINCIPAL_INVESTIGATOR
References: