louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02926586: Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
Official title: Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
Core-Binding Factor
Keywords: RUNX1-RUNX1T1
CBFβ-MYH11
fludarabine
cytarabine
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with core-binding factor acute myeloid leukemia

Detailed description: The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).

Eligibility criteria: Inclusion Criteria:

* Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
* In status of complete remission after one to two courses of induction therapy
* Total bilirubinic acid ≤ 35μmol/L, AST/ALT\<2 times abnormal level, serum creatinine \< 1.5mg/ml
* Cardiac function: EF ≥ 50%
* Hydroxyurea can be used for patient with white blood cell count ≥ 50\*109/L
* ECOG (Eastern Cooperative Oncology Group) score: ≤ 2

Exclusion Criteria:

* Relapsed/refractory AML
* Serious liver/ kidney dysfunction
* Cardiac function level: 2 above
* Female in pregnancy or lactation
* With serious infection diseases or other diseases
* Not obey the principle of clinical study

Primary outcomes:
measure: Percentage of participants with disease recurrence
timeFrame: one year
Secondary outcomes:
measure: Percentage of Participants in survival
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xianmin Song
state: Shanghai
Study officials:
affiliation: Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang
name: Xianmin Song, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05542186: Immediate Effects of Kinesio Taping on Pain and Postural Stability in Persons With Discogenic Low Back Pain.
Official title: Immediate Effects of Kinesio Taping on Pain and Postural Stability in Persons With Discogenic Low Back Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Discogenic LBP is the leading cause of disability worldwide. Eventhough other types of Chronic LBP are more common, 63% of all patients reporting to tertiary care hospital with LBP are discogenic in nature. However, immediate effects of kinesio-taping on pain and postural stability in discogenic low back pain has not been well documented in existing literature. This study is focused on immediate effects of kinesiotaping on pain and postural stability in persons with discogenic low back pain.


Eligibility criteria: Inclusion Criteria:

* Participants in an age range of 20-65 years will be considered for this study.
* Participants with disc bulge, herniation or prolapse indicate by MRI.
* Positive straight leg raise (SLR) Positive centralization and peripheralization phenomenon.
* Participants with MRI findings conclusive of disc pathology will be included.

Exclusion Criteria:

-

Primary outcomes:
measure: Pain Pressure Threshold
timeFrame: 1 day
measure: Back Pain
timeFrame: 1 day
measure: Postural Stability
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University
Study officials:
affiliation: FUI
name: Bisma Mazhar, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: FUI
name: Muhammad Osama, PhD*
role: STUDY_CHAIR
References:
Clinical trial NCT02929186: Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
Official title: Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Colon
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 314
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).

Detailed description: This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:

1. Opt-In - subject must actively choose to receive a home FIT kit.
2. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

Eligibility criteria: Inclusion Criteria:

* Between 50 to 74 years old
* Has received care at the Division of Internal Medicine
* Due for screening
* Asymptomatic for colorectal cancer (CRC)

Exclusion Criteria:

* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
* Has a history of CRC
* Has a history of other GI cancer
* Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
* Has history of colitis other than Crohn's disease or ulcerative colitis
* Has had a colectomy
* Has a relative that has been diagnosed with CRC
* Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
* Has been diagnosed with Familial Adenomatous Polyposis (FAP)
* Has iron deficiency anemia
* Has history of lower GI bleeding
* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has cirrhosis
* Has heart failure
* Has dementia
* Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Primary outcomes:
measure: FIT Completion Rate
timeFrame: 3 months
Secondary outcomes:
measure: Mail/Electronic Message Engagement
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Chyke Doubeni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04669886: Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
Official title: Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nephrolithiasis
Urosepsis
Keywords: endotoxin
fever
infectious complications
endourology
percutaneous nephrolithotomy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for PCNL as surgical treatment for their kidney stones at Jackson and the University of Miami Hospitals.

Brief summary: The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.


Eligibility criteria: Inclusion Criteria:

* Adults that is able to consent (≥ 18 years of age)
* Scheduled to undergo PCNL at Uhealth tower and Jackson Memorial Hospitals
* not currently immunosuppressed \[White blood count (WBC) \>= 2, not on immunosuppressive medications\]

Exclusion Criteria:

* unable to consent and \< 18 years of age
* currently immunosuppressed (WBC \< 2, not on immunosuppressive medications)

Primary outcomes:
measure: Number of participants at each endotoxin activity level after surgery.
timeFrame: Day 1 (within 30 minutes postoperative)
measure: Corelation of endotoxin activity level with post-operative infectious complication
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hemendra N Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07018986: The MIND-BC Study: MIND Diet for Breast Cancer Cognition
Official title: The MIND-BC Study: MIND Diet for Breast Cancer Cognition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-06-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This fully, powered efficacy RCT, the MIND diet for Breast Cancer Cognition (MIND-BC), will evaluate the MIND diet in a rigorous, highly controlled academic cancer center. We will recruit breast cancer survivors reporting CRCI with a MIND diet score \< 8, based on a previously devised 14-item diet questionnaire designed to detect inadequate diet with respect to brain health (scores range from 0 to 14, with lower scores indicating a less adequate diet).14 Breast cancer survivors will have recently completed adjuvant treatment (i.e., 6 months to three years previously), to ensure that perceived cognitive impairment is likely chronic and due to cancer. To achieve maximal effect, the study consists of two 12-week phases 1) intervention phase, 2) maintenance phase.


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with stage I-III breast cancer.
* Able to speak and read English.
* Able to consume foods orally.
* \>18 years of age.
* Able to provide informed consent.
* Have no documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., schizophrenia).
* Report 'somewhat' to 'very much' cognitive impairment in the past week (i.e., a score ≥ 3 on a 1-5 scale) that they attribute to cancer or its treatment.
* Report a MIND diet score \< 8 (range 0 to 14, higher score equates to higher diet quality).
* Willing to consume the MIND diet.
* Completed adjuvant treatment 6 months to three years previously.

Exclusion Criteria:

* Not meeting all of the inclusion criteria.

Primary outcomes:
measure: Efficacy of the MIND diet: Self-reported cognition
timeFrame: At 12 weeks and 3 months
Secondary outcomes:
measure: Efficacy of the MIND diet: Fatigue
timeFrame: At 12 weeks and 3 months
measure: Efficacy of the MIND diet: Quality of life (QOL) and mood
timeFrame: At 12 weeks and 3 months
measure: Efficacy of the MIND diet: Objective cognition
timeFrame: At Baseline, 12 weeks, and 3 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Sylvia Crowder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04106063: A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Official title: A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Pediatric
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 154
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Children between 7 and 17 years old attending medical appointment for temporary or persistent deafness in our ENT department

Brief summary: Deafness significantly affects several auditory tasks of everyday life in children: understanding speech in quiet and noisy environments, spatial location of sounds ...

These difficulties in locating sound sources are often ignored by parents and underestimated by children. Nowadays we there is specific tools to evaluate these problems in children. Indeed, there is a validated French questionnaire (Speech and Spatial Questionnaire SSQ) for adults that evaluates auditory abilities, including sound localization, in different tasks of daily life. Although robust, this questionnaire includes 49 questions and is too long for daily use in consultation. For this reason, Moulin et al validated in 2018 a short version of the SSQ questionnaire for adults with only 15 items.

Based on this model, the aim of this study is to develop and test a paediatric questionnaire with 12 items to assess more specifically auditory difficulties in deaf children. This questionnaire will follow the validated frame of the adult SSQ questionnaire and will consist of three subscales: speech hearing (4 items), spatial hearing (4 items), and qualities of hearing (4 items). These 3 subscales are identical to those defined in long and short form pf the adult SSQ questionnaire.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 7-17 (inclusive)
* Attending medical appointment for temporary or persistent deafness
* Able to understand the experimental instructions

Exclusion Criteria:

none-

Primary outcomes:
measure: KID SSQ12 questionnaire score
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: ENT departement, Edouard Herriot Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric TRUY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02322463: Ethnicity and Analgesic Practice in a Pediatric Emergency Department
Official title: Ethnicity and Analgesic Practice in a Pediatric Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Limb Fracture
Keywords: patients who were admitted to the pediatric ED
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 5000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014

Brief summary: Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture.

Detailed description: Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture .

Eligibility criteria: Inclusion Criteria:

-Any patient with a limb fracture

Exclusion Criteria:

* Multi trauma patients
* Patients with unidentified ethnicity

Primary outcomes:
measure: Rate of oxycodone treatment by the nursing staff
timeFrame: At triage up to 1 hour after admission at the recpetion desk
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: ITAI Shavit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shavit I, Brumer E, Shavit D, Eidelman M, Steiner IP, Steinberg C. Emergency Department Pain Management in Pediatric Patients With Fracture or Dislocation in a Bi-Ethnic Population. Ann Emerg Med. 2016 Jan;67(1):9-14.e1. doi: 10.1016/j.annemergmed.2015.07.497. Epub 2015 Sep 3.
Clinical trial NCT00861263: The Clinical Utility of Overtube Use at the Time of Endoscopy
Official title: The Clinical Utility of Overtube Use at the Time of Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Bowel Visualization
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.


Eligibility criteria: Inclusion Criteria:

1. Subjects ≥ 18 years.
2. Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel.
3. Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
4. Subject must be able to give informed consent.

Exclusion Criteria:

1. Platelets \< 75,000.
2. INR \> 1.6.
3. NSAIDS within 48 hours of procedure.
4. Pregnancy.
5. Esophageal stricture.
6. Inability to give informed consent.

Primary outcomes:
measure: Number of Patients With Persistent or Recurrent Bleeding
timeFrame: up to 6 yrs after after the endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at UF
state: Florida
Study officials:
affiliation: University of Florida, Division of Gastroenterology
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williamson JB, Judah JR, Gaidos JK, Collins DP, Wagh MS, Chauhan SS, Zoeb S, Buscaglia JM, Yan H, Hou W, Draganov PV. Prospective evaluation of the long-term outcomes after deep small-bowel spiral enteroscopy in patients with obscure GI bleeding. Gastrointest Endosc. 2012 Oct;76(4):771-8. doi: 10.1016/j.gie.2012.05.025. Epub 2012 Jul 7.
citation: Judah JR, Collins D, Gaidos JK, Hou W, Forsmark CE, Draganov PV. Prospective evaluation of gastroenterologist-guided, nurse-administered standard sedation for spiral deep small bowel enteroscopy. Dig Dis Sci. 2010 Sep;55(9):2584-91. doi: 10.1007/s10620-010-1335-x. Epub 2010 Jul 15.
Clinical trial NCT02986763: Evaluation of Pesticide Exposure in the General Population
Official title: Evaluation of Pesticide Exposure in the General Population: Use of Spatial, Environmental, Toxicological and Biological Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pesticide Poisoning
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Cancéropôle Lyon Auvergne Rhône-Alpes
name: International Agency for Research on Cancer
name: Rovaltain Research Company
name: Centre de rechercher en Cancérologie de Lyon
First posted: 2016-12-08
Enrollment: 166
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers living in the Beaujolais region (France)

Brief summary: An association has been suggested with several diseases including cancer and IARC has classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a better characterisation of environmental pesticides exposures and identification of suitable biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen epidemiological hypotheses on the association with several cancer types.

The main objective of the project is to validate a GIS (geographic information system) based method to assess environmental pesticide exposures, using environmental (contamination of housedust) and biological (blood and urine samples) measures. The project aims further to investigate a potential link between housedust contamination and biological measures in healthy non-smoking male residents and explore the impact of environmental pesticide exposure on metabolomics, transcriptomic and epigenetic parameters.

Detailed description: The project involves a pilot phase involving repeated (twice) sampling in 20 male non-smoking volunteers living in the Beaujolais region (France) to perform appropriate calibrations for metabolomic, transcriptomic and epigenetic analyses. The main study will be conducted in a sample of 150 male non-smoking volunteers and 50 professional pesticides applicators from the same region (3 sampling periods).

Eligibility criteria: Inclusion Criteria:

* Non smokers in the last two years Living in the Beaujolais region (France) within 1000m of vignards Informed consent signed

Exclusion Criteria:

* Volunteers sharing the same households with professional applicators of pesticides

Primary outcomes:
measure: level of pesticide exposures
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: