louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01290107: Biomarkers in Samples of Bone Marrow From Patients With Acute Myeloid Leukemia
Official title: MLL Rearrangements in Acute Myeloid Leukemia: A Pilot Project to Expand and Study MLL-ENL in NOD SCID Gamma Mice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities
childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-04
Enrollment: 9
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia.

Brief summary: RATIONALE: Studying samples of 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 is looking at bone marrow samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To successfully transplant human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells.
* To harvest the cells and use chromatin immunoprecipitation (ChIP) methods to identify the locations of the protein complexes on the genome.
* To study the interactions of the Super Elongation Complex (SEC) and Dot1 Complex (DotCom) complexes in human leukemia samples.
* To compare the genomic targets of the complexes formed by MLL-ENL chimeras to non-MLL-rearranged leukemia samples to normal controls.

OUTLINE: Cryopreserved cells are implanted into NOD SCID gamma mice, expanded, harvested, and studied by chromatin immunoprecipitation (ChIP) methods (using antibodies to ENL, Af9, and AF10). Results are then analyzed by PCR, DNA sequencing, and/or microarray analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved mixed-lineage leukemia (MLL) ENL AML rearrangement cells, normal karyotype and non-MLL rearrangement AML cells, and non-leukemic bone marrow samples from the COG tissue bank

  * 3 specimens of each type

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells
Secondary outcomes:
measure: Identification of the locations of the protein complexes
measure: Interactions of the SEC and DotCom complexes in human leukemia samples
Other outcomes:
Locations:
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Eric Guest, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05998707: The Application of the New Magnetic Resonance UTE Technique in Thoracic Lesions
Official title: The Application of the New Magnetic Resonance Technique-UTE in Thoracic Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases
Keywords: Lung mass, UTE, ZTE, nodule, MRI
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who meet the inclusion criteria.

Brief summary: Quantitative characteristic values of lung lesions were obtained by UTE technique, so as to make qualitative diagnosis of benign and malignant lesions. And to explore the clinical feasibility of CT-like technology - high resolution ZTE technology in the diagnosis of pulmonary diseases.

Detailed description: Ultrashort echo time (UTE) sequence can obtain data from T2\* for lung imaging before T2\* decays in lung parenchyma with extremely short echo time, which makes up for the defect that conventional MRI cannot clearly display short T2 tissue imaging, and can provide more supplementary information for lung CT scan. There has been a lot of research progress in the evaluation of neonatal lung disease, chronic obstructive airway disease and pneumonia. The 3D UTE sequence developed on this basis has made great progress in improving the resolution, signal-to-noise ratio and shortening the scanning time of lung MR Images, and has successfully obtained submillimeter high-resolution images. The purpose of this study was to explore the value of MRI ultra-short echo technology in the qualitative diagnosis of benign and malignant lung lesions, and to explore the clinical application of CT-like technology - high resolution ZTE technology in the lung.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. There are lung lesions, and the solid component is ≥6mm;
3. Chest CT plain scan or /+ enhanced examination within 4 weeks.

Exclusion Criteria:

1. There are metal implants in the corresponding parts of the chest;
2. MRI contrast agent allergy;
3. Claustrophobia;
4. Pregnant women;
5. High fever;
6. Respiratory failure;
7. Lung lesion biopsy within 4 weeks prior to examination.

Primary outcomes:
measure: proton density fat fraction (PDFF)
timeFrame: baseline (before surgery)
measure: T2 relaxation rate
timeFrame: baseline (before surgery)
measure: Magnetization Transfer Ratio (MTR)
timeFrame: baseline (before surgery)
Secondary outcomes:
measure: Subjective rating
timeFrame: baseline (before surgery)
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Radiography department
state: Guangdong
Study officials:
affiliation: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Shaolin Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT04385407: Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
Official title: Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Virus Infection
Keywords: Egyptian patients
HCV GT4
Naive
Ribavirin
Simeprevir
Sofosbuvir
Experinced
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

Detailed description: A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Eligibility criteria: Inclusion Criteria:

* Participants with plasma HCV RNA level \>10,000 IU/L for the two groups.
* Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
* Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion Criteria:

