louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00439920: GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
Official title: GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2007-02-26
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.

Detailed description: The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated.

This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.

Eligibility criteria: Inclusion Criteria:

* Patients aged 16-60
* Diagnosed with previously untreated T-ALL and B-ALL

Exclusion Criteria:

* previously treated ALL patients
* L3 B-ALL

Primary outcomes:
measure: Number of patients with complete response
Secondary outcomes:
measure: Number of patients that reach disease-free-survival
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi di Roma "La Sapienza"
name: Franco Mandelli, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
Clinical trial NCT03498820: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use
Official title: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anesthesia
Keywords: Analgesia-Nociception Index (ANI)
General anesthesia
Opioids
Remifentanil
Pain
Monitoring
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.


Eligibility criteria: Inclusion Criteria:

* Elective gynecological surgery under general anesthesia
* Duration of surgery 1-7 hours
* Duration of hospital stay \> 24 hours

Exclusion Criteria:

* chronic pain
* chronic analgesic medication
* neurologic disease
* psychiatric disease
* history of addiction
* kidney or liver failure
* allergy to any anesthetic or analgesic drug
* BMI \> 35

Primary outcomes:
measure: Intraoperative remifentanil consumption
timeFrame: up to 7 hours after the beginning of general anesthesia
Secondary outcomes:
measure: Postoperative morphine consumption
timeFrame: obtained 24 hours after the end of general anesthesia
measure: Persistent pain
timeFrame: : obtained one month after surgery
measure: Persistent pain
timeFrame: Obtained three months after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nada SABOURDIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00494520: Cognitive Therapy to Improve Word Finding
Official title: Learning Paradigms in Aphasia Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anomia
Aphasia
Traumatic Brain Injury
Cerebrovascular Accident
Keywords: Anomia
Aphasia
Traumatic Brain Injury
Cerebrovascular Accident
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2007-06-29
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.

Detailed description: Difficulty finding words is common in patients with aphasia subsequent to left hemisphere stroke. This study will compare two cognitive therapies for the treatment of acquired word finding difficulties. The therapies use different types of cues. All participants will receive both therapies. Participants in this study will undergo a comprehensive and detailed assessment of language and other cognitive skills. The two treatments will be compared for their efficacy.

Eligibility criteria: Inclusion Criteria:

* Word finding difficulty subsequent to stroke, traumatic brain injury, brain surgery or other brain damage occuring at least 6 month prior to participation
* Ability to attend 2 sessions per week for several months at Georgetown University in Washington, DC

Exclusion Criteria:

* History of learning disabilities
* Best corrected vision less than 20/40
* Corrected hearing within functional limits
* Less than 10 years formal education
* Significant memory or comprehension problems

Primary outcomes:
measure: Improved picture naming of trained words.
timeFrame: Following conclusion of word treatment.
Secondary outcomes:
measure: Improved picture naming of trained words.
timeFrame: At 6 months after conclusion of word treatment
measure: Improved picture naming of untrained words.
timeFrame: Following conclusion of word treatment.
measure: Improved picture naming of untrained words.
timeFrame: At 6 months after conclusion of word treatment
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Rhonda B. Friedman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02262520: Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
Official title: Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: N/A - Healthy Subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2014-10-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.


Eligibility criteria: Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations

Exclusion Criteria:

• Any significant acute or chronic medical illness, history of important arrhythmias, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years

Primary outcomes:
measure: Apixaban and Digoxin plasma concentration
timeFrame: Days 8-21
Secondary outcomes:
measure: Safety and Tolerability based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, electrocardiograms, digoxin concentrations,and clinical laboratory tests
timeFrame: Days 1-22
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00523120: Topical Voltaren in Otitis Externa
Official title: Topical Voltaren as an Alternative Treatment for Otitis Externa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Otitis Externa
Lead sponsor: Sieff Medical Center
Sponsor class: OTHER
First posted: 2007-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

Detailed description: anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

Eligibility criteria: Inclusion Criteria:

* Adults having otitis externa as single diagnosis mild to moderate

Exclusion Criteria:

* Diabetes
* Children
* Pregnant women
* Immune compromise
* Starting other treatment
* Moderate to severe otitis externa

Primary outcomes:
measure: reducing oral analagestic use
timeFrame: 1 week
Secondary outcomes:
measure: adding an alternative treatment for otitis externa
timeFrame: 1 week
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Sieff Medical Center
Study officials:
affiliation: Sieff Medical Center, Safed, ISRAEL
name: victor kizhner, m.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05447520: Montelukast Use in Rheumatoid Arthritis
Official title: Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators.

Considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. Therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csDMARDs in RA patients with moderate and high disease activity.


Eligibility criteria: Inclusion Criteria:

* Adult patients ages ≥ 18 years old.
* Patients diagnosed with RA according to American College of Rheumatology/European league Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \>3.2.
* Patient received stable regimen of one or more csDMARDs for at least the past 3 months.

Exclusion Criteria:

* Patient taking biological DMARDs.
* Known hypersensitivity to montelukast.
* Patients receive montelukast for any other indications.
* Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits).
* Patients with impaired kidney (estimated glomerular filtration rate (eGFR) \< 30 ml/min).
* Pregnancy and lactation.
* Patients with active or severe infections.
* Patients with other inflammatory or autoimmune diseases and malignancies.
* Patients with any psychiatric disorder.
* Patients taking IV, IM, orally (dose \> 10 mg daily) or intra articular corticosteroides,
* Smokers.

Primary outcomes:
measure: Disease activity score in 28 joints (DAS-28)
timeFrame: 16 weeks
Secondary outcomes:
measure: Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: Noha Mansour
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00074620: A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
Official title: A Randomised, Multicenter, Open-Label, Parallel Group Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis Via an Arteriovenous Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Failure
Vascular Graft Occlusion
Keywords: Haemodialysis
PEG-Hirudin
Vascular graft occlusion
Renal replacement therapy
Hemodialysis
Lead sponsor: Speedel Pharma Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2003-12-19
Enrollment: 260
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.


Eligibility criteria: * Patients undergoing chronic haemodialysis via an arteriovenous graft
* Arteriovenous graft in place for at least 3 months
* Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session
* Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception
* Women patients must have a negative serum pregnancy test within one week of randomisation
* Able to provide written informed consent prior to study participation

Primary outcomes:
measure: To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.
Secondary outcomes:
measure: To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital - Franklin Dialysis Center
state: Pennsylvania
Study officials:
affiliation: Speedel Bio Ltd
name: Jessica M Mann, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02997020: Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)
Official title: Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: CRS
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be derived from those patients presenting to UAB for endoscopic evaluation of CRS, or who present for standard-of-care sinus or skull base surgery.

Brief summary: The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease.

Detailed description: The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease. This assay provides a means to measure Cl- secretion across the sinus epithelium in human subjects with chronic rhinosinusitis (CRS) and test the relationship between this data and endoscopic findings of inflammation. The technique is appropriate for investigating acquired CFTR dysfunction in sinus epithelium and examining the therapeutic potential of CFTR potentiators for CRS.

Eligibility criteria: Patient eligibility criteria are designed to limit enrollment otherwise healthy individuals who are scheduled for standard-of-care nasal endoscopy in the clinic or sinus/skull base surgery.

Inclusion criteria:

* Age \> 18 years
* Able to give consent
* A diagnosis of CRS, as determined by the Sinus and Allergy Health Partnership criteria
* Has cultured out at least one gram negative bacteria (e.g. Pseudomonas aeruginosa, Escherichia coli, Stenotrophomonas maltophila) within the previous month
* Is scheduled for either routine endoscopic surgery or has previously undergone endoscopic surgery and presents to clinic for routine endoscopic evaluation

Exclusion criteria:

* Age \< 18 years
* Unable to give consent
* Active diagnosis of cancer, autoimmune disease, or any know immunodeficiency
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Ability to measure CFTR difference using EDSPD testing
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Brad Woodworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05961020: Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
Official title: Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the Effect of whole-body vibration on insulin resistance in obese postmenopausal women

Detailed description: The prevalence of obesity has tripled over the past four decades, imposing an enormous burden on people's health.

Obesity is associated with premature mortality and is a serious public health threat that accounts for a large proportion of the worldwide non-communicable disease burden, including type 2 diabetes, cardiovascular disease, hypertension, and certain cancers.

reported that "Whole-body vibration (WBV) training has been established as a useful method to improve physical fitness in obese individuals. Vibration stimulus during half squatting might suggest a long-term effect of WBV on the endocrine system. Therefore, in this study, The aim to investigate the effect of whole-body vibration on insulin resistance in obese postmenopausal.

Eligibility criteria: Inclusion Criteria:

* All women were postmenopausal with no menses at least 1 year.
* Their ages were ranged from 50-60 years old.
* Their body mass index (BMI) \> 30 kg/m2.
* They were not engaged in any other treatment program.

Exclusion Criteria:

* Women with body mass index (BMI) \< 30 kg/m2.
* Any cardio-respiratory diseases.
* Diabetes mellitus.
* with malignancy.
* with severe hemorrhage, acute viral disease and mental disorders.
* Smokers.
* Women with life threatening disorders as renal failure

Primary outcomes:
measure: The Homeostatic model assessment (The HOMA-IR).
timeFrame: up to 3 months
measure: BMI
timeFrame: up to 3 months
measure: Waist circumference
timeFrame: up to 3 months
measure: Skin fold thickness
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kerolous Ishak Shehata kelini
Study officials:
References:
Clinical trial NCT01361620: Genotypic and Phenotypic Correlates of Resistance to Aspirin
Official title: Genotypic and Phenotypic Correlates of Resistance to Anti-platelet Actions of Aspirin in an At-risk Patient Population and in the General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Dysfunction Due to Aspirin
Keywords: genomic markers
aspirin resistance
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 190
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study seeks to identify genomic markers associated with aspirin resistance.

Detailed description: Not desired

Eligibility criteria: Inclusion Criteria:

* Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.

Exclusion Criteria:

* Patient requiring more than 81 mg aspirin daily
* Known GI bleeding attributed to ASA
* Active peptic ulcer disease or history within the last year
* Known aspirin allergy
* Current use of:

  * warfarin,
  * heparin,
  * NSAIDs (except aspirin),
  * clopidogrel,
  * dipyridamole,
  * fish-oil/omega 3 supplements,
* Women of childbearing potential who are pregnant, planning to become pregnant or nursing.

Primary outcomes:
measure: Whole Blood Coagulation
timeFrame: Single measurement at 7-10 days after beginning aspirin
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: GWU Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: GWU Medical Faculty
name: Jonathan Reiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fallahi P, Katz R, Toma I, Li R, Reiner J, VanHouten K, Carpio L, Marshall L, Lian Y, Bupp S, Fu SW, Rickles F, Leitenberg D, Lai Y, Weksler BB, Rebling F, Yang Z, McCaffrey TA. Aspirin insensitive thrombophilia: transcript profiling of blood identifies platelet abnormalities and HLA restriction. Gene. 2013 May 15;520(2):131-8. doi: 10.1016/j.gene.2013.02.032. Epub 2013 Feb 27.