* coinfected with hepatitis B virus or human immunodeficiency virus infection,
* any cause of liver disease other than HCV GT4 infection;
* liver decompensation,
* hepatocellular carcinoma,
* major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C \>9)
* Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count \<50,000 cells/mm3)

Primary outcomes:
measure: Percentage of Participants With HCV 12
timeFrame: 12 weeks after last dose
measure: Number of Participants With Adverse Events
timeFrame: up for 12 weeks after planned EOT.
Secondary outcomes:
measure: Percentage of Participants With Virologic relapse
timeFrame: 12 weeks after the last dose
measure: Percentage of Participants With Virologic null response
timeFrame: 24 or 36 weeks stating from the first dose
Other outcomes:
Locations:
Study officials:
References:
citation: Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Elbary AAA, Ramadan M. Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4. Ann Gastroenterol. 2019 Jan-Feb;32(1):93-98. doi: 10.20524/aog.2018.0327. Epub 2018 Nov 24.
Clinical trial NCT01210807: Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)
Official title: Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.


Eligibility criteria: Inclusion Criteria:

* bilateral cataracts and otherwise healthy eyes
* visual potential of Decimal 0.8 in each eye

Exclusion Criteria:

* any medications affecting vision
* any chronic disease/illness that would affect risk to subject or outcomes of the study
* any ocular pathology/abnormalities that may affect visual outcomes or confound study results
* desire for monovision

Primary outcomes:
measure: Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
timeFrame: 4-6 Months
Secondary outcomes:
measure: Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
timeFrame: 4-6 months
Other outcomes:
Locations:
Study officials:
name: Peter Szurman, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06634407: Outcome of Transcatheter Closure of Patent Ductus Arteriosus in Pediatric Cardiology Unit in 3 Years Duration
Official title: Transcatheter Closure of Patent Ductus Arteriosus. Experience of Pediatric Cardiology Unit-Assiut University Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patent Ductus Arteriosus (PDA)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transcatheter Closure of Patent Ductus Arteriosus to evaluate the outcome of percutaneous transcatheter closure of patent ductus arteriosus in children


Eligibility criteria: Inclusion Criteria:

* Children with Patent Ductus Arteriosus confirmed by echocardiography
* aged from 6 months to 16 years underwent percutaneous transcatheter PDA closure at Pediatric Cardiology Unit.

Exclusion Criteria:

* Children with PDA younger than 6 months or older than 16 years and that are not candidate for transcatheter closure .

Primary outcomes:
measure: outcome of trancathter PDA closure
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02051907: Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis
Official title: A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiation Dermatitis
Lead sponsor: Kamedis Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.


Eligibility criteria: Inclusion Criteria:

* Female above 18 years of age
* Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
* Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
* Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
* Minimum of 3 weeks from chemotherapy to start of radiation therapy.
* Patient agrees to use only the test products during the study period

Exclusion Criteria:

* Tumor involvement of the skin
* Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
* Patient has a previous history of allergy to the ingredients of the tested formulations
* Paget's disease of the nipple.
* Pregnant or lactating females

Primary outcomes:
measure: Changes in Radiation dermatitis symptoms
timeFrame: Day 0, weeks 2, 4, 6.5, 8.5
Secondary outcomes:
measure: Subjects' self evaluation
timeFrame: Day 0, weeks 2, 4, 6.5, 8.5
measure: Number of Adverse Events
timeFrame: Day 0, weeks 2, 4, 6.5, 8.5
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sourasky Medical Center
name: Diana Matchiavsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05435807: Therapeutic Neuroscience Education in Individuals With Fibromyalgia
Official title: Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of Therapeutic Neuroscience Education (TNE) in individuals with Fibromyalgia (FM). The study included 25 females with FM, randomly separated into two groups as the intervention group (Clinical Pilates Exercises+TNE, n=11) and the control group (Clinical Pilates Exercises, n=14).


Eligibility criteria: Inclusion Criteria:

* age between 18-65 years,
* female gender,
* a VAS of at least 40mm to report the pain intensity of the last week,
* having been diagnosed with FM for at least 1 year to present a range of somatic and cognitive symptoms in addition to widespread pain,
* using a fixed dose of medication for at least the past 6 months (serotonin noradrenaline reuptake inhibitors \[Ex, duloxetine, milnacipran\]; alpha 2-delta receptor ligand \[Ex, pregabalin\]; gabapentinoids).

Exclusion Criteria:

* the presence of another disease which may affect the physical condition,
* cognitive impairment at a level preventing cooperation,
* being pregnant,
* inability to understand or speak Turkish,
* concurrent autoimmune or inflammatory disease,
* the presence of a central nervous system disease (eg multiple sclerosis, Parkinson's disease),
* serious psychiatric conditions (eg, psychotic disorders) that would prevent participation,
* participation in a rehabilitation program in the past year,
* have been exercising regularly for 6 months,
* not participating in at least 75% of treatments.

Primary outcomes:
measure: Fibromyalgia Impact Questionnare
timeFrame: 10 min
measure: Visual Analogue Scale
timeFrame: 5 min
measure: Widespread Pain Index
timeFrame: 10 min
measure: Symptom Severity Scale
timeFrame: 7 min
measure: Brief Pain Inventory
timeFrame: 7 min
measure: Pain Catastrophizing Scale
timeFrame: 10 min
measure: Tampa Scale for Kinesiophobia
timeFrame: 10 min
Secondary outcomes:
measure: Biopsychosocial Questionnaire
timeFrame: 10 min
measure: Dynamic Loewenstein Occupational Therapy Cognitive Assessment
timeFrame: 1 hour
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Merkezefendi
Study officials:
affiliation: Pamukkale University
name: Bilge Basakcı Calık, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Ummuhan Bas ASLAN, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Uğur Karasu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00571207: Oral Fluid Screening Devices
Official title: Scientific Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-impaired Driving
Keywords: driving under the influence of drugs
on-site oral fluid screening devices
checklist
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Hospital District of Helsinki and Uusimaa
name: European Commission
First posted: 2007-12-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Drivers suspected of driving under the influence of drugs. Also drivers who are not suspected of driving under the influence.

Brief summary: This research includes the evaluation of a checklist and on-site screening devices to pre-select drivers suspected of being drug-impaired. The reliability of a limited number of promising on-site screening devices will be investigated. The devices tested will have to be promising regarding both reliability and practicality. In addition to the scientific evaluation of the checklist and the oral fluid screening devices, the time consumption of the selection procedure as a whole (checklist + oral fluid screening) will be evaluated.

Outcome of the study will be recommendations for the roadside selection procedure of drivers suspected of drug-related impairment. The recommendations will concentrate on the reliability of the selection procedure.

The study is part of an EU project DRUID. Two other countries in Europe take part to this study along with Finland.


Eligibility criteria: Inclusion Criteria:

* Drivers of motorised vehicles
* 18 years or older
* Willing to participate

Exclusion Criteria:

* Younger than 18
* Not willing to participate

Primary outcomes:
measure: scientific evaluation of the on-site oral fluid screening devices
timeFrame: three years
Secondary outcomes:
measure: evaluation on the police checklist
timeFrame: three years
measure: the time consumption of the selection procedure as a whole (checklist + oral fluid screening)
timeFrame: three years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Public Health Institute
Study officials:
affiliation: National Public Health Institute
name: Pirjo Lillsunde, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05759507: Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy
Official title: Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy :a Retrospective Study Between 2014 and 2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Pregnancy Complications
Pregnancy Related
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women going through pregnancy with no limitation of age

Brief summary: About 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis.

Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late.

The management of these patients is therefore complex and the literature is poor on the subject.

Detailed description: In the CHRU of Nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy.

The aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.'

The aim is also to describe the consequences of the surgery and analyse the end of the pregancy

Eligibility criteria: Inclusion Criteria:

* Women going through pregnancy

Exclusion Criteria:

-

Primary outcomes:
measure: Number of patients with no mistakes from the diagnosis to the surgery.
timeFrame: 1 year
Secondary outcomes:
measure: Impact on pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale et Universitaire de Nancy
state: Meurthe-et-moselle
Study officials:
References: